Studies

Performance Testing:

Since the MMSDA is a class II medical device based on a predicate device, clinical studies will not be required for regulatory approval. However, substantial equivalence testing will need to be completed to ensure that our device performance is adequate for its intended use and is comparable to the predicate device, Materialise Interactive Medical Image Control System (Mimics). This testing will help prove substantial equivalence by comparing the results of the following tests using our device with the data already obtained by the predicate device.

• Bench:

  • Mechanical/electrical engineering performance testing: tests for tensile strength, compression, wear, fatigue, stability, sterility, and electromagnetic capability (EMC) pertaining to the physical set-up of the device.

  • Software validation testing: evaluation of the device software and its performance.

• Animal: Includes biocompatibility testing if required due to the physical set-up of the device (only by FDA request).

• Human: Includes testing the device system on human tissue to determine overall device (software + physical set-up) capability and safety (only by FDA request).

Testing Timeline: