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SpaceFlex Knee disposable cement spacer molds are indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. The molded temporary knee prosthesis is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (G3A Bone Cement), the molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

G21 SpaceFlex Knee system are disposable cement spacer molds made of polypropylene (PP) intended to be filled with low-viscosity polymethyl methacrylate bone cement directly in the operating room. Once the bone cement has hardened, the SpaceFlex Knee system creates a polymethyl methacrylate based bone cement spacer for patients undergoing a two-stage procedure following a periprosthetic joint infection. The device can be used in either the left or right knee joint. The SpaceFlex Knee molds are single-use and cannot be re-sterilized.

The provided text describes the regulatory clearance of the G21 s.r.l SpaceFlex Knee, a disposable cement spacer mold. This device is classified as Class II and is indicated for use in molding a temporary total knee replacement for skeletally mature patients undergoing a two-stage procedure due to a septic process.

However, the provided document does not contain information about an AI/ML-based medical device study. Instead, it focuses on the substantial equivalence of a physical medical device (a knee spacer mold) to existing predicate devices, based on typical mechanical and material performance testing.

Therefore, I cannot extract the information required by your request about acceptance criteria and a study proving an AI/ML device meets those criteria, as the document details a different type of medical device and a different type of clearance process.

To answer your request, I would need a document describing the study and acceptance criteria for an AI/ML-driven medical device, not a physical orthopedic device.

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