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The KineMatch™ Patello-Femoral Resurfacing Implant is intended to be used in patellofemoral joints with degenerative arthritis of the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery where patello-femoral joint pain, deformity, or dysfunction persists. The KineMatch™ Patello-Femoral Resurfacing Implant is intended for use with bone cement.

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This document is a 510(k) premarket notification letter from the FDA to Kinamed Incorporated for their KineMatch™ Patello-Femoral Resurfacing Implant. It states that the device has been found substantially equivalent to legally marketed predicate devices.

This document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria as requested in the prompt.

The prompt asks for details related to an AI/ML device and its performance, including:

• Acceptance criteria and reported device performance.
• Sample size and data provenance for the test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size and ground truth establishment for the training set.

Since the provided document is a 510(k) clearance for a physical medical implant (a knee joint prosthesis), it does not involve AI/ML performance studies, ground truth establishment, or human reader comparisons. Therefore, I cannot extract the requested information from this text.

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