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The HemiCAP™ Patello-femoral Resurfacing Prosthesis is intended to be used in cemented arthroplasty in patients with osteoarthritis limited to the distal patello-femoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.

The HemiCAP™ Patello-Femoral Resurfacing Prosthesis incorporates a distal femoral trochlear surface articular component that mates to a fixation stud via a taper interlock, and an allpolyethylene patella component. The prosthesis is intended to be used in cemented arthroplasty.

The femoral articular component is manufactured of a Cobalt-Chromium-Molybdenum alloy per ASTM F799 and ASTM F1537. The component has a bone contact surface that is coated with a spray-applied CP Titanium coating and a polished articular bearing surface. The fixation stud component is a short tapered cylinder, 13mm in length, manufactured of a Ti-6Al-4V ELI alloy per ASTM F136. The stud has a tapering helix, a full-length cannulation, and a proximal female taper bore. The patella prosthesis component is comprised of ultra-high-molecular weight polyethylene (UHMWPE) manufactured and tested to meet standards specified in ASTM F 648-04, Type I. The materials, manufacturing methods, and surface finish requirements for these components are identical to those used for the Sponsor's previously cleared devices (K021549, K023096, K031859, K050373).

The provided document is a 510(k) summary for the HemiCAP™ Patello-Femoral Resurfacing Prosthesis. It discusses the device's description, indications for use, and a statement regarding performance testing. However, it explicitly states that clinical data was not needed for this device as part of its substantial equivalence determination.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and the study that proves the device meets those criteria.

Specifically, the following information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not establish specific performance acceptance criteria or report on device performance against them.
2. Sample size used for the test set and the data provenance: No clinical test set data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is discussed.
4. Adjudication method for the test set: No test set adjudication is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a medical prosthesis, not an AI diagnostic tool, so an MRMC study with human readers and AI is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a prosthesis.
7. The type of ground truth used: No clinical ground truth is discussed.
8. The sample size for the training set: No training set (clinical or otherwise for an AI/diagnostic algorithm) is mentioned.
9. How the ground truth for the training set was established: Not applicable.

The document highlights Non-Clinical Performance Testing was completed as part of the Arthrosurface Design Control Procedure to demonstrate safety and substantial equivalence to predicate devices. However, details of these non-clinical tests (e.g., specific acceptance criteria, test results) are not provided in this summary. The materials and manufacturing methods are stated to be identical to those used for the Sponsor's previously cleared devices, implying reliance on the established safety and effectiveness of those predicates.

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