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The Foundation® Plasma Sprayed Metal-backed Patella is intended to be used as a cemented patellar surface replacement in treating patients who are candidates for primary total knee arthroplsty as a result of osteoarthritis, inflammatory arthritis, traumatic arthritis or rheumatoid arthritis with or without varus, valgus, or flexion deformities, or revision arthroplasty where bone loss is minimal. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.

The Foundation® Plasma Sprayed Metal-backed Patella has a " sombrero" shaped plastic articulating surface and a metal baseplate. The baseplate has three smooth pegs for rotational stability. The plastic component is manufactured from UHMWPe that conforms to ASTM F648. The metal baseplate is fabricated from wrought Ti-6A1-4V (ASTM F136) and is plasma sprayed with commercially pure titanium to provide a roughened surface to enhance cement fixation.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for K973672:

This 510(k) submission for the Foundation® Plasma Sprayed Metal-backed Patella relies heavily on substantial equivalence to predicate devices rather than a comprehensive clinical study to establish new acceptance criteria. The "study" described is limited to engineering performance testing. As such, many of the requested categories (especially those related to human readers, ground truth for training sets, and multi-reader multi-case studies) are not applicable or not detailed in this type of submission.

Here's the breakdown based on the provided information:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated for the "axial pushout and shear fatigue tests." The number of units tested is not provided.
   • Data Provenance: This is an in-vitro engineering test, not a clinical study involving patient data. Therefore, concepts like country of origin or retrospective/prospective do not apply. The tests were performed presumably by or for Encore Orthopedics, Inc.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. The "test set" here refers to physical devices undergoing mechanical tests, not clinical data requiring expert review.

3. Adjudication method for the test set:

   • Not Applicable. As this is mechanical testing, the "ground truth" is determined by the physical outcome of the test (e.g., whether the attachment mechanism failed, or what force it withstood), not by human adjudication.

4. 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:

   • No. This is a medical device (implant), not an AI-powered diagnostic tool. MRMC studies are not relevant here.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This is not an algorithmic device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Engineering Test Results/Physical Properties: The "ground truth" for the mechanical tests is the quantitative measurement of force/load at failure or the confirmation the device withstood specified loads without failure, compared against internal engineering specifications or industry standards for similar devices. For material conformance, the ground truth is the chemical and physical analysis results compared to ASTM standards.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of this 510(k) submission, as it does not involve machine learning or AI models.

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no training set.

Summary of the 510(k) Approach:

This 510(k) clearance is primarily based on substantial equivalence to previously cleared predicate devices. The "study" mentioned is limited to engineering bench testing (axial pushout and shear fatigue tests) to demonstrate that the specific modification (plasma sprayed coating) for cement fixation does not negatively impact the critical mechanical integrity of the baseplate-plastic assembly, and that the materials used conform to relevant ASTM standards. The core design, geometry, and intended use are argued to be identical to predicate devices. The FDA's determination letter further emphasizes the "cemented use only" limitation, which is related to the design and testing presented.

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