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The subject devices are single use components, intended for cemented use only. They are intended for use in conjunction with associated Duracon femoral components as part of cemented total knee replacement surgery. Indications for use, in keeping with those of other commercially-available, Class II total knee devices, are as follows:

• . Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis.
• Rheumatoid arthritis. .
• . Correction of functional deformity.
• . Revision procedures where other treatments have failed.
• . Post-traumatic loss of knee joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy.
• . Irreparable fracture of the knee.

The subject 25mm Duracon Inset Patellar Component is identical to the commercially-available Duracon Inset Patellar Components (available in sizes 27, 29, 31, and 33mm), except for its smaller diameter.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for AI/ML medical devices. The document describes a 510(k) submission for an additional size of an existing patellar component (Duracon Inset Patellar Component, 25mm).

Here's an analysis based on the information provided, highlighting why it doesn't fit the requested format for AI/ML device evaluation:

1. Acceptance Criteria and Reported Device Performance: This information is not present. The submission focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific quantitative performance metrics as an AI/ML system would. The "Performance Data" section briefly mentions "Comparative testing (simulated chair rising and stair climbing) confirmed that the wear resistance of the modified component is not significantly different from that of existing product," but no specific numerical acceptance criteria or detailed results are given.

2. Sample Size for Test Set and Data Provenance: Not applicable. This is a physical medical device (knee implant), not an AI/ML algorithm evaluated on a dataset. The "comparative testing" likely refers to mechanical stress tests on the physical component.

3. Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. Ground truth as typically defined for AI/ML (e.g., expert labels on medical images) is not relevant here.

4. Adjudication Method: Not applicable.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable. There is no AI assistance involved with human readers for this physical implant.

6. Standalone Performance: Not applicable. This is a physical implant; its "performance" would be related to its mechanical properties and biocompatibility, not an algorithm's standalone output.

7. Type of Ground Truth Used: Not applicable in the context of AI/ML evaluation. The "ground truth" for a physical implant's safety and effectiveness relies on established engineering principles, material science, and clinical outcomes data from similar devices. The comparative testing mentioned focuses on wear resistance, which would be measured directly from mechanical tests, not an "expert consensus" on data labels.

8. Sample Size for Training Set: Not applicable. There is no AI/ML model being trained.

9. How Ground Truth for Training Set was Established: Not applicable.

Summary based on the provided text:

The submission is for a physical medical device (knee implant), specifically an additional size (25mm) of an already cleared patellar component. The 510(k) process for such devices relies on demonstrating substantial equivalence to a predicate device.

The key points from the provided text are:

• Device: Duracon Inset Patellar Component, additional 25mm size.
• Predicate Device: Existing Duracon Inset Patellar Components (27, 29, 31, 33mm sizes) cleared via K961482 and K965173.
• Basis for Substantial Equivalence:
  • Identical intended use and indications for use.
  • Identical materials.
  • Identical design, except for the smaller diameter.
• Performance Data (limited details): "Comparative testing (simulated chair rising and stair climbing) confirmed that the wear resistance of the modified component is not significantly different from that of existing product." This suggests that the wear performance of the new 25mm size was found to be comparable to the existing, cleared sizes.

Therefore, the requested information about acceptance criteria, sample sizes for test/training sets, expert qualifications, and adjudication methods (which are typical for AI/ML device evaluations) are not applicable to this 510(k) submission for a physical knee implant component.

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