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1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure or previous joint replacement procedure.
   The device is indicated for implantation with cement.

The Narrow Ascent™ Interlok® Femoral Components are primary femoral components intended for use with an Ascent™ tibial component and patella for total knee replacement. The device is manufactured from cast cobalt alloy (Co-Cr-Mo) conforming to ASTM F-75 with Biomet's Interlok®, 30 grit blasted finish. Three sizes, x-small, small, and medium are available in left and right configurations.
The device varies from the predicated device in that the width of the component in the medial-lateral direction has been reduced by approximately 4mm. This has been accomplished by reducing the width of each condyle by approximately 2mm. All other dimensions remain the same. A narrower femoral component is desired to avoid overhang of the device in a patient with a naturally narrow femur.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Narrow Ascent™ Interlok® Femoral Components:

Summary of Acceptance Criteria and Device Performance:

The provided document, a 510(k) premarket notification for the Narrow Ascent™ Interlok® Femoral Components, does not explicitly state specific quantitative acceptance criteria or a clinical study proving the device meets them. Instead, the basis for clearance is substantial equivalence to a previously cleared predicate device (Ascent™ Primary Interlok® Femur, K982869).

The "acceptance criteria" in this context are implicitly met by demonstrating that the modifications to the device (reduced width) do not compromise safety and effectiveness when compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not applicable. No clinical test set data was presented in this 510(k) submission for the modified device.
• Data Provenance: Not applicable. No clinical testing or data from human subjects was provided for this specific device modification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable. No clinical ground truth was established through expert evaluation for a test set, as no clinical testing was performed for the modified device.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "Clinical Testing: None provided." (Section {1})

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This device is a physical medical implant (a femoral component for knee replacement), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The "standalone performance" here refers to the device's physical and mechanical performance, which was assessed through engineering analysis.

7. The Type of Ground Truth Used:

• The "ground truth" for the modified device was based on engineering analysis (Section {1}: "Engineering analysis was provided to demonstrate that the design change would not compromise the strength of the component.") and the established safety and effectiveness of the predicate device. The FDA's substantial equivalence determination implies that the existing clinical evidence and safety profile of the original Ascent™ Interlok® Femur serve as the "ground truth" for the narrower version, given that the changes are minor and assessed as not impacting core performance.

8. The Sample Size for the Training Set:

• Not applicable. The device is a physical implant. The concept of a "training set" typically applies to machine learning algorithms. In a manufacturing context, a "training set" might loosely refer to the historical data and experience gained from manufacturing the predicate device, but it is not explicitly mentioned or quantified in this submission.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable due to the device type.

In summary, the clearance of the Narrow Ascent™ Interlok® Femoral Components was based on a demonstration of substantial equivalence to a legally marketed predicate device (Ascent™ Primary Interlok® Femur, K982869) through engineering analysis of the design change, rather than direct clinical testing of the modified device.

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