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The Series II X3® Large Diameter Acetabular Inserts are single use sterile components, intended for use in conjunction with an associated Howmedica Osteonics metal acetabular shell, femoral bearing, and femoral hip stem as part of a cemented or cementless total hip arthroplasty.

The indications for use of total hip replacement prostheses include:

1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis.
2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
3. Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
4. Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

This Special 510(k) submission is a line extension to address modifications made to the Series II X3ª Acetabular Inserts. The modifications made to the previously cleared Series II X3® Acetabular Inserts (K052748) are as follows: new larger head sizes, an alternate 4mm lateralization (with 0 and 10 degree hood), and additional 0 degree hood design to the existing 6mm lateralization.

The provided text describes the Series II X3® Large Diameter Acetabular Inserts and seeks to establish their substantial equivalence to predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria.

The document discusses modifications to an existing device (Series II X3® Acetabular Inserts cleared under K052748) to include new larger head sizes, an alternate 4mm lateralization, and an additional 0-degree hood design. The core of the submission is to demonstrate that these modified devices are substantially equivalent to the predicate devices, thereby not requiring a new PMA.

Therefore, there is no specific acceptance criteria or a study proving the device meets those criteria in the sense of a clinical trial or performance evaluation designed to measure specific performance metrics against predefined thresholds. Instead, the "acceptance criteria" here implicitly refers to the FDA's regulatory requirement of demonstrating substantial equivalence to a legally marketed predicate device.

The study that "proves" the device meets this "acceptance criteria" (substantial equivalence) is a summary of non-clinical testing and evaluation.

Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, there are no explicit acceptance criteria or direct device performance metrics reported in the provided text in the way one might expect from a clinical trial. The "performance" is demonstrated through engineering analysis and comparison to predicate devices to establish substantial equivalence.

1) Poly thickness analysis (Series II X3 and Series II X3 % Large Diameter) 
2) Engineering analysis of locking mechanism (Series II X3® and Series II X3® Large Diameter) 
3) Engineering analysis of inner diameter, head center, and liner head clearance (Series II X3 ° Large Diameter) 

• Predicate preclinical testing that was leveraged:
  1. Lever Out Testing (Series II X3® and Trident® X3® Large Diameter)
  2. Push Out Testing (Series II X3® and Trident® X3® Large Diameter)
  3. Evaluation of Wear Characteristics (Trident® X3® Large Diameter) |
     | - No new questions of safety or effectiveness | - The document concludes: "The results of the above testing verify that the new device is substantially equivalent to the predicate device." This implicitly indicates that no new questions of safety or effectiveness were raised. |

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

• Sample Size: Not specified in terms of number of devices tested. The evaluations were engineering analyses and leveraging of predicate preclinical testing, not a "test set" in the context of human data or a large number of physical units.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Given that it's preclinical/engineering analysis, it would be laboratory-based rather than patient-based. These are likely prospective engineering analyses and tests conducted by the manufacturer.

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

• Not applicable. This is not a study involving human interpretation of data where ground truth is established by experts (e.g., radiologists). The "ground truth" for engineering analyses would be defined by established engineering and biomechanical principles and accepted test methodologies (e.g., ISO standards for FMEA).

4. Adjudication Method for the Test Set

• Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. The outcome of engineering analyses and physical tests is typically objective.

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

• Not applicable. This document pertains to a hip prosthesis, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI performance evaluation was conducted or reported.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical device (hip insert), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For the engineering analyses and preclinical tests, the "ground truth" would be objective physical measurements, material properties, and adherence to established engineering standards and biomechanical performance expectations applicable to hip prosthesis components. This is verified by the results of the physical and engineering tests themselves rather than external expert consensus, pathology, or outcomes data in the usual sense.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI study that involves training data.

9. How the Ground Truth for the Training Set was Established

• Not applicable. This is not a machine learning or AI study.

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