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The Wagner SL Revision Stem Lateral is intended for prosthetic replacement of the proximal femur in total hip arthroplasty. It is intended for press-fit application. Specific diagnostic indications include:

• Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis; and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
• Patients with failed previous surgery where pain, deformity, or dysfunction persists.
• Revision of previously failed hip arthroplasty.

Both the existing Wagner SL Revision Stem and the proposed Wagner SL Revision Stem Lateral are manufactured from forged titanium alloy and are available in three lengths (165mm, 185mm, and 205mm). The neck design of both stems is provided with the standard 12/14 taper for connection with any Zimmer modular femoral head utilizing a 12/14 taper.

The Wagner SL Revision Stem Lateral incorporates a circular stem cross-section and equally spaced conical anchorage ribs, which run nearly the full length of the stem, as do the ribs on the previously cleared Wagner SL Revision Stem. The surface of both stems is rough-blasted.

To achieve the lateralization of the modified device, the CCD (i.e., neck) angle was lengthened. To compensate for the increased bending moments and lateral stresses, which result from the increased offset, the rib structure was modified so that the greatest bending moment would not be at the base of the rib; and the ribs were widened, which led to an increase in the stem strength.

In addition, a threaded coupling was added to the proximal portion of the stem for use with the new impacter/extractor. The stem neck was shortened to increase the range of motion, and two small holes were added to the proximal portion of the stem for securing non-metallic suture material.

This document is a 510(k) summary for a medical device (hip implant) and does not contain detailed information about acceptance criteria or specific study results that would typically be associated with AI/ML device performance. The document focuses on demonstrating substantial equivalence to a predicate device.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details for an AI/ML device is not applicable to this document. The document describes a traditional medical device (hip implant) submission, not an AI/powered diagnostic or therapeutic device.

However, I can extract information related to the device description, intended use, and the concept of "substantial equivalence" as the primary "acceptance criterion" in this context.

1. A table of (implied) acceptance criteria and the reported device performance

In the context of a 510(k) submission for a non-AI/ML medical device, the "acceptance criteria" are generally that the new device is substantially equivalent to a legally marketed predicate device. This substantial equivalence is demonstrated through comparisons of:

Note: The modifications in the "Wagner SL Revision Stem Lateral" (lengthened CCD angle, widened ribs for increased stem strength, threaded coupling, shortened stem neck, added holes for sutures) are presented as design changes that do not alter the fundamental safety and effectiveness to the point of requiring a PMA or new classification, thus maintaining substantial equivalence. These changes are improvements or variations within the established scope of the predicate.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This document describes a traditional medical device (hip implant) and does not include information on a "test set" in the context of an AI/ML algorithm evaluation. The demonstration of substantial equivalence relies on design comparisons, material specifications, and performance characteristics (like strength considerations due to design changes). There are no data described that would fit the "test set" definition for an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. As noted above, this 510(k) summary does not involve a "test set" or "ground truth" establishment by experts in the AI/ML sense. The approval is based on comparison to a predicate device and engineering design principles.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There is no described "test set" or adjudication process for clinical data in this 510(k) summary.

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 is a hip implant, not an AI/ML diagnostic device, so MRMC studies are not relevant.

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

Not applicable. This is a hip implant, not an AI/ML algorithm.

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

Not applicable. For a hip implant 510(k), "ground truth" typically relates to established clinical performance of the predicate device, material standards, and biomechanical principles, rather than a diagnostic 'truth' established for an AI algorithm.

8. The sample size for the training set

Not applicable. There is no AI/ML algorithm or associated "training set" described in this document.

9. How the ground truth for the training set was established

Not applicable. There is no AI/ML algorithm or associated "training set" described in this document.

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The CLS™ Spotorno™ Femoral Stem is intended for cementless use in total hip replacement in treatment of the following:

• patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis and conditions of inflammatory degenerative joint disease (IJD), e.g. rheumatoid arthritis;
• those patients with failed previous surgery where pain, deformity, or dysfunction persists;
• revision of previously failed hip arthroplasty.

The CLS™ Spotorno™ Femoral Stem is intended for use as a prosthetic replacement of the proximal portion of the femur during total hip arthroplasty. This Special 510(k) incorporates the following changes as compared to the original device configuration: 1) addition of the CLS 125° stem, with an increased offset; and 2) incorporation of a slim neck and short taper. Below the resection line, the design of the modified stem remains the same as the legally marketed device.

The provided text describes a medical device submission, specifically a Special 510(k) for a modified femoral stem (CLS™ Spotorno™ Stem). The core of the provided information relates to the fatigue testing of this device to ensure it continues to meet safety and effectiveness standards after modifications.

Here's an analysis of the acceptance criteria and study as per your request:

Acceptance Criteria and Study Details for the CLS™ Spotorno™ Femoral Stem

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states "All test samples" but does not specify the exact number of samples used for fatigue testing.
• Data Provenance: The study was conducted by the manufacturer, Zimmer Austin, Inc. and Zimmer GmbH. The data is prospective, generated specifically for this 510(k) submission to demonstrate the safety and effectiveness of the modified device. The country of origin for the testing would be where Zimmer GmbH (Switzerland) or Zimmer Austin, Inc. (USA) conducted the tests, which is not explicitly stated but implied to be within the manufacturer's quality system.

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

Not applicable. This study involves mechanical fatigue testing, not a clinical study where expert ground truth on patient data would be established. The "ground truth" here is the physical performance of the device under simulated physiological loading conditions as defined by engineering standards for orthopedic implants.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is mechanical testing, not a clinical study requiring expert adjudication of observations. The "adjudication" is based on whether the test samples pass or fail the predetermined engineering acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a submission for a medical device (femoral stem) based on mechanical testing (fatigue testing), not an AI-enabled diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The "standalone" performance here refers to the physical device itself (the femoral stem) undergoing mechanical testing without human interaction or an AI algorithm involved in its function or assessment during the test. The "algorithm" would be the engineering specifications and test protocols that determine acceptance.

7. The Type of Ground Truth Used

The ground truth used is derived from engineering standards and predetermined mechanical performance criteria for orthopedic implants, specifically for fatigue strength under physiological loading. These standards are typically established by regulatory bodies (e.g., ISO, ASTM) and industry best practices to ensure the long-term durability and safety of the implant.

8. The Sample Size for the Training Set

Not applicable. There is no AI algorithm being "trained" in this context. The study is a mechanical verification of a physical device.

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

Not applicable. As there's no AI training set, there's no ground truth for it to be established.

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