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The CLS, Wagner Revision and AlloClassic Zweymuller femoral stems will be used in conjunction with the Zirconia Ceramic Total Head. This stem/head combination is intended for prosthetic replacement of the proximal portion of the femur during total hip arthroplasty in which the ball head articulates with a polyethylene acetabular component. Specific diagnostic indications include:

• Patient conditions of inflammatory degenerative joint disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis):
• . Those patients with failed previous surgery where pain, deformity, or dysfunction persist; and,
• Revision of previously failed hip arthroplasty. ●

The CLS Stem. Wagner Revision Stem and AlloClassic Zwevmuller Stem, are intended for use with or without bone cement.

The CLS Stem. Wagner Revision Stem and AlloClassic Zwevmuller Stem are all designed for use with ceramic heads. These stems are manufactured from Ti-6A1-7Nb alloy and have the same proximal taper which is machined per the specifications of the 12/14 Sulzer taper.

The Zirconia Ceramic Total Head is a spherical head with a 12/14 taper, making it compatible with the above stems. The heads are available in 28mm and 32mm diameters and three neck lengths; short, medium and long.

Static compression testing demonstrated that the burst strength of the zirconia heads exceeds FDA requirements.

The provided 510(k) summary (K973837) for the Zirconia Ceramic Total Head for use with specific femoral stems does not describe a study involving an algorithm or artificial intelligence (AI).

Instead, this document pertains to a medical device for total hip arthroplasty, specifically discussing the material compatibility and mechanical performance of a ceramic hip head. The relevant "acceptance criteria" discussed are related to the physical properties and performance of the device itself, not the performance of a diagnostic algorithm.

Here's an analysis based on the information provided, recognizing that the request template is typically for AI/diagnostic device studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document only states "Static compression testing."
• Data Provenance: Not applicable. This refers to mechanical testing of a physical product, not a dataset.

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

• Not applicable. Ground truth for mechanical testing would align with engineering standards and direct physical measurements, not expert consensus in a medical imaging context.

4. Adjudication method for the test set

• Not applicable. This is not a study requiring adjudication of interpretations.

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 device is not an AI diagnostic tool.

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

• Not applicable. This device is not an algorithm.

7. The type of ground truth used

• Ground Truth Type: Engineering standards and direct physical measurements of burst strength during static compression testing.

8. The sample size for the training set

• Not applicable. There is no algorithm or training set mentioned.

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

• Not applicable.

In summary, the provided 510(k) summary focuses on the substantial equivalence and mechanical performance (burst strength) of a physical medical device (zirconia ceramic hip head) and does not involve any studies related to diagnostic algorithms, AI, or human-in-the-loop performance for image interpretation.

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The Wagner Revision Stem incorporates a circular cross-section with eight equally spaced conical anchorage ribs (or flutes) which run the entire length of the stem. This device is intended for cementless application where primary fixation occurs predominantly in the distal region and is primarily used in clinical situations where there are deficiencies in the proximal femur due to extensive bone resorption and/or damage in the prosthetic bed.

Currently, the Wagner Revision Stem is offered in four stem lengths (190, 225, 265 and 305mm) with distal diameters ranging from 14-20mm, and 14-25mm (in 1mm increments) for the 190, 225, and 265/305mm lengths respectively. The number of size offerings is being increased to include a stem length of 345mm with distal diameters of 14-25mm (1mm increments) and a stem length of 385mm with distal diameters of 14-25mm (1mm increments).

The additional sizes are identical in configuration to the original Wagner Stems, but have been designed in proportion to the sizes already available. Static and dynamic testing were performed, verifying that the additional sizes exhibit sufficient strength for clinical use.

This document describes a medical device, the Wagner Revision Stem, and its proposed modifications (additional sizes). It focuses on demonstrating substantial equivalence to predicate devices for 510(k) clearance, not on providing performance criteria or a clinical study proving its effectiveness in terms of diagnostic accuracy or treatment outcomes.

Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics (like sensitivity, specificity, or expert agreement) cannot be extracted from this document because it is not relevant to the type of submission described (a 510(k) for a modified implant).

Here's a breakdown of what can be extracted or inferred, and why other sections cannot be addressed:

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

This document does not specify performance acceptance criteria in terms of diagnostic accuracy or clinical outcomes, as it’s for a surgical implant modification. The "performance" reported is related to mechanical strength.

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

Not applicable. This document refers to mechanical testing of the implant, not a clinical study involving patients or a diagnostic test.

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. Ground truth, in the context of diagnostic accuracy, is not relevant to the mechanical testing described.

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

Not applicable.

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 not an AI/diagnostic device.

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

Not applicable. This is not an AI/diagnostic device.

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

For the mechanical testing, the "ground truth" would be the engineering specifications and material properties verified by the testing. This isn't clinical "ground truth."

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for the mechanical testing of an orthopedic implant in this context.

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

Not applicable.

Summary of what the document does convey:

• Device Type: Orthopedic implant (hip stem).
• Purpose of Submission: 510(k) for additional sizes of an existing device.
• Basis for Clearance: Substantial equivalence to predicate devices (Müller Type Proximal Femur, Proximal Third Femoral Prosthesis).
• Justification for Substantial Equivalence (for new sizes): The additional sizes are identical in configuration to the original Wägner Stems but proportioned differently. Static and dynamic mechanical testing was performed to verify that the new sizes exhibit sufficient strength for clinical use.

The document is a regulatory summary for a physical medical device, not a diagnostic algorithm or a device requiring clinical performance data in the way you've outlined for AI or diagnostic studies.

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