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The SPA Porcus Coated Proximal Sleeve components of the S-ROM Total Hip System are indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from theumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonumion of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion.

The SPA Porous Coated Proximal Sleeves are intended for cementless use.

The SPA Poeous Coated Peoximal Sleeve is a composent of the S-ROM Total Hip Replacement System. It is a porous coated Titanium femoral component with an elliptical shape that matches the contour of the bone and a stepped exterior to maximize compressive stresses. Fixation of the proximal sleeve to the femur is achieved by biologic fixation via tissue in-growth into the porous onsung.

This 510(k) premarket notification is for a medical device called "DePuy SPA™ Porous Coated Proximal Sleeves". It's a component of a total hip replacement system. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with acceptance criteria for device performance as would be seen for a novel AI/software component.

Therefore, many of the requested sections (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission. This document describes a traditional medical device (implant), not an AI/software device.

However, I can extract the information relevant to the concept of "acceptance criteria" and "proof" in the context of a 510(k) submission for a physical device.

1. Table of acceptance criteria and the reported device performance

For a 510(k) submission of a physical orthopedic implant, "acceptance criteria" and "device performance" are typically framed in terms of mechanical properties, biocompatibility, and substantial equivalence to a predicate device. The document states:

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

This information is not applicable as this is not a study measuring performance of an AI/software device. The "proof" for this device relies on demonstrating substantial equivalence to existing, legally marketed predicate devices through a comparison of design, materials, manufacturing, and intended use. There is no "test set" in the sense of patient data or algorithm output.

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)

This information is not applicable. Ground truth for a physical implant is typically established through engineering specifications, material standards, and clinical experience with similar devices, not through expert consensus on a test set of data.

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

This information is not applicable. There is no "adjudication method" for a test set in this kind of 510(k) submission.

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

This information is not applicable. This is a physical implant, not an AI or software device that would involve human readers or AI assistance.

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

This information is not applicable. This is a physical implant, not an algorithm.

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

For this type of device, the "ground truth" is established by:

• Engineering specifications and material standards: Ensuring the Titanium material meets biocompatibility and mechanical strength requirements.
• Clinical experience and regulatory clearances of predicate devices: The "ground truth" for safety and effectiveness is largely derived from the long-standing use and prior FDA clearance of the S-ROM™ 135 Porous Coated Femoral Stem Collar (K860207) and the Coated ZT Proximal Sleeve (K934412). The company argues that because the new device is "identical" or uses "identical" components, it shares the same safety and effectiveness profile.

8. The sample size for the training set

This information is not applicable. There is no "training set" for a physical implant.

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

This information is not applicable. There is no "training set" for a physical implant.

Summary of the Study/Evidence Provided:

The document describes a 510(k) premarket notification where DePuy Orthopaedics, Inc. seeks to demonstrate the "substantial equivalence" of their DePuy SPA™ Porous Coated Proximal Sleeves to legally marketed predicate devices. This is the primary "study" or evidence a 510(k) package provides for a physical device.

The core of the argument is built on direct comparisons:

• S-ROM™ 135 Porous Coated Femoral Stem Collar (K860207): The SPA Porous Coated Proximal Sleeve is claimed to be identical in design, materials, and manufacturing method to this predicate device. This predicate was cleared for cemented use.
• Coated ZT Proximal Sleeve (K934412): The porous coating of the SPA device is claimed to be identical to the porous coating used on this predicate, which was cleared for cementless use.

By combining the design/material/manufacturing equivalence from one predicate with the porous coating (and thus cementless use) equivalence from another, DePuy argues their new device is substantially equivalent to existing approved devices, therefore demonstrating its safety and effectiveness. The FDA's letter concurs with this assessment, stating the device is "substantially equivalent" for the stated indications for use.

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