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The OsteoRemedies Hip Spacer System consists of modular heads and stems, and optional acetabular cups. The REMEDY components of the OsteoRemedies Hip Spacer System include gentamicin and the REMEDY SPECTRUM GV components include gentamicin and vancomycin.

The OsteoRemedies Hip Spacer System is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin or gentamicin or gentamicin vancomycin are the most appropriate antibiotics based on the infecting micro-organism(s).

Following removal of the existing femoral and acetabular components and radical debridement, the head and stem components are inserted into the femoral medulary canal and can mate directly with the native actabular component which is placed in the acetabular cavity. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).

The OsteoRemedies Hip Spacer System is not intended for use than 180 days, at which time all components must be explanted, and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.).

The OsteoRemedies Hip Spacer System is a modular temporary spacer device inclusive of femoral stems, femoral heads, and acetabular cups. The OsteoRemedies Hip Spacer System is sterile and single-use, intended for temporary use (maximum 180 days) for joint replacement. This submission expands the existing system to include additional sizes of the acetabular cup and femoral head. The system components are made of fully formed polymethylmethacrylate (PMMA) with gentamicin (REMEDY®) and gentamicin with vancomycin (REMEDY SPECTRUM® GV).

The OsteoRemedies Hip Spacer System provides a functional-mechanical mode of action; the system provides patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. The system is designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure. The REMEDY® components are protected from bacterial adhesion due to the presence of gentamicin. The REMEDY SPECTRUM® GV components are protected from bacterial adhesion due to the presence of gentamicin and vancomycin.

This document is a 510(k) premarket notification for the OsteoRemedies Hip Spacer System, specifically focusing on expanding the system to include additional sizes of acetabular cups and femoral heads (XS REMEDY Modular Head, XS REMEDY SPECTRUM GV Modular Head, and XS REMEDY Acetabular Cup). This document does not describe an AI/ML powered device, therefore, many of the requested fields are not applicable.

Here's an analysis of the provided information, focusing on the acceptance criteria and study details for this medical device, with N/A for fields not applicable to this type of regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for specific tests within this summary document. For mechanical testing (fatigue, disassembly), standard practices involve testing a statistically representative number of samples for each design variant to ensure robustness. For antibiotic elution, multiple samples would also be tested.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies are primarily lab-based performance tests for mechanical properties and material characteristics. Clinical data is mentioned as having been performed on "predicate devices," implying existing data. The context is a US FDA submission, so industry standards are applied. Retrospective or prospective is not applicable for these engineering tests.

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

• N/A. This document describes engineering performance testing and material characterization, not studies requiring expert interpretation of medical images or patient outcomes for ground truth establishment. The "ground truth" for these tests is defined by established engineering and material science standards (e.g., ISO, ASTM).

4. Adjudication method for the test set:

• N/A. As above, this is not an AI/ML clinical validation study involving human interpretation and adjudication. The tests involve objective measurements against predefined criteria.

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:

• N/A. This device is a physical hip spacer, not an AI/ML software device.

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

• N/A. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Engineering Standards and Material Specifications: For mechanical properties (fatigue, strength, disassembly, wear, range of motion), the ground truth is established by recognized international standards (e.g., ISO 7206 series) and material specifications for PMMA.
• Biocompatibility Standards: For biocompatibility, the ground truth is established by ISO 10993 series.
• Pharmacokinetic/Pharmacodynamic Principles: For antibiotic elution kinetics, the ground truth is based on established principles of drug release and achieving therapeutic concentrations, typically supported by in vitro or in vivo studies on the predicate device.
• Sterilization Validation Standards: For sterility, pyrogenicity, and endotoxin, the ground truth is established by relevant sterilization and quality control standards.

8. The sample size for the training set:

• N/A. This is not an AI/ML device, so there is no "training set."

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

• N/A. As there is no training set, this question is not applicable.

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