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The Klassic HDTM Hip System is intended for prosthetic replacement without bone cement in treatment of the following:

• Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
• Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.
• Those patients with failed previous surgery where pain, deformity or dysfunction persists.
• Revision of a previously failed hip arthroplasty.
• Patients who require a total hip replacement.

The Klassic HD Offset Femoral Stem is a femoral component to be used within the Klassic HD Hip System as a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by helping to achieve proper leg length and offset. The Klassic HD Offset Femoral Stem is offered in both porous and non-porous options. Each configuration of the Klassic HD Offset Femoral Stem is offered in 9 sizes, is sterilized by gamma irradiation and is intended for single-use only.

Here's an analysis of the provided text regarding the Klassic HD™ Offset Femoral Stem, focusing on the acceptance criteria and the study performed, structured according to your requested points:

The provided 510(k) summary for the Total Joint Orthopedics Klassic HD™ Offset Femoral Stem describes a medical device component, not a software or AI-driven diagnostic device. Therefore, the information typically requested for AI/ML device studies regarding ground truth, expert adjudication, MRMC studies, and training/test sets is not directly applicable in this context.

Instead, the "acceptance criteria" and "study" refer to bench testing to demonstrate the physical and mechanical performance of the femoral stem and its substantial equivalence to predicate devices. The primary goal is to show that the new design (with a different neck shaft angle and offset) performs as safely and effectively as existing, legally marketed devices.

Here's the breakdown based on the provided text, reinterpreting the questions for a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The exact numerical acceptance criteria (e.g., specific load cycles for fatigue testing, exact force for disassembly) are not explicitly stated in this summary but are implicit by referring to industry guidance and ASTM standards. The reported performance is a general statement that the device meets these criteria and is equivalent to predicates.

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

This concept is not applicable as this is a physical medical device. The "test set" would refer to the number of physical samples of the femoral stem tested. The text does not specify the exact number of stems tested for each physical test (e.g., 5 stems for fatigue, 3 for disassembly).

• Data Provenance: Not applicable in the sense of patient data. The "provenance" of the testing is non-clinical bench testing, conducted in a laboratory environment, guided by FDA guidance (e.g., "Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses") and ASTM standards (e.g., "ASTM F1814-97a - Standard Guide for Evaluating Modular Hip and Knee Joint Components").

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

Not applicable. "Ground truth" for a physical device like this is established through validated engineering tests following recognized standards, not by expert consensus on clinical data. The "experts" involved would be engineering and testing personnel, but their number and specific qualifications are not detailed beyond the general statement of following guidance and standards.

4. Adjudication Method for the Test Set

Not applicable. Test results for physical device characteristics are typically quantitative and objective (e.g., did it break or not, what was the force to disassemble). There is no "adjudication" in the sense of reconciling different expert opinions.

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/ML device.

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

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

7. The Type of Ground Truth Used

For this physical device, the "ground truth" is based on:

• Physical and Mechanical Performance Standards: Demonstrated by adherence to recognized national/international standards (e.g., ASTM F1814-97a) and FDA guidance for similar devices.
• Comparison to Predicate Devices: The key "ground truth" here is the performance characteristics of the legally marketed predicate devices. The new device must demonstrate "substantial equivalence" in these characteristics.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in that context.

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

Not applicable. There is no training set for this type of device.

Summary of the Study and Conclusion for the Klassic HD™ Offset Femoral Stem:

The study involved non-clinical bench testing on physical samples of the Klassic HD™ Offset Femoral Stem. These tests included:

• Neck fatigue testing
• Stem fatigue testing
• Axial disassembly evaluation
• Torsional disassembly evaluation
• Range of motion determination

The testing was conducted based on established guidance from the FDA ("Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses, Document 1647 dated September 17, 2007") and ASTM standards ("ASTM F1814-97a - Standard Guide for Evaluating Modular Hip and Knee Joint Components").

The objective of the study was to demonstrate that the Klassic HD™ Offset Femoral Stem is substantially equivalent to its predicate devices (Klassic HD Hip System, K100445, and Alloclassic Zweymuller SL Offset Femoral Stem, K033664) in terms of safety and efficacy. The conclusion drawn from these bench tests was that "All bench testing and evaluation demonstrates the Klassic HD Offset Femoral Stem is equivalent in regards to safety and efficacy, is suitable for Total Hip Arthroplasty and is substantially equivalent to predicate devices." This substantial equivalence determination was upheld by the FDA in their 510(k) clearance letter (K133832).

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