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The Ortho Development Biolox Delta Ceramic Femoral Head is inteded for use in total hip arthroplasty procedures with the Ovation Hip Stem System (indicated for uncemented, biological fixation of the stem) and the Encompass Hip Stem System (indicated for both cemented and uncemented, biological fixation of the stem).

Total hip arthroplasty is indicated for the following conditions:

• Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post l . traumatic arthritis.
• 2. Previously failed hip surgery.
• Fractures of the femoral neck or head. 3.
• Avascular necrosis of the femoral head. 4.
• Congenital dysplasia or other structural abnormalities where sufficient bone stock ട്. exists to properly seat the prosthesis.

The Ortho Development Biolox Delta Ceramic Femoral Heads mate with the existing Ortho Development Ovation and Encompass 12/14 taper femoral hip stems and articulate against Ortho Development polyethylene acetabular liners. The femoral heads are available in 28mm, 32mm, and 40mm diameters in a variety of offsets.

This document is a 510(k) Premarket Notification for the Ortho Development Biolox Delta Ceramic Femoral Heads. The submission asserts substantial equivalence to previously cleared devices based on similarities in design, materials, manufacturing, and mechanical performance. The "study" proving the device meets the acceptance criteria is a series of mechanical tests.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily states that mechanical testing data demonstrates equivalence to currently marketed devices and the ability to withstand expected in vivo loading. It references "burst fracture, taper dissemble (pull off) and wear tests as described in the Summary of Design Control Activities." However, the specific acceptance criteria (e.g., minimum load for burst fracture, maximum wear rate) and the numerical results for the Ortho Development Biolox Delta Ceramic Femoral Heads are not detailed within this Summary of Safety and Effectiveness. The document relies on comparison to predicate devices rather than absolute performance metrics being explicitly stated as acceptance criteria within this summary.

Based on the information provided, a table explicitly outlining acceptance criteria and numerical performance is not entirely possible, as the specific criteria are only generically mentioned as being "equivalent" to predicates.

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

• Sample Size for Test Set: Not specified in the provided summary. Mechanical testing typically involves a certain number of samples for each test (e.g., 5, 10, or more per test type), but the exact numbers are not detailed here.
• Data Provenance: The tests are conducted by the manufacturer, Ortho Development Corporation. The data would be prospective for the specific device being submitted, generated in a laboratory setting. There is no information about country of origin of data or use of retrospective data in this summary.

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

This type of information is not applicable to this device and study. The "ground truth" for mechanical testing of an orthopedic implant is typically established by engineering standards (e.g., ISO, ASTM) and the performance of well-established predicate devices, not by expert medical consensus on individual cases. The "study" here is a set of mechanical engineering tests, not a clinical study involving human patients or evaluations by medical experts.

4. Adjudication Method for the Test Set

This is not applicable to mechanical laboratory testing. Adjudication methods (like 2+1, 3+1) are used in clinical studies or image review where multiple human readers assess data and discrepancies need to be resolved. For mechanical tests, the results are typically quantitative measurements, and the interpretation and reporting are done by test engineers.

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 is not applicable. This submission is for a physical orthopedic implant (a ceramic femoral head) and involves mechanical testing, not an AI-driven diagnostic or assistive device that would involve human readers.

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

This is not applicable. This submission is for a physical orthopedic implant and does not involve any algorithms or software.

7. The Type of Ground Truth Used

The "ground truth" used for this type of device and study is primarily engineering standards and the established performance characteristics of predicate devices. The goal is to demonstrate that the new device performs at least as well as, or equivalently to, devices already on the market that have a known safety and effectiveness profile through their long-term clinical use and prior mechanical testing.

8. The Sample Size for the Training Set

This is not applicable. This is a physical device undergoing mechanical testing, not a machine learning model that requires a training set.

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

This is not applicable, as there is no training set for a mechanical testing study of a physical implant.

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