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The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cup are intended for uncemented fixation and single use implantation. These prostheses may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur.

Apex Modular Head sizes 28, 32, 36, and 40 mm with a + 10.5mm offset

Here's an analysis of the provided text regarding the acceptance criteria and study for the Apex Modular Heads, +10.5mm offset:

Acceptance Criteria and Device Performance Study for Apex Modular Heads, +10.5mm offset

This submission (K101575) is for a medical device seeking substantial equivalence to previously cleared predicate devices. Therefore, the "acceptance criteria" are primarily established by demonstrating equivalency to the predicate devices through non-clinical testing, rather than defining novel performance thresholds for clinical outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for substantial equivalence based on non-clinical testing, the "acceptance criteria" are implicitly met by demonstrating that the subject device's performance is comparable to or better than previously cleared predicate devices for relevant mechanical and material properties. The device performance is reported as meeting the specified standards, thereby indicating compliance with the implicit acceptance criteria for safety and effectiveness in comparison to the predicates.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in terms of number of physical units tested beyond the mention of "tests were conducted." For mechanical and material testing, sample sizes are typically defined by the specific ASTM/ISO standards referenced (e.g., minimum number of specimens for fatigue testing). The provided text indicates that the tests were conducted, implying adequate sample sizes were used as required by the standards.
• Data Provenance: Not explicitly stated (e.g., specific country or lab). The tests are described as "Non-Clinical Test Summary," meaning they were laboratory-based and not derived from human subjects. The reference to ISO and ASTM standards suggests internationally recognized testing protocols. Retrospective or prospective designations are not applicable as these are non-clinical lab tests.

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

• Not applicable. For this type of mechanical and material performance testing, "ground truth" is established by adherence to recognized international standards (ISO, ASTM) and the results obtained from the tests themselves using calibrated equipment. There is no concept of expert consensus for establishing ground truth in this context, unlike clinical studies involving image interpretation or diagnosis.

4. Adjudication Method for the Test Set

• Not applicable. As described above, the "test set" refers to the mechanical and material testing of the device components. Adjudication methods (like 2+1, 3+1) are employed in clinical studies, particularly in situations where there is subjective human interpretation or diagnostic agreement required (e.g., radiology reads).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC comparative effectiveness study was conducted. This device is seeking clearance based on substantial equivalence to predicate devices through non-clinical performance data and material specifications.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device is a physical medical implant (hip prosthesis), not a software algorithm or AI-powered diagnostic tool. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. Type of Ground Truth Used

• Engineering and Material Standards Compliance, and Mechanical Test Results: The "ground truth" for this device's performance is established by demonstrating compliance with recognized international standards (ISO, ASTM) for mechanical properties, material composition, and manufacturing processes relevant to hip implants. The results of the non-clinical tests (ROM, FEA, Fatigue Strength) serve as the evidence to support this compliance and demonstrate substantial equivalence to the predicate devices.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical implant and does not involve AI or machine learning algorithms that require a "training set."

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

• Not applicable. No training set was used or required for this device.

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