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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. The Apex Acetabular Cup liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2, Apex K2 mid length or Apex K1 Hip in total hip replacement procedures. The acetabular cup inserts are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. 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

Non hooded (0 deg neutral) and Hooded (10 deg) +4mm offsets for use with 28, 32, 36, 40mm Apex Modular heads.

The provided text describes a 510(k) summary for the Interface Acetabular System, Acetabular Insert. The documentation primarily focuses on the device's design, materials, indications for use, and a comparison to predicate devices, along with non-clinical testing.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: The document does not specify the exact number of samples used for each non-clinical test (ROM analysis, artificial aging, push-out & lever-out). It only states "All samples tested."
• Data Provenance: Not applicable in the context of this device and testing. The tests are in vitro mechanical/material tests, not data derived from human subjects or clinical settings based on a specific country of origin or retrospective/prospective nature.

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

• This information is not applicable as the document explicitly states, "No clinical studies were performed." The "ground truth" for the non-clinical tests would be the performance standards defined in the ASTM and ISO standards, which are engineering specifications, not expert medical consensus.

4. Adjudication method for the test set:

• This information is not applicable as there were no clinical studies involving human readers or subjective interpretations of data that would require an adjudication method. The testing involved objective physical measurements against established engineering standards.

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:

• No, an MRMC comparative effectiveness study was not done. This is a medical device (hip insert), not an AI diagnostic or image analysis tool. The document explicitly states, "No clinical studies were performed."

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

• This information is not applicable. This device is a mechanical implant, not an algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" was established by engineering performance standards specified by ASTM F2003-02 (extreme artificial aging) and ISO-21535-2007 (ROM analysis), along with industry-standard "Push-out & Lever-out Test" criteria.

8. The sample size for the training set:

• This information is not applicable as no clinical studies or AI/machine learning models were involved in the evaluation of this device.

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

• This information is not applicable as no clinical studies or AI/machine learning models were involved.

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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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