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The Apex Modular™ Acetabular Cup is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures. This acetabular cup is intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and 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.

The Apex Modular™ Acetabular Cups are manufactured of titanium alloy, with a sintered bead porous coating (commercially pure titanium, irregular bead geometry). The liners are manufactured of ram extruded ultrahigh molecular weight polyethylene, sterilized using ethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or ceramic, 28 or 32 mm diameter, with various offsets.

The provided text is a 510(k) summary for the Apex Modular™ Acetabular Cup, a medical device. This document is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. It does not describe acceptance criteria for a performance study or a study that proves the device meets specific acceptance criteria in the way typically required for AI/ML medical devices.

Instead, the provided document focuses on demonstrating substantial equivalence to existing predicate devices (DePuy Pinnacle™ Acetabular Cup and Wright Medical Lineage™ Acetabular Cup) based on design, materials, and intended use. The "study" mentioned is "Liner retention studies were performed on the Apex Modular liners as per the relevant FDA guidance documents," but no specific acceptance criteria, results, or details of the study itself are provided beyond this general statement.

Therefore, for many of your points, the information is not present in the provided text.

Here's a breakdown of what can and cannot be answered from the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of a detailed performance study with quantitative metrics, as one would expect for an AI/ML device. The assessment is primarily a comparison to predicate devices, asserting "substantial equivalence."

Table of Acceptance Criteria and Reported Device Performance:

Explanation: The "acceptance criteria" here are inferred from the features compared against the predicate devices to establish substantial equivalence. The "reported device performance" is the statement that the Apex Modular Acetabular Cup meets or is similar to these features. The liner retention study is the only specific "study" mentioned, with the implied "acceptance criteria" being compliance with FDA guidance and "performance" being that such studies were conducted.

Additional Information (Based on the Provided Text):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable / Not Provided. The document describes a comparison to predicate devices and mentions "liner retention studies," but does not detail sample sizes, data provenance, or whether test sets were used in the way one would for an AI/ML algorithm's performance evaluation.

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

• Not Applicable / Not Provided. This type of evaluation (expert-established ground truth) is not described in the document for the Apex Modular Acetabular Cup.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable / Not Provided.

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 study is not mentioned as this device is a physical implant, not an AI diagnostic tool for human readers.

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

• Not Applicable / No. This refers to AI/ML algorithm performance, which is not relevant for this physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not Applicable / Not Provided (for performance evaluation). The "truth" for this device's regulatory clearance is its substantial equivalence in design, materials, and intended use to existing legally marketed devices, and compliance with relevant guidance for mechanical testing (like liner retention).

8. The sample size for the training set:

• Not Applicable / Not Provided. This concept is not relevant to the clearance of this physical implant.

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

• Not Applicable / Not Provided. This concept is not relevant to the clearance of this physical implant.

In summary: The provided document is a 510(k) summary for a physical medical device (an acetabular cup), which focuses on demonstrating substantial equivalence to existing predicate devices through comparison of design features, materials, and intended use, along with general statements about compliance with FDA guidance for certain mechanical tests. It does not contain the kind of detailed performance study information, acceptance criteria, or ground truth establishment typically associated with the evaluation of AI/ML software as a medical device.

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