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Intended Use: The Osteonics® Secur-Fit™-HA PSL® ABC Shell is intended for cementless fixation within the prepared acetabulum. Osteonics® ABC Cementable Polyethylene Insert is intended for cemented assembly to the metal shell. The Osteonics® Modular Acetabular Cup is compatible with any appropriately selected Osteonics hip stem/femoral head combination. In addition, the Osteonics® ABC Cementable Polyethylene Insert - because its assembly method is independent of the inner geometry of the mating shell - is compatible with any commercially available Osteonics metal acetabular shell component.

Indications: Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

The Osteonics® Modular Acetabular Cup components are single-use devices. Each Osteonics® Modular Acetabular Cup consists of two pieces: an Osteonics® Secur-Fit™-HA PSL® ABC Shell, and a mating Osteonics® ABC Cementable Polyethylene Insert.

The provided text is a 510(k) Premarket Notification Summary for a medical device (Osteonics® Modular Acetabular Cup), which primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not present in the provided document.

Here's a breakdown of the available information and what's missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Push-out Strength: Not explicitly stated in terms of a numerical range or minimum value. The text only states that the performance is "comparable" to predicate devices.

Reported Device Performance:

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

• Sample Size for Test Set: Not specified. The document mentions "laboratory testing" but does not provide details on the number of samples tested.
• Data Provenance: The testing was "Laboratory testing" undertaken to characterize the push-out strength. No information on country of origin or whether it was retrospective/prospective (which is not applicable for this type of lab testing).

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This section describes a lab test for mechanical strength, not a study requiring expert interpretation or ground truth establishment in a clinical context.

4. Adjudication Method for the Test Set

• Not applicable. This refers to a review process for clinical data, which is not relevant to a mechanical lab test.

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

• No. An MRMC study was not done. The document describes a mechanical test of device components, not a clinical effectiveness study involving human readers or AI.

6. Standalone (Algorithm Only) Performance Study

• No. This is not relevant. The device is a physical medical implant, not an algorithm or AI system.

7. Type of Ground Truth Used

• Not applicable. The "ground truth" for a mechanical test like push-out strength is the physical measurement itself, as determined by laboratory instruments and protocols. It's not based on expert consensus, pathology, or outcomes data in the traditional sense.

8. Sample Size for the Training Set

• Not applicable. This refers to machine learning. The device is a physical implant, and no machine learning model was developed or trained.

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

• Not applicable. (See point 8).

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