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Intended Use: The Osteonics® Modular Acetabular Cup components are single-use devices. The polyethylene insert is intended for cemented assembly to the metal shell. The metal shell is intended for cemented or cementless fixation within the prepared acetabulum. 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, theumatoid 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® PSL® MicroStructured® ABC Shell, and a mating Osteonics® ABC Cementable Polyethylene Insert. The metal shell is intended for cemented or cementless fixation within the prepared acetabulum. The polyethylene insert is intended for cemented assembly to the metal shell.

Here's an analysis of the provided text, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) Premarket Notification Summary from 1996 for a medical device (Osteonics® Modular Acetabular Cup). This type of document is a regulatory submission for demonstrating substantial equivalence to a predicate device. It is not a clinical study report or a publication detailing a rigorous scientific investigation with statistical endpoints as would be expected for modern AI/ML device submissions. Therefore, many of the requested categories (especially those related to AI/ML device performance, ground truth, expert opinions, and multi-reader studies) are not applicable to this historical device submission.

Acceptance Criteria and Reported Device Performance

Study Details Based on Provided Text

Given the nature of the document (a 510(k) summary), it primarily focuses on demonstrating substantial equivalence rather than presenting detailed clinical trial results or standalone algorithm performance.

1. Sample Size(s) Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not explicitly stated. The document mentions "Laboratory testing" and "test results" for push-out strength, but does not provide the number of samples tested.
   • Data Provenance: The "Laboratory testing" was conducted to characterize the device. This implies internal company testing rather than external or patient data. No country of origin is specified, but it's an Osteonics Corporation submission (USA). It is a prospective test of the device components.

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

   • Not applicable. This device is a mechanical implant; "ground truth" in the context of expert medical opinion for diagnostic or AI performance is not relevant here. The ground truth for mechanical properties (like push-out strength) would be derived directly from physical measurements and engineering standards.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods (like 2+1) are used for resolving disagreements among human reviewers (e.g., radiologists) when establishing ground truth for diagnostic studies. This is a mechanical device performance evaluation.

4. 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:

   • Not applicable. This document predates widespread AI/ML in medical devices and focuses on an orthopedic implant. No MRMC studies or AI assistance were involved.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • Not applicable. This is a physical orthopedic implant, not a software algorithm.

6. The Type of Ground Truth Used:

   • Engineering Measurements/Physical Testing: For the push-out strength, the "ground truth" is the measured force required to cause failure, compared against predetermined engineering specifications or predicate device performance. For material composition and dimensions, the ground truth is established through material testing and dimensional measurements against design specifications.

7. Sample Size for the Training Set:

   • Not applicable. There is no "training set" in the context of this mechanical device submission. The device design and materials are based on established engineering principles and prior predicate devices.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable. As there is no training set, this question is not relevant.

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