Search Results

The indications for the use of the Osteonics® GAP-II Restoration Acetabular Shells, in keeping with those of other legally marketed Osteonics acetabular components, are as follows:

• 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.
• Class III cavitary and segmental defects.

The Osteonics® GAP-II and GAP-IIS Restoration Acetabular Shells are single use components which are intended for placement within the acetabulum, and which are intended to provide an articulating surface for corresponding Osteonics' femoral head/stem components. The two iliac plates on the GAP-IIS shell are shorter than those of the GAP-II shell. Each Osteonics® GAP-II or GAP-IIS Restoration Acetabular Cup is assembled from two separate components: an Osteonics® GAP-II or GAP-IIS Restoration Acetabular Shell and a predicate Osteonics® Omnifit® Cup Insert, ABC Cementable Polyethylene Insert, Osteonics® Concentric Polyethylene Acetabular Cup, or Osteonics® Flanged Polyethylene Acetabular Cup. The polyethylene cups and inserts are intended to be affixed to the shell via polymethylmethacrylate (PMMA) bone cement.

The Osteonics® GAP-II and GAP-IIS Restoration Acetabular Shells are manufactured from ASTM F-67 Commercially Pure Titanium (CP Ti). The shells are available in a range of outer diameter shell sizes. The Osteonics® GAP-II and GAP-IIS Restoration Acetabular Shells feature a basic spherical geometry. 18 to 26 acetabular dome screw holes (depending on the size of the shell), two superior plates, a 20° superior/posterior hood, an inferiorly located acetabular notch hook, a satin-finished interior surface, and a grit-blasted exterior surface.

Bone screws placed through the dome and/or lip of the acetabular shell are used to secure the Osteonics® GAP-II or GAP-IIS Restoration Acetabular Shell within the prepared acetabulum. The shells are designed to allow some of the bone cement (used to fix the polyethylene liner to the shell) to be extruded through any unoccupied acetabular dome screw holes. In additional acetabular dome screws, and in order to further enhance the potential for initial and long term stable shell fixation despite large bony defects, the Osteonics® GAP-IIS Restoration Acetabular Shells employ an inferior hook, superior plates, and a superior posterior hood. The inferior hook is crimped around the acetabular notch. The shell hood covers the superior rim of the acetabular cavity, and the superior plates and can be secured to the acetabulum and/or ilium with Osteonics® 6.5mm Restoration GAP Plate Screws.

This document, a 510(k) Premarket Notification, describes the Osteonics® GAP-II Restoration Acetabular Shells. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets specific acceptance criteria based on novel performance metrics.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of regulatory submission. The assessment here is primarily based on comparing features and intended use to an already cleared device and mechanical testing to ensure foundational safety and performance.

Here's the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable for clinical performance study. The submission focuses on substantial equivalence through material properties, design comparison, and mechanical bench testing. There is no mention of a "test set" in the context of clinical data or patient outcomes. The "test set" would be the specific devices or components subjected to the mechanical tests. The document doesn't specify the sample size for these mechanical tests, nor the country of origin or whether the data was retrospective or prospective.

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

• Not applicable. No ground truth established by experts in the context of clinical performance is mentioned or required for this type of submission focused on substantial equivalence.

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

• Not applicable. No adjudication method for a test set is mentioned.

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

• Not applicable. This device is a hip implant component, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a hip implant component, not an algorithm.

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

• For the mechanical testing, the "ground truth" would be the established engineering standards and performance of the predicate device. The document states "Mechanical testing has been performed to demonstrate the substantial equivalence of this Osteonics acetabular shell design to predicate acetabular shell designs in terms of its fatigue strength and shell/insert assembly method." This implies that the performance of the predicate device and relevant mechanical standards served as the benchmark.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of AI or machine learning for this device.

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

• Not applicable. There is no "training set" for this device.

Ask a specific question about this device