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Components of the Allofit Acetabular System are intended for use in total hip arthroplasty for treatment of the following:

• patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular . necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
• those patients with failed previous surgery where pain, deformity, or dysfunction persists. .
• revision of a previously failed hip arthroplasty. .

This Special 510(k) submission seeks to obtain clearance for addition of the Allofit 32mm Alpha Durasul Inserts to the existing, previously cleared (K003578) Allofit 28mm Alpha Durasul Insert product line. The only difference from the existing product is the internal diameter of the insert (32mm vs. 28mm).

There are also no changes to the other previously cleared components of the system which are used in conjunction with the inserts (e.g, acetabular shells, dome hole covers, screw hole covers, instrumentation).

The Allofit 32mm Alpha Durasul inserts incorporate the same general design features as the existing, previously cleared Allofit 28mm Alpha Durasul insert components and Allofit 32mm Alpha inserts (standard Sulene polyethylene). The inserts are snapped into the respective Allofit titanium shell intraoperatively. A peripheral locking mechanism holds the insert within the shell. A peg shaped eminence at the apex of the insert slips into the dome hole of the shell and provides further stability of the insert within the shell. Upon impaction into the short spikes in the dome of the metallic shell minimally penetrate the polyethylene insert, providing additional resistance to rotation. Both a standard and hooded insert configuration will continue to be offered.

The Allofit 32mm Alpha Durasul inserts will also use the same materials as the previously cleared devices (ISO 5834-1/2). The Durasul material is identical to that which was previously characterized and cleared for use in the Allofit 28mm Alpha Durasul Inserts.

The provided text is a 510(k) summary for a medical device (Allofit Acetabular System 32mm Alpha Durasul Inserts) and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a diagnostic AI/ML device would.

This document describes a medical device rather than a software or AI/ML diagnostic tool. The "acceptance criteria" discussed in such a submission relate to showing substantial equivalence to a predicate device, primarily through design, materials, manufacturing processes, and intended use, rather than performance metrics like sensitivity, specificity, or AUC as one would expect for a diagnostic AI.

Therefore, many of the requested fields (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.

Here's an analysis based on the information available in the document, and a clear indication where information is not present:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The submission demonstrates substantial equivalence to a predicate device rather than fulfilling specific performance acceptance criteria through clinical or diagnostic studies. The "acceptance criteria" here are implicitly tied to demonstrating that the new device (32mm Alpha Durasul Inserts) is as safe and effective as the previously cleared predicate device (28mm Alpha Durasul Inserts) and other existing components of the Allofit system.

1. A table of acceptance criteria and the reported device performance

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. This submission is for a physical medical device (acetabular inserts), not a diagnostic algorithm. It does not involve a "test set" of patient data in the typical sense of AI/ML performance evaluation. The "test" here is the comparison against the predicate device based on design, materials, and established manufacturing controls.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. There is no "ground truth" to be established by experts for a test set in this context. The evaluation is based on engineering principles, material science, and regulatory comparison.

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

• Not applicable. No adjudication method for a test set is relevant for this device submission.

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 is not a diagnostic AI device, so MRMC studies and human reader improvement with AI assistance are not relevant.

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

• Not applicable. This is a physical medical implant, not an algorithm.

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

• Not applicable. No "ground truth" in the clinical or diagnostic sense is used. The basis for safety and effectiveness is substantial equivalence to a predicate device, relying on established performance of similar materials and designs, backed by manufacturing quality systems and material standards (e.g., ISO 5834-1/2).

8. The sample size for the training set

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

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

• Not applicable. There is no "training set" or "ground truth" in this context.

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