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The Tritanium Acetabular Shell is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function.
Indications:

1. Painful, disabling joint disease of the hip resulting from: non-inflammatory degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis.
2. Revision of previous failed femoral head replacement, shell arthroplasty or other procedure.
3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
4. Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
   This acetabular shell is intended for cementless use only.

The Tritanium® Acetabular Shell consists of a hemispherical acetabular shell in both solid-backed and cluster screw-hole design and is compatible with all polyethylene Trident inserts. Both shell designs will be available in sizes 44-72 mm outside diameter (OD) in 2 mm increments. The Trident shell is being modified to include a proprietary porous coating, Particle Sintered Foam. The particle sintered foam (PSF) porous metal technology offers net-shape coatings on acetabular shells from which devices can be fabricated.

The provided text is a 510(k) summary for a medical device called the "Tritanium Acetabular Shell System." It describes the device, its intended use, indications for use, and establishes substantial equivalence to predicate devices.

However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for an AI/algorithm device submission. This document pertains to a physical orthopedic implant. Therefore, the requested information elements related to AI device performance evaluation (such as sample sizes for test/training sets, data provenance, number/qualification of experts for ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable to this particular document.

The "acceptance criteria" for a physical device like this would generally relate to mechanical properties, biocompatibility, sterilization, and manufacturing quality, which are assessed through various engineering tests and quality control measures, not through clinical performance metrics against a ground truth as for an AI diagnostic algorithm.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance based on the input document when it comes to AI/algorithm specific performance metrics.

The document does describe the device's intended use and indications for use, which are foundational to its acceptance for market. The FDA's acceptance in this case is based on a determination of substantial equivalence to legally marketed predicate devices, meaning it has similar technological characteristics and is as safe and effective as the predicates.

If this were an AI device, the information would likely be found in sections describing clinical validation studies, performance metrics, and a comparison to a predefined standard or human performance. This document, being for a physical implant, focuses on design, materials, and equivalence to existing devices.

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