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The subject Trident Acetabular Shells are single-use devices intended for cementless fixation within the prepared acetabulum. The subject acetabular shells are intended for use with mating Trident Polyethylene Cup Inserts.

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.

This Special 510(k) submission is intended to address a surface coating modification from plasma sprayed CP Titanium to arc deposited CP Titanium to the Trident® Hemispherical Shells The intended use, manufacturing with Plasma Spray and/or Hydroxylapatite (HA) Coating. methods, materials, packaging and sterilization of the subject device are identical to those of predicate devices. The predicate Trident® Hemispherical Shells with Plasma Spray and HA were found substantially equivalent via the 510(k) process in K001448 and K001449 respectively. Likewise, the Arc Deposited (AD) CP Titanium surface roughness coating was found substantially equivalent in 510(k) #K943054, and the AD-HA combination was found substantially equivalent via 510(k) #K942900.

The substrate of the predicate hemispherical shells is Titanium (Ti-6AI-4V ELI) Alloy conforming to ASTM F-620. The surface coating of Arc Deposited CP Titanium meets ASTM standard F-67 while the Hydroxylapatite coating conforms to ASTM F-1185. The subject devices have a shell size or outer diameter range from 42mm to 82mm. Like the predicate devices, the subject devices are single-use devices intended for cementless fixation within the prepared acetabulum in primary or revision total hip arthroplasty. The subject acetabular shells are intended for use with mating Trident Polyethylene Cup Inserts and all legally marketed Howmedica Osteonics femoral head and femoral stem components.

The provided documents are a 510(k) summary and an FDA clearance letter for a medical device (Trident® Hemispherical Acetabular Shells) and do not contain information about acceptance criteria or a study proving the device meets said criteria in the context of AI/ML performance.

This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through comparing materials, design, intended use, and manufacturing processes, rather than reporting on the performance of a software algorithm based on specific acceptance criteria and a detailed study as would be expected for an AI/ML medical device.

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size, or ground truth establishment for the training set) from the provided text.

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