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The b-ONE® Total Hip System is intended for primary or revision total hip replacement in skeletally mature patients with a severely disabled hip joint and/or hip damage due to the following conditions:

Osteoarthritis, traumatic arthritis, avascular necrosis of the femoral head, noninflammatory degenerative joint disease (NIDJD), slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis and congenital dysplasia; treatments of nonunion, acute traumatic fracture of the femoral head or neck; failed endoprosthesis, femoral osteotomy, or Girdlestone resection: and fracture-dislocation of the hip.

The b-ONE® Total Hip System is intended for cementless use only.

b-ONE® Total Hip System components are not intended for use with other total hip systems.

The b-ONE™ Total Hip System is an artificial hip replacement system comprised of femoral stems and mating femoral heads; acetabular shells and mating acetabular liners; and, optional 6.5mm acetabular screws. Acetabular Shell options include no-hole and multiple hole configurations.

The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. Compatibility of the femoral head to the stem is only claimed for the b-ONE® Total Hip System. There is no allowed interchangeability with systems manufactured by other companies.

The Tapered Wedge Stem and Acetabular Shells are made from Ti-6A1-4V-ELI. Stem and shell coatings include CPTi Plasma Porous Spray with or without HA. The subject devices are identical to the predicate devices, with the exception that there has been an additional supplier qualified for coatings.

All system components are supplied sterile and are single use devices.

This looks like a 510(k) clearance letter and summary for a medical device, specifically the b-ONE Total Hip System. The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML powered device.

The document describes the b-ONE Total Hip System, its intended use, and a comparison to a predicate device. It lists several non-clinical bench tests that were performed to support substantial equivalence, such as "Endurance and Performance," "Fatigue Test," "Accelerated Wear," and "Biocompatibility." These tests are typical for orthopedic implants and assess the physical and mechanical properties of the device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: These are not provided for performance related to an AI/ML component.
2. Sample size used for the test set and the data provenance: Not applicable as there's no AI/ML component described.
3. Number of experts used to establish the ground truth... and their qualifications: Not applicable.
4. Adjudication method: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone performance (algorithm only): Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document is about a traditional orthopedic implant, not an AI/ML-powered device.

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