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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 KOSMO™ HA coated stems and Grit-Blasted stems are intended for cementless use only.

The b-ONE® Total Hip System KOSMO™ Stainless Steel stems are intended for cemented use only.

The b-ONE® Cement Restrictor is intended to restrict bone cement migration into the distal medullary canal and aid in cement pressurization during total hip arthroplasty.

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

b-ONE Total Hip System KOSMO Femoral Stem consists of cementless and cemented bone compacting stem options. The b-ONE KOSMO Femoral Stems Sizes are offered in 12 femoral stem sizes ranging from size 0 to 10 with half size of 4.5 for Cementless Collared Standard, High, and Proportional Offset families and 11 femoral stem sizes ranging from size 1 to 10 with half size of 4.5 for Cementless Collarless/Collared Coxa Vara families and Cemented Standard and Proportional Offset families.

The subject stems are laser marked with the catalog number, company logo, size, and material. The KOSMO Femoral Stem is composed of titanium alloy Ti-6A1-4V-ELI (ASTM F136) for cementless stems and Stainless Steel (ASTM F1586) for cemented stems. The cementless stems are offered as either HA coated or Grit-blasted.

The b-ONE Cement Restrictor is made from UHMWPE (ASTM F648/ISO 5834-1). The restrictor is offered in 7 different sizes with a major diameter of 9, 11, 13, 15, 17, 20, and 23mm and have a total length of 17mm. The cement restrictor is to be used for cement implantation. This b-One Cement Restrictor is intended to restrict bone cement migration into the distal medullary canal and aid in cement pressurization during total hip arthroplasty.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the b-ONE® Total Hip System, which primarily discusses the substantial equivalence of the subject device to legally marketed predicate devices.

The content focuses on:

• The FDA's decision regarding the 510(k) submission (K240528).
• Regulatory information, classifications, and requirements for the device.
• Indications for Use for the b-ONE® Total Hip System.
• A comparison of technological characteristics with predicate devices.
• A list of non-clinical performance tests conducted, but not the acceptance criteria for these tests, nor the detailed results proving they were met.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance, or describe the study details (sample size, ground truth, expert qualifications, adjudication, MRMC, or standalone performance) because that information is not present in the provided text.

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