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This device is intended for use in combination with UNITED Femoral System for cemented or cementless hip replacement in skeletally mature patients with the following conditions: non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; inflammatory degenerative joint disease such as rheumatoid arthritis; correction of function deformity; revision procedures where other treatments or devices have failed; treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

"UNITED" U2 Bipolar Implant, designed with a simple one-step assembly interface between femoral head and U2 Bipolar Implant, is a hemiarthroplasty design. U2 Bipolar Implant consists of an outer shell into which a bearing insert has been permanently assembled. The bearing insert has a factory assembled stopper ring and metal wire. The assembled prosthesis provides for primary articulation at the femoral head/inner polyethylene bearing interface and secondary articulation at the outer shell/acetabulum interface. The internal aspect of the shell is designed to lock the polyethylene liner. The outer metal surfaces of the bipolar hip prosthesis are highly polished for articulation with the patient's acetabulum. Components are available in a range of sizes to fit varying anatomical requirements. U2 Bipolar Implant are offered in 41-73 mm outer diameters and is designed to be used with either 26mm, 28mm, or 36 mm femoral heads, depending on the inner diameter liner. The minimum thickness of the polyethylene at its thinnest point at a load bearing area of the liner is at lest 5.mm in U2 Bipolar Implant.

The provided 510(k) summary for the U2 Bipolar Implant (K101670) does not contain the detailed information requested regarding specific acceptance criteria, study designs, sample sizes for test sets, expert qualifications, or ground truth establishment.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (U1 Hip System - Bipolar (K050269) and "Wright" GLADIATOR Bipolar System (K062693)) through device description, intended use, and a limited set of performance bench tests.

Here's a breakdown of what can be extracted and what is missing based on your request:

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

Note: The document only lists the types of performance tests performed, not specific quantitative acceptance criteria or the numerical results of those tests. The basis for acceptance appears to be substantial equivalence to predicate devices, meaning the U2 Bipolar Implant performs similarly to the U1 Hip System - Bipolar and the "Wright" GLADIATOR Bipolar System for these tests.

2. Sample size used for the test set and the data provenance

The document only mentions "Performance Test - Bench" and lists two tests. It does not specify any sample sizes for these tests or the data provenance (e.g., country of origin, retrospective/prospective). These were likely conducted in vitro (bench tests) rather than using patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided as the tests described are bench tests and do not involve human expert assessment for ground truth.

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

This information is not applicable and not provided as the tests described are bench tests and do not involve human adjudication.

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

This information is not applicable and not provided. This submission is for a physical orthopedic implant, not an AI-assisted diagnostic device or software that would involve human readers.

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

This information is not applicable and not provided. This submission is for a physical orthopedic implant, not an algorithm or software.

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

For the bench tests mentioned, the "ground truth" would be the engineering specifications and design requirements for the locking mechanism and range of motion for hip implants, which are typically established through industry standards, regulatory guidance, and comparisons to predicate devices. The document does not explicitly state the type of ground truth used but implies adherence to established engineering principles for orthopedic devices.

8. The sample size for the training set

This information is not applicable and not provided. The device is a physical hip implant, not an AI model that requires a training set.

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

This information is not applicable and not provided. The device is a physical hip implant, not an AI model.

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