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The device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
4. Correction of functional deformity.
5. Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur with head involvement that is unmanageable using other techniques.
   The device is intended for cementless use.

U-Motion II PS Cup is an extension of cleared "UNITED" U-Motion II Acetabular System (K122185). The indications, major design features, materials, major manufacture processing and methods, size distribution of this subject are identical to the cleared U-Motion II Acetabular System (K122185). This device is manufactured from titanium alloy forging (ASTM F620) which are forged by titanium alloy bars (ASTM F136). The outer surface of U-Motion II PS+ Cup is coated with CP Ti power (ASTM F1580), and the coating layer is thicker than the cleared U-Motion II PS Cup (K122185). U-Motion II PS* Cup includes cluster-holed, no-hole and multi-hole series, and there are nineteen sizes of acetabular shell available, ranging from 44 through 80 mm outer diameter in 2 mm increments.

The provided text is a 510(k) Summary for the "U-Motion II PS+ Cup" acetabular cup, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of a clinical trial or AI model validation.

Therefore, many of the requested elements (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable in this regulatory submission for a orthopedic implant.

Here's an analysis based on the available information:

Description of Acceptance Criteria and Proving Device Meets Them

The "acceptance criteria" in this context are for demonstrating substantial equivalence to a legally marketed predicate device, as required for 510(k) clearance by the FDA. The study proving the device meets these criteria is the comparison presented in the 510(k) summary, specifically focusing on physical and mechanical properties.

The core "acceptance criteria" are that the device shares the same intended use, materials, basic design features, and performs at least as safely and effectively as the predicate device, or any differences do not raise new questions of safety and effectiveness.

The document states:
"The mechanical properties of the modified surface have been evaluated to conform to FDA guidance: 'Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Guidance for Industry and FDA' and 'Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement.' The analysis results demonstrate that the coating layer thickness increase would not affect the safety and effectiveness."

This indicates that the acceptance criteria for the device involved adherence to specific FDA guidance documents for mechanical property testing of orthopedic implants with modified metallic surfaces. The "study" proving this was the mechanical property evaluation of the modified surface.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for an orthopedic implant extension, specific numerical performance metrics like sensitivity, specificity, accuracy (which would be common for AI/diagnostic devices) are not presented in this summary. Instead, the "performance" is about meeting safety and effectiveness standards through material and mechanical testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size used for the test set: Not applicable in this context. The "test set" here refers to physical components undergoing mechanical testing, not patient data or images. The specific number of physical samples tested is not disclosed in the summary.
• Data provenance: Not explicitly stated for the mechanical testing. This would typically be generated by the manufacturer's R&D or an accredited testing lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of experts: Not applicable. Ground truth in this context refers to the results of mechanical and material property tests (e.g., tensile strength, fatigue resistance), which are objectively measured, not subject to expert consensus in the same way as diagnostic image interpretation.
• Qualifications of experts: N/A.

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

• Adjudication method: Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for physical product testing.

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

• MRMC study: No, this is not an AI/diagnostic device. This is a medical implant (acetabular cup).

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

• Standalone performance: Not applicable. This is not an AI algorithm.

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

• Type of ground truth: The "ground truth" for this device revolves around objective engineering and material science measurements, such as:
  • Material composition analysis (e.g., ASTM F620, ASTM F136, ASTM F1580 standards).
  • Dimensional accuracy checks.
  • Mechanical strength tests (e.g., fatigue, static strength), as per the specified FDA guidance documents.
  • Verification of coating thickness and adhesion.

8. The sample size for the training set

• Sample size for the training set: Not applicable. This is not an AI/machine learning device.

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

• How ground truth was established: Not applicable. This is not an AI/machine learning device.

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