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

• 1. Non-inflammatory degenerative joint disease such as osteoathritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• 2. Inflammatory degenerative joint disease such as rheumatoid arthritis;
• 3. Correction of function deformity;
• 4. Revision procedures where other treatments or devices have failed; and
• 5. Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
     This device is a single use implant and intended for cementless use only.

The U2 Hip Stem, Ti plasma spray is composed of a metallic femoral stem, which is designed to articulate with commercially available U1 and U2 acetabular components and They are manufactured from titanium alloy (ASTM F620). The stems femoral heads. are designed to provide secure fit and fixation in revision hip arthroplasty for anteroposterior bone loss, calcar area defects, metaphyseal bone loss situation. The U2 Hip Stem have a 130° neck angle and Morse taper to receive modular femoral heads. The U2 Hip Stem are available in with collar and collarless types. Each type is available in two lengths, 180mm and 230mm, and 7 diameters: 11mm, 12mm, 13mm, 14mm, 15mm, 16.5mm, 18mm. Distally, the stem is cylindrical with a polished bullet shape tip. The 180mm U2 Hip Stem is available as a straight stem, the 230mm femoral stem has an anterior bow for left and right specific applications. The U2 Hip Stem are fully coated with CP Ti (ASTM F1580). The coating is sprayed with CP Ti powder in thickness 500 um +/-100 um using 200~350 um powder to establish a rough surface for press-fit fixation. This device is a single use implant and intended for cementless use only.

This 510(k) summary (K062978) for the U2 Hip Stem, Ti Plasma Spray, does not contain specific acceptance criteria or details of a study proving the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity, as would be expected for an AI/ML powered device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices based on materials, design, and indications for use. For medical implants like this hip stem, the "acceptance criteria" primarily relate to demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through characterization of its mechanical properties, biocompatibility, and manufacturing processes, rather than performance metrics measured against a ground truth.

Therefore, many of the requested categories related to AI/ML device studies (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of traditional medical device submission.

Here's a breakdown of the information that is available or implied in the provided text:

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

• Acceptance Criteria (Implied for Substantial Equivalence): The primary "acceptance criteria" for a 510(k) submission for this type of device is demonstrating substantial equivalence to predicates. This means showing that the U2 Hip Stem is as safe and effective as the predicate devices, the Reach® Hip Stem, Ti plasma spray (K000760) and United U2 HA/Ti Plasma Spray (K003237). This is typically achieved by demonstrating comparable performance in areas like:

  • Material composition (ASTM F620 titanium alloy, CP Ti coating per ASTM F1580).
  • Design features (130° neck angle, Morse taper, cylindrical distal stem, collar/collarless options, lengths, diameters, anterior bow for 230mm stem).
  • Intended Use/Indications (same clinical conditions as predicates).
  • Mechanical properties, fatigue strength, and wear characteristics (though not detailed in this summary, these would be evaluated in the full submission).
  • Biocompatibility of materials.
  • Manufacturing processes (implicitly assessed for consistency and quality).

• Reported Device Performance: The summary states: "Features comparable to predicate devices, United U2 HA/Ti Plasma Spray (K003237), Reach® Hip Stem, Ti Plasma Spray (K000760), include same materials, design and indications." This is the core "performance" claim for substantial equivalence. No specific quantitative performance metrics (e.g., in vivo survival rates, specific biomechanical test results) are provided in this summary document beyond the physical characteristics.

Regarding items 2-7 (which are primarily relevant for AI/ML device studies):

These items are not applicable to this 510(k) submission for a mechanical implant. This document is a summary for a traditional medical device, not an AI/ML software device or diagnostic tool. Therefore, there's no discussion of test sets, training sets, ground truth derived from experts or pathology, or multi-reader studies.

However, to address them directly for completeness:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* N/A. This device is a mechanical implant, not an AI/ML diagnostic tool requiring a test set of data. Substantial equivalence is typically proven through bench testing, material characterization, and comparisons to predicate device designs and indications.

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)
* N/A. No expert ground truth establishment for a diagnostic test set.

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

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
* N/A.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* N/A. The "ground truth" for this device type would be established standards for implant design, material science, and biocompatibility, as well as clinical experience with similar predicate devices.

8. The sample size for the training set
* N/A. This is not an AI/ML device.

9. How the ground truth for the training set was established
* N/A. This is not an AI/ML device.

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