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Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
   The C-Stem AMT LE Hip Prosthesis is indicated for cemented use only.

The C-Stem AMT LE Hip Prosthesis is a collarless, triple-tapered, cemented femoral stem designed to be used as one component of a system of prostheses in hip arthroplasty. It is manufactured from wrought stainless steel conforming to ISO 5832-9 (Ortron-90®) and is polished overall. It is designed to be used with commercially available modular femoral heads, either metal or ceramic. The subject device is compatible with DePuy acetabular shells and liners.
The C-Stem AMT LE Hip Prosthesis is a line extension of the predicate C-Stem AMT Hip Prosthesis cleared under 510(k) numbers K042959 and K082239.
The subject C-Stem AMT LE Hip Prosthesis and the predicate C-Stem AMT Hip Prosthesis are comprised of identical materials and share common design features, including a polished full-length triple tapered intramedullary geometry, 12/14 Articul/EZE Mini Taper and a raised lateral shoulder.

The provided text is a 510(k) Summary for the C-Stem AMT LE Hip Prosthesis. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical testing and comparison of technological characteristics. It explicitly states that no clinical tests were conducted.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, and ground truth establishment for a clinical study proving device meets acceptance criteria cannot be extracted from this document. This type of information is typically found in documents detailing clinical trials or performance evaluations of AI/ML-based devices.

The document discusses non-clinical tests and their adherence to ISO standards and other specifications, which function as acceptance criteria for those specific tests to demonstrate substantial equivalence, but not for overall device clinical performance against established clinical acceptance criteria.

However, I can provide the following based on the document:

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

The document doesn't present a table of specific acceptance criteria for overall device performance and corresponding clinical results. Instead, it describes non-clinical tests performed to demonstrate substantial equivalence to predicate devices. The "reported device performance" in this context refers to the device meeting the requirements of these standards.

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

This information is not applicable as the document explicitly states "No clinical tests were conducted to demonstrate substantial equivalence." The non-clinical tests would have involved specific test articles (physical devices or components), but the sample sizes of these are not detailed in the summary. Data provenance is not relevant as it's not clinical data.

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)

This information is not applicable as no clinical tests were conducted and thus no "ground truth" established by experts in a clinical context. The non-clinical tests are evaluated against predefined engineering and material standards.

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

This information is not applicable as no clinical tests were conducted.

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. This describes a device for hip replacement surgery, not an AI/ML-based diagnostic or assistive technology that would involve "human readers" or "AI assistance."

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

This information is not applicable as this device is a physical hip prosthesis and not an algorithm.

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

This information is not applicable as no clinical tests were conducted requiring a "ground truth." The product's compliance is demonstrated through adherence to engineering and material standards.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI/ML system requiring a training set.

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

This information is not applicable as this is a physical medical device, not an AI/ML system requiring a training set and ground truth establishment.

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