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This femoral stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions:
• Noninflammatory degenerative joint disease (NIDJD), e. g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e. g., rheumatoid arthritis.
• Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists.
• Optional use in revision: in some medical conditions (e. g., early revision when healthy and good bone stock exists) the surgeon may opt to use primary implants in a revision procedure.
This stem is for uncemented use only.

The Fitmore® Hip Stem is a modular femoral stem intended for total or hemi-hip arthroplasty. The component is an uncemented stem which is coated proximally with Titanium Vacuum Plasma Spray and rough-blasted distally for primary stability. The stem design is curved and features a trapezoidal cross-section.
The 12/14 femoral stem is available in multiple sizes, consisting of three stem families. The different family designs were developed in order to meet various patients' anatomic needs. As the anatomic offset varies considerably between individuals, the Fitmore® Hip Stem offers a wide range of offset options. Each family is designed with a CCD angle of 140°, 137°, 129° and 127°.

This document is a 510(k) premarket notification for a medical device called the "Fitmore Hip Stem." It concerns the substantial equivalence of the device to legally marketed predicate devices.

Based on the provided text, the device is a hip implant, and the performance data described is focused on non-clinical aspects like packaging and sterilization, not on the clinical performance or diagnostic accuracy of an AI or software-as-a-medical-device (SaMD) product.

Therefore, most of the requested information regarding acceptance criteria, study methodologies (sample size, expert ground truth, adjudication, MRMC, standalone performance), and training set details for AI/SaMD devices is not applicable to this document. This document is for a physical orthopedic implant.

Here's what can be extracted and what cannot:

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

The document describes non-clinical performance testing for packaging and labeling integrity. It does not provide specific quantitative acceptance criteria or performance metrics in a table format that would be typical for an AI/SaMD product.

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

• Sample Size: The document mentions "representative worst-case products" were used for packaging configuration testing, but no specific sample size (N) is provided.
• Data Provenance: Not applicable in the context of clinical data for a physical implant. The testing was conducted by the manufacturer (Zimmer GmbH). The document implies the tests are laboratory-based, not patient-derived 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 applicable. The "ground truth" for a physical implant's packaging integrity is based on testing against ISO standards, not expert medical opinion on imaging or diagnostic accuracy.

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

This information is not applicable. Adjudication methods are relevant for subjective interpretations of data (e.g., radiologist reads) in clinical studies, not for objective engineering tests of packaging.

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 device is a physical hip stem, not an AI or software product. Therefore, no MRMC study or AI assistance is relevant.

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

This information is not applicable. This is not an algorithm or software device.

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

The "ground truth" for the non-clinical performance (packaging) was based on compliance with international standards (ISO 11607-1:2009 and ISO 11607-2:2006) and physical integrity. No expert consensus, pathology, or outcomes data were used for this type of testing.

8. The sample size for the training set:

This information is not applicable. There is no "training set" as this is not a machine learning or AI device.

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

This information is not applicable for the same reason as above.

In summary: The provided document is an FDA 510(k) clearance letter for a conventional medical device (a hip stem), not a software or AI-driven diagnostic/therapeutic device. Therefore, the questions related to AI/SaMD performance metrics and study methodologies are generally not relevant to the content of this document.

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