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The Femoral Trochanteric Nail System - Neonail is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric and shaft regions of the femur.

An intramedullary nail is a metal rod implanted into the medullary cavity of a bone to treat fractures that occur in long bones of the body. Femoral Trochanteric Nail System – Neonail consists of metal rods, bone screws, and end caps. The rods are cannulated and are provided with screw holes to accommodate screws of various diameters and lengths. The rods are available in a range of sizes used for specific anatomic locations and fracture configurations.

I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them with the level of detail requested. The document is an FDA 510(k) clearance letter for a medical device (Femoral Trochanteric Nail System - Neonail), which primarily focuses on demonstrating substantial equivalence to a predicate device.

Here's why I cannot fulfill your request completely:

• No acceptance criteria are explicitly stated in a tabular format. The document describes a comparison to a predicate device to establish substantial equivalence, not a set of specific performance acceptance criteria for the new device.
• The document states "Clinical data were not submitted in this premarket notification." This means there was no clinical study conducted on the device to prove it meets clinical acceptance criteria. Instead, the submission relies on non-clinical data (engineering analysis, dimensional analysis, and mechanical testing) to show substantial equivalence.

Therefore, I cannot provide information on:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set or data provenance for a clinical study.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• A multi-reader multi-case (MRMC) comparative effectiveness study.
• A standalone performance study based on clinical data.
• The type of ground truth used from a clinical study.
• Sample size for a training set (as no AI/machine learning component is mentioned or evaluated).
• How ground truth for a training set was established.

However, I can extract the following relevant information regarding the non-clinical data used for demonstrating substantial equivalence:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical)

While not in your requested format, the device's performance was evaluated against standards applicable to intramedullary fixation devices. The "acceptance criteria" here are implicitly meeting the requirements of these standards and demonstrating equivalence to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set (Non-clinical): The document refers to "worst case nail" and "worst case screws" being subjected to testing. It doesn't specify the exact number of nails or screws tested beyond referencing "worst case." The data provenance is from non-clinical mechanical testing conducted by the manufacturer (Neoortho Produtos Ortopédicos SA). It is prospective in the sense that the tests were conducted specifically for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

• Not applicable. This information pertains to clinical studies, which were explicitly stated as "not submitted."

4. Adjudication Method for the Test Set:

• Not applicable. This information pertains to retrospective clinical studies or expert consensus processes, neither of which were performed for this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This type of study involves human readers interpreting cases, often with and without AI assistance, and was not performed.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

• No. This device is a physical medical implant, not an algorithm. The standalone performance refers to the device's mechanical integrity as tested against industry standards.

7. The Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" is established by engineering and mechanical testing standards (e.g., ASTM F1264, ASTM F384-17, ASTM F543) and a referenced scientific article for cut-out testing (SOMMERS et al., 2004). The "truth" is whether the device meets the physical requirements and behaviors defined by these standards.

8. The Sample Size for the Training Set:

• Not applicable. No training set is mentioned as this is a physical device, not an AI or machine learning model.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. No training set is involved.

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