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The Syntec Femoral Nail System is indicated for long bone fracture fixation which may include the following: Fractures, and tumor resections; Fractures proximal to a total knee arthroplasty; Supracondylar and ipsilateral fractures; Delayed union fractures; Open and closed femur shaft fractures; Combined inter and subrochanteric fractures; High subtrochanteric fractures; Pseudoarthrosis and correction osteotomy; Pathological fractures, impending pathologic and tumor resections; Pertrochanteric fractures; and Nonunions and malunions.

The Syntec Femoral Nail System are manufactured from commercially SUS316L (stainless steel) and Ti-6AL-4V (Titanium alloy). It is an intramedullary (IM) nail with a 5° proximal bend allows the nail to be inserted through the tip of the greater trochanter for an easier surgical approach. These nails have a 135° recon screw angle for easier placement of two 6.3 mm Recon Screws into the femoral neck and ø5mm internal hex captured screws in various lengths for cross-screw fixation in both the proximal and distal portion of the nail. Also, an End Cap ø13 in 3, 5, 10, 15mm lengths is available for proximal closing of the nail. The Syntec Femoral Nail System (nail, screw and end cap) are provided Non-Sterile and single use only. Also, it is not for spinal use. Associated instrumentation such as aiming device for proximal and distal, insertion guide wire, drill accessories, system and removal instruments are available with the system.

This document describes the Syntec Femoral Nail System, an intramedullary fixation rod. The information provided outlines the system's design, intended use, and a comparison to predicate devices, but it contains limited details regarding specific acceptance criteria and study outcomes.

Here's an analysis of the provided text in relation to your request:

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

The document mentions that "The procedure of evaluating the device tests was according to the standard of ASTM-F1264-16." It also states, "According device test report of performance data demonstrate that the Syntec Femoral Nail is as safe and effective as K040462, K984543 and K161327."

However, the document does not provide a table of specific acceptance criteria (e.g., minimum bending strength, torsional stiffness, fatigue life) or the actual reported device performance values against those criteria. It only states that the testing was performed and demonstrated substantial equivalence to the predicate devices. To fulfill this request, concrete numerical values for both acceptance criteria and the device's performance would be needed.

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

The document states, "The testing was done to our Syntec Femoral Nail System device to demonstrate substantial equivalence."

The document does not specify the sample size used for the test set, nor does it provide information on the data provenance (e.g., country of origin, retrospective or prospective study design). Given that the testing was "to our Syntec Femoral Nail System device," it's likely referring to a bench testing study on the device itself, rather than a clinical study with human patients.

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 to the type of study described. The document refers to "device tests" according to a standard like ASTM-F1264-16, which are typically mechanical or material property tests performed in a lab setting, not evaluations requiring expert interpretation of medical images or clinical outcomes.

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

This information is not applicable for the same reasons as point 3. Adjudication methods are relevant for studies involving human interpretation or clinical endpoint assessments, which are not detailed here.

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. The device described is an intramedullary fixation rod, a physical implant for fracture fixation. It is not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.

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

This information is not applicable as the device is a physical medical implant, not an algorithm or software.

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

For the "device tests" mentioned (which are presumed to be mechanical testing), the "ground truth" would be established by the specific test methods and measurement standards outlined in ASTM-F1264-16. For example, force exerted, displacement measured, or cycles to failure. These are objective, measurable physical properties, not ground truth established by expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

This information is not applicable as the device is a physical product and does not involve machine learning or AI that would require a training set.

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

This information is not applicable for the same reasons as point 8.

In summary, the provided text describes the regulatory clearance of a physical medical device (Syntec Femoral Nail System) based on substantial equivalence and performance testing to an industry standard (ASTM-F1264-16). It lacks the detailed information typically found in documentation for AI/software medical devices regarding acceptance criteria, study design, expert involvement, and ground truth establishment. The context of your questions seems to overlap with requirements for AI/ML-based medical devices, which the Syntec Femoral Nail System is not.

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