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The intended use of the Intramedullary Nail System is as follows:

Femoral and Tibial Nails

The Intramedullary Nail System femoral and tibial nails are indicated for use in fixation of femoral fractures including subtrochanteric, intertrochanteric, comminuted or segmental fractures, as well as fractures with bone loss, proximal and distal fractures, and nonunions.

Humeral Nail

The humeral Nail is indicated for comminuted fractures, segmental fractures. fractures with bone loss proximal and distal fractures, as well as nonunions, delayed unions, pathological fractures, floating elbow, nerve lesion, and multiple trauma injuries

The Intramedullary Nail System is a series of cannulated intramedullary rods and interlocking screws for use in fixation of long bone fractures. Included in the system are femoral, tibial and humeral nails in varying diameters and lengths. The design of the nail includes four longitudinal flutes along the length of the nail. The larger sized nails have a sawcut over the majority of the length of the nail to aid in insertion. The distal tip of the nail is conical in shape and tapered. All nails include proximal and distal holes for the insertion of interlocking screws. The nails can be used in either the locked or unlocked mode and can be inserted with or without prior reaming of the medullary canal. The nails and screws are manufactured from stainless steel. The nails are inserted using a closed technique.

This document is a 510(k) summary for a medical device (Intramedullary Nail System), not a study evaluating AI or computational device performance. It describes the device, its intended use, and performance data related to its mechanical properties (bending and torsional strength), comparing it to predicate devices.

Therefore, most of the requested information regarding acceptance criteria, study design for AI/computational devices, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies, is not applicable to this document.

However, I can extract the relevant performance data related to the device's mechanical properties, which serves a similar function to "acceptance criteria" in terms of confirming the device's physical capabilities.

Here's the information that can be extracted from the provided text:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document refers to mechanical testing of physical implants, not data derived from human subjects or clinical imaging.

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)
Not applicable. Ground truth for mechanical testing is based on objective physical measurements and engineering specifications, not expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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
Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this type of device performance is based on objective mechanical engineering measurements according to a specified standard (ASTM Standard F 383).

8. The sample size for the training set
Not applicable. There is no "training set" for mechanical device testing.

9. How the ground truth for the training set was established
Not applicable.

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