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The Flow-Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric, and high subtrochanteric fractures and combinations of these fractures. The Flow-Nail can also be used to deliver injectable bone void fillers to a surgical site.

The Flow-Nail is a dynamic compression trochanteric nail system and includes an intramedullary nail, a fenestrated lag screw, anti-rotation screw, cortical screws, a cap and accompanying surgical instruments. The Flow-Nail components are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The purpose of this Special 510(k) is to add the 10mm IM Nail to the Flow-Nail System. The IM Nail (10mm) is manufactured from Ti-6Al-4V per ASTM F136. The components are provided non-sterile, for single use, by prescription only.

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Flow-Nail." It contains information about the device's classification, indications for use, and a summary of the 510(k) submission, including predication and performance testing.

However, the document does not contain any information about an AI-powered device or a study involving acceptance criteria, ground truth, expert readers, or multi-reader multi-case (MRMC) comparative effectiveness studies. The performance testing mentioned is mechanical testing (compression bending strength) per ASTM standards for an intramedullary fixation rod, not an AI or imaging device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is absent from the provided text.

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The Flow-Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric, and high subtrochanteric fractures and combinations of these fractures. The Flow-Nail can also be used to deliver injectable bone void fillers to a surgical site.

The Flow-Nail is a dynamic compression trochanteric nail system and includes an intramedullary nail, a fenestrated lag screw, anti-rotation screw, cortical screws, a cap and accompanying surgical instruments. The Flow-Nail components are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The purpose of this Special 510(k) is to add Flow-Nail with Laglock to the Flow-Nail System. The components are provided non-sterile, for single use, by prescription only.

This document concerns a medical device called "Flow-Nail," an intramedullary fixation rod, and an addition to the system called "Flow-Nail with Laglock." The submission is for a 510(k) premarket notification, which is a process to demonstrate that a device is substantially equivalent to a predicate device already legally marketed.

The document does not contain information about the performance or acceptance criteria of an Artificial Intelligence (AI) / Machine Learning (ML) enabled medical device. The testing described is non-clinical performance data for an implantable orthopedic device, specifically mechanical strength tests (Compression Bending Strength Dynamic and Static per ASTM F384).

Therefore, I cannot provide the requested information regarding the acceptance criteria and study proving an AI/ML device meets these criteria, as the provided text pertains to a traditional mechanical medical device, not an AI/ML device.

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The Flow-Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric, and high subtrochanteric fractures and combinations of these fractures. The Flow-Nail can also be used to deliver injectable bone void fillers to a surgical site.

The Flow-Nail is a dynamic compression trochanteric nail system and includes an intramedullary nail, a sliding fenestrated lag screw, anti-rotation screws, a cap and accompanying surgical instruments. The Flow-Nail components are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136.

Acceptance Criteria and Study for Flow-Nail (K140601)

The Flow-Nail is an intramedullary fixation rod intended to treat stable and unstable proximal femur fractures and to deliver injectable bone void fillers. The device's substantial equivalence to predicate devices was established through a comparison of various attributes, including mechanical performance.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The provided document (K140601 510(k) Summary) does not explicitly detail the sample size or data provenance (e.g., country of origin, retrospective/prospective) for the test set used in the mechanical performance studies. The study primarily relies on a comparative mechanical testing approach rather than clinical trial data.

3. Number of Experts and Qualifications for Ground Truth of Test Set

This type of submission (510(k) for an intramedullary fixation rod) does not typically involve human expert adjudication for a "test set" in the context of clinical outcomes or imaging classification. The evaluation is based on engineering and material science standards and physical testing. Therefore, the concept of "experts establishing ground truth" as it would apply to, for example, image interpretation, is not relevant here. The "experts" would be the engineers and scientists conducting the mechanical tests and comparing the results to established standards and predicate device performance.

4. Adjudication Method for the Test Set

Given the nature of the mechanical performance studies for a medical device like an intramedullary nail, there is no adjudication method described or typically applied in the way it would be for a clinical diagnostic study (e.g., 2+1 or 3+1). The evaluation is based on objective measurements from standardized mechanical tests.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for evaluating the impact of AI on human readers in diagnostic tasks, which is not applicable to the Flow-Nail's pre-market submission which focuses on substantial equivalence through mechanical and material testing.

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

Not applicable. The Flow-Nail is a physical medical device, not an AI algorithm. Therefore, "standalone performance" in the context of an algorithm without human-in-the-loop is not relevant.

7. Type of Ground Truth Used

The "ground truth" for the Flow-Nail's substantial equivalence is based on engineering standards, material specifications, and the established performance of existing predicate devices through standardized mechanical testing. This includes:

• ASTM F136 for titanium alloy composition.
• Static and dynamic compression bending loads for mechanical performance.
• Qualification testing for BVF delivery (Injectability Testing, Experimental Void Fill Imaging Studies, Static Extraction Torque, BVF Property characterization).

8. Sample Size for the Training Set

Not applicable. The concept of a "training set" is relevant for machine learning algorithms. The Flow-Nail is a physical medical device, and its development and testing do not involve a training set in this context.

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

Not applicable, as there is no "training set" for this physical device.

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