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The Flex-Thread Fibula Pin System is intended for use in the fixation of fibula fractures and osteotomies.

The Flex-Thread Fibula Pin System is comprised of an intramedullary fixation device with a flexible threaded tip to engage the proximal portion of a Fibula, and cortical screws to further enhance stability and fixation of the Fibula.

This document is a 510(k) summary for the Flex-Thread Fibula Pin System, a medical device intended for the fixation of fibula fractures and osteotomies. It does not describe an AI/ML-enabled device or a study involving human readers or comparative effectiveness in the context of diagnostic performance. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

A nonclinical testing study was performed to characterize the performance of the Flex-Thread Fibula Pin System. The document states: "All necessary testing has been performed for the worst-case Flex-Thread Fibula Pin to assure substantial equivalence to its predicates and to demonstrate the subject device performs as intended. All testing was performed on test units representative of finished devices."

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "test units representative of finished devices" for nonclinical testing. This typically implies a defined number of devices tested according to specific protocols, but the exact count is not given.
• Data Provenance: Not applicable in the context of clinical data for this type of device. The testing described is nonclinical (bench testing).

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

Not applicable. The ground truth for mechanical testing is based on engineering specifications and direct measurement, not expert medical opinion.

4. Adjudication Method for the Test Set:

Not applicable for nonclinical mechanical testing.

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 device is a mechanical implant, not an AI/ML diagnostic aid for human readers.

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

Not applicable. This device is a mechanical implant, not an algorithm.

7. The Type of Ground Truth Used:

• For mechanical performance (bench testing): Engineering specifications, established testing standards (e.g., ASTM standards implied by the type of tests), and direct physical measurements serve as the ground truth.
• For biocompatibility: International Standard ISO 10993-1 and relevant FDA guidance.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML model that requires a training set.

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

Not applicable.

Summary of the Study:

The study described is a nonclinical performance evaluation of the Flex-Thread Fibula Pin System. It involved a series of bench tests to assess the mechanical properties and biocompatibility of the device, primarily to demonstrate substantial equivalence to predicate devices. Key tests included:

• Insertion & Removal Testing
• Static & Fatigue 4-Point Bending Testing
• Torsion Testing
• Implant Tip Flexibility Testing

The material used, titanium 6Al-4V ELI (ASTM F136), was also assessed for biocompatibility according to ISO 10993-1 guidelines. The conclusion of these tests was that the device performs as intended and is substantially equivalent to its predicate devices in terms of indications for use, design, performance, and function. The document explicitly states: "Clinical data were not needed to support the safety and effectiveness of the subject device."

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The Flex-Thread Clavicle Pin System is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.

The Flex-Thread Clavicle Pin System is comprised of an intramedullary fixation device with a flexible threaded distal tip to engage the curved medial portion of a clavicle, and a proximal cross screw to further enhance stability and fixation to the lateral portion of the clavicle.

This document describes the Flex-Thread Clavicle Pin System, a medical device, and its acceptance criteria for premarket notification (510(k)) to the FDA. The information provided is for device and mechanical performance testing, not AI/algorithm performance. Therefore, many of the requested fields related to AI study design (e.g., sample size for AI test set, expert ground truth, MRMC studies) are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "The mechanical testing demonstrates that the design differences between the Flex-Thread Clavicle Pin and the Elastic Intramedullary Nail introduce no new issues of safety or effectiveness." and "Side-by-side performance testing demonstrates the substantial equivalence of the Flex-Thread Clavicle Pin System to the Elastic Intramedullary Nail predicate device." This implies the performance of the Flex-Thread Clavicle Pin System met or exceeded the performance of the predicate device for all tests.

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

This section is not applicable as the document describes mechanical and material testing of a physical medical device, not an AI/algorithm. No patient data or clinical images were used in this specific submission. All testing was performed on "test units representative of finished devices."

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

This section is not applicable. Ground truth, in the context of AI, refers to expert labeling of data. This document describes physical device testing, not AI performance evaluation.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods are used in studies involving human interpretation or expert consensus on data, typically in AI performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This section is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance, which is not described here. Clinical data were explicitly stated as "not needed to support the safety and effectiveness of the subject device" for this 510(k) submission.

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

This section is not applicable. This document describes a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this medical device's performance is established through physical and mechanical testing standards and comparison to a legally marketed predicate device's performance. The "ground truth" here is the established safe and effective performance characteristics of similar devices, as demonstrated through objective mechanical tests.

8. The Sample Size for the Training Set

This section is not applicable. There is no training set mentioned, as this is not an AI/algorithm.

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

This section is not applicable. There is no training set for an AI/algorithm in this document.

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