(34 days)
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
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Summary) |
|---|---|
| Insertion & Removal | Performed (assumed to meet internal specifications) |
| Static & Fatigue 4-Point Bending | Performed (assumed to meet internal specifications) |
| Torsion Testing | Performed (assumed to meet internal specifications) |
| Implant Tip Flexibility Testing | Performed (assumed to meet internal specifications) |
| Biocompatibility | Established per ISO 10993-1 and relevant FDA guidance |
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."
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.