(98 days)
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
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Insertion & Removal Testing | Not explicitly stated, but implied to demonstrate safe and proper usage. | Performed. |
| Static 4-Point Bending | Not explicitly stated, but implied to meet or exceed predicate device performance. | Performed. Demonstrate that the design differences between the Flex-Thread Clavicle Pin and the Elastic Intramedullary Nail introduce no new issues of safety or effectiveness. Side-by-side performance testing demonstrates substantial equivalence to the Elastic Intramedullary Nail predicate device. |
| Fatigue 4-Point Bending | Not explicitly stated, but implied to meet or exceed predicate device performance for durability. | Performed. Demonstrate that the design differences between the Flex-Thread Clavicle Pin and the Elastic Intramedullary Nail introduce no new issues of safety or effectiveness. Side-by-side performance testing demonstrates substantial equivalence to the Elastic Intramedullary Nail predicate device. |
| Tensile Testing | Not explicitly stated, but implied to meet or exceed predicate device performance for strength. | Performed. |
| Torsion Testing | Not explicitly stated, but implied to meet or exceed predicate device performance for rotational forces. | Performed. |
| Implant Tip Flexibility Testing | Not explicitly stated, but implied to demonstrate appropriate flexibility as designed. | Performed. |
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.
§ 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.