(114 days)
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
| Criteria | Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | The ability of the Flow-Nail to withstand static and dynamic compression bending loads. | The Flow-Nail must demonstrate substantial equivalence in mechanical performance to the identified predicate devices (Zimmer Natural Nail System, Stryker Gamma 3 Nail System, AOS Trochanteric Nail). | "Mechanical testing demonstrates the substantial equivalence of the Flow-Nail relative to the identified predicates when subjected to static and dynamic compression bending loads." (K140601, Page 1) |
| BVF Delivery | The ability of the device to deliver injectable bone void fillers (BVF). | The Flow-Nail must be capable of delivering injectable bone void fillers. | "Yes" (Flow-Nail row under BVF Delivery) (K140601, Page 1) |
| BVF Delivery System Qualification | Qualification testing for the bone void filler delivery system. | Qualification testing (Injectability, Experimental Void Fill Imaging, Static Extraction Torque, BVF Property characterization) performed with specified BVF. | "The qualification testing (i.e., Injectability Testing, Experimental Void Fill Imaging Studies, Static Extraction Torque, BVF Property characterization), was performed with ETEX Beta-bsm and CarriGen (K062630, K072355, K090242, K101557)." (K140601, Page 1) |
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.
§ 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.