(62 days)
WIN Flexible Nail System
WIN Nails (for use in pediatric patients) are to be used for treatment of long-bone fractures including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures.
This device is intended for osteosynthesis.
The WIN Flexible Nail System is to be used for treatment of long-bone fractures including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, distal third fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures.
The subject WIN Flexible Nail System is made of titanium alloy, which has been continuously made commercially available since the 1950s. This device is to be implanted by insertion into long bones for fixation of fractures.
This document is a 510(k) premarket notification for the "WIN Flexible Nail System" and focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in the context of AI/software performance.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, ground truth, and MRMC studies is not applicable to this type of submission.
Here's an analysis based on the provided document:
1. Table of acceptance criteria and the reported device performance
- Not Applicable. This document does not describe performance metrics for a diagnostic or AI device with specific acceptance criteria. It's for a physical medical device (bone fixation nails) and focuses on mechanical properties and material equivalence to a predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No test set or data provenance details are relevant for this type of device submission. The submission relies on demonstrating equivalence through comparison of materials, design features, and intended use, rather than a clinical performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. There is no "ground truth" establishment in the context of an AI/diagnostic device performance study mentioned in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method for a test set is discussed.
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 is not an AI/software device, so no MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. There is no ground truth concept as defined for AI/diagnostic devices in this submission. The "ground truth" in this context is established by the known properties and clinical history of the predicate device and the materials used.
8. The sample size for the training set
- Not Applicable. No training set is involved as this is not a machine learning/AI device.
9. How the ground truth for the training set was established
- Not Applicable. No training set or ground truth for it is relevant.
Information provided in the document related to the device and its assessment:
- Device Name: WIN Flexible Nail System
- Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories
- Regulatory Class: Class II
- Product Code: JDS
- Indications for Use: To be used for treatment of long-bone fractures (including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures) in pediatric patients.
- Predicate Device: Pediatric Fixation Rods (K000764) and 2mm Pediatric Flex Nail (K022531)
- Basis for Substantial Equivalence:
- Intended Use: Identical to predicate
- Indications for Use: Identical to predicate
- Materials: Identical to predicate (titanium alloy, commercially available since the 1950s)
- Design Features: Similar to predicate
- Sterilization: Identical to predicate
- Non-Clinical Tests: "None provided" - The document explicitly states no non-clinical tests were provided in this section of the summary. This implies reliance on the equivalence to the predicate and the established properties of the materials.
- Clinical Tests: "None provided" - No clinical tests were provided for this submission.
Conclusion from document: The submission concludes that the differences between the subject device and the predicate do not raise new questions of safety and effectiveness, and the subject device is at least as safe and effective as the legally marketed predicate devices. This is a common approach for Class II devices demonstrating substantial equivalence.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.