(67 days)
The Smith & Nephew Rail System components are intended to be used on adult or pediatric patients as required and are intended to be used for fracture fixation (open and closed); fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudarthrosis of long bones; limb lengthening; infected fractures or non-unions; and correction of long bone deformities. Components in the Smith & Nephew Rail System are for single use only.
Subject of this premarket notification is the Smith & Nephew Rail System. The Smith & Nephew Rail System Subject of the promation notified offers specially designed components used in the management of Is a unlateral extential inxanon system that enoric openally, orthopedic surgery. System lower extremly bone fraction and rooms, distraction/compression devices and associated accessories components include fail Sognions, pir dainter, al. Like the predicate devices listed below, the subject made lion and minute and components that can be used with the rail segments (or frame) to provide a device customized to meet specific patient needs.
This document, K090926b, is a 510(k) summary for the Smith & Nephew Rail System, an external fixation system used in orthopedic surgery. The purpose of this document is to establish substantial equivalence to previously marketed devices.
This submission does not contain information on acceptance criteria or a study proving the device meets acceptance criteria related to device performance in the way a diagnostic AI would be evaluated (e.g., sensitivity, specificity).
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this document refer to the regulatory process for medical devices in the United States, specifically the 510(k) pathway.
The "acceptance criteria" for this device are satisfied by demonstrating substantial equivalence to pre-existing, legally marketed predicate devices. This means the device's technological characteristics, intended use, and performance are sufficiently similar to those already approved by the FDA, such that it can be considered equally safe and effective.
The "study that proves the device meets the acceptance criteria" in this case is the 510(k) submission itself, which presents a detailed comparison of the new device to its predicate devices.
Here's an breakdown of why the requested information about acceptance criteria and performance studies in the context of AI/diagnostic devices isn't present in this 510(k) summary, and what information is provided:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (for this 510(k) submission): Substantial equivalence to identified predicate devices regarding design features, materials, and overall indications for use.
- Reported Device Performance: The document implicitly states performance is equivalent to the predicate devices. No specific quantitative performance metrics (like sensitivity, specificity, accuracy) are provided because this is a mechanical medical device, not a diagnostic or AI algorithm. The performance is assessed through comparing technological characteristics and intended use.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. This information is not relevant for a mechanical external fixation system being submitted through a 510(k) pathway. There are no "test sets" or "data provenance" in the sense of patient data for evaluating a diagnostic algorithm. The "test" is the comparison to predicate devices, and the "data" is the engineering specifications and intended use.
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. See point 2. There's no "ground truth" to establish in this context because it's not a diagnostic device. The ground truth, if anything, is the established safety and efficacy of the predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. See point 2. No adjudication method for a test set is relevant here. The "adjudication" is performed by the FDA reviewers assessing the substantial equivalence claim.
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 an external fixation system, not an AI or diagnostic tool. MRMC studies evaluate the performance of diagnostic aids, which is outside the scope of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. As noted earlier, there's no "ground truth" in the way it's used for diagnostic algorithms. The closest equivalent would be the established clinical performance and safety history of the predicate devices, which serve as the benchmark for substantial equivalence.
8. The sample size for the training set
- Not applicable. This device does not involve training data or algorithms.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve training data or algorithms.
Summary of the 510(k) Submission's Approach to "Meeting Acceptance Criteria":
The Smith & Nephew Rail System demonstrates "acceptance" by establishing substantial equivalence to existing, legally marketed predicate devices. This involves comparing:
- Intended Use: The indications for use match or are very similar to the predicate devices (fracture fixation, deformity correction, limb lengthening, etc., in adult and pediatric patients).
- Technological Characteristics: The device shares similar design features, materials, and overall technological characteristics with the predicate devices.
Predicate Devices Identified:
- Smith & Nephew External Fixation System Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories - K994143
- Taylor Spatial Frame External Fixation System K970748
- Heidelberg External Fixator K970751
- Jet-X Bar System Clamps, Bar and Posts MR Conditional K072212
- Hex-Fix Field External Fixator K953397
The "study" proving the device meets the acceptance criteria is the documentation provided in the 510(k) submission itself, which articulates these similarities and justifies the claim of substantial equivalence to the FDA. The FDA's issuance of the substantial equivalence letter (pages 1-3) confirms their agreement with this assessment.
§ 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.