(144 days)
Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation devices are intended to be used on adults or pediatric patients as required and are intended to be used for fracture fixation (open and closed): post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; joint arthrodesis; and management of comminuted intractures of the distal radius. Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation devices are for single use only.
The Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation systems. The devices consist of various clamps, posts, and bars, which are used to in the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. The materials used in their manufacture are chosen to address a wide range of applications. These devices have been designed to allow for the appropriate amount of rigidity and stability.
This document describes the premarket notification (510(k)) for Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices. It's a reprocessed device, meaning it's been cleaned, disinfected, and prepared for reuse. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantifiable sense (e.g., "device must achieve X level of performance"). Instead, it outlines performance tests conducted to demonstrate that the reprocessed devices maintain the same functional characteristics as the predicate device. The underlying acceptance criterion for a 510(k) for reprocessed single-use devices is generally that the reprocessed device must perform at least as safely and effectively as the original device.
Based on the provided text, the performance "metrics" are qualitative assurances of equivalence to the predicate.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence | The reprocessed devices were determined to be substantially equivalent to the predicate device based on:Simulated use and artificial soiling studiesStructural integrity studiesCarbon rod stiffness per 4-point bend test (pre-conditioning)Cyclical axial compression and tension bending testCarbon rod stiffness per 4-point bend test (post-conditioning)Disassembly and reassembly (pre-and post-sterilization) |
| Cleaning Efficacy | Demonstrated through:Visual inspectionCleaning efficacy tests (residual protein and residual carbohydrate) |
| Maintenance of Original Properties | "The principle of operation of the reprocessed devices is identical to that of the predicates. There are no changes in intended use, performance specifications or method of operation. These devices utilize stainless steel, titanium, carbon fiber and aluminum materials and technological characteristics that are very similar when compared to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the tests.
The data provenance is not explicitly stated. Given that it's a 510(k) submission for a reprocessed device, the testing would typically be conducted by the reprocessing company (Medline ReNewal) or a contract lab on behalf of Medline ReNewal. It is prospective testing designed to show equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable or provided in this document. The "ground truth" for this device, which is a physical medical instrument, is its physical and functional performance, not a diagnostic interpretation that would require expert consensus. The "truth" is established by direct measurement and observation during the performance testing.
4. Adjudication Method for the Test Set
This information is not applicable or provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human interpretation of data (e.g., radiological images) is involved. For a physical device performance study, the results are typically quantitative measurements or observations against predefined specifications.
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
This is not applicable. This document describes an external fixation device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader improvement with AI is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. As stated above, this is not an AI algorithm. The performance evaluation focuses on the physical and functional aspects of the reprocessed surgical instruments.
7. The Type of Ground Truth Used
For this device, the "ground truth" is established through physical and functional performance testing that compares the reprocessed device's characteristics (e.g., structural integrity, stiffness, cleanliness) directly against the known performance of the original predicate device. This involves objective measurements and observations, rather than expert consensus on diagnostic interpretations or pathology.
8. The Sample Size for the Training Set
This is not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable. This is not a machine learning or AI device.
§ 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.