(27 days)
The MICRONAIL® Intramedullary Distal Radius System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:
• Joint destruction and/or subluxation visible on x-ray;
- · Failed fracture fixation with or without bone graft;
- · Osteotomy and repair of distal radius malunion with or without bone graft;
- · Displaced or non-displaced fracture which may or may not involve angulation or fragmentation of bone;
- · Comminuted articular fractures of the articular surface, severely comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with or with or with or without an external fixator.
The MICRONAIL™ Distal Radius System was cleared (K040938) as a system consisting of a radial nail, cortical bone screws, buttress pins, and buttress screws. All components are manufactured from titanium alloy, Ti 6Al-4V-ELI. Changes to the subject devices include changes made to the radial nail, buttress screws, and cortical bone screws and availability of sterile and non-sterile devices.
This document is a 510(k) summary for the MICRONAIL® Distal Radius System, a medical device used for fixing unstable distal radius fractures. As such, it focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might find for a novel diagnostic AI algorithm.
Therefore, many of the requested categories regarding acceptance criteria and study details for an AI/diagnostic device are not applicable (N/A) in this context. The document describes a mechanical device (intramedullary fixation rod), and the evaluation is based on non-clinical evidence (mechanical testing and FEA).
Here's the information extracted and categorized as best as possible, with explanations for the parts that are N/A:
1. Table of acceptance criteria and the reported device performance
Since this is a mechanical device submission demonstrating substantial equivalence, the "acceptance criteria" are not reported as specific performance metrics like sensitivity/specificity for a diagnostic. Instead, the acceptance criterion implied is mechanical equivalence or superiority to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance statistically equivalent or greater than the predicate device (e.g., Static Bending Strength, FEA analysis) | "Mechanical testing, including Static Bending Strength, as well as FEA analysis has shown that the performance of the subject screw is statistically equivalent or greater than the predicate screw." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified quantitatively. For mechanical testing, this typically refers to the number of devices tested.
- Data Provenance: Not explicitly stated, but mechanical testing is typically performed in a laboratory setting by the manufacturer (Wright Medical Technology, Inc., Memphis, TN, USA). It's a prospective technical evaluation, not a retrospective analysis of patient data.
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)
- N/A. Ground truth establishment by experts is relevant for diagnostic performance assessments. For mechanical device testing, the "ground truth" is determined by established engineering principles and measurements against validated test methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are relevant for expert consensus in diagnostic or clinical interpretations. Mechanical testing uses objective measurements.
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
- N/A. This is a mechanical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. As explained in #3, ground truth in this context refers to objective mechanical properties and performance measurements as determined by standardized testing methods and engineering analysis (FEA).
8. The sample size for the training set
- N/A. There is no "training set" in the context of mechanical device testing for 510(k) submission, as it's not a machine learning model.
9. How the ground truth for the training set was established
- N/A. As there is no "training set," this question is not applicable.
§ 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.