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510(k) Data Aggregation
(63 days)
ROGACHEFSKY DISTAL RADIUS PLATES
The Rogachefsky Distal Radius Plates are intended for use in internal fixation of fractures of the distal radius.
This submission describes a distal radius plating system including one volar and two dorsal plates ( left and right configurations) with a curved profile designed to fit the contour of the distal radius. It is intended for use in internal fixation of fractures of the distal radius. Plates are a modified T shape and are 1.0 mm thick. The plates are manufactured from titanium alloy , Ti 6Al 4V, which conforms to ASTM specification F136. The Rogachefsky Distal Radius Plates are attached to the underlying bone using bone screws previously cleared in the Leibinger Radius Reconstruction Plate System [RRPS] 510(k) submission K961496. The plates are available in sterile and non-sterile versions.
The provided text is related to a 510(k) submission for Rogachefsky Distal Radius Plates. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
This type of document (510(k) summary) does not typically include detailed studies involving a "device performance" comparison against "acceptance criteria" through clinical trials, expert review, or AI assistance as would be expected for a diagnostic or AI-powered device.
Instead, the core of a 510(k) submission is to demonstrate substantial equivalence to an existing predicate device based on similarities in intended use, material, design, and operational principles. Clinical effectiveness studies with detailed performance metrics, ground truth establishment, and expert adjudication are usually reserved for de novo classifications, PMAs, or when significant new indications or technologies are introduced that render equivalence to existing devices difficult to prove.
Therefore, many of the requested items (e.g., acceptance criteria table, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not present or applicable in this specific 510(k) summary.
However, I can extract the information that is available from the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) or report detailed "device performance" data from a study for this device against such criteria. The "acceptance" for this 510(k) is based on demonstrating substantial equivalence to predicate devices.
2. Sample sized used for the test set and the data provenance
Not applicable/Not provided. The document describes a medical device (distal radius plates), not a diagnostic or AI system that would typically undergo testing with a "test set" of patient data. Equivalence is based on design, materials, and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No test set requiring ground truth established by experts is described for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided.
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/Not provided. This device is a surgical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable/Not provided. This is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided.
8. The sample size for the training set
Not applicable/Not provided. This relates to machine learning models, which is not what this document describes.
9. How the ground truth for the training set was established
Not applicable/Not provided.
Summary of what is provided regarding equivalence and regulatory acceptance:
- Device: Rogachefsky Distal Radius Plates (volar and two dorsal plates, 1.0 mm thick, made of titanium alloy Ti 6Al 4V)
- Intended Use: Internal fixation of fractures of the distal radius.
- Predicate Devices:
- Basis of Equivalence: Similarities in intended use, material, design, and operational principle to the predicate devices.
- Regulatory Acceptance: The FDA reviewed the 510(k) notification and determined the device is substantially equivalent to predicate devices marketed prior to May 28, 1976. This determination allows the sponsor to market the device, subject to general controls and GMP regulations.
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