FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

This anatomically contoured plate system offers several sizes and styles of distal heads in either titanium (ASTM F-136) or stainless steel (ASTM F-138). The distal head of the plate contains two rows of two screw holes each that accept 2.7 mm screws. The distal row of screw holes are threaded allowing for fixed angle support of the fracture fragments utilizing the threaded head screws. The proximal row of screw holes has a spherical seat allowing for variability in screw angle fixation while still using the threaded head screws. The threaded head screws vary in length from 16mm to 26mm and are fully threaded. K-wires may also be used for stabilization of bone fragments. The device utilizes a press fit intramedullary fixation for the proximal stem when inserted into the radial intramedullary canal while the distal head is secured to the fracture fragment using the above described bone screws.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device called the "Dorsal Intramedullary Plate." It aims to demonstrate that this new device is substantially equivalent to existing, legally marketed predicate devices.

Summary of Acceptance Criteria and Device Performance:

This submission is a 510(k) premarket notification for a medical device (Dorsal Intramedullary Plate), not an AI/ML software device or a diagnostic device. Therefore, the concepts of "acceptance criteria" and "device performance" in terms of clinical metrics like sensitivity, specificity, or AUC, as would be relevant for an AI study, do not apply here.

Instead, the "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. This is typically achieved by showing similar:

Intended Use
Performance Characteristics (e.g., mechanical properties, fit)
Materials of Construction
Manufacturing Methods
Design

The study that "proves the device meets the acceptance criteria" in this context is the comparison to the predicate devices as described in the 510(k) Summary.

Detailed Information based on the provided document:

Table of acceptance criteria and the reported device performance

As this is a 510(k) for a physical medical device (bone plate) and not an AI/ML or diagnostic device, there are no specific performance metrics like sensitivity, specificity, or F1-score listed. The "acceptance criteria" is the demonstration of substantial equivalence to predicate devices, and the "reported device performance" is implicitly that it meets the same functional and safety profiles as the predicates.

Acceptance Criterion (for 510(k))	Deo Volente Orthopaedics Dorsal Intramedullary Plate	Predicate Devices (Hand Innovations K032705, Wright Medical K994061)
Intended Use	Fixation of fractures and osteotomies involving the distal radius. Cementless use only.	Fixation of fractures and osteotomies involving the distal radius. (Implied similar)
Performance Characteristics	Similar to predicate devices (as stated).	Established for predicate devices.
Materials of Construction	Titanium (ASTM F-136) or Stainless Steel (ASTM F-138)	Similar (Implied for predicate devices)
Manufacturing Methods	Similar to predicate devices (as stated).	Established for predicate devices.
Design	Anatomically contoured plate, two rows of screw holes, threaded distal row for fixed angle support. Press fit intramedullary fixation.	Similar (Implied by the substantial equivalence claim).
Classification	Class II per 21 CFR § 888.3030 (Plate, Fixation, Bone)	Class II (Implied as current predicates).

Sample size used for the test set and the data provenance

Not applicable. This is a 510(k) submission for a physical orthopedic plate. The "test set" for such a device would typically refer to mechanical bench testing or sometimes animal studies, not clinical data in the sense of patient images or outcomes. The PROVIDED document does not contain information about the sample size of any mechanical tests or their provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no "ground truth" derived from expert consensus mentioned in the context of this 510(k) submission.
Adjudication method for the test set

Not applicable. No clinical test set requiring expert adjudication is described in the provided document.
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/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For a physical orthopedic device, "ground truth" would relate to its structural integrity, biocompatibility, and functional performance, typically assessed through engineering tests and adherence to standards rather than clinical ground truth as defined for diagnostic AI.
The sample size for the training set

Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Conclusion based on the document:

The provided document is a 510(k) premarket notification for an orthopedic bone plate. It explicitly states that the device is "similar to the listed predicate devices in intended use, performance characteristics, materials of construction, manufacturing methods and design." The FDA's letter confirms a "substantial equivalence determination." This means the device met the regulatory "acceptance criteria" by demonstrating that it is as safe and effective as already legally marketed devices, without presenting new questions of safety or effectiveness. The document does not describe clinical studies or AI/ML algorithm development, so most of the requested information regarding ground truth, expert consensus, and test/training sets for AI is not present.

Summary

Regulation Number and Section

§ 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.