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

The modified Distal Volar Radius Anatomical Plate System is a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices: • Distal Volar Plates • Distal Dorsal Nail Plate • Pegs • Screws. Included in the sterilization tray are the following re-useable instruments: • Peg drivers • Other standard surgical tools. In addition, the following are non-reusable instruments included in the sterilization tray: • F.A.S.T. Guide Technology Drill Guide; and • Drill bits

AI/ML Overview

The provided text describes a medical device, the "Distal Volar Radius Anatomical Plate System," seeking 510(k) clearance. However, the document does not contain specific acceptance criteria for device performance or the study details that would prove the device meets such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on meeting predefined performance criteria through a detailed clinical or performance study with acceptance thresholds.

Here's an analysis based on the information provided, highlighting the absence of the requested details:

Acceptance Criteria and Device Performance

Not applicable/Not provided in the document. The document states:

"Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act."
"The modified Distal Volar Radius Anatomical Plate System is substantially equivalent to the predicate Distal Volar Radius Repair System. The equivalence was confirmed through pre-clinical testing."

This indicates that the submission relied on demonstrating equivalence to an already legally marketed device rather than proving performance against specific quantitative acceptance criteria in a study. The "pre-clinical testing" mentioned is likely mechanical testing to show similar physical properties to the predicate, not a study with performance metrics in a clinical context.

Table of Acceptance Criteria and Reported Device Performance

Criterion Type	Acceptance Criteria	Reported Device Performance
Performance Standards	Not established by FDA.	Not applicable.
Substantial Equivalence	Demonstrates equivalence (e.g., in design, materials, indications for use, and performance where applicable) to the predicate device: Distal Volar Radius Plate System (510(k) # K032705).	"The modified Distal Volar Radius Anatomical Plate System is substantially equivalent to the predicate Distal Volar Radius Repair System." (Confirmed through pre-clinical testing).
Biocompatibility	The titanium used meets requirements of ASTM F 136-96 (Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications).	"The implantable components... do not require biocompatibility testing because the titanium used in fabrications meets the requirements of ASTM F 136-96."

Study Details

Based on the provided text, the specific study details for proving performance against acceptance criteria (as would be typical for an AI/diagnostic device) are not present. The submission relies on "pre-clinical testing" to demonstrate substantial equivalence, which typically involves mechanical and material testing rather than studies involving ground truth from experts or multi-reader reviews in a clinical setting.

Therefore, the following points will indicate "Not applicable" or "Not provided" as the information is absent in this 510(k) summary.

Sample size used for the test set and the data provenance: Not provided (no clinical test set described). The "pre-clinical testing" typically involves material samples or mechanical models.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided (no independent ground truth establishment described, as the focus is on substantial equivalence confirmed by pre-clinical testing).
Adjudication method for the test set: Not applicable/Not provided.
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 a medical implant, not an AI diagnostic device).
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable (Not an algorithm-based device).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided (No ground truth, in the clinical sense, is discussed for performance evaluation). Instead, the "truth" for this submission is established by the accepted performance and safety profile of the predicate device.
The sample size for the training set: Not applicable/Not provided (No AI model training described).
How the ground truth for the training set was established: Not applicable/Not provided.

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.