(110 days)
The OIC Variable Angle Small Fragment Locking Plate System is indicated for the fixation of fractures, mal-unions, nonunions or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.
The OIC Variable Angle Small Fragment Locking Plate System consists of titanium plates for the Distal Radius, Clavicle, Proximal Humerus, Tibia, Distal Fibula, a Low Profile 1/3 Tubular and Hook plate, bone screws and instruments for implantation. The plates come in a variety of sizes and accept 2.5mm, 3.5mm and 4.0mm bone screws. The bone screws are available in two diameters of cortex screws (2.5mm and a 4.0mm cancellous screw. They range in length from 6mm to 130mm. The cortex screws are available with both threaded (locking) and non-threaded (non-locking) heads. The OIC Variable Angle Small Fragment Locking Plate System is made of titanium alloy in compliance with ASTM F136, ASTM F1472 or ASTM F67. The OIC Variable Angle Small Fragment Locking Plate System is provided non-sterile and is steam-sterilized by the medical facility prior to implantation.
This document describes the OIC Variable Angle Small Fragment Locking Plate System and its 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of an AI/ML device.
Therefore, the requested information elements related to AI/ML device studies (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this submission.
The acceptance criteria here refer to the mechanical properties required for a bone plate system to be considered safe and effective, and the "study" is the performance testing conducted to confirm those properties.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard & What it Measures) | Test Method | Reported Device Performance (Summary) |
|---|---|---|
| Plate Strength (Worst Case: 1/3 Tubular Plate) | ASTM F382 (Single cycle bend testing) | Acceptable mechanical characteristics for intended uses, comparable to predicate. (No specific numerical values provided in this summary, but the test ensures it meets the standard's requirements for metallic bone plates). The 1/3 tubular plate was tested directly against the Synthes (USA) One-Third Tubular Plate with Collar. |
| Hook Plate Strength | Engineering Analysis | Acceptable mechanical characteristics for intended uses, comparable to predicate. (Evaluated against the Microware plate). |
| Screw Strength (Worst Case: 4.0mm Cancellous Screws, compared to 2.5mm Non-locking Screw) | Geometric Comparison, Bending Strength Calculation, Torsional Strength Calculation, Axial Pullout Strength Calculation per ASTM F543-07 | Acceptable characteristics for intended uses, comparable to predicate. (No specific numerical values provided). |
| Material Composition | ASTM F136, ASTM F1472, or ASTM F67 compliance | Made of titanium alloy in compliance with these standards. (Indicates material quality and biocompatibility). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of an AI/ML device study. For mechanical testing, samples were likely taken to represent each type of plate and screw for destructive testing. The data provenance is from in vitro mechanical testing performed by the manufacturer, not from patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. "Ground truth" for mechanical testing is established by the physical properties measured against industry standards (ASTM). No human experts are involved in establishing this type of ground truth beyond standard laboratory practices.
4. Adjudication Method for the Test Set
Not applicable. Mechanical testing results are 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
Not applicable. This is a medical device (bone plate system), not an AI/ML diagnostic or assistive tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implantable device.
7. The Type of Ground Truth Used
Mechanical Property Standards: The ground truth for this device's performance is adherence to established ASTM (American Society for Testing and Materials) standards for metallic bone plates (ASTM F382) and metallic medical bone screws (ASTM F543-07), and material composition (ASTM F136, ASTM F1472, ASTM F67). These standards define the acceptable range of mechanical properties for such devices to ensure safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of mechanical medical device testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" for this type of medical device submission.
§ 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.