(155 days)
The OIC External Fixation system is intended to be used in adult and pediatic patients for provisional fixation of open and or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of periarticular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.
The device is used for the external stabilization of bone fractures. It consists of: Carbon fiber composite bars, 11mm diameter, 100mm to 600mm lengths Titanium and aluminum combination clamp. 5 & 8 hole pin clamp Aluminum straight and angled posts Stainless steel 4mm and 5mm pins, blunt tip and threaded 150mm lengths, 15mm through 120mm thread lengths. Stainless steel 5mm transfixing pin, 250mm length Stainless steel instruments for implantation The pins are implanted into bone and then they are connected using the clamps, rods and posts to form a rigid construct which holds the bone fragments rigidly in place. The pins are offered in various lengths and thicknesses.
This document describes the OIC External Fixation System, a medical device for stabilizing bone fractures. It has been cleared by the FDA under K171211. The document does not contain information about a study proving the device meets acceptance criteria related to an AI/ML product or performance metrics like accuracy, sensitivity, or specificity. Instead, the "Performance Testing" section refers to mechanical testing for external fixation systems.
Since the provided document does not pertain to an AI/ML device, many of the requested fields are not applicable.
Here's the information based on the provided text, with "N/A" for inapplicable fields:
Acceptance Criteria and Device Performance (Mechanical Testing)
While the document doesn't provide a table of acceptance criteria and reported performance in the typical sense of an AI/ML device (e.g., accuracy, sensitivity), it does discuss mechanical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliant with ASTM F1541-02 for clamping ability | FEA simulations conducted using methods outlined in ASTM F1541-02. |
| Withstand greater loads than the predicate device (mechanical static axial load) | Mechanical static axial load testing per ASTM F1541-02 determined that the device will withstand greater loads than the predicate device. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of number of physical units tested, but references Finite Element Analysis (FEA) simulations and mechanical static axial load testing. These tests typically involve a defined number of test samples or simulation runs.
- Data Provenance: N/A (mechanical testing, not patient data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A (Ground truth for mechanical testing is based on engineering specifications and test standards, not expert medical opinion).
4. Adjudication method for the test set:
- N/A (Not applicable to mechanical testing).
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 device is an external fixation 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:
- N/A (Not an AI/ML algorithm).
7. The type of ground truth used:
- Ground Truth Type: Engineering specifications, industry standards (ASTM F1541-02), and mechanical properties of materials.
8. The sample size for the training set:
- N/A (Not an AI/ML device; no training set in the AI sense).
9. How the ground truth for the training set was established:
- N/A (Not an AI/ML device).
§ 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.