(101 days)
The OIC External Fixation system is intended to be used in adult and pediatric 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 peri-articular 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 650mm 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, 300mm 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.
The provided text does NOT describe a study involving an AI/ML powered device, but rather a traditional medical device (OIC External Fixation System) used for bone fracture fixation. Therefore, most of the requested information regarding acceptance criteria and study design for an AI/ML device is not present in the document.
The document focuses on demonstrating substantial equivalence to predicate devices for a physical medical device. This involves comparing indications for use, operating principles, design, and materials, along with performance testing relevant to the physical characteristics of the device.
Here's a breakdown of what can be extracted from the provided text, and what cannot be provided due to the nature of the device:
Information NOT APPLICABLE/AVAILABLE for this traditional medical device:
- Table of acceptance criteria and reported device performance related to AI/ML metrics: There are no AI/ML metrics (e.g., sensitivity, specificity, AUC) for this device. The "performance testing" mentioned is for MRI compatibility, not diagnostic accuracy.
- Sample size for the test set and data provenance: No test set for AI/ML performance.
- Number of experts and qualifications for ground truth: No ground truth establishment related to diagnostic imaging or AI output.
- Adjudication method for the test set: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable, as there's no AI to assist human readers.
- Standalone (algorithm-only) performance: Not applicable, as it's a physical device, not an algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI/ML performance.
- Sample size for the training set: Not applicable (no AI/ML model to train).
- How the ground truth for the training set was established: Not applicable.
What is available from the document (relevant to a traditional medical device):
- Device Name: OIC External Fixation System
- Indications for Use: The OIC External Fixation system is intended to be used in adult and pediatric 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.
- Performance Testing Mentioned: Magnetic resonance imaging (MRI) compatibility testing was performed on the OIC External Fixation System. Testing shows that the system has acceptable MRI characteristics for the intended uses.
- Conclusion of Performance Testing (for MRI compatibility): "Testing shows that the system has acceptable MRI characteristics for the intended uses." This acts as the acceptance criterion for MRI compatibility.
- Predicate Devices: K171211 OIC External Fixation System, K082650 Synthes Large External Fixation MR Conditional
If this were an AI/ML medical device, here's how the information would typically be structured:
Acceptance Criteria and Study for AI/ML Device (Hypothetical as per your request, but NOT based on the provided document)
This section outlines the acceptance criteria and the study performed to demonstrate that the hypothetical AI/ML device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Primary Endpoints | ||
| [e.g., Sensitivity for detecting X] | [e.g., ≥ 90%] | [e.g., 92.5% (95% CI: 90.1-94.6%)] |
| [e.g., Specificity for detecting X] | [e.g., ≥ 80%] | [e.g., 85.2% (95% CI: 83.0-87.1%)] |
| Secondary Endpoints | ||
| [e.g., AUC] | [e.g., ≥ 0.90] | [e.g., 0.93] |
| [e.g., Negative Predictive Value] | [e.g., ≥ 95%] | [e.g., 96.1%] |
| [e.g., Time to diagnosis reduction] | [e.g., ≤ 10% reduction in read time] | [e.g., 12% reduction] |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: [e.g., 500 cases (e.g., 200 positive, 300 negative for the condition)]
- Data Provenance: [e.g., Retrospective, multi-center data collected from hospitals in the United States, Germany, and Japan.]
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: [e.g., 3 independent expert radiologists per case]
- Qualifications: [e.g., All radiologists were board-certified with at least 5 years of experience in reading [relevant imaging modality, e.g., chest X-rays] and specialized in [relevant area, e.g., pulmonary imaging]. Additional experts included two board-certified pathologists with 10+ years of experience.]
4. Adjudication Method (for the test set)
- Method: [e.g., 2+1 adjudication. Initial reads by two independent experts. If disagreement, a third senior expert (adjudicator) provided the final consensus. Alternatively: 3+1 (three readers, then a fourth tie-breaker), or Unanimous Consensus, or Majority Vote.]
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- Was it done? [Yes/No]
- If Yes:
- Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance:
- [e.g., Human readers using AI assistance demonstrated a statistically significant increase in diagnostic accuracy by X% (e.g., 5.3 percentage points, p
- Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance:
- If Yes:
§ 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.