(270 days)
The Stabiliz Fixation System is intended for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.
The Stabiliz Fixation System includes standard straight LCP plates, metal locking screws, cortical screws, and fully-threaded and partially-threaded cancellous screws in various sizes and geometries.
The provided text does not contain information about the acceptance criteria and study proving a device meets these criteria in the context of an AI/ML medical device. Instead, it details a 510(k) submission for a Stabiliz Fixation System, which is a physical orthopedic device (plates, screws).
The 510(k) submission process for such a device focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than defining specific performance acceptance criteria and conducting studies to prove them in the same way an AI/ML device would.
Therefore, I cannot provide the requested table and information based on the given input regarding an AI/ML device. The document describes a traditional medical device clearance process, not an AI/ML device study.
However, I can extract the information relevant to the provided device's "acceptance criteria" and "study" from the text, framed within the context of a 510(k) submission for a non-AI device.
Acceptance Criteria and Study for the Stabiliz Fixation System (Non-AI Device)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for 510(k) Substantial Equivalence) | Reported Device Performance |
|---|---|
| Indications for Use Equivalence | Stabiliz Fixation System indications for use are substantially equivalent to predicate devices (fixation of fractures, osteotomies, nonunions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula). |
| Device Design/Composition Equivalence | Stabiliz Fixation System includes standard straight LCP plates, metal locking screws, cortical screws, and fully-threaded and partially-threaded cancellous screws in various sizes and geometries, found to be substantially equivalent to predicates in geometry and available sizes. |
| Material Equivalence | Materials used in the Stabiliz Fixation System are substantially equivalent to predicate devices. |
| Method of Fixation to Bone Equivalence | Methods of fixation to bone for the Stabiliz Fixation System are substantially equivalent to predicate devices. |
| Performance (Mechanical) Equivalence | Preclinical testing demonstrated that the strength of the Stabiliz Fixation System plates and screws is substantially equivalent to legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance (for mechanical testing)
- Sample Size: Not explicitly stated in the provided text. The document mentions "an analysis of strength" but does not detail the number of plates, screws, or test configurations used in the preclinical testing.
- Data Provenance: Not explicitly stated. The preclinical testing was "performed by the company" (Stabiliz Orthopaedics, LLC).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This is not applicable to preclinical mechanical testing for a traditional orthopedic fixation system. The "ground truth" for such devices is established through engineering standards and mechanical test methods.
4. Adjudication Method for the Test Set
- Not applicable to preclinical mechanical testing. Results are based on quantitative measurements against defined mechanical standards or comparative performance against predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study (MRMC) is relevant for AI/ML devices where human readers evaluate cases with and without AI assistance. The Stabiliz Fixation System is a physical implant; its assessment does not involve human readers interpreting images or data.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not applicable as the Stabiliz Fixation System is a physical medical device, not an algorithm.
7. The type of ground truth used
- For the preclinical testing, the "ground truth" would be established mechanical and material properties, and comparative performance data against legally marketed devices, demonstrating equivalent strength and function. This is typically based on engineering specifications and empirical measurements.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML algorithm.
Summary for AI/ML Context:
Based on the provided input, there is no information about an AI/ML device, its acceptance criteria, or a study to prove it meets those criteria. The document describes a 510(k) submission for a physical orthopedic fixation system.
§ 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.