(266 days)
The IRENE Locking Compression Plate System is indicated for patients with age above 21 for fixation of fractures. Indicated facture areas include ulna, radius, humerus, femur, and tibia.
The IRENE Locking Compression Plate System is designed for internal fixation of bones that subject to fracture. The system includes bone plates and screws that can be used with the plate. Various sizes of plate are available for different fracture areas or clinical conditions. Bone screws are incorporated in the system and are intended to fix with plate with appropriate size. The plate has a limited-contact design. The plate system is provided unsterile. And the system is intended for single-use.
This document is a 510(k) Summary for the IRENE Locking Compression Plate System, which is a medical device for orthopedic fixation. It's a regulatory filing, not a research study. Therefore, most of the information requested about acceptance criteria and study details (like sample sizes, expert adjudication, MRMC studies, ground truth) is not applicable or present in this type of document because it describes a submission for regulatory clearance, not the results of a clinical effectiveness study.
Here's an analysis of the provided text based on your request, highlighting what's available and what's explicitly stated as not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific numerical performance targets. Instead, it states that the device's performance was evaluated against predicate devices using recognized ASTM standards. The acceptance criterion implicitly is that the proposed device performs comparably to the predicate devices and meets the requirements of these standards.
The document states:
- "Results of testing indicates no gap between the level of performance of proposed device and the predicate device" (Page 6)
The performance data mentioned are:
- Plate: Static and dynamic testing conducted as per ASTM F382-13.
- Screw: Torsional properties, driving torque, and pull-out strength conducted as per ASTM F543-13.
No specific numerical results for these tests are provided, only the general conclusion of "no gap" in performance compared to predicate devices.
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document refers to "mechanical testing" and "testing the mechanical properties of the proposed and predicate device" (Page 5, 6) but does not provide the number of units/samples tested for either the proposed or predicate device.
- Data provenance: The mechanical testing was conducted by Tianjin ZhengTian Medical Instrument Co., Ltd. in China, as indicated by the submitter's address (Page 3). It is preclinical (bench) testing, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was preclinical mechanical testing, not a study requiring expert clinical opinion for ground truth.
4. Adjudication method for the test set
Not applicable. This was preclinical 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
Not applicable. This device is a bone fixation plate system, not an AI diagnostic or assistive tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
Not applicable in the conventional sense of clinical ground truth (e.g., pathology, outcomes). The "ground truth" for this submission's performance evaluation lies in the established mechanical testing standards (ASTM F382-13 and ASTM F543-13) and the performance of legally marketed predicate devices. The goal was to show the proposed device met these standards and was comparable to predicates.
8. The sample size for the training set
Not applicable. This device is a physical product, 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 a physical product, not an AI/ML algorithm.
§ 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.