(103 days)
The Merete Locking Bone Plate System can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes.
The Merete Locking Bone Plate System consists of contoured, anatomically shaped locking bone plates in various sizes and different curvatures, Merete 3.0mm and 3.5mm locking screws and cannulated 3.0mm compression screws. The system is made of titanium alloy Ti-6Al-4V.
The provided text describes a 510(k) submission for the "Merete Locking Bone Plate System" and focuses on its substantial equivalence to predicate devices, rather than a study demonstrating acceptance criteria met by the device itself through performance evaluation.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: The document does not specify quantitative acceptance criteria or report performance metrics for the Merete Locking Bone Plate System. The submission is based on demonstrating substantial equivalence to existing devices.
- Sample size used for the test set and the data provenance: No test set or associated data are mentioned for evaluating device performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of a test set requiring ground truth establishment by experts.
- Adjudication method for the test set: No test set is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: This type of study is not mentioned. The device is a bone plate, not an imaging or diagnostic AI tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is irrelevant for a physical bone plate device.
- The type of ground truth used: Not applicable as no performance study is detailed.
- The sample size for the training set: Not applicable as this is a physical medical device, not an AI/algorithm-based one.
- How the ground truth for the training set was established: Not applicable.
Summary from the provided document:
The 510(k) submission focuses on demonstrating substantial equivalence for the Merete Locking Bone Plate System to legally marketed predicate devices, rather than presenting a study with acceptance criteria and performance data. The FDA's letter states that the device is substantially equivalent "for the indications for use stated in the enclosure" to predicate devices, meaning it has similar technological characteristics, materials, and intended use as devices already on the market. This pathways allows medical devices to be marketed without requiring new clinical trials, if they can show they are as safe and effective as a legally marketed predecessor.
§ 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.