(84 days)
The plates are intended for use in patients requiring craniofacial reconstruction of the internal orbit. These plates provide structure and support to the orbital walls and/or floor when anatomical reconstruction of the internal orbit is necessary.
The Orbital Reconstruction Plates are a series of plates made from titanium with different configurations and thicknesses. The configurations vary to accommodate the level of reconstruction required or the patient's anatomy. The difference in thickness provides the necessary support for the internal orbit based on the type and extent of reconstruction required. The screws used with plates were previously cleared under various premarket notifications.
This 510(k) submission (K973982) for Orbital Reconstruction Plates does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way described in your request.
Medical devices such as these orbital reconstruction plates, which are cleared via the 510(k) pathway, usually demonstrate substantial equivalence to a legally marketed predicate device. This typically involves comparing the new device's intended use, materials, design, and operational principles to those of the predicate device, rather than conducting a new effectiveness study with specific acceptance criteria as you've outlined.
Here's a breakdown of why your specific questions cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: This document explicitly states, "The substantial equivalence of these components is based on an equivalence in intended use, materials, design, and operational principles to other predicate devices...". It does not describe any specific performance metric, acceptance criteria, or a study that measures and reports the device's performance against such criteria.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, clinical data, or study data is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): No ground truth establishment or expert review is mentioned, as no study was described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set or study is described.
- 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: This device is a passive implantable medical device (bone plates), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI assistance are not relevant to this product.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no study or ground truth establishment is described.
- The sample size for the training set: Not applicable, as no training set or machine learning components are involved.
- How the ground truth for the training set was established: Not applicable, as no training set or machine learning components are involved.
In summary: The provided 510(k) summary for the Orbital Reconstruction Plates focuses on establishing substantial equivalence to predicate devices based on design and intended use, not through performance studies with predefined acceptance criteria. This is a common approach for many Class II medical devices, especially those that are analogous to existing technologies.
§ 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.