(58 days)
The DARCO® Locking Bone Plate System is intended for use in stabilization of fresh fractures, joint fusion, and reconstruction of small bones of the feet, ankles and toes. The system can be used in both adult and pediativ patients.
The DARCO® Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary essentially through different curvatures, material strengths, number of plate holes and through different grades or bridge widths.
This document is a 510(k) premarket notification for the DARCO® Locking Bone Plate System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for device performance. Therefore, many of the requested details, particularly those related to a clinical study (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance), are not available in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of numerical performance metrics for the device. Instead, it relies on demonstrating substantial equivalence in technological characteristics and performance to a predicate device.
| Acceptance Criteria Category | Specific Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Not worse than predicate device for bone fixation. | "Analysis has shown that the performance of the subject bone locking plate system is not a worse case construct of the predicate DARCO® Locking Bone Plate family..." |
| Material Composition | Identical material composition to predicate. | "Both of these plates have identical indications, identical material composition and similar design features compared to other plates of the DARCO® System." |
| Design Features | Similar design features to predicate. | "Both of these plates have identical indications, identical material composition and similar design features compared to other plates of the DARCO® System." |
| Intended Use | Identical indications for use as predicate. | "Both of these plates have identical indications..." |
| Biocompatibility | Biocompatible materials. | "The DARCO® Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium." |
2. Sample size used for the test set and the data provenance
Not applicable. This document describes a submission for a medical device that relies on substantial equivalence to a predicate device based on mechanical testing and design comparison, not a clinical study with a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth based on expert review of a test set is mentioned.
4. Adjudication method for the test set
Not applicable. No adjudication method is described as there is no test set of clinical data.
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 document describes a physical medical device (bone plate system), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe the use of a "ground truth" derived from clinical data in the context of a performance study. For the mechanical testing, the "ground truth" would implicitly be engineering standards and established mechanical properties, benchmarked against the predicate device.
8. The sample size for the training set
Not applicable. This document describes a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is mentioned.
§ 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.