(92 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, and toes. The system can be used in both adult and pediatric patients.
The DARCO ™ Locking Bone Plate System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the feet, ankles and toes. The system can be used in both adult and pediatric patients.
The DARCO™ Locking Bone Plate system is comprised of a variety of titanium plates and screws designed for internal fixation of bone fragments. The plates are designed with rhombus (parallelogram) plates with an assortment of width, lengths, and configurations to address varying patient anatomy. The system includes locking and non-locking 2.7 mm and 3.5 mm diameter screws of various lengths.
This document is a 510(k) Summary of Safety and Effectiveness for the DARCO™ Locking Bone Plate System, essentially a premarket notification for a medical device. As such, it does not contain a study proving the device meets acceptance criteria in the typical sense of a clinical or performance study with defined performance metrics and acceptance thresholds like those seen for AI/ML devices.
Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K061808 DARCO™ Locking Bone Plate System) through non-clinical testing and comparison of characteristics. The "acceptance criteria" here is met by demonstrating that the modified device performs at least as well as the predicate device in relevant non-clinical tests.
Here's an analysis based on the provided text, addressing your points where applicable:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for a mechanical device, the "acceptance criteria" are implied by successful completion of mechanical and performance tests, demonstrating equivalence to the predicate. Specific numerical acceptance criteria are not explicitly stated in the summary, but rather the conclusion that the testing supports substantial equivalence.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Summary of Study Results) |
|---|---|
| Equivalent pullout strength | Testing performed, supports substantial equivalence. |
| Equivalent insertion characteristics | Testing performed, supports substantial equivalence. |
| Equivalent removal characteristics | Testing performed, supports substantial equivalence. |
| Equivalent ultimate/yield strength | Testing performed, supports substantial equivalence. |
| Equivalent screw head locking torques | Testing performed, supports substantial equivalence. |
| No new types of questions of safety or effectiveness | Design characteristics do not raise new questions. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided summary. The summary refers to "testing" but does not give specific numbers of components tested.
- Data Provenance: The testing is "non-clinical" and likely conducted in a controlled lab environment by Wright Medical Technology, Inc. The country of origin and whether it's retrospective or prospective are not relevant for this type of non-clinical mechanical testing.
3. 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)
Not applicable. This is a submission for a physical medical device (bone plate system), not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is mechanical performance as measured in lab tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device undergoing a clinical study with human readers/interpreters. The "adjudication" is based on comparing test results against established engineering standards or the predicate device's performance.
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 is a physical medical device, not an AI system. No MRMC study was performed.
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 (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device, in the context of demonstrating substantial equivalence, is primarily mechanical and material properties as measured through standardized engineering tests (e.g., measuring pullout strength, torque, yield strength). The comparison is made against the performance of the legally marketed predicate device (K061808 DARCO™ Locking Bone Plate System) to demonstrate "at least as good as" performance.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/ML device that requires a training set.
§ 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.