(59 days)
The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.
The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System consists of the plate types Long, Short and Button which can be used to treat simple and complex clavicle fractures including malunions, non-unions and isolated ligamentous injuries of the AC joint. The subject plates are available in three hook depths, in left- and right-side versions, in both sterile and non-sterile configurations and are available in stainless steel and titanium. The system also consists of non-implantable templates that correspond to the implants. Templates are intended for implant size selection and are available non-sterile.
The provided text describes a 510(k) premarket notification for a medical device, the DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a study to prove acceptance criteria for a novel AI/software device.
Therefore, many of the requested elements for describing an AI-driven device's acceptance criteria and studies (like sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this document. The document describes a traditional medical device (metallic bone fixation appliance).
Here's a breakdown based on the information that is available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table of acceptance criteria in the way it would for an AI device. Instead, it focuses on demonstrating that the performance of the new device is at least equivalent to the predicate device.
| Criteria/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Mechanical performance is at least equivalent to the predicate device (Synthes 3.5mm LCP Clavicle Hook Plates, K061753). | "Mechanical performance testing of constructs has been performed to compare the subject DePuy Synthes 2.7mm VA LCP Clavicle Hook Plates to the predicate DePuy Synthes 3.5mm LCP Clavicle Hook Plates. This data supports that the mechanical performance of the subject devices is at least equivalent to that of the predicate devices." |
| MR Compatibility | Established MR Conditional parameters. | "A magnetic resonance compatibility assessment has been performed to establish MR Conditional parameters for the subject DePuy Synthes 2.7mm VA LCP Clavicle Hook Plates." |
| Endotoxin Content | Meets specified endotoxin requirement of 20EU/device. | "Endotoxin testing has been performed according to the LAL test method to establish that the sterile subject DePuy Synthes 2.7mm VA LCP Clavicle Hook Plates meet the specified endotoxin requirement of 20EU/device." |
| Biocompatibility | Biologically safe when used as intended, in accordance with ISO 10993-1. | "Biocompatibility evaluation and testing has been performed in accordance with ISO 10993-1 and it is concluded that the subject DePuy Synthes 2.7mm VA LCP Clavicle Hook Plates are biologically safe when used as intended." |
| Substantial Equivalence | No new issues of safety and effectiveness compared to the predicate device. | "The non-clinical performance data as well as the comparison of design features included in this premarket notification demonstrate that any differences in technological characteristics of the subject devices compared to the predicate devices do not raise any new issues of safety and effectiveness." |
2. Sample size used for the test set and the data provenance:
- Not applicable. This document describes mechanical, material, and biological testing, not a clinical study on patient data to evaluate algorithmic performance. The "test set" would refer to physical devices or materials used in the non-clinical performance tests. Specific sample sizes for these tests are not provided in this summary but would be detailed in the full submission. Data provenance is implied to be from laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the context of an AI device typically refers to expert labels on a dataset. For this medical device, "ground truth" would be established by validated engineering tests and established biological safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling for AI/software ground truth. This is not a study involving expert review of images or 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:
- No. An MRMC study is not mentioned as this is not an AI-assisted device. The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
- For mechanical performance: Ground truth is established by engineering standards and comparison to a known predicate device's performance.
- For MR Compatibility: Ground truth is established by specific testing protocols and standards (e.g., ASTM F2503).
- For Endotoxin Testing: Ground truth is established by established laboratory methods (LAL test) and regulatory limits (20 EU/device).
- For Biocompatibility: Ground truth is established by international standards (ISO 10993-1) and biological safety evaluations.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI/ML model, this question does not apply.
§ 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.