(67 days)
The DePuy Synthes 2.7mm VA LCP Clavice Plate System is indicated for fixation of fractures, and nonunions of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.
The DePuy Synthes 2.7mm VA LCP Clavicle Plate System consists of lateral, shaft and medial plates designed for temporary fixation, correction or stabilization of clavicle bones. The subject plates are available in various sizes in both sterile and non-sterile configurations and are available in stainless steel and titanium alloy. The system also consists of non-implantable templates that correspond to the implants. Templates are intended for implant size selection and are available in non-sterile.
This submission describes a medical device, the DePuy Synthes 2.7mm VA LCP Clavicle Plate System, and its substantial equivalence to predicate devices, rather than a study evaluating the performance of an AI-powered diagnostic device against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and performance metrics for an AI system is not applicable to this document.
However, I can extract and structure the relevant information regarding the device acceptance and the studies conducted to support its substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Mechanical performance of the subject devices (DePuy Synthes 2.7mm VA LCP Clavicle Plates) is at least equivalent to that of the predicate devices (DePuy Synthes 3.5mm LCP Reconstruction Plates). | Static and cyclic mechanical testing of constructs has been performed to compare the subject DePuy Synthes 2.7mm VA LCP Clavicle Plates to the predicate DePuy Synthes 3.5mm LCP Reconstruction Plates. This information supports that the mechanical performance of the subject devices is at least equivalent to that of the predicate devices. |
| Magnetic Resonance (MR) Compatibility | Establish MR Conditional parameters for the subject DePuy Synthes 2.7mm VA LCP Clavicle Plates. | Magnetic Resonance compatibility testing has been performed to establish MR Conditional parameters for the subject DePuy Synthes 2.7mm VA LCP Clavicle Plates. |
| Endotoxin Level | Sterile subject DePuy Synthes 2.7mm VA LCP Clavicle Plates meet the specified endotoxin requirement of 20 EU/device. | Endotoxin testing has been performed using to the LAL test method to establish that the sterile subject DePuy Synthes 2.7mm VA LCP Clavicle Plates meet the specified endotoxin requirement of 20EU/device. |
| Biocompatibility | The subject DePuy Synthes 2.7mm VA LCP Clavicle Plates are biologically safe when used as intended. | 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 Plates are biologically safe when used as intended. |
| Substantial Equivalence | The subject device is substantially equivalent to legally marketed predicate devices, with no new issues of safety and effectiveness identified compared to the predicate devices. | The non-clinical performance data as well as the comparison of indications and 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 questions of safety and effectiveness. It is concluded that the information provided herein supports substantial equivalence of the subject devices. (This is the overarching conclusion required for 510(k) clearance). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified for any of the non-clinical tests. For mechanical testing, samples of constructs (presumably plate-bone models) would have been used, but the specific number is not stated. Same for MR compatibility, endotoxin, and biocompatibility - "testing has been performed" implies a sample set was used, but the size is absent from this summary.
- Data Provenance: The studies are described as "non-clinical performance data." This strongly suggests laboratory-based testing rather than patient data. No country of origin is specified for the data itself, but the manufacturer is Synthes GMBH, Switzerland, and the sponsor (DePuy Synthes) also has a US address (West Chester, PA). The testing appears to be retrospective, as it was conducted to support a premarket notification for an existing device design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This document describes non-clinical testing of a medical implant, not an AI diagnostic device where expert ground truth is typically assessed. The "ground truth" for these tests would be the measured physical, chemical, or biological properties conforming to established standards and predicate device performance.
4. Adjudication Method for the Test Set
- Not Applicable. As this is not an AI diagnostic study involving human interpretation of results against a gold standard, no adjudication method is relevant.
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. This is not an AI-powered diagnostic device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or reported.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Not Applicable. This is a physical medical device (clavicle plate system), not an algorithm or AI system.
7. The Type of Ground Truth Used
- For Mechanical Performance: The "ground truth" is the established mechanical properties of the predicate device (DePuy Synthes 3.5mm LCP Reconstruction Plate) and relevant engineering standards for bone fixation devices. The subject device's performance is compared against these benchmarks.
- For MR Compatibility: The "ground truth" is the established MR conditional parameters based on standardized testing procedures.
- For Endotoxin: The "ground truth" is the regulatory specified endotoxin limit (20 EU/device) for sterile devices. The LAL test method is a standard to determine this.
- For Biocompatibility: The "ground truth" is established biological safety criteria as defined by ISO 10993-1, which guides biocompatibility evaluation and testing.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/machine learning device that requires a training set. The device is a physical implant.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. No training set for an algorithm is involved.
§ 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.