(93 days)
The 2.4mm Variable Angle LCP Volar Rim Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
The 2.4mm Variable Angle LCP Distal Radius Plates are used with a range of 2.4 mm variable angle locking screws, 2.4 mm cortex screws, and 2.7 mm cortex screws. These new plates incorporated variable angle locking technology. The Variable Angle LCP Volar Rim Distal Radius Plates are designed as low profile plates, designed to minimize soft tissue irritation by featuring a low contoured plate profile with countersunk screws, rounded edges, and polished surfaces. The plates feature both variable angle locking screw holes in the head and shaft and elongated variable angle combination holes along the shaft only. The plates are offered in 6- and 7-hole head configurations each with two additional contourable wing tabs with screws holes to provide even greater variability in screw placement for additional fragment capture and fracture reduction.
The provided document is a 510(k) summary for the Synthes 2.4mm Variable Angle LCP Volar Rim Distal Radius System. This type of submission is for medical devices that are substantially equivalent to a predicate device and, as such, does not contain acceptance criteria and studies demonstrating device performance in the same way a de novo or PMA submission would.
Instead, the documentation focuses on demonstrating substantial equivalence through:
- Comparison of intended use and design features to predicate devices.
- Mechanical testing to show comparable performance in terms of mechanical strength and fatigue to predicate devices.
Therefore, the requested information regarding acceptance criteria, specific device performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies are not typically included or required for a 510(k) submission based on substantial equivalence to existing devices. Such detailed studies are usually reserved for novel devices or those with higher risk classifications where clinical efficacy and safety need to be established independently.
However, I can extract the information related to the device description and the type of testing performed to support substantial equivalence.
Here's a breakdown of what can be extracted from the provided text, addressing the closest relevant points:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail metrics. The general implied acceptance criterion is "comparable mechanical strength and fatigue" to predicate devices.
- Reported Device Performance: The document states that "Mechanical testing demonstrates substantial equivalence of the subject components to the predicate device in regards to mechanical strength" and "Testing conducted to support the substantial equivalence for the 2.4mm VA-LCP Volar Rim Distal Radius Plates was aimed to assess the fatigue strength of the subject device." It also mentions "Functional & mechanical testing demonstrates the comparable mechanical and functional properties of the 2.4mm Variable Angle LCP Volar Rim Radius System to the predicate devices."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Comparable mechanical strength to predicate device | Mechanical testing demonstrates substantial equivalence in regards to mechanical strength. |
| Comparable fatigue strength to predicate device | Testing assessed the fatigue strength; finite element analysis and dynamic loading testing determined the worst-case construct is substantially equivalent to the predicate device construct. |
| Comparable functional properties to predicate device | Functional & mechanical testing demonstrates comparable mechanical and functional properties. |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not specified. Mechanical testing typically involves a set number of specimens, but this detail is not provided in a 510(k) summary.
- Data Provenance: The testing was conducted by Synthes (USA), the sponsor of the device. The data would be internal to the company, performing the tests to demonstrate equivalence. It is not patient data, but rather mechanical test data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Ground Truth/Experts: This question is not applicable. The "ground truth" for mechanical testing is established by engineering standards and test methods, not by expert consensus on clinical data. No human experts are involved in establishing a "ground truth" for mechanical properties in this context.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Mechanical test results are objective measurements against defined engineering parameters, not subjective interpretations requiring adjudication.
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
- MRMC Study: No. This is a medical implant (bone plate) used for fixation of fractures, not an image-based diagnostic or AI-powered device. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This is not an algorithmic device. The performance is physical and mechanical.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: For this type of device and study, the "ground truth" refers to established engineering standards for mechanical properties (e.g., strength, fatigue limits) and the mechanical properties of the predicate devices. It is based on objective physical measurements and engineering analysis.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. There is no "training set" as this is not a machine learning/AI device. Finite element analysis (FEA) was used, which involves computational models, not a data training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable for the same reason as above. FEA relies on material properties and geometric models, not a "ground truth" for a training set. The FEA was used to "determine the worst case construct" for further dynamic loading testing.
§ 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.