(105 days)
The system is used to stabilize and aid in the fusion of fractures and osteotomies of the distal radius.
The DRLock Distal Radius Volar System is indicated for the fixation of unstable distal radius fractures and osteotomies.
The DRLock ™ Distal Radius Volar System (DRLock) is a series of metallic (stainless steel), implantable, bone fixation plates, pegs and screws. Its' intended use is to stabilize and aid in the fusion of fractures and osteotomies involving the distal radius.
The System includes four (4) fixation plates, twenty-five (25) screws and eleven (11) pegs. All screws and plates are made from type 316L Stainless Steel in conformance with ASTM F 138 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is present and noting what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices | Finite Element Analysis in conjunction with mechanical testing confirms that the DRLock System is substantially equivalent to its' predicate devices. |
| Meets specified requirements for its intended use | Finite Element Analysis in conjunction with mechanical testing confirms that the DRLock System... meets specified requirements for its' intended use. |
| Stabilize and aid in the fusion of fractures and osteotomies of the distal radius | Implied performance based on the claim of substantial equivalence and meeting intended use requirements. The device's intended use is to stabilize and aid in the fusion of fractures and osteotomies involving the distal radius. |
| Material conformance to ASTM F 138 | All screws and plates are made from type 316L Stainless Steel in conformance with ASTM F 138 Standard Speciation for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants. |
2. Sample Sizes and Data Provenance
- Test Set Sample Size: Not specified. The document refers to "mechanical testing" and "Finite Element Analysis" (FEA) but does not provide details on the number of physical samples tested or the specific parameters used in the FEA.
- Data Provenance: Not specified. It's a premarket notification for a medical device submitted to the FDA in the USA, so the studies would presumably be conducted in the USA or under regulations compliant with FDA submissions. However, no specific geographic origin for the data is mentioned. The studies are described as "mechanical testing" and "Finite Element Analysis," which are typically laboratory-based and can be prospective in nature (new tests performed for the submission).
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts: Not applicable. The "ground truth" for this type of device (metallic fixation appliances) is typically established through engineering standards, mechanical tests, and simulation rather than expert human interpretation of medical images or specimens.
- Qualifications of Experts: Not applicable.
4. Adjudication Method (Test Set)
- Adjudication Method: Not applicable. As the evaluation relies on objective mechanical and computational tests, there's no need for an adjudication method involving human experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done?: No. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., radiologists reading images). This device is a surgical implant for fixation, and its performance is assessed mechanically and computationally.
6. Standalone Performance Study (Algorithm Only)
- Standalone Study Done?: Yes, in a sense. The "Finite Element Analysis" is a computational simulation (algorithm only) that predicts the device's mechanical performance under specified loads without human intervention in the simulation process itself (though humans design the FEA). The "mechanical testing" is also a standalone evaluation of the device hardware.
7. Type of Ground Truth Used
- Ground Truth Type:
- Engineering Standards: Conformance to ASTM F 138 for material.
- Mechanical Test Data: Results from physical tests (implied).
- Computational Modeling: Results from Finite Element Analysis (FEA).
- Predicate Device Performance: The "ground truth" for substantial equivalence is the established performance of the legally marketed predicate devices.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This document describes a medical device's mechanical and material performance, not an AI/ML algorithm that requires training data. Finite Element Analysis involves model creation and simulation, not "training" in the typical AI sense.
9. How Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set in the AI/ML sense for this device. For the FEA, the "ground truth" for the model would be based on validated material properties, established engineering principles, and potentially prior empirical test data used to develop and validate the FEA models themselves.
§ 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.