(31 days)
The DVO™ Volar Plate System is intended for volar fixation of fractures and osteotomies involving the distal radius. This single use device is for cementless use only.
This non-sterile volar plate system offers several sizes and styles of volar plates, in either titanium (ASTM F-136) or stainless steel (ASTM F-138 or ASTM 2229). The three versions include a volar T-plate, a volar intramedullary T-plate and a volar T-plate with translating head. The distal head of the plate contains two rows of fixed angle screw holes that accept 2.7 mm screws. Dorsal and ulnar sheaths are secured into the plate recesses to cover the screw heads. The screws vary in length from 16mm to 26mm. K-wires may also be used for stabilization of bone fragments.
This 510(k) premarket notification describes a medical device, specifically a Volar Plate System for fixing distal radius fractures. However, it does not contain specific acceptance criteria or the details of a study proving the device meets acceptance criteria in the way a clinical performance study would.
In a 510(k) submission, especially for devices like plates and screws that are substantially equivalent to existing predicate devices, the "acceptance criteria" are generally met by demonstrating substantial equivalence in terms of:
- Intended Use: The device is for the same medical purpose.
- Technological Characteristics: The device has similar design, materials, and operating principles.
- Performance: The device performs as safely and effectively as the predicate device(s). This is typically demonstrated through non-clinical testing (e.g., mechanical testing, materials characterization, dimensional analysis, finite element analysis) rather than human clinical trials.
The provided document explicitly states: "The Volar Plate System is similar to the listed predicate devices in intended use, performance characteristics, materials of construction, manufacturing methods and design. This is evidenced by comparison of technological characteristics, dimensional analysis and finite element analysis."
Therefore, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by 510(k) Substantial Equivalence) | Reported Device Performance (as per document) |
|---|---|
| Similar Intended Use (to predicate devices) | "The DVO™ Volar Plate System is intended for volar fixation of fractures and osteotomies involving the distal radius. This single use device is for cementless use only." (Matches predicate's general use for distal radius fixation). |
| Similar Performance Characteristics (to predicate devices) | "Evidenced by comparison of technological characteristics, dimensional analysis and finite element analysis." (Implies mechanical and functional performance is comparable to predicate devices, without specific numerical acceptance values provided in this summary). |
| Similar Materials of Construction (to predicate devices) | "titanium (ASTM F-136) or stainless steel (ASTM F-138 or ASTM 2229)" (Implies these materials are standard and comparable to those used in predicate medical devices for bone fixation). |
| Similar Design (to predicate devices) | "This non-sterile volar plate system offers several sizes and styles of volar plates... The three versions include a volar T-plate, a volar intramedullary T-plate and a volar T-plate with translating head." "The distal head of the plate contains two rows of fixed angle screw holes that accept 2.7 mm screws." (Implies design features are standard for volar plates and comparable to predicates). |
Note: Specific numerical acceptance criteria for mechanical strength, fatigue life, or other performance aspects are typical for bone fixation devices but are not detailed in this 510(k) summary. These would be found in the full submission, likely in the form of pre-established performance standards or comparison to predicate device data.
Regarding the study proving the device meets acceptance criteria (as requested):
The document describes a bench testing/analysis approach rather than a human clinical study with patients or expert readers.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of human data. For "dimensional analysis and finite element analysis," the "sample" would be the device designs and material properties themselves, for which specific quantification of "sample size" is not provided in this summary.
- Data Provenance: Not applicable for human data. The analysis is based on engineering principles and material science.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for non-clinical engineering analysis is based on established scientific principles, material standards (ASTM), and engineering models.
4. Adjudication method for the test set:
- Not applicable. There is no human (e.g., radiologist) adjudication process described.
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 not an AI-assisted diagnostic device, nor is it a clinical outcomes study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical orthopedic implant, not a software algorithm. The "standalone performance" is assessed through engineering tests.
7. The type of ground truth used:
- The "ground truth" for demonstrating substantial equivalence for this device category typically relies on:
- Engineering Standards: Adherence to ASTM standards (e.g., for materials F-136, F-138, 2229).
- Biomechanical Equivalence: Finite element analysis and dimensional analysis comparing the device's mechanical behavior to that of predicate devices, ensuring it can withstand typical physiological loads.
- Predicate Device Performance History: The long-standing safety and effectiveness of the predicate devices establish the "ground truth" for what constitutes acceptable performance in this therapeutic area.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI/machine learning model.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
In summary: This 510(k) submission seeks clearance based on substantial equivalence to existing, legally marketed predicate devices through bench testing and engineering analysis, not clinical trials with patient data or human interpretation studies. The "acceptance criteria" are intrinsically tied to demonstrating that the new device is as safe and effective as its predicates based on its design, materials, and mechanical performance.
§ 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.