(40 days)
The Volition Plating System is indication and fixation of fractures or osteotomies, revision procedures, joint fusion, and reconstruction of small bones of the feet and ankles, including the toes, talus, and calcaneus; the distal fibula and tibia; as well as the fingers, hands, and wrists.
In addition, the non-locking screws and washers are in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
The Volition Plating System is a set of implantable metallic (Titanium Alloy) bone plates consisting of a series of tubular plates of varying lengths as well as anatomically contoured plates. The Volition Plating System plates are provided with locking and non-locking in Ø2.7mm, Ø3.5mm, & Ø4.0mm previously cleared under K202764. All implants are made from Titanium Alloy (Ti-6AL-4V ELI) per ASTM F136 and are provided non-sterile.
This is a 510(k) premarket notification for the Volition Plating System, a metallic bone fixation device. The document states that the device is substantially equivalent to legally marketed predicate devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document describes a medical device called the "Volition Plating System" which is a metallic bone fixation device. The provided text is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. In such submissions, explicit "acceptance criteria" and "reported device performance" are typically framed in terms of equivalence to the predicate device through various tests and analyses.
Therefore, the "acceptance criteria" here is that the Volition Plating System demonstrates substantial equivalence to the predicate devices in terms of material, geometry, design, indications for use, and mechanical performance. The "reported device performance" is the conclusion that this equivalence has been demonstrated.
Since this is a substantial equivalence determination and not a performance claim against specific quantitative thresholds for a new function, a typical acceptance criteria table with numerical performance metrics isn't directly applicable in the same way it would be for, say, an AI diagnostic tool.
However, based on the "Performance Analysis" and "Conclusion" sections of the 510(k) summary, we can infer the following:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence in material | The Volition Plating System uses Titanium Alloy (Ti-6AL-4V ELI) per ASTM F136, which is stated to be substantially equivalent to the predicate devices. |
| Substantial equivalence in geometry | The Volition Plating System's plates consist of tubular plates of varying lengths and anatomically contoured plates, with locking and non-locking screws in Ø2.7mm, Ø3.5mm, & Ø4.0mm, which are stated to be substantially equivalent to the predicate devices. |
| Substantial equivalence in design | The design characteristics of the subject device do not raise new types of questions regarding safety or efficacy. |
| Substantial equivalence in indications for use | The Indications for Use for the Volition Plating System are the same as the predicate devices: stabilization and fixation of fractures or osteotomies, revision procedures, joint fusion, and reconstruction of small bones of the feet and ankles, and fingers, hands, and wrists. Non-locking screws and washers are for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation. |
| Substantial equivalence in mechanical performance (e.g., bending strength) | Engineering analysis was employed to demonstrate that the Volition System bone plates are substantially equivalent to the predicate(s) with respect to bending strength performance. |
2. Sample size used for the test set and the data provenance
The document describes an engineering analysis and comparison to predicate devices. It does not describe a clinical study involving human subjects or a test set of data with a specified sample size. The provenance of such a "test set" is therefore not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As noted above, this is a 510(k) submission based on engineering analysis and comparison to predicate devices, not a study involving a "test set" with ground truth established by experts.
4. Adjudication method for the test set
Not applicable. There is no mention of a test set or adjudication process.
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 MRMC comparative effectiveness study was done. This device is a bone fixation system, not an AI-powered diagnostic tool, so such a study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical bone fixation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As this is not a diagnostic device or a study requiring ground truth establishment, this information is not relevant to this 510(k) submission. The "ground truth" in this context is the performance of the legally marketed predicate devices, which the new device aims to be substantially equivalent to.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device. The "training" in this context would be the design and testing of the device to meet engineering specifications and ensure equivalence to predicates.
9. How the ground truth for the training set was established
Not applicable. As there is no training set discussed, this question is not relevant.
§ 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.