(65 days)
The Piccolo Composite Distal Volar Radius Plate System is indicated for fractures and osteotomies of the distal volar radius.
The Piccolo Composite Distal Volar Radius Plate System comprises implants (plates and screws), and a set of instruments. The "triangular" plates, added in this 510(k) Notification, are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with a tantalum thread, to provide for their visualization under fluoroscopy, like the rest of the Piccolo Composite plates. The "triangular" Piccolo Composite distal volar radius plate is 2.4mm thick. The plate shaft comprises 3 - 5 holes, corresponding to plate lengths in the range of 54 - 72 mm. The screws and pegs are made of titanium alloy. Various screw types are available, such as cortical screws and locking screws, as well as pegs, in various dimensions.
This document is a 510(k) premarket notification for the Piccolo Composite® Distal Volar Radius Plate System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria using human readers or AI.
Instead, the document focuses on mechanical performance testing and substantial equivalence to legally marketed predicate devices, which is a common pathway for medical device clearance in the U.S.
Here's what can be extracted and what is missing based on your request:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bending of construct strength comparable to predicate devices (per ASTM F 382) | "comparable to those of predicate devices" |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. This typically refers to the number of devices tested in the mechanical bending test.
- Data provenance: Not applicable in the context of human reader studies or AI. The data provenance here refers to the mechanical testing performed on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a bone plate system, not an AI or diagnostic imaging device that requires expert ground truth for its performance evaluation against clinical findings. Its evaluation is based on mechanical properties and substantial equivalence.
4. Adjudication method for the test set:
Not applicable.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is not an algorithm.
7. The type of ground truth used:
For the mechanical performance testing, the "ground truth" would be the established mechanical properties and performance standards of the predicate devices or relevant ASTM standards (ASTM F 382 in this case). The performance of the new device is compared against these benchmarks.
8. The sample size for the training set:
Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable.
Summary of what is available in the document regarding performance:
The device's performance was evaluated through mechanical testing, specifically bending of construct as per ASTM F 382. The results were found to be comparable to those of predicate devices, which is the basis for demonstrating its safety and effectiveness for its intended use in the context of substantial equivalence. The document does not describe any clinical studies involving human readers, AI, or diagnostic image interpretation.
§ 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.