(76 days)
The Piccolo Composite foot and ankle plates are indicated for fixation of osteotomies, fusions, fractures, nonunions, malunions and replantations of small bone fragments in adult and adolescent (12 - 21 years) patients, including the foot and ankle, and including in osteopenic bone.
The Lapidus plates are indicated for fusion and arthrodesis of the 1st tarsometatarsal joint (Lapidus Fusions).
The Piccolo Composite Lapidus Plate System comprises implants (plates and screws), and a set of instruments.
The plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with a tantalum thread, to provide for their visualization under fluoroscopy.
The screws are made of titanium alloy. Both non-locking and locking 2.7mm screws are available, in various lengths. Cannulated Lag Screws are also provided.
This document is a 510(k) premarket notification for the "Piccolo Composite® Plate System" and primarily focuses on establishing substantial equivalence to predicate devices, rather than an AI/ML device study. Therefore, most of the requested information regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable to this submission.
However, I can extract the relevant performance criteria and summary from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Evaluation Type) | Reported Device Performance |
|---|---|
| Static Bending (per ASTM F 382) | Comparable to predicate devices |
| Dynamic Bending (per ASTM F 382) | Comparable to predicate devices |
| Bacterial Endotoxin Testing | Conducted (implied acceptable) |
2. Sample size used for the test set and the data provenance: Not applicable. This document describes the mechanical testing and material compatibility of an orthopedic plate system, not an AI device.
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 mechanical testing is established by engineering standards and measurements, not expert consensus.
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: Not applicable, as this is not an AI device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
7. The type of ground truth used:
- Mechanical Performance: Established through standardized engineering tests (ASTM F 382) for static and dynamic bending. The "ground truth" here is the measured mechanical properties of the device and its predicate devices.
- Biocompatibility: Established through bacterial endotoxin testing.
8. The sample size for the training set: Not applicable, as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.
§ 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.