(167 days)
Piccolo Composite™ Diaphyseal Plate: The Piccolo Composite™ Diaphyseal Plate is indicated for the fixation of various long bones, such as the humerus, femur and tibia, including osteopenic bone, osteotomies, and nonunions or malunions in adult patients. These plates are also indicated for fracture fixation of diaphyseal areas of long bones in pediatric patients.
Piccolo Composite™ Proximal Humerus Plate: The Piccolo Composite™ Proximal Humerus Plate is indicated for fractures, fracture dislocations, osteotomies, and nonunions of the proximal humerus, including in osteopenic bone.
Piccolo Composite™ Distal Volar Radius Plate: The Piccolo Composite™ Distal Volar Radius Plate is indicated for fractures and osteotomies of the distal volar radius.
The Piccolo Composite Plate System comprises implants (plates and screws/pegs), 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 following types of plates are available: Diaphyseal Plates (thickness: 4.5 mm or 5 mm); Proximal Humerus Plate (thickness: 3.7 mm); Distal Volar Radius Plate (thickness: 2.4 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 (to be used only with the Distal Radius Plate), in various dimensions.
The Piccolo Composite™ Plate System is a bone plating system, and its acceptance criteria and supporting study are described below, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Method) | Reported Device Performance (Results) |
|---|---|
| Single cycle (static) 4-point bending per ASTM F 382 | Results were comparable to those of similar predicate devices. |
| Dynamic (fatigue) 4-point bending per ASTM F 382 | Results were comparable to those of similar predicate devices. |
| MRI compatibility (MR Conditional labeling parameters) | Testing in support of MR Conditional labeling parameters was provided. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample sizes for the mechanical testing (static and dynamic bending) or MR Conditional testing. It simply states that "Performance characteristics... were evaluated" and "Testing in support of the MR Conditional labeling parameters was also provided."
The data provenance is intrinsic to the device development and testing, meaning the tests were conducted in a controlled environment to assess the physical properties of the device (likely in a lab setting). This is prospective in the sense that the tests were designed and executed to evaluate the new device. There is no indication of retrospective data or country of origin for the data beyond the manufacturer's location (Israel).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The "test set" in this context refers to the physical devices undergoing mechanical and material property testing, not an AI algorithm evaluated against expert-established ground truth. The "ground truth" for these tests are objective, measurable physical properties, not subjective expert interpretations.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth from multiple human reviewers, which is not relevant for the mechanical and material testing performed for this device. The results of the mechanical tests are quantitative measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a mechanical implant, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. This device is a physical implant, not an algorithm. Therefore, there is no "standalone" algorithm performance to evaluate. The performance discussed is the physical integrity and characteristics of the plate itself.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation of the Piccolo Composite™ Plate System was based on:
- ASTM F 382 Standard Specification: This provides the defined methodology and criteria for evaluating the mechanical properties (static and dynamic bending) of metallic bone plates. The acceptance is based on the device's performance relative to these established standards and its predicate devices.
- Material Properties and MRI Compatibility Standards: For the CFR-PEEK material, previous clearances (K091425, K100497) established its material properties. For MR Conditional labeling, defined standards and guidelines for MRI safety testing would have been used.
8. Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not an AI algorithm. There is no concept of a "training set" for its development in the context of machine learning. The device's material (CFR-PEEK) was previously cleared, indicating prior testing and validation for its use in medical devices.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this device. The "ground truth" for the material and design principles of the device would have been established through extensive material science research, engineering principles, and prior regulatory clearances for similar materials and device types.
§ 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.