(48 days)
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.
The Piccolo Composite 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 Piccolo Composite Diaphyseal Plate is either 4.5mm, or 5.3mm thick; 14.5mm or 17.5mm wide; and is provided in lengths of 82 - 220mm (4 - 13 holes), depending on plates thickness and width.
The screws are made of titanium alloy. Both locking (04.0mm and Ø5.0mm) and nonlocking (04.5mm) screws are available in a range of lengths.
This document describes the mechanical testing performed to demonstrate the substantial equivalence of the Piccolo Composite® Plate System.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (ASTM F382) | Reported Device Performance (Compared to Predicate Devices) |
|---|---|---|
| Single Cycle (Static) 4-Point Bending | Meets or exceeds performance of predicate devices | Comparable to predicate devices |
| Dynamic (Fatigue) 4-Point Bending | Meets or exceeds performance of predicate devices | Comparable to predicate devices |
| Selected Screws Characteristics | Meets or exceeds performance of predicate devices | Performed and determined to be safe and effective |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the mechanical testing. However, it indicates that "Performance characteristics... were evaluated per ASTM F 382 - Standard Specification and Test Method for Metallic Bone Plates." This implies that the sample sizes used would have conformed to the requirements of ASTM F382 for such testing.
The data provenance is from laboratory testing conducted by CarboFix Orthopedics Ltd. There is no information regarding country of origin of data in terms of clinical data, as this study refers to mechanical testing. This was a prospective study in the sense that the tests were specifically designed and executed to evaluate the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This study involves mechanical performance testing of a medical device against an ASTM standard and predicate devices, not the evaluation of clinical data requiring expert review for ground truth.
4. Adjudication Method for the Test Set
Not applicable. This is mechanical testing, not a clinical study requiring adjudication of expert opinions. The "adjudication" is met by comparing test results against the established ASTM standard and predicate device data.
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 document describes the mechanical testing of a bone plate system, not an AI-assisted diagnostic or therapeutic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This document describes the mechanical testing of a bone plate system, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this study is defined by:
- ASTM F382 - Standard Specification and Test Method for Metallic Bone Plates: This standard provides the methodologies and acceptable performance benchmarks for bone plates.
- Performance of Predicate Devices: The measured performance of existing, legally marketed devices (Piccolo Composite® Plate System K102597, K120409, and Synthes Locking Compression Plate System e.g., K000682, K082807) served as the comparative "ground truth" to establish substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is mechanical testing of a physical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is mechanical testing, not machine learning.
§ 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.