(291 days)
Piccolo Composite™ Distal Fibula Plate System: The Piccolo Composite™ Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, including in osteopenic bone.
Piccolo Composite™ One-Third Tubular Plate System: The Piccolo Composite™ One-Third Tubular Plates are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, radius, ulna, pelvis, and fibula including in osteopenic bone.
Piccolo Composite™ Proximal Humerus Plate System: 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 System: The Piccolo Composite™ Distal Volar Radius Plate is indicated for fractures and osteotomies of the distal volar radius.
The Piccolo Composite™ Distal Fibula and One Third Tubular Plate Systems comprise implants (plates and screws), and sets 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 screws and locking screws are available, in various dimensions. The general description of the Piccolo Composite™ Proximal Humerus and Distal Volar Radius Plate Systems is not changed as compared to the predicates.
The provided document describes a 510(k) premarket notification for a medical device, the Piccolo Composite™ Plate System. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting clinical studies with specific acceptance criteria in the way a pharmaceutical or novel high-risk device might.
Therefore, the information requested regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance as typically applied to AI or diagnostic imaging devices is not applicable to this submission.
Instead, the "study" proving the device meets its acceptance criteria here is a series of biomechanical and material performance tests compared against relevant ASTM standards and predicate devices.
Here's a breakdown of the available information in the requested format, adapted for a device submission of this nature:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Comparable static and dynamic (fatigue) 4-point bending performance to predicate devices and adherence to ASTM F 382 standard. | |
| Comparable axial static and dynamic bending performance. | |
| Selected screw characteristics evaluation. | Performance characteristics for the Piccolo Composite™ Distal Fibula and One Third Tubular Plate Systems, such as single cycle (static) 4-point bending and dynamic (fatigue) 4-point bending, were evaluated per ASTM F 382 - Standard Specification and Test Method for Metallic Bone Plates and are comparable to those of predicate devices (where applicable). Axial static and dynamic bending tests, selected screws characteristics evaluation, and evaluation in support of the MR Conditional labeling parameters were also provided. All the above demonstrate that the device is safe and effective for its intended use. |
| Material Composition: | |
| CFR-PEEK plates with tantalum thread for visualization. | |
| Titanium alloy screws. | 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 screws and locking screws are available, in various dimensions. |
| Intended Use & Design: | |
| Similar indications for use and design principles as predicate devices. | The Piccolo Composite™ Plate System intended use, design, materials, technological characteristics, and principles of operation are substantially equivalent to those of the predicate devices, as applicable. The indications for use match those of the predicate devices (e.g., fractures, osteotomies, non-unions of specific bones). |
| Safety & Effectiveness: | |
| Demonstrate overall safety and effectiveness for intended use. | All the above (performance tests, material composition, design and intended use equivalence) demonstrate that the device is safe and effective for its intended use. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of "cases" or "patients." Instead, the "test set" consists of physical samples of the device components (plates and screws) that undergo biomechanical testing. The number of samples for each specific test (e.g., 4-point bending, axial bending) is not detailed in the provided summary.
- Data Provenance: The tests are likely conducted in a controlled laboratory environment. The document does not specify a country of origin for the testing data, but the applicant's address is in Herzeliya, Israel. The data is prospective in the sense that the tests are performed specifically to support this regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. For this type of device (bone plate system), ground truth is established through adherence to standardized engineering and material science testing protocols (e.g., ASTM F 382) and comparison to the known performance of predicate devices, not through expert consensus on clinical cases. The "ground truth" is the objective outcome of these physical tests.
4. Adjudication method for the test set
- Not applicable. Adjudication typically applies to ambiguous clinical or imaging data reviewed by multiple experts. For biomechanical testing, the results are typically quantitative measurements that are compared directly to predefined standards or 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 device is a bone plate system, not an AI or diagnostic imaging device. MRMC studies are not relevant to its regulatory approval process.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical implant, not an algorithm or AI system.
7. The type of ground truth used
- Engineering Standards and Predicate Device Performance: The "ground truth" for this submission is established by the requirements of recognized industry standards like ASTM F 382 for metallic bone plates, and the known, legally marketed performance characteristics (material, mechanical properties) of the identified predicate devices.
8. The sample size for the training set
- Not applicable. This device approval does not involve a "training set" in the context of machine learning or AI. The design and manufacturing process would involve internal development and testing, but not a formally defined "training set" for regulatory purposes here.
9. How the ground truth for the training set was established
- Not applicable. As a physical implant and not an AI system, there is no "training set" or corresponding "ground truth" to be established in this context. The engineering design and manufacturing processes follow established medical device quality systems.
§ 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.