(90 days)
The Piccolo Composite Proximal Tibia Plate System is intended to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused.
For Lateral Plates - non-unions, and factures including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
For Medial Plates - intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia.
The Piccolo Composite Proximal Tibia Plate System comprises implants (pre-contoured lateral and medial plates (in left and right configurations), and screws) in different dimensions, and instruments.
The Piccolo Composite proximal tibia plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK) and incorporate tantalum markers. The screws are made of titanium alloy.
The provided text is a 510(k) summary for a medical device (Piccolo Composite Proximal Tibia Plate System) and focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing. It does not contain information about studies involving human readers, AI, or diagnostic performance metrics typically associated with acceptance criteria for such studies.
Therefore, many of the requested sections about acceptance criteria, human reader performance, AI, and ground truth establishment cannot be answered from the provided document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Mechanical Performance) | Reported Device Performance |
|---|---|
| Performed per ASTM F 382 (for plate static and dynamic bending) | Comparable to predicate devices |
| Screw pushout from the plate | Comparable to predicate devices |
| Screw insertion torque | Comparable to predicate devices |
| Screw pull out force | Comparable to predicate devices |
| Screw dimensional equivalence | Comparable to predicate devices |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The performance testing described is mechanical, not clinical, and thus terms like "test set" for human or AI performance or "data provenance" in this context are not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The "ground truth" in this context refers to engineering standards and comparisons to predicate devices, not expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Arbitration methods are typically used for clinical studies with human observers, which is not the type of study described.
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
There is no indication that an MRMC comparative effectiveness study was done. This document describes the mechanical testing of a bone plate system, not a diagnostic or AI-assisted device. Therefore, no information on AI assistance or human reader improvement is available.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no indication that a standalone algorithm performance study was done. The device is a physical bone plate system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the mechanical performance testing appears to be established engineering standards (ASTM F 382) and performance data from legally marketed predicate devices.
8. The sample size for the training set
This information is not provided. The concept of a "training set" is not applicable to the mechanical performance testing described for this physical device.
9. How the ground truth for the training set was established
This information is not provided. The concept of a "training set" and its ground truth is not applicable to the mechanical performance testing described for this physical 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.