(92 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 MTP plates are indicated for treatment of deformations, fractures, nonunions and replantations of the 1st metarsophalangeal joint and 1st metatarsal bone.
The Piccolo Composite MTP 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.
The provided text describes a 510(k) premarket notification for a medical device called the "Piccolo Composite® Plate System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria in a clinical study sense with AI algorithms.
Therefore, the information requested in your prompt (Acceptance Criteria, Study details, Sample sizes, Expert qualifications, Adjudication method, MRMC studies, Standalone performance, Ground truth, Training set information) is not applicable to this document. The document outlines:
- Device Name: Piccolo Composite® Plate System
- Manufacturer: CarboFix Orthopedics, Ltd.
- Regulation Number: 21 CFR 888.3030 (Single/Multiple Component Metallic Bone Fixation Appliances And Accessories)
- Regulatory Class: Class II
- Product Code: HRS
- Indications for Use: 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 in osteopenic bone. Specifically, MTP plates are indicated for the 1st metatarso-phalangeal joint and 1st metatarsal bone.
- Predicate Devices: Primarily previous versions of the Piccolo Composite® Plate System (K102597, K120409, K130061, 143496, 160002), and additional predicates from Synthes and Tornier (OrthoHelix Surgical Designs Inc.).
- Substantial Equivalence Claim: Based on intended use, design, materials, technological characteristics, and principles of operation, and performance characteristics including static and dynamic bending (evaluated per ASTM F 382).
The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical performance testing, specifically mechanical testing per ASTM standards, rather than clinical trials or AI algorithm validation studies.
Here's a breakdown of why your specific questions cannot be answered by this document:
- Acceptance Criteria/Reported Performance: The document only states that performance characteristics were "comparable to those of predicate devices (as applicable)" and "demonstrating that the device is safe and effective for its intended use" based on tests like ASTM F 382. It does not provide a table of numerical acceptance criteria or reported device performance metrics from a clinical study, as these are not required for this type of submission for a bone fixation device.
- Sample Size/Data Provenance/Experts/Adjudication/MRMC/Standalone Performance/Ground Truth/Training Set: These concepts are relevant to the validation of AI/ML-based medical devices or complex diagnostic devices, often involving human readers interpreting data. This document describes a mechanical implant, not an AI algorithm. Therefore, there are no "test sets," "training sets," "experts establishing ground truth," "adjudication methods," or "MRMC studies" in the context of human interpretation of medical images or data. The "ground truth" for this device's performance would be engineering specifications and mechanical test results (e.g., force at failure, fatigue life).
In summary: The provided text is a regulatory clearance letter for a mechanical medical device (bone plate system), not an AI-powered diagnostic or therapeutic device. Thus, the questions related to AI/ML validation methodologies are not applicable. The "proof" of meeting acceptance criteria for this device came from engineering and mechanical testing, not clinical studies involving expert readers or AI algorithms.
§ 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.