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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 Lapidus plates are indicated for fusion and arthrodesis of the 1st tarsometatarsal joint (Lapidus Fusions).

The Piccolo Composite Lapidus 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.

This document is a 510(k) premarket notification for the "Piccolo Composite® Plate System" and primarily focuses on establishing substantial equivalence to predicate devices, rather than an AI/ML device study. Therefore, most of the requested information regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable to this submission.

However, I can extract the relevant performance criteria and summary from the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. This document describes the mechanical testing and material compatibility of an orthopedic plate system, not an AI device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus.

4. Adjudication method for the test set: Not applicable.

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, as this is not an AI device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.

7. The type of ground truth used:

• Mechanical Performance: Established through standardized engineering tests (ASTM F 382) for static and dynamic bending. The "ground truth" here is the measured mechanical properties of the device and its predicate devices.
• Biocompatibility: Established through bacterial endotoxin testing.

8. The sample size for the training set: Not applicable, as this is not an AI device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

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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.

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