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510(k) Data Aggregation
(76 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 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
| Acceptance Criteria (Evaluation Type) | Reported Device Performance |
|---|---|
| Static Bending (per ASTM F 382) | Comparable to predicate devices |
| Dynamic Bending (per ASTM F 382) | Comparable to predicate devices |
| Bacterial Endotoxin Testing | Conducted (implied acceptable) |
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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(133 days)
The ORTHOLOC® 3Di Small Bones Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles. The system can be used in both adult and pediatric patients. Examples include:
- Metatarsal, metacarpal, or phalangeal fractures and osteotomies
- Lesser metatarsal shortening osteotomies (e.g. Weil)
- Fifth metatarsal fractures (e.g. Jones Fracture)
The ORTHOLOC® 3Di comprises of variety of plates and screws for fixation of bone fragments. The subject device is composed of titanium alloy per ASTM F136. This system consists of plates in left, right, and universal configurations. The plates can feature polyaxial locking holes and compression holes. The plates are provided non-sterile.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) premarket notification for the ORTHOLOC® 3Di Small Bones Plating System, outlining its substantial equivalence to previously marketed devices. It primarily discusses the device's intended use, technological characteristics, and non-clinical and clinical evidence provided for FDA clearance.
The document states:
- (b)(1). Substantial Equivalence - Non-Clinical Evidence: "Performance testing and analysis demonstrated substantial equivalence in static and fatigue bending."
- (b)(2). Substantial Equivalence Clinical Evidence: "N/A"
This indicates that the clearance was based on non-clinical performance testing against a predicate device, rather than a clinical study with detailed acceptance criteria, ground truth establishment, or human reader performance evaluations as typically seen for AI/software-as-a-medical-device (SaMD) products.
Therefore, I cannot provide the requested table or details about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information based on this document.
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