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510(k) Data Aggregation
(167 days)
Piccolo Composite™ Diaphyseal Plate: The Piccolo Composite™ Diaphyseal Plate is indicated for the fixation of various long bones, such as the humerus, femur and tibia, including osteopenic bone, osteotomies, and nonunions or malunions in adult patients. These plates are also indicated for fracture fixation of diaphyseal areas of long bones in pediatric patients.
Piccolo Composite™ Proximal Humerus Plate: 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: The Piccolo Composite™ Distal Volar Radius Plate is indicated for fractures and osteotomies of the distal volar radius.
The Piccolo Composite Plate System comprises implants (plates and screws/pegs), 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 following types of plates are available: Diaphyseal Plates (thickness: 4.5 mm or 5 mm); Proximal Humerus Plate (thickness: 3.7 mm); Distal Volar Radius Plate (thickness: 2.4 mm). The Screws (and Pegs) are made of titanium alloy. Various screw types are available, such as cortical screws and locking screws, as well as pegs (to be used only with the Distal Radius Plate), in various dimensions.
The Piccolo Composite™ Plate System is a bone plating system, and its acceptance criteria and supporting study are described below, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Method) | Reported Device Performance (Results) |
|---|---|
| Single cycle (static) 4-point bending per ASTM F 382 | Results were comparable to those of similar predicate devices. |
| Dynamic (fatigue) 4-point bending per ASTM F 382 | Results were comparable to those of similar predicate devices. |
| MRI compatibility (MR Conditional labeling parameters) | Testing in support of MR Conditional labeling parameters was provided. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample sizes for the mechanical testing (static and dynamic bending) or MR Conditional testing. It simply states that "Performance characteristics... were evaluated" and "Testing in support of the MR Conditional labeling parameters was also provided."
The data provenance is intrinsic to the device development and testing, meaning the tests were conducted in a controlled environment to assess the physical properties of the device (likely in a lab setting). This is prospective in the sense that the tests were designed and executed to evaluate the new device. There is no indication of retrospective data or country of origin for the data beyond the manufacturer's location (Israel).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The "test set" in this context refers to the physical devices undergoing mechanical and material property testing, not an AI algorithm evaluated against expert-established ground truth. The "ground truth" for these tests are objective, measurable physical properties, not subjective expert interpretations.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth from multiple human reviewers, which is not relevant for the mechanical and material testing performed for this device. The results of the mechanical tests are quantitative measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a mechanical implant, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. This device is a physical implant, not an algorithm. Therefore, there is no "standalone" algorithm performance to evaluate. The performance discussed is the physical integrity and characteristics of the plate itself.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation of the Piccolo Composite™ Plate System was based on:
- ASTM F 382 Standard Specification: This provides the defined methodology and criteria for evaluating the mechanical properties (static and dynamic bending) of metallic bone plates. The acceptance is based on the device's performance relative to these established standards and its predicate devices.
- Material Properties and MRI Compatibility Standards: For the CFR-PEEK material, previous clearances (K091425, K100497) established its material properties. For MR Conditional labeling, defined standards and guidelines for MRI safety testing would have been used.
8. Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not an AI algorithm. There is no concept of a "training set" for its development in the context of machine learning. The device's material (CFR-PEEK) was previously cleared, indicating prior testing and validation for its use in medical devices.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this device. The "ground truth" for the material and design principles of the device would have been established through extensive material science research, engineering principles, and prior regulatory clearances for similar materials and device types.
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(119 days)
Indications for the Piccolo Composite Humeral Nail and Proximal Humerus Nail include simple humeral fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The Piccolo Composite Humeral and Proximal Humerus Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the humerus.
The Piccolo Composite Nailing System includes humeral and proximal humerus nails. interlocking screws and a set of instruments.
The Piccolo Composite Nail is a cylindrical solid rod, made of carbon fiber reinforced polymer. The humeral nail diameter ranges from 7 mm to 8.5 mm, with lengths in the range of 180 mm to 280 mm. The dimensions of the proximal humerus nail are 8 mm diameter (11 mm at proximal end), and length of 150 mm. The nails provide for holes at proximal and distal sections, designed for the insertion of self-tapping, titanium-allovmade, interlocking screws. The nails have a closed, pointed distal end, and their proximal end incorporates a thread enabling connection of insertion/extraction instrumentation.
The provided text is a 510(k) summary for the Piccolo Composite Nailing System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical properties and intended use, rather than a clinical study evaluating diagnostic performance, as might be done for AI/ML-driven devices. Therefore, much of the requested information regarding acceptance criteria, study design for diagnostic performance, ground truth establishment, and expert involvement is not present in this document.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The term "acceptance criteria" in this context refers to the criteria for demonstrating substantial equivalence based on mechanical testing and intended use. The document states: "Biomechanical evaluation demonstrates comparable mechanical properties to the predicate device."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use substantially equivalent to predicate devices. | Intended use is presented as identical to the predicate device (implied through the substantial equivalence claim and the re-naming of the previous Quantum IM device). |
| Design substantially equivalent to predicate devices. | The system description suggests a similar design to predicate devices for intramedullary nails, with specific dimensions and material (carbon fiber reinforced polymer). |
| Materials substantially equivalent to predicate devices. | The nail is made of carbon fiber reinforced polymer, and interlocking screws are titanium-alloy made. This is implied to be comparable to predicate devices. |
| Technological characteristics substantially equivalent to predicate devices. | The principles of operation are stated to be substantially equivalent. |
| Principles of operation substantially equivalent to predicate devices. | Principles of operation are stated to be substantially equivalent. |
| Biomechanical properties comparable to predicate devices. | Biomechanical evaluation demonstrates comparable mechanical properties to the predicate device. |
2. Sample size used for the test set and the data provenance
Not applicable. This is a mechanical device, and the "test set" would refer to the samples used in biomechanical testing. The document states "Biomechanical evaluation demonstrates comparable mechanical properties," but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in this context would typically refer to clinical outcomes or definitive diagnoses for performance studies of AI/ML devices. For a mechanical device, the "ground truth" for biomechanical evaluation would be the physical properties and performance measured against engineering standards or predicate devices. No external experts for "ground truth" establishment are mentioned.
4. Adjudication method for the test set
Not applicable. No clinical test set or adjudication method is described. The evaluation is based on biomechanical testing.
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 is a medical device, not an AI/ML diagnostic software. No MRMC study was performed or needed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical medical device, not an algorithm.
7. The type of ground truth used
For the biomechanical evaluation, the "ground truth" would be established by standardized mechanical testing protocols and comparison against the known mechanical properties of the predicate devices. The specific type of ground truth (e.g., specific load-bearing capacity, fatigue strength) is not detailed, but it falls under "biomechanical properties."
8. The sample size for the training set
Not applicable. This is a physical device, and the concept of a "training set" is not relevant in the context of this 510(k) submission.
9. How the ground truth for the training set was established
Not applicable. As above, a "training set" and its "ground truth" are not relevant to this device's evaluation as described.
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