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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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(253 days)
Indications for the Quantum IM Composite Humeral 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 Quantum IM Composite Humeral Nail is indicated for fixation of fractures that occur in and between the proximal and distal third of the humerus.
The Quantum IM Composite Nailing System includes nails, interlocking screws and a set of instruments.
The Quantum IM Composite Nail is a cylindrical solid rod, made of carbon fiber reinforced polymer. Its diameter ranges from 7 to 8.5 mm, with lengths in the range of 180 to 280 mm. The nail provides for holes at its proximal and distal sections, designed for the insertion of the 3.5 mm self-tapping, cortical, titanium-alloy-made, interlocking screws. The nail has a closed, pointed distal end, and its proximal end incorporates a thread enabling connection of insertion/extraction instrumentation.
This 510(k) summary describes a medical device, the Quantum IM Composite Nailing System, and its substantial equivalence to predicate devices, rather than a study proving performance against acceptance criteria for a new AI/software-as-a-medical-device (SaMD) product.
Therefore, most of the requested information regarding acceptance criteria, AI performance metrics, expert adjudication, and training/test set details are not applicable to this document. This submission focuses on demonstrating that a physical medical device (an intramedullary nailing system) is safe and effective through comparison to existing, legally marketed devices.
However, I can extract the relevant information from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria. Instead, it asserts substantial equivalence to predicate devices. The performance characteristic evaluated is mechanical.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices in intended use, design, materials, technological characteristics, and principles of operation. | "The Quantum IM Composite Nailing System intended use, design, materials, technological characteristics, and principles of operation are substantially equivalent to those of the predicate devices, as applicable." |
| Performance characteristics comparable to predicate devices. | "Performance characteristics, evaluated per ASTM F 1264, are also comparable to those of predicate devices, thus demonstrating that the device is safe and effective for its intended use." |
2. Sample size used for the test set and the data provenance
Not applicable. This is a physical medical device. The "test set" would refer to mechanical testing, not a dataset for an algorithm. The document mentions evaluation "per ASTM F 1264," which is a standard for mechanical testing of intramedullary fixation devices. The specific sample size or provenance of the materials tested under this standard is not detailed in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical medical device. "Ground truth" in this context would refer to material properties or mechanical test results, not expert consensus on medical images or clinical outcomes.
4. Adjudication method for the test set
Not applicable. Mechanical testing typically follows standardized protocols (e.g., ASTM F 1264), and results are based on measurement, not adjudication.
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
No. This is a physical medical device, not an AI/SaMD.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device, not an AI/SaMD.
7. The type of ground truth used
For mechanical performance, the "ground truth" would be the measured physical and mechanical properties and performance under standardized testing conditions (ASTM F 1264) compared to known properties of predicate devices.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/SaMD.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/SaMD.
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