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510(k) Data Aggregation
(119 days)
QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)
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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