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510(k) Data Aggregation
(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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