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510(k) Data Aggregation
(283 days)
Sonoma Fifth Metatarsal Repair System
The Sonoma Fifth Metatarsal Repair System is intended for use in the fixation of fractures of the fifth metatarsal, including Jones, avulsion and shaft fractures.
The Sonoma Fifth Metatarsal Repair System is intended for use in the fixation of fractures and osteotomies of the fifth metatarsal, including Jones, avulsion, and shaft fractures. The Fifth Metatarsal Repair System includes the Sonoma Fifth Metatarsal Nail, End Caps and related instruments. Sonoma's Fifth Metatarsal Nail differs from traditional nails or rods as it utilizes Sonoma's ActivLoc® fixation gripper system at the distal end of the rod to supplement distal fixation without the use of screws, threads or K-wires. The implants are composed of 316 stainless steel per ASTM F138.
The provided text is a 510(k) summary for the Sonoma Fifth Metatarsal Repair System, an intramedullary fixation rod. It describes the device, its intended use, and its substantial equivalence to a predicate device (K032548 IP-XS Compression Nail).
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured?) | Reported Device Performance (Result) |
|---|---|
| Cyclic fatigue strength | Confirmed that the subject rods are equivalent to the predicate device in cyclic fatigue testing within a clinically relevant fracture model. |
| Static fatigue strength | Confirmed that the subject rods are equivalent to the predicate device in static fatigue testing within a clinically relevant fracture model. |
| Fixation during insertion | Demonstrated adequate fixation during insertion. |
| Fixation over time | Demonstrated adequate fixation over time. |
| Pyrogenicity | The Sonoma Fifth Metatarsal Repair System meets the pyrogen limit specifications. |
| Material composition | The implants are composed of 316 stainless steel per ASTM F138, which is the same material as the predicate device (IP-XS Nails K032548). |
| Device dimensions | The dimensions of the subject device are within the range of the predicate device. |
| Compressive end cap | The subject device utilizes a compressive end cap similar to the predicate IP-XS nail. |
2. Sample size used for the test set and the data provenance
The document states "Engineering analysis and mechanical testing in a clinically relevant fracture model." However, it does not specify the sample size for these tests.
The data provenance is also not explicitly stated beyond being "engineering analysis and mechanical testing." It's typically laboratory-based testing rather than patient data for this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing described is mechanical and engineering-based, not clinical interpretation requiring expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the testing is mechanical and comparative to a predicate device, not interpretative and requiring 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
An MRMC comparative effectiveness study was not performed. This device is an orthopedic implant, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance testing appears to be based on established engineering standards and comparisons to the performance of a predicate device. For instance, material composition is verified against ASTM F138, and mechanical properties are compared to the predicate's known performance.
8. The sample size for the training set
This information is not applicable as the device is an intramedullary fixation rod, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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