(77 days)
The Sonoma FasTrac Clavicle Fracture Repair Device is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
The Sonoma FasTrac Clavicle Fracture Repair Devices are stainless steel or titanium intramedullary fixation devices that utilize threads for fixation and a hub with cross screw. The device is available in nominal 3, 4, 5, and 6mm nominal OD and sizes 70-150mm nominal lengths. The Sonoma FasTrac Clavicle Fracture Repair Device is intended to be made of Ti-6Al-4V Titanium or 316L Stainless Steel.
This document describes the premarket notification (510(k)) for the Sonoma FasTrac Clavicle Fracture Repair Device, which focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (from predicate equivalence) | Reported Device Performance (Sonoma FasTrac) |
|---|---|---|
| Dynamic Compression, Bending and Torsion | Equivalent to Ensplint CMx biomechanical loads in a simulated in-vivo environment. | Substantially equivalent to the Ensplint CMx under compressive, bending, and torsional loads in a simulated in-vivo environment with respect to biomechanical loads. |
| Cyclic Bending Fatigue | Equivalent to predicate Depuy Rockwood Pin under similar loading. | Substantially equivalent to the predicate Depuy Rockwood Pin when tested under similar loading. |
| Static Bending | Equivalent to predicate Depuy Rockwood Pin under similar loading. | Substantially equivalent to the predicate Depuy Rockwood Pin when tested under similar loading. |
| Static Torsion | Equivalent to predicate device (Rockwood Pin) static torsional stiffness properties under similar loading. | Substantially equivalent to the predicate device (Rockwood Pin) when tested under similar loading. |
| Indications for Use | Equivalent in size, configuration, and fixation methods to predicate devices. | Equivalent in size, configuration, and fixation methods to the predicate devices, demonstrating equivalent fixation and alignment properties. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of devices tested for cyclic bending fatigue). The performance data is derived from non-clinical, empirical testing, and engineering analysis, as stated in the "Performance Data (Non clinical)" section and the "Performance Testing Summary" table headers. There is no information about data provenance in terms of country of origin or whether it's retrospective or prospective, as it's mechanical testing of physical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as this is a 510(k) submission for a mechanical medical device, and the "ground truth" is established through engineering and biomechanical testing against established standards and predicate devices (e.g., ASTM F1264-03). Expert clinical opinion or medical imaging interpretation is not the primary mode of evaluation for this type of device submission.
4. Adjudication method for the test set
This information is not applicable for mechanical device testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert interpretation (e.g., radiology reads) to resolve discrepancies.
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
This information is not applicable. An MRMC study is relevant for diagnostic imaging AI systems where human readers interpret medical images. This 510(k) is for an intramedullary fixation device, which is a physical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for the performance evaluation of the Sonoma FasTrac device is established through:
- Mechanical requirements of ASTM F1264-03 (07): These are established industry standards for intramedullary fixation devices.
- Performance of predicate devices: The predicate devices (Ensplint CMX and Depuy Rockwood Pin) against which the Sonoma FasTrac device's performance is compared serve as the benchmark or "ground truth" for substantial equivalence.
8. The sample size for the training set
This information is not applicable. This is a physical medical device, not an AI system that requires a "training set." The device is manufactured and tested based on design specifications and material properties.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" in the context of this device's evaluation.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.