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510(k) Data Aggregation
(131 days)
The BioPro Kwick-Wire™ Universal Screw System is indicated for use in the internal fixation of fractures, fusions and revisions. The system is intended for but not limited to hand surgery, orthopedic surgery and podiatric surgery - but is not intended for Spinal Use.
The BioPro Kwick-Wire™ Universal Screw System comes in two diameter pin sizes of 2.5mm and 3.0mm and in a length of 4.0in. and is used for reduction and fixation of fractures appropriate for the size of the device. A mating compression nut of either the 2.5mm or 3.0mm size is mated with the proper pin size. Both the pin and nut are manufactured from either high strength 6-4 Alloyed Titanium to ASTM F136 or high strength 316 LVM Stainless Steel to ASTM F138. Ancillary instrumentation is available for device implantation and removal. The implant is sold in a 'sterile' condition for single-use. The sterilization method used is Ethylene Oxide.
The provided document is a 510(k) summary for the BioPro Kwick-Wire™ Universal Screw System, which is a medical device for internal fixation of fractures, fusions, and revisions. It is a regulatory submission for premarket notification to the FDA, not a study evaluating the device's performance against specific acceptance criteria.
Therefore, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria.
Specifically, the document states:
- "No nonclinical testing was used in the determination of substantial equivalence." (Page 1, Section "EQUIVALENCE")
- The determination of substantial equivalence is based on the device being "Similar in Material, Geometry Design/Markings, and Indications to other predicate system(s) currently sold in the U.S. market." (Page 1, Section "SUMMARY OF TECH-NOLOGICAL CHAR-ACTERISTICS")
This means the submission relies on the established safety and effectiveness of predicate devices, rather than presenting new performance data for the BioPro Kwick-Wire™ Universal Screw System.
As such, I cannot provide the requested information for the following points:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
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(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.
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