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510(k) Data Aggregation
(257 days)
SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)
The Sonoma CWG Clavicle fracture repair device is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
Sonoma CWG devices are 316L SS intramedullary fixation devices that utilize internal grippers for fixation, similar to the Sonoma CMx predicate and also use a compression screw similar to the predicate Rockwood pin, to compress the fracture. The device is available in 4 & 5mm OD and sizes 90-120mm in length.
This submission describes the Sonama CWG Clavicle Fracture Repair Device, an intramedullary fixation device for clavicle fractures. The submission leverages non-clinical performance data against predicate devices to demonstrate substantial equivalence.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM F1264-008 (Static Bending, Torque, Cyclic Bending Fatigue) | Equivalence to predicate device Sonoma CRx WG | Demonstrated subject device (Sonoma CRx CWG) is equivalent to predicate device (Sonoma CRx WG). |
| In-Vitro Cyclic Fatigue Test (Proprietary) | Equivalence to predicate device Sonoma CRx WG | Demonstrated subject design (Sonoma CRx CWG) is equivalent to predicate device (Sonoma CRx WG). |
| Indications for Use Test (Cadaveric Torso Specimens) | Substantial equivalence to predicate device Sonoma CRx WG for fracture fixation and anatomical alignment through pendant range of motion of the affected appendage. | Demonstrated substantial equivalence to the predicated device (Sonoma CRx WG) for fracture fixation and anatomical alignment through pendant range of motion of the affected appendage. |
| Fixation Verification Test (Explanted Cadaveric Clavicle Samples) | Equivalence to predicate device Sonoma CRx WG in terms of opposing tensile force to distract the fracture greater than 2 millimeters. | Demonstrated subject design (Sonoma CRx CWG) is equivalent to the predicate device (Sonoma CRx WG). |
2. Sample Size Used for the Test Set and Data Provenance
This submission relies entirely on non-clinical (in-vitro and cadaveric) testing, not on human clinical data. Therefore, there isn't a "test set" in the traditional sense of patient data.
- Cadaveric Torso Specimens: The "Indications for Use Test" and "Fixation Verification Test" were performed using cadaveric torso specimens. The exact number of specimens is not specified in the provided text, but it included "one clavicle" for the predicate device and "the opposite clavicle" for the subject device within the same specimens, implying paired testing.
- Data Provenance: The data provenance is internal laboratory testing and cadaveric studies. The country of origin of the data is not explicitly stated but is implied to be in the USA given the company and FDA review. The studies are prospective in their conduct within the testing environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As this is a non-clinical study, there are no human experts establishing ground truth for a patient test set. The "ground truth" is established through the physical measurement and biomechanical performance directly observed in the testing environments (e.g., force required for distraction, range of motion).
4. Adjudication Method for the Test Set
Not applicable. There is no human test set or human interpretation involved that would require an adjudication method. The outcome measures are based on direct physical measurements and observations during mechanical and cadaveric performance tests.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This submission focuses on the biomechanical equivalence of the device to predicate devices through non-clinical testing, not on the effectiveness of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical intramedullary fixation rod, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for these studies is based on direct biomechanical measurements and observations in controlled laboratory and cadaveric settings. This includes:
- Static bending, torque, and cyclic bending fatigue measurements against defined standards (ASTM F1264-008).
- Proprietary in-vitro cyclic fatigue data.
- Observations of fracture fixation and anatomical alignment in cadaveric specimens.
- Measurements of tensile force required to distract fractures in explanted cadaveric bones.
The comparison is made against the performance of a legally marketed predicate device (Sonoma CRx WG), establishing the "ground truth" for acceptable performance.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this device. The device is a physical medical implant, not an AI or machine learning model that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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