(147 days)
The Tensyn™ Band is intended to provide fixation during the healing process following a isolated syndesmotic trauma, such as fixation of syndesmosis disruptions).
The Tensyn™ Band is a knotless system for fixation of syndesmosis disruptions. The Tensyn™ Band is a low profile system comprised of a flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a lock. The Tensyn™ Band is available in stainless steel.
The Tensyn™ Band is a medical device intended for fixation of syndesmosis disruptions during the healing process following isolated syndesmotic trauma. The device's performance was evaluated through various mechanical tests to demonstrate its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test Type) | Reported Device Performance |
|---|---|
| Rotational Loading | Demonstrated substantial equivalence to predicate devices. |
| Cyclic Loading | Demonstrated substantial equivalence to predicate devices. |
| Ultimate Load | Demonstrated substantial equivalence to predicate devices. |
| Load at 3 mm | Demonstrated substantial equivalence to predicate devices. |
| Shear Test | Demonstrated substantial equivalence to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for each mechanical test. The data provenance is not explicitly stated in terms of country of origin but is implicitly from Dallen Medical, Inc. The nature of the testing (mechanical tests on the device itself) means it is not retrospective or prospective in the clinical sense, but rather laboratory-based testing on the device prototypes.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The ground truth for this device's performance is established through mechanical engineering principles and laboratory testing, not expert clinical consensus or interpretation of medical images.
4. Adjudication Method for the Test Set:
Not applicable. As the device evaluation is based on mechanical testing, there is no need for expert adjudication of results in the traditional sense. The results are quantitative measurements against predefined specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of medical images or data. The Tensyn™ Band is a surgical implant, and its performance is evaluated through mechanical testing.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device is a mechanical implant and does not involve an algorithm. The performance is the inherent mechanical properties of the device itself.
7. Type of Ground Truth Used:
The ground truth used is based on mechanical engineering principles and physical measurements from laboratory testing. The device's performance is compared against the known performance characteristics of legally marketed predicate devices.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance evaluation focuses on the physical properties and mechanical behavior of the device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set for this type of medical device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.