(98 days)
Tensyn ™ Band is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn™ Band apart from any other fixation hardware. For fixation during the healing process of acromioclavicular separations due to coracoclavicular ligament disruptions, the Tensyn™ Band is used in conjunction with, but not connected to, supplemental fixation.
The Tensyn™ Band is a knotless system for fixation of syndesmosis disruptions and AC joint in the shoulder. The Tensyn™ Band is a low profile system comprised of a polymer coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a lock. The Tensyn™ Band is available in titanium and stainless steel.
This document is a 510(k) premarket notification for the Tensyn™ Band, a medical device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically seen in an AI/ML device submission.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices, which is the regulatory pathway for Class II devices like the Tensyn™ Band. The "Performance Data" section briefly describes the types of tests performed but does not provide specific acceptance criteria or detailed results.
Therefore, I cannot provide the requested information from the provided text. The document states:
- Performance Data: "All necessary testing has been performed with the Tensyn™ Band to assure substantial equivalence to the predicate devices. Testing included rotational loading, cyclic loading, ultimate load, load at 3 mm and shear test. The testing demonstrated that the Tensyn™ Band is substantially equivalent to the predicate devices."
This indicates that mechanical and physical performance tests were conducted to show the new device performs similarly to existing, legally marketed predicate devices, rather than meeting specific pre-defined quantitative acceptance criteria in the context of an AI/ML study.
To directly answer your numbered points based only on the provided text, I must state that the relevant information is not present or applicable in the context of an AI/ML device study:
- A table of acceptance criteria and the reported device performance: Not provided. The document states testing was performed to assure substantial equivalence, but no specific performance metrics or acceptance criteria are listed.
- Sample sized used for the test set and the data provenance: Not provided. The performance data refers to mechanical testing, not a clinical test set with human data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a mechanical fixation device, not an AI/ML diagnostic tool requiring expert ground truth.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This is not an AI/ML device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML context. For a mechanical device, "ground truth" would be engineering specifications and validated test methods.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.