(56 days)
The TENSOR® Suture Button System is intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the TENSOR® implants are intended to provide fixation during the healing process for the following indications:
Syndesmotic trauma, such as ankle syndesmosis fixation (syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures; fixation of dorsal distal radioulnar ligament (DRUL) disruptions; Acromioclavicular separations due to coracoclavicular ligament disruptions; Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal intermetatarsal angle; and, Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process.
The TENSOR® Suture Button System consists of metal buttons, a polymer suture, an optional washer, and instruments. The buttons are available in various sizes to accommodate varying patient anatomy and surgical needs. The buttons and washer are manufactured from titanium alloy or stainless steel, and the suture is manufactured from ultra high molecular weight polyethylene (UHMWPE) and polyethylene terephthalate (PET). The implants are sterile packaged with various instruments to aid in insertion.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the TENSOR® Suture Button System. It outlines the device's classification, indications for use, and the basis for its substantial equivalence to previously cleared predicate devices.
However, the document does not contain any information about a study proving the device meets acceptance criteria related to AI/Machine Learning performance. The "Performance Data" section specifically mentions "Mechanical testing (static and dynamic tension)" and "Bacterial endotoxin testing (BET)," which are standard tests for evaluating the mechanical properties and biocompatibility of implantable devices. There is no mention of clinical trials, AI/ML algorithm development, or human-in-the-loop performance studies.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria in the context of AI/ML performance, as the provided document does not pertain to an AI/ML device.
To directly answer your questions based only on the provided text, a significant portion of the requested information is absent because the device is a mechanical implant, not an AI/ML-driven diagnostic or assistive system.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria Mentioned (Implicit/Explicit):
- Mechanical Performance: Static and dynamic tension (implied to meet relevant standards for load-bearing and fatigue).
- Biocompatibility/Sterility: Bacterial endotoxin testing (BET) in accordance with ANSI/AAMI ST72:2011 (acceptance criteria would be below a certain endotoxin limit).
- Substantial Equivalence: To predicate devices in terms of design, intended use, material composition, and range of sizes, and that differences "do not raise any different questions of safety or effectiveness."
- Reported Device Performance:
- "Performance data demonstrates substantial equivalence to the predicate devices." (This is a summary statement, specific numerical results are not provided).
2. Sample size used for the test set and the data provenance
- Not applicable/Not provided. The testing mentioned (mechanical, endotoxin) uses material samples, not a "test set" in the sense of patient data for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. Ground truth, in the context of the requested AI/ML study, is not relevant for this device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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
- No, not applicable/Not provided. This is a mechanical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, not applicable/Not provided.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. For mechanical testing, the "ground truth" would be engineering specifications and validated test methods.
8. The sample size for the training set
- Not applicable/Not provided. No AI/ML training set is mentioned.
9. How the ground truth for the training set was established
- Not applicable.
In summary: The provided document is a regulatory clearance for a traditional medical implant, not an AI/ML device. Therefore, the requested information pertaining to AI/ML development, testing, and clinical validation is not present.
§ 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.