(106 days)
Tensyn Plug is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn Plug apart from any other fixation hardware. For fixation during the healing process of acromioclavicular separations due to coracoclavicular ligament disruptions, the Tensyn Plug is used in conjunction with, but not connected to, supplemental fixation. The subject device is intended 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 Tensyn Plug is intended to provide fixation during the healing process following: 1) Syndesmotic trauma, such as fixation of dorsal distal radiolunar ligament (DRUL) disruptions; 2) Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and 3) Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal -2nd metatarsal intermetatarsal angle. The Tensyn Plug, when used for fixation of bone-to-bone or soft-tissue-to-bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Tensyn Plug is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
The Tensyn Plug is a knotless system for fixation of syndesmosis disruptions, acromio-clavicular repair, tarasometatarsal injury, hallux valgus reconstruction, and carpal metacarpal joint arthroplasty. The Tensyn Plug is a low profile system comprised of a coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a locking cap assembly. The Tensyn Plug is available in stainless steel.
The provided document is a 510(k) summary for the Tensyn™ Plug, a medical device for fixation during healing processes. It discusses the device's indications for use, technical characteristics, and performance data for demonstrating substantial equivalence to predicate devices. However, the document does not include specific acceptance criteria, detailed results of the studies, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, or details about multi-reader multi-case studies.
Therefore, I cannot provide the requested information in the format specified because the necessary details are not present in the provided text.
Here's an overview of what is available and what is missing:
What is present in the document:
- Device Name: Tensyn™ Plug
- Device Description: Knotless system for fixation, comprised of a coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a locking cap assembly, available in stainless steel.
- Indications for Use: Detailed for various conditions (syndesmotic trauma, acromioclavicular separations, fracture repair, Lisfranc injury, Hallux Valgus reconstruction, Carpal Metacarpal (CMC) joint arthroplasty).
- Predicate Devices: Tensyn Band (K141264, K131850), Arthrex, Inc. Mini TightRope Repair Kit (K061925), Arthrex, Inc. CMC Mini TightRope (K140328), Biomet, Inc. ToggleLoc System (K083070).
- Types of Performance Testing: Rotational loading, cyclic loading, ultimate load, load at 3mm, and shear test.
- Conclusion from Testing: "The testing demonstrated that the Tensyn Plug is substantially equivalent to the predicate devices."
What is missing from the document (and therefore cannot be provided in the answer):
- Table of Acceptance Criteria and Reported Device Performance: While types of tests are listed, the specific quantitative acceptance criteria (e.g., "ultimate load must be > X N") and the numerical results obtained for the Tensyn™ Plug are not provided.
- Sample Size Used for the Test Set and Data Provenance: No information is given regarding the number of devices or units tested for each performance test, nor the origin or nature (retrospective/prospective) of any clinical data, as this is a mechanical testing report, not a clinical study report.
- Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications: Not applicable, as this involves mechanical testing, not a diagnostic or AI-driven device requiring expert adjudication of ground truth from images or clinical data.
- Adjudication Method for the Test Set: Not applicable for mechanical testing.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No information is provided about such a study. This is a mechanical device, not an AI or imaging diagnostic tool that would typically involve human readers.
- Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study: No information is provided about such a study. This is not an algorithm-driven device.
- Type of Ground Truth Used: For mechanical testing, the "ground truth" would be the measured physical properties or failure points, not expert consensus, pathology, or outcomes data. The document does not detail the specific ground truth metrics or methods used for "ultimate load," "load at 3mm," etc.
- Sample Size for the Training Set: Not applicable, as this is a mechanical device, not an AI system that requires a "training set."
- 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.