(84 days)
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:
- A syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures
- -Acromioclavicular separations due to coracoclavicular ligament disruptions
- Syndesmotic trauma, such as fixation of dorsal distal radiolunar ligament (DRUL) disruptions;
- -Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
- -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, acromioclavicular 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 and titanium.
This document is a 510(k) premarket notification for the Tensyn™ Plug, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study where the device meets acceptance criteria. Therefore, much of the requested information regarding specific acceptance criteria metrics, detailed study design, and performance outcomes for a device that "meets acceptance criteria" in terms of clinical accuracy or diagnostic performance is not present in this regulatory filing.
However, I can extract information related to the device's performance testing which serves to establish substantial equivalence.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical "acceptance criteria" in a table format that would typically be seen for diagnostic or AI-based devices. Instead, it refers to performance testing conducted to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion is that the Tensyn™ Plug performs similarly or equivalently to the predicate devices in the described tests.
| Acceptance Criterion (Implicit) | 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 3mm | 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 refers to "testing" performed but does not specify the sample size for the test set (e.g., number of devices tested, number of simulated applications). It also does not mention data provenance (e.g., country of origin, retrospective/prospective) as the testing appears to be primarily mechanical performance testing on the device itself, rather than clinical data from human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This type of information is relevant for studies involving human interpretation or diagnostic accuracy. The testing described (rotational loading, cyclic loading, ultimate load, load at 3mm, and shear test) is mechanical and likely involves engineering analysis and measurements, not human expert consensus for "ground truth."
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like "2+1" or "3+1" are used when multiple readers/experts are involved in establishing ground truth, which is not the case for the mechanical performance testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. An MRMC comparative effectiveness study is typically performed for diagnostic devices to assess how much human readers improve with AI assistance. This document describes a mechanical fixation device, and an MRMC study is not relevant to its regulatory submission for substantial equivalence.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Not applicable. The Tensyn™ Plug is a mechanical implant, not an algorithm. The "standalone performance" refers to the device's mechanical integrity and strength under various loads.
7. The Type of Ground Truth Used:
For the mechanical performance tests, the "ground truth" would be established by physical measurements and engineering standards for mechanical properties (e.g., specific load at which failure occurs, displacement at a certain load). This is not expert consensus, pathology, or outcomes data in the usual clinical sense.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this mechanical 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.