(28 days)
The Mini TightRope FT Repair Kit 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 Mini TightRope FT Repair Kit is intended to provide fixation during the healing process following:
- Syndesmotic trauma, such as fixation of dorsal distal radioulnar 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 Mini TightRopeTM FT Repair Kit is designed as one metal button, one bioabsorbable suture anchor, and one FiberWireTM suture. The button and anchor are pre-threaded with FiberWire looped twice.
The provided text is a 510(k) summary for the Arthrex Mini TightRope FT Repair Kit. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and a detailed performance evaluation. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the provided document.
Here's a breakdown of what can be extracted and what is not present:
1. A table of acceptance criteria and the reported device performance
- This information is not present in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on specific performance metrics against defined acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not present. The document does not describe any clinical or pre-clinical performance testing with a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not present. No ground truth establishment for a test set is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not present. There is no mention of a test set or an adjudication method.
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
- This information is not present. The device is described as a medical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not present. The device is a surgical repair kit, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This information is not present. No ground truth for performance evaluation is discussed.
8. The sample size for the training set
- This information is not present. The device is not an algorithm that requires a training set.
9. How the ground truth for the training set was established
- This information is not present. Not applicable as the device is not an algorithm.
Summary of available information:
The document describes the Arthrex Mini TightRope FT Repair Kit (K071978) and its intended use, which includes:
- Adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated.
- Adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
- Specifically, fixation during the healing process following:
- Syndesmotic trauma (e.g., fixation of dorsal distal radioulnar ligament disruptions).
- Tarasometatarsal (TMT) injury (e.g., fixation of foot soft tissue separations due to a Lisfranc injury).
- Hallux Valgus reconstruction (correction) by providing for the reduction of the 1st metatarsal - 2nd metatarsal intermetatarsal angle.
The entire 510(k) submission is based on demonstrating substantial equivalence to a predicate device, the Arthrex Mini TightRope Repair Kit (K061925). The key argument for equivalence is that "the basic features and intended uses are the same. Any differences... are considered minor and do not raise questions concerning safety and effectiveness."
The FDA's letter confirms that the device is deemed "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed subject to general controls. It does not provide details of specific performance criteria or outcomes from a new study beyond the comparison to the predicate 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.