(210 days)
The TACTIX Vector Syndesmosis System 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 TACTIC Vector Syndesmosis System 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.
The TACTIX Vector Syndesmosis System is intended to provide fixation during the healing process following a syndesmotic trauma using a TACTIX Vector suture loop and buttons.
The TACTIX Vector System features the following advantageous characteristics: a tensioner to apply suture tension for surgical repair, line lock suture technology without the need to tie a knot, removal of periosteum through a minimal medial button, and a small thru hole in the bone, only large enough to pass a 2.0 mm suture loop. The TACTIX Vector Syndesmosis System can be used in conjunction with Vilex fibular bone plates and screws, as deemed necessary by the surgeon.
The TACTIX Vector Syndesmosis System is composed of two titanium alloy buttons and one UHMWPE suture.
The instruments of TACTIX System are composed of stainless steel, UHMWPE, and nylon material.
The TACTIX Vector Syndesmosis System is intended for single use and provided sterile to the end user via ethylene oxide sterilization.
This document is for a medical device called the "TACTIX Vector Syndesmosis System," which is a metallic bone fixation appliance. It is a 510(k) premarket notification to the FDA. The document focuses on establishing substantial equivalence to previously cleared predicate devices.
The information provided does not describe a study that proves the device meets acceptance criteria in the context of clinical performance or diagnostic accuracy, as would be relevant for an AI/ML-driven medical device. Instead, the document describes non-clinical (bench) testing to demonstrate the device's mechanical performance and safety characteristics.
Therefore, for aspects related to "acceptance criteria" for performance metrics like sensitivity, specificity, AUC, human reader improvement with AI, or ground truth establishment relevant to AI/ML, there is no information provided in this document.
However, I can extract the information relevant to the non-clinical testing performed:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Cyclic fatigue testing | TACTIX Vector Syndesmosis System performs comparably to or better than the additional predicate device (K173278). | "The nonclinical testing showed that the TACTIX Vector Syndesmosis System performs substantially equivalent to a predicate device." |
| Static pullout testing | TACTIX Vector Syndesmosis System performs comparably to or better than the additional predicate device (K173278). | "The nonclinical testing showed that the TACTIX Vector Syndesmosis System performs substantially equivalent to a predicate device." |
| Stability testing on product packaging | Ensure packaging maintains device integrity and sterility over shelf life. | Performed; conclusions support substantial equivalence. |
| Packaging performance testing | Ensure packaging adequately protects the device during transit and handling. | Performed; conclusions support substantial equivalence. |
| Biocompatibility evaluation (per ISO 10993-1) | Device materials are biocompatible and do not elicit adverse biological responses. | Performed; conclusions support substantial equivalence. |
| Bacterial endotoxin testing | Device is free of unacceptable levels of bacterial endotoxins. | Performed; conclusions support substantial equivalence. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for each non-clinical test (e.g., number of devices tested for fatigue, pullout).
- Data Provenance: The tests are non-clinical (bench testing) performed by the manufacturer (Vilex LLC). The document does not specify the country of origin for these tests. The tests are "retrospective" in the sense that they are done in a lab setting to assess the final device design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document describes non-clinical engineering bench testing, not clinical studies or AI/ML performance evaluations requiring expert ground truth for interpretation.
4. Adjudication method for the test set:
- Not applicable. This document describes non-clinical engineering bench testing.
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. This document describes a medical device (physical implant), not an AI/ML diagnostic or assistive tool. No MRMC study was mentioned or performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, not applicable. This document is for a physical medical device.
7. The type of ground truth used:
- Not applicable in the AI/ML context. For the non-clinical tests, the "ground truth" is established by standard engineering test methods and their defined pass/fail criteria (e.g., meeting a certain force threshold, cycles to failure, absence of toxins). Comparison to a predicate device serves as the benchmark for "truth."
8. The sample size for the training set:
- Not applicable. This document does not describe an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This document does not describe an AI/ML device that requires a training set.
§ 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.