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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 TACTIX 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 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 skin nick, a larger 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 provided text is a 510(k) premarket notification letter from the FDA regarding the TACTIX Vector Syndesmosis System. It clearly states:

"No clinical data was required in support of the subject device."

Therefore, the information requested for a clinical study proving the device meets acceptance criteria is not applicable in this case. The FDA's substantial equivalence determination for this device was based on non-clinical tests and analyses.

Here's a breakdown of the requested information based on the provided document, clarifying that clinical study details are absent:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (as implied by the non-clinical tests):
     • Steam sterilization validation successful.
     • Mechanical performance equivalent to predicate device.
     • Biocompatibility (based on biological evaluation) acceptable.
   • Reported Device Performance: "All results met the acceptance criteria."
   • Note: Specific quantitative performance metrics are not provided in this document, only that the criteria were met.

2. Sample sizes used for the test set and the data provenance:

   • Not applicable as this was a non-clinical evaluation (e.g., sterilization validation, mechanical testing, biological evaluation). The "test set" would refer to the physical devices/materials tested in these non-clinical studies. Data provenance would be from the studies themselves (e.g., in-house testing, or third-party lab testing). No details on the number of samples for these non-clinical tests are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable for non-clinical testing. Ground truth for these tests is established by standardized testing protocols and analytical methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable for non-clinical 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 MRMC study was done. This device is not an AI/software device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a medical device (surgical system) and not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the non-clinical tests, the "ground truth" is defined by the established scientific and engineering principles for sterilization, mechanical properties, and biocompatibility.

8. The sample size for the training set:

   • Not applicable. No training set was used as this was not an AI/machine learning device.

9. How the ground truth for the training set was established:

   • Not applicable. No training set was used.

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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:

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.

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