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The Firebow Wire Torque Assist Device is used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. The Firebow Wire Torque Assist Device is not intended for use in the neurovasculature.

The Firebow Wire Torque Assist Device is an electrically driven device that delivers a controlled, predictable number of rotations to guidewires.

The device consists of an ergonomically designed black case, onto which is attached a green guidewire holder with a white spring tension, push button clamp. Once the push button clamp is depressed, the lumen is opened to permit the insertion of guidewires ranging in size from 0.014" - 0.038" in diameter into the holder. Releasing the push button on the clamp causes the inserted device to be firmly clamped into place.

The inside of the case contains two AAA batteries, a miniature stepper motor and a software driven electronic control unit (ECU). The outside of the case has a white button to turn the power on, a green light that illuminates when the unit is turned on, and a white adjustment knob at the bottom of the case to control the number of rotations. The number of rotations can be adjusted from 0 - 8 by rotating the knob. If the user requires that the rotations be halted midprocedure, then either the power may be turned off using the white button, or the green clamp can be held. Both actions will stop the rotations from occurring.

In order to ensure that the batteries are at full capacity and that the power to the device is not accidentally turned on during shipping, an activation strip is positioned through the case and in between one of the batteries and the battery terminal to prevent completion of the electrical circuit.

The device is provided sterile and is intended for single use.

The provided text describes a medical device, the Firebow Wire Torque Assist Device, and its regulatory submission. It lists the types of non-clinical performance data collected but does not provide specific acceptance criteria or the reported device performance for each criterion. It also explicitly states that "No pre-clinical or clinical data were generated to establish substantial equivalence." This means there is no study assessing the device's performance in a clinical setting, nor comparing it against human readers or establishing ground truth from patient outcomes.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be inferred and what cannot:

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

Note: The document only states that "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements." It does not provide the specific numerical acceptance criteria or the quantitative results of the tests.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified for any of the design verification tests.
• Data Provenance: The tests are design verification tests, which are typically performed in a lab setting by the manufacturer (Vesatek, LLC). The document does not specify country of origin for the data, nor whether it's retrospective or prospective (which isn't applicable for non-clinical bench testing).

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

Not applicable. Ground truth as typically defined in clinical studies (e.g., expert interpretation, pathology) was not established. These were engineering design verification tests.

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

Not applicable. There was no expert review or adjudication process described as these are engineering tests.

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 comparative effectiveness study was done. The device is a mechanical "Wire Torque Assist Device" and not an AI-powered diagnostic tool involving human readers.

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

This question is typically relevant for AI/software devices. The device is a mechanical, electrically driven torque assist device. Its "standalone" performance is established through the design verification tests (e.g., rotational output, torque, battery life).

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

The "ground truth" for the design verification tests would be defined by the specified engineering requirements and external standard requirements (e.g., the device must rotate 'X' number of times, the grip must withstand 'Y' force). This is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning or AI.

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

Not applicable. No training set was used.

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