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The LiteSaber WTAD is used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. The LiteSaber WTAD is not intended for use in the neurovasculature.

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

The device consists of an ergonomically designed white case, onto which is attached a guidewire holder with a pin vise clamp. Once the pin vise is screwed open, the lumen is opened to permit the insertion of guidewires ranging in size from 0.009" – 0.018" in diameter into the holder. Screwing the pin vise clamp closed causes the inserted device to be firmly clamped into place.

The inside of the case contains a pack of three AAA batteries, a miniature brushed DC motor and a software driven electronic control unit (ECU). The outside of the case has a red button to turn the power on, a green light that illuminates when the unit is turned on, and a black 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 in the direction shown by the indicator (increase or decrease rotations). If the user requires that the rotations be halted mid-procedure, then either the power may be turned off using the red button, or the white clamp can be held. Both actions will stop the rotations from occurring.

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

The provided text is a 510(k) Summary for the LiteSaber Wire Torque Assist Device. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing, rather than presenting a study where a device's performance is compared against acceptance criteria in the way typically seen for diagnostic AI/ML devices or clinical effectiveness studies.

Therefore, much of the requested information regarding acceptance criteria for device performance, study details (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance), ground truth details (type, training set size, and how established) is not applicable or not present in this type of FDA submission.

However, I can extract information related to the device's technical specifications and the non-clinical performance data that was collected to support substantial equivalence.

Here's the breakdown of the information that can be extracted from the provided text:

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

The document does not provide specific numerical acceptance criteria and reported device performance for these tests in a table format. It only lists the types of tests performed and states that "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The document states "bench testing" was performed, which typically involves a defined number of units or test configurations, but specific sample sizes are not provided.
• Data Provenance: Not specified. The tests were performed pursuant to Vesatek's risk analysis, implying internal testing, likely in the US (where Vesatek is located). The data is from "bench testing," which is a form of prospective simulation/testing rather than data collected from patients.

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)

Not applicable. This device is a mechanical torque assist device. "Ground truth" in the clinical or imaging sense (e.g., expert consensus on medical images) is not relevant to its performance evaluation for substantial equivalence in this context. The performance was evaluated against engineering specifications and standards.

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

Not applicable. This concept applies to human interpretation of data, typically in diagnostic studies. Bench testing of a mechanical device does not involve adjudication.

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

Not applicable. This device is not an AI/ML diagnostic tool, and no MRMC study was conducted or mentioned. The submission explicitly states: "No pre-clinical or clinical data were generated to establish substantial equivalence. Bench data are considered adequate to support a determination of substantial equivalence."

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

Not applicable. This device is a manual assist device for guidewires, not an algorithm, and does not have a "standalone" algorithmic performance in the context of AI/ML or diagnostic imaging. The bench tests evaluate the device's mechanical and electrical functions.

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

Not applicable. The "ground truth" for this type of device's performance evaluation would be its adherence to engineering specifications, design requirements, and relevant industry standards, as measured by various bench tests. It's an objective measurement against defined parameters, not a subjective clinical "ground truth."

8. The sample size for the training set

Not applicable. This device is not an AI/ML product that undergoes machine learning training.

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

Not applicable. As above, this device does not involve a training set for machine learning.

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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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