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VascuChek® Kit, VascuChek® Transceiver, VascuChek® Clinical Probe, VascuChek® Charger: The VascuChek® device is intended for the non-invasive transcutaneous evaluation of blood flow in Peripheral Vasculature.

VascuChek® Kit, VascuChek® Transceiver, VascuChek® Surgical Probe, VascuChek® Charger: The VascuChek® device is intended for the intraoperative and transcutaneous evaluation of blood flow in the following clinical applications:

• Intraoperative (Microvascular and Vascular)
• Intraoperative Neurological
• Transrectal and Peripheral Vascular.

VascuChek® Surgical is a cardiovascular blood flowmeter comprised of two components: a sterile VascuChek™ Surgical Probe with sheath which connects to the reusable, nonsterile VascuChek™ Transceiver. The sheath is deployed over, and encapsulates the transceiver, allowing it to be used within the sterile field.

VascuChek® Clinical is a cardiovascular blood flowmeter comprised of two components: a sterile VascuChek™ Surgical Probe with sheath which connects to the reusable, nonsterile VascuChek™ Transceiver. The sheath is deployed over, and encapsulates the transceiver, allowing it to be used within the sterile field.

The VascuChek® device follows Track 1.

A transmitter in the transceiver drives the ultrasonic transmitting crystal located at the tip of the probe component. The ultrasonic waves generated by the sensor travel through the tissue just under the probe tip in a narrow beam. The reflected ultrasonic waves are received by the transducer and are converted via the piezoelectric effect into a high frequency electronic signal. band audio Doppler shifted signal which is filtered and converted to audio via a speaker. During the intervals when the unit is not transmitting, the device passes any reflected signals that it receives to a receiving circuit. This circuit amplifies the returning echoes, compares their frequency to that of the transmitted signal and converts any frequency differences into an audible tone.

The provided text is a 510(k) summary for a medical device called VascuChek®. It outlines the device description, indications for use, comparison to predicate devices, and a summary of non-clinical performance testing.

However, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML-based device. Specifically, it lacks:

• A table of acceptance criteria and reported device performance: While it mentions electrical safety, EMC, firmware verification, and biocompatibility testing, these are general device safety and performance criteria, not specific performance metrics for an AI/ML algorithm (e.g., sensitivity, specificity, AUC).
• Sample size and data provenance for a test set: No information regarding a test set, its size, or where the data came from (country, retrospective/prospective) is provided.
• Number and qualifications of experts for ground truth: There's no mention of experts, how many, or their qualifications, as the device doesn't appear to rely on such ground truth establishment for its performance claims.
• Adjudication method: Not applicable as there's no mention of expert review or ground truth establishment in this context.
• MRMC comparative effectiveness study: There is no indication of such a study being performed or any effect size for human reader improvement with AI assistance.
• Standalone (algorithm only) performance: The device described is a blood flowmeter, a hardware device with firmware, not an AI/ML algorithm that would have standalone performance metrics like sensitivity/specificity.
• Type of ground truth used: Not applicable for a non-AI/ML device that measures physiological parameters.
• Sample size for training set: Not applicable as it's not an AI/ML device.
• How ground truth for training set was established: Not applicable.

Explanation Based on the Provided Document:

The VascuChek® device is a cardiovascular blood flowmeter that uses ultrasonic technology to detect blood flow and convert frequency differences into an audible tone. It's a hardware device with integrated firmware, not an AI/ML-driven diagnostic or assistive tool. The performance studies mentioned are related to:

• Electrical Safety Testing (ANSI AAMI ES60601-1): Ensures the device is electrically safe.
• EMC Testing (IEC 60601-1-2, IEC 60601-2-37): Ensures the device operates correctly in its electromagnetic environment and doesn't interfere with other devices.
• Firmware Verification Testing: Confirms the embedded software functions as intended.
• Biocompatibility information: Addresses the safety of the materials in contact with the patient.

These are standard regulatory requirements for medical devices but are not related to the performance evaluation of an AI/ML algorithm. The document explicitly states that the device employs "identical technology" and "identical firmware requirements and performance" to its predicate devices, indicating that its performance is established through equivalence to existing, cleared devices, rather than through complex AI/ML validation studies.

Conclusion:

The provided 510(k) summary does not contain the information requested regarding acceptance criteria and study details for an AI/ML device because the VascuChek® device is an ultrasonic blood flowmeter and not an AI/ML-based medical device. Therefore, a study demonstrating AI/ML performance metrics (e.g., sensitivity, specificity, reader studies) was not conducted or reported for this submission.

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The Remington Medical, Inc. VascuChek™ Clinical Device is intended for the non-invasive transcutaneous evaluation of blood flow in Peripheral Vasculature.

VascuChek™ is a cardiovascular blood flowmeter comprised of two components: a nonsterile, single-use VascuChek™ Clinical Probe which connects to the reusable, nonsterile VascuChek™ Transceiver.

The VascuChek™ device follows Track 1.

A transmitter in the transceiver drives the ultrasonic transmitting crystal located at the tip of the probe component. The ultrasonic waves generated by the sensor travel through the tissue just under the probe tip in a narrow beam. The reflected ultrasonic waves are received by the transducer and are converted via the piezoelectric effect into a high frequency electronic signal. The received electronic signal is amplified and detected. The result is a base band audio Doppler shifted signal which is filtered and converted to audio via a speaker. During the intervals when the unit is not transmitting, the device passes any reflected signals that it receives to a receiving circuit. This circuit amplifies the returning echoes, compares their frequency to that of the transmitted signal and converts any frequency differences into an audible tone.

The provided document is a 510(k) summary for the Remington Medical, Inc. VascuChek™ Clinical Device. The product is a cardiovascular blood flowmeter intended for non-invasive transcutaneous evaluation of blood flow in peripheral vasculature. The submission demonstrates substantial equivalence to the predicate device, Vascular Technology Incorporated (VTI) Surgical Doppler (K082870).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" for performance metrics in a quantitative manner (e.g., minimum sensitivity or specificity). Instead, the performance evaluation is based on demonstrating substantial equivalence to a predicate device through various non-clinical and an in vivo simulated use test. The criteria for acceptance are implied by the successful completion of these tests and a conclusion of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions an "in vivo Simulated Use" test. However, it does not specify the sample size used for this test (e.g., number of subjects, number of measurements). It also does not provide details about the data provenance beyond stating it was an in vivo test. Therefore, information regarding country of origin of the data or whether it was retrospective or prospective is not available in the provided text.

3. Number of Experts Used to Establish the Ground Truth and Qualifications:

The document does not mention the use of experts to establish ground truth for any test set. The in vivo simulated use test focused on assessing audio quality and comparing performance to the predicate device, implying that the predicate's output or a direct measurement was used as a reference rather than expert consensus on a diagnostic outcome.

4. Adjudication Method for the Test Set:

Since the document does not describe the use of multiple experts or a diagnostic task requiring consensus, there is no mention of an adjudication method (e.g., 2+1, 3+1).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. The study focused on demonstrating substantial equivalence of the device's technical characteristics and performance to a predicate device, not on how human readers' performance might improve with or without AI assistance. The device itself is a blood flowmeter, not an AI-assisted diagnostic tool for interpretation by human readers in the traditional sense of an MRMC study.

6. Standalone Performance:

The primary focus of the performance data section is on the standalone performance of the VascuChek™ Clinical Device, both through non-clinical bench testing and the in vivo simulated use test. The purpose was to show that the device itself performs comparably to the predicate device.

7. Type of Ground Truth Used:

For the in vivo simulated use test, the ground truth appears to be established by comparison to the predicate device in terms of measuring the velocity of blood flow. The phrasing "compare performance of the new device to its predicate" suggests the predicate's output served as the reference for evaluating the subject device's audio quality in measuring blood flow velocity. There is no indication of pathology, outcomes data, or expert consensus being used as ground truth for this device's specific function.

8. Sample Size for the Training Set:

The document does not mention a training set because the VascuChek™ Clinical Device is a cardiovascular blood flowmeter, not a device that employs machine learning or artificial intelligence requiring a training set in the typical sense.

9. How the Ground Truth for the Training Set Was Established:

As there is no mention of a training set, there is no information on how its ground truth might have been established.

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