Search Results

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.

Ask a specific question about this device

Remington Medical, Inc. 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™ 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. 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 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.

Here's a summary of the acceptance criteria and study information for the VascuChek™ device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than explicitly listing acceptance criteria with numerical performance targets and reported values. Instead, it describes a series of non-clinical and in vivo tests performed. The "reported device performance" is essentially that the device passed these tests and was found to be "substantially equivalent" to the predicate.

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

• Sample Size: Not explicitly stated for each test beyond "the subject device and predicate device" for the in vivo test. It implies a sufficient number of units or test scenarios were used to generate data for each performance test.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be non-clinical (laboratory/engineering) and in vivo (likely animal or simulated human models for the blood flow assessment, although this is not explicitly stated). The report does not mention human clinical trials. All studies are presumably prospective as they were conducted to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For the in vivo simulated use test comparing audio quality, it would typically involve trained personnel for evaluation, but their number and qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the tests (engineering, biocompatibility, in vivo simulation), formal adjudication methods like 2+1 or 3+1 typically used in image interpretation studies are unlikely to be directly applicable. The test results would be assessed against pre-defined engineering or biological standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing was required." The in vivo test was a "simulated use" assessment comparing the subject device to the predicate in terms of audio quality for blood flow measurement, not a clinical study involving human readers/interpreters.

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

This concept is not directly applicable in the context of the VascuChek™ device. This device is a cardiovascular blood flowmeter that produces an audible tone based on the Doppler effect. Its performance is evaluated on its ability to generate an accurate audible signal representing blood flow, which is inherently designed for human interpretation (listening to the audio). There is no "algorithm only" component that would operate without human input in its intended use.

7. The Type of Ground Truth Used

The ground truth for the various non-clinical tests would be established by:

• Engineering Standards/Specifications: For mechanical, electrical, EMC, and software performance.
• Regulatory Standards/Guidelines: For biocompatibility (e.g., ISO 10993), pyrogenicity, sterility, and reprocessing.
• Predicate Device Performance: For the in vivo simulated use test, the performance of the predicate device serves as the comparative "ground truth" or benchmark, implying that the subject device should produce similar (substantially equivalent) audio quality and blood flow detection capabilities.

8. The Sample Size for the Training Set

This information is not applicable as the VascuChek™ device, as described, does not appear to be an AI/machine learning device that requires a "training set." It is a hardware device based on the Doppler effect for real-time blood flow detection.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as point 8; there is no "training set" for this type of device.

Ask a specific question about this device