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The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems flostat™ Clamp. The device is intended to seize and hold the cervix and to hold and secure the flostat Clamp in place, during audible Doppler procedures.

This Tenaculum is only indicated for use with the flostat Clamp and Transvaginal Doppler Probe for bilateral uterine artery detection and temporary control of bleeding during conservative gynecologic surgery such as laparoscopic myomectomy.

The Burbank Tenaculum is a ring-handled instrument with a tooth at the distal end of one arm and a guiderod attached to the distal end of the other arm. The proximal end of the guiderod is threaded to guide insertion of the Vascular Control Systems flostat Clamp into the vagina and secure the Clamp in place.

A uterine sound, at the distal end of the guiderod, is intended for insertion through the cervical opening into the uterine cavity.

The provided text describes a medical device, the Burbank Tenaculum, and its regulatory clearance process through a 510(k) submission. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the other specific study-related details requested in your prompt.

The document is a "Summary of Safety and Effectiveness" and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance study results that would typically include acceptance criteria and specific statistical outcomes.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document explicitly states:

• "The Burbank Tenaculum has been designed and tested per design control procedures and was found to meet its product specifications." This is a general statement and does not provide specific acceptance criteria or study details.
• "The Burbank Tenaculum does not raise new issues of safety, effectiveness, or performance of the product." This reinforces the substantial equivalence claim but doesn't offer performance metrics.

To answer your request, I would need a document that specifically details the design verification and validation studies, including the test protocols, acceptance criteria, results, and statistical analyses performed for the device.

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The VCS Doppler Transceiver is designed for the evaluation of blood flow in uterine arteries.

The VCS Doppler Transceiver is a battery powered pulsed Doppler ultrasound system designed for the evaluation of blood flow in vessels. An 8 MHz Doppler device, which plugs into the transceiver unit, emits a pulsed ultrasonic signal. A varying audible signal is produced when the device is placed upon a vessel within which there is flow. The frequency (i.e., pitch) of the signal is proportional to the blood velocity within the vessel. Distinctive tonal patterns are produced which are indicative of the flow pattern in terms of velocity vs. time. The volume of the tone may be adjusted by the means of a control on the transceiver. Rechargeable batteries power the transceiver. An 8 MHz transmitter in the transceiver periodically drives the ultrasonic transmitting sensor located at the tip of the device. The ultrasonic waves generated by the sensor travel through the tissue just under the device tip in a fairly narrow beam. The waves are then reflected back towards the device whenever they encounter a boundary between tissues of different densities. 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 re-turning echoes, compares their frequency to that of the transmitted signal and converts any frequency differences into an audible tone.

The provided text, KOS2209, is a 510(k) summary for the VCS Doppler Transceiver. It seeks to establish substantial equivalence to predicate devices, not to present a de novo study proving that the device meets specific acceptance criteria through a clinical trial. Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets them, sample sizes, expert qualifications, or ground truth establishment.

Instead, the document focuses on:

• Device Description: A battery-powered pulsed Doppler ultrasound system for evaluating blood flow.
• Intended Use: Evaluation of blood flow in uterine arteries.
• Predicate Devices: Komen and Associates Mini Doppler II Ultrasound Flow Detector (K915550) and Meadox Medicals, Inc. MS Disposable Rigid Doppler Probe (K930227).
• Technological Characteristics Comparison: States that the VCS Doppler Transceiver has the same device characteristics as the predicate devices, with the exception of the Meadox Medicals device being 20MHz.
• Nonclinical Tests: Electrical Safety testing was conducted to IEC 60601-1 and UL 60601.
• Conclusion: The device does not raise new issues of safety, effectiveness, or performance because it is substantially equivalent to legally marketed predicate devices.

Therefore, it is not possible to fill out the requested table and answer the study-related questions based on this document. This summary outlines a regulatory submission for substantial equivalence based on comparison to existing devices, not a clinical study to prove performance against specific acceptance criteria for a novel device.

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The Cstat is intended for detection and temporary occlusion of blood vessels during vascular surgical procedures.

The Cstat is a ring-handled instrument with integrated Doppler sensor, which allows for blood flow sensing of blood vessels by connecting to a commercially available portable transceiver box. The Cstat is manufactured from nylon and polycarbonate.

The provided text describes a 510(k) summary for a medical device called "Cstat," a vascular clamp with an integrated Doppler sensor. However, it does not explicitly detail acceptance criteria or a study that proves the device meets specific performance metrics in the way a typical clinical study report would.

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against predefined acceptance criteria for a new clinical indication.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance Study for the Cstat

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy, detection rates, occlusion success rates) and their corresponding reported device performance values are NOT explicitly stated.

The document's "acceptance criteria" are primarily related to safety, electrical/thermal compliance, and acoustic output, rather than clinical efficacy. The "reported device performance" is a general statement of compliance.

2. Sample Size for the Test Set and Data Provenance

• Test Set Sample Size: Not specified. The document does not describe a clinical test set with a patient sample size for evaluating the device's diagnostic or therapeutic performance. The "tests" mentioned are nonclinical (electrical, thermal, acoustic).
• Data Provenance: Not applicable, as no clinical test data with patient provenance is described. The tests were nonclinical, likely performed in a lab setting by the manufacturer.

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

• Number of Experts: Not applicable. No human experts were involved in establishing ground truth for a clinical test set in the provided document, as it describes nonclinical tests.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set or human interpretation requiring adjudication is described.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done or described in the provided text.
• Effect Size of Human Readers with/without AI: Not applicable, as this device is not an AI-assisted diagnostic tool, and no human reader study (with or without assistance) is mentioned.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No, a standalone (algorithm only) performance study was not done or described. This device is a physical instrument with an integrated sensor, not a software algorithm. Its "performance" in the context of the document refers to its physical and functional integrity.

7. Type of Ground Truth Used

• Type of Ground Truth: For the nonclinical tests, the "ground truth" would be established by technical specifications, engineering standards, and regulatory guidance documents (e.g., IEC 60601-1 compliance, FDA acoustic output guidance). There is no "clinical ground truth" (like pathology or outcomes data) mentioned, as no clinical study is described.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."

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

• Ground Truth for Training Set Establishment: Not applicable. As there is no training set, this question is not relevant to the provided information.

In summary: The provided 510(k) summary focuses on demonstrating that the Cstat device is substantially equivalent to existing predicate devices based on its intended use, technological characteristics, and compliance with nonclinical safety and performance standards. It does not contain information about a clinical study with specific acceptance criteria, test set characteristics, expert ground truth, or an MRMC/AI performance evaluation that would typically be found in submissions for novel diagnostic algorithms or devices requiring clinical performance data.

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The Transvaginal Doppler Clamp is intended for bilateral detection and temporary occlusion of the uterine arteries during conservative gynecological surgery such as laparoscopic myomectomy.

Transvaginal Doppler Clamp

This document is a 510(k) clearance letter from the FDA for a medical device called the "Transvaginal Doppler Clamp." It does not contain any information about acceptance criteria, device performance, studies, sample sizes, expert qualifications, or ground truth establishment.

The letter explicitly states that the clearance is granted on the condition that the manufacturer submits a "postclearance special report" which "should contain complete information, including acoustic output measurements based on production line devices." It also notes that if this report contains "unacceptable values," the 510(k) clearance may not apply. This implies that performance testing and acceptance criteria for acoustic output will be evaluated after this clearance, not before.

Therefore, I cannot fulfill your request using the provided text. The document is an administrative notification of substantial equivalence, not a summary of device performance studies.

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The Transvaginal Doppler Probe is intended for bilateral detection of uterine blood vessels.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transvaginal

The Transvaginal Doppler Probe is a ring-handled instrument with integrated Doppler sensors, which allow for bilateral blood flow sensing of the uterine blood vessels by connecting to a commercially available portable transceiver box. The Transvaginal Doppler Probe is manufactured from stainless steel.

This document describes a 510(k) premarket notification for a Vascular Control Systems, Inc. Transvaginal Doppler Probe (K031358). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data for new claims. Therefore, the information regarding acceptance criteria and detailed study performance as typically found for novel devices with specific performance claims is limited.

However, based on the provided text, here's an analysis:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a specific clinical "test set" in the context of efficacy or diagnostic performance. The testing mentioned (electrical, thermal, acoustic output) are non-clinical engineering and safety tests. Thus, this information is not applicable or provided for a clinical test set.

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

This information is not applicable as the document does not describe a clinical study requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not applicable as the document does not describe a clinical study requiring adjudication for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission is a 510(k) demonstrating substantial equivalence through non-clinical testing and comparison to a predicate device, not a comparative clinical trial.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is not an algorithm, but rather a physical probe (transducer) that connects to a transceiver box. Therefore, the concept of "standalone algorithm performance" is not applicable. The device's performance is inherently linked to its use by a human operator with the transceiver.

7. The Type of Ground Truth Used

For the non-clinical tests (electrical, thermal, acoustic output), the "ground truth" would be established by physical measurements and adherence to international standards (IEC 60601-1) and FDA guidance documents for acoustic output.
For the substantial equivalence claim, the "ground truth" is the established characteristics and performance of the predicate device (K023024).

8. The Sample Size for the Training Set

This information is not applicable as this device does not involve a machine learning algorithm that requires a training set. The "training" here refers to manufacturing and design to meet specified engineering and safety standards.

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

This information is not applicable for the reasons stated above. The "ground truth" for manufacturing and design would be engineering specifications and regulatory standards.

Summary of Device and Evidence:

The Vascular Control Systems, Inc. Transvaginal Doppler Probe is an 8 MHz pulsed-wave Doppler sensor intended for bilateral detection of uterine blood vessels. Its 510(k) clearance was based on demonstrating substantial equivalence to its own previously cleared device (K023024).

The primary evidence presented for meeting "acceptance criteria" (though not explicitly framed as such with specific numerical targets in the summary) is:

• Compliance with IEC 60601-1 for electrical and thermal safety.
• Acoustic output measurements performed in accordance with FDA guidance, which implicitly met acceptable levels to ensure "reliable performance" and no "new issues of safety, effectiveness, or performance."
• Technological similarity to the predicate device, including the 8 MHz pulsed-wave Doppler sensor, distal crystal location, and stainless steel construction, which supports the claim of similar performance for the stated intended use.

The submission is a regulatory pathway for devices considered substantially equivalent, and therefore, it does not typically involve detailed clinical studies with specific performance metrics against clinical ground truth, expert adjudication, or MRMC studies for human reader improvement. The focus is on demonstrating that the new device is as safe and effective as a legally marketed one.

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The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems Transvaginal Doppler Probe. The device is intended to seize and hold the cervix and to hold and secure the Transvaginal Doppler Probe in place, while performing audible Doppler procedures.

The Burbank Tenaculum is a stainless steel, ring-handled instrument with a hook at the distal end of one arm and a guide rod attached to the distal end of the other arm. The proximal end of the guide rod is threaded to guide insertion of the Vascular Control Systems Transvaginal Doppler Probe (TDP) into the vagina and secure the TDP in place. A uterine sound is brazed at the distal end of the guide rod intended to be inserted through the cervical opening into the uterine cavity.

The provided text describes a medical device, the Burbank Tenaculum, seeking 510(k) clearance. This means it is claiming substantial equivalence to legally marketed predicate devices, rather than establishing entirely new performance criteria through extensive clinical trials. Therefore, the information typically associated with acceptance criteria and a study to prove they are met (like a multi-reader multi-case study, detailed ground truth establishment, or specific performance metrics with statistical analysis) is not present in this document.

Instead, the document focuses on demonstrating that the Burbank Tenaculum is as safe and effective as its predicate devices based on design similarities and intended use.

Here's an analysis based on the information provided, specifically addressing your points where possible:

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

The document does not provide a table of explicit, quantifiable acceptance criteria or reported device performance in the manner one might expect for a new, higher-risk device. The clearance is based on substantial equivalence to predicate devices. The "reported device performance" is essentially the qualitative claim that it meets its product specifications and does not raise new safety or effectiveness issues, similar to already marketed devices.

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

No test set sample size or data provenance is mentioned. The clearance is based on design and material comparisons to predicate devices, and internal design control procedures.

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

Not applicable. No ground truth was established by experts for a test set in the context of this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication was used.

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 is a medical instrument (tenaculum), not an AI device or imaging analysis tool. No MRMC study was performed.

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

Not applicable. This is a manual surgical instrument, not an algorithm.

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

The concept of "ground truth" as it applies to diagnostic or AI devices is not relevant here. The ground for substantial equivalence is the design, materials, intended use, and functioning characteristics comparison to existing, legally marketed predicate devices, and the claim that it meets its own product specifications.

8. The sample size for the training set

Not applicable. As a physical instrument, there is no "training set" in the machine learning sense. The "training" essentially comes from engineering design, material selection, and manufacturing processes, guided by existing device standards and performance of predicates.

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

Not applicable. There is no training set mentioned. The "ground truth" for its design and manufacturing would be established through engineering specifications, material properties, and adherence to quality systems and design controls (as mentioned: "The Burbank Tenaculum has been designed and tested per design control procedures and was found to meet its product specifications and does not raise new issues of safety, effectiveness, or performance of the product.").

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The VCS-A Series Clamp is intended for use in the temporary occlusion of blood vessels during vascular surgical procedures.

The VCS-A Series Clamp is a ring-handled instrument with integrated Doppler sensor, which allows temporary occlusion of blood vessels. The Doppler sensor allows audible sensing of blood flow by connecting to a commercially available portable transceiver box. The VCS-A series Clamp is manufactured from stainless steel.

The provided 510(k) summary for the VCS-A Series Clamp with Doppler Ultrasound is for a device that detects blood flow via Doppler ultrasound, intended for temporary blood vessel occlusion during surgery. It is a submission for substantial equivalence to a predicate device, and as such, the focus of the documentation is on demonstrating that the modified device does not introduce new questions of safety or effectiveness.

Therefore, the document does not contain information typically found in an AI/ML device submission, such as explicit acceptance criteria for model performance, details of a study proving those criteria were met, sample sizes for test and training sets, details on ground truth establishment by experts, or MRMC studies.

Instead, the "acceptance criteria" for this device are its compliance with general electrical and thermal safety standards (IEC 60601-1) and acoustic output power measurements (FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers"). The "study" proving these criteria are met is the performance of these non-clinical tests.

Below is a summary of the requested information based on the provided document, highlighting the absence of AI/ML-specific details.

Acceptance Criteria and Device Performance Study (VCS-A Series Clamp with Doppler Ultrasound)

The provided 510(k) summary focuses on demonstrating substantial equivalence of a modified medical device to a predicate device. As such, it does not detail performance metrics typical of AI/ML device evaluations. The "acceptance criteria" are related to non-clinical safety and performance standards for the hardware, and the "study" is the execution of these non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

This information is not applicable as the device is a hardware product and not an AI/ML diagnostic tool evaluated on a clinical test set. The testing described is non-clinical (electrical, thermal, acoustic output).

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

This information is not applicable. Ground truth establishment by clinical experts is not relevant for the non-clinical hardware testing described.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are typically used for clinical data interpretation in AI/ML studies, not for hardware safety and performance testing.

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. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to this hardware device.

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

This information is not applicable. The device is a physical vascular clamp with an integrated Doppler sensor, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed relates to engineering specifications, regulatory standards, and physical measurements. For example, the "ground truth" for electrical safety would be defined by the specified limits in IEC 60601-1, and the "ground truth" for acoustic output would be the acceptable power levels specified in FDA guidance.

8. The Sample Size for the Training Set

This information is not applicable. The device is a hardware product, and the concept of a "training set" for an algorithm is not relevant.

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

This information is not applicable. As there is no training set for an algorithm, the method for establishing its ground truth is irrelevant.

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The Transvaginal Doppler Probe is intended for bilateral detection of uterine blood vessels.

The Transvaginal Doppler Probe is a ring-handled instrument with integrated Doppler sensors, which allow for bilateral blood flow sensing of the uterine blood vessels by connecting to a commercially available portable transceiver box. The Transvaginal Doppler Probe is manufactured from stainless steel.

The provided document for K023024, "Vascular Control Systems, Inc. Transvaginal Doppler Probe," is a 510(k) premarket notification. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through clinical studies.

Therefore, the document does not contain information on:

• Acceptance criteria and reported device performance in a table. No specific quantitative performance metrics or acceptance thresholds are provided.
• A study proving the device meets acceptance criteria. The document references nonclinical tests for electrical, thermal, and acoustic safety, but not a study demonstrating clinical performance or meeting specific acceptance criteria.
• Sample size used for the test set or data provenance. No test set for clinical performance is described.
• Number of experts used to establish ground truth or their qualifications. Ground truth for clinical performance is not discussed.
• Adjudication method for the test set. No test set or adjudication process is mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is not mentioned.
• Standalone (algorithm only) performance. This device is a probe, not an algorithm.
• Type of ground truth used. No ground truth for clinical performance is mentioned.
• Sample size for the training set. No training set for an algorithm is applicable.
• How the ground truth for the training set was established. Not applicable.

What the document does include regarding performance:

The document states under "Brief summary of nonclinical tests and results" (Section 7 from {1}) that:

• The Transvaginal Doppler Probe was "designed and tested to comply with the requirements of IEC 60601-1 for electrical and thermal safety."
• "Acoustic output power measurements were performed in accordance with the FDA Guidance document 'Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers'."
• "Test results indicate reliable performance when the device is used in accordance with the Instructions for Use."
• "The Transvaginal Doppler Probe does not raise new issues of safety, effectiveness, or performance of the product."

In the FDA's clearance letter ( {3} and {4}), there's a condition for clearance:

• "This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a post clearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 'Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.' If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded."

This indicates that while initial acoustic output measurements were submitted, further confirmation from production units was required post-clearance. The "unacceptable values" here refer to regulatory limits for acoustic output, not clinical performance acceptance criteria in the sense of a diagnostic accuracy study.

In summary, the 510(k) submission for the Vascular Control Systems, Inc. Transvaginal Doppler Probe relies on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and nonclinical safety testing, rather than presenting a clinical study with specific acceptance criteria and performance metrics.

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The VCS-A Series Clamp is indicated for use in the temporary occlusion of blood vessels during vascular surgical procedures.

The VCS-A Series Clamp with Ultrasound Doppler is a ring handled mechanical surgical instrument with a ratchet closure to adjust the tension required to occlude the target vessel. The Clamp has an integrated Doppler probe, which allows for blood flow monitoring by using a conventional portable Doppler Ultrasound unit. The VCS-A Series Clamp is made of surgical grade stainless steel and is available in various sizes. The clamp is a sterile, single use device. The method of sterilization will be Gamma Radiation with a SAL of 106.

1. Table of Acceptance Criteria and Reported Device Performance:

   The provided document states that "The performance and functional testing demonstrated that the vascular clamp is substantially equivalent to the predicate devices. The VCS-A series Clamp with Ultrasound Doppler does not raise any new safety, effectiveness, or performance issues. Data are on file at Vascular Control Systems, Inc."

   Since the document doesn't explicitly list numerical acceptance criteria or specific performance metrics, the table below reflects this general statement of substantial equivalence to predicate devices.

   Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
   Overall Performance	Substantial equivalence to predicate devices regarding safety, effectiveness, and performance.	The VCS-A series Clamp with Ultrasound Doppler demonstrated substantial equivalence to predicate devices, raising no new safety, effectiveness, or performance issues.
   Functionality	(Implicit: Temporary occlusion of blood vessels and integrated Doppler functionality)	Demonstrated functionality consistent with intended use and predicate devices.
   Safety	(Implicit: No new safety concerns compared to predicate devices)	No new safety issues were identified.
   Effectiveness	(Implicit: Achieves intended purpose effectively)	No new effectiveness issues were identified.
   Biocompatibility	(Implicit: Suitable for contact with blood vessels)	(Not explicitly stated, but implied by regulatory clearance and lack of new safety issues)
   Sterilization	Gamma Radiation with SAL of 10-6	Sterilization method (Gamma Radiation with SAL of 10-6) is specified. Performance of this method implies it met acceptance criteria for sterility.
   Material Properties	(Implicit: Suitable for surgical use)	(Not explicitly stated, but implied by regulatory clearance and lack of new safety issues)

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

   The document states that "Data are on file at Vascular Control Systems, Inc." without providing specific details regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).

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

   This information is not provided in the document. The study focuses on "performance and functional testing" rather than expert-driven ground truth assessment for image interpretation or diagnosis.

4. Adjudication method for the test set:

   This information is not provided in the document.

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:

   An MRMC comparative effectiveness study was not done. The device is a mechanical surgical clamp with an integrated Doppler, not an AI-assisted diagnostic tool for human readers.

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

   This is not applicable as the device is a physical surgical instrument, not an algorithm. Therefore, a standalone algorithm-only performance study would not be relevant.

7. The type of ground truth used:

   The "ground truth" for this device would be its ability to physically perform its intended function (temporary occlusion of blood vessels) and the accurate function of the integrated Doppler. This would be assessed through engineering and functional testing rather than expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic device. The performance and functional testing implicitly served as the "ground truth" verification against engineering specifications and predicate device performance.

8. The sample size for the training set:

   This information is not applicable. The VCS-A Series Clamp with Ultrasound Doppler is a mechanical device, not a machine learning or AI algorithm that requires a training set.

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

   This is not applicable, as there is no training set for this type of device.

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