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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 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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