(88 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1 | Designed and tested to comply with IEC 60601-1 for electrical and thermal safety. |
| Compliance with FDA Acoustic Output Guidance | Acoustic output power measurements performed in accordance with FDA guidance. |
| Reliable Performance (General) | Test results indicate reliable performance when the device is used in accordance with the Instructions for Use. |
| No new issues of safety/effectiveness/performance compared to predicate product | The modified VCS-A Series Clamp does not raise new issues of safety, effectiveness, or performance of the product. |
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.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).