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The VascuView ultrasound system provides ultrasound imaging of peripheral vascular structures in order to provide for ultrasound guidance for placement of needles and catheters in these structures. The VascuView ultrasound system is not intended for fetal or ophthalmic applications.

The VascuView ultrasound system provides ultrasound imaging of peripheral vascular structures in order to provide for ultrasound guidance for placement of needles and catheters in these structures. The VascuView system consists of the following components: Ultrasound Probe and Cable, Tablet PC, VascuView Software.

Here's a breakdown of the acceptance criteria and study information for the VascuView Ultrasound System based on the provided K080049 510(k) summary:

This device is an ultrasound system and its performance evaluation often relies on meeting safety standards and demonstrating equivalent physical characteristics to predicate devices, rather than clinical performance metrics typical of AI/ML devices. Therefore, a direct mapping to typical AI acceptance criteria like sensitivity/specificity or human-AI reader performance is not explicitly present in the provided documentation, as this is an older submission for a traditional medical device.

Acceptance Criteria and Device Performance

The acceptance criteria for the VascuView Ultrasound System appear to be primarily focused on safety, electromagnetic compatibility, and demonstrating comparable or superior physical and performance characteristics to its predicate devices.

Study Information

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

   • Test Set Sample Size: Not explicitly stated as a "test set" in the context of clinical performance data for metrics like sensitivity/specificity. The measurement validation was done using "wire phantoms."
   • Data Provenance: The studies mentioned are non-clinical (laboratory testing using phantoms and compliance with international standards). No patient data is mentioned.

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

   • Not applicable. The ground truth for measurement accuracy was established by the known dimensions/properties of "wire phantoms." For safety standards, the ground truth is the standard's requirements.

3. Adjudication method for the test set:

   • Not applicable. The non-clinical tests involved direct measurement against known standards or physical properties.

4. 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:

   • No. This is a traditional ultrasound imaging device, not an AI/ML device. Therefore, an MRMC study for AI assistance is not applicable and was not performed.

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

   • Not applicable. This is a traditional ultrasound imaging device. The "algorithm" here refers to the system's software functionality, which was validated, but not as a standalone AI diagnostic tool.

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

   • For measurement accuracy: Wire phantoms (known physical dimensions).
   • For safety and electromagnetic compatibility: International standards (IEC 60601 series).
   • For software validation: Test protocols designed to verify software functionality.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning.

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

   • Not applicable, as there is no training set for an AI/ML model.

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