(35 days)
The Volcano s5 Imaging System is used for the qualitative and quantitative evaluation of vasculature in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. ChromaFlo® is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.
The Volcano s5 Imaging System consists of the imaging catheter, the patient interface module, and the system console. The system console gathers and displays high-resolution intraluminal images that can be analyzed both qualitatively and quantitatively. In addition to supplying diagnostic information, the Volcano s5 Imaging System can be an adjunct to interventional therapies, such as balloon angioplasty. With ChromoFlo® a two-dimensional color map of relative blood flow is overlaid on the grayscale image, providing additional information for vessel analysis. The In-Line Digital option displays a two-dimensional, 360 rotations and longitudinal view of the vessel.
The provided document is a 510(k) summary for the Volcano s5 Imaging System. It describes the device, its intended use, and states that performance testing was conducted. However, it explicitly states that the test results were found to be acceptable as required by the respective test plans and protocols, but does not provide details about specific acceptance criteria or the specific studies conducted to prove the device met these criteria.
Therefore, I cannot provide the information requested in your table and numbered points, as the source document does not contain these details.
Here's what I can infer from the document regarding "Performance Data":
- 1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document vaguely states, "The test results were found to be acceptable as required by the respective test plans and protocols."
- 2. Sample sized used for the test set and the data provenance: This information is not provided.
- 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.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided.
- 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: This information is not provided, and given the nature of the device (ultrasound imaging system), it's unlikely to be an AI-assisted interpretation study in the modern sense.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not provided.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided.
- 8. The sample size for the training set: This information is not provided.
- 9. How the ground truth for the training set was established: This information is not provided.
In summary, the provided 510(k) document confirms that performance testing was done and yielded acceptable results according to internal protocols, but it does not disclose the specifics of those tests, their acceptance criteria, or the detailed results.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.