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The VTI Intraoperative Doppler Systems are intended for the intraoperative and transcutaneous evaluation of blood flow.

Indications for Use form filed with the FDA for the VTI Doppler Probes lists the clinical applications as Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.

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This document is a 510(k) clearance letter from the FDA for the "VTI Intraoperative Doppler Systems." It states that the device is substantially equivalent to legally marketed predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter focuses on the regulatory clearance process, general controls, and compliance with federal statutes. It does not include details about specific performance metrics, studies, or clinical trial results that would typically be used to demonstrate acceptance criteria.

Therefore, I cannot provide the requested information based on the text provided.

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The VTI 20 MHz Gated Doppler is intended for the intraoperative and transcutaneous evaluation of blood flow.

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The provided text is a 510(k) premarket notification letter from the FDA for a device called "VTI 20 MHz Gated Doppler." This letter does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in the prompt for evaluating a device's performance against acceptance criteria.

The document primarily focuses on:

• Confirming the FDA's review of the 510(k) submission.
• Stating that the device is substantially equivalent to legally marketed predicate devices.
• Outlining the regulatory requirements the manufacturer must comply with.
• Identifying the device's regulation number, regulation name, regulatory class, and product code.
• Providing an "Indications for Use Statement" which clarifies what the device is intended for (intraoperative and transcutaneous evaluation of blood flow).

Therefore, I cannot provide the requested table and information based on the given text. The information needed for such a description would typically be found in the 510(k) summary, clinical study reports, or validation reports that are part of a more comprehensive submission, not in the FDA's clearance letter itself.

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Ask a specific question about this device