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The intended use of the DVRS is for viewing, acquiring, archiving and retrieving video images of endoscopic and fluoroscopic procedures. The images may be monochrome or color. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device.

Digital Video Recording System (DVRS)

The provided text discusses regulatory approval for a Digital Video Recording System (DVRS) and its intended use, but it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) clearance letter from the FDA, which signifies that the device is substantially equivalent to a legally marketed predicate device. This process primarily focuses on demonstrating equivalence in terms of safety and effectiveness, rather than presenting a detailed study proving performance against specific acceptance criteria.

Therefore, I cannot provide the requested information. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication method.
5. Information on any Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
6. Details about a standalone (algorithm only) performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document merely states the intended use of the DVRS for "viewing, acquiring, archiving and retrieving video images of endoscopic and fluoroscopic procedures" and that it is for use by "medical doctors or clinicians such as speech pathologists."

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The device use would be indicated in those cases where vocal fold contact information is considered helpful in evaluating physiologically normal speakers for research purposes or clinically in cases of vocal fold pathologies.

Electroglottograph

This document is a 510(k) clearance letter from the FDA for an Electroglottograph device (K990240). It primarily addresses the regulatory approval process and the intended use of the device.

Based on the provided text, there is no information available regarding acceptance criteria, performance studies, or details about the validation of the device beyond its substantial equivalence to a legally marketed predicate device.

The letter states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that Kay Elemetrics, Corp. did not provide- or was not required to provide- extensive clinical or performance study data for this 510(k) submission. Instead, the device was cleared based on its substantial equivalence to a device already on the market before 1976. Therefore, all the specific information requested in your prompt (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, training set information) is not present in the provided document.

To obtain such information, one would typically need to review the full 510(k) submission summary or other regulatory documents that may have been filed by the manufacturer, which are not included here.

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Ask a specific question about this device