(45 days)
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.
§ 874.1325 Electroglottograph.
(a)
Identification. An electroglottograph is an AC-powered device that employs a pair of electrodes that are placed in contact with the skin on both sides of the larynx and held in place by a collar. It is intended to measure the electrical impedance of the larynx to aid in assessing the degree of closure of the vocal cords, confirm larygeal diagnosis, aid behavioral treatment of voice disorders, and aid research concerning the laryngeal mechanism.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.