(79 days)
The ELECTROSONOGRAM ESC-I is a non-invasive device that measures and records sounds enitted from the temporomandibular (jaw) joint along with the relative position of the jaw as a means of assessing the status of the temporomandibular joint.
ESG-1 Electrosonogram is a non-invasive device that measures and records sounds emitted from the temporomandibular joint along with the relative position of the jaw as a means of assessing the status of the temporomandibular joint.
I am sorry, but the provided text from the FDA 510(k) letter for the ESG-1 Electrosonogram (K970116) does not contain information regarding acceptance criteria, the study that proves the device meets acceptance criteria, or the specific details you requested about such a study.
This document is primarily concerned with the FDA's determination of substantial equivalence to a predicate device, allowing the ESG-1 Electrosonogram to be marketed subject to general controls. It references the device's indications for use and classification, but it does not delve into the detailed performance data or study specifics that would be part of a submission to demonstrate acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, details on MRMC or standalone studies, or how ground truth was established, as this information is not present in the provided text.
§ 872.2050 Dental sonography device.
(a)
Dental sonography device for monitoring —(1)Identification. A dental sonography device for monitoring is an electrically powered device, intended to be used to monitor temporomandibular joint sounds. The device detects and records sounds made by the temporomandibular joint.(2)
Classification. Class I. The device is exempt from the premarket notification provisions of subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental sonography device for interpretation and diagnosis —(1)Identification. A dental sonography device for interpretation and diagnosis is an electrically powered device, intended to interpret temporomandibular joint sounds for the diagnosis of temporomandibular joint disorders and associated orofacial pain. The device detects, records, displays, and stores sounds made by the temporomandibular joint during jaw movement. The device interprets these sounds to generate meaningful output, either directly or by connection to a personal computer. The device may be part of a system of devices, contributing joint sound information to be considered with data from other diagnostic components.(2)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices.”