(137 days)
Indications for Use:
At the present time, comparisons between patients of electromyograms, sonograms and / or jaw traces should not be made,
Sufficient normative data have not been collected to support such population-based measurements as "frean electromyographic clench," "standard deviation (Jaw Tracking) of freeway space," "integral (sonograph) of sound intensity" "average jaw tracing of chewing," etc., for non diseased individuals as well as for patients having various disease entitles that are now lumped within the terminology known as "TemporomandIbular Disorders and Associated Orofacial Pain (TMD/MPD)."
Jaw Tracking
- To track mandibular movement and position
- To aid in the diagnosis of TMJ / MPD syndrome, muscle tension and bruxing [instability of occlusion]
- To identify mandibular rest position and to identify interocclusal distance and freeway space
- To monitor the position of the jaw in three dimensions
- To represent the spatial position of the mandibular incisal edge relative to the skull
- To provide Baseline measurements for future reference
Electromyography
- To record electrical activity of muscles of the stomatognathic system, especially temporalis, masseter and digastric
- To clinically monitor up to eight different muscles as an aid in diagnosis and treatment evaluation by recording the electrical activity of the muscles of the stomatognathic system.
- To determine the degree of relaxation (intra-patient) of a single muscle / group of muscles at rest
- To measure relative (intra-patient) levels of activity of several muscles during a functional act
- To provide Baseline measurements for future reference
Sonography, joint vibration (sound) recording
- To record and display sounds / vibrations from the temporomandibular joint
- To aid the clinician in his analysis of a joint sound / vibration by allowing him to see the waveform in various standard plots
- To aid the clinician in companing a parient's current standard plots to previous recordings before, during and after treatment
- To provide numerical values that can be used to quantify the physical characteristics of the sounds / vibrations allowing intra-bationt commissions (only) by the clinician
- To provide Baseline measurements for future reference
Not Found
I apologize, but the provided text is a 510(k) summary letter from the FDA for a device called the "BioPak Measurement System." It outlines the device's classification, indications for use, and general regulatory information.
This document does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, the document does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes for test sets, data provenance, or training sets.
- Information about experts used for ground truth, adjudication methods, or MRMC studies.
- Results from standalone performance studies.
- The type of ground truth used.
- How ground truth for training data was established.
This letter is a regulatory approval document, not a scientific study report or clinical trial summary. To find the information you're looking for, you would typically need to refer to the device's 510(k) submission itself (which often includes performance data and clinical studies), or scientific publications related to the device.
§ 890.1375 Diagnostic electromyograph.
(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).