Search Results

• To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter
• To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system
• To measure relative (intra-patient) levels of activity of 2 muscles during a functional act

Not Found

While the provided text refers to the FDA's substantial equivalence determination for the TEETHAN 2.0 device, it does not contain the specific details regarding acceptance criteria, study design, or performance metrics that you've requested.

The document is primarily an FDA 510(k) clearance letter, confirming that the device is substantially equivalent to a legally marketed predicate device. It outlines general regulatory requirements and indications for use, but it does not include the technical study results or the detailed information about the validation process (like sample size, ground truth establishment, expert qualifications, etc.).

Therefore, I cannot provide the requested information based on the given input. To answer your questions, I would need a different document, such as the full 510(k) summary, clinical study reports, or a more detailed technical submission from the manufacturer to the FDA.

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Indications for use; 2 channel, hand held, mobile EMG amplifier

1. To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter
2. To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system
3. To determine the degree of relaxation (intra-patient) of 2 muscles at rest
4. To measure relative (intra-patient) levels of activity of 2 muscles during a function act

The M-Scan is a 2-channel, portable, battery operated electromyographic amplifier which includes: a) two (2) identical high-gain differential input amplifiers, b) two (2) buffer amplifiers, c) two (2) full wave rectifiers, and d) two (2) integrators. The overall amplification of the M-Scan is calibrated to 2500. The bandwidth filtering is set (fixed) from 30 Hz to 1000 Hz (± 3dB). The common mode rejection ratio is ≥ 130 dB at the power line frequency (50/60 Hz). The M-Scan does not include isolated power converter since it is battery operated, portable, and does not interface with any external equipment (it is never connected to the a-c line). Only three (3) functions are provided by the M-Scan: 1) amplification, 2) bandwidth limiting, and 3) integration of the signal for the integrated display.

Here's an analysis of the provided text regarding the M-Scan device, focusing on acceptance criteria and study details.

Important Note: The provided text is a 510(k) summary for a medical device (M-Scan). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with explicit acceptance criteria for a new clinical claim. Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for deep learning models, expert qualifications, etc.) is not present in this type of document because it's not a clinical effectiveness study. The "study" described here is a non-clinical performance comparison to a legally marketed predicate device.

Acceptance Criteria and Device Performance

There are no explicitly stated numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) in this 510(k) summary, as it's not a clinical performance study aiming to prove a specific diagnostic efficacy. Instead, the acceptance criteria implicitly involve demonstrating that the M-Scan's electrical characteristics are comparable or substantially equivalent to its predicate device (BioEMG III).

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of human patient or imaging data. The "test set" consisted of artificial signals generated by a calibrated function generator. The number of such test signals or their variations is not specified.
   • Data Provenance: Not applicable as it's not real-world patient data. The "data" was synthetically generated using a function generator.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The ground truth for the instrument's electrical performance was established by objective measurements using a calibrated function generator and oscilloscope, not clinical experts.

3. Adjudication method for the test set:

   • Not applicable. The "test" involved direct electrical measurement and comparison to the predicate device's measured characteristics, not a human reader adjudication process.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC study was done. This device is an electromyograph (EMG) amplifier, not an AI-powered diagnostic tool interpreting complex data. There is no AI component mentioned that would assist human readers, or any reader component at all other than clinical interpretation of the EMG signals generated.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a measurement instrument. Its "performance" is its ability to accurately amplify and filter EMG signals, not to provide a diagnostic interpretation that could be done "standalone." Software validation testing was performed on the device's software (likely firmware controlling components and display logic), but not a standalone 'algorithm' in the sense of AI.

6. The type of ground truth used:

   • Objective electrical measurements: The ground truth for the M-Scan's performance was established by applying known, calibrated electrical signals from a function generator and measuring the output with an oscilloscope. This allowed for direct comparison of amplification, bandwidth, and waveform characteristics against the predicate device.

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI that would require a "training set."

8. How the ground truth for the training set was established:

   • Not applicable, for the same reason as above.

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The GRINDCARE MEASURE device is indicated to aid in the evaluation of nocturnal bruxism by measuring the temporalis muscle EMG activity during sleep.

GRINDCARE MEASURE is a portable electromyographic (EMG) monitoring device. The device consists of the recorder, a tri-polar electrode and a docking station. The electrode is placed on the forehead with three integrated electrodes in close connection to the temporalis muscle by means of a double-adhesive patch incorporating three conductive gelpads and connected to the recorder. The device records EMG activity and processes the signal to detect a particular activity (tooth grinding/clenching). It uses EMG to sense contraction of the temporalis muscle that is associated with bruxing events. The EMG events are logged and stored on the recorder. This data can be transferred to a healthcare professional's PC for assessment of the user's bruxism.

The GRINDCARE MEASURE device underwent performance testing to ensure it met design specifications and complied with relevant standards. The provided document does not contain details about specific acceptance criteria related to clinical performance (e.g., sensitivity, specificity for bruxism detection) or a clinical study that proves the device meets such criteria. Instead, it references compliance with general electrical safety and electromagnetic compatibility standards, and that its performance was previously tested for the predicate device (K092675).

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not explicitly stated. The document refers to "device testing" and meeting "design specifications" and existing standards, but does not detail a clinical test set or its size for bruxism detection performance.
• Data Provenance: Not specified. Based on the manufacturer's location (Denmark) and the referenced standards, it's likely testing was conducted to international standards. Whether a dedicated clinical study with human subjects for the GRINDCARE MEASURE was performed, and its nature (retrospective/prospective, country of origin), is not detailed.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

• This information is not provided. The document focuses on technical and electrical safety standards rather than clinical performance validation against expert-established ground truth for bruxism diagnosis.

4. Adjudication Method for Test Set:

• This information is not provided. As there's no detailed clinical study described, there's no mention of an adjudication method for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a MRMC comparative effectiveness study is not mentioned. The document does not describe any human-in-the-loop performance evaluation or comparison of human readers with and without AI assistance for the GRINDCARE MEASURE. The device is a diagnostic tool for measuring EMG activity, not an assistive AI for human interpretation.

6. Standalone (Algorithm Only) Performance Study:

• Yes, in spirit, the device's ability to detect bruxing events represents a standalone performance. The document states: "It uses EMG to sense contraction of the temporalis muscle that is associated with bruxing events. The EMG events are logged and stored on the recorder." This implies the device's internal processing (algorithm) identifies these events independently. However, specific standalone performance metrics (e.g., accuracy, sensitivity, specificity) against a clinical ground truth for bruxing events are not provided. The "performance data" section primarily lists compliance with technical standards.

7. Type of Ground Truth Used:

• For the technical and safety standards, the ground truth would be the parameters defined by the respective IEC and FCC standards. For the detection of "bruxing events," the document implies that the EMG signals indicating muscle contraction serve as the basis for detection. However, it does not specify how the accuracy of this detection itself was validated against a gold standard for bruxism (e.g., polysomnography with video, expert observation, or clinical diagnosis).

8. Sample Size for Training Set:

• This information is not provided. The document does not describe the development of an AI algorithm based on a training set for bruxism detection. The device "processes the signal to detect" events, but details on how this processing was developed or "trained" are absent.

9. How Ground Truth for Training Set Was Established:

• This information is not provided as there is no mention of a training set for an AI algorithm in the provided text.

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Indications for use: 8 channel EMG amplifier

1. To record electrical activity of muscles of the stomatognathic system, especially temporalis, masseter and digastric
2. To clinically monitor up to eight different muscles as an aid in the diagnosis and treatments evaluation by recording the electrical activity of muscles of the stomatognathic system
3. To determine the degree of relaxation (intra-patient) of a single muscle / group of muscles at rest
4. To measure relative (intra-patient) levels of activity of several muscles during a functional act

Indications for Use: 2 channel JVA amplifier

1. To record and display sounds / vibrations from the temporomandibular joints
2. To aid the clinician in his analysis of a joint sound/vibration by allowing him/her to see the waveform in various standard plots (together with K981563)
3. To aid the clinician in comparing a patient's current stand plots to previous recordings before, during and after treatment
4. To provide numerical values that can be used to quantify the physical characteristics of the sounds / vibrations, allowing intra-patient comparisons (only) by the clinician

The BioEMG III is a multi-channel electromyographic amplifier which includes; a) eight (8) identical high-gain differential input amplifiers, b) eight (8) identical opto-coupler isolation units and c) eight (8) ourput buffer amplifiers. The overall amplification of the BioEMG III is calibrated to 5000X. The bandwidth filtering is set (fixed) from 30 Hz to 1000 Hz (± 3 dB). The common mode rejection ratio is ≥ 130 dB at the power line frequency (50/60 Hz). The BioEMG III includes an isolated power converter that converts non-isolated +5 vdc into isolated + 5 and - 5 vdc. It may be connected to a personal computer through an analog to digital converter. Only three (3) functions are provided by the BioEMG III; I) amplification, 2) bandwidth limiting and 3) electrical isolation of the patient.

Analogous to the BioEMG II, the BioEMG III also incorporates two (2) additional inputs for recording vibrations from the left and right temporomandibular joints. They consist of: a) two (2) identical high-gain amplifiers and b) two (2) output buffer amplifiers. For these inputs no isolation is required because there is no electrical connection to the patient. The amplification is calibrated to 5000X and the bandwidth filtering is set from 30 Hz to 1000 Hz (± 3dB). These channels are also powered from an external +5 vdc non-isolated source, which is converted to +5 and -5 vdc. The vibration signals may also be connected to a personal computer through an analog to digital converter. The two (2) functions performed by these "JVA" channels include: 1) amplification and 2) bandwidth limiting.

The provided text is a 510(k) summary for the BioEMG III device. It focuses on demonstrating substantial equivalence to a predicate device (BioEMG II) through technological characteristics and non-clinical test data. However, it does not contain information about acceptance criteria or a study that rigorously proves the device meets specific performance criteria in a clinical setting with human readers or a standalone algorithm.

Therefore, many of the requested sections (e.g., sample sizes, expert qualifications, HRMR studies, ground truth details) cannot be extracted from this document as it primarily addresses regulatory submission for substantial equivalence based on technical specifications.

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for clinical performance. Instead, it demonstrates performance by showing the BioEMG III retains the "same levels of amplification, isolation and band-pass filtering" as the predicate device (BioEMG II).

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable/Not mentioned. The testing was non-clinical, using a function generator and oscilloscope.
• Data Provenance: Not applicable/Not mentioned. The testing was described as non-clinical bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable/Not mentioned. The "ground truth" was established purely through instrumental measurements against known calibration signals.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/Not mentioned. No human assessment or adjudication process was described for the non-clinical tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No. This device is an electromyograph and joint vibration amplifier, not an AI-powered diagnostic imaging tool. No MRMC study was conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. The device is a hardware amplifier; its performance is based on its electronic specifications (amplification, filtering, isolation) rather than algorithmic output. The non-clinical test data focused on these hardware characteristics.

7. The type of ground truth used

• Ground Truth Type: Calibrated function generator signals and oscilloscope readings. This represents a technical "ground truth" for electrical signal processing.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device does not use machine learning or AI, so there is no "training set."

9. How the ground truth for the training set was established

• Training Set Ground Truth: Not applicable. As there's no training set, this is not relevant.

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1. To treat temporomandibular joint (TMJ) disfunction and associated pain
2. To relieve symptoms associated with muscle spasm
3. To relax muscles and establish a physiologic occlusion
4. To take occlusal registrations
5. To take denture impressions
6. To increase local blood circulation
7. To maintain or increase mandibular range of motic

The DOLOTENS DENTAL TM2 is an ultra low frequency muscle stimulator, sending an electrical impulse to the muscles via the nerves in order to provide a minor level of muscle contraction. This gentle contraction of the muscles provides a pumping action for the blood increasing circulation in the muscles. Muscle spasm is relieved because fresh nutrients are brought into the muscles and waste products are pumped out.

The provided text describes a medical device, the DOLOTENS DENTAL™ 2, and its 510(k) summary for FDA clearance. However, it does not contain any information regarding acceptance criteria, device performance studies, or the methodologies for establishing ground truth, sample sizes, or expert qualifications that would typically be found in a study proving the device meets acceptance criteria.

The document is a regulatory submission for premarket notification (510(k)), which primarily establishes substantial equivalence to a predicate device. This type of submission generally focuses on comparing the new device's technological characteristics and indications for use to an already cleared device, demonstrating that it's as safe and effective, rather than presenting new clinical study data with acceptance criteria.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study proving the device meets acceptance criteria based on the provided text. The following points explain why:

• No Acceptance Criteria or Performance Data: The document lists "Indications for Use" but does not define quantitative or qualitative acceptance criteria for these indications (e.g., "reduce TMJ pain by X% in Y% of patients"). It also does not present any performance data (e.g., sensitivity, specificity, accuracy, or clinical improvement rates) from a study that would demonstrate meeting such criteria.
• No Study Details: There is no mention of a particular study (clinical trial, standalone study, MRMC study, etc.) conducted to evaluate the DOLOTENS DENTAL™ 2's performance against defined acceptance criteria.
• Focus on Substantial Equivalence: The primary objective of the 510(k) summary is to state that the DOLOTENS DENTAL™ 2 is "substantially equivalent to the MODEL J-5 MVO-MONITOR (K031998)." This typically involves demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness as the predicate device. It does not necessarily require new clinical performance studies with acceptance criteria if a well-established technological basis and predicate device exist.

Conclusion:

Based on the provided text, it's not possible to describe the acceptance criteria or a study proving the device meets acceptance criteria because this information is not present in the 510(k) summary document. The document's purpose is to seek FDA clearance for market entry based on substantial equivalence, not to present detailed performance study results against predefined acceptance criteria.

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The BiteStrip is generally indicated for use by orofacial pain professionals or dentists, to aid in the evaluation and management of nocturnal masticatory muscles activity disorders, which may be related to the patient's bruxism. temporomandibular disorder (TMD) or other oral function disorders during sleep.

The BiteStrip is intended as an aid in the evaluation of excessive nocturnal jaw muscle activity The device is generally indicated for use by orofacial pain professionals or dentists, to evaluate nocturnal masticatory muscle activity level. which may be related to the patient's braxism. temporomandibular disorder (TMD) or other oral function disorders during sleep.

The BiteStrip is a disposable diagnostic device. The device is intended for use in monitoring masseter muscle contractions during sleep. It is generally indicated for use by physicians to aid in the evaluation of the presence and severity of bruxism, to determine the need for treatment, and for treatment follow-up. The BiteStrip is specifically indicated to obtain a quantitative measure of masseter muscle contractions during sleep, which correlates with bruxism severity derived from formal sleep lab studies. The BiteStrip is intended for adult users during an overnight sleep episode, i.e., 4-6 hours.

The BiteStrip display gives an indication of muscle contraction severity as a single number, from 0 to 3 (Where 0 is very low count, and 3 is high count) depending on the total number of masseter muscle contraction episodes that the patient performs for the duration of the test. This number is referred to as the Bscore. While both Bscore and traditional bruxism score are very similar, and have good correlation, the terms differ because the bruxism score is measured using sleep lab EMG and additional physiological measures (not only EMG signals), while the Bscore is obtained by EMG analysis alone.

The provided text describes the BiteStrip device and its 510(k) summary, but it does not contain a detailed study report that proves the device meets specific acceptance criteria.

However, it does describe the device's intended use and mentions a correlation study without providing specific performance metrics or detailed methodology. I can extract the information that is present and note where information is missing.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in the form of a table or specific measurable thresholds. It describes the device's output and how it correlates with bruxism severity.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only refers to "formal sleep lab studies" without further detail.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number or qualifications of experts used to establish ground truth for the test set. It mentions "formal sleep lab studies" as the source of "traditional bruxism score" used for comparison.

4. Adjudication method for the test set

The document does not specify any adjudication method used for the test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not describe an MRMC comparative effectiveness study directly involving human readers' improvement with or without AI assistance. The BiteStrip is presented as a diagnostic device that outputs a "Bscore," not as an AI-assistant for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the BiteStrip appears to be a standalone device that provides an automated output (the Bscore) based on EMG analysis. The description states: "The BiteStrip display gives an indication of muscle contraction severity as a single number, from 0 to 3..." and "the Bscore is obtained by EMG analysis alone." This indicates standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for comparison is the "traditional bruxism score" derived from formal sleep lab studies using sleep lab EMG and additional physiological measures.

8. The sample size for the training set

The document does not specify the sample size for any training set.

9. How the ground truth for the training set was established

The document does not describe how the ground truth for a training set was established. It implies the device was developed to correlate with "traditional bruxism score" from formal sleep lab studies, which would serve as the reference.

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For Jaw Tracking functions of this device:

• Tracks mandibular movement and position .
• . For the diagnosis of functionaldisorderssuch as TMJ/MPD syndrome, muscle tension, bruxing, and instability of occlusion
• Identification of mandibular rest position .
• Identification of interocclusal distance and freeway space .
• . Monitors the position of the jaw in three dimensions
• Represents the spatial position of the mandibular incisal edge relative to the skull .

For electromyographic function of this device:

• Intended for use for muscles of mastication, especially temporalis, masseter, and digastric ●
• . Designed to perform a limited number of functions in dental diagnosis
• For use as a stand alone system for clinical monitoring of up to eight differentmuscles. it is ■ ideally suited for diagnosis and treatment evaluation by recording function of the muscles of the stomatognathic system
• The determination of the degree of relaxation of a particular muscle or muscle group at rest .
• The precise measurement of relative levels of contraction of several muscles during a ■ functional test

For both functions of this device:

• Diagnosis and management of TMJ/MPD disorders, orthodontic patients, denture patients, . and reconstruction patients.
  The addition of the feature described in this new Premarket Notification does not expand upon the above indicated uses.

The Model K6-I Diagnostic System is a surface electromyographic device that measures and records electrical potential emanating from muscle (in addition to its ability to track and document mandibular position/range of motion). The feature being added to the software of this device, Fast Fourier Transformation (FFT) of captured data, has the same technological characteristics as other legally marketed devices described above and in the Special 510(k).

The provided document is a 510(k) premarket notification letter from the FDA to Myotronics-Noromed, Incorporated, regarding their Model K6-I Diagnostic System. It primarily addresses the substantial equivalence of the device to legally marketed predicates, especially concerning the addition of a Fast Fourier Transformation (FFT) feature to its software.

The document does not contain detailed information about specific acceptance criteria or an explicit study proving performance against those criteria in a quantitative manner. Instead, it focuses on regulatory clearance based on substantial equivalence.

However, based on the information provided, we can infer some aspects and highlight what is missing:

Table of Acceptance Criteria and Reported Device Performance

Missing Information from the Provided Document:

The following information, as requested in the prompt, is not present in the provided 510(k) letter:

1. Sample size used for the test set and the data provenance: The document does not describe a specific test set or its sample size for evaluating the FFT feature.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of experts or ground truth establishment for a test set.
3. Adjudication method for the test set: Not applicable as no explicit test set or expert evaluation is detailed.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: No MRMC study is mentioned.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document describes the device as a diagnostic system which implies human interpretation. No specific standalone algorithm performance study is described for the FFT feature.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is described for a performance study of the FFT feature.
7. The sample size for the training set: The document does not describe a training set as it pertains to software algorithms.
8. How the ground truth for the training set was established: Not applicable.

Context from the Document:

• Device Name: Model K6-I Diagnostic System
• Added Feature: Fast Fourier Transformation (FFT) of data to the K6-I Software.
• Method of Proof: Substantial Equivalence. The document states that the new FFT feature "has the same technological characteristics as other legally marketed devices described above and in the Special 510(k)." The predicate devices listed are:
  • ProComp DSP & ProComp mfg. by Thought Technology
  • Myosystem 1000 Electromyograph mfd. by Noraxon
  • I-330 Physiological Monitor mfd. by J & J Engineering
• Indications for Use: The device tracks mandibular movement and position for diagnosis of functional disorders (e.g., TMJ/MPD syndrome, muscle tension), identification of mandibular rest position and interocclusal distance. For its electromyographic function, it's intended for use with muscles of mastication (temporalis, masseter, digastric) for clinical monitoring, determining muscle relaxation, and measuring contraction levels during functional tests. The added FFT feature does not expand these indications.

In summary, the provided FDA letter relies on the concept of substantial equivalence to existing, legally marketed predicate devices rather than detailing a specific, quantitative performance study with explicit acceptance criteria, ground truth, and sample sizes for the new FFT feature. The "study" in this context is the comparison made by the manufacturer (Myotronics-Noromed) and reviewed by the FDA to determine that the technical characteristics of the new feature are comparable to those in existing devices.

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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.

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