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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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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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QuadraTENS is indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.

The QuadraTENS Model QT-42 is a 2 channel version of the BioTENS with the addition of a burst mode. Like the BioTENS, it is also intended to be used by or on the order of a licensed practitioner. The burst mode has been added specifically because a single stimulus is sometimes insufficient. By adding a second channel, the QuadraTENS Model QT-42 can be applied simultaneously to another separately enervated area on the same patient. The low frequency stimulation (1.0 Hz rate) of the QuadraTENS Model QT-42, the same as its predecessor BioTENS, is applied to a patient through surface electrodes. The Unit is powered by a single 9 volt battery. It produces a symmetrical bipolar pulse with a factory-set pulse-width of 600 microseconds and a rate of 1 pulse/second. The transformer-coupled outputs, which are equivalent to the both the BioTENS and the EMPI Model 989, apply 0.0 milliamps of net dc current to the patient. In the burst mode, a fixed train of 8 pulses with a repetition rate of 800 Hz is output once/second. The nominal pulse amplitude is controlled separately for each channel and ranges from 0.0 ma to a maximum of 40 milliamps peak. The 2 channels are isolated from each other and their output pulses are staggered in time to prevent any current from flowing between channels, which results in zero crosstalk. Each channel also includes a balance control that adjusts the amplitudes of the positive and negative half waves differentially. The balance is used to equalize the responses at each electrode site.

The provided text describes a 510(k) submission for the QuadraTENS Model QT-42, a transcutaneous electrical nerve stimulator (TENS) device. The information focuses on its design, comparison to predicate devices, and non-clinical performance assessment.

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

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes non-clinical performance testing and design validation. It does not mention a "test set" in the context of patient data or clinical trials. The tests performed are engineering-level validation tests. Therefore, information on sample size and data provenance for a clinical test set is not applicable based on the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes non-clinical engineering validation tests, not a study involving experts to establish clinical ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the same reasons as above.

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

This information is not applicable. The device is a Transcutaneous Electrical Nerve Stimulator (TENS), which is a physical device, not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a physical medical device, not an algorithm. The "standalone" performance would refer to the device's electrical characteristics, which are implicitly covered by the design qualification tests.

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

For the non-clinical performance assessment, the "ground truth" implicitly refers to the engineering specifications and design requirements for the device's electrical output, safety features, and functional characteristics. The validation tests (e.g., for waveform, DC current, channel isolation) were performed against these predefined specifications.

8. The sample size for the training set

This information is not applicable. The QuadraTENS Model QT-42 is a hardware device, not a machine learning model that requires a training set.

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

This information is not applicable for the same reason as above.

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The 3 Channel Knee Electronic Amplified Stethoscope is intended for use by a physician as a noninvasive tool to amplify and record distinct sounds (vibrations) within the three compartments (medial, lateral, and patellar) of the knee joint.

The device is intended for use by a physician as a noninvasive tool to amplify and record distinct sounds (vibrations) within the three compartments (medial, lateral, and patellar) of the knee joint.

The 3 Channel Knee Stethoscope System consists of three transducers, or sensors, to pick up the vibrations (sound) from three locations on the knee. The transducers are plugged into an amplifier box that is connected to a standard personal computer installed with Windows 3.1, or later version. A goniometer attachment is also plugged into the amplifier box. The system generates a metronome arrow that moves on the computer monitor screen (3 seconds per flex/extend cycle). The patient watches the arrow to pace the speed and direction of knee flexion and extension, while staying "in sync" with the metronome to maintain a 3 second cycle. Motion and sound vibrations are amplified, recorded in graph form, and stored in a patient database.

Here's an analysis of the provided text regarding the acceptance criteria and study for the 3 Channel Knee Electronic Amplified Stethoscope:

Acceptance Criteria and Study Analysis

Based on the provided documentation, the "acceptance criteria" for the 3 Channel Knee Electronic Amplified Stethoscope are primarily rooted in demonstrating substantial equivalence to existing legally marketed predicate devices. The device is not making claims of diagnostic capability, but rather as an adjunct tool for amplification and recording. Therefore, the "studies" presented are historical and foundational research on the broader concept of "vibration arthrography" rather than a direct, specific study proving the performance of this specific device against defined acceptance criteria.

The submission is a 510(k) for a Class II medical device, which typically relies on demonstrating equivalence rather than extensive clinical efficacy trials.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

The 510(k) submission does not mention a specific test set or sample size used for the performance evaluation of this particular device. The "studies" cited are published papers on the general concept of "vibration arthrography" or electro-acoustical techniques for detecting knee joint noise, dating from 1976 to 1990. These papers are foundational for the field, but not direct performance studies of the Biomet 3 Channel Knee Electronic Amplified Stethoscope itself. Therefore, details like data provenance specific to this device's testing are not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided as there is no specific test set described for this device's performance evaluation. The cited published papers (e.g., Chu et al., Kernohan et al., McCoy et al., Mollan et al., Wallace et al.) in the "Published Papers" section would have involved experts in their respective studies, but these are not studies of this specific device's performance or a means to establish "ground truth" for its acceptance.

4. Adjudication Method for the Test Set

This information is not provided as there is no specific test set described for this device's performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done for this device as described in the provided text. The device is not claiming interpretative or diagnostic capabilities, and the focus of the 510(k) is on substantial equivalence for amplification and recording. There is no mention of human readers improving with or without AI assistance, as the device itself is a purely signal amplification and recording tool, not an AI-driven diagnostic system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The concept of a "standalone" algorithm performance study is not applicable to this device in the way it's usually understood for AI/diagnostic algorithms. The device's primary function is to amplify and record, then display the data for a physician to interpret. It's a "human-in-the-loop" device by its very nature, where the human physician provides the interpretation. There is no algorithm that provides a standalone diagnostic output.

7. The Type of Ground Truth Used

Given the nature of the device (amplification and recording, not diagnosis), the concept of "ground truth" for its performance evaluation is not directly applicable in the sense of pathology, expert consensus on a diagnosis, or outcomes data. The "ground truth" for the device's acceptance is its ability to accurately amplify and record sounds and its substantial equivalence to predicate devices that perform similar functions. The historical research cited (e.g., "The Diagnosis Potential of Vibration Arthography," "Vibration Arthrography as a Diagnostic Aid") suggests that the field uses clinical findings, imaging, or surgical outcomes to correlate with vibration patterns, but this is for interpreting the data from such devices, not for validating the device's basic function of amplification and recording.

8. The Sample Size for the Training Set

This device does not contain a machine learning or AI algorithm in the contemporary sense that would require a "training set." Therefore, this information is not applicable and not provided.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI algorithm, this information is not applicable and not provided.

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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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