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• For evaluation of the status of muscles at rest and in function
• As an aid in muscle re-education and muscle relaxation therapy
• Provides ability to compare new captured data with past data to assess progress in treating patients relaxation state

The device incorporates circuitry enabling the same capabilities as the predecessor device. It is a computer based system offering options capable of evaluating muscle groups at rest or in function by means of surface electromyography. Muscle activity is quantified by means of re-usable or disposable surface electrodes positioned over the muscle groups being studied. Up to eight sites can be monitored simultaneously and displayed in time or frequency domains. The device is essentially identical to the predecessor device except that it utilizes wireless (Bluetooth) technology to transfer EMG data to host computer without a cable and to eliminate any connection between the patient and line voltage.

The provided text is a 510(k) summary for the Myotronics-Noromed Model MES 9200 EMG System. This submission focuses on demonstrating substantial equivalence to a predicate device (Model MES 9000 EMG System) rather than clinical performance against specific acceptance criteria. The key change is the introduction of wireless (Bluetooth) technology and battery operation to improve safety and data transfer.

Therefore, the document does not contain a detailed study proving the device meets specific performance acceptance criteria in the manner you've described for AI/CADe devices. There are no reported device performance metrics, sample sizes for test or training sets, expert consensus, or information on adjudication methods for clinical performance.

Here's a breakdown of what can be extracted based on your request, and what is missing:

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

• Acceptance Criteria: Not explicitly stated as performance metrics. The implicit acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device. This means demonstrating that the new device has the same intended use, fundamental scientific technology, and does not raise new questions of safety or effectiveness.
• Reported Device Performance: Not provided in terms of diagnostic accuracy, sensitivity, specificity, etc. The document highlights the functional equivalence and safety improvements over the predicate.

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

• Not Applicable / Missing: No information about a test set for clinical performance evaluation is mentioned. The submission focuses on engineering design changes and comparing them to the predicate device.

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)

• Not Applicable / Missing: No clinical "ground truth" establishment is described for a performance study.

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

• Not Applicable / Missing: No clinical performance study requiring adjudication is described.

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

• Not Applicable / Missing: This is not an AI/CADe device. No MRMC study was conducted or is relevant for this type of 510(k) submission.

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

• Not Applicable / Missing: This device is an EMG system, not an algorithm, so this concept does not apply.

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

• Not Applicable / Missing: No clinical ground truth is established or discussed as the focus is on device modification and safety.

8. The sample size for the training set

• Not Applicable / Missing: This device does not involve a "training set" in the context of machine learning or AI.

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

• Not Applicable / Missing: As above, no training set or associated ground truth establishment is relevant to this submission.

Summary of the Study (as described in the 510(k) Summary):

The "study" or justification for substantial equivalence presented in the 510(k) summary is a comparison of the new device (Model MES 9200) to its legally marketed predicate device (Model MES 9000).

• Objective: To demonstrate that the Model MES 9200 EMG System is substantially equivalent to the Model MES 9000.
• Methodology: The comparison highlights that the new device has the "same intended uses and fundamental scientific technology." The primary design change addressed is the incorporation of "wireless (Bluetooth) technology to transfer EMG data to host computer without a cable and to eliminate any connection between the patient and line voltage." This change is presented as an improvement in safety and convenience without altering the core functionality or intended use.
• Proof of Meeting (Implicit) Acceptance Criteria: The FDA's issuance of a substantial equivalence determination (K111687) serves as the "proof" that the device meets the regulatory acceptance criteria for market clearance under the 510(k) pathway. This determination is based on the provided comparison and assurances that the changes do not raise new questions of safety or effectiveness.

In essence, this 510(k) is about establishing regulatory clearance for a device modification, not a clinical performance study of a new diagnostic algorithm.

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As a disposable, adhesive, conductive interface between a patient's skin and muscle stimulating devices manufactured by Myotronics-Noromed, Inc. including the Models 54, JS, and BNS-40.

A disposable cutaneous TENS stimulating electrode consisting of a metal snap connector, adhesive foam and hydrogel (solid gel) conductive surface.

The provided text describes the Myo-trode SG disposable electrodes and its FDA 510(k) submission. It includes information about safety and effectiveness, but it does not contain a detailed study with specific acceptance criteria and reported device performance metrics in the format requested.

The document primarily focuses on establishing substantial equivalence to predicate devices and addressing potential hazards like skin irritation.

However, I can extract the information that is present and indicate where requested information is not available in the given text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective/prospective). The document mentions "an independent testing laboratory" for biocompatibility testing, but no further details.

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

• Not applicable/Not specified. The assessment primarily relied on laboratory testing (biocompatibility, impedance) rather than expert-established ground truth for a test set in the traditional sense of clinical or diagnostic studies.

4. Adjudication Method for the Test Set

• Not applicable/Not specified.

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

• No. This type of study (MRMC) is generally relevant for diagnostic devices where human readers interpret results, often with and without AI assistance. The Myo-trode SG is a disposable electrode for muscle stimulation, not a diagnostic device.

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

• Not applicable. This device is a physical electrode, not software or an algorithm with standalone performance.

7. The Type of Ground Truth Used

• Laboratory test results: Biocompatibility testing (irritation, cytotoxicity, allergic potential) was performed against established standards (ISO 10993).
• Impedance testing: Used to demonstrate effectiveness as a conductive interface.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This device is a physical product and does not involve a "training set" in the context of machine learning or AI models.

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

• Not applicable. (See point 8)

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Used to relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain, to relax muscles and establish a physiologic occlusion, to take occlusal registrations, to take denture impressions, to increase local blood circulation and to increase or maintain mandibular range of motion.

The device is an ultra-low frequency, battery operated muscle stimulator used to relax the muscles of the head and neck. It is capable of stimulating either two or four muscle groups at once.

This document is a 510(k) premarket notification for the Model J-5 Myo-monitor and does not contain the information required to answer the questions about acceptance criteria and a study proving device performance. The letter states that the device is substantially equivalent to a legally marketed predicate device (Model J-4 Myo-monitor) based on its intended uses and fundamental technology. The substantial equivalence is determined without requiring clinical studies or data that would typically include acceptance criteria or detailed study results.

Therefore, I cannot provide the requested information from the provided text.

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• For evaluation of the status of muscles at rest and in function
• As an aid in muscle re-education and muscle relaxation therapy
• Provides ability to compare new captured data with past data to assess progress in treating patients relaxation state

The device incorporates circuitry enabling the capabilities of the two predecessor devices to be offered as a single device. It is a computer based system offering options capable of evaluating muscle groups at rest or in function by means of surface electromyography. Muscle activity is quantified by means of re-usable or disposable surface electrodes positioned over the muscle groups being studied. Up to eight sites can be monitored simultaneously and displayed in time or frequency domains.

This document is a 510(k) summary and an FDA clearance letter for the Myotronics-Noromed, Inc. Model MES-9000/EMG System. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than providing a detailed study report with specific acceptance criteria and performance metrics typically found in clinical trial publications.

Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, sample sizes, expert qualifications, and ground truth establishment is not available in the provided text.

Here's what can be extracted and what is missing:

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

This information is not explicitly stated in the provided documents. Regulatory submissions for devices like this typically focus on demonstrating "substantial equivalence" to a predicate device, meaning it performs as safely and effectively as a device already on the market. This often involves showing that the new device has similar technical characteristics and achieves similar results in relevant tests, but explicit acceptance criteria with numerical performance targets are not detailed here.

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

This information is not available in the provided text. No specific "test set" or study data are described in terms of sample size or provenance.

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 available in the provided text.

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

This information is not available in the provided text.

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 available in the provided text. The MES-9000/EMG System is a biofeedback device for muscle evaluation, not an AI-assisted diagnostic imaging tool that would typically undergo MRMC studies.

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

This information is not available in the provided text. Given the nature of a biofeedback EMG system, it is inherently used with a human (patient and clinician), so a "standalone algorithm only" performance assessment is less applicable in the sense of a fully automated diagnostic system.

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

This information is not available in the provided text.

8. The sample size for the training set

This information is not available in the provided text. This device is from 2001, and the concept of "training sets" as understood in modern AI/machine learning was not generally a primary focus of regulatory submissions for medical devices of this type at that time. The submission emphasizes hardware and software enhancements and functional equivalence to previous models.

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

This information is not available in the provided text.

Summary of available information related to performance and equivalence:

• Device Name: Model MES-9000/EMG System
• Intended Use: Used in evaluation and recording of muscle status, at rest and in function, as an aid in muscle re-education and muscle relaxation therapy, and to provide ability to compare new captured data with past data to assess progress in treating patients relaxation state.
• Comparison to Predicate Devices: The device is "substantially equivalent" to its predecessors, Models ND-2000 (K922838A) and ND-8000 (K922270 & K992439). The design change is primarily to "update and enhance the electronic components and software to state-of-the-art and to provide the capabilities of the two predecessor devices as a single device."
• Fundamental Scientific Technology: The device uses the "same intended uses and fundamental scientific technology" as its predecessors: computer-based surface electromyography (SEMG).
• Performance (Implied by Substantial Equivalence): The device is presumed to perform comparably to the predicate devices in terms of accurately measuring and displaying muscle activity via SEMG, facilitating muscle re-education/relaxation therapy, and tracking patient progress. The specific "performance" relies on the established safety and effectiveness of the predicate devices.

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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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For evaluation of the status of muscles at rest and in function. As an aid in muscle re-education and muscle relaxation therapy. Provides ability to compare new captured data with past data to assess progress in treating patient's relaxation state.

The Norodyn: 8000 is a surface electromyographic device that measures and records the electrical potential emanating from muscle. 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 in the Special 510(k).

The provided text is a 510(k) summary for the Norodyn 8000 SEMG System and an FDA clearance letter. It outlines the device's purpose and its substantial equivalence to other legally marketed devices, specifically regarding the addition of Fast Fourier Transformation (FFT) to its software.

However, this document does not contain any information about acceptance criteria, device performance metrics, or a study (clinical or otherwise) that proves the device meets specific acceptance criteria. It is a regulatory submission for market clearance based on substantial equivalence, not a performance study report.

Therefore, I cannot provide the requested information from the given text.

To be clear:

• There is no table of acceptance criteria and reported device performance.
• There is no sample size used for a test set.
• There is no data provenance mentioned.
• There is no mention of experts establishing ground truth.
• There is no adjudication method described.
• There is no MRMC comparative effectiveness study mentioned.
• There is no standalone performance study described.
• There is no type of ground truth mentioned for any performance evaluation.
• There is no sample size for a training set.
• There is no information on how ground truth for a training set was established.

The document's purpose is to argue for substantial equivalence based on technological characteristics, not to provide detailed performance metrics against pre-defined acceptance criteria.

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