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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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• 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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This device is to be used for biofeedback applications.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the "Bagnoli-8 EMG System." It indicates that the device has been found substantially equivalent to a legally marketed predicate device. This document primarily focuses on regulatory clearance and does not contain detailed information about acceptance criteria or specific study results for device performance.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth cannot be extracted directly from this document.

However, based on the limited information, here's what can be stated:

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

• Not available in this document. The document is a regulatory clearance letter, not a performance study report. It states the device is "substantially equivalent" to a predicate device, implying its performance is considered acceptable for its stated indications for use, but specific performance criteria or reported performance values are not listed.

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

• Not available in this document. The document does not describe the specific studies or test sets used to demonstrate substantial equivalence.

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 available in this document.

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

• Not available in this document.

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 / Not available in this document. The Bagnoli-8 EMG System is for biofeedback applications, and the document does not suggest it is an AI-powered diagnostic tool that would involve human readers or MRMC studies for comparative effectiveness with AI assistance.

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

• Not available in this document. Since it's for biofeedback, it inherently involves human interaction, but the document does not detail specific performance studies, standalone or otherwise.

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

• Not available in this document.

8. The sample size for the training set

• Not available in this document.

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

• Not available in this document.

Summary of available information:

• Device Name: The Bagnoli-8 EMG System
• Indications for Use: This device is to be used for biofeedback applications.
• Regulatory Clearance: K990356, cleared on April 29, 1999, as substantially equivalent to a legally marketed predicate device.
• Regulatory Class: II
• Product Code: HCC and IRC

To obtain the detailed information requested, one would need to refer to the original 510(k) submission (K990356) and any supporting documentation that was provided to the FDA for review, which would describe the performance testing conducted. This document itself is merely the agency's clearance letter.

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This device is to be used for biofeedback applications.

Not Found

The provided document is an FDA 510(k) clearance letter for the Delsys Inc. Bagnoli-4 EMG System, stating that the device is substantially equivalent to legally marketed predicate devices for biofeedback applications. This document does not contain information on acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).

Therefore, I cannot provide the requested information based on the input document. The letter is a regulatory approval, not a scientific study report.

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The Advantage EMG System, Model #A100 is a Diagnostic Electromyography (EMG)/Evoked Response Electrical Stimulation System for the diagnosis of nervous and muscular system disorders in adult and pediatric patients.

The technological characteristics remain unchanged as a result of the modification to the device. Using surface electrodes, signals are recorded from the surface of the skin, or directly from the nerves or muscles by means of needle electrodes. It is also possible to provide a timed stimulus to the patient, so that the response to the stimulus can be recorded and analyzed. The signals from the subject are taken through the headbox to the control modules and the computer for display and analysis. The computer is based on the Intel XX086 architecture. The only modification made to the device is the removal of diodes contained in the pre-amplifier circuitry.

This 510(k) summary (K974010) is for a modification to an existing device, the Advantage EMG System, Model #A100. The submission focuses on demonstrating that a corrective modification (removal of diodes) did not adversely affect the device's safety or effectiveness, rather than establishing initial performance criteria or conducting studies for a new device. Therefore, much of the requested information about acceptance criteria for device performance, specific study designs (like MRMC or standalone performance), and ground truth establishment (as typically applied to diagnostic algorithm performance) is not directly present in this document.

Here's a breakdown of the available information based on your request:

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

This document does not outline specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for the diagnostic function of the EMG system, nor does it report such metrics. The "performance" described relates to the safety and effectiveness after a modification.

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

The document does not specify a distinct "test set" in the context of evaluating diagnostic performance. The testing described was to support the effectiveness of a corrective modification.

• Sample Size: Not specified for any particular test set. The document mentions "actual use testing" but no details on the number of subjects or tests.
• Data Provenance: Not explicitly stated. Given the submitter's address is in Canada, it's possible testing data originated there, but this is not confirmed. The testing was conducted to support the effectiveness of a corrective action.

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

This information is not applicable and not provided in the document. The study was not designed to establish "ground truth" for diagnostic performance in the way a new diagnostic algorithm would be evaluated. It was focused on the impact of a hardware modification.

4. Adjudication method for the test set

Not applicable and not provided.

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

No, an MRMC comparative effectiveness study was not done. This device is an EMG system, not an AI-powered diagnostic tool, and the submission concerns a hardware modification.

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

Not applicable. This is not an algorithmic device in the context of AI. The performance evaluation relates to the physical device's function after a modification.

7. The type of ground truth used

Not applicable in the conventional sense of diagnostic algorithm evaluation. The "truth" being established was that the corrective action worked and did not negatively impact the device's operation. This was verified through:

• Failure investigation: Likely involved analysis of the original failure mode.
• Electrostatic Discharge (ESD) testing: Verifying the device's resilience to static electricity.
• Actual use testing: Implies functional validation under practical conditions.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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

Not applicable.

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