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The disposable laryngeal electrodes are intended to be used as a disposable, self-adhesive electrodes attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures.

The Disposable Laryngeal Electrodes are single used electrodes constructed from an medical-grade ink with a conductive polymer film covered by an insulating coating, a connector made of polypropylene and a cable assembly. The electrodes are designed to monitor the recurrent nerve during thyroid, anterior cervical, carotid endartecrectomy surgery and vagus nerve monitoring during brain surgery. The monitoring is performed with a surface electrode that is attached to an endotracheal tube placed on the vocal cord. A neutral adhesive electrode is placed on the patient's shoulder. Both adhesive electrodes are connected to a reusable recording cable and to the nerve monitor.

The provided document is a 510(k) summary for a medical device called "Disposable Laryngeal Electrodes." It describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study conducted, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample sizes for the individual tests (adhesive property, electrode impedance, security, sterility, biocompatibility tests). It only states that testing was performed.

The data provenance is from non-clinical laboratory testing conducted by Suzhou Haishen United Medical Device Associates Co., Ltd. The document does not specify the country of origin of the data beyond the manufacturer's location (Suzhou, Jiangsu Province, China). The studies are by nature prospective as they are conducted specifically for the purpose of demonstrating device performance.

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 to this type of device and study. The testing performed is bench testing (e.g., electrical, mechanical, biological) against established engineering and biological standards, not clinical performance requiring expert interpretation of diagnostic outputs or ground truth establishment by clinical experts.

4. Adjudication method for the test set

Not applicable. As the studies are bench tests against objective criteria and standards, there is no need for expert adjudication methods like 2+1 or 3+1. The results are quantitative measurements or pass/fail determinations based on predefined criteria.

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 MRMC comparative effectiveness study was done. This device is a passive electrode for EMG monitoring during surgery, not an AI-powered diagnostic or assistive tool for human readers. Therefore, this section is not applicable.

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

Not applicable. This device is an electrode, which is a hardware component. There is no algorithm or AI component to be evaluated in a standalone manner.

7. The type of ground truth used

The "ground truth" for the non-clinical tests are established international standards and internal requirements for medical devices. Specifically:

• Performance (electrical/physical): Internal requirements, and likely general engineering principles for electrodes.
• Biocompatibility: ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-23, and FDA guidance on ISO 10993-1.
• Sterilization: ISO 11135:2014 and ISO 10993-7.
• Electrical safety: IEC 60601-1.

8. The sample size for the training set

Not applicable. This device is a hardware component and does not involve AI or machine learning models that require a training set.

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

Not applicable. As there is no training set, there is no ground truth to establish for it.

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The Invotec Laryngeal Electrodes are intended to be used as a sterile, single use, selfadhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of larynx during surgical procedure. This electrode is not to be adhesively attached to silicone endotracheal tubes.

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The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for the Invotec Laryngeal Electrode, stating its substantial equivalence to legally marketed predicate devices. It lists the indications for use but does not include any performance metrics, study designs, sample sizes, or ground truth establishment relevant to the questions asked.

Therefore, I cannot provide the requested information based on the input text.

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Non-invasively monitoring of the laryngeal nerves during thyroid surgery, and of the Xth cranial nerve during skull-base surgery.

Disposable Laryngeal Electrodes are non-invasive. The disposable device is constructed using a medical grade ink as electrode material suspended on a polyethylene substrate; a polyester connector with a separate available cable assembly or DIN 42802 connectors; The electrode is available in three sizes to suit different sexes and age groups. The 4/5mm electrode should be used with an 4 or 5mm endotracheal tube; the 6/7mm electrode should be used with a 6 or 7mm endotracheal tube; the 8/9mm electrode should be used with an 8 or 9mm endotracheal tube. The cable assembly is available separately and will have a long life if it is not abused and is stored appropriately. Using the laryngeal electrode lowers the risk of damage to the laryngeal or Xth cranial nerve (the Vagus nerve) during thyroidectomy or parathyroidectomy and, since it is noninvasive, it also lessens the risk of infection during the monitoring procedure.

The provided 510(k) summary for the Technomed Europe Laryngeal Electrode describes the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence, rather than providing acceptance criteria and a detailed study report. This submission does not contain a study that demonstrates device performance against specific acceptance criteria in the way typically found for AI/ML-enabled devices or performance studies with quantitative metrics.

Instead, the document focuses on establishing substantial equivalence based on design, materials, chemical composition, packaging, and other technological characteristics.

Here's an analysis of what information is present or absent based on your request:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy, F1-score) or clinical outcomes. The "acceptance" is implicitly defined by demonstrating equivalence to the predicate devices across various design and functional characteristics.
• Reported Device Performance: Not reported in quantitative terms. The document states that "Technomed Europe has been bench testing the Laryngeal Electrodes to confirm performance characteristics of this device" and that "The Technomed Europe Laryngeal electrodes are being bench tested in comparison to the predicated devices..." The characteristics to be tested include impedance and dimensions, among others. However, the results of these bench tests, or any performance metrics derived from them, are not provided in the summary. The "performance" is concluded to be "safe and effective" and "substantially equivalent" based on qualitative comparison.

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

• Not applicable. This submission does not describe a clinical performance study with a test set of patient data. The "testing" mentioned is bench testing of the electrode characteristics.

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. No ground truth establishment by experts is described as there is no human-interpreted test set data.

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

• Not applicable. No test set requiring expert 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

• No. This device is a laryngeal electrode, not an AI/ML-enabled device. Therefore, no MRMC study or AI assistance is relevant here.

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

• No. This is a hardware device, not an algorithm.

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

• Not applicable. There is no ground truth data in the context of clinical performance described. The "ground truth" for the bench testing would be established by validated measurement standards and equipment against the defined physical and electrical properties of the electrodes.

8. The sample size for the training set

• Not applicable. This is a hardware device, not an AI/ML system requiring a training set.

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

• Not applicable. This is a hardware device, not an AI/ML system requiring a training set.

Summary of the Document's Approach:

The provided 510(k) summary is for a traditional medical device (laryngeal electrode), not an AI/ML-enabled diagnostic or therapeutic device. The "study" referenced is a bench testing comparison to predicate devices, focusing on demonstrating that the new device has "equivalent" design, materials, and functional characteristics to devices already on the market. The FDA's letter confirms substantial equivalence based on this comparison and the declared intended use.

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The Inomed Adhesive Laryngeal Electrodes are intended to be used as a disposable, selfadhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures.

The Inomed Adhesive Laryngeal Electrodes are single used electrodes constructed from an medical grade ink with a conductive polymer film covered by an insulating coating, a connector made of polypropylene: and a cable assembly. The electrodes are designed to monitor the recurrent nerve during thyroid, anterior cervical, carotid endartecrectomy surgery and vagus nerve monitoring during brain surgery. The monitoring is performed with a surface electrode that is attached to an endotracheal tube placed on the vocal cord. A neutral adhesive electrode is placed on the patient's shoulder. Both adhesive electrodes are connected to a reusable recording cable and to the nerve monitor

The provided document describes a 510(k) premarket notification for the Inomed Adhesive Laryngeal Electrodes. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with detailed acceptance criteria and performance metrics in the way a clinical trial would for a novel device.

Here's an analysis of the information provided based on your request, highlighting what is present and what is absent:

Acceptance Criteria and Study Details for Inomed Adhesive Laryngeal Electrodes

No explicit "acceptance criteria" table with reported device performance is provided in the document. The submission is a 510(k) summary, which demonstrates substantial equivalence by comparing the new device's technical characteristics and intended use to a legally marketed predicate device. The "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as the predicate and introduces no new questions of safety or effectiveness.

The document states: "After analyzing performance and safety testing, it is the conclusion of Inomed that the inomed adhesive laryngeal electrodes are as safe and effective as the predicate devices and introduce no new questions concerning safety and effectiveness." This implies that the device successfully passed relevant tests, but the specific quantitative criteria and results are not detailed in this summary.

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, a formal table of quantitative acceptance criteria and reported numerical performance is not provided in this 510(k) summary for the Inomed Adhesive Laryngeal Electrodes. Instead, the comparison table focuses on qualitative and design characteristics between the new device and the predicate devices. The "performance" assessment is summarized as the device being "as safe and effective as the predicate devices."

The comparison table provided (page 2) lists characteristics to demonstrate equivalence, but not quantitative performance criteria:

The "agreement criteria" for this type of submission are that the new device performs equivalently to the predicate devices in terms of these characteristics.

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

The document mentions "performance and safety testing" and adherence to "appropriate electrical testing standard and biocompatibility standards," but does not specify a patient-based "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective clinical data). The tests performed are primarily non-clinical (electrical and biocompatibility) to support substantial equivalence, not a clinical effectiveness trial.

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/not provided as there is no described clinical study involving expert interpretation or "ground truth" establishment in the context of device performance in a diagnostic or interpretive sense. The testing focuses on product safety and functional equivalence to the predicate, likely through laboratory and engineering tests.

4. Adjudication method for the test set:

This is not applicable/not provided for the same reasons as point 3.

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 is not applicable/not provided. The device is a laryngeal electrode for EMG monitoring, not an AI-assisted diagnostic or interpretive tool that would involve human readers.

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

This is not applicable/not provided. The device is an electrode, not an algorithm. Its function is to facilitate EMG monitoring.

7. The type of ground truth used:

Given the nature of the device and the submission, the "ground truth" for the non-clinical tests would be established by engineering specifications, international standards (e.g., ISO 10993-1 for biocompatibility, IEC 60601-1 for electrical safety), and comparison to the predicate device's documented characteristics. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" in this summary.

8. The sample size for the training set:

This is not applicable/not provided. There is no "training set" in the context of this device, as it is a medical device (electrode) and not a machine learning model.

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

This is not applicable/not provided for the same reason as point 8.

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Non-invasively monitoring of the laryngeal nerves during thyroid surgery, and of the Xth cranial nerve during skull-base surgery.

The Neurosign® Laryngeal Electrode, which was specially developed for use with the Neurosign® 100, 400 and 800 models, consists of: a single-use electrode constructed from medical-grade inks suspended in a polyester substrate; a connector made of polypropylene; and a cable assembly. The electrode is available in two sizes to suit different sexes and age groups. The 6/7mm electrode should be used with a 6 or 7mm endotracheal tube; the 8/9mm electrode should be used with an 8 or 9mm tube. The cable assembly is available separately and will have a long life if it is not abused and is stored appropriately.

Using the laryngeal electrode lowers the risk of damage to the laryngeal or Xth cranial nerve (the Vagus nerve) during thyroidectomy or parathyroidectomy and, since it is noninvasive, it also lessens the risk of infection during the monitoring procedure.

The Neurosign® Laryngeal Electrode is a device intended for intraoperative monitoring of laryngeal nerves during thyroid surgery and the Xth cranial nerve (Vagus nerve) during skull-base surgery. The device consists of a single-use electrode attached to an endotracheal tube, which then connects to a Neurosign® machine for EMG readout.

The submission does not contain specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) of the device. Instead, the FDA's clearance is based on a determination of substantial equivalence to predicate devices. This means that the Neurosign® Laryngeal Electrode is considered as safe and effective as existing legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a submission based on substantial equivalence, there are no predefined numerical acceptance criteria or reported performance metrics in the traditional sense (e.g., sensitivity, specificity, accuracy) as would be found in a clinical study evaluating diagnostic performance. The "acceptance" is based on the device having similar characteristics, intended use, and safety/effectiveness profiles to the predicate devices.

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

This document does not describe a clinical study with a "test set" for performance evaluation in the typical sense of diagnostic or AI device studies. The clearance is based on substantial equivalence to existing devices. Therefore, there is no sample size for an independent test set or information on data provenance.

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

Not applicable, as no clinical study with a "test set" requiring expert-established ground truth is described in this submission.

4. Adjudication method for the test set:

Not applicable, as no clinical study with a "test set" and 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. This device is a laryngeal electrode for nerve monitoring, not an AI-powered diagnostic tool requiring human reader interpretation or MRMC studies.

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

Not applicable. This device is a physical electrode used in conjunction with a nerve monitor, not an algorithm.

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

Not applicable. The basis for clearance is substantial equivalence based on technical characteristics and intended use, not a clinical trial with a ground truth established by expert consensus or other clinical endpoints.

8. The sample size for the training set:

Not applicable. This device is a physical electrode, not a machine learning algorithm.

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

Not applicable. This device is a physical electrode, not a machine learning algorithm.

Summary of the "Study" (Basis for Acceptance):

The "study" or basis for acceptance in this 510(k) submission is a comparison to predicate devices to demonstrate substantial equivalence. The manufacturer, The Magstim Company Ltd., compared the Neurosign® Laryngeal Electrode to two predicate devices:

• Neurovision LSE500 Laryngeal Surface Electrodes (K003745)
• Medtronic NIM™ EMG Endotracheal Tube (K925640)

The comparison focused on technical characteristics, intended use, and safety features. The conclusion drawn by the manufacturer (and accepted by the FDA for clearance) is that the Neurosign® Laryngeal Electrode is "both safe and is similar in its risks and benefits, as well as its manner of performance, to the predicate devices." This substantial equivalence determination means the new device is considered as safe and effective as the predicate devices that are already legally marketed. No new clinical trials demonstrating specific performance metrics for the Neurosign® Laryngeal Electrode were necessary for this type of submission.

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