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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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