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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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