(266 days)
The ALM Tube is intended for use as a means of providing both an open airway for patient ventilation and for intraoperative neuromonitoring by recording the EMG activity of the laryngeal musculature when connected to an appropriate neuromonitoring device.
This device must be used in connection with the C2 Xplore® or any approved IEC 60601-1, compatible EMG monitoring system with 42802 DIN compatible connectors.
The ALM Tube is an endotracheal intubation tube which combines the function of airway ventilation and intraoperative neuromonitoring purposes regarding recording of electrophysiological signals. It combines the recording of EMG signals from the vocal cords to monitor the recurrent laryngeal nerve or the vagal nerve function during surgical procedures. The product is used intraoperatively and is connected to an appropriate neuromonitoring device for signal recording outside of the sterile field via a connection cable. The connection cable is not part of the delivered package.
This FDA 510(k) clearance letter details a medical device, the ALM Tube, but it does not describe an AI/ML powered device or a study comparing its performance against acceptance criteria in the manner requested.
The questions in your prompt are geared towards evaluating AI/ML device performance and related studies (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment). The ALM Tube is an endotracheal intubation tube with integrated electrodes for neuromonitoring, which is a hardware device.
Therefore, many of the requested details cannot be extracted from this document because they are not applicable to the type of device described.
Here's an attempt to answer the questions based on the provided text, highlighting where information is absent or irrelevant:
1. A table of acceptance criteria and the reported device performance
The document describes the device's adherence to various international standards and internal requirements rather than specific, quantifiable acceptance criteria with corresponding performance metrics like sensitivity/specificity for an AI model.
| Acceptance Criteria Category (implied from standards/testing) | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993 series) | Complies with applicable standards. |
| Sterilization (ISO 11135) | Complies with applicable standards. |
| Packaging & Shelf-life (ISO 11607 series) | Complies with applicable standards. |
| Performance Testing – Bench (ISO 5356-1, ISO 5361) | Complies with applicable standards, except for clause 6.7.1 of IEC 5361:2023. (No further detail on this exception). |
| Electrical Insulation | Electrical insulation on all surfaces until the head of the electrode. |
| Electrode Impedance | Average value of impedance measured within neuromonitoring comparative testing: 0.27 kΩ. (Comparable to predicate's 0.30 kΩ). |
| Software Functionality | Not applicable (device does not contain software). |
| Electrical Safety | Not electrically powered. Must be used with IEC 60601-1 and IEC 60601-1-2 compliant neuromonitoring system. |
| Electromagnetic Compatibility | Not electrically powered. Must be used with IEC 60601-1 and IEC 60601-1-2 compliant neuromonitoring system. |
| Human Factors / Usability | User interface evaluation conducted as a knowledge test with representative US citizens. |
The study that proves the device meets the acceptance criteria is a compilation of various engineering, bench, biocompatibility, sterilization, and packaging tests, as well as a human factors evaluation. This is stated in the "Summary of Performance Testing" section and the "Conclusion," which claims: "Verification and validation activities and human factors engineering testing were undertaken in order to establish the performance and safety characteristics of the ALM Tube. The results of these activities demonstrate that the ALM Tube is as safe, effective and perform as well as the predicate device, despite the differences in technology between the subject and predicate device."
Missing/Not Applicable Information based on the provided document:
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- N/A. The document states: "No additional clinical testing was performed for the ALM tube. Therefore, this section does not apply." The performance evaluation relies on bench testing, biocompatibility, sterilization, and packaging validation. For the human factors testing, the 'sample size' is described as "representative US citizens" for a knowledge test, but no specific number is provided.
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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)
- N/A. No "ground truth" establishment by medical experts is described, as this is not an AI/ML diagnostic or prognostic device requiring expert consensus on clinical cases.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- N/A. No expert adjudication of clinical cases is described.
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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
- N/A. The device is a physical endotracheal tube with neuromonitoring capabilities, not an AI assistance tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an algorithm-only device. It requires connection to an "appropriate neuromonitoring device" and is used in a clinical setting by medical professionals.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A. For this type of physical medical device, "ground truth" typically refers to established engineering specifications, material properties, and standardized test methodologies. The document indicates adherence to relevant ISO and IEC standards for these aspects.
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The sample size for the training set
- N/A. This device does not use a training set as it is not an AI/ML product.
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How the ground truth for the training set was established
- N/A. This device does not use a training set.
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.