The Guardian with Cascade Surgical Studio software is an electroneurodiagnostic device that acquires, displays, and stores physiologic data from peripheral sensory and motor nerves, muscles, and the central nervous system, generated either spontaneously or elicited by stimuli.

Guardian can perform somatosensory, auditory, and visual evoked potentials (EPs), electroencephalography (EEG), electrocorticography (ECoG), spontaneous and triggered electromyography (EMG), transcranial motor evoked potentials (TcMEP), direct cortical stimulation (DCS), direct nerve stimulation (TEMG, DNS), nerve conduction studies (NCS), and Train of Four (TOF) analysis.

Guardian can provide remote review outside of the operating room.

Guardian is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing.

The following functions are specifically supported individually or in combination:

Evoked Potentials (EPs): Guardian can provide electrical, auditory, and visual stimulation and measure, display, record, and store the electrical activity of the nervous system in response to the stimulations delivered.

Electroencephalography (EEG): Guardian can measure, display, record, and store electrical activity of the brain from two or more electrodes on the scalp.

Electrocorticography (ECoG): Guardian can measure, display, record, and store electrical activity directly from the brain using two or more electrodes.

Free Run Electromyography (EMG): Guardian can acquire, display, record, and store EMG activity of motor nerves.

Triggered Electromyography (TEMG): Guardian can electrically stimulate motor nerves, and display, record, and store the results.

Transcranial Motor Evoked Potentials (TcMEP): Guardian can deliver electrical transcranial stimulation, and display, record, and store the results.

Direct Cortical Stimulation (DCS): Guardian can deliver electrical stimulation to various areas of the cerebral cortex, and display, record, and store the results.

Direct Nerve Stimulation (DNS): Guardian can electrically stimulate cranial and peripheral nerves, and display, record, and store the results.

Nerve Conduction Study (NCS): Guardian can measure, display, record, and store sensory and motor nerve conduction time (latency) by applying a stimulus to peripheral nerves, the spinal cord, and the central nervous system.

Train of Four (TOF): Guardian can deliver a train of four pulses, and measure, display, record, and store the results.

Device Description

The Cadwell Guardian is a multi-modality intraoperative neurophysiological monitoring system with up to 80 channels of data acquisition.

The Guardian system is designed to be flexible and scalable depending on customer and procedural requirements. All systems require a Power Comm and Guardian Base, which contains an electrical Transcranial Stimulator. The user may select up to two Omni Amplifiers, two ES-10 electrical stimulators, one AVX auditory and visual stimulator, and one SMX-32 EEG amplifier that contains a low current electrical stimulator, in order to meet specific requirements.

The Guardian requires a (PC) with Windows operating system. The Guardian system uses a new version (4.0) of previously cleared Cadwell Cascade Surgical Studio software. Surgical Studio acquires, stores and reviews a wide range of intraoperative neurophysiological data, such as EMG, EEG, SSEP, BAEP, VEP, MEP and TOF, and includes Report Generation.

AI/ML Overview

The provided text describes the Cadwell Guardian device, its indications for use, and a comparison to predicate devices, but it does not contain information about specific acceptance criteria or a study proving the device meets those criteria with quantitative performance metrics (like sensitivity, specificity, or accuracy) derived from a test set of data.

The document states:

"Performance Testing: The Cadwell Guardian was tested in accordance with internal software requirements, system requirements, and usability requirements. Test results indicate that the Cadwell Guardian complies with its predetermined specifications."
"Conclusion: Verification and validation activities were conducted to establish the performance and safety characteristics of the Cadwell Guardian. The results of these activities demonstrate that the Cadwell Guardian is as safe, as effective, and performs as well as the predicate devices. Therefore, the Cadwell Guardian is considered substantially equivalent to the predicate devices."

This indicates that internal performance testing was conducted, and the device met its specifications, leading to a determination of substantial equivalence to predicate devices. However, the details of these "predetermined specifications" or "internal software requirements" in terms of specific performance metrics are not provided in the given text. There's no mention of a clinical study or a study involving a "test set" of data for algorithm performance, human reader performance, or ground truth establishment in the way typically expected for AI/CADe device submissions.

Therefore, I cannot populate the requested tables and sections with quantitative data from the provided text. The document focuses on regulatory approval through substantial equivalence based on technical characteristics and safety standards rather than a detailed performance study against specific acceptance criteria for an AI component.

Summary of missing information based on the request:

Table of acceptance criteria and reported device performance: Not provided. The document states "complies with its predetermined specifications" but does not detail these specifications or measured performance.
Sample size used for the test set and data provenance: No information on a specific "test set" for performance evaluation, nor its size, origin (country), or whether it was retrospective/prospective.
Number of experts used to establish ground truth & qualifications: Not applicable, as there's no mention of a ground truth establishment process for a test set.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The approval is based on substantial equivalence to existing devices, not a comparative effectiveness study involving human readers with/without AI assistance.
Standalone (algorithm only) performance: Not mentioned, as the device is an electroneurodiagnostic system, not a standalone AI algorithm for interpretation.
Type of ground truth used: Not applicable, as no external ground truth establishment is described for performance evaluation.
Sample size for the training set: Not applicable, as the document doesn't describe an AI/ML component with a training set. The software is noted as "a new version (4.0) of previously cleared Cadwell Cascade Surgical Studio software."
How ground truth for the training set was established: Not applicable.

Summary

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August 17, 2023

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Cadwell Industries, Inc. Jason Ford Regulatory Affairs Manager 909 North Kellogg Street Kennewick, Washington 99336

Re: K230415

Trade/Device Name: Cadwell Guardian Regulation Number: 21 CFR §882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: Class II Product Code: GWF, ETN, GWE, GWJ, GWQ, GZO, IKN, JXE, OLT, PDQ Dated: July 20, 2023 Received: July 21, 2023

Dear Jason Ford:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

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Patrick Antkowiak

for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name Cadwell Guardian

Indications for Use (Describe)