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510(k) Data Aggregation
(179 days)
ISIS Headbox 5042xx products:
The products are intended for intraoperative neuromonitoring; for recording of electrophysiological signals and stimulating of nerve and muscle tissues.
The products are intended for use in the operating room to measure and display the electrical signals generated by muscle, peripheral nerves and the central nervous system. The products support the clinical application of Electroencephalography (EEG), Electromyography (EMG), Somatosensory Evoked Potentials (SEP), Motor Evoked Potentials (MEP), and Auditory Evoked Potentials (AEP).
The products are not intended for monitoring life-sustaining functions.
ISIS Neurostimulator 504180:
The ISIS Neurostimulator is intended for provision of neurophysiological stimulation when used in surgical procedures and for diagnostics. It is suitable for continuous operation and can be used in the following fields:
- Transcranial electrical stimulation (TES)
- Direct cortical stimulation (DCS)
- Direct nerve stimulation (DNS)
- Transcutaneous electrical nerve stimulation (TNS)
- Direct muscle stimulation (DMS)
The ISIS Headboxes and the ISIS Neurostimulator constitute multimodality intraoperative neuromonitoring systems called ISIS IOM Systems. These systems consist of custom stimulation and recording hardware, a standard laptop or desktop personal computer running an off-the-shelf operating system, and operating software called NeuroExplorer. As an option, these systems mount on device carriers or housings tailored for intraoperative use.
The ISIS IOM Systems support the following measurement modalities:
- Auditory Evoked Potentials
- Transcranial and cortical Motor Evoked Potentials
- Somatosensory Evoked Potentials
- Freerunning and triggered Electromyography
- Electroencephalography
- Train of Four
The provided text describes a 510(k) summary for the Inomed Medizintechnik GmbH's "ISIS Headboxes and ISIS Neurostimulator" (ISIS IOM Systems: ISIS Xpert®, ISIS Xpert®Plus, ISIS Xpress). This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device (Cadwell Industries Inc./Cascade Intraoperative Monitor K162199).
Crucially, this document does not contain acceptance criteria or a study proving device performance in the way a clinical study for a new diagnostic or AI-driven imaging device would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through engineering performance testing (bench testing, electrical safety, EMC, software validation) and a comparison of technical specifications and intended uses.
Therefore, I cannot populate all sections of your requested table and provide information on aspects like sample size for test sets, ground truth establishment, expert adjudication, or MRMC studies, as these types of studies were explicitly not performed for this 510(k) submission. The document states: "No additional clinical testing was performed for the ISIS Headboxes and ISIS Neurostimulator... Therefore, this section does not apply."
Here's the information that can be extracted relevant to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission relying on engineering performance and comparison to a predicate, the "acceptance criteria" are primarily adherence to relevant electrical safety and electromagnetic compatibility (EMC) standards, and meeting predetermined specifications during bench testing and software validation. The "reported device performance" is the successful compliance with these standards and specifications.
| Acceptance Criteria Type | Specific Criteria / Standard | Reported Device Performance | Notes |
|---|---|---|---|
| Software Validation | - Compliance with predetermined specifications. - Adherence to FDA guidance: "The content of premarket submissions for software contained in medical devices, May 11, 2005" - Adherence to FDA guidance: "Off-the-shelf software use in medical devices, Sep 27, 2019" - Adherence to FDA guidance: "General principles of software validation: Final guidance for industry and FDA staff, Jan 02, 2002" - Adherence to FDA guidance: "Content of premarket submissions for management of cybersecurity in medical devices. Oct 02, 2014" - Adherence to IEC 62304:2006, Medical device software - Software life cycle processes | "Test results demonstrate that the inomed NeuroExplorer Software complies with its predetermined specifications, the applicable guidance documents, and standards." | The software ("NeuroExplorer") is categorized as a "MODERATE level of concern software." |
| Electrical Safety | - Compliance with IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint). - Compliance with IEC 80601-2-26:2019 (electroencephalographs). - Compliance with IEC 60601-2-40:2016 (electromyographs and evoked response equipment). | "Test results demonstrate that the products comply with the applicable standards." | The document compares specific technical aspects like A/D resolution, hardware bandpass, sampling frequency, notch filter, CMRR, and amplifier noise to the predicate device, indicating equivalent or compliant performance with relevant standards. |
| Electromagnetic Compatibility (EMC) | - Compliance with IEC 60601-1-2:2014. | "Test results demonstrate that the products comply with the applicable standards." | |
| Bench/Performance Testing | - Fulfillment of requirements formulated at multiple levels: electrical medical systems, system carrier, amplifier (Headboxes) and stimulator (Neurostimulator) modules, operating software (NeuroExplorer) incl. firmware, and accessories. - Assessment of human factors influence on safety. | "The products successfully underwent the bench testing to confirm the fulfillment of the requirements at these levels as part of the verification and validation process." "The testing of the influence of human factors on the devices demonstrates that the products are safe to use and that no further improvement of the user interface design relating to safety is necessary." | This testing is internal to the manufacturer's verification and validation process. The specific quantitative "requirements" are not detailed in this public summary but are typically part of internal design specifications. |
| Biocompatibility | N/A | N/A | The devices do not have patient contact materials, therefore testing was not applicable. |
2. Sample Size Used for the Test Set and the Data Provenance
This information is not applicable and not provided in the document. As stated, "No additional clinical testing was performed for the ISIS Headboxes and ISIS Neurostimulator... Therefore, this section does not apply." The testing described are engineering verification and validation tests, not clinical studies with patients or data sets in the typical sense for AI/diagnostic devices.
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. The performance testing was based on engineering standards and internal requirements, not expert-established ground truth from clinical data.
4. Adjudication Method for the Test Set
This information is not applicable. There was no clinical test set requiring adjudication in the context of this 510(k) submission.
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 an intraoperative neuromonitoring system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting AI output.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is an intraoperative neuromonitoring system, not primarily an algorithm performing a standalone diagnostic task. Its function is to measure and display electrophysiological signals and provide stimulation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth or reference for device performance was established through engineering standards, technical specifications, and internal functional requirements. For example, electrical outputs meet specified ranges, and input signals are recorded with specified fidelity according to IEC standards. This is not clinical ground truth (e.g., pathology report, expert diagnosis).
8. The Sample Size for the Training Set
This information is not applicable. The document does not describe the use of an AI algorithm that requires a training set in the context of a machine learning model for diagnosis or interpretation. The software validation refers to standard software development practices, not AI model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there was no mention of a training set for an AI algorithm.
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