The Nurochek-II System is intended for prescription use in healthcare facilities for subjects aged between 16 and 46 years old, for the aid in diagnosis of mild traumatic brain injury (mTBI) in conjunction with a standard neurological assessment.

The Nurochek-II System is indicated for the generation of visual evoked potentials (VEPs) and to acquire, transmit, display, and store electroencephalograms (EEGs) during the generation of VEPs. Additionally, the system is indicated to analyze captured EEG signals to provide an aid in the diagnosis of mild traumatic brain injury (mTBI) in subjects aged between 16 and 46 years old who have sustained a potential head injury in the past 72 hours (3 days).

Device Description

The Nurochek-II System is a portable system designed to generate visual evoked potentials (VEPs) in patients and acquire, transmit, display, and store the resulting electroencephalogram (EEG). It is intended for prescription use in healthcare facilities for subjects aged between 16 and 46 years, to aid in the diagnosis of mild traumatic brain injury (mTBI). The primary components of the Nurochek-II System are the wearable headset, the Nurochek-II software application, and the Nurochek-II server.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Nurochek-II System:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state "acceptance criteria" for sensitivity and specificity in a separate section. However, it presents the performance of the Nurochek-II System and compares it to a predicate and reference device, implying these metrics are key for demonstrating substantial equivalence. Given the context, the performance metrics reported for the Nurochek-II System are the results of its performance against a clinical diagnosis.

Metric	Acceptance Criteria (Implied by reported performance for Nurochek-II System)	Reported Device Performance (Nurochek-II System)
Sensitivity (95% CI)	Achieved 86.05% (72.07-94.70)	86.05% (72.07-94.70)
Specificity (95% CI)	Achieved 67.16% (54.60-78.15)	67.16% (54.60-78.15)
Positive Predictive Value (PPV) (95% CI)	Achieved 62.7% (53.92-70.75)	62.7% (53.92-70.75)
Negative Predictive Value (NPV) (95% CI)	Achieved 88.2% (77.79-94.13)	88.2% (77.79-94.13)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 110 individual Steady-State Visual-Evoked Potential (SSVEP) readings.
Data Provenance: The document does not explicitly state the country of origin. However, the manufacturer, Headsafe MFG Pty Ltd., is based in Surry Hills, NSW, Australia, suggesting the study may have been conducted in Australia or related clinical sites.
Retrospective or Prospective: The study is described as a "clinical investigation" with a "clinical research protocol" and the collection of readings within 72 hours of suspected head injury, followed by a clinical evaluation. This indicates a prospective study design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not explicitly stated as a specific number. The document mentions "Each highly trained physician." This phrasing suggests multiple physicians were involved, but the exact count is not provided.
Qualifications of Experts: "Highly trained physician" using "their education and experience to deliver their mTBI determination." This included a neurological examination, a concussion-related signs and symptom evaluation, and a review of all relevant information provided by the study subject.

4. Adjudication Method for the Test Set

The document does not explicitly describe a formal adjudication method (e.g., 2+1, 3+1). It states that "Each highly trained physician used their education and experience to deliver their mTBI determination." This implies that the individual physician's diagnosis served as the ground truth without a stated consensus or adjudication process among multiple ground truth experts for each case.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focuses on the standalone performance of the Nurochek-II System against a clinical diagnosis. There is no information provided about human readers improving with AI vs. without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The reported sensitivity, specificity, PPV, and NPV are for the Nurochek-II System's classification algorithm in differentiating between subjects with and without mTBI, based solely on the analysis of captured EEG signals.

7. The Type of Ground Truth Used

The ground truth used was expert clinical diagnosis. This was established by "a licensed healthcare professional" (a "highly trained physician") based on a standard neurological assessment, a concussion-related signs and symptom evaluation, and a review of relevant patient information.

8. The Sample Size for the Training Set

The classification algorithm was "generated with 372 individual steady-state visual-evoked potential (SSVEP) readings." This indicates that the training set consisted of 372 individual SSVEP readings.

9. How the Ground Truth for the Training Set Was Established

The ground truth for the training set was established through the same method as the test set: a clinical evaluation by a licensed physician. The protocol required readings to be collected within 72 hours of suspected head injury, in addition to a clinical evaluation by a licensed physician. Their determination was based on a neurological examination, a concussion-related signs and symptom evaluation, and a review of all relevant information.

Summary

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December 27, 2023

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Headsafe MFG Pty Ltd. % Erin Gontang, Ph.D. Senior Consultant RQM+ 2251 San Diego Avenue, Suite B-257 San Diego, California 92110

Re: K231914

Trade/Device Name: Nurochek-II System Regulation Number: 21 CFR 882.1450 Regulation Name: Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid Regulatory Class: Class II Product Code: PIW, OMC Dated: November 24, 2023 Received: November 27, 2023

Dear Erin Gontang:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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Page

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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For comprehensive regulatory information about mediation-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).

Sincerely,

Xiaolin Zheng -S

Xiaolin Zheng, Ph.D. 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) K231914

Device Name Nurochek-II System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Registration Use (Part 31, GER, 301, Subpart D)	☐ On-Site Composting (31.25)
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Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for Headsafe. The logo consists of a green icon on the left and the word "HEADSAFE" in dark gray on the right. The icon is a stylized head with a gauge inside, suggesting a focus on safety and measurement related to the head.

510(k) Summary K231914

DATE PREPARED

December 26, 2023

MANUFACTURER AND 510(k) OWNER

Headsafe MFG Pty Ltd. 61 Marlborough Street, Suite 76 Surry Hills NSW 2010 Australia Telephone: +61 418 25 3333 Official Contact: Adrian Cohen, MD, CEO

REPRESENTATIVE/CONSULTANT

Erin A. Gontang, PhD RQM+ +1 (412) 899-7422 Telephone: Email: egontang@rqmplus.com

DEVICE INFORMATION

Proprietary Name/Trade Name:	Nurochek-II System
Common Name:	Brain injury adjunctive interpretive electroencephalographassessment aid
Regulation Number:	21 CFR 882.1450
Class:	II
Product Code:	PIW, OMC
Premarket Review:	Neurosurgical, Neurointerventional and NeurodiagnosticDevices (DHT5A)
Review Panel:	Neurology

PREDICATE DEVICE IDENTIFICATION

The Nurochek-II System is substantially equivalent to the following predicates:

510(k) Number	Predicate Device Name / Manufacturer	PrimaryPredicate
K190815	BrainScope TBI / BrainScope Company, Inc.	✓
DEN170091/K191183	EyeBOX / Oculogica Inc.	Reference
K200705	Nurochek System / Headsafe MFG Pty Ltd.	Reference

The predicate devices have not been subject to a design related recall.

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Image /page/5/Picture/0 description: The image shows the logo for Headsafe. On the left side of the logo is a green speedometer-like graphic that is also shaped like a head in profile. To the right of the graphic is the word "HEADSAFE" in bold, sans-serif font.

DEVICE DESCRIPTION

INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Headsafe believes that the Nurochek-II System is substantially equivalent to the predicate devices based on the information summarized here:

The subject device has a similar design to the device cleared in K190815. It is also identical in physical design and materials to the reference device, the Nurochek System cleared in K200705. Both the subject and predicate devices are worn on the head to record and analyze electroencephalograms (EEGs). They are both intended to aid in the diagnosis of mild traumatic brain injury (mTBI) through the analysis of these recorded EEGs. See below for a table comparing the device's technological characteristics.

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Image /page/6/Picture/0 description: The image shows the logo for HEADSAFE. The logo consists of a green speedometer-like graphic on the left, with the word "HEADSAFE" in bold, dark gray letters on the right. The speedometer graphic is designed to resemble a human head in profile.

	Subject Device	Predicate Device	Reference Device	Reference Device
	Headsafe	BrainScope Company,Inc.	Oculogica Inc.	Headsafe
	Nurochek-II SystemK231914	BrainScope TBIK190815	EyeBOXDEN170091/K191183	Nurochek SystemK200705
Image	Image: Nurochek-II System K231914	Image: BrainScope TBI K190815	Image: EyeBOX DEN170091/K191183	Image: Nurochek System K200705
Indicationsfor Use	The Nurochek-II Systemis intended forprescription use inhealthcare facilities forsubjects aged between 16and 46 years old, for theaid in diagnosis of mildtraumatic brain injury(mTBI) in conjunctionwith a standardneurological assessment.The Nurochek-II Systemis indicated for thegeneration of visualevoked potentials (VEPs)and to acquire, transmit,display, and storeelectroencephalograms(EEGs) during thegeneration of VEPs.Additionally, the systemis indicated to analyzecaptured EEG signals toprovide an aid in thediagnosis of mildtraumatic brain injury(mTBI) in subjects agedbetween 16 and 46 yearsold who have sustained apotential head injury inthe past 72 hours (3days).	BrainScope TBI is amulti-modal, multi-parameter assessmentindicated for use as anadjunct to standardclinical practice to aidin the evaluation ofpatients who havesustained a closedhead injury, and havea Glasgow ComaScale (GCS) score of13-15 (includingpatients withconcussion/mildtraumatic brain injury(mTBI)).	The EyeBOX is intendedto measure and analyzeeye movements as an aidin the diagnosis ofconcussion, also knownas mild traumatic braininjury (mTBI), withinone week of head injuryin patients 5 through 67years of age inconjunction with astandard neurologicalassessment ofconcussion.A negative EyeBOXclassification maycorrespond to eyemovement that isconsistent with a lack ofconcussion.A positive EyeBOXclassificationcorresponds to eyemovement that may bepresent in both patientswith or withoutconcussion.underlined textindicates IFU update inK191183.	The Nurochek System isintended for prescriptionuse in healthcarefacilities or clinicalresearch environmentsfor subjects ages 14years and older.The Nurochek System isindicated for thegeneration of visualevoked potentials (VEPs)and to acquire, transmit,display and storeelectroencephalograms(EEGs) during thegeneration of VEPs.The Nurochek Systemonly acquires anddisplays physiologicalsignals: no claims arebeing made for use as adiagnostic criterion or forthe analysis of theacquired signals withrespect to the accuracy,precision and reliability.
ProductCodes /RegulationNumber	PIW, OMC21 CFR 882.1450	PIW, PKQ, OLU21 CFR 882.1450	QEA21 CFR 882.1455	GWE, OMC21 CFR 882.1890
RegulationDescription	Brain injury adjunctiveinterpretiveelectroencephalographassessment aid	Brain injury adjunctiveinterpretiveelectroencephalographassessment aid	Brain injury adjunctiveinterpretive oculomotorassessment aid	Evoked response photicstimulator
Components	Software in a mobileapplication, reusableheadset (LED lights infront, EEG electrodes inback)	Software on handhelddevice, disposableelectrode headset	A PC with integratedtouchscreen interface,eye tracking camera,LCD stimulus screen,head-stabilizing rests forchin and forehead, anddata processing	Software in a mobileapplication, reusableheadset (LED lights infront, EEG electrodes inback)
	Subject Device	Predicate Device	Reference Device	Reference Device
	Headsafe	BrainScope Company, Inc.	Oculogica Inc.	Headsafe
	Nurochek-II SystemK231914	BrainScope TBIK190815	EyeBOXDEN170091/K191183	Nurochek SystemK200705
Power source	Rechargeable 3.7Vlithium-ion battery	Rechargeable	Mains power input	Rechargeable 3.7Vlithium-ion battery
Inputs	Patient identifyinginformation	Patient identifyinginformation	Patient identifyinginformation	Patient identifyinginformation
ElectrodePlacement	Occipital lobe	Frontal lobe	None	Occipital lobe
Outputs	• EEG• Quality of electrode contact with patient• Assessment of mTBI likelihood	• Concussion index• Structural injury classification• Brain function index	• Concussion score	• EEG• Quality of electrode contact with patient• Signal-to-noise ratio
DataAnalysis &Storage	Records and stores EEGsCompares results to normative EEG data.	Records and stores EEGsCompares results to normative EEG data.	Records gaze positions 500 times per second.Processed data are analyzed automatically to produce a EyeBOX score/clinical report.	Records and stores EEGsCompares results to normative EEG data.
Patientinterface	Worn on patient's head for 2 minutes.	Worn on patient's head for 10-30 minutes.	Patient's rests chin and forehead for ~4 minutes.	Worn on patient's head for 2 minutes.
Sterilization	Non-sterile	Non-sterile	Non-sterile	Non-sterile
Reuse	Headset is reusable(Foam cylinders for electrodes are single use only)	Electrodes are disposableHandheld device is reusable	Reusable	Headset is reusable(Foam cylinders for electrodes are single use only)
Sensitivity	0.860595% confidence intervals(0.7207, 0.9470)	0.859995% confidenceintervals (0.8050,0.9041)	0.804095% confidenceintervals (0.6610,0.9190)	N/A
Specificity	0.671695% confidence limits of(0.5460, 0.7815)	0.707895% confidence limitsof (0.6588, 0.7535)	0.661095% confidence limits of(0.5970, 0.7210)	N/A
PatientPopulation	Patients 16-46 years who have sustained a potential head injury in the past 72 hours (3 days)	Patients between the ages of 13-25 years who present with a GCS score of 15 following a head injury within the past 72 hours (3 days)	Patients between the ages of 5 to 67 years old who have sustained a head injury within the past week	Patients 14 years and older

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Image /page/7/Picture/0 description: The image shows the logo for Headsafe. The logo consists of a green icon that resembles a head with a gauge inside, followed by the word "HEADSAFE" in large, bold, dark gray letters. The gauge inside the head icon has a needle pointing towards the right, and the head itself is formed by a combination of curved and straight lines.

SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the Nurochek-II System. The following tests were performed to demonstrate safety based on current industry standards:

Biocompatibility:

The subject device was evaluated for cytotoxicity, sensitization, and irritation in compliance to ISO 10993-5:2009 and ISO 10993-10:2010.

Software Verification:

The software development and testing were executed with consideration to IEC 62304.

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Image /page/8/Picture/0 description: The image contains the logo for "HEADSAFE". To the left of the text is a green icon that resembles a gauge and a head in profile. The gauge is partially filled in with green, and the needle is pointing towards the middle. The text "HEADSAFE" is written in a bold, sans-serif font and is colored in dark gray.

Electromaqnetic Compatibility and Electrical Safety:

The subject device was tested in compliance to IEC 60601-1:2012, IEC 60601-1-2:2014, IEC 60601-2-40:2016.

SUMMARY OF CLINICAL TESTING

The primary objective of the clinical investigation was to evaluate the performance of the Nurochek-II System against clinical diagnosis by a licensed healthcare professional in the accurate detection of mild traumatic brain injury (mTBI). The study demonstrated that the device can differentiate between subjects with and without mTBI.

The Headsafe classification algorithm used in this device was generated with 372 individual steady-state visual-evoked potential (SSVEP) readings, in which there was an 11% prevalence of mTBI. The SSVEP readings from the study subjects (age range 14-55 years) were used to generate the database, to which the device compares new results. The clinical research protocol required readings to be collected within 72 hours of the suspected head injury, in addition to a clinical evaluation by a licensed physician. Each highly trained physician used their education and experience to deliver their mTBI determination. At the core of each assessment was a neurological examination, a concussion-related signs and symptom evaluation, and a review of all relevant information provided by the study subject in relation to their injury. A separate validation data set consisting of 110 individual SSVEP readings, in which there was a 39.1% prevalence of mTBI in the population (age range 16-46 years), resulted in a sensitivity of 86% (72.07-94.70, 95% confidence interval) and a specificity of 67% (54.60-78.15, 95% confidence interval). The resulting positive predictive value (PPV) and negative predictive value (NPV) were 62.7% and 88.2%, respectively. The table below tabulates the performance of the Nurochek-II System from this 110-individual study and compares it to the predicate and reference device based on publicly available information from their 510(k) and De Novo decision summaries.

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Image /page/9/Picture/0 description: The image shows the logo for HEADSAFE. The logo consists of a green icon on the left and the word "HEADSAFE" in dark gray on the right. The icon is a stylized head with a gauge inside, suggesting safety and measurement.

Device[FDA Reference #]	Nurochek-IISystem[K231914]Subject Device	BrainScope TBI[K190815]Predicate Device	EyeBOX[DEN170091/K191183]Reference Device
Sensitivity %[95% CI]	86.05 [72.07-94.70]	85.99 [80.50-90.41]	80.40 [66.10-91.90]
Specificity[95% CI]	67.16 [54.60-78.15]	70.78 [65.88-75.35]	66.10 [59.70-72.10]
#Patients clinicallydiagnosed asConcussed	43	207	46
#Patients clinicallydiagnosed asnot concussed	67	373	236
Prevalence of mTBIin Validation Study	39.1	35.69	16.31
Positive PredictiveValue (PPV) %[95% CI]	62.7 [53.92-70.75]	62.0	31.6 [26.89-36.73]
Negative PredictiveValue (NPV) %[95% CI]	88.2 [77.79-94.13]	90.1	94.5 [90.56-96.91]

CONCLUSION

Based on the testing performed, it can be concluded that the subject device does not raise different questions of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Nurochek-II System are assessed to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 882.1450 Brain injury adjunctive interpretive electroencephalograph assessment aid.

(a)
Identification. A brain injury adjunctive interpretive electroencephalograph assessment aid is a prescription device that uses a patient's electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient's brain in the setting of trauma. A brain injury adjunctive interpretive EEG assessment aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information:
(i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed.
(ii) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's condition, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed.
(2) The device parts that contact the patient must be demonstrated to be biocompatible.
(3) The device must be designed and tested for electrical safety, electromagnetic compatibility (EMC), thermal, and mechanical safety.
(4) Clinical performance testing must demonstrate the accuracy, precision-repeatability and reproducibility, of determining the EEG-based interpretation, including any specified equivocal zones (cutoffs).
(5) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for the medical condition for which the device is indicated. Performance measures must demonstrate device performance characteristics per the intended use in the intended use environment. Performance measurements must include sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with respect to the study prevalence per the device intended use.
(6) The device design must include safeguards to ensure appropriate clinical interpretation of the device output (
e.g., use in appropriate patient population, or for appropriate clinical decision).(7) The labeling and training information must include:
(i) A warning that the device is not to be used as a stand-alone diagnostic.
(ii) A detailed summary of the clinical performance testing, including any adverse events and complications.
(iii) The intended use population and the intended use environment.
(iv) Any instructions technicians should convey to patients regarding the collection of EEG data.
(v) Information allowing clinicians to gauge clinical risk associated with integrating the EEG interpretive assessment aid into their diagnostic pathway.
(vi) Information allowing clinicians to understand how to integrate the device output into their diagnostic pathway when the device is unable to provide a classification or final result.