The EarliPoint System is indicated for use in specialized developmental disabilities centers as a tool to aid clinicians in the diagnosis and assessment of ASD patients ages 16 months through 30 months.

Device Description

The device is a more compact version of the predicate device but otherwise has similar functions and features. The system uses an eye tracker to capture the patient's looking behavior while viewing a series of videos. The system then remotely analyzes the looking behavior data using software and outputs a diagnosis of the patient's ASD status and assesses the symptoms associated with ASD.

The system has two modules:

EarliPoint System consists of the following:

Eye-tracking module and a separate Operator Module that can control the Eye-tracking module remotely. The patient sits on a chair and the Eye-tracking module is adjusted by the operator such that the patient's eyes are within the specification of the eye tracking window
-Eye-tracking module captures the patient visual response to social information provided in the form of a series of age-appropriate videos
Operator's module is used to initiate and monitors the session remotely -
-WebPortal securely stores all patient information, analyzes the eye tracking data, and outputs the results. Users can retrieve the results directly from the web-portal.
-Artificial intelligence software analyzes the eye-tracking data and provides a diagnosis for ASD. In addition, it also outputs 3 indices (called EarliPoint Severity Indices) that proxy the ADOS-2 and Mullen validated ASD instruments
- o Social Disability Index correlates and proxies ADOS-2
- O Verbal Ability Index correlates and proxies the age equivalent Mullen Verbal Ability score
- O Non-verbal Ability Index correlates and proxies the age equivalent non-verbal Mullen Ability score

The eye-tracker used in the EarliPoint device has similar capability as the eye tracker used in the predicate device.

AI/ML Overview

The provided text describes a 510(k) submission for a modified EarliPoint System, which is an aid for diagnosing and assessing Autism Spectrum Disorder (ASD). The submission details performance testing and a pivotal clinical study.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria in this submission are derived from the clinical study's performance metrics against a reference standard (expert clinical diagnosis for ASD).

Performance Metric	Acceptance Criteria (from study results)	Reported Device Performance (EarliPoint mITD)	Reported Device Performance (EarliPoint CertainDx)
Sensitivity	Not explicitly stated as a pre-defined acceptance criteria, but observed performance	71% (95% CI: 64.6% - 76.9%)	78.0% (95% CI: 70.5% - 84.3%)
Specificity	Not explicitly stated as a pre-defined acceptance criteria, but observed performance	80.7% (95% CI: 75.3% - 85.4%)	85.4% (95% CI: 79.5% - 90.2%)
Safety	No serious adverse events related to device use	No reported serious adverse events	No reported serious adverse events
Correlation with ADOS-2	Positive correlation with EarliPoint Social Disability Index	Correlates and proxies ADOS-2	Correlates and proxies ADOS-2
Correlation with Mullen Verbal Ability	Positive correlation with EarliPoint Verbal Ability Index	Correlates and proxies age equivalent Mullen Verbal Ability score	Correlates and proxies age equivalent Mullen Verbal Ability score
Correlation with Mullen Non-verbal Ability	Positive correlation with EarliPoint Non-verbal Ability Index	Correlates and proxies age equivalent non-verbal Mullen Ability score	Correlates and proxies age equivalent non-verbal Mullen Ability score

Note: The document does not explicitly state pre-defined numerical acceptance criteria for sensitivity and specificity. The reported performance is the outcome of the study, and its acceptance implies these values were deemed sufficient by the FDA for substantial equivalence.

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

Sample Size: 475 evaluable patients for primary and secondary endpoint analysis. 25 patients had missing data for either the device or control diagnosis, bringing the total enrolled to 500.
Data Provenance:
- Country of Origin: United States
- Retrospective or Prospective: Prospective
- Multi-center: Six sites

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

Number of Experts: Not specified. The text mentions "expert clinicians" but does not quantify the number of individual experts or how many were involved per case.
Qualifications of Experts: Referred to as "expert clinicians" and their diagnosis is considered the "current best practice for diagnosis of ASD." No further specific qualifications like years of experience or board certifications are provided in the document.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. The text mentions "expert clinician diagnosis" as the reference standard but does not detail how consensus was reached if multiple experts were involved or if there was a single expert per case.

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

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in the traditional sense of comparing human readers with AI assistance versus human readers without AI assistance.
Effect Size: Therefore, no effect size for human reader improvement with AI assistance is reported. The study's design was a within-subject comparison where all patients were evaluated by both the EarliPoint system and expert clinicians, comparing the device's diagnostic output against the expert diagnosis.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Yes, the study evaluated the "EarliPoint System diagnosis" relative to the expert clinical diagnosis. The device's output (ASD diagnosis and severity indices) is generated by "Artificial intelligence software [that] analyzes the eye-tracking data and provides a diagnosis for ASD." This indicates a standalone performance evaluation of the algorithm. The "EarliPoint CertainDx" analysis further refined this by focusing on cases where clinicians were certain of the diagnosis, still representing the device's standalone output being compared to this subset of expert diagnoses.

7. The Type of Ground Truth Used

Type of Ground Truth: "Expert clinician diagnosis (current best practice for diagnosis of ASD)." This is a form of expert consensus or clinical standard of care. It is further supported by correlation with validated ASD instruments (ADOS-2 and Mullen).

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. The clinical study described (the pivotal study) is an evaluation study (test set) for the device's performance, not the dataset used to train the AI algorithm.

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

The document does not explicitly state how the ground truth for the training set was established. While it details the ground truth for the test set (expert clinician diagnosis), it does not provide information on the training data.

Summary

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EarliTec Diagnostics, Inc % Sew-Wah Tay, Ph.D. Regulatory Consultant Libra Medical Inc 8401 73rd Ave N. Suite 63 Brooklyn Park, Minnesota 55428

Re: K230337

Trade/Device Name: EarliPoint Regulation Number: 21 CFR 882.1491 Regulation Name: Pediatric Autism Spectrum Disorder Diagnosis Aid Regulatory Class: Class II Product Code: QPF Dated: May 31, 2023 Received: June 1, 2023

Dear Sew-Wah Tay:

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

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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 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 (OS) 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 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,

Patrick Antkowiak -S

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 EarliPoint System

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) SUMMARY

ADMINISTRATIVE INFORMATION 1

510(k) Submission Type:	Traditional 510(k)
Device Type (Common Name):	Pediatric Autism Spectrum Disorder Diagnostic Tool
Device Classification Name	Pediatric Autism Spectrum Disorder Diagnostic Aid
Device Trade Name	EarliPoint System
Predicate Device Name	EarliPoint System (K213882)
510(k) Submitter:	Thomas Ressemann, CEOEarliTec Diagnostics, Inc.755 Commerce Drive, Suite 700Decatur, GA 30030Tel:+1-320-267-7266Email: tressemann@earlitecdx.com
Primary Correspondent:	Sew-Wah TayRegulatory ConsultantLibra Medical, Inc.Tel: 612-801-6782Email: swtay@libramed.com
Classification Regulation:	21 CFR 882.1491
Class:	II
Panel:	Neurology Devices Panel
Product Code:	OPF

510(K) TYPE AND REASON FOR SUBMISSION 2

This 510(k) is submitted as a traditional 510(k) to obtain marketing clearance for the modified EarliPoint System, a modification to the form factor of the device to improve usability and portability.

3 INTENDED USE

The EarliPoint System is intended for use by healthcare providers to objectively diagnose and assess children for ASD using software algorithm to analyze a child's response to an external stimulus in the form of videos.

INDICATION FOR USE ব

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PREDICATE DEVICE റ

The predicate device is the EarliPoint System cleared under 510(k) K213882. Both devices have the same intended use as an aid to diagnose and assess the presence of autism spectrum disorders (ASD) using a proprietary algorithm based on the looking behavior of the patient.

DEVICE DESCRIPTION 6

The system has two modules:

EarliPoint System consists of the following:

Eye-tracking module and a separate Operator Module that can control the Eye-tracking module remotely. The patient sits on a chair and the Eye-tracking module is adjusted by the operator such that the patient's eyes are within the specification of the eye tracking window
-Eye-tracking module captures the patient visual response to social information provided in the form of a series of age-appropriate videos
Operator's module is used to initiate and monitors the session remotely -
-WebPortal securely stores all patient information, analyzes the eye tracking data, and outputs the results. Users can retrieve the results directly from the web-portal.
-Artificial intelligence software analyzes the eye-tracking data and provides a diagnosis for ASD. In addition, it also outputs 3 indices (called EarliPoint Severity Indices) that proxy the ADOS-2 and Mullen validated ASD instruments
- o Social Disability Index correlates and proxies ADOS-2
- O Verbal Ability Index correlates and proxies the age equivalent Mullen Verbal Ability score
- O Non-verbal Ability Index correlates and proxies the age equivalent non-verbal Mullen Ability score

The eye-tracker used in the EarliPoint device has similar capability as the eye tracker used in the predicate device.

Description	EarliPoint Eye Tracking Specifications
Wavelength	Near-Infrared Spectrum
Intensity	Conforms to safety limit for continue use per IEC/EN62471(Photobiological safety of lamps/lamp system)
Light source	IR LED
Duration ofUse/Exposure	~15 minutes

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Description	EarliPoint Eye Tracking Specifications
Accuracy/Precisionfor intended use(gaze position)	0.5°
RecordingMeasurement	2D Eye Movements
Video Hardware	Video Camera
Mounting Hardware	Remote eye-tracking system(Display Screen)
Processor Hardware	Personal computer
Sampling Rate	120 Hz

PERFORMANCE TESTING 6.1

The basis of the substantial equivalence between the device and its predicate is the bench performance tests. Both devices meet the electrical safety standards and both software were designed and tested per IEC 62304.

To ensure that the device is substantially equivalent, the new eye tracker is verified to meet the predicate eye tracker requirement specifications for the device. In addition, the performance of the eye trackers used in the predicate device and the current device were compared directly using adult participants for identifications of blinks, saccades, non-missing samples, and fixation accuracy. The eye-tracker tests demonstrated that both the new eye tracker and the predicate eye tracker meet the requirements for the eye tracker. Hence the two eye trackers are functionally equivalent and interchangeable.

The second performance test is to ensure that the analysis algorithm is equivalent and will output the same results as the original analysis algorithm. To demonstrate the equivalency of the software, the collected session data from the pivotal clinical study were processed through the current software. Each ASD diagnoses and Indices of Social Disability, Verbal Ability, and Nonverbal Ability provided by predicate and the current device were compared and found to be the same, demonstrating the equivalency of the current device's data analysis software to the predicate data analysis software.

6.2 MECHANICAL/ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY (EMC)

Mechanical/electrical safety and EMC testing were conducted on the EarliPoint device consisting of the patient console and the operator console for patient behavioral tracking. The EarliPoint device is classified as Class I for protection against electric shock with Type B

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applied part and is intended for continuous mode of operation. Compliance testing shows that the EarliPoint device complies with all the applicable tests of IEC 60601-1 standard for mechanical/electrical safety and the IEC 60601-1-2 standard for EMC.

SOFTWARE VERIFICATION AND VALIDATION TESTING 6.3

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "minor" level of concern as a failure or latent flaw in the software is unlikely to result in injury.

CLINICAL STUDIES 6.4

The safety and effectiveness of the EarliPoint System in collecting eve tracking data and analyzing the data for the diagnosing the presence of ASD was evaluated in a pivotal study where patients were diagnosed by the device as well and expert clinicians (reference standard).

The pivotal study was a prospective, double-blind, multi-center, within-subject comparison where 500 patients from six sites in the United States were enrolled, of which 475 were evaluable for primary and secondary endpoint analysis and 25 patients had missing data of the device or the control diagnosis (standard of care).

All patients were evaluated for ASD by both the EarliPoint system and by expert clinician diagnosis (current best practice for diagnosis of ASD) to evaluate the sensitivity and specificity of the EarliPoint System diagnosis relative to the expert clinical diagnosis. The study also correlated the three EarliPoint Severity Indices of social disability, verbal ability and nonverbal ability against the corresponding expert clinical instruments of ADOS-2 and Mullen.

The pivotal study showed that the EarliPoint device was safe and effective in the diagnosis of ASD in children. There was no reported serious adverse event related to the use of the EarliPoint system.

Population	SensitivityMean (n/N)95% CI	SpecificityMean (n/N)95% CI
EarliPoint (mITD)N=475	71% (157/221)64.6% - 76.9%	80.7% (205/254)75.3% - 85.4%
EarliPoint CertainDx(Clinicians are Certain ofDiagnosis only)N=335	78.0% (117/150)70.5%, 84.3%	85.4% (158/185)79.5% - 90.2%

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7 SUBSTANTIAL EQUIVALENT COMPARISON

DeviceCharacteristic	EarliPoint SystemK213882	Updated EarliPoint SystemCandidate Device
Intended Use	The EarliPoint System is intended for useby healthcare providers to objectivelydiagnose and assess children for ASDusing software algorithm to analyze achild's response to an external stimulus inthe form of videos.	The EarliPoint System is intended for useby healthcare providers to objectivelydiagnose and assess children for ASDusing software algorithm to analyze achild's response to an external stimulus inthe form of videos.
Indications forUse	The EarliPoint System is indicated foruse in specialized developmentaldisabilities centers as a tool to aidclinicians in the diagnosis and assessmentof ASD patients ages 16 months through30 months.	The EarliPoint System is indicated foruse in specialized developmentaldisabilities centers as a tool to aidclinicians in the diagnosis and assessmentof ASD patients ages 16 months through30 months.
Prescription Use	Yes	Yes
Product Code andRegulationNumber	QPF882.1491	QPF882.1491
DeviceComponents	Patient console with eye-trackingtechnology for data collection andsoftware analysis for diagnosis of ASD.Both patient and Operator screens arecontrolled by the same computer.	Similar components as EarliPoint Systemwith a smaller device form factor. Patientand Operator screens are separatecomputer devices connected indirectlythrough the web-portal
ASD Diagnosis	Use software algorithm to analyze the eyetracking data for ASD diagnosis adassessment	No change. Same software algorithm
Electrical SafetyTesting	Meets electrical safety standards per:• IEC 60601-1:2005/AMD1:2012/AMD2:2020• IEC 60601-1-2:2014/AMD1:2020	Meets electrical safety standards per:• IEC 60601-1:2005/AMD1:2012/AMD2:2020• IEC 60601-1-2:2014/AMD1:2020
Software	Compliant to ISO 62304	Compliant to ISO 62304
Clinical data	Pivotal data shows safety andeffectiveness. Data is analyzed using theData Analysis module.	Data Analysis software is verified so thatthe output is the same as the predicatedevice.
Risk level of thedevice	Low risk device, non-invasive	Low risk device, non-invasive

CONCLUSION 7.1

Both devices have the same intended use and the same indication for use. The technological differences between the two devices are minor and verified via bench testing to be equivalent. The conclusions drawn from the nonclinical demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device. Hence, the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 882.1491 Pediatric Autism Spectrum Disorder diagnosis aid.

(a)
Identification. A pediatric Autism Spectrum Disorder diagnosis aid is a prescription device that is intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including an evaluation of sensitivity, specificity, positive predictive value, and negative predictive value using a reference method of diagnosis and assessment of patient behavioral symptomology.
(2) Software verification, validation, and hazard analysis must be provided. Software documentation must include a detailed, technical description of the algorithm(s) used to generate device output(s), and a cybersecurity assessment of the impact of threats and vulnerabilities on device functionality and user(s).
(3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.
(4) Labeling must include:
(i) Instructions for use, including a detailed description of the device, compatibility information, and information to facilitate clinical interpretation of all device outputs; and
(ii) A summary of any clinical testing conducted to demonstrate how the device functions as an interpretation of patient behavioral symptomology associated with Autism Spectrum Disorder. The summary must include the following:
(A) A description of each device output and clinical interpretation;
(B) Any performance measures, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV);
(C) A description of how the cutoff values used for categorical classification of diagnoses were determined; and
(D) Any expected or observed adverse events and complications.
(iii) A statement that the device is not intended for use as a stand-alone diagnostic.