(211 days)
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Not Found
Yes
The device description explicitly states that it "utilizes a machine-learning algorithm."
No
This device is described as an aid in the diagnosis of Autism Spectrum Disorder (ASD), and its output is a classification (Positive for ASD, Negative for ASD, or No Result). It does not directly treat or alleviate symptoms, which is the function of a therapeutic device.
Yes
The device explicitly states its intended use is "as an aid in the diagnosis of Autism Spectrum Disorder (ASD)" and describes how its machine-learning algorithm produces an output of "Positive for ASD," "Negative for ASD," or "No Result." This output directly contributes to the diagnostic process by classifying patients.
Yes
The device description explicitly states it is "software as a medical device (SaMD)" and describes multiple software applications (Mobile App, Video Analyst Portal, HCP Portal) that run on various hardware platforms (iOS, Android, macOS, Windows). While it interacts with hardware for input (video upload via mobile app) and output (display on computer/mobile screens), the core medical device functionality is the machine-learning algorithm and associated software interfaces. The hardware platforms are general-purpose computing devices, not dedicated medical device hardware components included as part of the submission.
Based on the provided information, the Cognoa ASD Diagnosis Aid is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The definition of an IVD involves examining specimens such as blood, urine, tissue, etc., to provide information about a person's health.
- The Cognoa ASD Diagnosis Aid analyzes data about the patient. The input data comes from caregiver/parent questionnaires and videos, trained analyst observations of those videos, and healthcare provider input. This is information about the patient's behavior and development, not a biological sample taken from the patient.
Therefore, while it is a medical device used in the diagnostic process, it does not fit the definition of an In Vitro Diagnostic.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The "Control Plan Authorized (PCCP) and relevant text" section explicitly states "Not Found."
Intended Use / Indications for Use
The Cognoa ASD Diagnosis Aid is intended for use by healthcare providers as an aid in the diagnosis of Autism Spectrum Disorder (ASD) for patients ages 18 months through 72 months who are at risk for developmental delay based on concerns of a parent, caregiver, or healthcare provider.
The device is not intended for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process.
Product codes
QPF
Device Description
The Cognoa ASD Diagnosis Aid is a software as a medical device (SaMD) that utilizes a machine-learning algorithm that receives independent information from caregivers or parents, trained analysts, and healthcare professionals (HCPs) to aid in the diagnosis of ASD. It consists of multiple software applications and hardware platforms. Input data is acquired via a Mobile App, a Video Analyst Portal, and a HCP Portal.
- . Mobile App: User interface (UI) for the caregiver or parent to upload videos of the patient via Wi-Fi connection and answer questions about key developmental behaviors. Interfaces with Application Programming Interface (API) server for transmission and management of patient data. Compatible with both iOS (versions 12 and 13) and Android platforms (versions 9 and 10).
- Video Analyst Portal: UI for trained analysts to review uploaded patient videos . remotely and answer questions about the patients' behaviors observed in the videos.
- . HCP Portal: UI for the HCP to answer questions about key developmental behaviors for the patient's age group, view device output and access the interactive dashboard to view all patient results, patient videos, answers to questionnaires administered and device performance data. Compatible with computer operating systems macOS (Catalina or Mojave) and Windows 10, and browsers Safari (versions 12 or 13) and Chrome (versions 84 or 85).
Following analysis of the input data, the Cognoa ASD Diagnosis Aid machine-learning algorithm produces a single scalar value between (1) and (6) which is then compared to preset thresholds to determine the classification. If the value is greater than the upper threshold, then the device output is 'Positive for ASD.' If the value is less than the lower threshold, then the device output is 'Negative for ASD.' If the available information does not allow the algorithm to render a reliable result, the device output is 'No Result.'
Mentions image processing
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Mentions AI, DNN, or ML
The Cognoa ASD Diagnosis Aid is a software as a medical device (SaMD) that utilizes a machine-learning algorithm that receives independent information from caregivers or parents, trained analysts, and healthcare professionals (HCPs) to aid in the diagnosis of ASD.
Following analysis of the input data, the Cognoa ASD Diagnosis Aid machine-learning algorithm produces a single scalar value between (1) and (6) which is then compared to preset thresholds to determine the classification.
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 months through 72 months
Intended User / Care Setting
healthcare providers
Description of the training set, sample size, data source, and annotation protocol
Subjects whose medical records had been included in any internal Cognoa training or validation sets were excluded from the clinical study.
Description of the test set, sample size, data source, and annotation protocol
Subjects whose medical records had been included in any internal Cognoa training or validation sets were excluded from the clinical study.
Summary of Performance Studies
Study Design: The clinical validation study was a prospective, double-blinded, single-arm study conducted at 14 sites in the United States ["Cognoa ASD Diagnosis Aid Validation Study"] to evaluate the safety and effectiveness of the Cognoa ASD Diagnosis Aid to aid in the diagnosis of ASD, with the comparator being the clinical reference standard. Both parents or caregivers and HCPs were blinded to the results as provided by the device. Additionally, the parents or caregivers, trained video analysts, and HCPs providing inputs to the device algorithm were blinded to data inputs provided by each other.
Clinical Reference Standard: The clinical reference standard is the determination of clinical diagnosis based on the majority assessment of up to three specialists. This involved diagnosis by a site-specific specialist using the DSM-5 criteria, followed by validation via independent review by one or two central specialist clinicians. After the diagnosing clinician on-site completed the patient assessment, the patient case was reviewed by one central off-site reviewing specialist clinician who was provided with the standardized medical history and physical form, and a video of the diagnostic encounter. The diagnosing clinician was instructed to not state any diagnostic conclusion, decision on anv particular component of DSM-5 criteria, or diagnostic observation during the video of the assessment. If the assessment of the reviewing specialist clinician agreed with that of the diagnosing clinician, the diagnosis was considered validated and no further validation was conducted. If the reviewing specialist clinician disagreed with the diagnosing clinician, then the case was referred to a second reviewing specialist clinician. Majority rule was used to resolve discrepancies between the two central reviewers and the site diagnosing specialist who all evaluated the same subjects.
Enrollment/Sample Size: A total of 711 subjects were enrolled who signed the ICF, with 585 subjects having completed all inputs to the device assessment. Of these 585 subjects, 425 subjects were considered study completers (i.e., subjects who completed both the device assessment as well as the specialist assessment per the clinical reference standard). The 425 subjects who completed all study assessments per protocol was used as the analysis population for the assessment of the study endpoints.
Effectiveness: Of the 425 subjects who completed both the device assessment as well as the specialist assessment per the clinical reference standard, the device rendered either a positive or negative diagnostic output in 135 subjects (32%). This corresponds to a 'No Result' device output rate of 68% (64%, 73%).
Key Results: Measures of PPV, NPV, sensitivity, and specificity with associated 95% confidence intervals were calculated for the subset of patients for whom the device rendered a diagnostic output of 'Positive for ASD' or 'Negative for ASD', resulting in: PPV of 81% (70%, 89%), NPV of 98% (91%, 100%), sensitivity of 98% (92%, 100%), and specificity of 79% (68%, 88%).
Safety: No adverse events were reported during the study.
Key Metrics
PPV: 80.77% (63/78) (95% CI: 70.27%, 88.82%)
NPV: 98.25% (56/57) (95% CI: 90.61%, 99.96%)
Sensitivity: 98.44% (63/64) (95% CI: 91.6%, 99.96%)
Specificity: 78.87% (56/71) (95% CI: 67.56%, 87.67%)
No Response Rate: 68.24% (290/425) (95% CI: 63.58%, 72.64%)
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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DE NOVO CLASSIFICATION REQUEST FOR COGNOA ASD DIAGNOSIS AID
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Pediatric Autism Spectrum Disorder diagnosis aid. 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.
NEW REGULATION NUMBER: 21 CFR 882.1491
CLASSIFICATION: Class II
PRODUCT CODE: QPF
BACKGROUND
DEVICE NAME: Cognoa ASD Diagnosis Aid
SUBMISSION NUMBER: DEN200069
DATE DE NOVO RECEIVED: November 3, 2020
SPONSOR INFORMATION:
Cognoa, Inc. 2185 Park Blvd. Palo Alto, California 94306
INDICATIONS FOR USE
The Cognoa ASD Diagnosis Aid is intended for use by healthcare providers as an aid in the diagnosis of Autism Spectrum Disorder (ASD) for patients ages 18 months through 72 months who are at risk for developmental delay based on concerns of a parent, caregiver, or healthcare provider.
The device is not intended for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process.
LIMITATIONS
The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR 801.109.
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The device is not intended for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process.
The device is intended for use in conjunction with patient history, clinical observations, and other clinical evidence the healthcare provider determines are necessary before making clinical decisions. For instance, additional standardized testing may be sought to confirm the device output, especially when the device result is not Positive or Negative for ASD.
The device may give unreliable results if used in patients with other conditions that would have excluded them from the clinical study. Among those conditions are the following:
- . Suspected auditory or visual hallucinations or with prior diagnosis of childhood onset schizophrenia.
- Known deafness or blindness. ●
- . Known physical impairment affecting their ability to use their hands.
- Major dysmorphic features or prenatal exposure to teratogens such as fetal . alcohol syndrome.
- History or diagnosis of genetic conditions (such as Rett's syndrome or fragile X).
- . Microcephaly.
- History or prior diagnosis of epilepsy or seizures. ●
- History of or suspected neglect. .
- . History of brain defect injury or insult requiring interventions such as surgery or chronic medication.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The Cognoa ASD Diagnosis Aid is a software as a medical device (SaMD) that utilizes a machine-learning algorithm that receives independent information from caregivers or parents, trained analysts, and healthcare professionals (HCPs) to aid in the diagnosis of ASD. It consists of multiple software applications and hardware platforms. Input data is acquired via a Mobile App, a Video Analyst Portal, and a HCP Portal.
- . Mobile App: User interface (UI) for the caregiver or parent to upload videos of the patient via Wi-Fi connection and answer questions about key developmental behaviors. Interfaces with Application Programming Interface (API) server for transmission and management of patient data. Compatible with both iOS (versions 12 and 13) and Android platforms (versions 9 and 10).
- Video Analyst Portal: UI for trained analysts to review uploaded patient videos . remotely and answer questions about the patients' behaviors observed in the videos.
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- . HCP Portal: UI for the HCP to answer questions about key developmental behaviors for the patient's age group, view device output and access the interactive dashboard to view all patient results, patient videos, answers to questionnaires administered and device performance data. Compatible with computer operating systems macOS (Catalina or Mojave) and Windows 10, and browsers Safari (versions 12 or 13) and Chrome (versions 84 or 85).
Following analysis of the input data, the Cognoa ASD Diagnosis Aid machine-learning algorithm produces a single scalar value between (1) and (6) which is then compared to preset thresholds to determine the classification. If the value is greater than the upper threshold, then the device output is 'Positive for ASD.' If the value is less than the lower threshold, then the device output is 'Negative for ASD.' If the available information does not allow the algorithm to render a reliable result, the device output is 'No Result.'
SUMMARY OF NONCLINICAL/BENCH STUDIES
The Cognoa ASD Diagnosis Aid is a SaMD implemented on a general purpose computing platform. Non-clinical or bench testing was generally not needed to evaluate the hardware that the software is intended to be run on. Software documentation and a usability assessment were both provided to demonstrate the safety and effectiveness of the device.
SOFTWARE/CYBERSECURITY
Software verification and validation testing and documentation was provided according to a MODERATE level of concern and FDA's guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005), to demonstrate that the device software performs as intended. Adequate documentation describing the software, firmware, software specifications, architecture design, software development environment, traceability, revision level history, and unresolved anomalies conclude that the software will operate in the manner described in the specifications. Hazard analysis characterized software and cybersecurity risks, including device malfunction, measurement-related errors, protection of patient data when stored or in transit (including data encryption), and unauthorized access by malicious end users. The submission describes verification and validation testing to address the potential hazards with satisfactory results. The device algorithm was provided describing how the data are collected and analyzed by the underlying model that is applied to produce the final device outputs.
Regarding the cybersecurity, the documentation included all the recommended information from the FDA guidance document. "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." This includes a threat model, cybersecurity mitigation information, an upgrade and maintenance plan, and other information for safeguarding the device algorithms.
HUMAN FACTORS-USABILITY
An observational, simulated use study was performed in order to evaluate HCP completion of critical tasks associated with use of the HCP Portal component of the
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Cognoa ASD Diagnosis Aid. A total of "" primary care providers who completed residency training in Pediatrics, Medicine/Pediatrics, or Family Practice and who see pediatric patients were tested. Participants performed critical tasks across anticipated use scenarios, including (1) login per the instructions in the labeling to ensure access to the HCP Portal using user-specific account information and ability to locate the indications for use, precautions and warnings in the HCP Portal Instructions for Use; (2) ensure access to the patient dashboard for viewing patient data, labeling, and HCP Portal logout; (3) ensure completion of the patient questionnaire; and (4) to ensure the patient's results can be viewed and querying how the HCP interpreted the results provided for each available device output (Positive for ASD, Negative for ASD, No Result).
A test moderator facilitated the testing, provided information regarding the test procedures beforehand, and asked questions specific to each use scenario evaluated. Specific to scenarios testing the use and interpretation of the device outputs, participants were asked to access patient records, discuss their clinical interpretation of each device output, and discuss how they would proceed with clinical decision making, both in the event that the device output affirmed or differed from how the patient presented clinically. Following completion of testing, post-evaluation interviews were conducted using 10 open-ended, neutrally worded questions to evaluate clinical end user perspectives of any use difficulties experienced during the testing.
Study results indicated that participants were able to complete identified critical tasks associated with use of the device. All participants understood and were able to navigate the labeling and recite or affirm understanding of the content. All participants were able to access patient records, complete the questionnaire and submit responses. All participants were able to access and review results, with 100% of participants reporting being able to communicate an accurate understanding of each type of device output. In response to probative inquiry, all clinical end users were able to communicate adequate understanding of use of the device as an aid in diagnosis of ASD and that the device does not provide a stand-alone diagnosis.
SUMMARY OF CLINICAL INFORMATION
Study Design
The clinical validation study was a prospective, double-blinded, single-arm study conducted at 14 sites in the United States ["Cognoa ASD Diagnosis Aid Validation Study"] to evaluate the safety and effectiveness of the Cognoa ASD Diagnosis Aid to aid in the diagnosis of ASD, with the comparator being the clinical reference standard. Both parents or caregivers and HCPs were blinded to the results as provided by the device. Additionally, the parents or caregivers, trained video analysts, and HCPs providing inputs to the device algorithm were blinded to data inputs provided by each other.
Clinical Reference Standard
The clinical reference standard is the determination of clinical diagnosis based on the majority assessment of up to three specialists. This involved diagnosis by a site-specific specialist using the DSM-5 criteria, followed by validation via independent review by one or two central specialist clinicians. After the diagnosing clinician on-site completed the patient assessment, the
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patient case was reviewed by one central off-site reviewing specialist clinician who was provided with the standardized medical history and physical form, and a video of the diagnostic encounter. The diagnosing clinician was instructed to not state any diagnostic conclusion, decision on anv particular component of DSM-5 criteria, or diagnostic observation during the video of the assessment. If the assessment of the reviewing specialist clinician agreed with that of the diagnosing clinician, the diagnosis was considered validated and no further validation was conducted. If the reviewing specialist clinician disagreed with the diagnosing clinician, then the case was referred to a second reviewing specialist clinician. Majority rule was used to resolve discrepancies between the two central reviewers and the site diagnosing specialist who all evaluated the same subjects.
Inclusion Criteria
- Caregiver must be able to read, understand and sign the Informed Consent Form (ICF). ●
- Caregiver or HCP concern for developmental delay. .
- Female or Male, ≥ 18 to