Daylight is a prescription device delivering Cognitive Behavioral Therapy and can be made available on the order of a licensed healthcare provider. Daylight is a digital therapeutic intended to treat generalized anxiety disorder (GAD) by improving a patient's GAD symptoms as an adjunct to usual care in patients aged 22 years and older.

Device Description

Daylight is a digital therapeutic designed to address the symptoms of adults with generalized anxiety disorder (GAD) through the use of Cognitive Behavioral Therapy (CBT) techniques. The Daylight program is has been demonstrated to help improve symptoms of GAD, if followed correctly, and is supported by evidence from peer-reviewed studies and clinical trials. The program is delivered digitally through the Daylight iOS/Android apps, giving users easy access to effective techniques.

AI/ML Overview

The document provided focuses on asserting the substantial equivalence of the Daylight device to a predicate device (Somryst) for regulatory clearance, primarily based on the similarity of their intended use, technological characteristics, and a clinical study demonstrating the efficacy of Daylight for its specific indication (Generalized Anxiety Disorder).

This type of submission document (510(k) Summary) does not typically contain detailed information about specific acceptance criteria for device performance in the same way one might describe the performance of a diagnostic AI algorithm against a set of quantitative metrics. Instead, "acceptance criteria" here refer to the overall regulatory requirements for establishing substantial equivalence and demonstrating safety and effectiveness for a digital therapeutic. The primary "proof" of the device meeting these criteria is via the clinical trial results.

Below is an interpretation of "acceptance criteria" in the context of this 510(k) and the information provided to substantiate that the device meets these criteria.

Acceptance Criteria and Device Performance for Daylight

Based on the 510(k) summary, the "acceptance criteria" are implicitly tied to demonstrating safety and effectiveness for the device's intended use and establishing substantial equivalence to a predicate device. For a digital therapeutic, effectiveness is primarily demonstrated through clinical outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (a digital therapeutic delivering CBT for GAD), the acceptance criteria are not in the form of typical quantitative performance metrics like sensitivity/specificity for a diagnostic device. Instead, they relate to:

Clinical Efficacy: Improvement in GAD symptoms.
Safety: Acceptable adverse event profile.
Substantial Equivalence: Alignment with predicate device in terms of intended use, technology, and risk profile.

Acceptance Criterion (Implicit)	Reported Device Performance (from GATE Trial)
Primary Efficacy Endpoints:
1. Remission based on CGI-I scores of 1 or 2 (co-primary)	Week 10: Daylight: 71% remission (n=103)Psychoeducation Control: 35% remission (n=54)Odds Ratio (OR): 4.63; p<0.001 (95% CI: 2.85, 7.54)Week 24: Daylight: 78% remission (n=115)Psychoeducation Control: 52% remission (n=78)Odds Ratio (OR): 3.22; p<0.001 (95% CI: 1.95, 5.32)
2. Patient-reported GAD symptom severity (GAD-7) (co-primary)	Mean GAD-7 Scores and Adjusted Differences (Daylight vs. Psychoeducation Control):Baseline: Daylight: 15.58 (SD=3.50), Control: 16.14 (SD=3.07)Week 6: Daylight: 8.82 (SD=4.50), Control: 12.45 (SD=4.35) --> Adjusted Difference: 3.42 (2.50, 4.34), Cohen's d: 1.04, p<0.001Week 10: Daylight: 7.88 (SD=4.76), Control: 11.68 (SD=4.42) --> Adjusted Difference: 3.58 (2.66, 4.50), Cohen's d: 1.09, p<0.001Week 24: Daylight: 7.23 (SD=4.88), Control: 10.68 (SD=4.73) --> Adjusted Difference: 3.15 (2.21, 4.09), Cohen's d: 0.96, p<0.001 (Daylight group observed to have significantly lower anxiety scores than the control group at all post-baseline time points).
Safety and Adverse Event Profile	One adverse event rated "probably" related to Daylight use (worsening panic attack severity). A few other events "possibly" related (panic attacks, depression symptoms, thoughts of death or suicide, etc.). Two serious adverse events (SAEs) reported in the Daylight arm were not related to device use or study participation. No unanticipated adverse device effects. Conclusion: Acceptable safety profile for intended use.
Software Verification and Validation	Completed and documented as recommended by FDA guidance for a Moderate level of concern device.
Substantial Equivalence	Daylight has identical intended use, nearly identical technological characteristics (SaMD, mobile platform, software architecture, prescription-only, adjunct use), and comparable software safety classification (Class B) to the predicate device, Somryst. The clinical data supports its safety and effectiveness for its specific indication (GAD) and does not raise different types of safety or effectiveness questions compared to the predicate. Conclusion: Substantially equivalent to Somryst.

2. Sample Size and Data Provenance

Test Set (Clinical Trial Data):
- Sample Size: 351 adults, randomized 1:1, with 175 assigned to Daylight and 176 to online anxiety psychoeducation.
- Data Provenance: Participants were recruited from across the United States via social media. The study was a two-arm, parallel group, randomized controlled trial (RCT), indicating prospective data collection.

3. Number of Experts and their Qualifications (for Ground Truth)

Not applicable in this context. The device is a digital therapeutic for generalized anxiety disorder, and the "ground truth" for its effectiveness is based on patient-reported outcomes (GAD-7, PHQ-8, SCI-8, OASIS), and clinician-reported outcomes (CGI-I, CGI-S) from a Randomized Controlled Trial, rather than expert interpretation of images or other data typically requiring consensus for ground truth. The "experts" involved would be the clinicians conducting the CGI assessments and diagnosing GAD, but the document does not specify their number or qualifications.

4. Adjudication Method for the Test Set

Not applicable in this context. As the effectiveness is measured through standardized questionnaires and clinical scales in an RCT, there is no need for expert adjudication of cases/data points in the same way as, for example, reviewing medical images.

5. MRMC Comparative Effectiveness Study

No, this was not an MRMC study. This was a randomized controlled trial (RCT) comparing a digital therapeutic (Daylight) to an active control (online anxiety psychoeducation).
Effect Size of Human Readers Improvement: This concept is not relevant to this type of device or study. The study investigates the effect of the digital therapeutic on patient symptoms, not how AI assists human readers in a diagnostic task. The "human readers" in this context are the patients interacting with the digital therapeutic.

6. Standalone Performance Study

Yes, in the sense that the clinical trial evaluated the performance of the Daylight algorithm/program as a standalone therapeutic intervention. The study compared Daylight (the intervention) to a psychoeducation control. The device is a "Software as a Medical Device (SaMD)" intended to treat GAD. Its performance is its ability to improve GAD symptoms.
The study design evaluated the device's direct therapeutic effect on participants, not its ability to assist a human in performing a diagnostic or interpretive task.

7. Type of Ground Truth Used

Clinical Outcomes / Patient-Reported Outcomes (PROs) and Clinician-Reported Outcomes (CROs):
- Primary:
  - Generalized Anxiety Disorder 7-item questionnaire (GAD-7) for patient-reported symptom severity.
  - Clinical Global Impression - Improvement scale (CGI-I) for remission (scores of 1 or 2).
- Secondary:
  - Patient Health Questionnaire (PHQ-8) for depression symptoms.
  - Sleep Condition Indicator (SCI-8) for insomnia symptoms.
  - Clinical Global Impression - Severity (CGI-S) for anxiety severity.
  - Overall Anxiety Severity and Impairment Scale (OASIS).
- Diagnosis of GAD at baseline according to DSM-5 criteria.

8. Sample Size for the Training Set

Not explicitly stated in the 510(k) summary. For digital therapeutics based on established CBT principles, a traditional "training set" for a machine learning model might not be applicable in the same way it is for image-based AI diagnostics. The device's "training" might refer to the development and refinement of the CBT content and delivery structure, which is typically based on clinical psychology principles and past research, rather than a data-driven machine learning training set of patient data to optimize an algorithm. The clinical trial serves as the primary validation.

9. How Ground Truth for the Training Set Was Established

Not applicable / Not detailed in the document. As mentioned above, the "training set" concept is different for this type of device. The "ground truth" for developing the therapeutic content of Daylight would be the established principles of Cognitive Behavioral Therapy for anxiety, supported by decades of psychological and clinical research. The document highlights that Daylight "is supported by evidence from peer-reviewed studies and clinical trials," implying that its efficacy framework is built upon existing scientific understanding of CBT. The GATE trial served as the definitive evaluation of the product's effectiveness as developed.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 30, 2024

Big Health, Inc. Reuben Lawson Vice President, Regulatory Affairs & Quality Systems 461 Bush St. Suite 200 San Francisco, California 94108

Re: K233872

Trade/Device Name: Daylight Regulation Number: 21 CFR 882.5801 Regulation Name: Computerized Behavioral Therapy Device For Psychiatric Disorders Regulatory Class: Class II Product Code: SCP Dated: August 1, 2024 Received: August 1, 2024

Dear Reuben Lawson:

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" (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).

{1}------------------------------------------------

Your device is also subject to, among other requirements, the Quality System (OS) 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 QS 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.

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,

Pamela D. Scott -S

Pamela D. Scott Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K233872

Device Name Daylight

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary - K233872

1. Submitter

Submitted by:	Big Health Inc.
Contact Name:	Reuben Lawson,Vice President, Quality Systems & Regulatory Affairs
Contact Phone:	(949) 439 3629
Additional Contact:	Dr. Tali M. Ball, Senior Manager, Clinical Research
Device
Device name:	Daylight
Classification name:	Computerized Behavioral Therapy forPsychiatry Disorders (21 CFR 882.5801)
Regulatory class:	Class II (Special Controls)
Product code:	SCP
Predicate device
Device name:	Somryst
Manufacturer:	Pear Therapeutics
Classification name:	Computerized Behavioral Therapy forPsychiatry Disorders (21 CFR 882.5801)
Regulatory class:	Class II (Special Controls)
510(k) Number:	K191716

4. Device Description

Product code:

QVO

5. Intended use / Indications for use

{4}------------------------------------------------

6. Substantial equivalence

Daylight has an identical intended use and nearly identical technological characteristics compared to the predicate device, Somryst. Like Somryst, Daylight delivers cognitive behavioral therapy for treatment of psychiatric disorders by way of an app provided as an adjunct to usual care by the patient's healthcare provider. The specific indication differs, in that Daylight is indicated for use in treatment of generalized anxiety disorder (GAD), not insomnia disorder. Patients can only access the product on the order of a licensed healthcare provider, who will themselves have access to patient progress through an online portal where salient patient information is provided. The software and clinical validation data demonstrate that Daylight doesn't raise different types of questions of safety or effectiveness. Thus, considering available performance testing, Daylight is considered substantially equivalent to Somryst.

Category	Daylight (this submission)	Somryst (predicate)
510(k) number	K233872	K191716
Classification regulation	21 CFR 882.5801Computerized behavioraltherapy device for psychiatricdisorders	21 CFR 882.5801Computerized behavioraltherapy device for psychiatricdisorders
Intended use	SaMD intended to becomputerized behavioraltherapy device to treat patientswith generalized anxietydisorder (GAD)	SaMD intended to becomputerized behavioraltherapy device to treat patientswith chronic insomnia
Indications for use	Daylight is a digital therapeuticintended for the treatment ofgeneralized anxiety disorderas an adjunct to usual care inpatients aged 22 years andolder. Daylight is a prescriptiondevice delivering CognitiveBehavioral Therapy and canbe made available on theorder of a licensed healthcareprovider.	Somryst is a prescription-onlydigital therapeutic intended toprovide a neurobehavioralintervention (CognitiveBehavioral Therapy forInsomnia - CBT-I) in patients22 years of age and older withchronic insomnia. Somrysttreats chronic insomnia byimproving a patient's insomniasymptoms
Intended User population	Patients, licensed healthcareproviders (physicians,practitioners, psychologists,and registered nurses)	Patients, licensed healthcareproviders (physicians,practitioners, psychologists,and registered nurses)
Medical Device Type	Software as a Medical Device(SaMD)	Software as a Medical Device(SaMD)
Access	Prescription only	Prescription only
Adjunct use	Adjunct to supervisedoutpatient treatment	Adjunct to supervisedoutpatient treatment

Table 1: Substantial Equivalence Assessment

{5}------------------------------------------------

Mobile platform	Mobile application(Smartphones, tablets [iOSand Android])	Mobile application(Smartphones, tablets [iOSand Android])
Software architecture	Patient facing mobileapplication, clinician facingdashboard, backend services	Patient facing mobileapplication, clinician facingdashboard, backend services
Software safetyclassification	Class B	Class B

7. Performance data

7.1. Summary of nonclinical performance data

Software verification and validation testing was completed and documentation was provided as recommended by Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005), for a Moderate level of concern device.

7.2. Summary of clinical performance data

Daylight was evaluated in the Generalized Anxiety Therapy Effectiveness (GATE) trial which was a two-arm, parallel group, randomized controlled trial (RCT) comparing digital CBT (Daylight) with online anxiety psychoeducation in 351 adults aged 22+ with generalized anxiety disorder (GAD). Participants were recruited from across the United States via social media. Participants with a diagnosis of GAD according to DSM-5 were allocated to receive Daylight (n=175) or online anxiety psychoeducation (n=176), using a blind-tohypothesis approach.

Although psychoeducation and Daylight have some differences in format and interactivity, the psychoeducation control used in the GATE trial matched Daylight on key characteristics including human contact, self-pacing, and retention. Although Daylight included more content separated into modules and required more time to complete, both groups were able to access all of the content immediately and neither treatment was time-locked. In prior research1 on the Daylight device and the same psychoeducation treatment, psychoeducation has also been shown to match Daylight on patient perceptions of credibility and expectation of benefit (Table 2).

	Psychoeducation	Daylight
Credibility	22.0 (SD = 3.8)	19.5 (SD = 4.0)
Expectancy(average expectedsymptom reduction)	32%	39%

Table 2. Patient credibility and expectancy of Psychoeducation and Daylight

Carl et al (2020). Efficacy of digital cognitive behave symptoms of generalized anxiety disorder: A randomized ontrolled trial. Depression and Anxiety, 37(12), 1168–1178. https://doi.org/10.1002/da.23079; and additional unpublished internal data

{6}------------------------------------------------

Note: SD = standard deviation.

The co-primary outcome measures were remission based on the Clinical Global Impression - Improvement scale (CGI-I) scores of 1 or 2 and patientreported generalized anxiety symptom severity, assessed using the generalized anxiety disorder 7-item questionnaire (GAD-7). The primary endpoint was 10 weeks post-randomization and a follow-up assessment occurred at 24 weeks post-randomization. Secondary outcomes included depression symptoms assessed by the Patient Health Questionnaire (PHQ-8), insomnia symptoms assessed by the Sleep Condition Indicator (SCI-8), and anxiety severity assessed by the Clinical Global Impression - Severity (CGI-S) scale and the patient-reported Overall Anxiety Severity and Impairment Scale (OASIS).

Across the total sample, 24% of participants (23% Daylight and 25% Control) were taking concomitant prescription anxiety medications at baseline, and 18% of participants (19% Daylight, 18% Control) were taking non-prescription substances to target anxiety. In addition, 4% of participants reported having seen a treatment provider for anxiety in the 3 weeks prior to their baseline assessment (4% Daylight, 4.5% Control), and 41% of participants reported previous therapy experience (38% Daylight, 43% Control).

A summary of the results of the GATE trial for Daylight vs psychoeducation is provided in Tables 3 and 4 and Figure 1 below.

	Unadjusted mean (SD)		Adjusted difference	Cohen's d	p-value
	Daylight	PsychoeducationControl	(95% CI)
Baseline	15.58 (3.50)n = 175	16.14 (3.07)n = 176	N/A	N/A	N/A
Week 6	8.82 (4.50)n = 159	12.45 (4.35)n = 170	3.42 (2.50, 4.34)	1.04	p<0.001
Week 10	7.88 (4.76)n = 157	11.68 (4.42)n = 168	3.58 (2.66, 4.50)	1.09	p<0.001
Week 24	7.23 (4.88)n = 156	10.68 (4.73)n = 166	3.15 (2.21, 4.09)	0.96	p<0.001

Table 3: GAD-7 scores from the GATE trial, including summary statistics by group and time, and estimated treatment effects (i.e., adjusted differences)

Note: CI=Confidence Interval; SD=Standard Deviation

{7}------------------------------------------------

Image /page/7/Figure/0 description: The image shows a line graph comparing the anxiety severity scores between a daylight group and a control group over a period of time. The x-axis represents the time points: Baseline, Week 6, Week 10, and Week 24. The y-axis represents the anxiety severity scores, measured by GAD-7. The daylight group consistently has lower anxiety scores than the control group at each time point, and the difference between the two groups is statistically significant at Week 6, Week 10, and Week 24, as indicated by the asterisks.

Figure 1. GAD-7 scores from the GATE trial through 24 weeks post randomization. Error bars = standard error of the mean. *** p<0.001

Table 3: CGI-I based remission rates from the GATE trial

	N (% of group)		OR; p-value (95% CI)
	Daylight	PsychoeducationControl
Week 10 – No	42 (29%)	102 (65%)	4.63; p<0.001 (2.85, 7.54)
Yes	103 (71%)	54 (35%)
Week 24 – No	33 (22%)	72 (48%)
Yes	115 (78%)	78 (52%)	3.22; p<0.001 (1.95, 5.32)

Note: Remission defined as CGI-I score of 1 or 2; OR > 1 indicates greater odds of remission in Daylight than Psychoeducation Control; OR = Odds Ratio; Cl=Confidence Interval.

One adverse event was rated "probably" related to Daylight use during the treatment period: worsening panic attack severity. Adverse events that were rated "possibly" related to Daylight use were: panic attacks (n=4 [2.3%]), depression symptoms (n=5 [2.9%]), premenstrual/post-partum/seasonal mood symptoms (n=3 [1.7%]), thoughts of death or suicide (n=3 [1.7%]), PTSD symptoms (n=1 [0.6%]), musculoskeletal pain (n=6 [3.4%]), and headache (n=3 [1.7%]).Two serious adverse events were reported by study participants in the Daylight arm; neither of these were related to use of Daylight or participation in the trial. There were no unanticipated adverse device effects.

{8}------------------------------------------------

8. Conclusion

Daylight and the predicate Somryst have the same Intended Use as computerized behavioral therapy devices for psychiatric disorders. There are slight differences in indications for use in that Daylight is indicated for treatment of symptoms of generalized anxiety disorder, but this does not constitute a new intended use. Daylight has similar technological characteristics to Somryst, including software architecture and delivery of digital cognitive behavioral therapy through a mobile application. Software testing and pivotal clinical study results validate Daylight towards its proposed Indications for Use. This validation reasonably assures that Daylight is substantially equivalent to the predicate device. Further, Daylight met all of the Special Controls per the requirements of the regulation (21 CFR 882.5801). Thus, Daylight is substantially equivalent to Somryst.

Regulation Number and Section

§ 882.5801 Computerized behavioral therapy device for psychiatric disorders.

(a)
Identification. A computerized behavioral therapy device for psychiatric disorders is a prescription only device intended to provide a computerized version of condition-specific behavioral therapy as an adjunct to clinician supervised outpatient treatment to patients with psychiatric conditions. The digital therapy is intended to provide patients access to therapy tools used during treatment sessions to improve recognized treatment outcomes.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical data must be provided to fulfill the following:
(i) Describe a validated model of behavioral therapy for the psychiatric disorder; and
(ii) Validate the model of behavioral therapy as implemented by the device.
(2) Software must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Software verification, validation, and hazard analysis must be performed. Software documentation must demonstrate that the device effectively implements the behavioral therapy model.
(3) The following labeling must be provided:
(i) Patient and physician labeling must include instructions for use, including images that demonstrate how to interact with the device.
(ii) Patient and physician labeling must list compatible devices.
(iii) Patient and physician labeling must include a warning that the device is not intended for use as a standalone therapy.
(iv) Patient and physician labeling must include a warning that the device does not represent a substitution for the patient's medication.
(v) Physician labeling must include a summary of the clinical testing with the device.