(219 days)
EndeavorRx is a digital therapeutic indicated to improve attention as measured by computer-based testing in children ages 8-17 years old with primarily inattentive or combined-type ADHD, who have demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure Tests of Variables of Attention (TOVA) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include: clinician-directed therapy, medication, and/ or educational programs, which further address symptoms of the disorder.
EndeavorRx is a modification to the previously granted EndeavorRx (DEN200026) with the primary difference being the expansion of the indicated patient population from 8-12 years old to 8-17 years old. In addition, minor software changes were made to improve app accessibility and user engagement. The core therapeutic software technology was not changed.
EndeavorRx is a prescription-only digital therapeutic software indicated for use in the treatment of attention impairment in pediatric patients (8-17 years of age) with primarily inattentive or combinedtype ADHD. EndeavorRx is a software-as-a-medical device (SaMD) that resides on the user's mobile device and can be executed at home.
EndeavorRx is engineered as a therapeutically active treatment for attention in pediatric patients affected by ADHD. EndeavorRx is built on Akili's proprietary, patented, technology platform and uses adaptive algorithms (also known as Selective Stimulus Management Engine, SSME™) to deliver stimuli that are designed to engage the patient in a manner that improves their attention function. In a closedloop system, the adaptive SSME™ algorithms automatically adjust the difficulty level for a personalized treatment experience that is tailored to the needs of each individual patient.
EndeavorRx is delivered through a video game experience which leverages art, music, storytelling, and reward cycles to keep patients engaged. The adaptive algorithm constantly pushes patients precisely at predefined performance bounds relative to each individual, such that they are continuously encouraged to exceed their historic performance. The science behind EndeavorRx was developed at the University of California, San Francisco by Adam Gazzaley, M.D., Ph.D., Founding Director of the University of California San Francisco's Neuroscape and Akili's Chief Science Advisor.
The basic program inputs are steering, which is accomplished by using the mobile device's internal accelerometer to measure the degree to which it is tilted, and tapping, which is accomplished using the touch screen to measure correct and incorrect targeting. The basic outputs are the visual display of the game progression along with audio, which is accomplished by using the internal high resolution display and internal speaker. The program includes features to ensure it is used per the prescribed regimen (approximately 25 minutes per day, 5 days per week, for 4 weeks or as recommended by the health care provider).
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for EndeavorRx (K231337):
Device Name: EndeavorRx
Indication for Use: Digital therapeutic indicated to improve attention as measured by computer-based testing in children ages 8-17 years old with primarily inattentive or combined-type ADHD, who have demonstrated attention issue.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily details efficacy results rather than explicitly stated "acceptance criteria" as pass/fail thresholds for regulatory approval outside of the comparison tables for substantial equivalence. However, the core acceptance criterion for efficacy appears to be a significant positive mean change from baseline in the TOVA-ACS score.
| Acceptance Criterion (Inferred from Study Design & Outcomes) | Reported Device Performance (Subject Device: EndeavorRx v3.0, K231337) |
|---|---|
| Significant positive mean change from baseline to Day 28 in TOVA-ACS (Primary Efficacy Endpoint) | Mean Change: 2.639 (SD 3.7986) |
| 95% CI: 2.018, 3.261 | |
| p-value: < 0.0001 (Highly significant) | |
| Low rates of adverse device events | TE-ADE: 4 (2.5%) of 162 subjects |
| No serious adverse device events (SAEs) | Serious TE-ADE: 0 (0%) |
| No study discontinuations related to adverse device events | TE-ADE leading to discontinuation: 0 (0%) |
| No unanticipated treatment-emergent adverse events (TE-ADE) | Unanticipated TE-ADE: 0 (0%) |
| Performance of the device in the expanded age range (13-17) is similar or better than the predicate (8-12) | TOVA-ACS Change (Adolescents): 2.64 vs. 0.93 (Predicate) |
| % Responders with final TOVA score ≥0 (Adolescents): 24.7% vs. 11% (Predicate) | |
| TE-ADE rate (Adolescents): 2.5% vs. 6.7% (Predicate) |
2. Sample Sizes and Data Provenance
-
Test Set (Clinical Study for Subject Device EndeavorRx v3.0 - K231337):
- "Efficacy Population" (Complete Case Analysis - CCA): N = 146
- "Safety Population" (Intent-to-Treat with Multiple Imputation - ITT with MI): N = 162
- Provenance: Multi-center open-label study across 14 sites in the US.
- Retrospective/Prospective: The description "multi-center open-label study enrolled 162 adolescents" indicates a prospective study.
-
Predicate Device Study (STARS - DEN200026):
- "ITT Population": N = 179 (for TOVA-ACS primary endpoint)
- Provenance: Multi-site study across 20 sites in the US.
- Retrospective/Prospective: Described as "Randomized, controlled, parallel arm," indicating a prospective study.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
The ground truth for the device's efficacy is based on the objective, computer-based testing measure, TOVA-ACS (Test of Variables of Attention - ADHD Composite Score). This is a normed, standardized test, not subjective expert assessment requiring multiple readers or qualifications.
- Diagnosis of ADHD: Confirmed by Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-Kid) Version 7.0.2, administered by a trained clinician. The document does not specify the number or specific qualifications (e.g., years of experience) of these clinicians, but implies they are qualified to administer the MINI-Kid and make diagnoses based on DSM-5 criteria.
- High inattention: Measured by baseline TOVA-ACS score ≤ -1.8. This is a predefined numerical threshold.
4. Adjudication Method for the Test Set
Since the primary efficacy outcome (TOVA-ACS) is an objective, computer-based measure, and ADHD diagnosis was established by trained clinicians using a standardized interview (MINI-Kid), there is no mention of a traditional "adjudication method" involving multiple human readers reviewing results and resolving discrepancies. The data is either directly collected from the TOVA test or from structured diagnostic interviews.
The study design for the subject device was a "Single arm, open-label" study. This means there was no control group, and no 2+1 or 3+1 adjudication for comparing against a different intervention or sham.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. This device is a digital therapeutic, not a diagnostic imaging AI that assists human readers. Its primary claim is to improve attention as measured by a computer-based test, not to aid human interpretation of various cases. The clinical study for the subject device was:
- Standalone (algorithm only without human-in-the-loop performance): Yes, the device itself is the intervention, and its effect is measured directly.
- Human Reader Improvement with AI vs. Without AI Assistance (Effect Size): Not applicable, as this is not an AI-assisted diagnostic tool for human readers. The clinical study evaluated the direct therapeutic effect of the device on patients.
6. Standalone (Algorithm only) Performance
Yes, the primary efficacy endpoint (TOVA-ACS change) reflects the standalone performance of the EndeavorRx device in its effect on attention, as it is a direct therapeutic intervention.
7. Type of Ground Truth Used
- Primary Efficacy: Objective, digitally assessed measure of sustained and selective attention (Test of Variables of Attention - TOVA-ACS). This is a quantitative, standardized neurocognitive test.
- Secondary Outcomes: Clinical scales like ADHD-RS (Attention-Deficit/Hyperactivity Disorder Rating Scale), which are subjective clinician/parent-reported measures designed to assess symptom severity.
- Diagnosis (for inclusion criteria): Standardized diagnostic interview using DSM-5 criteria (MINI-Kid), performed by trained clinicians.
8. Sample Size for the Training Set
The document does not specify the sample size for the training set of the EndeavorRx device's algorithms (Selective Stimulus Management Engine, SSME™). It only describes the adaptive nature of the algorithm that "automatically adjust the difficulty level for a personalized treatment experience." This suggests an on-device adaptive learning system rather than a pre-trained machine learning model in the conventional sense where a large, separate training dataset is explicitly used for model development and then locked. However, the underlying "proprietary, patented, technology platform" and SSME™ algorithms would have been developed and refined using clinical and behavioral data over time, but details on such training data are not provided in this 510(k) summary.
9. How the Ground Truth for the Training Set was Established
As the document does not detail a distinct "training set" in the context of a fixed machine learning model, it also does not explain how ground truth was established for such a set.
The "adaptive algorithms" (SSME™) adjust difficulty based on the individual patient's real-time performance ("closed-loop system," "automatically adjust the difficulty level," "pushes patients precisely at predefined performance bounds relative to each individual"). This implies that the individual patient's performance within the game itself serves as the dynamic "ground truth" to adapt the therapeutic experience, rather than a separate, pre-labeled training dataset.
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December 13, 2023
Akili Interactive Labs, Inc. Bhupinder Singh Head of Quality and Regulatory Affairs 22 Boston Wharf Road 7th Floor Boston, MA 02210
Re: K231337
Trade/Device Name: EndeavorRx Regulation Number: 21 CFR 882.5803 Regulation Name: Digital therapy device for attention deficit hyperactivity disorder Regulatory Class: Class II Product Code: OFT Dated: November 13, 2023 Received: November 13, 2023
Dear Bhupinder Singh:
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.
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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).
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 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).
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Sincerely,
Robert Kang -S
for Pamela Scott, MS 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
Enclosure
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Indications for Use
510(k) Number (if known) K231337
Device Name EndeavorRx
Indications for Use (Describe)
EndeavorRx is a digital therapeutic indicated to improve attention as measured by computer-based testing in children ages 8-17 years old with primarily inattentive or combined-type ADHD, who have demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure Tests of Variables of Attention (TOVA) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include: cliniciandirected therapy, medication, and/ or educational programs, which further address symptoms of the disorder.
Type of Use (Select one or both, as applicable)
| Reproduction Use (Part 21 CFR 201 Subpart D) | Sample, Test, or Control Use (21 CFR 201.25) |
|---|---|
| -------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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8. 510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92.
| Date Prepared: | May 5, 2023 |
|---|---|
| Legal Manufacturer: | Akili Interactive Labs, Inc.125 Broad Street, 5th FloorBoston, MA 02110 |
| Primary Contact Person: | Bhupinder SinghHead of Quality and Regulatory AffairsPhone: +1 (408) 832-7124 |
| E-mail: bsingh@akiliinteractive.com |
Regulatory Information
| Device Trade Name: | EndeavorRx |
|---|---|
| Device Classification Name: | Digital Therapeutic Software for Attention DeficitHyperactivity Disorder |
| Regulation Number: | 21 CFR § 882.5803 |
| Classification Product Code: | QFT |
| Review Advisory Committee: | Neurology |
| Device Classification: | Class II |
Predicate Device Information
| Device Manufacturer: | Akili Interactive Labs, Inc. |
|---|---|
| ---------------------- | ------------------------------ |
- Submission Number: DEN200026
- Device Name: EndeavorRx
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Device Description: EndeavorRx is a modification to the previously granted EndeavorRx (DEN200026) with the primary difference being the expansion of the indicated patient population from 8-12 years old to 8-17 years old. In addition, minor software changes were made to improve app accessibility and user engagement. The core therapeutic software technology was not changed.
EndeavorRx is a prescription-only digital therapeutic software indicated for use in the treatment of attention impairment in pediatric patients (8-17 years of age) with primarily inattentive or combinedtype ADHD. EndeavorRx is a software-as-a-medical device (SaMD) that resides on the user's mobile device and can be executed at home.
EndeavorRx is engineered as a therapeutically active treatment for attention in pediatric patients affected by ADHD. EndeavorRx is built on Akili's proprietary, patented, technology platform and uses adaptive algorithms (also known as Selective Stimulus Management Engine, SSME™) to deliver stimuli that are designed to engage the patient in a manner that improves their attention function. In a closedloop system, the adaptive SSME™ algorithms automatically adjust the difficulty level for a personalized treatment experience that is tailored to the needs of each individual patient.
EndeavorRx is delivered through a video game experience which leverages art, music, storytelling, and reward cycles to keep patients engaged. The adaptive algorithm constantly pushes patients precisely at predefined performance bounds relative to each individual, such that they are continuously encouraged to exceed their historic performance. The science behind EndeavorRx was developed at the University of California, San Francisco by Adam Gazzaley, M.D., Ph.D., Founding Director of the University of California San Francisco's Neuroscape and Akili's Chief Science Advisor.
The basic program inputs are steering, which is accomplished by using the mobile device's internal accelerometer to measure the degree to which it is tilted, and tapping, which is accomplished using the touch screen to measure correct and incorrect targeting. The basic outputs are the visual display of the game progression along with audio, which is accomplished by using the internal high resolution display and internal speaker. The program includes features to ensure it is used per the prescribed regimen (approximately 25 minutes per day, 5 days per week, for 4 weeks or as recommended by the health care provider).
Indications for Use:
EndeavorRx is a digital therapeutic indicated to improve attention
AKILI CONFIDENTIAL
Akili Interactive Labs, Inc. Premarket Notification [510(k) Submission] EndeavorRx
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| function as measured by computer-based testing in children ages 8-17 years old with primarily inattentive or combined-type ADHD, who have demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure Tests of Variables of Attention (TOVA) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include: clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder. | |
|---|---|
| Limitations | Prescription-only medical device restricted to sale by or on the order of a licensed health care provider. |
| EndeavorRx may not be appropriate for patients with photo-sensitive epilepsy, color blindness, or physical limitations that restrict use of a mobile device; parents should consult with their child's health care provider. | |
| This single arm study did not include a sham control group and it is therefore possible that a placebo effect may have impacted the study results by inflating the effect of the EndeavorRx device. The study had sufficient statistical power to detect a significant effect of treatment compared to a similarly sized control group with placebo response of up to a 1.7-point improvement in TOVA-ACS. Patients and health care providers should consider the totality of the clinical evidence in light of this before using this product. |
| Attribute | Subject Device:EndeavorRx v3.0 | Predicate Device:EndeavorRx (DEN200026) | Comparison |
|---|---|---|---|
| Manufacturer | Akili Interactive Labs, Inc. | Akili Interactive Labs, Inc. | Same |
| DeviceClassification Name | Digital Therapeutic Softwarefor Attention DeficitHyperactivity Disorder | Digital Therapeutic Softwarefor Attention DeficitHyperactivity Disorder | Same |
| Product Code | QFT | QFT | Same |
| Regulation Number | 21 CFR § 882.5803 | 21 CFR § 882.5803 | Same |
| Intended Use | Digital therapeutic adaptivestimulus software for theclosed-loop treatment of | Digital therapeutic adaptivestimulus software for theclosed-loop treatment of | Same |
| psychiatric disorders andcognitive dysfunctionassociated with medicalconditions. | psychiatric disorders andcognitive dysfunctionassociated with medicalconditions. | ||
| Indications for Use | EndeavorRx is a digitaltherapeutic indicated toimprove attention function asmeasured by computer basedtesting in children ages 8-17years old with primarilyinattentive or combined-typeADHD, who have ademonstrated attention issue.Patients who engage withEndeavorRx demonstrateimprovements in a digitallyassessed measure Tests ofVariables of Attention (TOVA)of sustained and selectiveattention and may not displaybenefits in typical behavioralsymptoms, such ashyperactivity. EndeavorRxshould be considered for useas part of a therapeuticprogram that may include:clinician-directed therapy,medication, and/oreducational programs, whichfurther addresssymptoms of the disorder. | EndeavorRx is a digitaltherapeutic indicated toimprove attention function asmeasured by computer basedtesting in children ages 8-12years old with primarilyinattentive or combined-typeADHD, who have ademonstrated attention issue.Patients who engage withEndeavorRx demonstrateimprovements in a digitallyassessed measure Tests ofVariables of Attention (TOVA)of sustained and selectiveattention and may not displaybenefits in typical behavioralsymptoms, such ashyperactivity. EndeavorRxshould be considered for useas part of a therapeuticprogram that may include:clinician-directed therapy,medication, and/oreducational programs, whichfurther address symptoms ofthe disorder. | Substantiallyequivalent.EndeavorRx v3.0is indicated for alarger range ofpediatricpatients (8-17years of age)compared to thepredicate device(8-12 years ofage). This doesnot change theintended use ofthe device, andclinical testingdemonstratesthe subjectdevice is safe andeffective in theexpandedpopulation. |
| SystemComponents | Patient facing video gameapplicationMobile device platform | Patient facing video gameapplicationMobile device platform | Same |
| ProprietaryAlgorithm | Selective StimulusManagement Engine(SSMETM) | Selective StimulusManagement Engine(SSMETM) | Same |
| Basic Operations | Steering, Tapping, Multi-tasking | Steering, Tapping, Multi-tasking | Same |
| Presentation | Structured manner across | Structured manner across | Same |
| game "Challenges" and"Worlds" | game "Challenges" and"Worlds" | ||
| Mobile PlatformCompatibility | iOS and Android | iOS | Substantiallyequivalent.Addition ofAndroidcompatibilitydoes not presentdifferentquestions. |
| Access | Prescription use only.Authorized and overseen by alicensed health care provider. | Prescription use only.Authorized and overseen by alicensed health care provider. | Same |
Summary Comparison of technological Characteristics
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.KILI
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Summary of Non-Clinical Performance Data: Bench software testing has been performed on the EndeavorRx and demonstrates compliance with the following international and FDA-recognized consensus standards and FDA guidance documents:
- ISO 14971:2019 Medical devices - Application of risk management to medical devices
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION ● Medical device software - Software life cycle processes
- IEC 82304-1 Edition 1.0 2016-10 Health software - Part 1: General requirements for product safety
- FDA Guidance Document for Industry and FDA Staff -Guidance for the content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005
- . FDA Guidance Document for Industry and FDA Staff -Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued October 2, 2015
The results of bench software verification and validation testing supports that EndeavorRx functions as intended.
Summary of Clinical performance testing was conducted to evaluate the efficacy and safety Clinical Data: of EndeavorRx in adolescents 13 to 17 years of age. Efficacy was determined primarily by the change from baseline in a digitally assessed measure of sustained and selective attention, the Test of Variables of Attention (TOVA®), after 4 weeks of treatment. The multi-center open-label study enrolled 162 adolescents subjects with inattentive or combined-type ADHD. The results of the clinical performance study support the performance and safety of
AKILI CONFIDENTIAL
Akili Interactive Labs, Inc. Premarket Notification [510(k) Submission] EndeavorRx
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EndeavorRx in the expanded pediatric age range. Analysis of the primary efficacy endpoint in the Efficacy Population (N=146) showed a significant positive mean change from baseline to study day 28 in the TOVA of 2.639 (SD 3.7986 [95% Cl: 2.018, 3.261]; P < 0.0001). Overall, 4 (2.5%) subjects experienced a treatmentemergent adverse device event (3 decreased frustration tolerance, 1 headache; all mild or moderate). There were no serious adverse device events.
Prior clinical trial results that supported the original clearance of EndeavorRx for 8-12 year old patients under DEN200026 support the use of EndeavorRx in the younger cohort.
The clinical performance studies demonstrate that EndeavorRx is safe and effective for its intended use in the indicated patient population.
Table of Complete Case Analysis (CCA) and Intent-to-Treat (ITT) Analysis with Multiple Imputation (MI) of the Primary Efficacy Endpoint – TOVA-ACS Change from Baseline to Day 28
| Analysis | Baseline | Exit (Day 28) | Change from |
|---|---|---|---|
| TOVA-ACS | TOVA-ACS | Baseline | |
| STARS ITT Population | |||
| n | 179 | 170 | 169 |
| Mean (SE) | -5.11 (0.22) | -4.16 (0.28) | 0.93 (0.24) |
| 95% CI | 0.45, 1.40 | ||
| p-value1 | 0.0002 | ||
| Efficacy Population (CCA, assumes | |||
| MCAR) | |||
| n | 146 | 146 | 146 |
| Mean (SE) | -5.447 (0.3106) | -2.808 (0.3546) | 2.639 (0.3144) |
| 95% CI | 2.018, 3.261 | ||
| p-value1 | <0.0001 | ||
| Safety Population (ITT with MI,2 | |||
| assumes MAR) | |||
| n | 162 | 162 | 162 |
| Mean (SE) | -5.421 (0.2870) | -2.784 (0.3486) | 2.637 (0.3147) |
| 95% CI | 2.020, 3.253 | ||
| p-value1 | <0.0001 |
Abbreviations: CCA = complete case analysis; ITT = intent-to-treat, MI = multiple imputation; MCAR = missing completely at random; MAR = missing at random; FCS = fully conditional specification
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1 From a one-sample t-test of change greater than zero. Positive changes indicate improvement.
2 Multiple imputation for participants with missing data at Day 28 was performed using FCS with 100 imputations and included covariates age, sex, race, ethnicity, education plan, age of ADHD symptom onset, concomitant stimulant use, treatment exposure defined as number of non-practice missions completed, and baseline TOVA-ACS value. Estimates of mean and standard error at baseline, Day 28 and change from baseline were calculated for each imputation and combined using PROC MIANALYZE in SAS version 9.4.
Clinical Study Comparison Summary Table
| Clinical Study for SubjectDevice EndeavorRx v3.0(K231337) | Clinical Study forPredicate Device(DEN200026) | Comparison | |
|---|---|---|---|
| Adolescents(ages 13-17) | STARS(ages 8-12) | ||
| Population UnderStudy | Verified ADHD diagnosiswith impaired attention;on or off medication | Verified ADHDdiagnosis withimpaired attention;medicationexclusionary | Similar - adolescent studyallowed for medication aslong as use was stable for ≥4weeks prior to studyenrollment and throughoutthe study. A prior studydemonstrated benefits ofintervention on the pediatricpopulation with ADHD bothon and off medication. |
| Study Design | Single arm, open label;25 min/day, 5days/week, 4 weeks;multi-site study acrossUS | Randomized,controlled, parallelarm; 25 min/day, 5days/week, 4weeks; multi-sitestudy across US | Different -the adolescentstudy intended forevaluation of substantialequivalence via comparisonof results to the STARS AKL-T01 group. The companymade a decision not toinclude a control/sham armas part of this study for threeprimary reasons:1) the safety and efficacy ofthe product was already |
| Clinical Study for SubjectDevice EndeavorRx v3.0(K231337) | Clinical Study forPredicate Device(DEN200026) | Comparison | |
| Adolescents(ages 13-17) | STARS(ages 8-12) | ||
| established in a randomizedcontrolled trial in the youngerpopulation;2) the primaryendpoint used in STARS-Adolescent was identical tothe original STARS RCT; and3) based on the predicateRCT and multiple publishedstudies of ADHD children andadolescents in the literature,the primary outcomemeasure demonstrates littleto no placebo effects inrandomized, controlledtrials. | |||
| Outcomes | Significant treatmenteffect on primaryoutcome measure(attention function);treatment effects in keyprespecified secondaryoutcomes (ADHDsymptoms) | Significanttreatment effect onprimary outcomemeasure (attentionfunction);treatment effects inkey prespecifiedsecondaryoutcomes(responder analysisfor impairment) | Similar - primary outcomesare the same. Both studieshad ADHD-RS as secondarymeasures. Whereas theSTARS study listed multiplesecondary measures, theadolescent study focused onADHD-RS as the secondarymeasure, which previousstudies showed to besensitive to the AKL-T01treatment. The TOVA-ACS(primary outcome) is notsusceptible to placebo effectwhen measuring attentionalcontrol processes within thecontext of ADHD, and this issupported by the predicateRCT and multiple published |
| Clinical Study for SubjectDevice EndeavorRx v3.0(K231337) | Clinical Study forPredicate Device(DEN200026) | Comparison | |
| Adolescents(ages 13-17) | STARS(ages 8-12) | ||
| studies in the literature. | |||
| Safety | Low rates of adversedevice events; noserious adverse deviceevents; no studydiscontinuations relatedto adverse device events | Low rates ofadverse deviceevents; no seriousadverse deviceevents; no studydiscontinuationsrelated to adversedevice events | Similar |
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Clinical Study Design Comparison Table
| Study Design | Clinical Study forSubject DeviceEndeavorRx v3.0(K231337)Adolescents(ages 13-17) | Clinical Study forPredicate Device(DEN200026)STARS(ages 8-12) | Comparison |
|---|---|---|---|
| Study design | Single-arm, open-label | Randomized clinicaltrial | Different - the adolescentstudy intended forevaluation of substantialequivalence via comparison ofresults to the STARS AKL-T01group. The company made adecision not to include acontrol/sham arm as part ofthis study for three primaryreasons:1) the safety and efficacy ofthe product was alreadyestablished in a randomized |
| Study Design | Clinical Study forSubject DeviceEndeavorRx v3.0(K231337)Adolescents(ages 13-17) | Clinical Study forPredicate Device(DEN200026)STARS(ages 8-12) | Comparison |
| controlled trial in the youngerpopulation;2) the primaryendpoint used in STARS-Adolescent was identical to theoriginal STARS RCT.; and 3)based on the predicate RCTand multiple published studiesof ADHD children andadolescents in the literature,the primary outcome measuredemonstrates little to noplacebo effects in randomized,controlled trials Additionally,4) AKL-T01 is a low-risk device,and 5) the predicate study(STARS) was an RCT using thesame device that alreadyshowed the effectiveness ofAKL-T01 against an activecontrol. Therefore, comparisonof the device's effectiveness toactive control was not part ofthe study design rationale. | |||
| Sites | Multi-site: 14 sitesacross the US (a mix ofinstitutional sites andprivate practicecenters) | Multi-site: 20 sitesacross the US (a mixof institutional sitesand private practicecenters) | Similar |
| Enrollment | 162 enrolled | 348 enrolled | Similar - the larger N in STARSstudy takes into account twoarms. Sample size inadolescent study was |
| Study Design | Clinical Study forSubject DeviceEndeavorRx v3.0(K231337) | Clinical Study forPredicate Device(DEN200026) | Comparison |
| Adolescents(ages 13-17) | STARS(ages 8-12) | determined by powercalculations. | |
| Intervention | EndeavorRx (AKL-T01) | EndeavorRx (AKL-T01)EVO: Words (Activecontrol) | Similar - the adolescent studyis a single arm study that didnot require the use of anactive control. AKL-T01 is alow-risk device, and thepredicate study (STARS) was anRCT that already showed theeffectiveness of AKL-T01against an active control.Therefore, comparison of thedevice's effectiveness to activecontrol was not part of thestudy design rationale. |
| Treatmentregimen | 25 minutes per day(equivalent to 6-8missions), 5days per week for 4weeks | 25 minutes of AKI-T01 or activecontrol per day, 5days perweek for 4 weeks | No differences |
| ParticipantDuration | Approximately 4weeks ontreatment | Approximately 4weeks ontreatment | No differences |
| Key EligibilityCriteria | Clinical Study for SubjectDevice EndeavorRx v3.0(K231337) | Clinical Study for PredicateDevice (DEN200026) | Comparison |
| Adolescents(ages 13-17) | STARS(ages 8-12) | ||
| 1. Diagnosis ofADHD | Inclusion: Confirmeddiagnosis of ADHDcombined or inattentivetype, according toDiagnostic and StatisticalManual of MentalDisorders, Fifth Edition(DSM-5) as confirmed byMini- InternationalNeuropsychiatric Interviewfor Children andAdolescents (MINI-Kid)Version 7.0.2 | Inclusion: Confirmed ADHDdiagnosis, any presentation,at screening based on DSM-5 criteria and establishedvia the MINI-KIDadministered by a trainedclinician | Similar |
| 2. Highinattention asmeasured byTOVA or othervalidatedmeasures ofattention | Inclusion: Baseline visitscore on the TOVA-ACSscore ≤ -1.8 | Inclusion:Screening/baseline (Visit 1or 1a) score on the TOVAAPI ≤ -1.8 | Same - ACS is theupdated term forAPI. TOVA-ACSwas determinedas the primaryoutcome for thissingle arm studybecause TOVA-ACS is notsusceptible toPlacebo whenmeasuringattentionalcontrol processeswithin the contextof ADHD, and thishas beensupported by thepredicate RCT andmultiple publishedstudies of children |
| Key EligibilityCriteria | Clinical Study for SubjectDevice EndeavorRx v3.0(K231337)Adolescents(ages 13-17) | Clinical Study for PredicateDevice (DEN200026)STARS(ages 8-12) | Comparison |
| 3. Stably on or offADHDmedications | Inclusion: Stably on or offADHD medication for ≥4weeks prior to studyenrollment and throughoutthe 4-week study | Inclusion: Not undergoingpharmacological treatmentwith methylphenidate oramphetamine-basedproducts at time ofscreening; or, if undergoingpharmacological treatment,must be willing andappropriate (i.e., notoptimally treated in theinvestigator's judgment) towash out of currentregimenExclusion: Participantscurrently treated with anonstimulant medicationfor ADHD (i.e., atomoxetine,clonidine, or guanfacine) | and adolescentswith ADHD..Adolescent studyallowed the use ofADHDmedications aslong as theparticipant wasstable onmedication priorto and throughoutstudyparticipation. Aprior studydemonstratedbenefits ofintervention onthe pediatricpopulation withADHD both onand offmedication. |
| 4. Not onpsychoactivemedications | Inclusion: Stably on or offpsychoactive medicationsfor ≥4 weeks prior to studyenrollment and throughoutthe 4-week study | Exclusion: Regular use ofpsychoactive drugs(nonstimulant) that, in theopinion of the investigator,could confound studydata/assessments | Different - theadolescent studyallowed the use ofpsychoactivemedication aslong as use anddosage was stableprior to andthroughout studyparticipation. Aprior study |
| Key EligibilityCriteria | Clinical Study for SubjectDevice EndeavorRx v3.0(K231337)Adolescents(ages 13-17) | Clinical Study for PredicateDevice (DEN200026)STARS(ages 8-12) | Comparison |
| demonstratedbenefits ofintervention onthe pediatricpopulation withADHD both onand offmedication. | |||
| 5. Stably on or offnonpharmacological treatments | Exclusion: Plans to initiate,or to make significantchanges in frequency, ofnonpharmacologicalbehavioral therapy duringthe studyExclusion: Plans to initiateor to make significantchanges in frequency orduration of non-pharmacological trainingswith the aim to improvecognition by means ofgame or app-basedcognitive trainings orneurofeedback, during thestudy | Exclusion: Initiation ofbehavioral therapy withinthe last 4 weeks.Participants who had beenin behavior therapyconsistently for more than 4weeks could participateprovided their routine wasunchanged during thecourse of the study.Participantsplanning on changing orinitiating behavior therapyduring the course of thestudy were excluded | Similar |
| 6. Absence ofcomorbidpsychiatricdiagnosis and/ortreatments thatmay confoundstudy | Exclusion: Currentcontrolled or uncontrolled,comorbidpsychiatric diagnosis that inthe opinion of theInvestigator may confoundstudy data/assessments | Exclusion: Current,controlled (requiring arestricted medication) oruncontrolled, comorbidpsychiatric diagnosis, basedon MINI-KID andsubsequent clinical | No differences |
| Key EligibilityCriteria | Clinical Study for SubjectDevice EndeavorRx v3.0(K231337) | Clinical Study for PredicateDevice (DEN200026) | Comparison |
| Adolescents(ages 13-17) | STARS(ages 8-12) | ||
| data/assessments | interviewing, withsignificant symptomsincluding, but not limited to,posttraumatic stressdisorder, psychosis, bipolarillness, pervasivedevelopmental disorder,severe obsessivecompulsive disorder, severedepressive or severe anxietydisorder, conduct disorder,or other symptomaticmanifestations that in theopinion of the investigatormay confoundstudy data/assessments.Participants with a clinicalhistory of learning disorderswere allowed to participate,provided the disorder didnot impact their ability toparticipate in the trial,based on PI judgmentExclusion: Regular use ofpsychoactive drugs(nonstimulant) that, in theopinion of the investigator,could confound studydata/assessments | ||
| 7. Meets IQ levelthreshold | Inclusion: Estimated IQscore ≥80 as assessed bythe Kaufmann BriefIntelligence Test, Second | Inclusion: Estimated IQscore ≥ 80 as assessed bythe Kaufmann BriefIntelligence Test, Second | Same |
| Key EligibilityCriteria | Clinical Study for SubjectDevice EndeavorRx v3.0(K231337) | Clinical Study for PredicateDevice (DEN200026) | Comparison |
| Adolescents(ages 13-17) | STARS(ages 8-12) | ||
| Edition (KBIT-II) | Edition | ||
| 8. Not consideredat-risk ofattemptingsuicide at time ofenrollment | Exclusion: Participant iscurrently considered at riskfor attempting suicide, hasmade a suicide attemptwithin the past year, or iscurrently demonstratingactive suicidal ideation orself-injurious behavior, inthe opinion of theInvestigator based on theMINI-kid clinical interview | Exclusion: Participantscurrently considered asuicide risk in the opinion ofthe investigator, hadpreviously made a suicideattempt, or had a history of,or were currentlydemonstrating, activesuicidal ideation orselfinjurious behavior, as | Similar |
| 9. Absence ofconditions thatwould preventthe proper use oftheinvestigationalproduct | Exclusion: Motor condition(e.g., physical deformity ofthe hands/arms) thatprevents game playing asreported by the participantor observed by theInvestigatorExclusion: Color blindnessas detected by IshiharaColor Blindness TestExclusion: Known sensitivityto playing video games,such as photosensitiveepilepsy, light-headedness,dizziness, nausea, ormotion sickness | Exclusion: Motor condition(e.g., physical deformity ofthe hands/arms;prostheses) that preventedplaying the digital therapy,as reported by the parent orobserved by the investigatorExclusion: Diagnosis of orparent-reported colorblindness (confirmed inclinic via Ishihara ColorBlindness Test)Exclusion: History ofseizures (exclusive of febrileseizures) or significantmotor or vocal tics | Similar |
| Key Eligibility | Clinical Study for SubjectDevice EndeavorRx v3.0(K231337) | Clinical Study for PredicateDevice (DEN200026) | Comparison |
| Criteria | Adolescents(ages 13-17) | STARS(ages 8-12) | |
| Exclusion: History ofseizures (excluding febrileseizures), significant tics, ora current diagnosis ofTourette's Disorder | Tourette syndrome | ||
| 10. Absence ofrecent substanceuse | Exclusion: Recent history (6months prior to screening)of substance use disorderExclusion: Urine testpositive for nicotine ormarijuana | Exclusion: Recent history(within the past 6 months)of suspected substanceabuse or dependence | Similar - anexclusion due todrug test wasincluded in theadolescent studysince theadolescentpopulation ismore likely thanpediatricpopulations tohave access tosubstances |
| 11. Absence ofother conditions,treatments, orinvolvementsthat mayconfound studydata/assessmentS | Exclusion: Any othermedical condition that inthe opinion of theInvestigator may confoundstudy data/assessments.Exclusion: Participation in aclinical trial within 3months prior to screeningExclusion: Previousexposure to Akili Productswithin the 6 months priorto study enrollment | Exclusion: Any othermedical condition that, inthe opinion of theinvestigator, couldconfound studydata/assessmentsExclusion: Had participatedin a clinical trial within 90days before screeningExclusion: Had previouslyparticipated in a study ofAkili's videogame-like digitaltherapy | Similar |
| Outcome Measure | Clinical Study forSubject DeviceEndeavorRx v3.0(K231337) | Clinical Study forPredicate Device(DEN200026) | Comparison |
| Adolescents(ages 13-17)(EfficacyPopulation; n=146) | STARS(ages 8-12)(IIT;n=180) | ||
| 1. pre-post change scoreon TOVA ACS(Positive changeindicates improvement) | 2.64 | 0.93 | Adolescents show nearly3 times the improvementin TOVA ACS than inSTARS |
| 2. pre-post changescore on ADHD-RSInattention subscale(Negative changeindicatesimprovement) | -3.0 | -3.6 | Adolescents show asmaller absolute meanchange, but given loweroverall Baseline scoresfor adolescents, theproportional change wassimilar |
| 3. pre-post change scoreon ADHD-RS Total Score(Negative changeindicatesimprovement) | -4.6 | -6.2 | Adolescents show asmaller absolute meanchange, but given loweroverall Baseline scoresfor adolescents, theproportional change wassimilar. Clinicallymeaningful improvementbased on literature forthe ADHD-RS isestimated at 10 pointdifference1 or a 30% |
| Outcome Measure | Clinical Study forSubject DeviceEndeavorRx v3.0(K231337)Adolescents(ages 13-17)(EfficacyPopulation; n=146) | Clinical Study forPredicate Device(DEN200026)STARS(ages 8-12)(IIT;n=180) | Comparison |
| change in Total Score.2 | |||
| 4. % Responders withfinal TOVA score >0 | 24.7% | 11% | The percentage ofresponders with finalTOVA score ≥0 is morethan doubled inadolescents as comparedto STARS |
| 5. % Responders with >1.4 point change onTOVA-ACS | N/A (66.4% for ≥ 1.0point improvementfrom Baseline to Day28) | 46.7% | Adolescents show asimilarly positive rate |
| 6. % Responders with>30% change in ADHD-RS Total Score | 27% | 24% | Higher percentage ofresponders inadolescents than STARS.Clinically meaningfulimprovement based onliterature for the ADHD-RS is estimated at 10point difference3 or a30% change in Total |
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Comparison of Inclusion/Exclusion Criteria for Subject and Predicate Studies
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Clinical Study Outcome Comparison Table
4 Nasser A, Kosheleff AR, Hull JT, et al. Translating Attention-Deficit/Hyperactivity Disorder Rating Scale-5 and Weiss Functional Impairment Rating Scale-Parent Effectiveness Scores into Clinical Global Impressions Clinical AKILI CONFIDENTIAL
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Significance Levels in Four Randomized Clinical Trials of SPN-812 (Viloxazine Extended-Release) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2021;31(3):214-226. doi:10.1089/cap.2020.0148
Akili Interactive Labs, Inc. Premarket Notification [510(k) Submission] EndeavorRx
2 Zhang, S., Faries, D. E., Vowles, M., & Michelson, D. (2005). ADHD rating scale IV: psychometric properties from a multinational study as clinician-administered instrument. International journal of methods in psychiatric research, 14(4), 186-201.
3 Nasser A, Kosheleff AR, Hull JT, et al. Translating Attention-Deficit/Hyperactivity Disorder Rating Scale-5 and Weiss Functional Impairment Rating Scale-Parent Effectiveness Scores into Clinical Global Impressions Clinical Significance Levels in Four Randomized Clinical Trials of SPN-812 (Viloxazine Extended-Release) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2021;31(3):214-226. doi:10.1089/cap.2020.0148
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| Outcome Measure | Clinical Study forSubject DeviceEndeavorRx v3.0(K231337) | Clinical Study forPredicate Device(DEN200026) | Comparison |
|---|---|---|---|
| Adolescents(ages 13-17)(EfficacyPopulation; n=146) | STARS(ages 8-12)(IIT;n=180) | ||
| Score.4 |
Clinical Safety Outcome Comparison Table
| Safety Outcomes | Clinical Study forSubject DeviceEndeavorRx v3.0(K231337) | Clinical Study forPredicate Device(DEN200026) | Comparison |
|---|---|---|---|
| Adolescents(ages 13-17)(EfficacyPopulation; n=162) | STARS(ages 8-12)(IIT;n=180) | ||
| 1. Any TE-ADE | 4 (2.5%) | 12 (6.7%) | Adolescents show better(lower) TE-ADE rate |
| 2. TE-ADE related tostudy treatment(possibly, probably, anddefinitely-related) | 4 (2.5%) | 12 (6.7%) | Adolescents show better(lower) TE-ADE rate |
| 3. Serious TE-ADE | 0 (0%) | 0 (0%) | No difference |
| 4. TE-ADE leading tostudy discontinuation | 0 (0%) | 0 (0%) | No difference |
| 5. Unanticipated TE-ADE | 0 (0%) | 0 (0%) | No difference |
4 Zhang, S., Faries, D. E., Vowles, M., & Michelson, D. (2005). ADHD rating scale IV: psychometric properties from a multinational study as clinician-administered instrument. International journal of methods in psychiatric research, 14(4), 186-201.
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Substantial Equivalence Discussion:
EndeavorRx has the same intended use and similar indications, technological characteristics, and principles of operation as the predicate device, EndeavorRx (DEN200026). Moreover, EndeavorRx complies with the same special controls as the predicate Endeavor Rx (DEN200026) set forth in 21 CFR § 882.5803. The expanded age range and minor software changes do not raise different questions of safety or efficacy.
Substantial equivalence was supported by clinical and non-clinical performance (verification and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards, ISO 14971, IEC 62304, and IEC 82304. The non-clinical testing included software testing, which verified the minor software changes in EndeavorRx. Clinical testing validated the safety and effectiveness of EndeavorRx for its intended use in the indicated patient age range of 8-17 years old. The prior clinical trial results that supported the original clearance of EndeavorRx for 8-12 vear old patients under DEN200026 support the use of EndeavorRx in the younger cohort. A new clinical study was executed to demonstrate the performance and safety of EndeavorRx in the older cohort of adolescents 13 to 17 years of age. The clinical trial results showed a significant improvement in the primary effectiveness measure, TOVA, a digitally assessed measure of sustained and selective attention. Results also showed improvements in ADHD symptoms as assessed in key secondary measures, the ADHD-RS inattention scale and ADHD-RS total score. These results were similar to the findings of the prior clinical trial that supported the original clearance of EndeavorRx for 8-12 year-old patients under DEN200026. The clinical testing also showed no new or increased safety risks in the expanded patient population compared to the predicate device.
The results of these tests demonstrate that EndeavorRx is as safe and effective as its predicate device. Therefore, EndeavorRx is substantially equivalent.
No serious adverse events were reported. Of 342 participants who Benefit-Risk Profile: received AKL-T01 in the two clinical trials supporting EndeavorRx authorization for age ranges 8-17, 16 participants (9.88%) experienced treatment-related adverse events (TE-ADE) (possible, probable, likely). TE-ADEs reported at greater than 1% across the studies include: frustration tolerance decreased (2.34%) and headache (1.17%). Other adverse events occurred less than 1% and included dizziness, emotional disorder, nausea, and aggression. All adverse events were transient and no events led to device discontinuation. All adverse events resolved by the end of treatment.
EndeavorRx showed a general improvement in attention as well as areas
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of improvement in other symptoms associated with ADHD. The totality of the evidence demonstrated clinical benefit in attention, as measured by the TOVA, as well as other assessments of symptoms and functioning in children with ADHD with a demonstrated attention issue. Improvements in ADHD symptoms and impairment favored EndeavorRx over control, including rates of participants exhibiting clinically meaningful symptom reductions. As noted, the risks associated with EndeavorRx are minimal
For EndeavorRx the AE rates were extremely low, in mild-moderate severity range. There were no SAEs, and all AE's were resolved. Given the favorable safety profile, even small benefit would justify use of the product.
§ 882.5803 Digital therapy device for Attention Deficit Hyperactivity Disorder.
(a)
Identification. A digital therapy device for Attention Deficit Hyperactivity Disorder (ADHD) is a software intended to provide therapy for ADHD or any of its individual symptoms as an adjunct to clinician supervised treatment.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate and document the following under the labeled conditions for use, which include considerations for the ability of the device to:
(i) Use a validated measure to evaluate effectiveness of device to provide therapy for ADHD or any of its individual symptoms; and
(ii) Capture all adverse events.
(2) Software must be described and provided in a clear and detailed manner to include all features and functions of the software implementing the digital therapy. Software verification, validation, and hazard analysis must also be provided.
(3) The labeling must include the following items:
(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 the minimum operating system (OS) requirements that support the software of the device;
(iii) Patient and physician labeling must include a warning that the digital therapy device is not intended for use as a standalone therapeutic device;
(iv) Patient and physician labeling must include a warning that the digital therapy device does not represent a substitution for the patient's medication; and
(v) Physician labeling must include a summary of the clinical performance testing conducted with the device.