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Sleepio is a digital therapeutic intended for the treatment of chronic insomnia disorder as an adjunct to usual care in patients aged 18 and older. Sleepio is a prescription device delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) and can be made available on the order of a licensed healthcare provider.

Sleepio is a digital therapeutic for the treatment of chronic insomnia / insomnia disorder. Sleepio treats chronic insomnia disorder by delivering evidence-based techniques targeting the cognitive and behavioral factors that maintain insomnia and chronic sleep problems. Patient experience is tailored based on symptoms and daily sleep tracking. In addition to core therapeutic components, there is in-the-moment therapeutic content for help falling asleep. Content is delivered via smartphone and tablet applications (iOS and Android), as well as via web. Sleepio is intended as an adjunct to usual care treatment for chronic insomnia / insomnia disorder by a healthcare provider. Healthcare providers have access to a dashboard to track patient engagement with Sleepio.

Based on the provided text, the device in question is Sleepio, a digital therapeutic for the treatment of chronic insomnia disorder. Here's a breakdown of the acceptance criteria and the study proving the device meets them:

Disclaimer: The provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit acceptance criteria for this specific device's performance in a new, de novo fashion. The clinical data presented serves to support the substantial equivalence claim by showing similar or superior performance to standard care (Sleep Hygiene Education, SHE) and implicitly, to the predicate. Therefore, the "acceptance criteria" table below is inferred from the goals of the clinical study and the claims made about the device's efficacy in the context of demonstrating substantial equivalence for an FDA 510(k) submission.

1. Table of inferred acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Test set sample size: The clinical effectiveness was evaluated in the CrEDIT trial, a two-arm, parallel group, randomized controlled trial (RCT) with 336 adults.
  • Sleepio group (n=168)
  • Online sleep hygiene education (SHE) group (n=168)
• Data provenance: Participants were recruited from across the United States via social media. The study was prospective (Randomized Controlled Trial).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the use of human experts to establish ground truth for the test set in the conventional sense of image or diagnostic adjudication. The ground truth for insomnia was established clinically based on self-reported patient assessments using standardized questionnaires (Insomnia Severity Index, ISI) and sleep diaries (SOL, WASO), and a DSM-5 diagnosis of insomnia disorder as criteria for study inclusion. The study evaluated the effectiveness of a therapeutic intervention, not the diagnostic accuracy of an AI model against expert consensus.

4. Adjudication method for the test set

Not applicable. As noted above, this study measures the therapeutic effectiveness of Sleepio based on patient-reported outcomes, not the performance of a diagnostic or classification algorithm that would require an adjudication method for ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This was a clinical trial evaluating a digital therapeutic directly delivered to patients for treatment, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in a way. Sleepio is a digital therapeutic that delivers Cognitive Behavioral Therapy for Insomnia (CBT-I) directly to patients via smartphone/tablet apps and web. While it's a "prescription device" and "can be made available on the order of a licensed healthcare provider" who "have access to a dashboard to track patient engagement," the core therapeutic delivery and patient interaction are directly from the algorithm/software. The study design directly assesses the effect of this standalone digital intervention compared to sleep hygiene education.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth or clinical endpoints were based on patient-reported outcomes data derived from:

• Insomnia Severity Index (ISI) scores: A standardized, self-reported questionnaire.
• Sleep diary data: Self-reported sleep onset latency (SOL) and wake after sleep onset (WASO).
• DSM-5 diagnosis of insomnia disorder: Used as an inclusion criterion for participants.
• Sleep Condition Indicator (SCI-8): A secondary outcome measure.

8. The sample size for the training set

The document does not specify a training set sample size in the context of an AI/ML model for this device. Sleepio delivers Cognitive Behavioral Therapy for Insomnia (CBT-I), which is an evidence-based therapeutic approach. The "training" for such a device would typically relate to the development of the CBT-I content and algorithms based on established clinical guidelines and research in psychology and sleep medicine, rather than a machine learning training dataset in the typical sense for image recognition or diagnostic AI. The software verification and validation are noted, but this refers to engineering and quality assurance processes, not a machine learning training curriculum.

9. How the ground truth for the training set was established

Not applicable directly, as this is not described as a device that uses a trained AI model in the sense of predictive or diagnostic capabilities. Sleepio is a digital delivery mechanism for an established therapy (CBT-I). The "ground truth" for its therapeutic approach is the established principles and efficacy of CBT-I as validated in clinical literature and practice over many years. The clinical study (CrEDIT trial) served as a validation study to demonstrate that Sleepio's digital implementation of CBT-I is effective, rather than a study to establish ground truth for a novel AI algorithm's training.

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