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Modius Sleep is a non-invasive, home-use neurostimulation device to treat chronic insomnia in adults aged 22 and older.

Modius Sleep is a low-risk non-invasive transdermal neurostimulation device to treat chronic insomnia. The proposed mechanism of the device is through a technology known as electrical vestibular nerve stimulation (VeNS).

It consists of a battery-powered device designed to transcutaneously deliver low-level electrical energy (up to 1mA) to the skin behind the ears, over the mastoid processes. The delivery of this neurostimulation is through two self-adhesive electrode pads. These pads are placed on the skin behind each ear (mastoid area). The intensity of the electric pulse can be adjusted up or down by the user. When turned on, the device delivers a small electrical impulse which stimulates the vestibular nerve. Adjustments to the stimulation level may be made using the up and down buttons on the device, which are located just above the power button. The device can also be paused by pressing the power button twice. When finished the user removes the device and disposes of the electrode pads after each use. When the device is not being used it can be charged through a micro-USB cable. For safety reasons, it is not possible to recharge the battery while the device is in use in stimulation mode.

The key components of the Modius Sleep include the Modius Sleep device (plastic enclosure and printed circuit board assembly (PCBA), stimulation pads (K210448 and K132588), skin cleansing wipes (K121655) and charging accessories. The PCBA consists of a microcontroller, USB connector (charging only), transformer driver, IO expander and EEPROM memory. The embedded software within the device manages overall functionality of the device from Stimulation Control, Power Management, and user interaction (Indication LED and Audio tones).

The provided text is a 510(k) Summary for the Modius Sleep device. It details a clinical study to demonstrate the device's safety and effectiveness for treating chronic insomnia. Here's a breakdown of the requested information based on the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for performance in a table format. However, it defines the primary effectiveness endpoint as a "change in the Insomnia Severity Index (ISI) score at Week 0 and Week 4 between the Modius Sleep group and sham control group." The study then reports the mean change and statistical significance. The implicit acceptance criterion is a statistically significant greater reduction in ISI score for the Modius Sleep group compared to the sham control.

Note: The table uses data from the "Complete case" analysis as it represents those who adhered to the intervention and showed a statistically significant difference in Model 1. Other models and ITT analyses are also provided in the document.

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

• Test Set (Participants with available data for analysis): 126 participants (61 in Modius Sleep group, 65 in Sham control group for complete case analysis). A total of 149 participants were enrolled and randomized (75 Modius Sleep, 74 Sham control).
• Data Provenance:
  • Country of Origin: United Kingdom (UK) and Hong Kong (HK). The UK site also included remote recruitment from the Republic of Ireland (ROI).
  • Retrospective or Prospective: Prospective. The study was a "4-week pivotal 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 mention the use of experts to establish a "ground truth" for the test set in the traditional sense (e.g., radiologists interpreting images). Instead, the "ground truth" for insomnia diagnosis and severity (ISI scores) was established via self-reported patient outcomes and an online survey based on clinical diagnostic criteria (AASM ICSD and DSM-V) prior to enrollment. There is no information provided about the number or specific qualifications of experts involved in the initial diagnosis or ISI score evaluation for the study participants, beyond the general statement that "further information was collected by an online survey to establish that the participants had chronic insomnia at the time of enrolment as defined by ICSD and DSM-V."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This was a clinical trial evaluating a treatment device based on self-reported patient outcomes (ISI scores), not an AI device requiring reader adjudication of findings.

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

Not applicable. This study evaluated a medical device for treatment of insomnia in a direct patient-use scenario, not an AI-assisted diagnostic tool for human readers.

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

This was a clinical trial of a medical device used by patients, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. The device's performance is inherently tied to human interaction (patient use).

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

The "ground truth" for effectiveness was outcomes data based on the Insomnia Severity Index (ISI) scores, which are a validated patient-reported outcome measure for insomnia. The initial diagnosis of chronic insomnia for inclusion criteria was based on patient self-reporting via an online survey aligned with AASM (American Academy of Sleep Medicine) International Classification of Sleep Disorders (ICSD) and The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria.

8. The sample size for the training set

Not applicable. This clinical study evaluated the device's performance in a randomized controlled trial. There is no mention of a "training set" in the context of an algorithm or AI development.

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

Not applicable, as there was no training set in the context of an algorithm.

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