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Esprit Nova is a software-only product intended to assist a physician in the diagnostic evaluation of sleep quality and sleep disordered breathing in adults only. Esprit Nova analyzes the physiological signals and automatically scores sleep events; including the stages of sleep, microarousals, snoring, periodic limb movements, desaturations and sleep disordered breathing events apneas, hypopneas, and respiratory event related arousals). This device is to be used under the supervision of a physician. The device does not provide any diagnostic conclusion about the patient's condition.

Esprit Nova is a software application that analyzes previously recorded physiological signals obtained during sleep. The software can analyze any EDF files acquired with Trackit SleepWalker (K010460) Compumedics Somté PSG System( K072201) and/or Sandman (K040113). Automated algorithms are applied to the raw signals to interpret the raw signal information. The software automates recognition of:

• Sleep stages Rapid Eye Movement (REM), nREM (N1, N2, N3) and wake
• Heart rate
• Snoring
• Sleep/wake
• Body position
• Arousals
• EEG, ECG, EOG, EMG waveforms
• Sa02
• Airflow
• Respiratory Effort
• Apneas and Hypopneas
• Oxygen desaturations.
• Limb movements .
  The software identifies and rejects periods with poor electroencephalography signal quality. The output of the device is a comprehensive sleep study report. Medical and history information can be entered from a questionnaire. The automated analysis of physiological data is integrated with the questionnaire data, medical and history information and included in the report. The Esprit Nova analysis module is hosted on a central server, while the administrative module is a stand-alone application for use on Microsoft Windows 7 (or higher) operating system platforms. The administrative module works as a local database to keep records of patients' and to transmit data back and forth to the central server.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for Esprit Nova's performance was to demonstrate equivalence to the reported performance of the predicate device (Sleep Profiler K153412 for sleep staging, and Sandman Elite K153353 for PLM detector) and to "perform equivalently to the gold standard" (panel of 3 electrophysiologists). The table above shows the reported performance and how it compares to these benchmarks.

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

• Sample Size: 60 PSG studies.
• Data Provenance: The studies were from "adult patients that were seen at a Sleep Clinic." The specific country of origin is not explicitly stated, but the submitter's address is in Dundas, Ontario, Canada, which could suggest Canadian data. The studies comprised a mix of diagnoses:
  • 40 studies with varying degrees of Obstructive Sleep Apnea (12 severe, 14 moderate, 14 mild)
  • 1 study for Restless Legs Syndrome
  • 3 studies for Restless Legs Syndrome + OSA
  • 7 Titration studies
  • 9 normal studies
• Retrospective/Prospective: Not explicitly stated, but the description "studies from adult patients that were seen at a Sleep Clinic" typically implies retrospective data collection from existing patient records.

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

• Number of Experts: 3
• Qualifications of Experts: "3 EEG board certified medical professionals" (referred to as "electrophysiologists" in another section).

4. Adjudication method for the test set

• The text describes the ground truth as "a panel of 3 EEG board certified medical professionals scoring studies as done in their daily practice (i.e gold standard)". This implies that the consensus or individual scores of these three experts served as the ground truth. However, the specific adjudication method (e.g., 2+1, 3+1, majority vote, or if each expert's scoring was considered individually against the algorithm's output without inter-expert adjudication for the final ground truth) is not explicitly stated. It just says their scoring was the "gold standard."

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 MRMC comparative effectiveness study was done in the context of human readers with AI assistance versus without AI assistance. The study focused on the standalone performance of the algorithm against expert scores. The "gold standard" was the panel of experts, not human readers assisted by AI.

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

• Yes, a standalone performance study was done. The entire clinical validation section describes the "Algorithm Performance Comparison" of Esprit Nova against the "expert scoring," which establishes its standalone performance.

7. The type of ground truth used

• Expert Consensus/Opinion: The ground truth for the sleep staging and PLM detection was established by a "panel of 3 EEG board certified medical professionals" scoring the studies. This is explicitly stated as the "gold standard."

8. The sample size for the training set

• The document does not explicitly state the sample size used for the training set. It only describes the test set.

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

• The document does not provide information on how the ground truth for the training set was established. It only details the ground truth establishment for the clinical validation (test) set.

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