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The DormoTech Vlab is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It is intended for use by or on the order of a physician is intended for use on adults in a supervised (hospital) or unsupervised (home) environment.

The DormoTech Vlab is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It consists of: The Head Unit, The Body Unit, and The Central Unit.

This FDA 510(k) summary describes the DormoTech Vlab, a physiological data recorder intended for polysomnography and sleep disorder studies. The acceptance criteria and the study proving it meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" in a tabular format with specific thresholds. However, it presents a clinical study comparing the DormoTech Vlab to a "gold standard PSG study" by evaluating the agreement of various physiological parameters. The "conclusion" section of the clinical study acts as the implicit acceptance criteria, indicating that "Most parameters show good agreement between the devices, as indicated by the mean difference values close to zero and narrow limits of agreement." This implies that the device is considered acceptable if its measurements are statistically comparable to the gold standard.

The table below summarizes the device's performance based on the clinical study's agreement analysis (Bland-Altman statistics) between the DormoTech Vlab and a gold standard PSG (likely the NOX Sleep System, K192469, which is used as a reference).

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 47 subjects.
• Data Provenance: Prospective clinical study conducted in two sleep labs in Israel:
  • Shamir Medical Center – Be'er Ya'akov, Israel
  • Millenium Sleep Clinic - Be'er Sheva, Israel
    The study was "comparative, self-controlled, randomized, prospective study designed to assess the Vlab and compare its performance to a gold standard polysomnogram (PSG) conducted over 1 night in a sleep lab."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not explicitly state the number of experts used for ground truth establishment or their specific qualifications (e.g., "radiologist with 10 years of experience"). However:

• The "gold standard polysomnogram (PSG)" implies scoring by trained sleep technologists or physicians, as PSG analysis typically requires specialized expertise.
• The "Conclusion" section mentions "the role of human scoring," which suggests human experts were involved in generating the ground truth from the gold standard PSG data.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method used for the test set (e.g., 2+1, 3+1, none). It only mentions that the study compared the Vlab's performance to a "gold standard PSG study" with implied human scoring.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study, as typically described (measuring human reader improvement with AI vs. without AI assistance), was not done. The study focused on the standalone performance of the DormoTech Vlab device in comparison to a gold standard PSG system, not on how the Vlab system assists human interpretation.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone performance study was done. The clinical study directly compared the measurements obtained from the DormoTech Vlab ("the device") to those from a "gold standard PSG study." The Vlab device collects and records physiological data for use by "clinical software," and the performance reported is of the device's data collection compared to the gold standard, rather than evaluating the accuracy of any integrated AI for interpretation or how it assists a human.
The 510(k) summary states: "The subject and predicate device are sensor arrays for use in collecting and transmitting data from sleep studies that is analyzed by automated, FDA-cleared software, which is not part of this submission." This reinforces that the Vlab's performance study is focused on its ability to acquire signals accurately, which is then fed into other (cleared) software for analysis.

7. Type of Ground Truth Used

The ground truth used was established via a "gold standard PSG study." This gold standard involves the comprehensive recording of physiological signals during sleep, which are then typically scored and interpreted by trained professionals according to established clinical guidelines (e.g., AASM rules). The measurements from these gold standard PSG studies (e.g., AHI, sleep stages) served as the reference against which the DormoTech Vlab's measurements were compared.

8. Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This is a performance study comparing the device to a gold standard, not a study describing the development or training of an AI algorithm within the DormoTech Vlab itself. The Vlab is described as a "physiological data recorder," and any software for analysis is mentioned as "clinical software used in polysomnography and sleep disorder studies" that is "FDA-cleared software, which is not part of this submission."

9. How the Ground Truth for the Training Set Was Established

As no information about a training set is provided, there is no description of how ground truth for a training set was established.

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