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The Falcon HST is an EEG and respiratory signal recorder. The device is intended for use by adult patients in the home or clinical environment, under the direction of a qualified healthcare practitioner, to aid in the diagnosis of sleep disorders.

The Falcon HST comprises hardware and software which provide separate parameters for recording, review, and analysis of collected and stored physiological parameters, including EEG, EOG, ECG and respiratory signals, which are then used as an aid in the diagnosis of respiratory and/or cardiac related sleep disorders by qualified physicians.

The Falcon system consists of the main unit and the charging cradle. The main unit is a small device that is worn on the patient's chest over clothing. It is equipped with a touch-screen LCD and contains various channel inputs such as for the inductive plethysmography bands, and electrodes. The Falcon charging cradle is used to charge the device, as well as provide a USB interface for transferring study data to the PC.

The manufacturer, Compumedics Limited, demonstrates the substantial equivalence of the Falcon HST to its predicate devices for aid in the diagnosis of sleep disorders. The acceptance criteria and the study that proves the device meets the acceptance criteria are described below.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Falcon HST are based on establishing substantial equivalence to its predicate devices, the Zmachine Synergy (K172986) and Zmachine DT-100 (K101830). The performance of the Falcon HST was deemed acceptable if its capabilities for recording EEG, respiratory effort, respiratory airflow, body position, and pulse oximetry, as well as its software's ability to produce AHI and sleep staging results, were found to be substantially equivalent to the predicate devices and gold standard polysomnography (PSG) data.

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Bench Testing (Side-by-Side Comparison): The text does not specify the exact number of devices or data points used for the side-by-side bench comparison tests between the Falcon HST and Zmachine Synergy for EEG input, respiratory effort, respiratory airflow, body position, and pulse oximetry. The description implies at least one of each device was used, subject to repeated measurements or simulated inputs.
   • Clinical Performance Testing (Profusion PSG Software): The text does not provide a specific sample size for the clinical performance testing used to validate the software's ability to calculate AHI and sleep staging.
   • Data Provenance: The document does not explicitly state the country of origin or whether the data for the mentioned tests was retrospective or prospective. For bench testing, it involved simulated inputs or direct comparison against predicate devices. For clinical performance testing of the software, it's compared against "gold standard polysomnography data," implying real patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • For the clinical performance testing of the Profusion PSG software, the ground truth for AHI and sleep staging was established through "expert review of gold standard polysomnography data." The number of experts and their specific qualifications (e.g., years of experience, specific certifications) are not specified in the provided text.

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

   • The document does not specify an adjudication method for establishing ground truth, particularly for the clinical performance testing where expert review was used.

4. 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:

   • The provided text does not mention an MRMC comparative effectiveness study involving human readers or any AI assistance. The study focuses on the device's equivalence to existing technology and the accuracy of its software against expert-reviewed data, not on human reader performance with or without AI assistance. The Falcon HST is an EEG and respiratory signal recorder, and its software is used to aid in the diagnosis by processing these signals, not primarily as an AI assistance tool for human interpretation in the context of what would typically be considered an MRMC study for AI.

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

   • For the hardware components (EEG, respiratory effort, airflow, body position, pulse oximetry), standalone performance testing was conducted by comparing the Falcon HST's output directly against that of the predicate devices or against angular references/simulated inputs.
   • For the Profusion PSG software 5.1, its ability to calculate AHI and sleep staging was validated by comparing its outputs directly against "expert review of gold standard polysomnography data." This indicates a standalone performance evaluation of the algorithm's output against established ground truth, effectively without human-in-the-loop for the algorithm's calculation step itself. The device is intended "to aid in the diagnosis," implying that its output will be reviewed by a human practitioner.

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

   • For testing the accuracy of AHI and sleep staging calculations by the Profusion PSG software, the ground truth used was expert review of gold standard polysomnography data.
   • For the bench testing of individual physiological parameters (EEG, respiratory effort, airflow, body position, pulse oximetry), the ground truth was established by comparison to the predicate device (Zmachine Synergy) or by using controlled simulated inputs and angular references.

7. The sample size for the training set:

   • The document does not provide any information regarding a training set size. This might be because the device's algorithms or software features (like sleep staging) may have been developed and validated previously, or the submission focuses on demonstrating equivalence to established technologies rather than novel algorithm training. The software, Profusion PSG software 5.1, is mentioned to be identical to versions previously cleared (K072201 and K093223), suggesting its core functionality and training (if any) happened prior to this submission.

8. How the ground truth for the training set was established:

   • As no information about a training set is provided, how its ground truth was established is not detailed in the document.

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