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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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The WatchPAT™200U (WP200U) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200U is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Deep Sleep and Wake), snoring level and body position. The WP200U generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), Central Apnea-Hypopnea index ("PAHIc"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position sensor. The WP200U's PSTAGES and snoring level and body position provide supplemental information to its PRDI/PAHIC. The WP200U's PSTAGES and snoring level and body position are not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.

PAHIc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older.

The Watch-PAT200U System (WP200U) is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200U is a diagnostic aid for the detection of sleep related breathing disorders Respiratory disturbance index (pRDI), apnea - hypopnea index (pAHI), central apnea - hypAHIc) and sleep staging (Rapid Eye Movement (REM), Light Sleep, Deep Sleep and Wake) based on Peripheral Arterial Tonometry (PAT), a non-invasive technology. In accordance with physician discretion, the WP200U may be connected to a chest sensor for measuring snoring level, body position states and chest movements.

The WP200U device consists of the following: (1) unified finger PAT probe to measure PAT and oximeter signals; (2) actigraph, which provides a signal that is used to determine periods of sleep/wake based on the motion of the wrist; (3) chest sensor to measure snoring level, body position and chest movements (optional); (4) electronics, which include a controller that records the signals provided by the uPAT finger probe, actigraph and chest sensor; (5) Tamper-Proof Bracelet (Optional); (6) power supply; (7) Wrist strap and (8) Management and Analysis Software Program.

The subject WP200U introduces new algorithms to its software allowing the identification of arrhythmia events occurred during the night - Atrial Fibrillation and Premature Beats.

Beside the introduction of the new arrhythmia information, the SW provides identical output information as that previously provided for the predicate.

The additional arrhythmia information presented by the modified WP200U device follows the AASM (American Academy of Sleep Medicine) guidelines to provide the sleep physician with information regarding cardiac events occurred during the night. The WP200U arrhythmia feature is to be used for informational use only, to flag patients suspected of having arrhythmias, thereby aiding the physician to decide if further arrhythmia investigation is needed. The device is not intended to be used as a diagnostic device for cardiac arrhythmia and it is not intended to replace traditional methods of diagnosis. The WP200U's arrhythmia detection is not intended for use in life supporting or sustaining systems or monitor and alarm devices.

The new analysis provides the sleep physician with additional information to that of the WP200U cleared capabilities of detecting sleep disorders, to be considered in conjunction with the physician's knowledge of patient background, clinical history, symptoms, and other diagnostic information.

Here's a breakdown of the acceptance criteria and the study details for the Watch-PAT200U (WP200U) device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a detailed, quantitative table within the provided document. However, the document describes the clinical testing performed to evaluate the device's ability to identify cardiac arrhythmias (Atrial Fibrillation and Premature beats). The reported performance is generally stated as "acceptable performance" against a "Gold Standard."

Given the information, we can infer the acceptance criteria would be related to the accuracy of arrhythmia detection. The table below represents the available information and how performance against these implied criteria is reported:

Study Details that Prove the Device Meets Acceptance Criteria

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

   • Sample Size: One hundred and fifty-seven (157) subjects.
   • Data Provenance: The document does not explicitly state the country of origin. It indicates that subjects were evaluated in an overnight sleep study using the subject device and a single-lead ECG in a sleep lab. This suggests it was likely a prospective study.

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

   • Number of Experts: Not explicitly stated, but the ground truth was established by "cardiologist-scored ECG channel." This implies at least one cardiologist, and potentially multiple for consensus, reviewed the ECG data.
   • Qualifications of Experts: "Cardiologist-scored." Specific years of experience are not mentioned, but a cardiologist is a highly qualified medical professional specializing in heart conditions.

3. Adjudication method for the test set:

   • The document does not explicitly describe a specific adjudication method like "2+1" or "3+1." It simply states "cardiologist-scored ECG channel" was the "Gold Standard," implying their scoring was accepted as the truth.

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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done. The study focuses on the standalone performance of the device's arrhythmia detection algorithm against a gold standard, not on how human readers (physicians) might improve with AI assistance.

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

   • Yes, a standalone study was done. The clinical performance testing evaluated "the capability of WP200U to identify arrhythmic events," directly comparing the device's outputs to the "Gold Standard" cardiologist-scored ECG data. This is a standalone assessment of the algorithm's performance.

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

   • Expert Consensus/Diagnosis: The ground truth for arrhythmia detection was established by a "cardiologist-scored ECG channel of a polysomnography (PSG)." This falls under expert diagnosis from a recognized "Gold Standard" method.

7. The sample size for the training set:

   • The document does not provide the sample size for the training set. It only describes the clinical testing performed to evaluate the device, which would typically be a test set after training and development.

8. 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, as it doesn't mention specifics about the training process or dataset.

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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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The X8 System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, transmit, and display physiological signals from adult patients. All X8 models (SP40, SP29, and XS29) acquire, record, transmit, and/or display electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic signals. Model SP29 additionally includes a nasal pressure transducer and cannula (for airflow), thoracic and abdomen respiratory effort, and pulse rate and oxyhemoglobin saturation from the finger. The X8 system only acquires and displays physiological signals; no claims are being made for analysis of the acquired signals with respect to the accuracy, precision, and reliability.

The X8 System is indicated for acquiring, recording/storing, transmitting, and displaying physiological data in patients. It can be used by patients in the home, healthcare facility, or clinical research environment. Patients can move within their home or healthcare environment without having to remove the device (e.g. walk to the restroom).

The X8 System is comprised of the X8 device which is worn on the patient's head and body, accessories, the Device Manager software, and the X-Series Basic-Utility Software. The study records are saved to the PC in EDF format and are available for analysis by third party software applications, such as Persyst Reveal (K011397).

The X8 System combines hardware, firmware, and software to acquire physiological signals. It acquires physiological data through a battery powered headset worn by the patient and provides a flexible platform for applying sensors and acquiring signals from multiple locations on the head or body, transmitting and recording the signals, and providing visual and auditory indications to ensure high quality data are obtained.

Model SP40 Sleep Profiler is applied by the patient to acquire and record electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic signals during sleep. This model utilizes the X8 Sleep Profiler Strip.

Model SP29 Sleep Profiler PSG2 is applied by the patient to acquire and record electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic signals during sleep. This model additionally includes a nasal pressure transducer and cannula (for airflow), thoracic and abdomen respiratory effort, and pulse rate and oxyhemoglobin saturation from the finger. This model utilizes the X8 Sleep Profiler Strip.

Model XS29 X8 Stat is applied by a technician to acquire, record, transmit, and/or display electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic signals acquired during non-sleep conditions. This model utilizes either the X8 Midline or the X8 Referential strip.

The Device Manager software application provides a means to communicate with the X8 Device, transfer study data, and format a device. The software transfers data saved in the memory of the X8 device using either a PC application or a web-based data entry application operating in a cloud server environment.

The X-Series Basic-Utility Software acquires, presents, and stores physiological signals from the X8 Device. The software has a modular architecture that allows the users to interact using either the Graphical User Interface (GUI) provided with the installation, or programmatically via a Software Development Kit. Additional functionalities provided by X-Series Basic-Utility Software include impedance measurements, custom markers, and interface with the Bluetooth Receiving Dongle.

Here's a breakdown of the acceptance criteria and study details based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Device: X8 System (Sleep Profiler (SP40), Sleep Profiler PSG2 (SP29), Stat X8 (XS29))
Study Type: Prospective Comparison and Self-Application Study of X8 System Model SP29

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

• Test Set Sample Size:
  • For comparison of airflow and respiratory effort signals (part A of the study): The specific number of breathing events analyzed is provided (225 for thorax, 232 for abdomen), but the number of subjects contributing to these events is not explicitly stated.
  • For self-application and signal quality (part B of the study): 11 subjects.
  • For audio alerts acceptance criterion: 10 subjects (one subject was excluded from this analysis).
• Data Provenance: The study was described as "prospective," indicating that the data was collected specifically for this study under controlled conditions defined prior to data collection. The document does not specify the country of origin for the data.

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 or their qualifications for establishing the ground truth for this comparative study. However, the ground truth for part A (comparison of signals) was implicitly the readings from the predicate device, Compumedics Somte (K072201), an FDA-cleared device. For part B (self-application and signal quality), the ground truth for signal quality likely involved assessment against predefined criteria or by qualified personnel, but this is not detailed.

4. Adjudication Method for the Test Set

The document does not specify an explicit adjudication method (e.g., 2+1, 3+1). For the comparative study (part A), the comparison was against an "FDA cleared device," implying the predicate device's output served as the reference standard. For self-application (part B), signal quality was assessed, presumably against accepted norms for such physiological signals, but no multi-expert adjudication process is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or described in this document. The X8 System "acquires and displays physiological signals; no claims are being made for analysis of the acquired signals with respect to the accuracy, precision, and reliability." Therefore, this device does not involve AI analysis or human reader interpretation for diagnostic claims, but rather accurate signal acquisition.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device's intended use is to "acquire, record, transmit, and display physiological signals." It does not include automated analysis or diagnostic algorithms. Therefore, a standalone algorithm performance study was not applicable and not done. The focus of the performance study was on the quality and equivalence of the acquired physiological signals.

7. The Type of Ground Truth Used

• For comparison of airflow and respiratory effort signals (Part A): The ground truth was based on the signals obtained from an FDA-cleared predicate device (Compumedics Somte (K072201)).
• For self-application and signal quality (Part B): The ground truth for "valid" recording time and "high EEG quality" would have been established by assessing the acquired physiological signals against accepted physiological standards and criteria for signal integrity, likely by trained professionals. The specific method of establishing this ground truth is not detailed beyond the term "good data."

8. The Sample Size for the Training Set

The document describes "prospective studies" for verification and validation. Given that the device's function is signal acquisition and display, and no claims for analysis accuracy or reliability are being made, there isn't a "training set" in the context of machine learning. The studies described are performance evaluations of the hardware and software's ability to accurately capture and transmit signals.

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

As noted above, no "training set" in the machine learning sense is described for this device. The ground truth for performance evaluation was established through comparison with a predicate FDA-cleared device and assessment against physiological signal quality standards.

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