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The Cadwell ApneaTrak device is intended for home sleep testing, including the acquisition of physiological and environmental data. The recorded signals are then transmitted to a PC so that they can be viewed. ApneaTrak is intended for use on patients older than 2 years of age.

ApneaTrak is intended for use in hospitals, sleep centers and other sleep testing environments, including the patient's home. ApneaTrak is intended to be used when prescribed by a qualified healthcare provider for use on patients suspected of sleep disorders, specifically Sleep Disordered Breathing (SDB) and requires review by qualified medical personnel. ApneaTrak is NOT intended to perform automatic diagnosis.

Cadwell's ApneaTrak is a sleep diagnostic system consisting of: (1) acquisition hardware that can acquire, record, store, and transfer up to 3 channels of ExG (including EEG, EMG, ECG, and EOG signals) data, 2 respiratory effort channels, 1 thermistor channel, 1 pressure channel, 1 snore channel, and 1 oximetry channel; (2) a host electronic device (typically a PC) capable of running the software as well as charging and interfacing with the acquisition device; and (3) software that allows for device configuration and data download.

ApneaTrak is connected, by a clinical user, to a host device via USB cable for initialization. After initialization and having been given instruction on correct clinical use of the device, ApneaTrak is then used by the patient at home. The device acquires and stores physiological and/or environmental data to onboard memory. After use, the device is returned to the clinical user, who connects the device to the host PC. The software downloads and stores data from the device in European Data Format (EDF).

The provided document does not contain an acceptance criteria table detailing specific performance metrics and a study describing how the device meets those criteria with clinical data. Instead, it details that the ApneaTrak device underwent performance testing against recognized electrical safety, electromagnetic disturbance, and performance standards for its various signal acquisition functionalities.

The document indicates that the device's technical specifications and intended use are similar to predicate devices (Zmachine Synergy and Nox T3 Sleep Recorder). The testing primarily focuses on demonstrating compliance with standards and equivalence in signal acquisition performance through bench testing rather than a comparative effectiveness study involving human readers or a standalone algorithm-only performance study.

Here's a breakdown of the available information based on your request:

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

The document does not provide a table of acceptance criteria with specific performance thresholds for diagnostic accuracy (e.g., sensitivity, specificity for identifying sleep disorders) that the device must meet against a ground truth. Instead, it lists the following performance tests and their outcomes:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes "performance bench tests" where "a known oscillating input signal was injected" or "tested in accordance with internal software requirements, system requirements, and usability requirements." This implies laboratory-based testing with simulated data or controlled inputs rather than a clinical test set with patient data. Therefore, there is no sample size of patients or information on data provenance (country, retrospective/prospective) for a clinical test set provided.

3. 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)

Given the nature of the bench testing described (injecting known signals), the concept of "experts establishing ground truth for a test set" as typically understood in AI/clinical validation studies does not apply here. The ground truth for these tests was the "known oscillating input signal" or the performance requirements of the standards themselves.

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

No adjudication method is mentioned, as the testing described focuses on device functionality and signal accuracy against known inputs or standards, not on diagnostic interpretations requiring adjudication.

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 or reported in the provided document. The device is described as a data acquisition system for home sleep testing, and it "is NOT intended to perform automatic diagnosis." The focus is on accurate signal acquisition, not AI-assisted interpretation or improvement of human readers.

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

The document does not describe a standalone algorithm performance study. The device's purpose is to acquire and transmit physiological data for review by qualified medical personnel. It explicitly states, "ApneaTrak is NOT intended to perform automatic diagnosis."

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

For the bench tests, the ground truth was known oscillating input signals or the defined specifications and requirements of the relevant IEC/ISO standards. For the purpose of regulatory substantial equivalence, the ground truth for the device's claims implicitly relies on the predicate devices and their established performance for similar data acquisition.

8. The sample size for the training set

No training set is mentioned as the document does not describe a machine learning or AI-based diagnostic algorithm that would require a training set. The device is an electrophysiological signal acquisition system.

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

As no training set is discussed, this question is not applicable.

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The Nox Sleep System is used as an aid in the diagnosis of different sleep disorders and for the assessment of sleep.

The Nox Sleep System is used to measure, record, display, organize, analyze, summarize, and retrieve physiological parameters during sleep and wake.

The Nox Sleep System allows the user to decide on the complexity of the study by varying the number and types of physiological signals measured.

The Nox Sleep System allows for generation of user/pre-defined reports based on subject's data.

The user of the Nox Sleep System are medical professionals who have received training in the areas of hospital/clinical procedures, physiological monitoring of human subjects, or sleep disorder investigation.

The intended environments are hospitals, institutions, sleep clinics, or other test environments, including patient's home.

The Nox Sleep System is intended for patients undergoing physiological measurements, for the assessment of sleep quality and the screening for sleep disorders.

The Nox Sleep System does not provide any alarms and is not intended to be used for continuous monitoring where failure to operate can cause injuries or death of the patient.

The basic Nox Sleep System consists of two recording/acquisition devices (Nox A1 Recorder and Nox C1 Access Point), a software running on a PC (Noxturnal PSG), an Android application (Noxturnal App) running on mobile platform, along with sensors and accessories. The system supports full Polysomnography (PSG) studies both in ambulatory and online/attended setups but also more simple sleep study setups, recording only few channels. The ambulatory sleep studies may take place in the clinic or in the home environment, but the online/attended sleep studies are only conducted in the clinical environment.

The Nox A 1 Recorder is a small battery-operated recording unit that is worn by the patient during the study. It records signals from patient applied sensors that connect to the unit but also supports recording of signals from auxiliary devices over Bluetooth. The Nox A1 Recorder allows for communication over Bluetooth with the Noxturnal App during ambulatory setup and with the Nox C1 Access Point during online setup. The recorder is intended to be worn over clothing.

New accessories and sensors as part of this submission are the Nox A 1 EEG 5 Lead Gold Electrode Cable and Nox A1 EEG Head Cable that are used for recording of EEG/EOG. These components are in direct contact with the patient.

The Nox C1 Access Point is a separate mains powered unit located remotely from the patient that allows for recording of signals from auxiliary devices. It supports communication over LAN/Ethernet to the Noxturnal PSG, and communication with the Nox A1 Recorder and Noxturnal App over Bluetooth. The Nox C1 Access Point is only used for online study setup and is thus not intended to be used in the home environment.

The Noxturnal App is used as a mobile interface to the Nox A1 Recorder and Nox C1 Access Point. The communications are via Bluetooth link. The app is normally used in the beginning of a sleep study, for basic tasks such as device configuration, starting a recording, checking the signal quality of signals being recorded and marking events during bio calibration.

The Noxturnal PSG is used for configuration of the Nox recording/acquisition devices, to download a study from ambulatory recording or to collect an online study. The software supports the viewing, retrieving, storing and processing of data recorded/collected, manual and automatic analysis and reporting on the results from the recorded studies. The purpose with the automatic scoring function in Noxturnal PSG is to assist the trained physician in the diagnosis of a patient. It is not intended to provide the trained physician with a diagnostic results. The type of automatic analysis events scored by Noxturnal PSG include: Sleep Stages (Wake, N1, N2, N3, REM), Apneas, Hypopneas, Apnea Cassification (Obstructive, Mixed and Central Apneas), Limb Movements, Periodic Limb Movements, SpO2 Desaturation Events. and potential Bruxism-Related Events.

The result of the automatic analysis/scoring must always be manually verified by the trained physician prior to diagnosis.

The Nox Sleep System is designed to aid in the diagnosis of sleep disorders and assess sleep quality by measuring, recording, displaying, organizing, analyzing, summarizing, and retrieving physiological parameters during sleep and wake. The system includes automatic scoring functionalities for various sleep events, which are intended to assist trained medical professionals in diagnosis.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

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

The document presents separate sections for the performance of different automatic scoring algorithms rather than a single consolidated table. However, the information can be extracted and presented as follows:

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

The document states that the clinical performance testing for the automatic scoring algorithms involved "retrospectively analyzing pre-existing clinical data from sleep studies that had already been collected and manually scored as part of routine clinical care."

• Bruxism Analysis: "adult Polygraphy recordings, including masseter EMG signal, recorded from multiple U.S. dental clinics."
• PLM Analysis: "adult Polysomnography recordings recorded at a national hospital serving a general population who seeks medical attention at a sleep clinic."
• Respiratory Flow Analysis (AHI & ODI): "adult Polysomnography recordings recorded at a national hospital serving a general population who seeks medical attention at a sleep clinic."
• Apnea Classification: "adult Polygraphy recordings recorded at a national hospital serving a general population who seeks medical attention at a sleep clinic."
• Sleep Staging Analysis: "adult recordings recorded at a national hospital serving a general population who seeks medical attention at a sleep clinic."

The exact sample size (number of patients/studies) for each test set is not explicitly provided in the given text. The provenance is retrospective and data was collected from U.S. dental clinics (for bruxism) and a national hospital (for other sleep studies).

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

The ground truth for the test set was established by "qualified polysomnographic technologists" who "followed the American Academy of Sleep Medicine (AASM) scoring guidelines."

The number of experts is not specified. Their qualification is: "qualified polysomnographic technologists." No details on years of experience are provided, but adherence to AASM guidelines suggests a standardized and recognized level of expertise.

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

The document states, "All scorers were qualified polysomnographic technologists and followed the American Academy of Sleep Medicine (AASM) scoring guidelines." It then describes comparison of the automatic scoring results to "the results of the manually scored data."

This implies that the manual scoring by the polysomnographic technologists served as the ground truth. There is no explicit mention of an adjudication method (like 2+1 or 3+1) among multiple human scorers for establishing the ground truth. It seems to rely on single-expert scoring as the reference 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 described where human readers' performance with and without AI assistance was evaluated. The study focused on the standalone performance of the automatic scoring algorithms against human-scored ground truth. The device is intended as an aid for professionals, requiring manual verification.

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

Yes, standalone performance was done. The clinical performance testing directly compared the output of the automatic scoring algorithms to the manually scored ground truth data. The results (sensitivity, specificity, PPV, NPV, ICC, Cohen's Kappa, and accuracy) reported are measures of the algorithm's performance on its own.

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

The ground truth used was expert consensus (manual scoring by qualified polysomnographic technologists) following the American Academy of Sleep Medicine (AASM) scoring guidelines. This is a form of expert consensus, even if the "consensus" here refers to the adherence to established scoring rules rather than explicit multi-reader agreement on individual cases.

8. The sample size for the training set

The document details the "clinical performance testing," which involved "retrospectively analyzing pre-existing clinical data." This section describes the test set used for validation.

The sample size for the training set is not provided or mentioned in this document. Information about the training data used to develop the automatic scoring algorithms is absent.

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

Since the document does not discuss the training set, there is no information provided on how its ground truth was established.

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The device is indicated for use by the Health Care Professional (HCP), where it may aid in the diagnosis and assessment of sleep disordered breathing for adult patients.

MATRx plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep.

The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing. The device is intended for home and hospital use under the direction of a HCP.

The MATRx plus is a new ventilatory effort recorder device. The MATRx plus recorder is a 5-channel battery-powered respiratory pressure sensor and oximetry system. MATRx plus provides recordings of respiratory pressure, respiratory effort, pulse rate, oxygen saturation, snoring and body position during sleep. The physician prescribed device is worn on the patient's abdomen attached to a reusable effort belt and all relevant respiratory information during sleep is collected via nasal cannula, pulse oximetry module and respiratory effort sensor. The disposable plastic nasal cannula is connected to the MATRx plus recorder and fixed at the patient's nose. The cannula is dual lumen and functions to individually sample the pressure from each naris. The oximetry sensor is fixed at the patient's finger and connects directly to the device. The Recorder receives input from the sensors and wirelessly transmits the data to a bedside Tablet during the study.

The Tablet is set up through a connection to the web portal by the Health Care Professional (HCP) prior to deploying the device to the patient for use in the home. The Tablet runs the MATRx plus application according to the selected study type, records and stores the data. The MATRx plus application on the Tablet is also used to guide the user through the set up and conduct of the study through a stepwise user interface. At the end of a recording the Tablet advises the patient if sufficient data for analysis were recorded during the night.

After recording, the MATRx plus must be returned to the HCP. The data are automatically uploaded to the secure Portal where they can be accessed and downloaded to the Data Viewer. The Data Viewer can generate a report with the recorded and analyzed data (respiratory pressure, respiratory effort, pulse rate, oxygen saturation) to aid in diagnosis.

The Zephyr Sleep Technologies MATRx plus device, a ventilatory effort recorder for aiding in the diagnosis and assessment of sleep-disordered breathing in adult patients, underwent bench testing and performance comparisons to demonstrate substantial equivalence to its predicate device, the ApneaLink Air (K143272).

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for clinical performance metrics (like sensitivity, specificity for diagnosing sleep-disordered breathing). Instead, it focuses on demonstrating technological equivalence to the predicate device and satisfactory performance in bench testing.

Therefore, the table below reflects the comparison of technological characteristics between the MATRx plus and its predicate device, ApneaLink Air, as presented in the submission. The acceptance criterion is implicit: the MATRx plus should be "substantially equivalent" in its performance and features to the predicate device.

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

The document mentions validation of the "Autoscoring algorithm for ODI" (Oxygen Desaturation Index) by comparing its output with the Snore SAT monitor (K002159).

• Test Set Sample Size: 179 patients.
• Data Provenance: Not explicitly stated (e.g., country of origin). It's mentioned as "data from 179 patients" when comparing the autoscoring algorithm. The study appears to be retrospective, using existing data for comparison.

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

The document states: "Autoscoring algorithm for ODI was compared with the Snore SAT monitor output (K002159) on data from 179 patients."

• This implies that the "ground truth" for the ODI autoscoring comparison was the output of the Snore SAT monitor (K002159).
• The document does not specify the number of human experts, their qualifications, or their role in establishing this ground truth for the test set. It relies on the predicate device's (or reference device's) established output as the comparative standard.

4. Adjudication method for the test set

Not applicable. The ground truth for the ODI autoscoring was based on the output of a previously cleared device (Snore SAT monitor), not on human consensus or adjudication in this specific context.

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 is mentioned for the MATRx plus. The submission focuses on demonstrating substantial equivalence to a predicate device through technological comparison and bench testing, not on assessing human reader improvement with AI assistance.

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

Yes, a standalone performance assessment was done for the Autoscoring algorithm for ODI.

• "Autoscoring algorithm for ODI was compared with the Snore SAT monitor output (K002159) on data from 179 patients."
• This suggests the MATRx plus's algorithm-driven ODI calculation was directly compared to the output of a reference device without human interpretation as part of this specific comparison.

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

For the ODI autoscoring algorithm validation, the ground truth was the output of a legally marketed predicate/reference device, the Snore SAT monitor (K002159). This is a form of "reference device data" ground truth, not pathology, expert consensus, or outcomes data in this specific study.

8. The sample size for the training set

The document does not provide information on the sample size used for training any algorithms within the MATRx plus device. The focus of this 510(k) summary is on demonstrating equivalence, not on detailing algorithm development and training.

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

Not provided in the document. As no information on the training set is included, the method for establishing its ground truth is also absent.

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The AUDICOR System when used with AUDICOR Sensors on the chest wall and properly attached Holter unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting ECG, heart sound, sleep disordered breathing and snoring detection and to provide interpretation of the data in an integrated report for consideration by physicians. The sleep disordered breathing analysis and reporting is intended for use on adult patients only as a screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography based on the patient's score.

Subjects screened for sleep disordered breathing should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature. The AUDICOR recording may be obtained at any location specified by a physician including home, hospital or clinic.

The device is intended for use only under the direct supervision of a physician.

The Audicor CPAM with SDB (Cardiopulmonary Holter with Sleep Disordered Breathing detection) is an ambulatory device that can be used to capture 10second snapshots or up to 48 hours of continuous data from ECG, heart sounds, sleep disordered breathing and snoring detection, and activity level, particularly in patients suspected of heart failure or acute coronary syndrome. The Audicor CPAM with SDB includes software to display, analyze and provide a summary of patient data over time in a trended format. Notable events are detected and displayed for review by the clinician. The Audicor System analyzes and reports the following parameters: Heart rate including bradycardia and tachycardia events . Atrial fibrillation . ECG beat classification and morphology grouping with user-editing . . Heart rate variability . Snoring detection Sleep disordered breathing (apnea/hypopnea) events . Sleep disordered breathing score . Activity level - Heart sound and combined ECG/heart sound measurements - Heart rate distributions of heart sound parameters ●

The clinician can review automatically detected events and measurements, and modify them as well as modify the interpretative statements generated.

The provided text does not contain detailed acceptance criteria or a specific study proving the device meets said criteria in the format requested. It primarily describes the device, its intended use, and states that it complies with certain standards. There is no information on sample sizes, data provenance, ground truth establishment, expert qualifications, or comparative effectiveness studies.

Here's a breakdown of what could be extracted and what is missing, based on the input:

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

• Acceptance Criteria: Not explicitly stated in measurable terms (e.g., sensitivity, specificity thresholds). The document mentions compliance with standards (EN 60601-1, EN 60601-1-2, ANSI/AAMI EC38, ANSI/AAMI EC57) which likely contain performance requirements, but these are not detailed here. For the sleep disordered breathing analysis, it states it's intended "as a screening device...to determine the need for evaluation by polysomnography based on the patient's score," which implies a screening performance standard, but none is provided.
• Reported Device Performance: Not reported in quantitative terms (e.g., specific sensitivity, specificity, accuracy values for any of the detected parameters).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned.

3. 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)

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

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

• Adjudication Method: Not mentioned.

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

• MRMC Study: Not mentioned. The document primarily focuses on the device's technical specifications and equivalency to predicates, not its impact on human reader performance.
• Effect Size: Not applicable as no MRMC study is reported.

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

• The document implies a standalone algorithm performance for features like sleep disordered breathing detection as it mentions "analysis and reporting" and "interpretation of the data in an integrated report for consideration by physicians," suggesting the algorithm generates an interpretation before physician review. However, specific performance metrics for this standalone functionality are not provided.

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

• Type of Ground Truth: Not explicitly stated. For sleep disordered breathing, it implies comparison to polysomnography ("screening device to determine the need for evaluation by polysomnography"), which would likely be the ground truth for that specific function, but this is not confirmed.

8. The sample size for the training set

• Sample Size: Not mentioned.

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

• Ground Truth Establishment: Not mentioned.

In summary, the provided text from the 510(k) K120462 document is a submission for a medical device modification (AUDICOR System - CPAM with SDB). It details the device's capabilities, intended use, and declares substantial equivalence to predicate devices, along with compliance with relevant safety and performance standards. However, it does not include the detailed study design, acceptance criteria, test set specifics, or performance metrics that would be necessary to populate the requested table and answer the study-related questions. Such information would typically be found in more detailed technical reports or clinical study summaries, which are not part of this "Summary of Safety and Effectiveness."

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