Search Results

The Circadia C100 System is indicated for both contactless spot checking and continuous measurement of respiratory rate data as part of a vital signs assessment. The system records, transmits, and displays respiratory rate from multiple connected devices for retrospective analysis only. The system is intended to be used under the care of clinicians and medically qualified personnel.

The system is indicated for use in adult patients during no-motion conditions, for patients in health care facilities. It is available for sale only upon the order of a physician or licensed health care provider.

The Circadia C100 System is not indicated for active patient monitoring, as it does not provide alarms for timely response in life-threatening situations. It is not intended to monitor vital signs. This system is not an apnea monitor.

The Circadia C100 System consists of three components:

• "The Monitor" - Circadia Contactless Breathing Monitor: The Monitor is a contact-less breathing monitor placed at a bedside table. The Monitor records respiratory rate of adult patients in hospitals and clinical settings (e.g. post-acute care settings such as General Care Floors (GCF), Inpatient Rehabilitation Facilities (IRF), and Skilled Nursing Facilities (SNF)). The Monitor utilizes a UWB-based (Ultra-Wideband based) motion sensor to detect the movement of the abdomen and the chest to derive respiratory data.
• "The App" - Circadia Pro Android App: The App allows Technical Support Staff to setup and configure monitors and allows Clinical Staff to review data collected by the monitors. The App is operated from the central "hub" of a ward or nursing station to monitor data collected by multiple monitors for retrospective analysis only, not for active patient monitoring. The App operates from an Android tablet and uses a USB-C connection for initial configuration. The App is designed to communicate with The Monitor and allow it to connect to a Wi-Fi network and subsequently, The Cloud Service.
• "The Cloud Service" - Circadia Cloud Service: The Cloud Service offers a set of APIs that allows the monitor to connect to server, send respiratory data over a secure channel, and allows the monitor to track Clinical Staff's personal data and the patient's respiratory data.

Here's a breakdown of the acceptance criteria and study that proves the device meets them, based on the provided FDA 510(k) summary for the Circadia C100 System:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Circadia C100 System, specifically for its respiratory rate (RR) accuracy, are derived from the clinical testing results that demonstrated its substantial equivalence to a predicate device.

Note: The document states that the performance met 'acceptance' but does not explicitly list the target acceptance criteria in the format of a table with specific thresholds. Instead, it presents the results of a comparison study intended to demonstrate substantial equivalence to a predicate device and a gold standard. The +/- 2 breaths/min accuracy and the -3.2 to +0.7 breaths/min 95% Limits of Agreements (LoA) are the results that satisfied the FDA's requirements for substantial equivalence for this device.

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

• Sample Size:
  • Comparison to end-tidal CO2 capnography (gold standard): 12 patients
  • Comparison to chest and abdomen worn band (predicate/reference device): 26 patients
  • Total unique patients: While not explicitly stated, it seems these are two distinct sub-studies, leading to a total of 38 unique subjects (12 + 26).
• Data Provenance: Not specified (e.g., country of origin, specific healthcare facilities). The document mentions "patients in health care facilities" (page 2) and "adult patients in hospitals and clinical settings" (page 4), but no specific location.
• Retrospective or Prospective: Not explicitly stated. However, clinical testing for 510(k) submissions typically involves prospective data collection to evaluate real-time performance. Given the details about monitoring various conditions and subject postures, it suggests prospective data collection.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The ground truth for the capnography data is implicitly established by the device producing that data ("manually scored end-tidal CO2 capnography data"). For the chest/abdomen worn band, it serves as a comparative reference rather than a direct ground truth source that required expert interpretation for its output.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. The ground truth was established by readings from established medical devices (end-tidal CO2 capnography and a chest/abdomen worn band), not through expert consensus requiring adjudication.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
• The study design focused on comparing the device's measurements against established methods (gold standard capnography and a predicate band), rather than evaluating how AI (or the device's) assistance improves human reader performance. This device is a measurement device, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance evaluation was done. The "accuracy of Respiration rate" and "95% limits of agreements" reported are for the Circadia C100 system itself, directly measuring the respiratory rate. The clinical testing specifically describes comparing the device's performance against the gold standard and the predicate device.

7. Type of Ground Truth Used

• Clinical/Physiological Reference Data: The primary ground truth was "manually scored end-tidal CO2 capnography data" (from devices cleared in K040875 and K120888), which is considered a gold standard for respiratory rate measurement.
• Comparative Reference: Performance was also compared against data from a "chest and abdomen worn band" (device cleared in K122516), which serves as a predicate/reference device rather than a ground truth in itself.

8. Sample Size for the Training Set

• Not specified. This document is a 510(k) summary for a medical device that uses UWB-based motion sensing, not a machine learning or AI algorithm in the contemporary sense that typically relies on large training datasets for feature learning. While the device certainly processes signals, the document doesn't indicate a machine learning training phase with a distinct training set. The device likely uses signal processing algorithms tuned during development rather than trained on a large dataset in the way a deep learning model would be.

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

• Not applicable, as a distinct training set with established ground truth as for a machine learning model is not mentioned or implied by the description of the device's technology. The device utilizes physical principles (UWB radar to detect chest/abdomen movement) and signal processing, not a data-driven "training" process in the AI/ML context.

Ask a specific question about this device

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:

Ask a specific question about this device

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 an HCP.

The MATRx plus device is a ventilatory effort recorder. 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 oximeter, and respiratory effort sensor. The disposable plastic nasal cannula is connected to the MATRx plus recorder and positioned 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. The Tablet 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 provided text describes a 510(k) premarket notification for the MATRx Plus device, a ventilatory effort recorder. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (K163665 MATRx Plus) and includes modifications to the scoring algorithms.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided information:

Acceptance Criteria and Device Performance

The document doesn't explicitly list "acceptance criteria" in a table format with specific thresholds. Instead, it demonstrates performance through clinical validation and by showing the new features (3% oxygen desaturation index, 3% and 4% apnea-hypopnea index, preceding peak baseline option, and improved event scoring algorithms) produce "adequate results" and that the device has "comparable sensitivity and accuracy" to a cleared predicate.

However, we can infer the implicit acceptance criteria from the clinical validation study's goal: to demonstrate that the autoscoring algorithm for the detection of apneas and hypopneas was accurate, and that its sensitivity and accuracy are comparable to previously FDA cleared devices.

Inferred Acceptance Criteria & Reported Performance:

Note: The document provides very high-level summaries of the testing and the results. Specific quantitative metrics (e.g., exact sensitivity/specificity values, or statistical results demonstrating "comparable" performance) are not detailed within this 510(k) summary.

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: 27 individuals
   • Data Provenance: Subjects had "confirmed or suspected sleep apnea." The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is implied to be prospective clinical validation.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • The document states that the performance was compared to "the gold standard, polysomnography." It does not specify the number of experts (e.g., sleep specialists, polysomnography technologists) involved in interpreting the polysomnography or establishing the ground truth, nor their specific qualifications. It is generally understood that polysomnography interpretation is performed by qualified sleep physicians or technologists.

3. Adjudication Method for the Test Set:

   • The document does not describe any specific adjudication method for the ground truth of the test set beyond stating that polysomnography was the "gold standard." There is no mention of 2+1, 3+1, or other multi-reader adjudication processes.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

   • No. The study described is a comparison of the device's autoscoring algorithm against a polysomnography gold standard, not a comparative effectiveness study involving human readers with and without AI assistance. Therefore, there is no effect size reported for human readers' improvement with AI vs. without AI.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

   • Yes. The clinical validation directly assesses the performance of the "autoscoring algorithm for the detection of apneas and hypopneas" by comparing its output to polysomnography. This is a standalone assessment of the algorithm's performance.

6. The Type of Ground Truth Used:

   • Expert Consensus / Physiological Gold Standard: The ground truth used was polysomnography (PSG), which is considered the clinical gold standard for diagnosing sleep disordered breathing. While PSG involves expert interpretation, the document frames PSG itself as the "gold standard" rather than raw pathological findings or purely outcome data.

7. The Sample Size for the Training Set:

   • The document does not provide any information about the sample size (or any details) of the training set used for the algorithm's development. The focus of this 510(k) summary is on the validation of the modified algorithm.

8. How the Ground Truth for the Training Set Was Established:

   • This information is not provided in the document. As mentioned, the document focuses on the validation of the device's modified algorithms.

Ask a specific question about this device

The Watch-PAT200U (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"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position (SBP) sensor. The WP200U's PSTAGES and SBP provide supplemental information to its PRDI/PAHI. The WP200U's PSTAGES and SBP 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.

The WP200U is indicated for use in patients 12 years of age or greater.

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 (RDI), apnea hypopnea index (AHI)] and sleep staging (Rapid Eye Movement (REM), Light Sleep, Deep Sleep and Wake) based on Peripheral Arterial tonometry (PAT), a non-invasive technology. According to the physician discretion, the WP200U may be connected to an external integrated snoring and body position (SBP) sensor.

The WP200U device consists of the following: (1) a unified PAT and pulse oximeter probe which is used to detect the PAT signal and to measure blood oxygen saturation; (2) an embedded actigraph, which is used to determine periods of sleep based on the motion of the wrist; (3) external integrated snoring and body position sensor — SBP (Optional); (4) electronics, which include a controller that records the signals provided by the PAT finger probe, oximeter, actigraph and SBP; (5) the device software; and (6) a power supply.

The provided text describes the Watch-PAT200U (WP200U) device and outlines its substantial equivalence to a predicate device, primarily focusing on the expansion of its intended use to include an adolescent population (12 to 17 years old). The document highlights performance data and clinical studies used to support this expanded indication.

Here's an attempt to extract the requested information, understanding that certain details like specific acceptance criteria numerical values for RDI/AHI or the number of experts for polysomnography scoring are not explicitly stated in this document.

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device