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The Serenity Piezo and Serenity Thermocouple Sensors are intended to measure and limb movement and thermal respiratory flow signals, respectively, from a patient for archival in a polysomnography study.

The sensors are accessories to a polysomnography system which records and conditions the physiological signals for analysis and display, such that the data may be analyzed by a qualified sleep clinician to aid in the diagnosis of sleep disorders.

The Serenity Piezo and Serenity Thermocouple Sensors are intended for use on both adults and children by healtheare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under the direction of a medical professional.

The Serenity Piezo and Serenity Thermocouple Sensors are not intended for the life monitoring of high risk patients, do not include or trigger alarms, and are not intended to be used as a critical component of:

• an alarm or alarm system;
• · an apnea monitor or apnea monitoring system; or
• · life monitor or life monitoring system.

Serenity sleep sensors are intended to measure and output physiologic signals used for Polysomnography (PSG) or Sleep Studies. These devices are to be used as an accessory to compatible amplifiers.

Typical sleep amplifiers use sensors and electrodes to collect physiological signals to further digitize, and the amplifiers send these signals to a host PC.

Serenity sleep sensors are worn by the patient and connected directly to compatible inputs of an amplifier. The amplifier and related software then processes the signal for review by qualified practitioners to score polysomnograms and diagnose Sleep Disorders.

The Serenity Piezo Sensor uses an embedded piezo sensing element to detect the vibrations of snoring or to sense a patient's limb movement. The sensor outputs a signal which corresponds to movements of the limbs or snore vibrations. The Piezo sensor can be placed on the skin or worn in a heel strap.

The Serenity Thermocouple Sensor uses thermocouple wire that is ioined together to form sensing elements. Thermocouple junctions under each nostril and in front of the mouth output a signal which corresponds to the patient's thermal airflow. The Serenity Thermocouple sensor is available with an optional cannula hanger to aid in patient usability when worn with an airflow pressure cannula.

The Neurotronics Serenity Piezo Sensor and Serenity Thermocouple Sensors are medical devices intended to measure and output physiological signals (snore, limb movement, and thermal respiratory flow) for polysomnography studies. The provided text describes several non-clinical tests conducted to demonstrate the device's performance and safety.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific numerical sample size used for each individual test (e.g., "50 devices were tested"). Instead, it states "All samples passed the acceptance criteria" for electrical safety, piezo sensor verification, and thermocouple sensor verification. The reference device comparison also mentions "comparison testing shows equivalent performance."

• Sample Size: Not explicitly quantified. "All samples" is used consistently, implying a sufficient number were tested to be representative and satisfy the acceptance criteria.
• Data Provenance: The studies are non-clinical testing conducted by the manufacturer, Neurotronics, Inc. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of human patient data. These are engineering and performance validation tests, not clinical trials.

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

This section is not applicable as the tests described are non-clinical engineering and performance validations, not studies involving human interpretation or diagnosis. Therefore, there is no "ground truth" established by human experts in the context of the device's diagnostic performance. The ground truth for these tests is defined by the technical specifications and standards (e.g., signal level, resistance, tensile strength, ISO standards).

4. Adjudication Method for the Test Set

This section is not applicable as the tests are non-clinical and do not involve human interpretation or subjective assessment that would require adjudication. The results are objective measurements against defined technical criteria.

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

This section is not applicable. The device (Serenity Piezo Sensor, Serenity Thermocouple Sensor) is a sensor that collects physiological signals, not an AI-powered diagnostic tool for interpretation by a human reader. Its function is to accurately measure and output signals, not to process them with AI or aid in human interpretation improvement.

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

This section is not applicable. The device is a sensor; it does not contain a standalone algorithm for diagnostic performance. It outputs raw physiological signals for analysis by a polysomnography system and qualified sleep clinician.

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

For the non-clinical tests described, the "ground truth" is based on:

• Technical Specifications: Defined parameters for signal level, electrical properties (dielectric strength, resistance), mechanical properties (connector retention, tensile strength, mating cycles).
• International Standards: ISO 10993 for biocompatibility and IEC 60601-1 for electrical safety.
• Reference Device Performance: The performance of the Serenity sensors was compared to established performance characteristics of predicate and reference devices, implying these established devices serve as a benchmark for "ground truth" equivalence in signal output.

8. The sample size for the training set

This section is not applicable. The device is a sensor, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML development.

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

This section is not applicable for the same reasons as #8.

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The MATRx plus device may also be used with an automated mandibular positioner that uses feedback control to record changes in the patient's respiratory status related to repositioning of the mandible during an overnight study.

MATRx plus uses these recordings to produce a report for the HCP that can be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for therapy with an oral appliance and to recommend a target mandibular position.

The use of the device does not replace the need for follow-up testing to determine the initial and ongoing effectiveness of the therapy as recommended by clinical practice guidelines.

This De Novo request is for an expanded indication (new intended use) for use with an automated mandibular positioner that uses feedback control to record changes in the patient's respiratory status related to repositioning of the mandible during an overnight study.

The device is an automated temporary oral appliance that manipulates the mandible through multiple protrusion levels during an overnight sleep study in the home. The device uses the same interface as the MATRx plus Home Sleep Apnea Test, also from Zephyr Sleep Technologies, cleared under product code MNR, regulation 21 CFR 868.2375, cleared in K163665. These components include the recorder, tablet, oximeter, effector belt, and nasal cannula. The MATRx plus device for a titration study includes a mandibular positioner to determine an optimal titration position based on inputs of airflow and an oxygen desaturation index (ODI) of less than 10 events per hour. The device analyses the collected information and generates a report to assist the Healthcare Provider in the clinical management of oral appliance therapy for patients with mild to moderate obstructive sleep apnea. From this report, patients may be informed on the future efficaciousness of oral appliance (OA) therapy.

Specifically, the clinical management may be assisted by this type of oral appliance assessment study by prospectively identifying patients that are expected to achieve therapeutic success with oral appliance therapy. The oral appliance assessment study also includes the provision of a recommended target protrusive setting for the mandible through use of a legally marketed intraoral appliance (regulated under 21 CFR 872.5570, product code LQZ). The target protrusive setting is the amount of mandibular protrusion where the patient is expected to achieve efficacious therapy with the intraoral appliance and is used by the HCP to more effectively complete the titration process.

The use of the MATRx plus device for an oral appliance assessment study does not replace the clinical titration process or the need for follow-up testing to determine the initial and ongoing therapy as recommended by clinical practice guidelines.

The MATRx plus test identifies patients as suitable for intraoral therapy if a mandible protrusion level can be found where the patient has an oxygen desaturation index (ODI) of less than 10 events per hour with a 4% desaturation criterion.

Here's a structured breakdown of the acceptance criteria and the study that proves the MATRx plus device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Clinical Endpoints

Bench Performance Testing

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

• Sample Size for Test Set:
  • Clinical Study: The document provides "49" for "Successful Identification of Responders" and "2" for "Failure to Identify Responders" in the "Predictive Success Category," and "3" for "Successful Identification of Responders" and "6" for "Failure to Identify Responders" in the "Predictive Failure Category." This totals 49 + 2 + 3 + 6 = 60 participants in the mild to moderate OSA population for the effectiveness endpoints.
  • Human Factors: 15 patients were recruited for each study.
• Data Provenance: The MATRx plus is by Zephyr Sleep Technology, located in Calgary, Alberta, Canada. The clinical study was conducted in a clinical setting (dental professional's office for deployment, home environment for use). The study is prospective, as it involved recruiting participants, conducting the MATRx plus study, and then following up with custom oral appliance therapy.

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

• Number of Experts:
  • Effectiveness Ground Truth (Oral Appliance Outcome): While not explicitly stated how many individual experts reviewed each case, the process involved a "Sleep Health professional" reviewing baseline HSAT data and a "licensed dentist" conducting intraoral exams and subjective interviews post-study. The final determination of "successful treatment with an oral appliance" (ODI

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The RMX is a physiological data recorder intended to collect and record data from multiple physiological channels and additional auxiliary inputs from undesignated channels. It is indicated for use by or on order of a physician. The RMX is intended for use in a supervised (hospital) or unsupervised (home) environment.

The RMX is an ambulatory unattended recording device intended for the recording of sleep physiological data. The RMX functions exclusively as a data-recording device and is not intended to monitor Apnea or other vital signs in an intensive care unit or any other real time application. It is used by or on the order of a physician.

The RMX data recording device offers a platform for collecting multiple channels of physiological signals such as pulse rate, ECG, EEG, airflow, thoracic and abdominal respiratory effort, sounds intensity (i.e. noise due to snoring), body position and movements, leg movement, pulse oximetry or similar physiological signals. The data collection box is normally attached over the clothes of the patient's chest using the chest inductive effort sensor band made of clothing-standard woven elastic laces. The device may use its internal sensors, standard wired physiological sensors or several wireless sensors (not covered in this application) to match the specific needs of the patient.

Data collected is transferred on an SD memory card from the recorder to a PC at the physician's clinic, where it is converted into industry standard EDF format, after which it is analyzed by standard scoring software to generate a detailed final report with recommendations.

The RMX data recording device includes 3 software elements; 1) the SETUP part that runs on a PC and uploads the recorder setup parameters to the SD (secure digital) card as determined by the physician, 2) The Firmware operating the main and auxiliary CPU hardware which control the A/D conversion and storage of the data, and 3) the Post-Study Software which runs on a PC, reads the raw data file from the SD card as a single file and converts it into the industry standard EDF format suitable for input to analytical systems (see section 16 for software description).

This document describes the RMX Physiological Data Recorder, but it does not contain a typical acceptance criteria table with performance metrics and a study comparing those metrics against predetermined thresholds. Instead, it focuses on functional testing to ensure accurate data recording.

Here's an analysis of the provided information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or performance metrics in the way a diagnostic device might (e.g., sensitivity, specificity). The "acceptance criteria" can be inferred from the "FUNCTIONAL TEST" section, which describes the device's ability to accurately record signals.

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

• Sample Size for Test Set: Not specified. The description of the "FUNCTIONAL TEST" implies a single setup (a single device or system under test) where simulated signals were injected. It does not mention a "test set" of patient data or a specific number of tests.
• Data Provenance (country of origin, retrospective/prospective): Not applicable. The test involved "known simulated signals injected to its inputs," not real patient data.

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

• Number of Experts: Not applicable. The "ground truth" for the functional test was the "known simulated signals" that were injected into the device. The output was then compared to these known signals.
• Qualifications of Experts: Not applicable for establishing ground truth. The document mentions that the recorded signals are of "sufficient quality for later analysis by trained experts," but these experts are for downstream analysis, not for establishing the ground truth of the recording capability itself.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The functional test involved comparing the device's output to the "known simulated signals" (the ground truth). There's no mention of human adjudication in this technical verification process.

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

• Performed? No. The RMX is described as a "physiological data recorder," not an AI-powered diagnostic tool. The document focuses on its ability to accurately record data, not on the interpretation of that data by humans or AI. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's functional validation as presented.
• Effect Size: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Performed? Not applicable in the context of an "algorithm only" study for diagnostic performance. The device's primary function is recording, not automated interpretation or diagnosis. The "FUNCTIONAL TEST" describes the standalone performance of the recording system (hardware and firmware) in replicating input signals.
  • If "standalone performance" refers to the device's accuracy in recording data without human intervention, then the "FUNCTIONAL TEST" could be considered a form of standalone performance assessment. It confirms the device's ability to capture and store data correctly on its own.

7. Type of Ground Truth Used

• Type of Ground Truth: Known simulated signals. For the functional test described, the ground truth was the precisely known electrical signals injected into the RMX device's inputs.

8. Sample Size for the Training Set

• Sample Size: Not applicable. The RMX is a physiological data recorder, not a machine learning model that requires a training set. Its functionality is based on hardware design and firmware logic, not learned patterns from data.

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

• How Established: Not applicable, as there is no training set for this type of device.

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The WIM-PCTM is intended for the analysis, interpretation and documentation of lung sounds. The WIM-PC™ is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds.

The WIM-PC™ is a computer based electronic stethoscope that utilizes two contact sensors simultaneously to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea and thorax and provides high fidelity audio outputs, visual displays and printed reports. The WIM-PCTM system consists of: Acoustic sensors (attached to the patient using adhesive pads), Sensor pod with a built-in dielectric microphone for ambient noise pick-up, Tension-sensitive respiration belt, A/D data acquisition device, USB cable and signal cable, Laptop PC unit with Data Analysis software.

The provided document is a 510(k) summary for the WIM-PCTM device by KarmelSonix Israel Ltd. It focuses on demonstrating substantial equivalence to a predicate device (PulmoTrack™ model 1010) and outlines the validation tests performed. However, it does not contain detailed information about specific acceptance criteria, comprehensive study results (like sensitivity/specificity, effect sizes), or the detailed methodology of how ground truth was established for a testing or training set in the way a clinical study report would.

Therefore, I can only extract limited information based on what is present in the document.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Wheeze detection validation test" and "Breath detection validation test" as performed on the software, but it does not provide specific numerical acceptance criteria (e.g., minimum sensitivity, specificity, or agreement rates) nor does it report the quantitative performance results of these tests.

2. Sample Size and Data Provenance for the Test Set

The document does not specify the sample size used for the "Wheeze detection validation test" or "Breath detection validation test." It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

The document does not mention the number of experts used or their qualifications for establishing ground truth in the reported validation tests.

4. Adjudication Method (Test Set)

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, no effect size for human reader improvement with AI assistance can be determined from this text.

6. Standalone Performance Study

Yes, a standalone validation was performed for the device's software components. The document explicitly states:

• "The following validation tests were performed on the WIM-PCTM software:
  • Wheeze detection validation test.
  • Breath detection validation test."
    However, the actual performance metrics (e.g., sensitivity, specificity, accuracy) are not reported.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the "Wheeze detection validation test" or "Breath detection validation test." Given the nature of pulmonary sound analysis, it's highly likely to be expert consensus (e.g., auscultation by physicians) or potentially correlated with other clinical findings, but this information is not provided.

8. Sample Size for the Training Set

The document does not specify the sample size used for training the software algorithms.

9. How Ground Truth for the Training Set was Established

The document does not describe how the ground truth for the training set was established.

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