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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 DYMEDIX, Inc. Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor are used with existing sleep study recording devices in support of diagnostic recording of respiratory effort and limb movement. The sensors are used with patients who require a sleep study recording.

The Respiratory Effort Belt Sensor and Limb Movement Sensor are reusable devices. The sensors use a self-generating, piezo material technology. The piezo material generates a small voltage in response to stretch, compression and vibration due to motion. The sensors contain no active electronics or software.

The Respiratory Effort Belt Sensor attaches to the patient with a Velcro belt and a cloth strap. The Limb Movement Sensor is applied to the patient with a Velcro belt.

The Respiratory Effort Belt Sensor is applied to the upper chest and/or abdomen. Respiration effort results in stretch of the sensor with chest and/or abdomen circumference change indicative of respiration effort. The sensor transfers this change to a small voltage signal which can be recorded.

The Limb Movement Sensor is applied to the arm, hand, leg or foot of the patient. The sensor translates limb movement into a small voltage signal which can be recorded.

The sensors connect to the user's sleep study recording equipment. The sleep study recording equipment amplifies and conditions the sensor signal to the user's preferences. The sleep study recording device provides electrical isolation for the applied sensors.

Here's a breakdown of the requested information based on the provided text, along with a note on the limitations of the document for this specific request:

The provided text is a 510(k) Summary of Safety and Effectiveness for the Dymedix Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor. It aims to demonstrate substantial equivalence to previously marketed devices rather than presenting a detailed study proving the device meets acceptance criteria in the way a clinical trial for a novel device would. Therefore, much of the requested information about clinical studies, ground truth, and acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy, is not present in this type of document.

This document focuses on:

• Device Description: What the device is and how it works.
• Intended Use: The purpose of the device.
• Technological Characteristics: The materials and basic setup.
• Comparison to Predicate Devices: Establishing that it's similar to already approved devices.
• Safety Information: Biocompatibility and lead wire compliance.

Analysis of Provided Information Against Request:

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

• Acceptance Criteria: Not explicitly stated as performance metrics (e.g., sensitivity, specificity, accuracy thresholds). The "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. This means showing that the new device has the same intended use, technological characteristics, and safety/effectiveness profile as a legally marketed device.
• Reported Device Performance: No quantitative performance data or metrics (like accuracy, sensitivity, or specificity) are reported for the new device or against specific acceptance criteria. The document only generally states: "Laboratory data are presented to establish the performance of the Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor in comparison to predicate sensors." However, the details of this "laboratory data" are not provided in this summary.

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 for Test Set: Not specified.
• Data Provenance: Not specified. The document only mentions "Laboratory data." It does not indicate if this data came from human subjects, animal models, or purely bench testing, nor does it specify if it was retrospective or prospective.

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 applicable/not specified. The nature of the "laboratory data" is not detailed, so there's no mention of experts establishing a ground truth in a clinical context.

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

• Adjudication Method: Not applicable/not specified.

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: No. This device is a sensor, not an AI-powered diagnostic system, so an MRMC study with human readers and AI assistance is not relevant to its type. The document makes no mention of AI.

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

• Standalone Performance: Not applicable. The device contains "no active electronics or software." It generates a raw voltage signal that connects to existing sleep study recording equipment, which then requires interpretation by "Professionals (physicians, clinicians)." It is not an algorithm performing a standalone task.

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

• Type of Ground Truth: Not explicitly stated. Given the comparison to "predicate sensors," the "ground truth" for performance may have been implied as the known and accepted performance of those predicate devices, but the specific methodologies are not described. The document states "Professionals (physicians, clinicians) interpret the recorded signals in support of sleep study diagnosis."

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a passive sensor without software or active electronics, so there is no "training set" in the context of machine learning or algorithms.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary of what the document does provide regarding "studies":

The document primarily relies on:

• Comparison to Predicate Devices: This is the core "study" or justification for a 510(k). The regulatory review determined the new device is "substantially equivalent" to predicate devices (K001030, K923402, K940014) from Dymedix Inc. and Pro-Tech, Inc.
• Laboratory Data: Mentioned generally to establish performance "in comparison to predicate sensors." No details are provided on what this data entails.
• Biocompatibility Testing: Patient contact material biocompatibility is mentioned as provided.
• Regulatory Compliance Certification: Certification of Conformance to FDA Performance Standard for Lead Wires and Patient Cables (21 CFR Part 898) is provided.

Conclusion:

This 510(k) Summary of Safety and Effectiveness document is primarily a regulatory filing to demonstrate substantial equivalence for a non-AI, passive medical device. It does not contain the detailed performance study results, acceptance criteria, or ground truth methodologies typically found in clinical trial reports for novel or software-driven devices. The "study" here is largely a demonstration of similarity to existing, approved devices and adherence to basic safety standards.

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