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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 Serenity RIP and Serenity Body Position Sensors are intended to measure and output respiratory effort signals and body position, 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 RIP and Serenity Body Position Sensors are intended for use on both adults and children by healthcare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under the direction of a medical professional.

The Serenity RIP and Serenity Body Position 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 studies use sensors and electrodes to collect, digitize, and send physiological 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 Body Position uses a 3-axis accelerometer to track the patient's body orientation; outputting a voltage which corresponds to one of 5 positions (sitting/upright, supine, prone, left-side, and rightside).

The Serenity RIP Sensor uses respiratory inductance plethysmography to output a waveform which corresponds to patient's respiratory effort. The patient wears an adjustable elastic belt which connects to the RIP driver, the RIP driver then connects to the host device. The Serenity RIP sensor is available for both thorax and abdomen. Thorax and abdomen versions are identical, except that they operate at different frequencies to avoid interference.

The provided text, K173868, details the 510(k) premarket notification for the Serenity Body Position Sensor and Serenity RIP Sensors. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study data with specific acceptance criteria and performance metrics for an AI-powered device. Therefore, a comprehensive answer to your request, particularly regarding AI-specific criteria, human reader improvement with AI assistance, and detailed ground truth establishment, cannot be fully extracted from this document as the device in question is a sensor, not an AI algorithm.

However, based on the information provided for the sensors, here's a breakdown of what can be inferred:

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

The document doesn't provide acceptance criteria and reported performance in terms of clinical accuracy or diagnostic capabilities for the sensors themselves in a traditional table format with quantitative metrics. Instead, it demonstrates compliance with safety and performance standards and comparative performance to predicate devices.

• Humidity Preconditioning
• Determination of Applied Part and Accessible Parts
• Legibility of Marking
• Durability of Marking
• Patient Leakage Current
• Dielectric Voltage Withstand
• Resistance to Heat
• Excessive Temperature
• Ingress of Liquids (IEC 60529)
• Cleaning, Disinfection and Sterilization of ME Equipment and ME Systems
• Enclosure Mechanical Strength (Push, Impact, Drop Test Hand-Held ME Equipment)
• Mold Stress Relief | "All samples passed the acceptance criteria." (for both Serenity Body Position Sensor and Serenity RIP Sensor). The document notes that predicate devices were not found to publish testing to a basic safety standard. |
  | Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility) concerning:
• Radiated Emissions (CISPR11 ed5.0)
• Electro-Static Discharge Immunity Test (IEC 61000-4-2 ed2.0)
• Conducted, Radio-Frequency, Electromagnetic Immunity Test (IEC 61000-4-6 ed2.0)
• Power Frequency Magnetic Field Immunity Test (IEC 61000-4-8 ed2.0) | "All samples passed the acceptance criteria." (for both Serenity Body Position Sensor and Serenity RIP Sensor). The document notes that predicate devices were not found to publish testing for electromagnetic compatibility. |
  | Body Position Sensor Specific | The Serenity Body Position sensor is expected to accurately detect and output signals corresponding to 5 positions: Right Side, Left Side, Supine, Prone, and Upright (Sitting).
  It should also meet specified performance for:
• Position test
• Dielectric strength
• Transition and Hysteresis
• Output Impedance
• Operational Battery Life Calculation
• Dimensional Analysis
• Output Noise
• Connector Tests
• Strap Fasten/Unfasten Cycle
• Wire Construction Test
• Operational Battery Voltage Range Test | "All samples passed the acceptance criteria." The document notes that predicate devices were not found to publish testing details. Comparative testing showed "equivalent performance of the Serenity sensors and the reference devices, using the same host system configurations." |
  | RIP Sensor Specific | The Serenity RIP sensor is expected to accurately detect and output a waveform corresponding to respiratory effort.
  It should demonstrate performance equivalent to the predicate device in detecting respiratory effort from chest or abdomen movement. | Comparative testing showed "equivalent performance of the Serenity sensors and the reference devices, using the same host system configurations." |
  | Predicate Comparison | The Serenity Body Position Sensor and Serenity RIP Sensors should demonstrate substantial equivalence to identified predicate devices (Braebon Ultima Body Position Sensor and Ambu RIPmate for technical characteristics, and Neurotronics Polysmith Sleep System/Nomad Sleep System for overall intended use and integration as accessories). This implies similar physical, electrical, and environmental designs, and no new questions of safety or effectiveness. | The document concludes: "Based on the results of the Intended Use Comparison, the Technical Comparison, and Testing Data, it is believed that the Serenity Body Position Sensor and Serenity RIP Sensors present no new questions of safety and effectiveness and, are substantially equivalent to the identified predicate. Both sensors have similar physical, electrical, and environmental designs. Both share the same intended use." |
  | Biocompatibility | No toxic or irritating effects from patient contact. | "Not Applicable" for the regulatory submission, implying the materials are standard and well-understood for patient contact, or fall under a category where specific biocompatibility testing for this 510(k) was not deemed necessary for substantial equivalence given the context of a sensor accessory. The document notes that predicate devices were not found to publish biocompatibility information. |
  | Sterility | If applicable, the device should meet sterility requirements. | "Not applicable." The document notes that predicate devices were not found to publish sterility information. |

2. Sample sizes used for the test set and the data provenance:

• Sample Size: The document mentions "All samples passed the acceptance criteria" for the safety, EMC, and specific sensor verification tests. However, it does not specify the exact number of samples (devices) used for these tests. It's common for these types of engineering verification tests to use a small, representative sample size (e.g., 3-10 units) rather than large clinical trial numbers.
• Data Provenance: The tests appear to be retrospective engineering verification and validation tests conducted by the manufacturer, Neurotronics, Inc. The document does not specify the country of origin for the data or testing other than being performed by the applicant (Neurotronics, Inc.) located in Gainesville, Florida, USA.

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

This information is not applicable/provided in the context of this 510(k) submission. This submission is for physical sensors that measure physiological signals (body position and respiratory effort) for archival in a polysomnography study. It is not an AI algorithm that performs an "analysis" or "diagnosis" by itself requiring expert consensus on ground truth for an AI test set. The sensors output raw signals, which are then analyzed by a "qualified sleep clinician." The expertise required is in the manufacturing and testing of medical devices to relevant standards, and the comparison is largely on technical specifications and intended use.

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

This is not applicable/provided. Adjudication methods are typically used in clinical studies where multiple human readers interpret medical images or data and their interpretations need to be reconciled to establish a ground truth or resolve discrepancies, particularly for AI algorithm validation. This document describes engineering and performance verification of physical sensors, not a clinical study involving human interpretation consensus.

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 is not applicable/provided. The device is a sensor, not an AI algorithm. Therefore, an MRMC study assessing human reader improvement with AI assistance is not relevant to this submission.

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

This is not applicable/provided. The device is a sensor, not an algorithm, and its output is explicitly stated to be "for archival in a polysomnography study" and for analysis "by a qualified sleep clinician." It is not a standalone diagnostic algorithm.

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

For the sensor performance tests, the "ground truth" is established by engineering measurements and compliance with specified physical and electrical parameters and industry standards. For comparative performance, the ground truth is simply the measured output of both the new device and the predicate device when subjected to the same inputs/conditions, demonstrating "equivalent performance." There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for the sensor's direct output. The interpretation of the sensor data by a sleep clinician in a PSG study implicitly relies on established clinical ground truth for sleep disorders, but this is downstream from the sensor itself.

8. The sample size for the training set:

This is not applicable/provided. This device is a physical sensor, not an AI algorithm that requires a "training set."

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

This is not applicable/provided, as no training set for an AI algorithm is involved.

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The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a sleep study. The physiological signals and conditioned for analysis and display. The data may be analyzed in real-time or offline on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of Sleep Disorders.

The device is intended for use by healthcare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under direct supervision of a medical professional.

The device is intended for use on both adults and children only under the direction of a physician or qualified sleep technician.

The device or any accessory, does not include alarms, and is not intended to be used as a critical component of an alarm system.

The device or any accessory, is not to be used alone as an apnea monitor or as a component in an apnea monitoring system.

The device or any accessory, is not to be used alone as a life support device or as a critical component of a life support system.

The Polysmith Sleep System, Model NTI6600 is intended to amplify and record physiologic potentials used for Polysomnography (PSG) or Sleep Studies. The device consists of a compatible amplifier, head box, PC, patient sensors, and may include optional external devices, USB DC Box, and audio/video input devices.

Compatible amplifiers may use commercially available sensors and electrodes, an internal SpO2 module, and internal pressure transducers to collect, digitize, and send physiological signals to the host PC.

The Polysmith software may record from video, speaker and microphone equipment. The Polysmith software may also record auxiliary signals from compatible amplifiers or USB DC Box which allow for data inputs from compatible sources.

Polysmith records and displays the data for online or offline review. Qualified practitioners use the information to score Polysomnograms and diagnose Sleep Disorders.

Here's a breakdown of the acceptance criteria and study details for the Polysmith Sleep System, Model NTI6600, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as separate performance thresholds the device must meet. Instead, it presents the "Automated Analysis Agreement" as the device's performance, which is then compared against "Average Human Scoring Agreement." Assuming the implied acceptance is substantial equivalence to human performance for these metrics, the table is structured as follows:

In the "Additional Sleep Staging Analysis," which seems to be a more detailed analysis, the total agreement for automated scoring against consensus human scoring is:

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

• Sample Size (Automated Analysis): 8,053 recorded epochs, of which 7,606 were scored.
• Sample Size (Additional Sleep Staging Analysis): 20 sleep studies.
• Data Provenance: The studies were chosen at random from existing sleep studies of acceptable signal quality from accredited labs. For the automated analysis, studies were chosen at random from a sleep lab independent of Neurotronics. The document does not specify the country of origin, but given the FDA submission, it's likely US-based or compliant with US standards. The data is retrospective.

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

• Automated Analysis: Two expert scorers from different organizations. Each is a registered sleep clinician with at least 5 years' experience scoring sleep records.
• Additional Sleep Staging Analysis: Three independent scorers. Each is a registered sleep specialist with at least five years' experience in the field. Each had some prior experience using Polysmith to manually score studies.

4. Adjudication Method for the Test Set

• Automated Analysis: The document states "The human scoring was completed by two expert scorers." It then calculates "Average Human Scoring Agreement," implying an average of their individual scores or comparison. It doesn't explicitly describe an adjudication process for disagreements between the two human scorers to establish a single ground truth for direct comparison with the automated analysis. Instead, it compares the automated system's performance against this average human agreement, and also compares the two human scorers' agreement with each other.
• Additional Sleep Staging Analysis: This section explicitly used a majority method (2/3 majority-rule) to establish the "true sleep staging (consensus)." Epochs where there was no agreement among the human scorers were discarded (non-consensus).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a direct MRMC comparative effectiveness study "with AI vs without AI assistance" was not explicitly described in the context of improving human reader performance. The study focused on the standalone performance of the automated analysis system compared to human scoring. While humans scored the data, the goal was to assess the device's accuracy relative to human experts, not to measure the improvement in human performance aided by the device.

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

• Yes, a standalone performance analysis was conducted. The "Automated Analysis Agreement" and the "Results" section for "Additional Sleep Staging Analysis" directly report the performance of the algorithm itself against human expert assessments (either average or consensus). The scorers for the "Additional Sleep Staging Analysis" were explicitly provided with a version of Polysmith that "did not have any automated analysis capability," emphasizing that the human scoring served purely as ground truth.

7. The Type of Ground Truth Used

• Expert Consensus / Expert Scoring: For both analyses, the ground truth was established by human expert scorers. In the "Automated Analysis," it's based on two expert scorings. In the "Additional Sleep Staging Analysis," it's based on a 2/3 majority rule consensus of three expert scorers.

8. The Sample Size for the Training Set

• Not provided. The document states, "The studies used for this testing were not used to train the algorithm," but it does not specify the size or characteristics of the training set used for the algorithm's development.

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

• Not provided. The document focuses solely on the ground truth for the test sets and explicitly states the test sets were not used for training. Information on how the training data's ground truth was established is absent.

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