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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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SleepSense sensors provide a qualitative measure of a patient's physiological parameters for recording onto an FDA-cleared data acquisition system. Their target population: Children and adult patients who are screened during sleep disorder studies. Their environment of use is usually at a sleep laboratory or sometimes at the patient's home.

Monitoring various physiological parameters is standard practice in sleep disorder testing. Standard overnight recordings show, among others, traces of parameters like respiration movement, leg and arm movement, snoring sounds, respiration airflow and body position during sleep.

In order to record tracings showing these parameters, sensors are needed to convert the physiological parameter into an electrical signal. These sensors are very simple sensing elements like piezo-crystals that convert mechanical force or vibrations to an electrical signal. Other sensing elements may be thermocouples which generate a signal proportional to temperature, or gravity switches, that switch and electrical circuit on and off depending on their position.

In practice, these sensing elements are packaged in small, patient-friendly enclosures which are applied to the patient, and connected to the recording system via a long and flexible cable. There is no electrical contact of any kind between the sensors and the patient.

All signals received from the sensors are qualitative, and are only used to record the dynamic nature or existence of the physiological parameter recorded. A specially trained sleep technician called "scorer" reviews the overall recording in the morning following the study. The signals recorded, together with additional channels like EKG or EEG, are analyzed to arrive at a diagnosis of a sleep disorder like sleep apnea or insomnia.

This 510(k) summary for the SleepSense Sleep Sensors outlines the device's classification, intended use, and substantial equivalence to predicate devices. However, it does not include any specific acceptance criteria or details of a study demonstrating the device meets such criteria.

The document states:

• "No performance standards are specified for physiological sensors for sleep disorder testing."
• The manufacturer claims substantial equivalence because they are the OEM manufacturer for the predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them because this information is not present in the provided text.

Based on the provided text, I can only confirm the following:

• 1. A table of acceptance criteria and the reported device performance: This information is not provided.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not 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): Not provided.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
• 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: Not provided. The device is a sensor, not an AI system for clinicians.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as it's a sensor providing qualitative signals for human interpretation.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided.
• 8. The sample size for the training set: Not applicable, as it's a sensor without a "training set" in the context of an algorithm.
• 9. How the ground truth for the training set was established: Not applicable.

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Intended Use:
The Stardust is a respiratory disorder diagnostic device that is intended to measure and record five parameters. These parameters are percent SpO2 (functional), pulse rate, oral/nasal airflow, respiratory effort, and body position (i.e., supine or non-supine). It can also be connected to a Respironics Virtuoso Smart CPAP System to record and display continuous positive airway pressure (CPAP) and ainway index level.

The Stardust can be used as a stand-alone unit for recording data. It also interfaces with a commercially available IEC 950 compliant computer, which enables you to view data real-lime in a recording mode. The Stardust does not have any audible alarms and, therefore, should not be used for continuous monitoring of oxygen saturation or as a replacement for pulse oximeter monitors.

Indications for Use: The Stardust is indicated for use in the diagnosis of respiratory disorders, such as sleep apnea.

A low-power, diagnostic, recording device that interfaces with predefined sensors, and processes and records physiologic patient data.

The Stardust is a respiratory disorder diagnostic device that is intended to be used to measure and record five parameters. These parameters are:

• D percent SpO, (functional)
• 0 pulse rate
• oral/nasal airflow
• 0 respiratory effort
• body position (i.e., supine or non-supine) o

It can also be connected to a Respironics Virtuoso Smart CPAP System to record and display continuous positive airway pressure (CPAP) and airway index level. The Stardust can be used as a stand alone unit for recording data. It also interfaces with a commercially available IEC 950 compliant computer and can be used to view data real-time in a recording mode. The Stardust does not have any audible alarms and, therefore, should not be used for continuous monitoring.

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets those criteria. Instead, it describes the Stardust device, its intended use, software capabilities, and general safety and effectiveness testing to demonstrate substantial equivalence to predicate devices (HMS 4000 and HMS 5000).

The document mentions:

• "Testing was performed to demonstrate that the performance of the Stardust in its intended environment is as safe and effective as that of the legally marketed predicate devices."
• "The safety and effectiveness of Stardust were verified through performance-related testing that consisted of Electrical Safety, Electromagnetic Compatibility, Mechanical and Environmental Testing."
• "The Stardust was tested and found compliant with the standards referenced in the 'Draft FDA Reviewer Guidance for Premarket Notifications,' November 1993."

However, it does not provide:

• A table of specific numerical acceptance criteria (e.g., accuracy thresholds, sensitivity, specificity values).
• Reported device performance against such criteria.
• Details about a clinical study involving a test set, ground truth establishment, sample sizes, expert qualifications, or adjudication methods for diagnostic accuracy.
• Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or a standalone algorithm-only performance study.
• Sample sizes or methods for establishing ground truth for training data.

The software section describes "manual scoring" and "automatic scoring" rules for identifying apneas and hypopneas based on parameters like minimum event duration and peak inspiratory value percentages. While these are rules for the algorithm's operation, they are not presented as acceptance criteria for the device's diagnostic performance against a clinical ground truth.

Therefore, requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not available in the provided text.

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