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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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