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The N10, N12, N15, N10MPro, N12MPro, NM15Pro Multi-parameter Patient Monitors are intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 12-lead selectable), Arrhythmia Analysis, ST Segment Analysis, QT Analysis, Heart Rate (HR) and Heart-Rate-Variability(HRV)), interpretations of resting 12-lead ECG, Respiration rate(Resp), Temperature(Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Carbon Dioxide (CO2). The N10MPro, N12MPro, NM15Pro Multi-parameter Patient Monitors are also intended for monitoring, displaying, reviewing, storing, alarming and transferring of physiological parameters including Masimo Rainbow SpO2, Anesthesia gas (AG), oxygen (O2) respiratory gas monitoring, Bispectral Index (BIS), Respiration Mechanics (RM) and Neuromuscular Transmission Monitoring (NMT). All the parameters can be monitored on single adult, pediatric, and neonatal patient except for the following:

• Arrhythmia analysis is intended to use on adult patients only and is not intended and shall not be used on pediatric and neonatal population.
• NIBP measurement continual mode is not applicable to neonates.
• When using COMEN SpO2, the monitor is intended to be used on adult patient only.
• PAWP is intended for adult and pediatric patients only.
• C.O. measurement is intended for adult patients only.
• BIS monitoring is intended for adult patients only.
• RM is intended for adult and pediatric patients only.
• NMT monitoring is intended for adult and pediatric patients only.

The monitors are to be used in healthcare facilities by healthcare professionals or under their guidance.

The Multi-parameter Patient monitors are not intended for emergency and transport use, aircraft environment or home use.

The monitors are not intend for use as apnea monitors.

The monitors are not intended for use in MRI or CT environments.

The monitors are not used on patients who have a demonstrated need for cardiac monitoring known arrhythmias of VT, Accelerated Idioventricular rhythm and Torsades de Pointes.

There are six (6) models under evaluation, namely N10, N12, N15, N10MPro, N12MPro, N15MPro. All models share the same intended condition of use, the same intended patient population and operator profile, biological safety characteristic and principle of operation. All these models are the same on electric and electrical circuit and components, mechanical construction, software and alarm system. The only difference lies on the screen and configuration of with/without plug-in module slot and the number of battery packs.

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Cadwell Hypnos is a software application used for Polysomnography (PSG) and other clinical sleep studies. It is intended for use by research and clinical sleep professionals. It measures, records, displays, organizes, analyzes, summarizes, and retrieves physiological signals during sleep and wake used to assist in the assessment of sleep and the diagnosis of various sleep disorders including sleep related breathing disorders. The software can be used for analysis (computer-assisted as well as manual scoring of events), display, retrieval, summarization, reporting and networking of data received from devices used to monitor sleep related parameters.

Hypnos is indicated for use in all sleep disorders patient populations from neonate to adult, including infants, pediatrics and geriatric populations. Computer-assisted analysis features of the application are only intended for use on adults.

Hypnos is only indicated for use by trained medical professionals for the purpose of assessing sleep disorders.

Intended environments include hospitals, institutions, sleep centers, sleep clinics, and other sleep disorders testing environments.

Hypnos is NOT intended to be used to perform automatic diagnosis.

Hypnos software is used to acquire, record, transmit, analyze, store, manage, report, and display physiological and environmental data collected by PSG and/or HSAT hardware. Hypnos software allows users to analyze signals both manually and using detectors to facilitate interpretation of a sleep study by a qualified user.

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HippoMind is a software application that displays neuroimaging and neurosignaling data for review by a health care provider. It provides simple tools for analysis of both medical images and EEG/MEG data. It also allows for storage and transfer of data, and association of data with electronic health records. It is intended for use by qualified health care professionals.

HippoMind is a cloud-based software platform designed for neurologists and neurodiagnostic technologists to review neurophysiological and neuroimaging data. It provides secure, remote access to patient data, through an intuitive interface, to support clinical decision-making.

The platform includes two main modules:

Neurophysiological signal platform: This module enables the review of EEG and MEG data with customizable settings such as amplitude, filtering, and channel templates. It features a labeling system to annotate events, and advanced signal visualization with topological energy graphs. The platform supports Natus EEG, EDF, and CTF MEG formats.

Neuroimaging Review Platform: This module displays 3D MRI, CT, PET, and SPECT images in DICOM or NiFTI format. It offers flexible viewing options, including 3D rendering, customizable color schemes, annotation tools, and an overlay system to superimpose imaging modalities (e.g., T1 and T2 images) using affine transformation.

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NX01 is intended for use in healthcare or home settings to acquire, record, and transmit electrical activity of the brain by placing non-invasive electrodes in the ears of patients. It acquires, records and transmits one channel of electroencephalogram (EEG) data. The medical use of data acquired by NX01 is to be performed under the direction and interpretation of a licensed medical professional. NX01 does not provide any diagnostic conclusions about the patient's condition.

The NX01 is intended for use with adult and pediatric patients (6+).

NX01 is a wearable device for continuous recording of non-invasive EEG signals in healthcare and home settings. NX01 is intended to be prescribed by a trained healthcare professional. It consists of a pair of earbuds (one per ear) integrating a pair of active, dry electrodes, connected by a cable to a command panel. This command panel houses the battery, the internal memory to store the data, the main acquisition unit with function buttons and LEDs which display the device's status.

The NX01 solution is composed of:

• Two earbuds (1) connected by 45 cm cables, to a command panel (5). This command panel houses the battery, the internal memory to store the data, the main acquisition unit with function buttons (2 - Left button and 3 - Right button) and LEDs (4) which display the device's status.
• A set of eartips, to be placed on the earbuds for the recording. Eartips are single use consumable that should be discarded and replaced for every recording that takes place.
• A medical grade PSU with the following specifications: Input AC 100-240V, 50/60Hz; Output USB-C DC 5.0V, min 1.0A; Compliance IEC 60601-1, IEC 62368-1 or IEC 60950-1.

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The Ceribell Infant Seizure Detection Software is intended to mark previously acquired sections of EEG recordings in newborns (defined as preterm or term neonates of 25-44 weeks postmenstrual age) and infants less than 1 year of age that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces. The Seizure Detection Software also provides notifications to the user when detected seizure prevalence is "Frequent", "Abundant", or "Continuous", per the definitions of the American Clinical Neurophysiology Society Guideline 14. Delays of up to several minutes can occur between the beginning of a seizure and when the Seizure Detection notifications will be shown to a user.

The Ceribell Infant Seizure Detection Software does not provide any diagnostic conclusion about the subject's condition and Seizure Detection notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.

The Ceribell Infant Seizure Detection Software is a software-only device that is intended to mark previously acquired sections of EEG recordings that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces.

Ceribell Infant Seizure Detection Software: Acceptance Criteria and Supporting Study

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 713 patients.
  • 25-36 weeks PMA: 155 patients
  • 37-44 weeks PMA: 321 patients

  • 44 weeks PMA: 237 patients

• Data Provenance: The EEG recordings were obtained from patients less than 1 year of age who received continuous EEG monitoring within the hospital environment. The study was retrospective. The country of origin is not explicitly stated in the provided text.

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

• Number of Experts: 3
• Qualifications of Experts: Expert pediatric neurologists who were fellowship-trained in epilepsy or clinical neurophysiology.

4. Adjudication Method for the Test Set

• Adjudication Method: A two-thirds majority agreement among the 3 expert pediatric neurologists was required to form a determination of seizures, establishing the reference standard for the test set.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focused on the standalone performance of the algorithm against an expert-adjudicated ground truth.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, a standalone performance study was done. The performance metrics (PPA and FP/hr) were evaluated for the Ceribell Infant Seizure Detection Software algorithm without human intervention in the detection process. The reviewing neurologists for ground truth establishment were explicitly blinded to the software's output.

7. The Type of Ground Truth Used

• Type of Ground Truth: Expert consensus (adjudication by a panel of 3 expert pediatric neurologists).

8. The Sample Size for the Training Set

• The sample size for the training set is not provided in the document. The document states, "Importantly, none of the data in the validation dataset were used for training of the Seizure Detection algorithm; the validation dataset is completely independent."

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

• The document does not explicitly state how the ground truth for the training set was established. It only mentions that the validation dataset was independent and not used for training.

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DeepRESP is an aid in the diagnosis of various sleep disorders where subjects are often evaluated during the initiation or follow-up of treatment of various sleep disorders. The recordings to be analyzed by DeepRESP can be performed in a hospital, a patient's home, or an ambulatory setting. It is indicated for use with adults (18 years and above) in a clinical environment by or on the order of a medical professional.

DeepRESP is intended to mark sleep study signals to aid in the identification of events and annotations of traces; automatically calculate measures obtained from recorded signals (e.g., magnitude, time, frequency, and statistical measures of marked events); and infer sleep staging with arousals with EEG and in the absence of EEG. All output is subject to verification by a medical professional.

DeepRESP is a cloud-based software as a medical device (SaMD), designed to perform analysis of sleep study recordings, with and without EEG signals, providing data for the assessment and diagnosis of sleep-related disorders. Its algorithmic framework provides the derivation of sleep staging, including arousals, scoring of respiratory events, and key parameters such as the Apnea-Hypopnea Index (AHI) and Central Apnea-Hypopnea Index (CAHI).

DeepRESP (K252330) is hosted on a serverless stack. It consists of:

• A web Application Programming Interface (API) intended to interface with a third-party client application, allowing medical professionals to access DeepRESP's analytical capabilities.
• Predefined sequences called Protocols that run data analyses, including artificial intelligence and rule-based models for the scoring of sleep studies, and a parameter calculation service.
• A Result storage using an object storage service to temporarily store outputs from the DeepRESP Protocols.

Here's a breakdown of the acceptance criteria and study details for DeepRESP, based on the provided FDA 510(k) clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "DeepRESP must achieve AHI ≥ 5 PPA% of at least X%"). Instead, it reports the performance of the device and compares it to predicate devices to demonstrate substantial equivalence and non-inferiority. The "Observed paired differences" columns, particularly those where the confidence interval does not cross zero, imply a comparison to show that the new DeepRESP v2.0 performs at least as well as the previous version or the additional predicate.

For the purpose of this analysis, I will present the reported performance of the Subject Device (DeepRESP v2.0) as the "reported device performance." Since no explicit acceptance criteria thresholds are given, the comparison to predicates and the demonstration of non-inferiority served as the implicit acceptance path for the FDA clearance.

Reported Device Performance (DeepRESP v2.0)

PPA%: Positive Percent Agreement, NPA%: Negative Percent Agreement, OPA%: Overall Percent Agreement.

2. Sample Sizes and Data Provenance

The clinical validation was conducted using retrospective data.

• Test Set Sample Size:

  • Type I/II Scoring Validation: 4,030 PSG recordings
  • Type III Scoring Validation: 5,771 sleep recordings
    • This comprised 4,037 Type I recordings and 1,734 Type II recordings, processed as Type III by using only the relevant subset of signals.

• Data Provenance:

  • Country of Origin: United States.
  • Data Type: Manually scored sleep recordings from sleep clinics, collected as part of routine clinical work for patients suspected of suffering from sleep disorders.
  • Settings: Urban, suburban, and rural areas.
  • Demographics: Included individuals in all age groups (18-21, 22-35, 36-45, 46-55, 56-65, >65) and all BMI groups (<25, 25-30, <30). The recording collection for Type I/II scoring consisted of 44% Females, and for Type III scoring, 35% Females. High level of race/ethnicity diversity (Caucasian or White, Black or African American, Other).

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not explicitly stated. The document refers to "manually scored sleep recordings" and "medical professional" for verification. It also mentions "board-certified sleep physicians" in the context of the training set. However, the specific number of experts used to establish the ground truth for the test set is not detailed.
• Qualifications of Experts: For the test set, it's implied that "medical professionals" performed the manual scoring, as the data originated from "routine clinical work." For the training set, "board-certified sleep physicians" were involved in establishing the ground truth.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1) for establishing the ground truth on the test set. It mentions "manually scored sleep recordings" but does not detail how potential disagreements between multiple scorers (if any were used) were resolved.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.

The study design was a retrospective data study comparing the automatic scoring of DeepRESP to manual scoring (ground truth) and also comparing DeepRESP's performance to two predicate devices (DeepRESP K241960 and Nox Sleep System K192469). This is a standalone performance evaluation against expert-derived ground truth, with a direct comparison to existing automated systems, not an MRMC study assessing human reader improvement with AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The reported PPA, NPA, and OPA values for DeepRESP v2.0 (Subject Device) represent its performance as a standalone algorithm without human-in-the-loop assistance. The subsequent comparison to the predicate devices also evaluated their standalone performance. The document explicitly states: "All output is subject to verification by a medical professional," indicating that while the device is intended to aid in diagnosis, its performance evaluation was conducted on its automated output before any human review.

7. Type of Ground Truth Used

The ground truth used was expert consensus (manual scoring). The study used "manually scored sleep recordings" from "routine clinical work" as the reference standard against which DeepRESP's automatic scoring was compared.

8. Sample Size for the Training Set

The document does not report the sample size used for the training set. It only states the sample sizes for the validation (test) sets: 4,030 PSG recordings for Type I/II validation and 5,771 sleep recordings for Type III validation.

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

The document states that the ground truth for the training set "was established through a rigorous process involving multiple board-certified sleep physicians." This implies an expert-driven process, likely involving consensus or reconciliation among several highly qualified professionals. However, the exact methodology (e.g., number of physicians, adjudication rules) is not detailed beyond "rigorous process."

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1. Persyst 15 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.

2. The Seizure Detection and Seizure Probability component of Persyst 15 is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with a full scalp montage according to the standard 10/20 system. Alternatively, the Seizure Detection can operate using reduced set of electrodes including Fp1, F7, T3, T5, O1, Fp2, F8, T4, T6, O2, but will have decreased sensitivity for seizures due to its limited spatial sampling.

3. The Persyst software's Electrographic Status Epilepticus (ESE) component is indicated for the diagnosis of Electrographic Status Epilepticus in patients greater than or equal to 18 years of age who are at risk for seizure. The (ESE) Component analyzes EEG waveforms and identifies patterns that may be consistent with electrographic status epilepticus as defined in the "(American Clinical Neurophysiology Society's Guideline 14)". EEG recordings used with this feature should be obtained with a full scalp montage (10/20 system) or a reduced set of electrodes (Fp1, F7, T3, T5, O1, Fp2, F8, T4, T6, O2). Using the reduced set of electrodes will result in some decrease in sensitivity and specificity for the detection of ESE in comparison to the full montage due to decreased spatial sampling.

   The (ESE) Component is intended to be used as an aid for determining patient treatment in acute-care environments. Detections from the (ESE) Component provide one input for the clinician that is intended to be used in conjunction with other elements of clinical practice to determine the appropriate treatment course for the patient. The (ESE) Component is intended for detection of electrographic status epilepticus only. The (ESE) Component does not substitute for the review of the underlying EEG by a qualified clinician with respect to any other types of pathological EEG patterns. The (ESE) Component is not intended for use in Epilepsy Monitoring Units or non-acute care environments.

4. The Neonatal Seizure Detection component of Persyst 15 is intended to mark previously acquired sections of neonatal patients' (defined as near-term or term neonates of conceptional age between 36 and 44 weeks and less than two weeks of chronologic age) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with scalp-recorded EEG using the standard International 10-20 system electrode placement, modified for neonates (this includes electrode sites Fp1/2 or alternate F1/2, C3/4, T3/4, O1/2, and Cz, optionally including Fz). Alternatively, the Neonatal Seizure Detection component can operate using a more reduced set of electrodes including C3/4, Fp1/2 (F1/2), and O1/2 (recorded in such a manner to allow creation of montage C3-4, Fp1-O1, Fp2-O2), or an even more simplified electrode set including only C3/4 and Cz (arranged as C3-Cz and C4-Cz), but the three-electrode montage will have decreased sensitivity for seizures due to its limited spatial sampling.

5. The Spike Detection component of Persyst 15 is intended to mark previously acquired sections of the patient's EEG recordings that may correspond to spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. The Spike Detection component is intended to be used in patients at least one month old. Persyst 15 Spike Detection performance has not been assessed for intracranial recordings.

6. Persyst 15 EEG Review and Analysis Software includes the Persyst Imaging Workflow (PIW), an imaging viewer. It is intended for use by qualified clinical practitioners on both adult and pediatric subjects at least 12 years of age to interpret EEG data in conjunction with any type of neuroimaging including magnetic resonance imaging (MRI) or computed tomography scans (CT). Persyst Imaging Workflow is not intended to provide diagnostic information.

7. The Persyst ESI component of Persyst 15 is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.

8. The Persyst 15 sleep state feature provides the user with output concerning wake-sleep states (wake or sleep,) present in an EEG recording as an aid in assessing which states are present and when they are present. The EEG being assessed for sleep state should utilize standard 10-20 system electrode recording positions and contain the expected EEG patterns of typical wake and sleep, with no major persistent pathological alterations. The sleep state output is subject to user confirmation via EEG waveform review and is not intended for the diagnosis of sleep disorders (e.g.: sleep apnea, narcolepsy, restless leg syndrome). The sleep state feature is intended for adult and pediatric subjects at least 13 years and older.

9. Persyst 15 includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include FFT, Rhythmicity, Peak Envelope, Artifact Intensity, Amplitude, Relative Symmetry, and Suppression Ratio. Automatic event marking is not applicable to quantitative measures. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms.

10. Persyst 15 displays physiological signals, including the calculation and display of a heart rate measurement based on the ECG channel in the EEG recording, which are intended to aid in the analysis of an EEG. Heart rate measurement of Persyst 15 is not applicable to patients with pacemaker and/or active implantable devices.

11. The aEEG functionality included in Persyst 15 is intended to monitor the state of the brain. The automated event marking function of Persyst 15 is not applicable to aEEG.

12. Persyst 15 provides notifications for seizure detection, quantitative EEG and aEEG that can be used when processing a record during acquisition. These include an on screen display and the optional sending of an email message. Delays of up to several minutes can occur between the beginning of a seizure and when the Persyst 15 notifications will be shown to a user. Persyst 15 notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.

13. Persyst 15 AR (Artifact Reduction) is intended to reduce EMG, eye movement, and electrode artifacts in a standard 10-20 EEG recording. AR does not remove the entire artifact signal, and is not effective for other types of artifacts. AR may modify portions of waveforms representing cerebral activity. Waveforms must still be read by a qualified medical practitioner trained in recognizing artifact, and any interpretation or diagnosis must be made with reference to the original waveforms.

14. This device does not provide any diagnostic conclusion about the patient's condition to the user.

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EEG-1260A Neurofax System
The EEG-1260A series Neurofax is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. These data may be used by the clinician in sleep disorders, epilepsies and other related disorders as an aid in diagnosis. The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic, or nursing home or outside of a medical facility under direct supervision of a medical professional.

JE-940A EEG Amplifier Unit
The EEG amplifier unit is intended to acquire and record the EEG and other biological signals (ECG, EMG, respiration, EOG, snoring, body position, SpO2, pulse waveform) of a patient, and transmit the measurement data to the electroencephalograph. The transmitted measurement data is displayed on the electroencephalograph screen and provides information to evaluate the functional state of the brain, brain-related diseases and disorders, and sleep disorders.

The device is intended for use by qualified medical personnel within a medical facility, or by staff in an equivalent facility under the direct supervision of qualified medical personnel.

The device is available for use on any patient as determined by qualified medical personnel.

LS-940A Photic Light
The photic stimulator is a light source for photic stimulation to confirm the responsiveness of EEG to photic stimulation during EEG tests and to test visual evoked potentials.

The device is intended for use by qualified medical personnel within a medical facility, or by staff in an equivalent facility under the direct supervision of qualified medical personnel.

The device is available for use on any patient as determined by qualified medical personnel.

The EEG-1260A Neurofax is an electroencephalograph system specifically designed for use in healthcare facilities. This device is designed to measure and display the patient's electroencephalogram (EEG) and polysomnography (PSG) signals, providing information and analysis of brain electrical activity.

The JE-940A EEG amplifier unit is a new amplifier unit and is an input unit of the EEG-1260A. The JE-940A Amplifier unit acquires and measures EEG and other polysomnography signals (ECG, EMG, respiration, EOG, snoring, body position, SpO2, and pulse waveforms) associated with EEG/PSG testing, and transmits the acquired data to the EEG-1260A Neurofax. The JE940A operates on AC power or on battery power for mobile EEG measurements. The JE-940A offers an option to connect with the JE-944A Mini electrode junction box, which enhances the operational efficiency and mobility in EEG measurements.

The LS-940A Photic stimulator is a device which provides visual stimuli in the form of flashing light and is used to assess a patient's EEG responses to light stimulation. The parameters for flashing the light signal are controlled by the EEG-1260A Neurofax.

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The SignalNED Device is intended to record and store EEG signals for the statistical evaluation of the human electroencephalogram (EEG) and display Quantitative EEG (qEEG) measures intended to help the user analyze the EEG. These measures include relative band power (e.g., alpha, beta, delta, theta) and band power asymmetry (displayed as a z-score compared to a normative database). The SignalNED does not provide any diagnostic conclusion about the patient's condition. The device is intended to be used on adults by qualified medical and clinical professionals.

The SignalNED Model RE machine uses 10 patient electrodes (4 left, 4 right, 2 midline), which are used to form the 8 channels. The SignalNED machine requires the use of the SignalNED Sensor Cap, and the system includes the following components:

• Portable EEG machine (Device)
• Battery & External Battery Charger
• SignalNED Sensor Cap
• SignalNED Sensor Cap Cable

The primary function of the SignalNED Model RE is to rapidly record EEG and derive Quantitative EEG (qEEG) measurements. These measurements include Relative Band Power for multiple bands (e.g., alpha, beta, delta, theta) at each electrode and band power asymmetry (displayed as a z-score compared to a normative database). These measurements are intended to help the user analyze the underlying EEG. The SignalNED Model RE (client) achieves its intended without relying on wireless connectivity. The SignalNED RE does not provide any diagnostic conclusion about the patient's condition.

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The PVDF Effort Sensor is intended to measure and output respiratory effort signals from a patient for archival in a sleep study. The sensor is an accessory 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 PVDF Effort Sensor is 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 PVDF Effort Sensor does not include or trigger alarms, and is not intended to be used alone as, or a critical component of,

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

The PV01 PVDF Effort Sensor is a respiratory effort monitoring accessory designed for use during sleep studies to assess breathing patterns by measuring chest and abdominal wall movement. The device functions as an accessory to polysomnography (PSG) systems, enabling qualified sleep clinicians to analyze respiratory data for the diagnosis of sleep disorders.

The sensor consists of two main components: a PVDF (polyvinylidene fluoride) sensor module and an elastic belt. The sensor module contains two plastic enclosures connected by a piezoelectric PVDF sensing element encased in a silicone laminate. The PVDF material generates a tiny voltage that is output through the lead wire to the sleep amplifier. The change in voltage as the tension on the PVDF film fluctuates corresponds to the breathing of the patient. Since the PVDF material generates voltage, the sensor does not require a battery or power from the amplifier. The output signal is processed by the sleep recording system for monitoring and post-study analysis.

The PV01 PVDF Effort Sensor is intended for prescription use only by healthcare professionals in hospitals, sleep laboratories, clinics, nursing homes, or in home environments under medical professional direction. The device is designed for use on both adult and children participating in sleep disorder studies. The sensor is intended to be worn over clothes and not directly on the patient's skin.

The 510(k) clearance letter for the PV01 PVDF Effort Sensor does not contain the specific details required to fully address all aspects of your request regarding acceptance criteria and the study proving the device meets them. This document is a regulatory approval letter, summarizing the basis for clearance, not a detailed study report.

However, based on the provided text, here's an attempt to extract and infer the information:

Overview of Device Performance Study

The PV01 PVDF Effort Sensor underwent "comprehensive verification and validation testing" including "functional and performance evaluations" and "validation studies" to confirm it meets design specifications and is safe and effective. Additionally, "comparative testing against the Reference Device" was performed.

This suggests that the performance evaluation primarily focused on:

1. Safety Tests: Compliance with UL 60601-1 standards to ensure electrical and liquid ingress safety.
2. Usability and Validation Test: Assessment of user experience and comfort during a simulated sleep study.
3. Performance Comparison Test: Electrical signal output comparison to a legally marketed predicate device under simulated breathing conditions.
4. Temperature Range Test: Verification of signal output performance at extreme operating temperatures.

Acceptance Criteria and Reported Device Performance

Based on the "Summary of Tests Performed" section, the following can be inferred:

Missing Information and Limitations:

The provided FDA 510(k) clearance letter is a high-level summary and does not contain the granular details typically found in a full study report. Therefore, most of the following requested information cannot be extracted directly from this document.

1. Sample size used for the test set and data provenance:

   • Test Set Size: Not specified for any of the performance tests. For the usability test, it mentions "Participants" (plural), but no number. For the performance comparison test, it states "Both devices were placed on a rig," implying a comparison, but no human subject or case count.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The usability test mentions "participants," potentially implying prospective data collection, but this is a broad inference.

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

   • Not Applicable/Not Specified: The device is a "PVDF Effort Sensor" that measures and outputs respiratory effort signals. Its purpose is to provide raw physiological data for a "qualified sleep clinician to aid in the diagnosis of sleep disorders." The device itself does not provide a diagnosis or interpretation that would require expert ground truth labeling in the traditional sense of an AI diagnostic device (e.g., image-based AI). The performance assessment appears to be against expected signal characteristics and comparison to a known device, not against clinical ground truth established by experts.

3. Adjudication method for the test set:

   • Not Applicable/Not Specified: Given the nature of the device (a sensor outputting physiological signals) and the described tests, a formal adjudication process (like for interpreting medical images) is not mentioned or implied.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

   • No: This type of study (MRMC for AI assistance) is not mentioned. The device is a sensor, not an AI interpretative tool designed to assist human readers directly. It provides raw data for clinicians to analyze.

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

   • Partially Yes (for the sensor itself): The "Performance Comparison Test" and "Temperature Range Test" assess the device's signal output performance independently without a human in the loop for interpretation. The "Safety Tests" are also standalone tests on the device's physical and electrical properties.

6. The type of ground truth used:

   • Physiological Simulation / Device Output Comparison: For the "Performance Comparison Test," the ground truth was essentially the simulated breathing patterns produced by a "rig" and the expected output signals of a known predicate/reference device.
   • User Feedback / Self-Reported Metrics: For the "Usability and Validation Test," the ground truth was the participants' subjective feedback on comfort and ease-of-use, and the absence of reported use errors or adverse events.
   • Compliance with Standards: For "Safety Tests," the ground truth was compliance with the specified clauses of the UL 60601-1 standard.

7. The sample size for the training set:

   • Not Applicable/Not Specified: The PV01 PVDF Effort Sensor is described as a passive hardware sensor ("generates a tiny voltage," "does not require a battery or power from the amplifier") that measures physical movement. It is not an AI/ML algorithm that requires a "training set" in the computational sense.

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

   • Not Applicable: As stated above, there is no mention or implication of a training set as this is a hardware sensor, not an AI/ML algorithm.

In summary, the provided document gives a high-level overview of the acceptance criteria met for regulatory clearance, primarily focusing on safety, basic functional performance relative to another device, and usability. It does not delve into the detailed statistical methodology and independent ground truth establishment typical of AI/ML device studies.

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