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The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks™/SleepWorks™ software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals. The amplifier is designed to facilitate functional mapping using a Digital Switch Matrix. The Digital Switch Matrix portion of the headbox is a combination of hardware relays and software controls allowing the user (physician or technologist) to switch electrode pairs between the EEG recording amplifier and the external cortical stimulator for stimulus delivery.

The Natus Quantum Amplifier is intended to be used by trained medical professionals, and is designed for use in clinical environments such as hospital rooms, epilepsy monitoring units, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use.

The Natus Quantum amplifier is comprised of a base unit and several breakout boxes. It is part of a system that is made up of a personal computer, a photic stimulator, an isolation transformer, video and audio equipment, networking equipment, and mechanical supports. The amplifier also contains an internal switch matrix to allow for a connection to an external cortical stimulator.

EEG and other physiological signals, from scalp electrodes, grid or needle electrodes, and other accessories such as pulse oximeters can be acquired by the Natus Quantum amplifier. These signals are digitized and transmitted to the personal computer running the Natus NeuroWorks software. The signals are displayed on the personal computer and can be recorded to the computer's local storage or to remote networked storage for later review.

The provided text describes the Natus Quantum Amplifier, an electroencephalograph, and its regulatory submission (K143440). However, the document does not contain a study that directly proves the device meets specific acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, or accuracy.

The document focuses on demonstrating substantial equivalence to predicate devices (EMU128S and NeuroLink IP 256) primarily through technical specifications and compliance with various safety, EMC, and quality standards. The "Performance Tests" section is very brief and refers to non-clinical verification testing rather than clinical efficacy studies.

Therefore, the following information is based on what is available or can be inferred from the provided text. Many requested fields will be marked as "Not Applicable" or "Not Provided" because the document does not describe the kind of clinical study you're asking about.

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document implies that meeting the specified technical characteristics that are substantially equivalent or superior to the predicate devices, and passing internal design verification tests, are the "acceptance criteria" for regulatory clearance based on substantial equivalence. It does not provide clinical acceptance criteria.

2. Sample size used for the test set and the data provenance

• Sample Size: Not Applicable. The document describes non-clinical verification testing of the device hardware/software, not a clinical study on patient data.
• Data Provenance: Not Applicable. No patient data was used for the described performance tests.

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

• Number of Experts: Not Applicable. Ground truth for clinical data is not relevant to the described non-clinical verification tests.
• Qualifications of Experts: Not Applicable.

4. Adjudication method for the test set

• Adjudication Method: Not Applicable. No clinical test set requiring adjudication was described.

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

• MRMC Study: No. This document describes an EEG amplifier, not an AI-assisted diagnostic tool.

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

• Standalone Performance: Not Applicable. This is a hardware device (EEG amplifier) with associated software for data acquisition, display, storage, and archiving. It is not an algorithm for standalone diagnostic performance.

7. The type of ground truth used

• Type of Ground Truth: For the "Performance Tests" (Signal Quality Verification Test, Functionality Verification Test), the ground truth would be the design specifications and expected operational parameters of the device. These tests verify if the actual output matches the designed output. No clinical "ground truth" (e.g., pathology, outcomes data) for diagnosis is mentioned for these tests.

8. The sample size for the training set

• Sample Size: Not Applicable. This is not an AI/machine learning device that requires a training set.

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

• Ground Truth Establishment: Not Applicable. (See point 8)

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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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The SleepCheck is intended for use in monitoring nasal and oral airflow. The device is intended for use as a prescreening tool to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's test score.
The SleepCheck is a small monitor designed to assess nasal and oral airflow. Apnea breathing events are counted based on a reduction in airflow. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score.

The SleepCheck is a pager-sized monitor that clips onto the patient's nightshirt. The monitor utilizes an air cannula sensor to capture the patient's nasal and oral airflow. The sensor cannula, containing 3 airflow ports, is placed under the nostrils, above the lip and held in place around the ears with a lanyard. The unit has an LCD readout that displays the total number of apneas and the apnealhypopnea index (AHI). The LCD also flashes a warning if the sensor is improperly applied or displaced. The LCD also provides a dynamic bar graph that displays the breathing pattern. As the patient inhales and exhales, the bar moves back and forth, verifying proper sensor application and monitor operation. When breathing decreases or is interrupted for 10 seconds or longer, this event is considered an apnea episode and is tallied on the LCD readout. The patient self-applies the unit before going to bed and wears the unit through the night. Upon waking, the patient will take off the unit and return it to the physician. The physician will check the LCD to learn the number of apneas and the rate of apnea events (AHI) that occurred throughout the night. The technical validity of the test is also indicated.

Here's a breakdown of the acceptance criteria and study information for the SleepCheck device, based on the provided text:

Acceptance Criteria and Device Performance

Note: The document only explicitly states "high sensitivity and specificity" as a general goal within the "Assessment of SleepCheck Performance Data" section. The predicate device's performance (SleepStrip) serves as an implicit benchmark for what constitutes an acceptable level of performance in the market. The SleepCheck's performance significantly exceeds that of the predicate device for all reported metrics, suggesting it meets or exceeds an implicit acceptance standard.

Study Information

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

• Sample Size: 111 sleep tests, totaling 151 sleep nights.
• Data Provenance: Not explicitly stated whether retrospective or prospective, or country of origin for the patient data. However, the studies were "sponsored by the National Institutes of Health" and conducted "both at-home and in the sleep laboratory," suggesting a U.S.-based context and potentially a mix of prospective and retrospective elements depending on study design.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set:

• Not specified.

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

• No, a MRMC comparative effectiveness study was not conducted with human readers comparing performance with and without AI assistance. The study focuses on the standalone performance of the device against a gold standard.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

• Yes, a standalone study was done. The reported performance metrics (Sensitivity, Specificity, r to PSG) are for the "SleepCheck" device directly, indicating its algorithmic performance in detecting apnea events. The physician only reads the LCD display of the device's calculated results.

7. Type of Ground Truth Used:

• Polysomnography (PSG): PSG is explicitly stated as the "gold standard" against which the SleepCheck was validated.

8. Sample Size for the Training Set:

• Not specified. The document describes clinical studies used for validation, but does not differentiate or provide details on any specific training set for the algorithm's development.

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

• Not specified. Assuming typical device development, ground truth for any training would also be established through expert interpretation of PSG data, similar to the validation set. However, this is not detailed in the provided text.

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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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