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SomniCheck is a prescription-use physiological data recorder intended to amplify, digitize, and record data from multiple physiological channels for subsequent transfer to polysomnography systems. The device measures the following signals:

• · EEG (4-channel),
• · PPG (by Maxim),
• · Temperature,
• · 3-axis accelerometer,
• · Gyroscope (position), and
• · Audio/ sound for snoring.

It is intended for use on adult patients (18 and older) and can be used in a hospital, clinic, or home.

SomniCheck is an integrated single-use disposable physiological data recorder intended to amplify, digitize, and record data from multiple physiological channels for subsequent transfer to polysomnography systems for neurophysiology or sleep disorder studies. It is intended for adult use and can be used in a hospital, clinic, or patient home. The associated software There is proprietary software that is currently under development, but the subject device's signal recording capabilities have been validated using the Natus Sleepworks K090277 via bench testing. The proprietary sleep software will be submitted in a future 510(k) Submission.

The device is affixed to the forehead of the patient and designed for continuous wear (e.g. during sleep) for up to approximately 10 hours. Once activated, the device records data for the duration of the wear period. After the wear period, the device is removed and may be thrown away. The device measures the following signals:

• · EEG (4-channel),
• PPG (by Maxim®),
• · Temperature,
• · 3-axis accelerometer,
• · Gyroscope (position), and
• Audio/ sound for snoring.

The provided text describes the predicate device information, applicable standards, and a comparison of the proposed device (SomniCheck) with predicate devices. However, it does not contain details about specific acceptance criteria for performance metrics, nor does it present the results of a study proving the device meets those criteria.

The document states:

• "(b)(1) Non-clinical bench performance tests included System Requirements Verification, Electromagnetic Compatibility (EMC) Verification, and Device Firmware Verification, including applicable clauses from the following standards: [lists various IEC and ISO standards]."
• "(b)(2) Clinical performance testing is not applicable to the device type."
• "(b)(3) The performance testing demonstrates that the device is as safe, as effective, and performs as well as the legally marketed predicate devices identified in paragraph (a)(3) of this section and therefore substantially equivalent."
• "The associated software There is proprietary software that is currently under development, but the subject device's signal recording capabilities have been validated using the Natus Sleepworks K090277 via bench testing. The proprietary sleep software will be submitted in a future 510(k) Submission."

Based on this, the device's clearance is based on bench testing against established standards and substantial equivalence to predicate devices, rather than a clinical performance study with specific acceptance criteria that would typically involve a test set, ground truth experts, and MRMC studies.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be inferred or stated based on the given document:

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

• Acceptance Criteria: Not explicitly stated as specific performance metrics (e.g., sensitivity, specificity) for signal detection or interpretation. The acceptance criteria are implicit in compliance with the listed IEC and ISO standards for electrical safety, EMC, usability, and risk management, and the demonstration of "as safe, as effective, and performs as well as the legally marketed predicate devices."
• Reported Device Performance: The document only states that "performance testing demonstrates that the device is as safe, as effective, and performs as well as the legally marketed predicate devices," and that "signal recording capabilities have been validated using the Natus Sleepworks K090277 via bench testing." No quantitative performance data (e.g., EEG signal fidelity, PPG accuracy) from these bench tests are 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 applicable as "Clinical performance testing is not applicable to the device type." The validation was done via bench testing.
• Data provenance: Bench testing.

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 applicable. The ground truth for bench testing involves adherence to engineering standards and comparison with predicate device specifications, not expert interpretation of data.

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

• Not applicable.

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

• No. This device is a physiological data recorder, not an AI-powered diagnostic aide for human readers. It records signals for subsequent transfer to polysomnography systems.

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

• The device's signal recording capabilities were validated via bench testing with Natus Sleepworks K090277. This is fundamentally a standalone hardware performance validation. There is no mention of a standalone algorithm performance in the context of interpretation, as the proprietary sleep software is still "under development" and will be "submitted in a future 510(k) Submission."

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

• The ground truth for this device's validation (signal recording) would be based on engineering specifications, known signal characteristics, and comparison to the performance of the predicate device/system (Natus Sleepworks K090277) under controlled bench conditions. It is not based on clinical "ground truth" such as expert consensus or pathology, as these are related to the interpretation of the collected physiological signals, which is outside the scope of this device's current submission.

8. The sample size for the training set

• Not applicable. This is a hardware/firmware device for signal acquisition, not a machine learning model for which a "training set" would be used in the context of this 510(k). The proprietary software is still under development.

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

• Not applicable. (See #8)

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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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