Search Results

The Empatica Health Monitoring Platform is a wearable device and paired mobile and cloud-based software platform intended to be used by trained healthcare professionals or researchers for retrospective remote monitoring of physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments. As the platform does not provide real-time alerts related to variation of physiologic parameters, users should use professional judgment in assessing patient clinical stability and the appropriateness of using a monitoring platform designed for retrospective review.

The device is intended for continuous data collection supporting intermittent retrospective review of the following physiological parameters:

• Pulse Rate,
• Blood Oxygen Saturation under no-motion conditions,
• Respiratory Rate under no motion conditions,
• Peripheral Skin Temperature,
• Electrodermal Activity,
• Activity associated with movement during sleep

The Empatica Health Monitoring Platform can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

The Empatica Health Monitoring Platform is not intended for SpO2 monitoring in conditions of motion or low perfusion.

The Empatica Health Monitoring Platform is intended for peripheral skin temperature monitoring, where monitoring temperature at the wrist is clinically indicated.

The Empatica Health Monitoring Platform is not intended for Respiratory Rate monitoring in motion conditions. This device does not detect apnea and should not be used for detecting or monitoring cessation of breathing.

The Empatica Health Monitoring Platform is not intended for Pulse Rate monitoring in patients with chronic cardiac arrhythmias, including atrial fibrillation and atrial/ventricular bigeminy and trigeminy, and is not intended to diagnose or analyze cardiac arrhythmias. The Empatica Health Monitoring Platform is not a substitute for an ECG monitor, and should not be used as the sole basis for clinical decision-making.

The Empatica Health Monitoring Platform is a wearable device and software platform composed by:

• A wearable medical device called EmbracePlus,
• A mobile application running on smartphones called "Care App",
• A cloud-based software platform named "Care Portal".

The EmbracePlus is worn on the user's wrist and continuously collects raw data via specific sensors. These data are wirelessly transmitted via Bluetooth Low Energy to a paired mobile device where the Care App is up and running. The data received are analyzed by one of the Care App software modules, EmpaDSP, which computes the user physiological parameters. Based on the version of the Care App installed, the user can visualize a subset of these physiological parameters. The Care App is also responsible for transmitting, over cellular or WiFi connection sensors' raw data, device information, Care App-specific information, and computed physiological parameters to the Empatica Cloud. On the Empatica Cloud, these data are stored, further analyzed, and accessible by healthcare providers or researchers via a specific cloud-based software called Care Portal.

The Empatica Health Monitoring Platform is intended for retrospective remote monitoring of physiological parameters in ambulatory adults in home-healthcare environments. It is designed to continuously collect data to support intermittent monitoring of the following physiological parameters and digital biomarkers by trained healthcare professionals or researchers: Pulse Rate (PR), Respiratory Rate (RR), blood oxygen saturation (SpO2), peripheral skin temperature (TEMP), and electrodermal activity (EDA). Activity sensors are used to detect sleep periods and to monitor the activity associated with movement during sleep.

The provided FDA 510(k) clearance letter and its attachments describe the acceptance criteria and study that proves the Empatica Health Monitoring Platform (EHMP) meets those criteria, specifically concerning a new Predetermined Change Control Plan (PCCP) for the SpO2 quality indicator (QI) algorithm.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are outlined for the proposed modification to the SpO2 Quality Indicator (QI) algorithm. The reported device performance is presented as a statement of equivalence to the predicate device, implying that the acceptance criteria are met, as the 510(k) was cleared.

Note: For the pre-existing functionalities (Pulse Rate, Respiratory Rate, Peripheral Skin Temperature, Electrodermal Activity, Activity and Sleep), the document states that "no changes to the computation... compared with the cleared version" have been introduced, implying their previous acceptance criteria were met and remain valid.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: Not explicitly stated for the SpO2 algorithm modification. The document only mentions "enhancing the development dataset with new samples" for the ML-based algorithm and clinical testing was "conducted in accordance with ISO 80601-2-61... and ... FDA Guidelines for Pulse Oximeters." These standards typically require a certain number of subjects and data points, but the exact numbers are not provided in this public summary.
• Data Provenance: Not specified in the provided document. It does not mention the country of origin, nor whether the data was retrospective or prospective.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document states the platform is "intended to be used by trained healthcare professionals or researchers," and later discusses "professional users" and "clinical interpretation," implying that the ground truth for clinical studies would likely involve such experts, but their specific roles, numbers, and qualifications for establishing ground truth are not detailed.

4. Adjudication Method for the Test Set

The adjudication method for establishing ground truth for the test set is not explicitly mentioned in the provided document.

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

There is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study being conducted, nor any effect size regarding human readers improving with AI vs. without AI assistance. The device is for "retrospective remote monitoring" by healthcare professionals, implying an AI-driven data collection/analysis with human review, but not necessarily human-AI collaboration in real-time diagnostic interpretation that an MRMC study would evaluate.

6. Standalone (Algorithm Only) Performance

The acceptance criteria for the SpO2 QI algorithm include "Bench testing conducted using a functional tester to simulate a range of representative signal quality issues." This falls under standalone performance, as it tests the algorithm's ability to discriminate data quality without direct human input. Clinical testing also evaluates the algorithm's accuracy (Arms error) in comparison to an established standard, which is also a standalone performance measure.

7. Type of Ground Truth Used

• For the SpO2 QI ML algorithm: The ground truth for low-quality and high-quality data discrimination seems to be an internal standard/reference based on the "FDA-cleared SpO2 algorithm" and potentially expert labeling of data quality during the "enhancing the development dataset."
• For the SpO2 Accuracy (Arms Error): The ground truth for SpO2 values would be established in accordance with ISO 80601-2-61, which typically involves comparing the device's readings against a laboratory co-oximeter or a reference pulse oximeter for arterial oxygen saturation.

8. Sample Size for the Training Set

The document mentions "enhancing the development dataset with new samples" for the ML-based algorithm but does not specify the sample size for the training set.

9. How Ground Truth for Training Set was Established

The ground truth for training the ML-based SpO2 QI algorithm was established by "enhancing the development dataset with new samples." It also mentions performing "feature extraction and engineering on window lengths spanning a 10-30-second range." While it doesn't explicitly state the methodology, given the context of a "binary output" (high/low quality), it implies a labeling process, likely by human experts or based on predefined criteria derived from the previous FDA-cleared algorithm's performance on various data types. For the SpO2 accuracy, the ground truth would typically be established by a reference method consistent with the mentioned ISO standard and FDA guidance.

Ask a specific question about this device

The QUEX ED and QUEX S device is indicated for use as an Electrophysiological System. The Electrophysiological System is made up of the following Items which are functions of the QUEX ED and S device:

1. Two channel EEG:

The QUEX ED and S Device is intended to record and store EEG signals, and to present the EEG signals in visual formats in real time. The visual signals assist trained medical staff to make neurological diagnoses. The EEG device does not provide any diagnoses conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The QUEX ED AND S Device is intended to be used in a professional healthcare facility environment.
2. GSR [galvanic skin response measuring]

The QUEX ED and S device is intended for use by trained healthcare professionals, to detect and monitor electrical signals produced by the body skin conductance by using electrodes placed on the skin.

QUEX ED or QUEX S devices are contains the following components:

• QUEX ED or QUEX S hardware.
• I QUEX Monitor software
• . USB - USB cable for data communication and power supply.
• EEG electrodes (head electrodes)
• Electrodes for GSR measurements (limbs)
• I Cable harnesses for head and limbs.

The QUEX Monitor software is exclusively used for QUEX ED or QUEX S as part of the system.

The EEG electrodes and the electrodes used for GSR measurements are connected to the QUEX ED or S devices. The device makes the necessary gain on the analog signals and digitalize the signals. The digitalized information is acquired and displayed by the QUEX Monitor software. The QUEX monitor software can run on PCs, notebooks with Windows OS.

Electroencephalography (EEG), measures brain wave activity. The system uses the head harness and electrodes to acquire the signals. The QUEX Devices are measures brain activity on two channels. The EEG wave recording electrodes are connected to the forehead with dry electrodes.

The galvanic skin response (GSR, which falls under the umbrella term of electrodermal activity, or EDA) refers to changes in sweat gland activity.

The GSR recording is done via limb electrodes attached to the wrists and ankles.

The provided FDA 510(k) summary (K232779) for the QUEX ED and QUEX S device describes the regulatory submission for an electrophysiological system, specifically for EEG and GSR measurements. While it details acceptance criteria for various technical aspects like electrical safety and electromagnetic compatibility, and states that “All samples passed the acceptance criteria” for these tests, it does not describe a clinical study meeting the criteria of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only performance study on a test set with an established ground truth assessed by multiple experts.

The submission focuses on establishing substantial equivalence to a predicate device (Neurosteer Inc. Neurosteer EEG Recorder K221563) primarily through technical comparisons and bench testing. The "performance data" mentioned in the conclusion refers to these bench tests, not a clinical study involving human readers or algorithmic performance against a clinical ground truth.

Therefore, many of the requested details about acceptance criteria and study designs are not present in this document because the device's substantial equivalence was established through technical specifications and bench testing, not through a clinical performance study as typically seen with AI/ML-driven diagnostic devices.

Here's an attempt to answer the questions based only on the provided text, highlighting what is present and what is absent:

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

The document provides acceptance criteria and performance for various bench tests, not for a clinical diagnostic performance study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes bench tests on hardware/software samples, not a clinical study with a test set of patient data. The sample size is referred to as "All samples." No patient data provenance is applicable given the nature of the tests.

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. No ground truth based on expert consensus for clinical diagnosis was established as this was not a clinical performance study. The tests focused on electrical, EMC, and signal performance according to industry standards.

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

Not applicable. No clinical test set and human readers for adjudication were involved.

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 MRMC study was performed or described. The product is an electrophysiological system for recording and displaying signals to assist trained medical staff in making neurological diagnoses, and it "does not provide any diagnoses conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event." Therefore, there is no AI component assisting human readers in this context.

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

No standalone algorithm performance study was performed or described. The device is a signal acquisition and display system for human interpretation, not an automated diagnostic algorithm.

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

Not applicable. The "ground truth" for the non-clinical tests was the adherence to specified engineering standards and the device's own technical specifications.

8. The sample size for the training set

Not applicable. This document pertains to the regulatory clearance of a medical device based on its functional and safety performance, not the training of an AI/ML algorithm.

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

Not applicable. No training set or ground truth for such a set is mentioned.

Ask a specific question about this device

The SafeOp 3: Neural Informatix System is intended for use in monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open/percutaneous, lumbar, thoracic, and cervical surgical procedures.

SafeOp 3 Accessories: The SafeOp Accessories are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.

The SafeOp™ 3: Neural Informatix System (SafeOp 3 System), consists of the SafeOp patient interface with power supply and IV pole mount, the Alpha Informatix Tablet with docking station and power supply and a data transfer USB cable. Associated disposable accessories consists of an electrode harness, surface and/or subdermal needle electrodes, MEP Activator, Cranial Hub, PMAP Dilators and stimulating probe or clip contained in various kits.

The subject device is intended for use by trained healthcare professionals, clinical neurophysiologists/technologists and appropriately trained non-clinical personnel. The subject device is intended for use in operating room environments of hospitals and surgical centers. System setup may be performed by both clinical and trained non-clinical personnel.

The subject device records the following modalities:

• Somatosensory evoked potentials (SSEP)
• Motor evoked potentials (MEP),
• . Train-of-four neuromuscular junction (TO4),
• Triggered electromyography (tEMG) and ●
• . Free run electromyography (sEMG)

The provided text does not contain detailed information about specific acceptance criteria for the device's performance, nor does it describe a study that rigorously proves the device meets such criteria through a clinical validation or similar performance evaluation.

The document is a 510(k) premarket notification summary for the "SafeOp 3: Neural Informatix System." Its primary purpose is to demonstrate substantial equivalence to a previously cleared predicate device (SafeOp2: Neural Informatix System, K213849, and reference device Cascade IOMAX Intraoperative Monitor, K162199), rather than to present a full clinical performance study with defined acceptance criteria and detailed results.

Here's a breakdown of what the document does say, and what it lacks in relation to your request:

What the document provides:

• Device Name: SafeOp 3: Neural Informatix System
• Intended Use/Indications for Use: Monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ) during various surgical procedures.
• Technological Comparison: A table comparing the SafeOp 3 System to predicate and reference devices, focusing on technical specifications like monitoring modalities, amplifier channels, stimulation parameters (voltage, current, pulse duration, repetition rate), and filter ranges. This comparison primarily aims to establish that the differences in technology do not raise new questions of safety or effectiveness.
• Performance Data (Non-clinical): Mentions that "Nonclinical performance testing demonstrates that the subject SafeOp 3 System meets the functional, system, and software requirements." It also states "EMC and Electrical Safety Testing... was performed to ensure all functions... are electrically safe, and comply with recognized electrical safety standards." Usability testing was also performed.
• Clinical Information Disclaimer: Explicitly states, "Determination of substantial equivalence is not based on an assessment of clinical performance data."

What the document lacks significantly for your request:

• A table of acceptance criteria and reported device performance: This is the most significant omission for your request. The document details technical specifications and comparisons but does not provide quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific error rates) against pre-defined acceptance thresholds for any of its functionalities (MEP, SSEP, EMG, NMJ). The performance data mentioned are non-clinical (functional, system, software, EMC, electrical safety, usability), not clinical performance metrics.
• Sample size used for the test set and data provenance: Since specific clinical performance studies are not detailed, this information is not provided.
• Number of experts used to establish ground truth and qualifications: Not applicable as a clinical ground truth establishment process for performance evaluation is not described.
• Adjudication method for the test set: Not applicable.
• MRMC comparative effectiveness study: No such study is mentioned or detailed.
• Standalone (algorithm only) performance: While the device is an "algorithm only" in a sense (it processes physiological signals), its performance isn't quantified in a standalone clinical evaluation or comparative study.
• Type of ground truth used: No clinical ground truth is described for performance evaluation.
• Sample size for the training set: Not applicable, as this is related to AI/ML development and training, which is not described. The device is a neuromonitoring system, not explicitly stated to be an AI/ML device in the context of this submission.
• How the ground truth for the training set was established: Not applicable.

Why this information is missing:

The FDA 510(k) pathway for "substantial equivalence" often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate, without necessarily requiring new clinical trials or detailed performance studies if the technological differences are minor and well-understood. The focus is on showing that any differences do not introduce new safety or effectiveness concerns.

In summary, based solely on the provided text, I cannot complete the table of acceptance criteria or describe a study that proves the device meets these criteria in a clinical performance context. The document focuses on demonstrating substantial equivalence through technical comparison and non-clinical testing, rather than presenting clinical performance metrics.

Ask a specific question about this device

The Empatica Health Monitoring Platform is a wearable device and paired mobile and cloud-based software platform intended to be used by trained healthcare professionals or researchers for retrospective remote monitoring of physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments. As the platform does not provide real-time alerts related to variation of physiologic parameters, users should use professional judgment in assessing patient clinical stability and the appropriateness of using a monitoring platform designed for retrospective review.

The device is intended for continuous data collection supporting intermittent retrospective review of the following physiological parameters:

• Pulse Rate,

• · Blood Oxygen Saturation under no-motion conditions,
• · Respiratory Rate under no motion conditions,
• · Peripheral Skin Temperature,
• · Electrodermal Activity,
• · Activity associated with movement during sleep

The Empatica Health Monitoring Platform can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

The Empatica Health Monitoring Platform is not intended for SpO2 monitoring in conditions of motion or low perfusion.

The Empatica Health Monitoring Platform is intended for peripheral skin temperature monitoring, where monitoring temperature at the wrist is clinically indicated.

The Empatica Health Monitoring Platform is not intended for Respiratory Rate monitoring in motion conditions. This device does not detect apnea and should not be used for detecting or monitoring cessation of breathing.

The Empatica Health Monitoring Platform is not intended for Pulse Rate monitoring in patients with chronic cardiac arrhythmias, including atrial fibrillation and atrial/ventricular bigeminy and trigeminy. and is not intended to diagnose or analyze cardiac arrhythmias. The Empatica Health Monitoring Platform is not a substitute for an ECG monitor, and should not be used as the sole basis for clinical decision-making.

The Empatica Health Monitoring Platform is a wearable device and software platform composed by:

• A wearable medical device called EmbracePlus,
• A mobile application running on smartphones called "Care App", ●
• A cloud-based software platform named "Care Portal". ●

The EmbracePlus is worn on the user's wrist and continuously collects raw data via specific sensors. These data are wirelessly transmitted via Bluetooth Low Energy to a paired mobile device where the Care App is up and running. The data received are analyzed by one of the Care App software modules, EmpaDSP, which computes the user physiological parameters. Based on the version of the Care App installed, the user can visualize a subset of these physiological parameters. The Care App is also responsible for transmitting, over cellular or Wi-Fi connection sensors' raw data, device information, Care App-specific information, and computed physiological parameters to the Empatica Cloud. On the Empatica Cloud, these data are stored, further analyzed, and accessible by healthcare providers or researchers via a specific cloud-based software called Care Portal.

The Empatica Health Monitoring Platform is intended for retrospective remote monitoring of physiological parameters in ambulatory adults in home-healthcare environments. It is designed to continuously collect data to support intermittent monitoring of the following physiological parameters and digital biomarkers by trained healthcare professionals or researchers: Pulse Rate (PR), Respiratory Rate (RR), blood oxygen saturation (SpO-), peripheral skin temperature (TEMP), and electrodermal activity (EDA). Activity sensors are used to detect sleep periods and to monitor the activity associated with movement during sleep.

Here's a summary of the acceptance criteria and the study details for the Empatica Health Monitoring Platform, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Pulse Rate:
  • Study 1: 12 healthy adult subjects.
  • Study 2: 85 healthy adult subjects.
  • Study 3: 49 adult subjects (healthy, PVCs, other comorbidities).
  • Total N = 146 adult subjects.
  • Data Provenance: Not explicitly stated, but clinical studies are generally prospective in nature for regulatory submissions. Country of origin not specified.
• Respiratory Rate:
  • Study 1: 14 healthy adult subjects.
  • Study 2: 46 healthy adult subjects.
  • Study 3: 17 adult subjects with various health conditions.
  • Study 4: 40 adult subjects with various health conditions.
  • Total N = 117 adult subjects.
  • Data Provenance: Not explicitly stated, but clinical studies are generally prospective in nature for regulatory submissions. Country of origin not specified.
• SpO2, Temperature, EDA, Activity/Sleep: For these parameters, the submission relies on previous clearance (K221282), indicating no new clinical test data was provided for this specific submission. The reported performance for these parameters is thus based on the studies supporting K221282. Sample sizes and provenance for those underlying studies are not detailed in this document.

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

• The document does not mention the use of human experts to establish ground truth for the test sets.
• Instead, for Pulse Rate, the ground truth was established using a reference electrocardiogram (ECG).
• For Respiratory Rate, the ground truth was established using a capnography reference device.

4. Adjudication Method for the Test Set

• Not applicable as the ground truth was established against reference medical devices (ECG, capnography) rather than human expert consensus requiring adjudication.

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 done. The studies described are focused on the standalone performance of the device against reference standards.

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

• Yes, standalone studies were performed. The clinical data presented for Pulse Rate and Respiratory Rate directly evaluate the accuracy of the device's computed values against reference standards, without human intervention in the measurement process. The device itself is described as a "platform intended to be used by trained healthcare professionals or researchers for retrospective remote monitoring," implying that the data collection and parameter computation are algorithmic, and review is done by humans.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)

• Pulse Rate: Reference Electrocardiogram (ECG).
• Respiratory Rate: Reference Capnography device.
• SpO2: Based on the technology description, it would typically be a co-oximeter or a clinically validated pulse oximeter meeting ISO standards. The document notes that no new clinical data for SpO2 was provided, relying on K221282, which would have established ground truth similarly.

8. The Sample Size for the Training Set

• The document does not provide details about the sample size for the training set used for the device's algorithms. It focuses entirely on the clinical validation (test set) data.

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

• The document does not provide details on how the ground truth for the training set was established. This information is typically not included in a 510(k) summary, which focuses on the validation of the final product.

Ask a specific question about this device

The Empatica Health Monitoring Platform is a wearable device and cloud-based software platform intended to be used by trained healthcare professionals or researchers to remotely monitor physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments.

The device supports continuous data collection for monitoring the following physiological parameters:

• · Peripheral skin temperature,
• · Electrodermal activity,
• · Blood Oxygen Saturation under no motion conditions,
• · Activity associated with movement during sleep.

The Empatica Health Monitoring Platform can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

The Empatica Health Monitoring Platform is not intended for SpO2 monitoring of motion or low perfusion.

The Empatica Health Monitoring Platform is intended for peripheral skin temperature monitoring temperature at the wrist is clinically indicated.

The Empatica Health Monitoring Platform is a wearable device and software platform composed by:

• A wearable medical device called EmbracePlus,
• A mobile application running on smartphones called "Care App",
• A cloud-based software platform named "Care Portal".

The EmbracePlus is worn on the user's wrist and continuously collects raw data via specific sensors. These data are wirelessly transmitted via Bluetooth Low Energy to a paired mobile device where the Care App is up and running. The data received are analyzed by one of the Care App software modules, EmpaDSP, which computes the user physiological parameters. Based on the version of the Care App installed, the user can visualize a subset of these physiological parameters. The Care App is also responsible for transmitting, over cellular or Wi-Fi connection sensors' raw data, device information, Care App-specific information, and computed physiological parameters to the Empatica Cloud. On the Empatica Cloud, these data are stored, further analyzed, and accessible by healthcare providers or researchers via a specific cloud-based software called Care Portal.

The platform is intended to continuously monitor adult patient physiological parameters in homehealthcare environment. It is designed for monitoring patients by trained healthcare professionals or researchers. It is intended to continuously monitor blood oxygen saturation (SpO2), peripheral skin temperature (TEMP), and electrodermal activity (EDA). Activity sensors are used to detect sleep periods and to monitor the activity associated with movement during sleep.

This document describes the Empatica Health Monitoring Platform, a wearable device and cloud-based software, and its validation for FDA clearance. The primary focus of the performance data in this document is on the Blood Oxygen Saturation (SpO2) monitoring feature.

Here's a breakdown of the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides specific performance criteria for several physiological parameters. For the SpO2 feature, a key acceptance criterion is its accuracy, which is compared to the predicate devices and relevant standards.

• FDA Guidance for Pulse Oximeters (2013) compliance
• Predicate Loop System: 3% Arms
• Predicate Current Wearable: ± 2 Digits | 2.6% Arms (across 70-100% SpO2 range) |
  | SpO2 Range | 70-100% (Matches predicates) | 70-100% |
  | SpO2 Resolution | 1% (Matches predicates) | 1% |
  | Temperature Accuracy | ± 0.1°C within 30.0°C - 45.0°C range (Matches predicate Current Wearable, which has ± 0.1°C) | ± 0.1°C within 30.0°C - 45.0°C range |
  | Temperature Range | 0°C to 50°C (Matches predicate Current Wearable) | 0°C to 50°C |
  | Temperature Resolution | 0.1°C (Matches predicate Current Wearable) | 0.1°C |
  | EDA Range | 0.01 µS – 100 µS (Matches predicate Empatica E4) | 0.01 µS – 100 µS |
  | EDA Resolution | Predicate Empatica E4: 1 digit ~ 900 pS | 1 digit ~ 55 pS |
  | Accelerometer Type | Microelectromechanical system (MEMS)-based integrated circuit (Matches predicate ActiGraph CentrePoint Insight Watch) | Microelectromechanical system (MEMS)-based integrated circuit |
  | Accelerometer Sampling Rate | Predicate ActiGraph CentrePoint Insight Watch: Digital method, 32 Hz - 256 Hz | Digital method, 26 Hz - 208 Hz |
  | Accelerometer Dynamic Range | Predicate ActiGraph CentrePoint Insight Watch: ± 8 g | ± 16 g |
  | Accelerometer Sensitivity | Predicate ActiGraph CentrePoint Insight Watch: 2.4 milli-g per Least Significant Bit | 0.488 milli-g per Least Significant Bit |

Note on "Analysis of differences" for EDA and Accelerometer: For EDA Resolution, Accelerometer Sampling Rate, Dynamic Range, and Sensitivity, the document explicitly states that the differences "shall not raise new concerns of device safety or effectiveness," implying that the reported performance, while numerically different, is still considered acceptable.

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

• Sample Size for SpO2 Accuracy Test Set: 13 healthy adult subjects.
• Data Provenance: The document does not explicitly state the country of origin but implies it was conducted by Empatica S.r.l., which is based in Milan, Italy. The study was a prospective clinical investigation, comparing the device to a gold standard.

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

• The ground truth for the SpO2 accuracy test was established using arterial blood gas analysis, which is a direct and objective physiological measurement and is considered the "gold standard." This method does not typically involve human experts for interpreting the ground truth itself, but rather trained medical professionals for collecting the samples and laboratory personnel for performing the analysis. The document does not specify the number or qualifications of these personnel.

4. Adjudication Method for the Test Set

• Not applicable for the SpO2 accuracy study, as the ground truth was established by direct physiological measurement (arterial blood gas analysis), not expert consensus requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. The study described is a direct comparison of the device's SpO2 measurements against a clinical gold standard (arterial blood gas analysis), focusing on the device's standalone accuracy rather than human-in-the-loop performance or improvement with AI assistance.

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

• Yes, a standalone performance study was done for SpO2 accuracy. The clinical study directly evaluated the performance of the Empatica Health Monitoring Platform (device and its algorithms) in measuring blood oxygen saturation against the ground truth, without an explicit human reader component. The device's output was compared to arterial blood gas analysis.

7. The Type of Ground Truth Used

• Clinical Gold Standard / Outcomes Data (Physiological Measurement): For SpO2 accuracy, the ground truth was established through arterial blood gas analysis.

8. The Sample Size for the Training Set

• The document does not provide information regarding the sample size of the training set for the device's algorithms. The clinical study described focuses on the validation of the device's performance, not its development or training data.

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

• The document does not provide information on how the ground truth for any potential training set was established. The clinical study details focus solely on the method for validating the device's performance against a gold standard.

Ask a specific question about this device

The Cascade IOMAX™ Intraoperative Monitor with Surgical Studio software (IOMAX) is an electroneurodiagnostic device that acquires, displays and stores physiologic data from peripheral sensory and motor nerves, muscles and the central nervous system, generated either spontaneously or elicited stimuli. The acquired data are necessary to perform somatosensory. auditory and visual evoked potentials (EPs), electroencephalography (EEG), electromyography (EMG), transcranial motor evoked potentials (TcMEPs), direct cortical stimulation, nerve conduction studies and Train of Four (TOF) analysis. SpO2 measures and displays oxygen saturation and heart rate information. The system also delivers direct nerve stimulation required for specific surgical procedures.

Evoked Potentials (EPs): IOMAX provides electrical, auditory or visual stimulation and measures, and stores the electrical activity of the nervous system in response to the stimulation.

EEG: IOMAX measures, displays, records, and stores electrical activity of the brain from two or more electrodes on the head.

Free Run EMG: IOMAX acquires, displays, records, and stores spontaneous EMG activity of motor nerves by continually displaying a live stream of mechanically induced myotome contractions.

TcMEP: IOMAX delivers transcranial stimulation via dedicated outputs for intraoperative assessment. Cortical Stimulation: IOMAX delivers Low Current Stimulation (LCS) during surgical procedures to map various areas of the cortex.

Triggered EMG (TEMG): IOMAX electrically stimulates the motor nerves, and displays, records, and stores the resulting compound muscle action potentials in the innervated muscle.

Nerve Conduction Study (NCS): IOMAX measures, displays, records, and stores sensory and motor nerve conduction time (latency) by applying a stimulus to peripheral nerves, the spinal cord, and the central nervous system.

Train of Four (TOF) or Twitch Test: IOMAX delivers a train of four pulses and measures, and stores the compound muscle action potential amplitude fade for analysis.

SpO2: IOMAX measures and displays oxygen saturation and heart rate information. Remote Reader: IOMAX provides passive, real time remote review of intraoperative monitoring for a physician outside of the operating room.

IOMAX is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing.

The IOMAX is a multimodality intraoperative neuromonitoring (IONM) system. It consists of Cadwell custom hardware, a standard laptop or desktop personal computer (PC) running a standard off-the-shelf (OTS) operating system (OS), and Cadwell custom software.

The modalities recorded, measured and displayed by the IOMAX are:

• . Evoked potential (EP) in the form of:
  • Brainstem auditory (BAEP): O
  • Visual (VEP); and O
  • Somatosensory (SSEP). O
• Transcranial electrical motor evoked potential (TcMEP).
• Electromyography (EMG). ●
• Triggered EMG.
• Electroencephalogram (EEG). ●
• Nerve conduction studies.
• Train of four (TOF). ●
• SpO2 and heart rate values. ●
• Threshold mode. ●
• Cortical stimulation.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Cadwell IOMAX Intraoperative Monitor:

Acceptance Criteria and Reported Device Performance

The provided document describes the Cadwell IOMAX Intraoperative Monitor, an electroneurodiagnostic device. The acceptance criteria are broadly focused on the device's technical performance, safety, and compliance with various medical device standards. The document does not present specific quantitative acceptance criteria or reported performance values in a distinct table format. Instead, it states that "Test results indicate that the IOMAX complies with its predetermined specifications and the applicable standards." and "Clinical results indicate that the IOMAX complies with the applicable requirements of the standard."

However, we can infer the categories of acceptance criteria based on the performance testing summary. The reported device performance is generally a statement of compliance.

Study Details:

The provided document summarizes various tests rather than detailing a single "study" as one might expect for a clinical trial. However, it does outline the testing performed to demonstrate compliance.

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

   • Biocompatibility: Not explicitly stated as a "sample size" for a test set in the clinical sense. The verification was on "component materials" of accessories. Data provenance is implied to be laboratory testing of materials.
   • Software, Electrical Safety, EMC, Bench Performance: Not applicable in terms of patient sample size. These involve engineering and laboratory testing of the device itself.
   • Clinical Performance (SpO2): The document states "Clinical results indicate that the IOMAX complies with the applicable requirements of the standard [ISO 80601-2-61:2011, Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment]". This standard defines requirements for pulse oximeters, which would necessitate testing on human subjects. However, the specific sample size for this clinical testing is not provided in the given text. The data provenance is clinical testing against a standard. The country of origin is not specified.

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

   • This information is not provided in the document. The testing described is primarily technical compliance with standards, and clinical performance for SpO2 which refers to a standard directly. There is no mention of independent expert review or ground truth establishment in the traditional sense for diagnostic accuracy.

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

   • This information is not provided and is unlikely to be applicable for the types of compliance testing described here. Adjudication methods are typically used for medical image interpretation or diagnostic accuracy studies involving human readers.

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 MRMC comparative effectiveness study was done or mentioned. This device is an intraoperative monitor and stimulator; it is not an AI-powered diagnostic imaging tool that would typically involve human readers interpreting cases with or without AI assistance. Therefore, no effect size of human improvement with AI assistance is applicable or provided.

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

   • The IOMAX is an electroneurodiagnostic device that acquires and displays physiological data. Its "performance" is based on the accuracy and reliability of its measurements and stimulation. The testing described (electrical safety, EMC, bench, and clinical for SpO2) assesses the device's inherent function, which is essentially "standalone performance" in the sense that the device directly performs the measurement or stimulation. It doesn't involve an "algorithm" in the AI sense, but rather the hardware and software's ability to accurately capture and present physiological signals or deliver specific stimuli.
   • The clinical performance for SpO2 (compliance to ISO 80601-2-61) is a test of the device's standalone accuracy in measuring oxygen saturation and heart rate.

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

   • For the technical compliance tests (biocompatibility, software, electrical safety, EMC, bench performance), the "ground truth" is defined by the requirements of the specified industry standards (e.g., ISO 10993-1, ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60068, IEC 60601-2-26, IEC 60601-2-40, IEC 60601-1-6, IEC 62366). The device's output is compared against the expected performance defined by these standards.
   • For the clinical performance testing for SpO2, the ground truth would be established by a reference method or device as required by ISO 80601-2-61, which typically involves comparing the pulse oximeter's readings against arterial blood gas analysis results.

8. The sample size for the training set:

   • This information is not applicable as the device is not described as an AI/machine learning device that requires a training set in the conventional sense. The "training set" for software development would be the requirements and specifications used during its creation, rather than a dataset for statistical model training.

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

   • As the concept of a "training set" for an AI model is not applicable here, the establishment of ground truth for such a set is also not applicable. The software's "ground truth" during development would be its specified functional requirements.

Ask a specific question about this device

QBioScan is indicated for the measurement of galvanic skin response to aid in the assessment of the sudomotor function. The device is intended for use on the general adult population in medical clinics, healthcare practices and out-patient departments of hospitals.

QBioScan™ is a galvanic skin response measurement device intended for the collection and display of galvanic skin response recorded by the device consists of the following components:

• . an off-the-shelf computer with proprietary device software pre-installed
• . a custom electronics box that houses the QBioScan circuitry
• a USB cable to connect the electronics box to the computer .
• reusable electrode lead cables .
• reusable hand and foot electrodes and optional disposable forehead electrodes .
• . an off-the-shelf printer (optional)
  The device allows for a evaluation of sweat gland function based on a measuring method where patients are in contact with surface electrodes (reusable stainless-steel plates and optional disposable electrodes) and are exposed to an incremental low voltage (under the 60601-1 standard safety limits). The device tests the electrochemical reaction between electrodes and the chloride ion released by the stimulated sweat glands. This active test method provides information and evidence of a sweat gland dysfunction that might otherwise not be detectable in a physiological examination. The Bioelectrical Conductance (BEC, in micro-Siemens, uS) representing galvanic skin response for the hands and feet are expressed as quantitative results along with an asymmetry value expressed as the percent difference between the BEC values of the right / left hands and the right / left feet. The device does not provide any direct diagnosis rather the device provides information to the physician for inclusion in their decision making process.

The QBioScan device does not appear to have acceptance criteria for clinical performance explicitly stated in this 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device (Sudoscan) primarily through technological characteristics and non-clinical testing.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As there are no specific performance acceptance criteria for clinical outcomes mentioned, a table cannot be fully provided. The non-clinical testing refers to compliance with safety and EMC standards and software V&V, which are typically pass/fail.

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

• No clinical test set was used for a performance study. The document explicitly states: "No Clinical testing was necessary to determine substantial equivalence."
• Data Provenance: Not applicable for clinical testing. For the non-clinical testing (electrical safety, EMC, software V&V), the data would have been generated internally by Medeia, Inc. or by a contract testing laboratory.

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

• Not applicable as no clinical test set with human subjects requiring ground truth establishment was used.

4. Adjudication Method for the Test Set

• Not applicable as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. The document states, "No Clinical testing was necessary to determine substantial equivalence." This type of study would fall under clinical testing.

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

• Not explicitly described as a standalone performance study. The device is a "galvanic skin response measurement device" which directly measures a physiological signal. While it processes data and displays it, it's not an "algorithm only" device in the context of, for example, an AI diagnostic tool. The focus is on the device's ability to accurately measure the physiological parameter, which is addressed through the technological comparison to the predicate and non-clinical safety/EMC testing.

7. The Type of Ground Truth Used

• Not applicable for clinical validation, as no clinical studies were performed. For the technical aspects, the "ground truth" would be the established safety standards (IEC 60601-1, EN 60601-1-2) and the functional specifications of the device itself (for software V&V).

8. The Sample Size for the Training Set

• Not applicable. This device is a measurement device, not an AI/machine learning device that requires a training set in the conventional sense. Its "training" would be its design and engineering to accurately measure galvanic skin response.

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

• Not applicable, as there is no training set in the context of AI/ML.

Summary of Approach:

The manufacturer, Medeia, Inc., pursued a 510(k) pathway for substantial equivalence. Their strategy was to demonstrate that the QBioScan device shares the same intended use and similar technological characteristics with a legally marketed predicate device (Sudoscan), and that any differences do not raise new questions of safety or effectiveness. This allowed them to forgo clinical testing and rely on non-clinical (electrical safety, EMC, software verification, and validation) testing, alongside a detailed technological comparison.

Ask a specific question about this device

SudoC device is a medical device for the measurement of galvanic skin response related to the sweat glands.

The SudoC provides values. It is the physician's responsibility to make proper judgments based on these numbers. The device is indicated for use in general adult population.

Prescription Use: Federal law restricts this device to sale by or on the order of a physician.

The SudoC is a programmable electro medical system including:

• USB plug and play hardware device including an electronic box, 2 reusable cables to connect . the box to electrodes and 2 tactile electrodes placed on the sole of each foot.
• Software installed on a computer. ●

As a galvanic skin response measurement device, it measures the skin resistance (i.e., conductance).

The provided text is a 510(k) Premarket Notification for a device named SudoC. This document primarily focuses on demonstrating that the SudoC device is substantially equivalent to a previously cleared predicate device (SudoPath K131568) and does not contain detailed information about specific acceptance criteria, study designs, or reported device performance for the SudoC as an independent, de novo submission would.

Therefore, many of the requested details cannot be extracted directly from this document. However, I can provide the information that is present and explain why other information is not available.

Here's a breakdown based on the provided text:

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

This document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) or reported performance values for the SudoC. The core of this submission is to demonstrate substantial equivalence to a predicate device, meaning it asserts that the modifications to SudoC do not change its performance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided. The document states that the modifications to the proposed device "do not change the performance of the device" as shown with:

• New risk management
• Software verification (SRS/SDS/STD/STR)
• Summary of Design Control Activities and Declaration of Design control conformity.
• Comparison of the conductance values using stainless steel electrodes versus conductive disposable cloth electrode.
• The removal of the hand electrodes does not affect the performance of the galvanic skin response measurement.

The crucial point is the "Comparison of the conductance values" which suggests some testing was done, but details like sample size, provenance, or whether it was a "test set" in the context of a clinical study are absent.

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)

This information is not provided. The SudoC is a galvanic skin response measurement device, which measures physiological responses. "Ground truth" in this context would likely refer to the accuracy of the measurements themselves or their correlation with a specific physiological state, which is not detailed in this type of submission for substantial equivalence.

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

This information is 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

This information is not provided. The device (SudoC) is described as a measurement device that provides values, and "It is the physician's responsibility to make proper judgments based on these numbers." This indicates it's a diagnostic aid, not an AI-assisted detection or interpretation system that would typically involve human reader performance studies.

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

The SudoC is a measurement device. It provides raw "values." The "algorithm" here would be the processing of the galvanic skin response to produce those values. The document asserts that the fundamental scientific technology and the range of conductance measurements (1 to 120 micro Siemens) are the same as the predicate. While software verification was done, a standalone performance study with specific metrics is not detailed as per the typical requirements for a new, complex algorithm or AI.

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

This information is not explicitly stated. For a galvanic skin response device, the ground truth would likely be the accurate measurement of skin conductance. The document states "Comparison of the conductance values using stainless steel electrodes versus conductive disposable cloth electrode," suggesting that the accuracy of the conductance measurement itself with the new electrodes was assessed against the prior electrode type.

8. The sample size for the training set

This information is not provided. Since this is a 510(k) for a measurement device and not an AI/ML algorithm requiring extensive training data, such details are typically not included unless the specific modifications involved significant new algorithmic development or a new intended use. The software changes primarily relate to "New design and change in time and sequence of measurement."

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

This information is not provided, for the same reasons as point 8.

Ask a specific question about this device

The Neuromaster G1 MEE 2000 Neural Function Measuring System is intended to monitor, record, and display the bioelectric signals produced by sensory and motor pathways in the operating room, critical care, and other areas where continuous monitoring is needed. The system measures and displays electric/auditory/visual evoked potential (EP), electroencephalography (EEG), and electromyography (EMG), skin temperature of distal portion of extremities, SpO2, and ETCO2 to provide health care professionals with information to help assess a patient's neurological status. The system is used as a nerve stimulator for surgical procedures and brain mapping during treatment of patients with seizure disorders and used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

· EEG - The device may also measure and record the electrical activities of the patient's brain obtained by placing two or more electrodes on the head (EEG).

· EP-Electrical/ Auditory/ Visual - Continuous and/or periodic measurements of evoked potential activities are displayed and stored. The device applies an electrical stimulus to a patient through commercially available skin electrodes for the purpose of measuring the evoked response. The photic stimulator is used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye and the auditory stimulator produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

· Free Run EMG - The Free Run EMG function identifies spontaneous EMG activity of nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.

· CoMEP - Cortical stimulation techniques for cortical mapping are used at "Low Output" for placement of electrodes during surgical procedures and for brain mapping during treatment of patients with seizure disorders.

· TcMEP - Transcranial electrical stimulation techniques for motor evoked potentials (TcMEP) are used at "TcMEP Output" for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency."

· Nerve conduction study - The device is intended to measure and display nerve conduction time by applying a stimulus to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

• SpO2 - When the SpO2 adapter and finger and toe probe for SpO2 measurement are used. oxygen saturation information is automatically measured and displayed.

· EtCO2 - When the CO2 adapter and sensor for EtCO2 measurement are used, endtidal carbon dioxide of respiratory gas information is automatically measured and displayed.

• Skin temperature - When the skin temperature sensor for skin temperature measurement is used, skin temperature information is automatically measured and displayed.

· Remote reader – The remote reader function provides real time remote access to the system for a monitoring physician outside of the operating room.

The device is intended for use by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional.

The device is available for use on any patient as determined by the medical professional including adults and children of all ages.

The Neuromaster G1 MEE2000 Neural Function Measuring System is a compact and multi-functional system for continuous monitoring of brain and neural pathways intraoperatively and in critical care areas. The system measures and displays electric/auditory/visual evoked potential (EP), electroencephalography (EEG), and electromyography (EMG), skin temperature of distal portion of the extremities, SpO2 and ETCO2. The system also measures and displays nerve conduction time by applying a stimulus to a patient's peripheral nerve. The system includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

The system uses electrical stimulus, visual stimulus, or sound stimulus in evoked responses measurements (EP). Continuous and/or periodic measurements of evoked potential activities are displayed and stored. The system applies an electrical stimulus to a patient through skin electrodes for the purpose of measuring the evoked response. The photic stimulator is used to generate and display a shifting light pattern or to apply a brief light stimulus for use in evoked response measurements or electroencephalogram activation. The system may measure and record the electrical activities of the patient's brain obtained by placing two or more electrodes on the head (EEG).

The system can be used as a nerve stimulator for surgical procedures and brain mapping during treatment of patients with seizure disorders and used for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

The system can be connected to SpO2 and ETCO2 sensors to display the patient's oxygen saturation values as measured by pulse oximetry and CO2 values respectively throughout the procedure.

The acquired waveforms are displayed in cascaded format and measurement data may be displayed on the trend graph with waveform annotations (events). The acquired waveforms with the measurement data can be saved to a large capacity storage media. The data can be printed directly on paper, printed to portable document format (pdf), and/or archived to other locations.

The Neuromaster G1 MEE2000 System consists of at minimum a main unit (DC-200B), an amp unit (JB-232B), one breakout box (JB-210B), four stimulation pods [JS-201B(A), JS-202B (B), JS-203B (C), JS-204B (D)], and a computer (CC-201BK) with specific software. There are several standard and optional accessories such as cables, connectors, SpO2 probes, ETCO2 sensors, and various types of electrodes and leads.

Here's a breakdown of the acceptance criteria and study information for the Neuromaster G1 MEE2000 Neural Function Measuring System, as derived from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting novel acceptance criteria and explicitly defining the new device's performance against them. Instead, the performance characteristics of the Neuromaster G1 MEE2000 System are presented in comparison to its predicate device (Neuromaster MEE1000 System) and other reference predicates. The "acceptance criteria" here are implicitly the performance specifications of the predicate devices, which the new device aims to meet or exceed where noted.

I will present a selection of key characteristics to illustrate this comparison format. Please note that the document contains a very extensive table (Table 3) outlining numerous characteristics; this is a summary of some of the most relevant ones to demonstrate the device's technical specifications and how they align with or improve upon predicates.

Table: Acceptance Criteria (Predicate Performance) and Reported Device Performance (Neuromaster G1 MEE2000)

Ask a specific question about this device

The SUDOSCAN System is a medical device for the measurement of galvanic skin response to aid in the assessment of sudomotor function. SUDOSCAN is indicated for use in the general adult population.

SUDOSCAN is based on two well-known principles, reverse iontophoresis and electrochemistry. SUDOSCAN collects physiological data by means of chronoamperometry and processes them with analysis software. SUDOSCAN devices use both technologies, coupled and complemented with exclusive software which analyzes cutaneous conductance data collected through the chronoamperometric measurements. The SUDOSCAN system is composed of: - analog acquisition electronic circuitry with low-noise front end - multiplexing control unit for selecting the appropriate acquisition channels - optically isolated USB interface controller - power converter - 4 electrodes placed on the feet and the hands - touch-screen computer running the proprietary SUDOSCAN software

The provided text is a 510(k) Summary for the SUDOSCAN device (K141872). It compares the proposed device to a predicate device (K100233), which is itself an earlier version of the SUDOSCAN.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for a new clinical study. Instead, it argues for substantial equivalence based on technological characteristics and a change in indication statement and labeling compared to its own predicate device. The performance data section refers back to the testing provided in the K100233 submission.

The "Performance Data" section states: "The modifications that are the subject of this 510(k) are to the indication statement, labeling and minor software and hardware upgrades. Therefore the performance testing provided in K100233 is applicable to this 510(k)."

This implies that the performance of the device, in terms of its ability to measure galvanic skin response, is considered unchanged from the predicate and thus already "meets acceptance criteria" from its previous clearance. The acceptance criteria would have been established during the K100233 submission.

The table below summarizes the technological characteristics of the proposed device as presented in the "Device Comparison Table" within the document, rather than specific performance metrics from a new study designed to meet pre-defined acceptance criteria for this 510(k).

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

The document for K141872 explicitly states that no new performance testing was conducted for this submission (K141872) related to the device's ability to measure galvanic skin response. It relies on the performance testing from the predicate device (K100233). Therefore, information on a "test set" and "data provenance" for this specific 510(k) application is not provided as new clinical performance data was not generated.

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

As no new clinical performance testing was conducted for K141872, this information is not available in the provided document. The original ground truth establishment would have occurred for the K100233 submission.

4. Adjudication method for the test set

Not applicable, as no new clinical test set and associated performance evaluation were conducted for K141872.

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 applicable. The SUDOSCAN device is a diagnostic measurement device for sudomotor function, not an AI-assisted interpretation tool for images or other complex data requiring human reader interaction in the way a MRMC study typically evaluates. No MRMC study is mentioned or relevant to this device's function.

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

The device itself is a standalone measurement system. The document does not describe "algorithm only" performance in the context of interpretation or diagnosis being done without human involvement. The device measures galvanic skin response, and a physician interprets the results. The statement "Used to provide feedback to physicians, not to diagnose" reinforces the human-in-the-loop aspect for diagnosis, but the measurement itself is standalone. The performance testing for K100233 would have established the accuracy of these standalone measurements.

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

Given that the device measures galvanic skin response, which is a physiological parameter, the ground truth for the original K100233 submission would likely have involved:

• Reference standards for conductivity measurements: Calibration against known electrical standards.
• Correlation with clinical conditions: For its intended use in assessing sudomotor function, the ground truth would have been established by comparing SUDOSCAN measurements with other validated methods for assessing sudomotor function or with clinical diagnoses of conditions affecting sudomotor function, possibly including expert clinical assessment or other established diagnostic tests.
• The provided document for K141872 does not specify the ground truth methodology for K100233.

8. The sample size for the training set

Not applicable. The document describes a 510(k) submission for an existing device with minor changes and expanded indications, relying on the previous clearance. It does not discuss a "training set" in the context of machine learning model development.

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

Not applicable, as this submission does not involve a machine learning model requiring a training set with established ground truth.

Ask a specific question about this device