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The Bluebird Single-Use Respiratory Effort Belt is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The respiratory effort belt signals are suitable for connection to sleep/polysomnography (PSG) systems. The intended environments are hospitals, institutions, sleep clinics, or other test environments, including the patient's home.

The Bluebird Single-Use Respiratory Effort Belt is intended for diagnostic purposes only on patients greater than 2 years of age and is not intended to be used as an apnea monitor.

The Bluebird Single-Use Respiratory Effort Belt (Bluebird) is used to measure chest and abdomen expansion and contraction during respiration. The sensor consists of a sinusoidal wire coil attached along the length of an elastic belt. The inductance of the sensor changes as the belt is stretched. The Bluebird is suitable for connection to the inputs of physiological recording equipment. The Bluebird measures inductance and generates an output signal proportional to the amount of stretch. The elastic belt is held in place by a quick release buckle with a cinch function and the belt is adjusted to fit snugly but comfortably. Electrical connection to the two ends of the embedded coil is through a 1.5mm female touch proof connection jack on each side of belt buckle. The materials are elastics and plastics used in the clothing industry, and fine gauge copper wire for the embedded coil.

The provided text describes a 510(k) summary for the "Bluebird Single-Use Respiratory Effort Belt" (subject device) and its equivalence to a predicate device, the "XactTrace® Single Use Respiratory Effort Belt System."

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail format like a clinical trial. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The performance testing outlined serves to demonstrate that the subject device performs comparably to the predicate and meets design requirements.

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

• Sample Size for Test Set: The document does not specify a sample size for the comparative performance testing. It mentions "Performance testing was performed for the Bluebird rip belt connected to a Cadwell recording device and simultaneously to an XactTrace belt." This suggests a comparative test, but the number of devices or data points isn't quantified.
• Data Provenance: The document does not provide information on country of origin or whether the data was retrospective or prospective. It describes non-clinical laboratory testing ("Nonclinical tests were performed on the subject device").

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

• This information is not provided in the document. As this is a non-clinical, performance-based study comparing a physical device to another, the concept of "ground truth" as established by medical experts for diagnostic accuracy studies does not directly apply here. The "ground truth" seems to be the expected physical and electrical performance characteristics of such a device, and its output signal, which were compared against the predicate.

4. Adjudication Method for the Test Set

• Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation by multiple readers. This information is not applicable/provided as this is a non-clinical performance study comparing two medical devices' physical and electrical outputs.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools or imaging devices where human readers interpret patient data. The Bluebird Single-Use Respiratory Effort Belt is a sensor intended to measure respiratory effort, not an interpretive AI tool.
• Therefore, information on the effect size of human readers improving with AI vs. without AI assistance is not applicable.

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

• No, a standalone (algorithm only) study was not done. This device is a physical sensor, not an algorithm. Its performance is about accurately capturing a physiological signal.

7. Type of Ground Truth Used

• The "ground truth" in this context is the expected physical and electrical performance of a respiratory effort belt and its output signal, as demonstrated by the legally marketed predicate device.
• The study aimed to show that the subject device's performance, particularly its breathing effort signal output, was equivalent to that of the predicate device. The statement "The resulting waveforms are the same for both belts" indicates that the predicate's output served as the benchmark.

8. Sample Size for the Training Set

• Not applicable. This device is a physical sensor, not an AI/ML algorithm that requires a training set.

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

• Not applicable. As no training set was used for an AI/ML algorithm.

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The Guardian with Cascade Surgical Studio software 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 by stimuli.

Guardian can perform somatosensory, auditory, and visual evoked potentials (EPs), electroencephalography (EEG), electrocorticography (ECoG), spontaneous and triggered electromyography (EMG), transcranial motor evoked potentials (TcMEP), direct cortical stimulation (DCS), direct nerve stimulation (TEMG, DNS), nerve conduction studies (NCS), and Train of Four (TOF) analysis.

Guardian can provide remote review outside of the operating room.

Guardian 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 following functions are specifically supported individually or in combination:

Evoked Potentials (EPs): Guardian can provide electrical, auditory, and visual stimulation and measure, display, record, and store the electrical activity of the nervous system in response to the stimulations delivered.

Electroencephalography (EEG): Guardian can measure, display, record, and store electrical activity of the brain from two or more electrodes on the scalp.

Electrocorticography (ECoG): Guardian can measure, display, record, and store electrical activity directly from the brain using two or more electrodes.

Free Run Electromyography (EMG): Guardian can acquire, display, record, and store EMG activity of motor nerves.

Triggered Electromyography (TEMG): Guardian can electrically stimulate motor nerves, and display, record, and store the results.

Transcranial Motor Evoked Potentials (TcMEP): Guardian can deliver electrical transcranial stimulation, and display, record, and store the results.

Direct Cortical Stimulation (DCS): Guardian can deliver electrical stimulation to various areas of the cerebral cortex, and display, record, and store the results.

Direct Nerve Stimulation (DNS): Guardian can electrically stimulate cranial and peripheral nerves, and display, record, and store the results.

Nerve Conduction Study (NCS): Guardian can measure, display, record, and store 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): Guardian can deliver a train of four pulses, and measure, display, record, and store the results.

The Cadwell Guardian is a multi-modality intraoperative neurophysiological monitoring system with up to 80 channels of data acquisition.

The Guardian system is designed to be flexible and scalable depending on customer and procedural requirements. All systems require a Power Comm and Guardian Base, which contains an electrical Transcranial Stimulator. The user may select up to two Omni Amplifiers, two ES-10 electrical stimulators, one AVX auditory and visual stimulator, and one SMX-32 EEG amplifier that contains a low current electrical stimulator, in order to meet specific requirements.

The Guardian requires a (PC) with Windows operating system. The Guardian system uses a new version (4.0) of previously cleared Cadwell Cascade Surgical Studio software. Surgical Studio acquires, stores and reviews a wide range of intraoperative neurophysiological data, such as EMG, EEG, SSEP, BAEP, VEP, MEP and TOF, and includes Report Generation.

The provided text describes the Cadwell Guardian device, its indications for use, and a comparison to predicate devices, but it does not contain information about specific acceptance criteria or a study proving the device meets those criteria with quantitative performance metrics (like sensitivity, specificity, or accuracy) derived from a test set of data.

The document states:

• "Performance Testing: The Cadwell Guardian was tested in accordance with internal software requirements, system requirements, and usability requirements. Test results indicate that the Cadwell Guardian complies with its predetermined specifications."
• "Conclusion: Verification and validation activities were conducted to establish the performance and safety characteristics of the Cadwell Guardian. The results of these activities demonstrate that the Cadwell Guardian is as safe, as effective, and performs as well as the predicate devices. Therefore, the Cadwell Guardian is considered substantially equivalent to the predicate devices."

This indicates that internal performance testing was conducted, and the device met its specifications, leading to a determination of substantial equivalence to predicate devices. However, the details of these "predetermined specifications" or "internal software requirements" in terms of specific performance metrics are not provided in the given text. There's no mention of a clinical study or a study involving a "test set" of data for algorithm performance, human reader performance, or ground truth establishment in the way typically expected for AI/CADe device submissions.

Therefore, I cannot populate the requested tables and sections with quantitative data from the provided text. The document focuses on regulatory approval through substantial equivalence based on technical characteristics and safety standards rather than a detailed performance study against specific acceptance criteria for an AI component.

Summary of missing information based on the request:

1. Table of acceptance criteria and reported device performance: Not provided. The document states "complies with its predetermined specifications" but does not detail these specifications or measured performance.
2. Sample size used for the test set and data provenance: No information on a specific "test set" for performance evaluation, nor its size, origin (country), or whether it was retrospective/prospective.
3. Number of experts used to establish ground truth & qualifications: Not applicable, as there's no mention of a ground truth establishment process for a test set.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The approval is based on substantial equivalence to existing devices, not a comparative effectiveness study involving human readers with/without AI assistance.
6. Standalone (algorithm only) performance: Not mentioned, as the device is an electroneurodiagnostic system, not a standalone AI algorithm for interpretation.
7. Type of ground truth used: Not applicable, as no external ground truth establishment is described for performance evaluation.
8. Sample size for the training set: Not applicable, as the document doesn't describe an AI/ML component with a training set. The software is noted as "a new version (4.0) of previously cleared Cadwell Cascade Surgical Studio software."
9. How ground truth for the training set was established: Not applicable.

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The Cadwell Apollo System is indicated for prescription use to acquire, record, transmit, and display physiological and environmental data for electroencephic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of patients of all ages.

The Cadwell Apollo System (Apollo) is used to acquire, record, transmit, and display physiological and environmental data for electroencephalographic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of patients of all ages. The Apollo system utilizes Cadwell Arc acquisition software (previously cleared in K180269) with support for Apollo hardware using single or combinations of amplifiers, a photic stimulator, and interfaces with a Cadwell or 3rd party oximeter devices. Additional channels can be added with multiple amplifiers. Apollo is intended for use in both home healthcare and professional healthcare environments.

The provided text does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML powered device. The document is a 510(k) premarket notification for the Cadwell Apollo System, an electroencephalograph, and focuses on demonstrating substantial equivalence to a predicate device through engineering and software testing for safety and performance against established standards.

Therefore, the requested table and detailed information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details for an AI/ML component cannot be extracted from this document. The document describes traditional device testing, not AI/ML model validation.

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The Cadwell ApneaTrak device is intended for home sleep testing, including the acquisition of physiological and environmental data. The recorded signals are then transmitted to a PC so that they can be viewed. ApneaTrak is intended for use on patients older than 2 years of age.

ApneaTrak is intended for use in hospitals, sleep centers and other sleep testing environments, including the patient's home. ApneaTrak is intended to be used when prescribed by a qualified healthcare provider for use on patients suspected of sleep disorders, specifically Sleep Disordered Breathing (SDB) and requires review by qualified medical personnel. ApneaTrak is NOT intended to perform automatic diagnosis.

Cadwell's ApneaTrak is a sleep diagnostic system consisting of: (1) acquisition hardware that can acquire, record, store, and transfer up to 3 channels of ExG (including EEG, EMG, ECG, and EOG signals) data, 2 respiratory effort channels, 1 thermistor channel, 1 pressure channel, 1 snore channel, and 1 oximetry channel; (2) a host electronic device (typically a PC) capable of running the software as well as charging and interfacing with the acquisition device; and (3) software that allows for device configuration and data download.

ApneaTrak is connected, by a clinical user, to a host device via USB cable for initialization. After initialization and having been given instruction on correct clinical use of the device, ApneaTrak is then used by the patient at home. The device acquires and stores physiological and/or environmental data to onboard memory. After use, the device is returned to the clinical user, who connects the device to the host PC. The software downloads and stores data from the device in European Data Format (EDF).

The provided document does not contain an acceptance criteria table detailing specific performance metrics and a study describing how the device meets those criteria with clinical data. Instead, it details that the ApneaTrak device underwent performance testing against recognized electrical safety, electromagnetic disturbance, and performance standards for its various signal acquisition functionalities.

The document indicates that the device's technical specifications and intended use are similar to predicate devices (Zmachine Synergy and Nox T3 Sleep Recorder). The testing primarily focuses on demonstrating compliance with standards and equivalence in signal acquisition performance through bench testing rather than a comparative effectiveness study involving human readers or a standalone algorithm-only performance study.

Here's a breakdown of the available information based on your request:

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

The document does not provide a table of acceptance criteria with specific performance thresholds for diagnostic accuracy (e.g., sensitivity, specificity for identifying sleep disorders) that the device must meet against a ground truth. Instead, it lists the following performance tests and their outcomes:

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

The document describes "performance bench tests" where "a known oscillating input signal was injected" or "tested in accordance with internal software requirements, system requirements, and usability requirements." This implies laboratory-based testing with simulated data or controlled inputs rather than a clinical test set with patient data. Therefore, there is no sample size of patients or information on data provenance (country, retrospective/prospective) for a clinical test set 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)

Given the nature of the bench testing described (injecting known signals), the concept of "experts establishing ground truth for a test set" as typically understood in AI/clinical validation studies does not apply here. The ground truth for these tests was the "known oscillating input signal" or the performance requirements of the standards themselves.

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

No adjudication method is mentioned, as the testing described focuses on device functionality and signal accuracy against known inputs or standards, not on diagnostic interpretations requiring adjudication.

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 reported in the provided document. The device is described as a data acquisition system for home sleep testing, and it "is NOT intended to perform automatic diagnosis." The focus is on accurate signal acquisition, not AI-assisted interpretation or improvement of human readers.

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

The document does not describe a standalone algorithm performance study. The device's purpose is to acquire and transmit physiological data for review by qualified medical personnel. It explicitly states, "ApneaTrak is NOT intended to perform automatic diagnosis."

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

For the bench tests, the ground truth was known oscillating input signals or the defined specifications and requirements of the relevant IEC/ISO standards. For the purpose of regulatory substantial equivalence, the ground truth for the device's claims implicitly relies on the predicate devices and their established performance for similar data acquisition.

8. The sample size for the training set

No training set is mentioned as the document does not describe a machine learning or AI-based diagnostic algorithm that would require a training set. The device is an electrophysiological signal acquisition system.

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

As no training set is discussed, this question is not applicable.

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1. Cadwell Bolt is a software-only device intended for post-hoc analysis of EEG data. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. This device is intended to be used with EEG data from patients of all ages.

2. Cadwell Bolt includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG data. These include the following 10 analyzers:

• -Amplitude Integrated EEG (aEEG),
• -Peak Envelope,
• -Envelope Asymmetry,
• -Spectrogram,
• -Band Power.
• -Power Ratio,
• -Spectral Entropy,
• -Burst Suppression Ratio,
• -Inter-burst Interval, and
• -Bursts-per-Minute.
  These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG data. A minimum of one epoch of data is required to perform Bolt analysis.

3. The aEEG functionality included in Cadwell Bolt is intended to monitor the state of the brain.

4. Cadwell Bolt can provide notifications, based on user-defined thresholds, for quantitative EEG measures such as a notification within the application software that can be used when processing a record during acquisition. Delays can occur between the beginning of an event and when the Bolt notification will be shown to a user. Cadwell Bolt notifications cannot be used as a substitute for real-time monitoring of the underlying EEG data by a trained expert.
   This device does not provide any diagnostic conclusion about the patient's condition to the user as part of its output. The software does not contain automated detection algorithms.

Cadwell Bolt is a software-only device for use with EEG data. The Cadwell Bolt receives EEG data as an input and uses this input to calculate and display the following quantitative measures of electroencephalographic data:
(1) amplitude integrated EEG (aEEG),
(2) peak envelope,
(3) envelope asymmetry,
(4) spectrogram,
(5) band power,
(6) power ratio.
(7) spectral entropy,
(8) burst suppression ratio.
(9) inter-burst interval, and
(10) bursts-per-minute.
In addition to the 10 analyzers mentioned above, Cadwell Bolt calculates if a value is greater than a user-defined threshold. A horizontal black bar is displayed in the trend window and signifies the current threshold setting. The user may move the bar up/down to adjust the threshold.
Thresholding is available for the following trends:
. peak envelope,
. envelope asymmetry,
spectrogram, .
band power, and ●
power ratio. .
The Cadwell Bolt device performs analysis on a userdefined set of EEG channels within the EEG data and displays graphical results to be interpreted by qualified medical practitioners. Additional user-selectable parameters are available depending on the analyzer selected for display. These parameters include frequency ranges or bands for analysis, number of epochs to average, and minimum burst suppression durations. Using the userdefined thresholds, Cadwell Bolt can provide notifications to the user and can optionally highlight the associated EEG data. Notifications and/ or highlights can be accepted or rejected by a qualified medical practitioner. Additional features and user-selectable parameters include:
Output display color
Output display size ●
Output display name
Epoch length ●
Notch filter ●
Selected inputs (bipolar or referential)
. Output display time scale (y-axis)

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Specific Performance Data from the Study:

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

The document states that "Arbitrary data of known value was input" and "sample EEG data at various time scales and with various montages and/or frequency bands" were used. However, it does not specify a numerical sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data).

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 involved "analyzing known arbitrary EEG data and confirming that the expected output was obtained" and comparing results with predicate devices, but it does not mention the involvement or qualifications of experts for establishing ground truth on the test data.

4. Adjudication method for the test set:

This information is not provided in the document. The evaluation involved a comparison of calculated metrics (correlation coefficient and percent difference) against predetermined thresholds, not an adjudication process by experts.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The document describes a standalone performance evaluation of the software's quantitative output compared to predicate devices, not impact on human reader performance.

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

Yes, a standalone performance study was done. The study focused on the Cadwell Bolt Software's ability to calculate and display quantitative EEG measures, and its outputs were compared against those of predicate devices. The device is intended for post-hoc analysis by qualified medical practitioners who exercise professional judgment, implying it functions as a tool rather than a diagnostic algorithm that provides conclusions or replaces real-time monitoring by an expert.

7. The type of ground truth used:

The ground truth for this performance study appears to be established through "known arbitrary EEG data" and by comparing the device's output to the output of legally marketed predicate devices, which serve as a reference for "substantial equivalence." The document states that the software "implements public domain (nonproprietary) quantitative analysis measures that are identical or similar to the predicate devices."

8. The sample size for the training set:

This information is not provided in the document. The document describes verification and validation but does not detail a training set for the Cadwell Bolt Software, implying it uses established algorithms rather than a machine learning model that requires a distinct training phase.

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

This information is not provided in the document, as no training set is explicitly mentioned or described.

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Zenith is an electroneurodiagnostic device that accepts, measures, and stores electrical activity of the brain via scalp and intracranial electroencephalography (EEG) signals, and, utilizing an integrated switch matrix, relays stimulation signals to the patient. It can obtain, display and store electrophysiological data from the central nervous system, generated either spontaneously or elicited by well-defined stimuli. The data is used to perform neurodiagnostic evaluations, including EEG and direct cortical stimulation. Zenith Cadwell acquisition software.

Zenith is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative testing on patients of all ages.

The Cadwell Zenith System is a high channel-count Electroencephalogram (EEG) system capable of cortical stimulation via the optional stimulator and built in switch matrix. The system is capable of acquiring, storing, and reviewing neurophysiological data and report generation. The Cadwell Zenith System can be configured in a portable or fixed room configuration. Carts are available for purchase with the system. The Cadwell Zenith System consists of one (1) or more Zenith amplifiers, an IOMAX Base Module, and an optional IOMAX Cortical Module. Additionally, a Patient Event Button, USB Photic Stimulator, and USB Footswitch can be purchased separately

The provided document is a 510(k) premarket notification summary for the Cadwell Zenith System, an electroencephalograph (EEG) device. It describes the device's technical specifications and how it compares to predicate devices, along with summaries of performance testing related to electrical safety, electromagnetic compatibility, and software validation.

However, the document does not contain information about "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based diagnostic device. This document describes a traditional medical device (an EEG system) and its substantial equivalence to previously marketed devices. There is no mention of an AI component, an algorithm that generates diagnostic outputs, or any performance metrics like sensitivity, specificity, or AUC that would be associated with such a study.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving device performance using the provided text, as the necessary information for AI/algorithm performance validation is absent. The document focuses on hardware performance, safety standards compliance, and software validation for its core functionality as an EEG system, not on intelligent diagnostic performance.

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The Cadwell Apollo System is indicated for prescription use to acquire, record, transmit, and display physiological and environmental data for electroencephalographic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of patients of all ages.

The Cadwell Apollo System (Apollo) is used to acquire, record, transmit, and display physiological and environmental data for ambulatory electroencephalograph (EEG) and polysomnography (PSG) and/or clinical studies of patients of all ages.

The Apollo system consists of a Recorder, a 64-channel and/or 32-channel Amplifier, a patient event button, a microphone, and various connecting cables. Optional accessories include the Arc photic stimulator, a video recording camera, and a cart for the equipment. Previously FDA cleared accessories used with the Apollo system consist of various electrodes, leads, and cables.

The Apollo system utilizes Cadwell Arc acquisition software (previously cleared in K133355) with support for Apollo hardware using single or combinations of amplifiers, and a photic stimulator.

Additional channels can be added with multiple amplifiers. Apollo is intended for use in both home healthcare and professional healthcare environments.

The provided document is a 510(k) summary for the Cadwell Apollo System, an electroencephalograph (EEG) and polysomnograph (PSG) device. It describes the device's indications for use, technological characteristics compared to a predicate device, and nonclinical testing performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document describes nonclinical testing for various aspects of the device, with the "reported device performance" being that the device conforms to the specified standards and its predetermined specifications.

Study Details

Based on the provided text for K180269, this submission is for a medical device (Cadwell Apollo System) to acquire, record, transmit, and display physiological and environmental data for EEG and PSG studies. The provided document details nonclinical testing to demonstrate substantial equivalence to a predicate device (K133355 Cadwell Flex EEG/PSG), rather than a clinical study evaluating diagnostic performance of an AI algorithm.

Therefore, many of the requested details related to clinical studies, AI algorithms, human readers, and ground truth establishment are not applicable or not provided in this specific 510(k) summary.

Here's an assessment based on the available information:

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

   • The document describes nonclinical testing (software verification/validation, electrical safety, EMC, and bench performance testing). These tests typically involve engineered test cases, simulations, and measurements on the device itself, rather than patient data test sets.
   • Not applicable / Not provided in terms of patient data test sets. The tests are focused on hardware and software functionality and compliance with engineering standards.

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

   • Since this is nonclinical testing against engineering standards and predetermined specifications, the concept of "ground truth" derived from expert consensus on patient data (e.g., radiologist reads) does not apply.
   • Expertise would be in engineering, quality assurance, and regulatory compliance for medical devices.
   • Not applicable.

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

   • Not applicable. This relates to clinical interpretation of patient data, which is not the focus of the nonclinical tests described.

4. 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, an MRMC study was not done. This 510(k) submission is for an EEG/PSG acquisition and display system, not a device with an AI-driven diagnostic component that assists human readers in interpreting clinical cases.

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

   • No, a standalone AI algorithm performance study was not done. The Cadwell Apollo System, as described, is a hardware system with acquisition software, not a standalone diagnostic AI algorithm.

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

   • For the nonclinical tests, the "ground truth" consists of the established engineering standards (IEC, ISO, FDA guidance) and the device's predetermined functional and performance specifications. The tests verify that the device's behavior matches these predefined requirements.
   • Engineering standards and predetermined product specifications.

7. The sample size for the training set:

   • This question is only relevant for AI/ML-driven devices that require a training set of data. The Cadwell Apollo System is an acquisition and display system, and while its software was developed, the document does not describe it as an AI/ML device requiring a training set in the conventional sense for diagnostic performance.
   • Not applicable.

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

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

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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.

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Cadwell Sierra Summit:

Cadwell Sierra Summit is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), Evoked Potentials (EP), and Autonomic Reponses (RR Interval Variability). The Cadwell Sierra Summit is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. The interface for third-party non-invasive imaging display and control is used to visualize the morphology and location of nerves and serves as an aid in confirming the results of the aforementioned modalities.

Cadwell Sierra Summit is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Cadwell Sierra Ascent:

Cadwell Sierra Ascent is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), and Somatosensory Evoked Potentials (SEP). The Cadwell Sierra Ascent is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system.

Cadwell Sierra Ascent is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.

The Cadwell Sierra Summit and Ascent systems are designed for the acquisition, display, analysis, storage, and reporting of electrophysiologic information from the human nervous and muscular systems. The systems are designed to perform nerve conduction studies (NCS), needle electromyography (EMG) studies and evoked potential (EP) studies. The Sierra Summit is the full featured version and also includes autonomic (RR Interval) studies and an interface to allow display and control of non-invasive third-party imaging modalities.. Hereafter, the Sierra Summit is described as the full featured variant. The Summary of Technical Characteristics table below details the differences between the Summit and Ascent systems.

The Sierra Summit provides a variety of test protocols spanning the various test modalities above.

The Cadwell Sierra Summit consists of the following major components:

• Sierra Summit console base unit with integrated control panel ●
• Amplifier (available in two types: 2 channel with two non-switched differential channels, or a 12 ● channel with 4 non-switched differential and 8 switched referential channels. The number of available channels is controlled by a software license)
• Laptop or Desktop computer (Windows OS) with keyboard and mouse ●
• Display monitor ●
• Summit software

The Sierra Summit has the following optional accessories/components:

• Remote Head Box (for 3-12 channel amplifier) ●
• StimTroller (Hand Held Electrical Stimulator)
• Electrical Stimulator Switch Box ●
• Footswitch (single) ●
• Visual Stimulators (LED Goggles, LCD Checks)
• VEP Calibration Sensor
• Headphones or other auditory transducers
• Reflex Hammer
• Temperature Probe ●
• Cart
• Isolation Transformer or Medical Grade Power Strip
• Printer

The provided text is a 510(k) Summary for the Cadwell Sierra Summit and Cadwell Sierra Ascent devices. It details the device descriptions, indications for use, and a summary of technical characteristics compared to predicate devices, along with performance testing. However, it does not include specific acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) or detailed results from studies designed to prove the device meets such criteria.

The "Performance Testing - Bench" section mentions conformance to various standards and internal requirements, concluding that "Test results indicate that the Sierra Summit and Ascent comply with the predetermined specifications and the applicable standards." This is a general statement of compliance, not a presentation of performance data against specific acceptance criteria.

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

Here is what can be inferred or explicitly stated from the document:

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

This information is not provided in the document. The document states compliance with "predetermined specifications and applicable standards" for various tests (biocompatibility, software, electrical safety, EMC, and bench performance), but it does not list specific numerical acceptance criteria or quantitative performance results for the device.

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 in the document. The document describes "Performance Testing - Bench" and "Verification and validation activities," but it does not specify sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective).

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 in the document. The document refers to the device being used by "qualified medical practitioners" for diagnosis but clarifies that the device "does not provide any diagnostic conclusion about the patient's condition to the user." There is no mention of experts establishing ground truth for any test sets related to diagnostic performance.

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

This information is not provided in the document. There is no mention of an adjudication method.

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 in the document. The device is a diagnostic electromyograph for measuring electrophysiological data and supporting the diagnosis of neuromuscular diseases. It is not described as an AI-assisted device for interpretation or diagnosis to be used "with AI vs without AI assistance" by human readers in the context of improving effectiveness. The document states, "This device does not provide any diagnostic conclusion about the patient's condition to the user."

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

This information is not provided in the document. Given the nature of the device (electromyograph for data acquisition and analysis, not providing diagnostic conclusions), it typically functions as a tool for a human practitioner, rather than as a standalone diagnostic algorithm.

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

This information is not provided in the document. As no specific performance studies against a diagnostic "ground truth" are detailed, the type of ground truth is not mentioned.

8. The sample size for the training set:

This information is not provided in the document. No training data or training set sample size is mentioned, as the device is not an AI/machine learning model in the sense of requiring a training set for diagnostic outcome prediction.

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

This information is not provided in the document. As no training set is mentioned, the method for establishing its ground truth is also not.

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1. Cadwell AmpliScan is a software-only device indicated for use with electroencephalographic (EEG) data from Cadwell Arc application software. Cadwell AmpliScan is distributed solely for use with Cadwell Arc software.
2. The Cadwell AmpliScan device is for prescription use only by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgement when using the information.
3. This device does not provide any diagnostic conclusion about the patient's condition to the user.
4. Cadwell AmpliScan uses electroencephalographic (EEG) data to calculate and display a quantitative aEEG measure. This quantitative measure should always be interpreted by the user in conjunction with review of the original EEG waveforms. The aEEG quantitative measure of Cadwell AmpliScan is intended to monitor the state of the brain.

Cadwell AmpliScan is a software-only device distributed solely for use with the application software commonly known and marketed as Cadwell Arc software. Cadwell Ampliscan software is installed with installation of Arc software, and does not require installation or removal separate from the Arc application. The Cadwell AmpliScan software-only device applies the Amplitude-Integrated EEG (aEEG) algorithm referred to as the Cerebral Function Monitor (CFM) to stored data within the Cadwell Arc software, and stores and displays the results.

The provided text appears to be a 510(k) summary for the Cadwell AmpliScan, a software-only device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and detailed performance metrics as one might find in a clinical trial report for an innovative device.

Therefore, the information requested by the user, particularly regarding acceptance criteria, sample sizes, expert qualifications, and detailed performance metrics, is not explicitly provided in the document in the format anticipated for a standalone clinical study. The document focuses on comparing the Cadwell AmpliScan to a predicate device based on technological characteristics and software verification/validation.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria or quantify device performance in terms of metrics like sensitivity, specificity, accuracy, or similar measures commonly found in a study proving a device meets specific criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device.

The "Performance Data" section states: "In the Substantial Equivalence Discussion, a comparison of outputs from Cadwell AmpliScan and the predicate with like input data demonstrate the resulting equivalence of analysis and display." This implies that the 'acceptance criterion' was that the output of Cadwell AmpliScan should be equivalent to that of the predicate device when given the same input data.

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

The document does not specify a "test set" in terms of patient data. The evaluation was likely performed using various EEG data files (the "like input data") to compare outputs, but the number of such files or their origin (country, retrospective/prospective) is not mentioned. Given it's a software device processing existing data, the data would inherently be retrospective.

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

The concept of "ground truth" established by experts for a test set is not discussed in this document. The evaluation was focused on the software's ability to produce equivalent outputs to an existing, legally marketed device (the predicate). The assessment of equivalence typically involves technical comparisons of algorithm implementation and output, not expert clinical interpretation of novel results.

4. Adjudication Method for the Test Set:

Not applicable, as no expert-adjudicated test set is described.

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

No, an MRMC study was not done. The document does not mention human readers or AI assistance in a comparative effectiveness study. The device is software that calculates and displays a quantitative aEEG measure, not an AI to assist human readers directly in diagnosis.

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

Yes, this was a standalone (algorithm only) evaluation. The device itself is "software-only" and its performance was assessed by comparing its outputs to a predicate device. The document explicitly states, "Cadwell AmpliScan uses electroencephalographic (EEG) data to calculate and display a quantitative aEEG measure." It also clarifies that "This device does not provide any diagnostic conclusion about the patient's condition to the user." and "This quantitative measure should always be interpreted by the user in conjunction with review of the original EEG waveforms." This indicates that the device operates as an algorithm generating a measure, with interpretation left to a qualified medical practitioner.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the output generated by the predicate device for the same input data, as the study aims to show equivalence. The document states a "comparison of outputs from Cadwell AmpliScan and the predicate with like input data demonstrate the resulting equivalence of analysis and display." This implies the predicate's output served as the reference for equivalence.

8. The Sample Size for the Training Set:

The document does not mention any "training set." This type of 510(k) submission, particularly for a device implementing a known algorithm (Cerebral Function Monitor/CFM), typically doesn't involve machine learning training on a large dataset. The substantial equivalence is based on the algorithm's implementation matching that of the predicate.

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

Not applicable, as no training set or ground truth for a training set is mentioned.

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