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The Cadwell EasyNet Nasal Pressure Module collects respiratory airflow data for adult and pediatric patients. The data is transmitted to a Cadwell EasyNet enabled system where it is displayed. The module may be used in a hospital, clinical or ambulatory setting for EEG studies, sleep disorder studies and other neuromonitoring and neurodiagnostic studies.

The Cadwell EasyNet® Nasal Pressure Module provides respiratory airflow data to Cadwell EasyNet® enabled systems. It outputs a digital representation of the data using the Cadwell proprietary EasyNet® communications protocol. The module measures 2 x 1.4 x .8 inches. It weighs about an ounce and is attached to the patient's chest or shoulder with elastic straps. An oral/nasal cannula is attached from the module to a patient's nose and mouth. A single small cable connects the device to the EasyNet® enabled system. The module requires no routine calibration or maintenance. The Nasal Pressure module determines functional respiratory airflow by recording pressure changes at the nose and mouth.

The Cadwell EasyNet Nasal Pressure Module (K061705) is a device that collects respiratory airflow data for adult and pediatric patients in various clinical settings. The provided information is a 510(k) summary, which outlines the device's substantial equivalence to a predicate device rather than a detailed study protocol and results with specific acceptance criteria and performance metrics. Therefore, some of the requested information, particularly quantitative measures of performance against specific acceptance criteria, sample sizes for test and training sets, and details of ground truth establishment by experts, are not explicitly present in the provided document.

However, based on the available information, here's an analysis:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for respiration measurement accuracy (e.g., specific thresholds for mean absolute error or agreement rates). Instead, it relies on the concept of "substantial equivalence" to a predicate device (Pro-Tech PTAF 2 Nasal Pressure Sensor, K982293).

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

The document mentions "clinical setting with human subjects" for testing but does not specify the sample size for this test set.

• Sample Size for Test Set: Not specified.
• Data Provenance: The device was tested "in a clinical setting with human subjects." The country of origin for the data is implied to be where Cadwell Laboratories, Inc. is located or where their clinical studies were conducted, but this is not explicitly stated. The study appears to be prospective as it involved testing the device "with human subjects" as part of its development and validation.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the device's performance.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method used for the test set.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or reported in this 510(k) summary. This device is a sensor for collecting physiological data, not an AI-assisted diagnostic tool for human interpretation.

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

This device itself is a standalone sensor/module that collects and transmits data. Its performance is evaluated on its ability to accurately measure respiratory airflow. The "Functional and Safety Testing" mentioned implies a standalone performance evaluation of the device's accuracy and precision, though the specific methodology is not detailed. There is no "algorithm" in the sense of an AI model being evaluated here; it's a physical sensor.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for performance evaluation. For a device measuring physiological parameters like respiratory airflow, ground truth would typically involve:

• Comparison to a gold standard reference device known for accurate respiratory airflow measurement.
• Potentially, expert observation or interpretation of respiration patterns synchronized with the device's output, but this is not specified.

8. The Sample Size for the Training Set

This device does not involve a "training set" in the context of machine learning. It is a hardware sensor. Therefore, this question is not applicable.

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

As this device does not involve a "training set" for machine learning, this question is not applicable.

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The Cadwell TES-1 constant voltage electrical stimulator is intended for cortical stimulation. The TES-1 is intended for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency. The Cadwell TES-1 Constant Voltage Stimulator is an accessory to the Cadwell Cascade Intra-operative monitoring system only. It is not a stand-alone device nor is it compatible with other systems.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "TES-1 Constant Voltage Electrical Stimulator." It largely focuses on the regulatory approval for marketing the device based on its substantial equivalence to previously marketed devices.

Therefore, the requested information regarding acceptance criteria and performance studies for this specific device is not available within the provided text.

Here's why and what's missing:

• 510(k) Clearance: This is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It doesn't typically include detailed clinical study reports or performance acceptance criteria in the clearance letter itself. These details would be submitted by the manufacturer to the FDA as part of their 510(k) submission, but they are not disclosed in this public-facing clearance letter.
• "Substantially Equivalent": The core of a 510(k) is proving substantial equivalence. This means the device has the same intended use as a predicate and similar technological characteristics, or, if there are differences, that they do not raise different questions of safety and effectiveness. The information to support this claim would be in the manufacturer's submission, not in this letter.

To answer your questions, one would need access to the full 510(k) submission document, which is not provided here.

However, I can tell you what is present in relation to the device:

• Device Name: TES-1 Constant Voltage Electrical Stimulator
• Intended Use: For cortical stimulation; intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
• Accessory Device: It is explicitly stated as an accessory to the Cadwell Cascade Intra-operative monitoring system only, not a stand-alone device, and not compatible with other systems.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based solely on the provided text.

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The Cadwell Easy Body Position Module is intended for use to detect body positions during physiological recording. It provides output data that corresponds to five body positions (supine, prone, left side, right side and sitting up). It may be used in a clinical or ambulatory setting for both EEG and sleep disorder studies.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA for a device called "EasyNet Body Position Module". This document primarily focuses on regulatory approval and does not contain the detailed information necessary to answer your request about acceptance criteria, study design, and performance metrics.

The document states the device's indications for use and general regulatory information, but it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or training set details.
3. Specific ground truth information.

Therefore, based solely on the provided text, I cannot answer the questions about the acceptance criteria and the study that proves the device meets them. This type of information is typically found in the full 510(k) submission, specifically in the performance testing sections, which are not included in this FDA decision letter.

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The Cadwell EasyNet Limb Movement Module is intended for use to detect periodic limb movements for recording onto a physiological recorder. It may be used in a clinical or ambulatory setting for both EEG and sleep disorder studies.

Not Found

This looks like a 510(k) clearance letter for the Cadwell Limb Movement Module. This type of document typically does not contain the detailed information requested about acceptance criteria and specific study results. 510(k) clearances establish substantial equivalence to a predicate device, and while they might reference performance data, the granular details of the studies (like sample sizes, expert qualifications, adjudication methods, training set details, or effect sizes for AI assistance) are usually found in the original submission documents, which are not publicly available in this format.

Therefore, I cannot extract the requested information from the provided text. The document confirms that the device is cleared for marketing based on its substantial equivalence to a predicate device and its stated indications for use.

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Kilowin is an electroneurodiagnostic device designed to measure and display the electrical signals generated by peripheral nerve, muscle and central nervous system. It will acquire the data necessary for electroencephalography (EEG), system. It will dequiry (ENG), electrocardiography (ECG), electromyography (EMG), nerve conduction velocity (NCV, F wave, and H reflex), evoked potentials (EP, brainstem, visual, somatosensory), repetitive nerve stimulation and sleep assessment.

The Kilowin instrument is designed for use during the duration of the procedure only.

Use of the proposed device is to be administered under the direction of a trained physician, surgeon, neurologist, or electrophysiologist in an operating room or clinic.

The Kilowin device(s) are intended for use during electroencephalography (EEG), electronystagmography (ENG), electromyography (EMG), nerve conduction velocity (NCV, F wave, and H reflex), evoked potentials (brainstem, visual, somatosensory), repetitive nerve stimulation testing and sleep assessment.

Kilowin is an electroneurodiagnostic device designed to measure and display the electrical signals generated by peripheral nerve, muscle and central nervous system.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) premarket notification letter from the FDA to Cadwell Laboratories, Inc. for their device, Kilowin. It confirms that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use.

The document includes:

• Device Name: Kilowin
• Indications for Use: Kilowin is an electroneurodiagnostic device designed to measure and display electrical signals generated by peripheral nerve, muscle, and central nervous system for electroencephalography (EEG), electronystagmography (ENG), electrocardiography (ECG), electromyography (EMG), nerve conduction velocity (NCV, F wave, and H reflex), evoked potentials (EP, brainstem, visual, somatosensory), repetitive nerve stimulation, and sleep assessment. It is for use during the procedure only, under the direction of a trained physician, surgeon, neurologist, or electrophysiologist in an operating room or clinic.

However, the letter does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
6. Information about standalone algorithm performance studies.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample sizes for the training set.
9. How ground truth for the training set was established.

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The general purpose of the proposed device is identical to the predicate device: "to perform the measurements needed for electromyography (EMG), nerve conduction velocity (NCV, F wave, and H reflex), and evoked potentials (brainstem, visual, and somatosensory), and repetitive nerve stimulation." The purpose of the proposed device is to allow compatibility with high-impedance electrodes. The proposed device allows electrode inputs to be made closer to the source of the signal for reduced signal noise during procedures requiring high-impedance electrodes.

The proposed device consists of the existing two-channel preamplifier and a buffered electrode input box with extension cable. These components provide electrode inputs that are closer to the source of the signal during electromyographic (EMG) testing. The intent of this design is to reduce signal noise during procedures requiring high-impedance electrodes. The proposed device is for use with the Cadwell Sierra (K924723) and 6200A (K931428) EMG instruments.

All device components are reusable and supplied non-sterile. The extension cable with electrode input box is compatible with EtO sterilization guidelines for procedures requiring a sterile field. The input box is available with separate active and reference input connectors or a single phono jack connector.

The attached extension cable connects the input box to the preamplifier by way of a cable adapter. The existing preamplifier will be fitted with three pin DIN connectors to accept the cable adapter.

The extension cable with buffered electrode input box allows electrode inputs to be made closer to the source of the signal for reduced signal noise during procedures requiring high-impedance electrodes. The electrode input box is available with separate active (labeled .) and reference connectors or a single phono jack connector to accommodate recording electrodes with these connector types.

The input box is enclosed in a white polyethylene foam sheath. The sheath houses a circuit board consisting of a buffer circuit, two electrostatic discharge (ESD) networks (one on each side of the buffer circuit), and a separate circuit designed to limit fault currents.

The circuit board is attached to a polyvinyl chloride extension cable terminated in an eight-pin DIN connector. The input box and extension cable are connected to the preamplifier by way of a polvyinyl chloride cable adapter terminated in a three-pin DIN connector. The adapter cable does not qualify as a class II device.

This document describes a modification to an existing Electromyography (EMG) and Evoked Potential (EP) equipment. The modification involves adding a buffered input box with an extension cable to allow electrode inputs closer to the signal source, aiming to reduce signal noise during procedures requiring high-impedance electrodes. The existing preamplifier is also modified to accommodate this new component.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a separate section, but rather presents a comparison of technical specifications between the existing and proposed devices, along with results from specific engineering and clinical tests. We can infer the acceptance criteria from these comparisons and test descriptions.

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

The document does not explicitly state the sample size for the test set used in the engineering or clinical tests (tests 1-7).
The data provenance is also not specified (e.g., country of origin, retrospective or prospective). It only mentions "clinical results from test 6" and "additional clinical results in test 7."

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical tests. The clinical tests compare the device's output to signals that do not pass through the proposed device.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set. The clinical results seem to be based on a direct comparison of waveforms.

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

No, an MRMC comparative effectiveness study was not done. The document describes engineering and clinical tests focused on verifying the device's signal integrity and safety, not on comparing human reader performance with and without AI assistance. The device itself is a hardware modification (buffered input box) for an EMG/EP system, not an AI-assisted diagnostic tool.

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

The concept of "standalone performance" typically applies to diagnostic algorithms. Since this device is a hardware component for an existing EMG/EP instrument, a standalone algorithm performance study is not applicable. The tests performed assess the hardware's impact on signal quality and electrical safety.

7. The Type of Ground Truth Used

For the engineering tests (ESD, Gain, Patient Auxiliary Current, Noise), the "ground truth" is based on established engineering standards and regulatory limits (e.g., IEC 601-1, UL 544, and internal specifications for gain, noise, and impedance).

For the clinical tests (Nerve Conduction and EMG Waveform Preservation), the ground truth is established by comparison to signals that do not pass through the proposed device. This implies an internal control where the same physiological event is recorded with and without the new component, and their waveform characteristics are compared. This method relies on the existing, well-understood properties of normal nerve conduction and EMG waveforms.

8. The Sample Size for the Training Set

The device is a hardware modification, not a machine learning algorithm that requires a training set. Therefore, there is no training set in the context of this submission.

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

As there is no training set for this hardware device, this question is not applicable.

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The general purpose of the proposed device is identical to the predicate device: "to perform the measurements needed for electromyography (EMG), nerve conduction velocity (NCV, F wave, and H reflex), and evoked potentials (brainstem, visual, and somatosensory), and repetitive nerve stimulation." The purpose of the proposed device is to allow compatibility with high-impedance electrodes. The design of the device provides inputs that can be made closer to the source of the signal for reduced signal noise during procedures requiring high-impedance electrodes.

The proposed device consists of the existing four- /eight-channel preamplifier and a buffered electrode input box with extension cable. These components provide electrode inputs that are closer to the source of the signal during electromyographic (EMG) testing. The intent of this design is to reduce signal noise during procedures requiring high-impedance electrodes. The proposed device is for use with the Cadwell Excel (K880088A) EMG instrument.

All device components are reusable and supplied non-sterile. The extension cable with electrode input box is compatible with EtO sterilization guidelines for procedures requiring a sterile field. The input box is available with separate active and reference input connectors or a single phono jack connector.

The attached extension cable connects the input box to the preamplifier by way of a cable adapter. The existing preamplifier will be fitted with three pin DIN connectors to accept the cable adapter.

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

Acceptance Criteria and Device Performance

Study Details

The provided text details engineering and clinical tests performed to validate the proposed device.

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

   • Clinical Test 6 (Nerve Conduction Waveform): Not specified.
   • Clinical Test 7 (EMG Waveform): Not specified.
   • Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are referred to simply as "clinical tests."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. The clinical tests compare the proposed device's signal to the signal that "does not pass through the proposed device," implying a direct comparison without independent expert ground truth establishment in the traditional sense. The "clinical results" suggest expert assessment of waveform morphology, but the number and qualifications of those experts are not provided.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.

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: Not applicable. This device is an electromyography (EMG) instrument component, not an AI-assisted diagnostic tool for human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the device's performance was evaluated in an objective, standalone manner for metrics like gain, noise, input impedance, and patient auxiliary current. The clinical tests also assessed the device's impact on waveform morphology and timing without explicit human interpretation as the primary outcome, but rather the device's fidelity to the original signal.

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

   • For electrical/performance metrics (impedance, noise, gain, current): Engineering specifications and regulatory limits (e.g., IEC 601-1).
   • For clinical waveform integrity (Nerve Conduction, EMG): Comparison against the signal "that does not pass through the proposed device." This implies the "ground truth" is the unadulterated signal captured by the existing system, and the device's performance is measured by its ability to faithfully reproduce or minimally alter that signal.

7. The sample size for the training set: Not applicable. This is a hardware modification for an EMG instrument, not a machine learning or AI model that requires a training set.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for this device.

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to perform the measurements needed for electromyography (EMG), nerve conduction velocity (NCV, F wave, and H reflex), and evoked potentials (brainstem, visual, and somatosensory), and repetitive nerve stimulation. The purpose of the proposed device is to allow compatibility with high-impedance electrodes. The proposed device allows electrode inouts to be made closer to the source of the signal for reduced signal noise during procedures requiring high-impedance electrodes.

The proposed device consists of the existing four-channel preamplifier and a buffered electrode input box with extension cable. These components provide electrode inputs that are closer to the source of the signal during electromyographic (EMG) testing. The intent of this design is to reduce signal noise during procedures requiring high-impedance electrodes. The proposed device is for use with the Cadwell Sierra (K924723) and 6200A (K931428) EMG instruments.

All device components are reusable and supplied non-sterile. The extension cable with electrode input box is compatible with EtO sterilization guidelines for procedures requiring a sterile field. The input box is available with separate active and reference input connectors or a single phono jack connector.

The attached extension cable connects the input box to the preamplifier by way of a cable adapter. The existing preamplifier will be fitted with three pin DIN connectors to accept the cable adapter.

The extension cable with buffered electrode input box allows electrode inputs to be made closer to the source of the signal for reduced signal noise during procedures requiring high-impedance electrodes. The electrode input box is available with separate active (labeled .) and reference connectors or a single phono jack connector to accommodate recording electrodes with these connector types.

The input box is enclosed in a white polyethylene foam sheath. The sheath houses a circuit board consisting of a buffer circuit, two electrostatic discharge (ESD) networks (one on each side of the buffer circuit), and a separate circuit designed to limit fault currents.

The circuit board is attached to a polyvinyl chloride extension cable terminated in an eight-pin DIN connector. The input box and extension cable are connected to the preamplifier by way of a polyvinyl chloride cable adapter terminated in a three-pin DIN connector. The adapter cable does not qualify as a class II device.

Here's an analysis of the provided text regarding the device's acceptance criteria and studies, structured per your request:

Device: Cadwell Sierra and Cadwell 6200A with the proposed four-channel preamplifier and buffered input box (modification of existing devices).

Purpose of Modification: To allow electrode inputs closer to the signal source for reduced signal noise during procedures requiring high-impedance electrodes.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a separate, quantified list with pass/fail thresholds. Instead, it compares the technical specifications and safety standards of the proposed device against the predicate device, implying that matching or maintaining these characteristics constitutes acceptance. The "Testing and Validation" section then describes specific tests and their outcomes, which serve as evidence of meeting performance expectations.

For the purpose of this request, I will construct a table based on the provided technical comparison and highlight the directly reported performance from the validation section.

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

The document does not explicitly state the sample size for clinical tests (Test 6 and Test 7). It mentions "clinical results" but provides no information on the number of subjects, cases, or specific data provenance (country of origin, retrospective/prospective). This information seems to be deferred to "Enclosure 3 of the previous submission dated October 16, 1996."

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

The document does not specify the number or qualifications of experts used to establish ground truth for the clinical tests (Test 6 and Test 7). It refers to the interpretation of waveform morphology, onset time, peak time, and amplitude, which would typically involve expert analysis in electrophysiology, but no details are provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

No MRMC study is mentioned. The device is an electrophysiology component designed to improve signal quality, not an AI diagnostic tool requiring multiple human readers to interpret its output in a comparative effectiveness study. The "clinical results" described are a comparison of signals with and without the proposed device, not a human-AI comparison.

6. Standalone Performance Study

Yes, a standalone performance assessment was conducted for the device in its intended function. The "Testing and Validation" section describes engineering and clinical tests (Tests 1-7) where the device's performance properties (input impedance, gain, noise, patient auxiliary current, waveform morphology) were measured and compared against regulatory limits or control signals (signals not passing through the device). This assessed the algorithm (or in this case, the hardware modification) performance in isolation.

7. Type of Ground Truth Used

The ground truth for the engineering tests (Tests 1-5) appears to be:

• Regulatory Limits: For patient auxiliary current (IEC 601-1), allowed noise levels.
• Engineering Specifications: For input impedance, gain (expected to be unchanged).
• Control Measurements: Direct comparison to signals that do not pass through the proposed device for gain and noise.

For the clinical tests (Tests 6-7), the ground truth was:

• Comparison to Signals Without the Device: Waveform morphology, onset time, peak time, and amplitude were compared to signals obtained without passing through the proposed device, with the expectation that these characteristics should not be significantly distorted. This implies a baseline reading from the existing system serves as a form of ground truth for assessing non-inferiority or lack of distortion.

8. Sample Size for the Training Set

The document does not refer to a "training set" in the context of machine learning or AI. This device is a hardware modification for an electromyography instrument, not an AI algorithm that undergoes training. The "testing and validation" described pertains to verifying the physical and functional aspects of the hardware.

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

As there is no "training set" in the AI sense for this device, this question is not applicable.

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