(158 days)
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).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to predicate device | "The Cadwell EasyNet® Nasal Airflow Module is substantially equivalent to the predicate device in terms of safety, accuracy, functional design and principles of operation." |
| Safety (e.g., electrical, mechanical, biocompatibility) | The device was subjected to "Functional and Safety Testing" in a development and clinical setting. Overall conclusion of "substantial equivalence to the predicate device in terms of safety." |
| Accuracy of respiratory airflow data collection | "confirm conformance to accuracy and precision specifications." (Specific specifications are not detailed in this summary.) "Substantially equivalent to the predicate device in terms of... accuracy." |
| Precision of respiratory airflow data collection | "confirm conformance to accuracy and precision specifications." (Specific specifications are not detailed in this summary.) |
| Suitability for indicated uses (EEG, sleep disorder, neuromonitoring) | "The Cadwell EasyNet® Nasal Pressure Module collects respiratory airflow data for adult and pediatric patients." Data is transmitted and displayed by an EasyNet® enabled system. "May be used in a hospital, clinical or ambulatory setting for EEG studies, sleep disorder studies and other neuromonitoring and neurodiagnostic studies." |
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.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).