(165 days)
The CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOV, E-sCAiOVX) are indicated for use with a host device for monitoring respiratory parameters (CO2, O2, N2O, anesthetic agent identification and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric and neonatal patients and gas exchange parameters (VCO2, VO2) of adult and pediatric patients.
When monitoring neonatal or other patients that have high respiration rate or low tidal volume these modules shall be used within the limits of respiration rates and tidal volumes to ensure specified measurement accuracy. These modules are intended for use by qualified medical personnel only.
The CARESCAPE Respiratory Modules, E-sCO, E-sCOV, sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, measure respiratory parameters (concentrations of Carbon Dioxide, Oxygen, Nitrous Oxide and anesthetic agents in the patient's breath, as well as the patient's respiration rate), ventilatory parameters (airway pressure, flow and breathing volumes) and gas exchange parameters (oxygen consumption and carbon dioxide production) of hospital patients.
Parameters measured by the CARESCAPE Respiratory Modules are CO2, N2O, O2, Anesthetic agents, Agent ID, Spirometry, oxygen consumption (VO2) and carbon dioxide production (VCO2) depending on the model used. The CARESCAPE Respiratory Modules is a family of single-width plug-in parameter modules for modular monitoring systems. The CARESCAPE Respiratory Modules are of the diverting type, which means that a small continuous flow of gas is sampled from the patient's breath to the module for measuring the gas concentrations. The CARESCAPE Respiratory Modules acquire the detected signals from the sensors of the modules, calculate the parameter values and communicate them to the host device. The CARESCAPE Respiratory Modules measure the patient's respiration rate and activate a status signal if no breaths are detected in 20 second time and the modules activate relevant status signals upon detecting failures or anomalies in the operation of the module hardware, software or gas sampling system.
The CARESCAPE Respiratory Modules do not trigger or issue any physiological or technical alarms by themselves. All management of alarms is entirely performed by the host monitors based on parameter and status data received from the modules, as well as on the alarm condition data stored in the host device.
The provided text describes a medical device, the CARESCAPE Respiratory Modules, and its 510(k) submission to the FDA. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested. The document states that "Verification and validation testing was performed according to predetermined acceptance criteria," but it does not list these criteria or the reported device performance against them. Similarly, it mentions "Extensive non-clinical testing was performed to establish substantial equivalence," but doesn't provide the specifics of these tests in a way that would answer the questions about sample size, ground truth, or MRMC studies.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted or inferred, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that "Verification and validation testing was performed according to predetermined acceptance criteria," but it does not list these criteria or the reported performance against them.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document mentions "Extensive non-clinical testing," but does not specify sample sizes or data provenance for any test sets.
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)
- Cannot be provided. The document does not describe the establishment of a ground truth by experts for the test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. The document does not describe any adjudication methods for a test set.
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
- Cannot be provided. This is not an AI device in the context of image interpretation that would typically involve human readers. The text describes a respiratory monitoring module, not an AI-powered diagnostic tool for human interpretation. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No specific details can be provided. The device itself is a measurement and monitoring module. The "performance testing (Verification)" and "Standard compliance testing (Verification)" would inherently involve assessing the algorithm's accuracy in measuring and calculating parameters without human intervention at the measurement level. However, specific details of these standalone tests, their methodology, or results are not included in the provided text.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be explicitly stated for test sets. For the type of device described (respiratory gas modules measuring parameters like CO2, O2, N2O, anesthetic agents, etc.), ground truth would typically be established through highly accurate reference measurement devices or calibrated gas mixtures. However, the document does not specify how ground truth was established for any specific "test set."
8. The sample size for the training set
- Not applicable / Cannot be provided. The device implements a gas exchange algorithm ("oxygen consumption (VO2) and carbon dioxide production (VCO2)") that was available on a predicate device. This suggests an established algorithm rather than a machine learning model that requires a distinct "training set" in the common sense. The text does not mention any training sets for machine learning.
9. How the ground truth for the training set was established
- Not applicable / Cannot be provided. As above, no training set for a machine learning model is mentioned.
Summary of what is present:
- Device: CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX)
- Purpose: Monitoring respiratory parameters (CO2, O2, N2O, anesthetic agents, respiratory rate), ventilatory parameters (airway pressure, flow, volume), and gas exchange parameters (VCO2, VO2).
- Indications for Use: Adult, pediatric, and neonatal patients.
- Validation statement: "Verification and validation testing was performed according to predetermined acceptance criteria, which concluded that the module and its applications are substantially equivalent to the predicate devices." and "Extensive non-clinical testing was performed to establish substantial equivalence of the CARESCAPE Respiratory Modules and its applications."
- Clinical studies: "The subject of this premarket submission, CARESCAPE Respiratory Modules... did not require clinical studies to support substantial equivalence."
- Technology change: The current submission adds models E-sCOVX and E-sCAiOVX with gas exchange calculation, leveraging an existing algorithm from a predicate device (Datex-Ohmeda S/5 Compact Airway Module). The software version is 2.
- Quality assurance measures: Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Final acceptance testing (Validation), Performance testing (Verification), Standard compliance testing (Verification).
- Standards compliance: A list of IEC and ISO standards the device was designed and tested for compliance with.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).