(163 days)
The Capnostream™35 is a portable capnograph/pulse oximeter, intended to provide professionally trained health care providers with continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath, respiration rate, arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients. The pulse oximeter is intended for use during both no motion conditions and for patients who are well or poorly perfused.
The Capnostream™35 also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up.
The device is intended for use in hospital-type facilities, during intra-hospital transport, and out-of-hospital Emergency Medical Service applications that include ground and air transport.
The Capnostream™35 is a 4-inch color screen portable two-parameter monitor consisting of a microMediCO2 capnography module and a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed.
The microMediCO2 module provides the following inputs to the host monitor:
EtCO2 numeric, Respiratory Rate, IPI (integrated Pulmonary Index), Continuous CO2 waveform, Apnea per Hour (A/hr) and Oxygen Desaturation Index (ODI).
The SpO2 module integrated in the Capnostream™35 monitor presented in this submission provides SpO2 and Pulse Rate parameters to the host for display.
The SpO2 measurements are also provided to the microMediCO2 module, enabling the calculation of IPI and ODI.
The host monitor will display this data to the user on a screen as numeric values, and will also display the CO2 waveform and SpO2 (pleth) waveform or pulse bar graph.
The device is intended for use in hospital-type facilities, and during intra-hospital transport as well as during out-of-hospital Emergency Medical Service applications. The device features IP54 Liquids & Solids ingress protection, 1.25M Shockproof status, sunlight readable display, automatic display brightness, hot swap battery capability and altitude use up to 15000 feet (4572m) for use in out-of-hospital Emergency Medical Service applications.
The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for AI/Machine Learning devices. Instead, it describes a medical device (Capnostream™35 Portable Respiratory Monitor) undergoing a 510(k) submission for substantial equivalence to predicate devices, focusing on regulatory compliance, safety, and general performance testing.
Therefore, many of the requested fields regarding AI/ML study details (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) cannot be extracted from this document.
However, I can extract information related to the device's general performance testing and intended use, which are analogous to acceptance criteria and their verification in a non-AI/ML context.
Here's an interpretation based on the provided text, focusing on the closest available information to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed with numerical targets as they would be for an AI model's precision or recall. Instead, the device's "performance" is considered in relation to meeting standards and demonstrating substantial equivalence to predicate devices.
| Feature / Performance Aspect | Acceptance Criteria (Implied from Standards & Equivalence) | Reported Device Performance |
|---|---|---|
| Capnography | Must perform as predicate device K112368 (Capnostream20p) | The microMediCO2 module performs as in the predicate K112368. |
| Pulse Oximetry | Must perform as predicate device K130320 (Bedside Respiratory Patient Monitoring System) | The SpO2 module integrated performs as in the predicate K130320. |
| Safety | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-49, IEC 60601-1-12, IEC 60601-1-6. | Successfully undergone electrical safety testing according to specified IEC standards. |
| Environmental | Compliance with IP54 Liquids & Solids ingress protection, 1.25M Shockproof status, sunlight readable display, automatic display brightness, hot swap battery, altitude use up to 15000 feet (4572m). | Successfully undergone environmental testing; device explicitly features these characteristics. |
| Electromagnetic | Compliance with IEC 60601-1-2. | Successfully undergone electromagnetic testing according to specified IEC standard. |
| Software | Must validate performance and substantial equivalence to predicate devices. | Software testing was performed to validate the performance of the new monitor and its substantial equivalence to the predicate devices. |
| Wireless Communication | Compliance with FDA guidance "Radio Frequency Wireless Technology in Medical Devices". | Wireless communication testing was conducted according to FDA guidance. |
| Hazard Analysis | Residual risks judged as acceptable. | Hazard analysis concluded that any residual risks were judged as acceptable when weighed against the intended benefits. |
2. Sample size used for the test set and the data provenance:
- Not applicable for AI/ML device. The document describes non-clinical performance and safety testing against engineering standards and comparison to predicate devices, not AI model evaluation with specific test sets of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This pertains to clinical data labeling for AI/ML, which is not described here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This pertains to expert consensus for AI/ML ground truth, which is not described here.
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 such study was mentioned. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was described in the context of AI/ML. The device itself is a standalone monitor, and its "performance" was evaluated through engineering tests and comparison to predicates.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground truth in this context typically refers to established engineering specifications, performance standards (e.g., ISO, IEC), and the known performance of the predicate devices. For instance, the accuracy of CO2 measurement would be validated against calibrated gas mixtures, and SpO2 against controlled hypoxia studies, which are the "ground truth" for those physiological parameters under specific test conditions. The document states "Appropriate safety, environmental and performance tests were conducted to ensure that the specifications of the Capnostream™35 were met."
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
Summary of the Study (as described in the document):
The "study" described is a non-clinical performance testing and substantial equivalence assessment for product clearance. It involves:
- Performance Testing: Conducted according to specific ISO standards (ISO 80601-2-55, ISO 80601-2-61) for the respective measurement parameters (capnography and pulse oximetry).
- Electrical Safety Testing: Performed per IEC standards (IEC 60601-1, IEC 60601-1-8, IEC 60601-2-49, IEC 60601-1-12, IEC 60601-1-6).
- Electromagnetic Compatibility (EMC) Testing: Performed per IEC 60601-1-2.
- Environmental Testing: Verification of features like IP54 rating, shockproof status, sunlight readability, hot swap battery, and altitude capacity.
- Software Testing: To validate performance and substantial equivalence.
- Wireless Communication Testing: According to FDA guidance for wireless medical devices.
- Hazard Analysis: Conducted in compliance with ISO 14971:2012 to assess and mitigate risks.
The overarching goal was to demonstrate that the Capnostream™35 Portable Respiratory Monitor has the "same intended use, technological characteristics and performance as its predicate devices" and that its functionality in new intended environments (out-of-hospital EMS) was verified through testing against relevant standards. The document concludes that "Testing did not raise any concerns when compared to its predicate devices therefore the subject device is substantially equivalent to its predicate devices."
§ 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).