(79 days)
The IntelliVue gas modules are indicated for measuring and monitoring CO2 concentration and the concentrations of N2O, O2, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane.
Federal law restricts this device to sale by or on the order of a physician.
The IntelliVue G5 M1019A / G1 M1013A gas modules provide a nondispersive infrared measurement of respiratory and anesthetic gases and a paramagnetic measurement of oxygen (Fast O2).
They are designed to work with Philips IntelliVue through a digital interface (RS232). They are intended for measuring the airway gases of ventilated patients during the induction of, maintenance of, and emergence from anesthesia.
The modules produce display waves for O2, CO2, N2O, and anesthetic agents, together with numerics for inspired and end-tidal values for O2, CO2, N2O, anesthetic agents, and airway respiration rate. Automatic identification of up to two anesthetic aqents and measurement of mixtures of up to two anesthetic agents are available as options. Return of the sample gas into the breathing circuit is available optional.
An automatic zero calibration is performed by the IntelliVue gas module as required to maintain measurement accuracy.
The provided document is a 510(k) summary for the IntelliVue G5 M1019A / IntelliVue G1 M1013A Anesthetic Multi Gas Monitor. This type of document is generally focused on establishing substantial equivalence to previously cleared devices rather than presenting detailed performance studies against specific acceptance criteria.
Therefore, the document does not contain the detailed information required to answer all parts of your request. Specifically, it lacks a table of acceptance criteria, detailed study designs, sample sizes for test and training sets, ground truth establishment methods, or information on multi-reader multi-case studies.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., accuracy, precision) or a table comparing them to reported device performance. It generally states:
"The testing and analysis of results provide assurance that the devices meet their specifications and are safe and effective for their intended use."
This implies that internal specifications were met, but these specifications are not detailed in the summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided 510(k) summary.
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 available in the provided 510(k) summary. The device is a gas monitor, and its "ground truth" would likely be established by reference gas mixtures or other calibrated instruments, not human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided 510(k) summary.
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 is not applicable to this device. The IntelliVue gas modules are anesthetic multi-gas monitors, not AI-powered diagnostic tools interpreted by human readers. Therefore, an MRMC study related to human reading improvement with AI is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is a standalone measurement instrument. Its performance would inherently be "algorithm only" (or rather, the device's sensor and processing capabilities) as it provides direct gas concentration readings. The summary implies performance testing was done on the device's ability to measure gases, but details of such testing (e.g., in isolation or integrated) are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
While not explicitly stated, for a gas monitor, the "ground truth" would typically be established using calibrated gas mixtures with known concentrations, or by comparison to a reference standard gas analyzer. It would not involve expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not available in the provided 510(k) summary. For device verification and validation, there isn't typically a "training set" in the machine learning sense. The device's internal algorithms are designed and then verified/validated.
9. How the ground truth for the training set was established
This information is not available in the provided 510(k) summary. Similar to point 8, the concept of a "training set" ground truth in this context is not directly applicable. If any internal calibration or development involved reference data, it would likely be from calibrated gas mixtures or reference instruments.
In summary of what is available:
The document focuses on establishing substantial equivalence to predicate devices based on intended use and technical characteristics, stating that "The technical characteristics of the IntelliVue gas modules do not raise new questions regarding safety or effectiveness." It also notes that "Design, development, verification and validation of the device was performed in accordance with FDA regulations and guidance and company internal standards," concluding that "The testing and analysis of results provide assurance that the devices meet their specifications and are safe and effective for their intended use." However, it does not provide the specific details of these "specifications," "testing," or "results" in this public summary.
§ 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).