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The EMMA Emergency Capnometer Monitor measures, displays and monitors carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.

The EMMA Emergency Capnometer Analyzer measures and displays carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.

The EMMA Emergency Capnometer is a miniature mainstream infrared gas analysis bench with an integrated user interface. The complete carbon dioxide analyzer is contained within a transducer that is attached to the breathing circuit via the EMMA Airway Adapter.

The provided text describes the EMMA Emergency Capnometer and states that testing was done in direct comparison to predicates throughout the operating range using calibrated gas samples and legally marketed anesthesia and ventilation devices. The conclusion was that the device demonstrated performance, safety, and effectiveness equivalent or superior to its predicates in all characteristics. However, the document does not explicitly detail specific acceptance criteria or provide a table of reported device performance against those criteria.

Given the information provided, I can only address some of your questions.

1. A table of acceptance criteria and the reported device performance

The provided text does not contain a specific table of acceptance criteria with corresponding reported device performance values. It only generally states that the device "demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text mentions "calibrated gas samples" but does not specify the sample size used for the test set. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).

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 is not applicable as the study involved "calibrated gas samples and legally marketed anesthesia and ventilation devices" rather than human-interpreted data requiring expert consensus for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable, as there's no indication of human adjudication for the device performance testing.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a capnometer, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The testing described ("Testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices") inherently represents a standalone performance evaluation of the EMMA Emergency Capnometer. There is no mention of a human-in-the-loop component for the performance assessment itself.

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

The ground truth was established by "calibrated gas samples" and the performance of "legally marketed anesthesia and ventilation devices" (presumably as a reference standard for comparison with the device's measurements).

8. The sample size for the training set

The device is a hardware capnometer, not based on a machine learning algorithm that requires a training set. Therefore, a training set is not applicable or mentioned.

9. How the ground truth for the training set was established

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

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The EMMA Emergency Capnometer Monitor measures, displays and monitors carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult and pediatric patients.

The EMMA Emergency Capnometer Analyzer measures and displays carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult and pediatric patients.

The EMMA Emergency Capnometer is a miniature mainstream infrared gas analysis bench with an integrated user interface. The complete carbon dioxide analyzer is contained within a transducer that is attached to the breathing circuit via the EMMA Airway Adapter.

The provided 510(k) summary for the EMMA Emergency Capnometer focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone study with specific performance metrics. Therefore, many of the requested details are not explicitly present in the document.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

The documentation does not provide specific quantitative acceptance criteria (e.g., a target accuracy range for CO2 concentration or respiratory rate) with corresponding reported device performance. Instead, it states a general conclusion about equivalence or superiority.

The key statement is from section 12: "The EMMA Emergency Capnometer demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics."

Study Information

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

   • Sample Size: Not specified.
   • Data Provenance: The study involved "calibrated gas samples and legally marketed anesthesia and ventilation devices." This suggests a laboratory or bench testing environment. There is no information regarding country of origin or whether the data was retrospective or prospective in a clinical setting.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not mentioned.
   • Qualifications of Experts: Not mentioned. The ground truth was likely established by the "calibrated gas samples" (known concentrations) and possibly measurements from the "legally marketed anesthesia and ventilation devices" (which would have their own validated measurement capabilities).

3. Adjudication method for the test set:

   • Not applicable/Not mentioned. The study appears to be a direct comparison against a known standard (calibrated gas) and established medical devices, rather than a subjective assessment requiring expert adjudication.

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:

   • Was an MRMC study done? No. This device is an emergency capnometer, a medical measurement device, not an AI-powered diagnostic tool requiring human reader interpretation. The study described is a device-to-device performance comparison.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, implicitly. The testing described ("Testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices") is a standalone performance test of the device itself, without human interpretation of its outputs being part of the primary evaluation.

6. The type of ground truth used:

   • Ground Truth Type: A combination of "calibrated gas samples" (representing a known, accurate CO2 concentration) and measurements from "legally marketed anesthesia and ventilation devices" (which are themselves considered accurate and reliable benchmarks). This is akin to a reference standard or benchmarking against established, validated measurement systems.

7. The sample size for the training set:

   • Not applicable/Not mentioned. This device does not appear to be an AI/machine learning product requiring a training set in the conventional sense. Its development and validation are based on established engineering principles for gas analysis.

8. How the ground truth for the training set was established:

   • Not applicable/Not mentioned, as there is no mention of a training set for an AI/ML model.

Summary of Device Performance and Equivalence Claim:

The 510(k) submission for the EMMA Emergency Capnometer establishes substantial equivalence primarily through direct comparative testing against its predicate devices (Tidal Wave Model 610, Novametrix Medical Systems Inc. and VEO Multigas Monitor for Pocket PC, Phasein AB). The "testing vs. predicates" section (11) indicates that the device was compared using "calibrated gas samples and legally marketed anesthesia and ventilation devices" across its operating range. The conclusion (12) states that the EMMA Emergency Capnometer "demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics." This implies that the device's accuracy in measuring CO2 concentration and respiratory rate was found to be at least as good as, if not better than, the predicate devices when tested under controlled conditions.

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