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The Maxtec MaxCap Neo and MaxCap Ped are indicated to provide a semi-quantitative visualization of the CO2 in the patient airvay. It is an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.

Patient Population: MaxCap Neo is intended for use with neonates and infants 250g to 6kg. MaxCap Ped is intended for use with pediatric patients 1kg to 15kg

Environment of Use: Hospital, sub-acute, pre-hospital, transport.

The proposed MaxCap Neo and MaxCap Ped are comprised of several components:

• . Housing with standard 15 mm / 22 mm fittings to connect to the ventilator assist device and a face mask or endotracheal tube
• . Colorimetric litmus media which has been treated with chemical to detect the presence of CO2 by a change in pH

The Maxtec MaxCap Neo and MaxCap Ped devices are semi-quantitative CO2 detectors that use a colorimetric, pH-sensitive dye to visualize CO2 in a patient's airway. The devices are intended for use as an adjunct in patient assessment.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for each performance metric, but rather lists specifications and performance data for the proposed devices and compares them to predicate and reference devices. We can infer the acceptance criteria from the context of these comparisons and discussions of "similar" or "lower" than predicates.

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

The document describes non-clinical performance testing that was conducted.

• Sample size: Not explicitly stated for each individual test. The statement "We have performed the following performance data and testing for the new models" implies that a sufficient number of devices were tested to evaluate each listed metric.
• Data provenance: Bench testing results performed by Maxtec, LLC. The document does not specify a country of origin for the data beyond that. It is retrospective in the sense that the testing has already been completed and is being reported as part of the 510(k) submission.

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 provided as the device is a colorimetric CO2 detector. The "ground truth" for the performance tests (e.g., CO2 concentration, flow rate, internal volume) would be measured by laboratory equipment and calibrated standards, not by human experts interpreting clinical cases.

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

This information is not applicable as the described studies are non-clinical performance bench tests, not studies involving human interpretation or clinical adjudication.

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 information is not applicable. The device is a physical, colorimetric CO2 indicator, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This information is not applicable. The device is a physical, colorimetric CO2 indicator, not an algorithm. The reported performance is based on the device's physical and chemical properties.

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

The ground truth for the non-clinical performance tests (e.g., color change accuracy, flow resistance, internal volume) was established using calibrated laboratory equipment and controlled gas mixtures to represent specific CO2 concentrations and flow rates. This is an objective measurement rather than expert consensus or pathology.

8. The sample size for the training set:

This information is not applicable. The device is a colorimetric indicator and does not involve machine learning or a training set.

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

This information is not applicable as there is no training set for this type of device.

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The use of the OmniCap™ capnometer is indicated to provide measurement and monitoring of carbon dioxide concentration of the expired breath and respiration rate of adult patients. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a qualified healthcare provider.

Environment of Use: Hospitals, Sub-acute care facilities and intra-hospital transport.

The OmniCap system incorporates three parts:

• . OmniCap monitor
• . Sensor cartridge with a colorimetric litmus media
• AC power adapter .

The OmniCap monitor houses the electronics including the color sensor, a LED light source, a miniature vacuum pump, internal sample gas tubing, a rechargeable nickel metal hydride battery pack, and the user interface.

The OmniCap Sensor cartridge is a colorimetric litmus media sealed in a plastic cartridge with clear windows on each side.

The AC power adapter is IEC 60601-1 compliant. The AC power adapter converts supplied AC power to DC power to facilitate charging the battery.

The OmniCap unit can operate with or without the AC adapter connected and powered.

Here's a breakdown of the acceptance criteria and study information for the OmniCap device, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

The document describes non-clinical bench testing to demonstrate performance and substantial equivalence.

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

   • The document does not explicitly state the specific sample sizes (e.g., number of test points, number of sensor cartridges) used for each individual test. It broadly mentions "various concentrations of CO2" and "the sensor cartridges."
   • Data Provenance: Not specified, but implied to be laboratory bench testing conducted by Respirion, Inc. (the manufacturer). No information on country of origin for data. The study is retrospective as it involves testing of the manufactured device.

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

   • Not applicable. The ground truth for the bench tests would have been established using reference gas mixtures with known CO2 concentrations and controlled respiration rates, not through expert opinions.

3. Adjudication method for the test set:

   • Not applicable, as ground truth was established by calibrated reference equipment/methods, not by human adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC study was not done. The document refers to "Comparative performance to the predicate - IR technology" but this is described as bench testing at various concentrations and respiration rates, not a multi-reader study.

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

   • Yes, the primary performance evaluation described is a standalone (algorithm only) bench test. The device's sensor detects color change and converts it to a numerical value, which is then assessed against known reference values. There is no human involved in interpreting the color change for the subject device's reported performance, unlike the reference device (Maxtec FloCap) where a user visually interprets color.

6. The type of ground truth used:

   • Reference gas mixtures with known CO2 concentrations and controlled respiration rates generated by test equipment. This falls under a form of "reference standard" based on calibrated instrumentation and scientific principles.

7. The sample size for the training set:

   • Not applicable. This is a non-AI/ML device. The device's technology uses a pre-set colorimetric system with a sensor, not a machine learning algorithm that requires a training set.

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

   • Not applicable, as there is no training set for this device.

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