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The Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired respiratory gases. The Airway Gas Sampling Products are single patient use devices with a cumulative duration of use of up to 72 hours.

The Airway Gas Sampling Products include Airway Gas Sampling Sets with integrated gas sampling lines, and an Airway Adapter without sample line, both for use with compatible GE Healthcare sidestream respiratory gas modules and patient monitors utilizing these modules.

The Airway Gas Sampling Sets are provided in two sizes: large for use with adult/pediatric patients, and small for use with infant patients, for connection to the patient's breathing circuit. They are provided in two lengths: 3 meter/10 feet, and 2 meter/7 feet. The Airway Gas Sampling Sets are intended for continuous monitoring of Carbon Dioxide (CO2), Oxygen (O2), and respiratory rate in professional/hospital care environments where agents are NOT used, such as intensive care units (ICU), emergency department (ED), coronary care unit (CCU), post anesthesia care unit (PACU) and in-hospital patient transport.

The Airway Adapter is provided in a large size for use with adult/pediatric patients, for connection to the patient's breathing circuit, and may be used with separately supplied gas sample lines. The Airway Adapter is intended for professional use environments and applications specified for the connected respiratory gas modules and patient monitors.

The Airway Gas Sampling Products are intended for use by qualified medical personnel only. Prescription use only.

The Bluepoint Medical disposable Airway Gas Sampling Products offered in this submission are specified for use with compatible GE Healthcare side stream respiratory gas modules and patient monitors utilizing these modules.

The Airway Gas Sampling Products include two product series:

• . Disposable Airway Gas Sampling Sets with airway adapter and integrated side stream TPE gas sampling lines
• . Disposable Airway Adapter with female Luer Connector and without sample line

The Airway Gas Sampling Sets are offered in both Adult/Pediatric and Infant airway sizes. Two lengths of the Adult/Pediatric size are offered: 3m/10ft, and 2m/7ft. The Infant size is offered in 2m/7ft.

The Airway Gas Sampling Sets are constructed with the following features:

• . Rigid clear medical grade plastic airway adapter designed for connection to patient breathing circuit
• . TPE (thermoplastic elastomer) gas sampling lines with moisture management properties that support their specified use duration of up to 72 hours
• . Molded male Luer connector for attachment to GE Healthcare respiratory gas modules

The Airway Adapter without sample line is offered in an Adult/Pediatric size, and includes a molded female Luer connector for attachment of a clinician-selected gas sample line.

All devices are disposable and labeled for single patient use.

The provided text describes the acceptance criteria and the studies performed for the Bluepoint Medical Airway Gas Sampling Products, but it does not contain information typically associated with AI/ML device studies, such as training sets, test sets, expert adjudication, or MRMC studies. This is a medical device clearance, not an AI/ML software clearance.

Based on the document, here's the information regarding the acceptance criteria and a detailed description of the studies:

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

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

The document does not specify exact sample sizes for each test mentioned (e.g., how many units were tested for biocompatibility or performance). It generally states that "Performance testing was executed on new device samples and on samples that have undergone accelerated aging to the duration of the proposed shelf life of three years." Data provenance is not mentioned beyond the fact that the tests were performed by Bluepoint Medical GmbH & Co. KG.

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

This information is not applicable and is not provided in the document. The studies performed are engineering and laboratory tests based on established medical device standards, not human expert evaluations of medical images or data.

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

This information is not applicable and is not provided in the document. The studies performed are objective laboratory and engineering tests, not subjective evaluations requiring 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

No such study was done. This device is a passive medical accessory (airway gas sampling product), not an AI/ML diagnostic or assistive device that would involve human readers or AI assistance.

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

This information is not applicable as the device is a physical medical accessory, not an algorithm or software. It does not have a "standalone" algorithmic performance.

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

The "ground truth" for the device's performance is established by recognized international standards and specifications for medical devices. For example:

• Biocompatibility: Determined by adherence to ISO 10993 series and ISO 18562 series, along with chemical characterization and inhalation risk assessment.
• Performance (Accuracy, Response Time): Determined by meeting specific thresholds set by ISO 80601-2-55 for respiratory gas monitors.
• Physical Compatibility: Determined by adherence to ISO 5356-1, ISO 594-1, and ISO 594-2 for various connectors.
• Risk Management: Determined by compliance with ISO 14971.

8. The sample size for the training set

This information is not applicable and is not provided. The development and testing of this type of medical device do not typically involve "training sets" in the context of AI/ML. The device is designed and validated through engineering principles and compliance with standards.

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

This information is not applicable. There is no concept of a "training set" or "ground truth" for a training set in the context of this device's development as described in the document.

In summary: The provided document describes the clearance of a non-AI/ML medical device. The acceptance criteria and testing are focused on demonstrating compliance with established physical, mechanical, and biological safety standards for medical accessories. Therefore, many of the questions related to AI/ML device studies (training sets, expert adjudication, MRMC studies) are not applicable to this submission.

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