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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

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The gas sampling lines are intended to connect to a port in the breathing circuit to the expired gas monitor. Disposable, single use.

Small bore tubing of various internal diameters and lengths, commonly referred to as gas-sampling lines. These connect to a port in the breathing circuit. May incorporate standard luer connector fittings and / or in-line filter at monitor end.

The provided text, K0235-79, describes a 510(k) premarket notification for "Gas Sampling Lines." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and study methodologies for an AI/CADe device's clinical performance assessment is not applicable to this submission.

Here's why and what the document does discuss:

• Device Type: This submission is for medical tubing (Gas Sampling Lines), which are considered accessories for carbon dioxide gas analyzers. These are standard medical devices, not AI or CADe systems.
• Regulatory Pathway: The 510(k) pathway for these types of devices relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. This typically involves engineering and bench testing, materials biocompatibility, and sometimes limited performance testing against established standards, but not clinical trials with performance metrics like sensitivity, specificity, or reader studies.
• Key Information Provided:
  • Intended Use: "The gas sampling lines are intended to connect from a port in the breathing circuit to the expired gas monitor. Disposable, single use."
  • Device Description: Small bore tubing of various internal diameters and lengths, connecting to a port in the breathing circuit, possibly with standard luer connectors and/or an in-line filter.
  • Predicate Devices: Catheter Research, Inc. - K946044 (Disposable gas sampling lines).
  • Performance Standards (Applicable): ISO 594-2 - Conical fittings for luer tapers. This is an engineering standard for luer connections, not a clinical performance standard.
  • Differences from Predicate: The submission states, "The data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially equivalent to the predicate devices." This implies that the tests performed (likely engineering and materials compatibility) showed no significant differences that would raise new questions of safety or effectiveness.

In summary, for K0235-79, the following information is not available or not applicable because it's a 510(k) for a non-AI/CADe device focused on substantial equivalence:

1. A table of acceptance criteria and the reported device performance: Not provided in the context of clinical performance metrics. Instead, the "performance standard" mentioned is ISO 594-2.
2. Sample sized used for the test set and the data provenance: Not relevant for a device like this; studies would be bench/engineering tests, not clinical test sets with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No.
7. The type of ground truth used: Not applicable in the context of clinical outcomes.
8. The sample size for the training set: Not applicable (no AI/ML model involved).
9. How the ground truth for the training set was established: Not applicable.

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