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The Altera Gas Sampling Lines are intended to connect from a port in the breathing circuit to the expired gas monitor.

The Altera Gas Sampling Lines consists of a disposable single patient use coextruded gas sampling line which is provided in 3 different lengths: 2, 2.5, and 3 meters. The disposable single patient use gas sampling lines are smooth narrow diameter tubes that have standardized male luer connectors at both ends.

The gas sampling line connects from a port in a circuit to an expired gas monitor. The gas sampling line provides a conduit for drawing gas samples from the sampling port to the gas monitor to analyze respiratory gases. These disposable single patient use gas sampling lines are used to transmit one directional flow of gas sample from the patient breathing circuit port to the gas module host device. A vacuum source and gas measurement sensors are in the host device, which pull the gas from the sampling port to the host device for gas monitoring.

This document is a 510(k) premarket notification for a medical device, specifically "Altera Gas Sampling Lines." It's important to understand that a 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than proving independent effectiveness through extensive clinical trials as might be seen for novel technologies or higher-risk devices.

Based on the provided text, the device is a simple, single-use, disposable component (a gas sampling line) that connects a breathing circuit to an expired gas monitor. There is no evidence in this document of AI or machine learning components, nor any mention of a study involving human readers improving with AI assistance. Therefore, the questions related to AI performance, expert ground truth establishment for AI, MRMC studies, or standalone algorithm performance are not applicable to this submission.

Here's an analysis of the provided information concerning the acceptance criteria and the study that proves the device meets them, primarily focusing on the device's physical and functional performance, as that is the scope of this 510(k).

Acceptance Criteria and Device Performance for Altera Gas Sampling Lines

Given the nature of this device (a gas sampling line), the "acceptance criteria" are primarily related to its physical and functional performance characteristics, ensuring it performs its intended function (transporting gas samples) safely and effectively, and equivalently to the predicate device. The "study" proving this involves various non-clinical performance tests.

1. Table of Acceptance Criteria and Reported Device Performance

The table below summarizes the key performance attributes tested and the results presented in the document. The general acceptance criterion for these tests is that the proposed device (Altera GSL) performs comparably or better than the predicate device (Vyaire Vital Signs) and meets relevant industry standards.

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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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