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The CO2 monitoring lines are intended to connect from a CO2 sampling port to the expired gas monitor.

The monitoring line tubing is single use, small diameter tubing intended to be connected to a port on a face mask or breathing circuit to allow for gas sampling from a patient's breath by gas sampling equipment. When used with a face mask the line connects between the female luer lock connector on the mask and a capnograph or similar gas monitoring device. The gas monitoring device will have a pump which pulls air from inside mask, along the monitoring line and into the gas monitoring equipment. The monitoring line is available with or without a hydrophobic filter, which prevents the transfer of water down the monitoring line and into the gas sampling equipment.

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

Disclaimer: This document describes a medical device called "C02 Monitoring Line and C02 Monitoring Line with Filter." The "study" described is a submission for 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device, rather than a clinical study establishing efficacy or a standalone algorithm performance study. Therefore, some of the requested categories (like MRMC studies, human reader improvement, and training set details) are not applicable or cannot be extracted from this type of regulatory document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds in this document, but rather implied by the comparison to a predicate device. The performance is reported by comparing the new device's characteristics to those of the predicate device (K946044). The "acceptance criteria" here implicitly mean that the new device's performance for these characteristics should be comparable or substantially equivalent to the predicate device to justify market clearance.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (which in this context is "substantial equivalence") is the nonclinical testing described in the document, specifically the "Summary of Testing" section.

2. Sample Sizes Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify exact sample sizes (e.g., number of lines tested) for each physical characteristic (resistance to flow, leakage, etc.). These are typically described in detailed test reports, not usually summarized in the 510(k) filing itself beyond stating that the tests were performed.
• Data Provenance: The data appears to be prospective testing conducted by the manufacturer, Intersurgical Incorporated, on their new devices. The country of origin for the data is not specified, but the manufacturer is based in Liverpool, NY, USA. However, given the predicate is from "Catheter Research Inc.," it implies the predicate data is also likely from the US, or at least from a study accepted by the FDA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable and not provided in this document. The "ground truth" for nonclinical performance characteristics like resistance to flow or leakage is established by validated testing methodologies and metrology, not by expert consensus. This is a technical device characteristic evaluation, not an diagnostic or interpretative one.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are relevant for studies where human interpretation of data (e.g., medical imaging, clinical symptoms) is involved, and discrepancies among observers need to be resolved to establish ground truth. For physical device performance tests, the outcome is typically measured objectively and does not require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

This information is not applicable. This document describes a C02 monitoring line, which is a physical accessory for gas monitoring equipment, not an AI-powered diagnostic or interpretive device. Therefore, MRMC studies, AI assistance, and human reader performance are not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. As stated above, this is a physical medical device accessory, not an algorithm or software-as-a-medical-device (SaMD).

7. Type of Ground Truth Used

The "ground truth" for the performance characteristics like resistance to flow, leakage, dimensions, and biocompatibility is established through objective physical measurements and standardized laboratory testing (e.g., in accordance with ISO standards) using established metrology and chemical/biological analysis. It is not based on expert consensus, pathology, or outcomes data in the traditional sense.

8. Sample Size for the Training Set

This information is not applicable and not provided. As this is not an AI/machine learning device, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided. There is no training set for this type of device.

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