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The Westmed nasal cannula styles are intended to deliver supplemental oxygen to patients and provide a means to sample expired gases. Cumulative duration of use

Device Description

Westmed has designed several 0%CO2 nasal cannula / exhaled gas sampling devices. They include:

. Nasal cannula style that can provide supplemental O2 and sample exhaled gases at only the nares and
Nasal cannula style that can provide supplemental O2 and sample exhaled gases at both ● the nares and at the mouth
The device configurations include nasal cannula that have a division to deliver oxygen through one nare and to sample exhaled gases through the other. There is also an oral sampling style which is positioned near the mouth to sample exhaled gases if the patient is a mouth breather.
The device includes a length of standard oxygen tubing and gas sampling lines.

AI/ML Overview

This document describes Westmed's Gas Sampling Cannula with O2 delivery, which is intended to deliver supplemental oxygen and sample expired gases. The information provided is primarily focused on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and performance through a dedicated study with a predefined test set. Therefore, some requested information may not be directly available from the provided text.

Here's an analysis based on the given document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it focuses on demonstrating equivalence to predicate devices through comparative testing. The performance is reported in terms of equivalence to the predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Ability to measure a breath and a gas	Performed comparative CO2 sampling and waveform performance at 3 different breathing rates, CO2 concentrations (2% and 5%), and oxygen flow rates (1, 3, and 5 lpm). The results showed "equivalent" performance to the predicates.
Ability to breathe waveforms under several simulated breathing conditions	Performed comparative CO2 sampling and waveform performance at 3 different breathing rates, CO2 concentrations (2% and 5%), and oxygen flow rates (1, 3, and 5 lpm). The results showed "equivalent" performance to the predicates.
Environmental and Age resistance	Environmental and Age testing was performed. All testing demonstrated that the proposed devices are substantially equivalent to the identified predicate and reference.
Mechanical strength (e.g., connections, resistance to kinks)	Mechanical testing was performed, including Luer Fitting, Flow, Strength of bonds, and Resistance to kinks. All testing demonstrated that the proposed devices are substantially equivalent to the identified predicate and reference.
Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Irritation)	ISO 10993 testing was performed on component materials, covering Cytotoxicity, Sensitization, and Intracutaneous Irritation. The device components are considered "Externally Communicating and Surface Contact with the patient." The results were acceptable given the device’s classification and intended use.

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

The document does not specify the exact sample sizes (e.g., number of units, number of simulated breathing cycles) used for the bench testing. It only mentions "comparative testing" under "several simulated breathing conditions."

Sample Size: Not explicitly stated for specific tests.
Data Provenance: The testing was conducted as "Bench Testing" by Westmed, Inc. The document does not specify the country of origin of the data beyond implying it was performed by the submitting company. The tests were non-clinical (i.e., not performed on human subjects) and are therefore retrospective.

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

This information is not applicable and not provided. The "ground truth" for this device's performance is based on physical and chemical measurements (e.g., CO2 concentration, waveform characteristics, tensile strength) against engineering specifications or comparative performance with predicate devices, not subjective expert assessment of clinical data.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As the testing involves objective measurements rather than subjective assessments requiring adjudication, no such method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was performed or described. This type of study is typically relevant for interpretative devices (e.g., AI in radiology) where human readers interpret medical images or data. The Westmed device is a gas sampling and oxygen delivery cannula, not an interpretive device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not directly applicable to a physical medical device like a cannula. The device's performance is inherent in its physical and functional characteristics. The "bench testing" described evaluates the device in a standalone manner (without a human patient), but it's not an "algorithm only" study as understood in AI/software contexts.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation was based on:

Objective Measurements: Such as CO2 concentrations, waveform characteristics, and mechanical properties (tensile strength).
Comparison to Predicate Devices: Performance was deemed equivalent to the predicate devices (K010024 – Oridion and K011050 – Oridion). This implies that the performance of the predicate devices served as a de facto "ground truth" or benchmark for acceptable performance.
Standardized Testing: Biocompatibility testing followed ISO 10993 standards, which define the "ground truth" for biological safety.

8. Sample Size for the Training Set

This information is not applicable. The Westmed device is a physical medical device, not a machine learning algorithm that requires 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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