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Endure Industries has designed an ETCO2/O2 nasal cannula and an exhaled gas sampling device. The features include sampling of CO2 from exhaled air to a capnograph. It can provide supplemental O2 and sample exhaled air at the same time. The device is configured in such a way that it has a nasal cannula with a division to deliver oxygen through one nares and sample exhaled gases through the other.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Endure ETCO2/O2 Nasal Cannula (K213767). It indicates that the device is substantially equivalent to a legally marketed predicate device (K010024 Oridion Nasal CO2/O2 Cannula). The document focuses on demonstrating this equivalence, rather than setting and proving acceptance criteria in the traditional sense of a clinical trial for a new therapeutic or diagnostic device.

However, based on the information provided, we can infer the "acceptance criteria" through the comparative performance testing and the "study" that proves the device meets (or is equivalent to) those criteria.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly that the Endure ETCO2/O2 Nasal Cannula performs similarly or identically to the predicate device (Oridion K010024) in key functional areas.

Feature/Test	Acceptance Criteria (Implied: Similar/Identical to Predicate K010024)	Reported Device Performance (Endure ETCO2/O2 Nasal Cannula K213767)
Indication for Use	To sample exhaled gas via nasal cannula and simultaneously provide supplemental Oxygen near the nose and mouth for inhalation	1) To deliver supplemental Oxygen to patients and 2) to obtain CO2 sampling of exhaled air
Environment of Use	Hospitals, sub-acute, pre-hospital settings	Hospitals, sub-acute, pre-hospital settings
Intended Population	Adults and Pediatrics - Patient requiring supplemental oxygen and/or sampling of expired gases	Adults and Pediatrics - Patient requiring supplemental oxygen and/or sampling of expired gases
Duration of Use	Single patient use - Disposable, Less than 24 hours	Single patient use - Disposable, Less than 24 hours
Single Patient Use	Yes	Yes
Dispensing	Only on prescription or as ordered by a medical provider.	Only as per the order of a physician or medical provider.
Basic Components	Nasal cannula, Oxygen tubing, Gas sampling line	Nasal Cannula, Oxygen tubing, Gas sampling line
Patient Interface	Nasal cannula	Nasal Cannula
Design	Split / channeled nasal cannula, sampling in one and Oxygen delivery in the other	Split / channeled nasal cannula with sampling in one and Oxygen delivery in the other
Material	Flexible PVC	Flexible PVC
Sampling Tube Specifications	ID-0.06" / OD-0.1" / Length -2" (for predicate)	ID-0.08" / OD-0.1" / Length -2"
Biocompatibility	ISO 10993-1 compliant (Cytotoxicity, Sensitization, Intracutaneous Irritation)	ISO 10993-1 compliant (Cytotoxicity, Sensitization, Intracutaneous Irritation)
Gas Pathway Test	Compliance with ISO 18562	Compliance with ISO 18562
CO2 Sampling/ETCO2 levels	Similar performance to predicate device	Found to be similar between the predicate device and the proposed device.
O2 Flow Rates	Similar performance to predicate device (at 2, 4, and 6 LPM)	Found to be similar between the predicate device and the proposed device.
Physical Measurements	Similar to predicate device	Found to be similar between the predicate device and the proposed one.
Luer Fitting	Similar and leak-free to predicate device	Found to be similar and leak-free.
Shelf Life	5 years	3 years (with supporting aging studies)

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

The document does not specify a distinct "test set" in terms of patient data or a specific number of devices. The performance testing appears to be primarily laboratory-based comparisons between the proposed device and the predicate.

Test Set Sample Size: Not explicitly stated for performance tests. The comparison of physical measurements, CO2 sampling, and O2 flow rates implies a limited number of devices were tested against each other.
Data Provenance: Not applicable in the context of patient data for the performance comparison. The tests were likely conducted in a controlled lab environment. The document states "Age testing done with cannulas manufactured in 2019" which suggests a retrospective analysis of previously manufactured devices for aging studies.

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

Not applicable. This is not a study requiring expert clinical assessment for ground truth. The performance testing involves objective measurements (e.g., CO2 levels, O2 flow, physical dimensions) and adherence to standards (e.g., ISO 10993, ISO 18562).

4. Adjudication Method for the Test Set

Not applicable. There is no clinical imaging or diagnostic interpretation involved that would require an adjudication method like 2+1 or 3+1.

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

Not applicable. This device is a medical accessory for delivering oxygen and sampling CO2, not an AI-powered diagnostic tool.

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

Not applicable. This is a hardware device, not an algorithm.

7. The Type of Ground Truth Used

For Biocompatibility: Compliance with international standard ISO 10993-1 and ISO 18562. This represents established biological safety standards.
For Performance Testing (CO2, O2, Physical): Comparison against the performance of the legally marketed predicate device (K010024 Oridion Nasal CO2/O2 Cannula). The predicate device's performance established the "ground truth" or benchmark for equivalence.
For Age Testing/Shelf Life: Laboratory-based aging studies where the performance of aged devices is compared to new devices (and found equivalent to "cannulas manufactured in 2022").

8. The Sample Size for the Training Set

Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.

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

Not applicable.

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