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The Dispo-Med gas sampling lines are intended to interface with the patient via nasal cannula, nares connector, or standard sampling port connectors to the expired gas monitor.

Environment of use - hospital, sub-acute, and pre-hospital settings

Patient population - Patients requiring supplemental oxygen and / or expired gas monitoring, adult to pediatrics.

Device Description

Dispo-Med has designed a series of exhaled gas sampling devices. They include:

Nasal cannula styles that can provide supplemental O2 and sample exhaled gases
Gas sampling only devices which sample the patient's exhaled gas at the nares or in the circuit

All of the devices have the same indications for use and therefore can be combined into a single submission.

We will present several different configurations which have been tested and compared to several predicates.

Gas sampling devices are not specific to a particular exhaled gas monitor. Almost all gas sampling design connect to the monitor via a standard luer fitting, whether it is a female or male fitting.

AI/ML Overview

The provided text describes a 510(k) summary for DISPO-MED (MALAYSIA) SDN BHD regarding their Oxygen Delivery / CO2 Sampling Cannula Style and Gas Sampling Only Style devices. The document aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" with numerical targets in the same way one might find for a diagnostic test's sensitivity or specificity. Instead, it frames "acceptance" as demonstrating substantial equivalence to predicate devices through comparative performance testing and shared characteristics. The performance criteria are implicit within the comparative testing performed.

Acceptance Criteria Category	Reported Device Performance (DISPO-MED)
Indications for Use	Oxygen Delivery / CO2 Sampling Cannula Style: "The Dispo-Med nasal cannula styles are intended to deliver supplemental oxygen to patients and provide a means to sample expired gases." (Identical to predicates K010024 and K011050)
Gas Sampling Only Style: "The Dispo-Med gas sampling lines are intended to interface with the patient via nasal cannula, nares connector, or standard sampling port connectors to the expired gas monitor." (Identical to predicates K980325 and K980327)
Environment of Use	"Hospitals, sub-acute, and pre-hospital settings." (Identical to predicates)
Patient Population	"Patients requiring supplemental oxygen and / or expired gas monitoring, adult to pediatrics." (Identical to predicates)
Technology / Construction	Oxygen Delivery / CO2 Sampling Cannula Style: Design, fabrication, shape, size etc. are equivalent to predicates. Design incorporates several styles of split/channeled nasal cannula.
Gas Sampling Only Style: Design, fabrication, shape, size etc. are equivalent to predicates. Design incorporates simple means to interface with the patient or breathing/ventilator circuit.
CO2 Sampling Performance	Oxygen Delivery / CO2 Sampling Cannula Style: Comparative CO2 sampling and waveform performance at breathing rates (12 bpm, 20 bpm), tidal volumes (300 ml, 500 ml), CO2 concentrations (1%, 5%), and oxygen flow rates (1 lpm, 5 lpm). "The results presented show that the proposed Dispo-Med Oxygen delivery / CO2 sampling cannula style devices performed equivalent to the predicates." Acknowledged that higher O2 flow (5 lpm) can cause lower CO2 values (washout), but "performance met the performance specifications" and differences "not considered clinically significant."
Gas Sampling Only Style: Comparative CO2 sampling and waveform performance at breathing rates (12 bpm, 20 bpm), tidal volumes (300 ml, 500 ml), CO2 concentrations (1%, 5%). "The results show that the proposed Dispo-Med CO2 sampling only style devices performed equivalent to the predicates." Noted "better performance of the proposed device vs. the predicates."
Mechanical Testing	Resistance to flow, Tensile strength of connections, Luer fitting testing (per ISO 594-2), O2 Flow, Strength of bonds. (Performed and deemed equivalent to predicates for both styles.)
Environmental/Age Testing	Performed for both device styles; results not explicitly detailed but stated to support substantial equivalence.
Biocompatibility (Materials)	ISO 10993 testing performed for cytotoxicity, sensitization, and intracutaneous irritation for indirect and direct (skin) contact materials. (Performed, ensuring materials are appropriate.)
Single Patient Use, Disposable	Yes (Identical to predicates)

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

Sample Size: The document does not specify exact sample sizes (e.g., number of devices tested, number of simulated breaths, or duration of tests) for the comparative performance and mechanical testing. It mentions "several different configurations which have been tested".
Data Provenance: The testing appears to be prospective (conducted specifically for this 510(k) submission) and simulated/laboratory-based. There is no mention of human subject data or data from a specific country of origin for the performance testing results themselves. The company, DISPO-MED (MALAYSIA) SDN BHD, is based in Malaysia.

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

This information is not provided in the document. The "ground truth" for comparative performance data in this context would likely be derived from a validated capnometer or gas analyzer, rather than expert interpretation of data. The document focuses on the objective measurement and waveform equivalency.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. Since the testing is focused on objective measurements of gas sampling and mechanical properties, there wouldn't typically be a need for an adjudication method in the way one would for clinical image interpretation.

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:

This information is not applicable. This submission is for a physical medical device (nasal cannula/gas sampling line), not an AI algorithm or a diagnostic imaging device requiring human reader interpretation. No MRMC study was performed.

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

This information is not applicable. This is not an AI algorithm. The device performance (standalone) was evaluated in laboratory settings.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the CO2 sampling performance was the measured CO2 concentration and waveform generated by the simulated breathing conditions. This would be established by a reference gas analyzer or capnometer, which serves as the "gold standard" for measuring CO2.
For mechanical and material testing, the ground truth refers to established standards and specifications (e.g., ISO 594-2 for Luer fittings, standard material properties, and mechanical limits).

8. The sample size for the training set:

This information is not applicable. As this is a physical medical device and not an AI algorithm, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

This information is not applicable as there is no training set.

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