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THE MICROSTREAM FILTERLINE NC DEVICE IS USED WHENEVER THE PHYSICIAN NEEDS TO MEASURE THE CO₂ IN A PATIENT'S BREATHING IN A NON INTUBATED PATIENT.

The common product name for this device is a gas sampling nasal cannula . The gas sampling nasal cannula is used with a capnograph (carbon dioxide analyzer 21CFR 868.1400). There is a nasal cannula at one end of the device for connecting to the patient's nose and a female Luer lock on the Other end for connecting to the capnograph. The design and construction of the nasal cannula is almost identical to the nasal oxygen cannula 21 CFR 868.5340. The main difference is that instead of flowing oxygen through the cannula to the patient we use a vacuum to draw a sample of the breathing from the patient.

The two connectors are joined by a plastic tube and an in line hydrophobic filter.

One end of the tube is connected to the source of the patient's breathing (exhalation) and the other end of the tube is connected to a capnograph. The capnograph has a pump that creates a vacuum of approximately 30mbar which draws a sample of the patient's Breathing (exhalation) through the sampling tube into the capnograph for analysis of the CO2 content of the patient's exhalation.

The anesthesiologist sometimes places a hydrophobic filter between the sample line and the capnograph to keep moisture from entering the capnograph. The microstream nasal cannula filterline has integrated an in line hydrophobic filter between the patient and the capnograph to reduce the amount of patient generated moisture that can enter the capnograph.

The provided text describes a 510(k) submission for a medical device called the "Microstream Nasal Cannula Filterline." This submission focuses on establishing substantial equivalence to a previously approved device rather than presenting a de novo study with specific acceptance criteria and performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, and ground truth cannot be extracted from this document, as it is not a clinical study report.

Here's an analysis of the provided information relative to your request:

1. A table of acceptance criteria and the reported device performance

• Not Applicable. The document does not provide a table of acceptance criteria or performance metrics. This submission is for a 510(k) and relies on demonstrating "substantial equivalence" to a predicate device (K964239), not on proving specific performance against predefined criteria in a new clinical study. The FDA's letter states, "we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. There is no mention of a test set with a specific sample size. The submission is based on the claim that the device is "identical to the same device described as an accessory to the NPB-75/microcap capnograph/pulse oximeter in approved submittal K964239." This implies that the performance data for the predicate device is being leveraged, rather than new performance data for this specific accessory.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No ground truth establishment is described, as there is no new test set or clinical study presented in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No test set or adjudication method is described.

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 gas sampling line accessory for a capnograph, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

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

• Not Applicable. This is a hardware accessory, not an algorithm. Standalone performance as described is not relevant.

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

• Not Applicable. No ground truth is described because no new clinical study is presented for this 510(k). The basis for approval is substantial equivalence to a predicate device.

8. The sample size for the training set

• Not Applicable. This device is a physical accessory, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI.

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

• Not Applicable. As above, there is no training set for this type of device.

Summary of available information:

The document is a 510(k) premarket notification for a Class II medical device (Microstream Nasal Cannula Filterline). Its purpose is to demonstrate substantial equivalence to an already approved predicate device (mentioned in K964239). The device is a "gas sampling nasal cannula" designed to conduct a sample of the patient's breathing from the nose to a capnograph for CO2 measurement, featuring an integrated hydrophobic filter. The FDA found the device substantially equivalent.

No clinical study data, performance metrics, or specific acceptance criteria are provided in this submission, as the regulatory pathway chosen (510(k)) for this type of device relies on demonstrating equivalence rather than conducting new efficacy or performance trials.

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