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Filter only - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired. Use up to 24 hours.

HME / Filter - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation. Use up to 24 hours.

Environment of use - clinical setting including hospital, sub-acute, pre-hospital and home

For patient with Tidal Volumes > 300 ml.

The subject device is provided in two (2) configurations.

• Filter only ●
• . HME / Filter combination
• The common features are:
  • Standard conical 15 mm / 22 mm fittings for connections
  • Female luer lock port for gas sampling for end-tidal CO2 ●

The provided text describes a 510(k) premarket notification for a medical device called "Altera Filter and HME/Filter". It details the device's characteristics, indications for use, and a comparison with a predicate device, including performance data from nonclinical testing.

Here's the breakdown of the requested information based on the provided text:

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

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

The document relates to nonclinical testing of a physical medical device. It does not mention clinical trials or studies involving human subjects in the typical sense of a "test set" for AI algorithms. The "tests" refer to laboratory-based performance and biocompatibility assessments of the device itself.

• Sample Size for Test Set: The sample sizes for each specific test (e.g., number of filters tested for flow resistance, BFE, etc.) are not explicitly stated in the provided text.
• Data Provenance: The document is a submission to the U.S. Food & Drug Administration (FDA) by Meditera Tibbi Malzeme San. ve Tic. A.S., located in Turkey. The tests are nonclinical, laboratory-based. The text does not specify where the testing laboratories are located, though it implies the data was generated to support a submission in the US. The data is nonclinical/laboratory test data.

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)

This question is not applicable to the provided document. The "tests" performed are objective measurements of the device's physical and performance characteristics against established international standards (ISO, ASTM). Ground truth in this context is defined by the requirements of these standards and the measured physical properties, not by expert human interpretation like in medical imaging.

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

This question is not applicable. Adjudication methods are typically associated with resolving discrepancies in expert interpretations (e.g., when multiple radiologists review images). For objective nonclinical device performance tests, the results are measured directly against defined criteria.

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 question is not applicable. The document describes a physical medical device (Altera Filter and HME/Filter) and its nonclinical performance testing. It does not involve any AI components, human readers, or image interpretation.

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

This question is not applicable. The device is a physical breathing circuit filter, not an algorithm.

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

For this nonclinical device, the "ground truth" for the test results is based on:

• Established International Standards: ISO (International Organization for Standardization) and ASTM (American Society for Testing and Materials) standards define the test methodologies and acceptable performance ranges.
• Predicate Device Equivalence: Many acceptance criteria are stated as "Equivalent to a predicate," indicating that the performance of the new device is compared against the known performance of a legally marketed, similar device (Zhejiang Haisheng Medical Device Co. Ltd - K151498).
• Direct Physical Measurements: The performance criteria (e.g., flow resistance, filtration efficiency, moisture output, burst pressure) are determined through direct, objective physical measurements in a laboratory setting.

8. The sample size for the training set

This question is not applicable. The device is a physical medical device, not an AI algorithm that requires a "training set."

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

This question is not applicable, as there is no training set for a physical device.

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