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For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired and to add, maintain, retain moisture for the exhaled breathe of the patient. Use up to 24 hours.

The Models of the filters are A501-1, A501-2, A501-3, and A501-4. The filters are intended for patient population that weighs greater than 10Kgs.

Breathing circuit bacterial/viral filter has into two models: - 1) Bacterial/ viral filters; 2) Bacterial/viral filters HME. Breathing circuit bacterial/viral filters are available in multiple sizes and shapes, rectangular and round, and incorporate standard 15/22 mm connectors with a gas sampling luer port. The depth filter use electrostatic media for filtration and a foam media for the HME media.

The provided document is a 510(k) premarket notification for a medical device: a Breathing Circuit Bacterial/Viral Filter manufactured by Zhejiang Haisheng Medical Device Co., Ltd. The document asserts that the device is substantially equivalent to a legally marketed predicate device (EMS Electra Filter and Filter/HME, K013122).

Based on the provided text, here's information regarding the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is compared directly to the predicate device, implying that the predicate's performance metrics serve as the acceptance criteria for achieving substantial equivalence.

Additionally, other characteristics are compared for substantial equivalence:

• Indications For Use: Same
• Product Structure: Same (top cover, filter media, lower cover, sampling port)
• Materials (Top Cover, Filter Media, Lower Cover, Gas Sampling Port, Package): Same (polystyrene, electrostatic polypropylene, PE, dialyzing paper and PE film)
• Color Additive: None (Same)
• Sterilization: EO (Same)

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

The document mentions that "Test data and reports were provided as part of the 510(k) submission," but does not specify the sample sizes of devices tested for each performance metric (e.g., how many filters were tested for bacterial filtration efficiency).

The data provenance is not explicitly stated in terms of country of origin for the testing, nor is it classified as retrospective or prospective. It is implied that the testing was conducted specifically for this 510(k) submission, suggesting it was prospective testing on the Zhejiang Haisheng device. The document states that some tests were performed by "Nelson Lab," which is a known independent laboratory (likely Nelson Laboratories, LLC in the USA), but this is not explicitly stated as the sole source of all test data.

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

This type of information (number and qualifications of experts) is not applicable to this device and submission. The device is a physical breathing circuit filter, and its performance (e.g., filtration efficiency, resistance) is measured objectively through standardized laboratory tests, not through expert interpretation or clinical judgment that would require establishing a "ground truth" by experts.

4. Adjudication Method for the Test Set

This is not applicable. As mentioned above, the performance is determined by objective laboratory measurements and does not involve human interpretation or adjudication in the context of, for example, image analysis or diagnostic tasks.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

This is not applicable as the device is a physical medical device (a filter) and not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and effects of AI assistance are not relevant.

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

This is not applicable as the device is a physical filter, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for verifying the device's performance is established through objective laboratory testing against recognized international standards and specific performance thresholds. For example:

• Bacterial/Viral Filtration: Determined by laboratory tests (e.g., Nelson Lab) measuring the percentage removal of specific microorganisms.
• Resistance to Flow: Measured using flow meters and pressure transducers.
• Humidification Output: Measured in a laboratory setting under controlled conditions (e.g., per ISO 9360).
• Material Compatibility/Biocompatibility: Determined by standardized material testing.
• Sterilization: Verified by ethylene oxide residual testing.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not a machine learning model, so there is no "training set" in the context of artificial intelligence or algorithm development. Production samples are tested for performance.

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

This is not applicable for the same reasons as #8.

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