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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 and retain moisture for the exhaled breathe of the patient

The EMS HEPA Filter and combined HEPA filter / HME are available in multiple sizes and shapes, recogular and round, and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. recoalignar and round, and morporativer for filtration and a foam media for the HME media. Each filter is individually tested for rating performance according to BS 3928 Sodium Flame for Air filters. The "HEPA" performance was in accordance to DOE 3202-97 and ASTM D2986 – DOP.

The provided text describes a 510(k) premarket notification for the EMS HEPA Filter and HEPA Filter / HME, which are bacterial/viral filters and heat and moisture exchangers. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a full study report with detailed performance metrics against those criteria.

However, the "General Technical Characteristics" table [1] lists several performance attributes of the proposed devices, which can be interpreted as acceptance criteria based on established standards and the characteristics of predicate devices. The "Reported Device Performance" column reflects the device's measured or designed specifications.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" and "reported device performance" in separate columns, nor does it present a formal study showing the device meets these criteria with numerical results from a specific test. Instead, it lists technical characteristics, which by their nature in a 510(k) summary, imply that the device performance meets or is equivalent to these values for substantial equivalence.

2. Sample size used for the test set and the data provenance

The document states that "Each filter is individually tested for rating performance according to BS 3928 Sodium Flame for Air filters." and "The "HEPA" performance was in accordance to DOE 3202-97 and ASTM D2986 – DOP." [0]. For BFE and VFE, it mentions "Nelson Lab." [1].

• Sample Size: The phrase "Each filter is individually tested" suggests that all manufactured filters undergo performance testing, but it doesn't specify the sample size of filters used for the validation testing that led to the reported performance figures in the table. It refers to ongoing quality control rather than a specific study sample size.
• Data Provenance: The testing for BFE and VFE was performed by "Nelson Lab." [1]. Other tests refer to specific standards (BS 3928, DOE 3202-97, ASTM D2986), implying these tests were conducted internally or by a contracted lab to meet those standards. The country of origin of the data is not explicitly stated, but the company is based in Indianapolis, IN, 46241, USA [0], and Nelson Labs is a US-based laboratory, suggesting US provenance. The data appears to be prospective in the sense of being generated specifically for the device's design verification and validation, as opposed to retrospective analysis of existing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a physical medical device (filter/HME) and its performance metrics (e.g., filtration efficiency, resistance to flow, dead space) are determined by objective physical and biological testing methods against established standards, not by expert interpretation or consensus on images or clinical cases.

4. Adjudication method for the test set

Not applicable, as the tests are objective measurements against standards, not subjective interpretations requiring adjudication.

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 physical filter/HME, not an AI-based diagnostic or assistive technology for human readers.

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

Not applicable. This device is a physical filter/HME, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance claims are the established international and national standards for medical device filters and HMEs. These include:

• BS 3928 Sodium Flame for Air filters [0]
• DOE 3202-97 and ASTM D2986 – DOP for HEPA performance [0, 1]
• ISO 5356-1 Conical 15/22 [1]
• ISO 594-2 Luer Fittings [1]
• ISO 9360 - HME moisture output [1]
• Bacterial and Viral Filtration Efficiency testing methods (likely based on ASTM F2101 for BFE and ASTM F2100 for VFE, implicitly performed by Nelson Labs as this is their specialty expertise and standard industry practice for these claims). [1]

These standards define the test methods and acceptable performance ranges.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for a machine learning model.

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