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GGM Breathing Circuit Bacterial Filter contains two types of bacterial Filters, namely "Bacterial Filter" with only filtering function and "HME Filter" with heat and moisture exchanger function.

Intended patient population: VF-2160, VF-2160-1 and VH-3110 are intended for adult patients with the tidal volume between 250ml-1500ml; VH-3210 is intended for adult patients with the tidal volume between 250ml-1000ml.

Bacterial Filter (VF-2160, VF-2160-1) -
The Bacterial Filter is intended to reduce the transmission of bacteria and viruses to a patient during anesthesia. For use with ventilators, anesthesia machines and open flow systems where filtration of inspired gases is desired. The Bacterial Filter is single use device for use on a single patient for up to 24hrs. The Bacterial Filter is designed to be used in hospital environments by trained personnel.

HME Filter (VH-3110, VH-3210) -
HME (Heat and Moisture Exchange) Filter is intended to reduce the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation.

HME Filter is normally positioned at the patient end of the breathing system between the circuits Y-piece and the catheter mount or patient airway device. HME Filter is a single use device for use on a single patient for up to 24hrs. HME Filter is designed to be used in hospital environments by trained personnel.

GGM Breathing Circuit Bacterial Filter contains two types of bacterial filters, namely "Bacterial Filter" with only filtering function and "HME Filter" with heat and moisture exchanger function.

Bacterial Filter (models VF-2160, VF-2160-1):
Bacterial Filter is a single-used medical device, which is used for filtering the bacteria and virus in the respiratory gas to the patient during the respiratory therapy. VF-2160 and VF-2160-1 are all intended for adult patients with the tidal volume between 250ml-1500ml.

HME Filter (models VH-3110, VH-3210):
HME Filter is a kind of breathing circuit bacterial filter with the function of passive heat and moisture exchanger (artificial nose). It is a breathing circuit bacterial filter that contains electrostatic cotton for filtration and contains heat preserved and moisture absorbed paper roll for airway heat preservation and humidification. The Heat and Moisture Exchanger Filter (HMEF) should be installed on the patient's end based on the principle of passive humidification treatment. VH-3110 is intended for adult patients with the tidal volume between 250ml-1500ml, and VH-3210 is intended for adult patients with the tidal volume between 250ml-1000ml.

Here's a breakdown of the acceptance criteria and study information for the GGM Breathing Circuit Bacterial Filter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document lists "Methodology only, no acceptance criteria" for some tests but then states "Meet the requirements of the clinical application" or "Meet the requirements of the standard" for their results. For such cases, I've used the general "Meets standards" or "Clinical application met" as the "Reported Performance" to reflect this. For metrics where specific criteria are given, those are included.

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

The document does not explicitly state the sample sizes used for each of the non-clinical tests (e.g., number of filters tested for filtration efficiency, number of animals for biocompatibility tests). It also does not specify the country of origin for the data or whether the studies were retrospective or prospective, beyond stating they were "non-clinical testing."

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable. The device is a breathing circuit bacterial filter, and the evaluations are based on laboratory, physical, and chemical tests against established standards and methodologies, not on expert interpretation of medical images or patient data to establish a "ground truth."

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human interpretation (e.g., radiologists reviewing images). This document describes non-clinical, laboratory-based testing against defined standards and measurement parameters. Therefore, an adjudication method in this sense is not applicable. The results are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical test data was used not needed for this submission" and focuses entirely on non-clinical, laboratory-based testing to demonstrate substantial equivalence to predicate devices. Therefore, there's no information on how human readers improve with or without AI assistance.

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

No, this question does not apply, as the device is a physical medical device (breathing circuit bacterial filter) and not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device performance is based on established international and national standards, test methodologies, and predefined acceptance criteria. This includes:

• ISO standards (e.g., ISO 10993 series for biocompatibility, ISO 9360-1 for HME performance, ISO 5356-1 for connections, ISO 11737-2 for sterility, ISO 18562 series for emissions).
• ASTM standards (e.g., ASTM F1608 for microbial ranking, ASTM F1929 for dye penetration, ASTM F1140 for burst/creep, ASTM F88 for seal peel strength, ASTM F2101 for filtration efficiency).
• Specific quantitative limits (e.g., cell viability > 70%, PM2.5 ≤ 12 µg/m3).

8. The Sample Size for the Training Set

This question does not apply, as the device is a physical medical device and does not involve AI model training sets.

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

This question does not apply, as the device is a physical medical device and does not involve AI model training sets or associated ground truth establishment.

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