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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.

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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Intended use for all models is the same. Different products are offered for variations in size. Specifically, MS-101 is for use in pediatric cases; MS-111 and VIS-121 are for use in cases where a larger dead space is not a concern for the physician.

Indications For Use:

1. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.
2. A Heat and Moisture Exchanger (HME) is a device intended to be positioned over a tracheotomy or tracheal tube to warm and humidify by passive means gases breathed in by a patient during anesthesia and ventilator care.

Device name: Bacterial/Viral filter and HME combination device.
Product numbers: MS-101, MS-111, MS-121

This document is an FDA 510(k) clearance letter for a medical device and does not contain the acceptance criteria or a study proving the device meets those criteria.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on its substantial equivalence to a predicate device, not on new clinical trials or detailed performance studies with acceptance criteria as one would find in a clinical trial report. The FDA is acknowledging that the device is similar enough to existing, legally marketed devices that it can be marketed without requiring new, extensive proof of safety and efficacy.

Therefore, I cannot extract the requested information from the provided text as it is not present.

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A bacterial filter is indicated for use when the care provider desires to protect the patient, care provider, equipment, or all three from the transference of bacteria or virus through the breathing circuit. This filter is provided only in combination with a King Systems Universal F2™ breathing circuit. Within this combination the overall intended use is to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.

Breathing Circuit Bacterial Filter

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a "Breathing Circuit Bacterial Filter" and discusses regulatory aspects, not performance studies or acceptance criteria for a device.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
6. If a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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