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Besmed HME Filter (Heat and Moisture Exchange) is intended to decrease the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient's respiratory tract while administering anesthesia gas, providing artificial respiration, or assisting with ventilation.

The Besmed HME Filter is typically placed at the patient's end of the breathing system, specifically between the circuits Y - piece and either the catheter mount or patient airway device. It is essential to note that the Besmed HME Filter is intended for single-use only and should be used on a single patient for up to 24 hours.

Besmed HME Filter is intended to be used within critical care and hospital/ institutional environments by qualified personnel.

Besmed Bacterial Filter

The purpose of the Besmed Bacterial Filter is to diminish the passage of bacteria and viruses to patients receiving anesthesia gas. Besmed Bacterial Filter is designed for utilization with ventilators, anesthesia machines, and open flow systems where there is a need for filtration of inhaled gases.

The Besmed Bacterial Filter is a disposable device intended for the exclusive use of a single patient within a 24-hour timeframe. Bacterial Filter is designed for utilization in hospital environments by medical professionals who possess adequate training in the operation of mechanical ventilators, respiratory systems, and humidification systems.

Besmed HMEF

The Besmed HME Filter absorbs the heat and moisture exhaled by the patients. Upon inhalation, it releases the previously retained heat and humidity to the dry inhalation gases. The HME filter is designed with electrostatic cotton for filtration, as well as a heat-preserved and moisture-absorbed paper roll for maintaining the warmth and humidity of the airway in a respiratory system. Additionally, it eliminates bacterial and viral contaminants from the breathing circuit gas. To ensure passive humidification treatment, it is recommended to install the Heat and Moisture Exchanger Filter (HMEF) on the patient's end. Besmed HME Filter is intended for adult and child patients with the tidal volume between 150ml-1000ml.

Besmed Bacterial Filter

Besmed Bacterial Filter is for single-use purpose. The intended use is achieved through the implementation of an electrostatic filtration mechanism. Transparent and compact housing material makes it easy to check the surface of the filter media for a foreign substance.

The provided text describes the acceptance criteria and the results of non-clinical testing for the "Besmed Bacterial Filter and HMEF." This summary focuses on the non-clinical test results, as no clinical testing was performed or required.

Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against a set of predetermined acceptance criteria across various standards. The table below summarizes these criteria and the reported results.

Study Details

The provided document describes a non-clinical testing summary to support the substantial equivalence of the "Besmed Bacterial Filter and HMEF."

1. Sample Size used for the test set and the data provenance: The document does not specify the exact sample sizes (number of devices) used for each individual test. The data provenance is implied to be from internal testing conducted by Besmed Health Business Corp., likely in Taiwan (New Taipei City, Taiwan is their address). The nature of the tests (performance, packaging, biocompatibility) indicates that these were prospective evaluations of manufactured devices.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not applicable as the studies are non-clinical, laboratory-based tests against established international and ASTM standards. Ground truth would be defined by the criteria within these standards, which are met if the device passes the specified thresholds. No human expert consensus for "ground truth" in clinical interpretation is relevant here.

3. Adjudication method for the test set: Not applicable for non-clinical, objective laboratory tests against defined standards.

4. 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 is not applicable as the device is a physical medical device (breathing circuit bacterial filter and HMEF), not an AI-powered diagnostic or assistive technology.

5. 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 medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for these tests is based on the acceptance criteria defined by international standards (ISO) and ASTM standards. These standards provide objective, measurable thresholds for performance, safety, and biocompatibility.

7. The sample size for the training set: This is not applicable as the device is a physical medical device, not a machine learning model that requires a training set.

8. How the ground truth for the training set was established: This is not applicable for the same reason as above.

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To filter a patient's inspiratory and expiratory respiratory gasses to remove bacteria and viruses.

For non-mechanically ventilated tracheostomy patients who are awake and alert or monitored by a trained healthcare provider or caregiver, where filtration of inspired and/or expired gases is desired. Use up to 24 hours.

Environment of use - clinical settings including hospital, sub-acute, pre-hospital, and home. For adults with Tidal Volumes >300 ml and pediatrics with Tidal Volumes >80 ml. Do not use on neonate or infant patients.

The Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) is a non-sterile, lightweight, single-patient use device for non-mechanically ventilated tracheostomy patients to filter viral, bacterial, and other particulate matter. The filter is intended to fit onto the 15mm hub of a tracheostomy tube. The filter is easy to apply and remove with a gentle twist motion.

The provided document is a 510(k) summary for the Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15). It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. Here is a 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

The document does not specify the exact sample sizes (N per test) for each performance test. It only states the acceptance criteria and results. The data provenance is non-clinical, likely laboratory testing, and no geographic origin is specified for these tests. All tests appear to be prospective, laboratory-based evaluations of the device's physical and filtration properties.

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

This information is not applicable. The study described is non-clinical performance testing of a physical filter device, not a study involving human or image interpretation by experts. Ground truth is established by measurable physical and chemical properties according to recognized standards (e.g., ISO, ASTM).

4. Adjudication method for the test set

Not applicable, as this is non-clinical performance testing, not a study requiring adjudication of expert opinions.

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 passive filtration device, not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI-related effectiveness was assessed.

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

Not applicable. This device does not involve an algorithm.

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

The ground truth for the non-clinical tests is based on pre-defined physical and chemical standards and objective measurements. For example:

• Conical Connector Compliance: Measured against ISO 5356-1 standard.
• Filtration Efficiency (BFE/VFE/PFE): Measured objectively against ASTM F2101 and ASTM F2299 standards.
• Leakage/Dead Space/Flow Resistance: Directly measured physical properties.
• Biocompatibility (Cytotoxicity, Sensitization, Irritation): Assessed according to ISO 10993 series standards, which involve laboratory assays and observations against established biological safety criteria.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable. No training set for an algorithm is involved.

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The filter kit is intended for single patient use as an accessory to a small volume nebulizer. The device can be used in a hospital, home, or clinic environment with patients 5 years and above to minimize the amount of medical aerosol exhaled into the air.

The Filtered Mouthpiece is an accessory to the AeroEclipse® BANTM nebulizer. The filtered mouthpiece kit will be sold as a stand-alone filter kit or as part of a kit with the AeroEclipse® BAN™ nebulizer. The replacement filters can be purchased in bulk pack. The device is a tube with a port to a check valve and a filter element. On inhalation the flow is straight through the tube from the nebulizer to the patient with a check valve preventing air from the filter exhaust from backflowing and diluting the delivered aerosol. On exhalation the check valve opens and all flow is directed through a filter to capture exhaled aerosol particles. This minimizes fugitive emissions from therapies such a methacholine challenge test or the delivery of antibiotics. The filter consists of a plastic body, which incorporates a mechanical filter pad (Synthetic Fibers and Foam) and connectors (male / female).

The provided text is an FDA 510(k) summary for a medical device called the "Monaghan Medical Filtered Mouthpiece Kit." This document focuses on demonstrating the substantial equivalence of this device to existing predicate devices based on non-clinical performance testing, rather than clinical performance data or AI/algorithm performance.

Therefore, many of the requested points regarding AI/algorithm acceptance criteria, study methodologies, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this document as they pertain to the evaluation of AI-driven medical devices.

However, I can extract the relevant acceptance criteria and performance data for the physical device based on the provided text.

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

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: The document does not explicitly state the numerical sample sizes for each non-clinical test (e.g., how many filters were tested for efficiency, how many batches for biocompatibility). It describes the types of tests performed.
• Data Provenance: The tests are described as in-vitro (lab-based) or in-vivo (animal studies for biocompatibility, e.g., rabbits, mice, guinea pigs). The document does not specify the country of origin of the data or whether it was retrospective or prospective, though performance testing is by nature prospective for a new device submission.

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

• Not Applicable. For non-clinical performance testing of a physical device, "ground truth" and "experts" in the context of human readability or AI performance are not relevant. The "ground truth" is established by the validated test methodologies and measurement instruments (e.g., filter efficiency testing protocols, chemical analysis for biocompatibility).

4. Adjudication method for the test set:

• Not Applicable. Adjudication methods like 2+1 or 3+1 typically refer to human expert consensus in image interpretation or diagnostic tasks, which is not relevant to non-clinical device performance testing.

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. No MRMC or human-in-the-loop study was conducted or is relevant to this physical device's non-clinical performance evaluation. The document explicitly states: "The determination of substantial equivalence is not based on Clinical Performance data."

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

• Not Applicable. This device is a physical medical accessory, not an AI algorithm.

7. The type of ground truth used:

• For Aerosol Characterization: Ground truth is established by the performance of the predicate device (AeroEclipse® Durable BAN™ nebulizer K080926) using standardized test methods.
• For Biocompatibility: Ground truth is established by the specified ISO 10993 series of standards and their acceptable limits for various biological responses (e.g., no cytotoxicity, no sensitization).
• For Dry Gas Pathway Testing: Ground truth is established by toxicological risk assessments and acceptable exposure limits for VOCs and PM2.5, based on established scientific principles.
• For Filter Efficiency: Ground truth is established by independent laboratory testing using standardized methods for Bacterial Filtration Efficiency (BFE) and Viral Filtration Efficiency (VFE).

8. The sample size for the training set:

• Not Applicable. This is a physical device, and the evaluation is based on non-clinical performance testing, not machine learning model training.

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

• Not Applicable. See point 8.

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To be used only as part of the softFlow® 50 device to protect the patient, care provider, equipment, or all three from the transference of bacteria or virus through the breathing circuit. The filter should be positioned in a non-humidified gas flow.

Clear-GuardTM 3 angled Breathing Filter, Model #1545020

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, or any studies conducted on a medical device. The document is a 510(k) clearance letter from the FDA for a breathing circuit bacterial filter, but it does not detail the technical performance or validation studies of the device itself. Therefore, I cannot generate the requested table and paragraphs based on this input.

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Filter CareStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use. Indications All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in pediatric (with a tidal volume between 100 and adult patients, depending on the respective device. Filter SafeStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use. Indications All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in adult patients. Filter/HME TwinStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and for respiratory use, as well as heat and moisture exchanger for humidifying respired gases for the patient. Indications All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in adult, pediatric and neonatal patients, depending on the respective device.

The devices are breathing circuit filters used to filter the inhaled and/or the exhaled air of the patient against microbiological and particulate matter from the gases in the breathing circuit. They enclose a filter material in a housing that fits to standard breathing system connectors. Additionally, there are breathing system filters combined with a foam to function as HME (Heat and Moisture Exchangers) for passively humidifying the inspired air. The portfolio contains the following types of breathing circuit filters: - Filter CareStar Plus are electrostatic filters for use against contamination with microorganisms - . Filter SafeStar Plus are mechanical filters for use against contamination with microorganisms - Filter/HME TwinStar Plus are filters for use against contamination with microorganisms and for passive humidification of breathing gases

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

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

The provided document describes three devices: Filter CareStar Plus, Filter SafeStar Plus, and Filter/HME TwinStar Plus. The table below compiles the acceptance criteria and reported performance for these devices based on the "Summary of non-clinical testing" section (pages 18-19).

• The DUT (Device Under Test) shows no signs of damage and retains functionality after simulated transport. | PASSED |
  | ISO 23328-1:2003 - Filtration Efficiency (Particulate Matter) incl. Usage Time | - Adult and pediatric electrostatic filters achieve a filtration efficiency of >90% before and after the specified usage time
• Neonatal filters achieve a filtration efficiency of >75% before and after the specified usage time
• Mechanical filters achieve a filtration efficiency of >99% before and after the specified usage time
• Mechanical filters achieve a HEPA classification ≥ class H13 | PASSED |
  | ASTM F2101:2019 - Filtration Efficiency (Viral and Bacterial) | - Electrostatic filters achieve 99.99% (bacterial) and 99.9% (viral) filtration efficiency
• Electrostatic filters for neo applications achieve 99.98% (bacterial) and 99.9% (viral) filtration efficiency. | PASSED |
  | ISO 10993:2018 and ISO 18562-1:2017 - Evaluation of Product's Biological Compatibility | Evaluation according to ISO 10993:2018 and/or ISO 18562-1:2017 | PASSED |
  | ISO 9360-1:2000 - Evaluation of HME Water Loss, Resistance | · pediatric/neonatal: The moisture loss shall be

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The EasyOne Filter is intended to be used in combination with NDD breathing mouthpieces to reduce bacteria, viruses and other particulates from the patient's exhaled air while performing flow measurements, such as spirometry tests. The EasyOne Filter is a single-use device and intended for single-patient use only.

The EasyOne Filter is a viral, bacterial filter designed to be used with NDD breathing mouthpieces during flow measurements, e.g. for spirometry testing with NDD spirometers. The EasyOne Filter exists in two variants which differ in the connection interface to enable mounting on the EasyOne FlowTube. The EasyOne Filter is composed of two injection molded polymeric parts which enclose a filter medium. The EasyOne Filter is an optional accessory and reduces viruses, bacteria, and other particles that may be released by the patient and thus contaminate the test environment. The EasyOne Filter is non-sterile and for single use.

The provided text is a 510(k) summary for the EasyOne Filter, a breathing circuit bacterial filter. It details the device's characteristics, comparison to predicate devices, and the results of non-clinical, and usability tests. However, it does not describe a study involving an AI/algorithm or human readers for diagnostic purposes (e.g., radiologists interpreting images). The device itself is a physical filter for spirometry, not a diagnostic AI tool.

Therefore, many of the requested points, such as MRMC studies, standalone algorithm performance, number of experts for ground truth, and training set details, are not applicable to this type of medical device submission.

Here's an attempt to answer the applicable points based on the provided text, and explicitly state when information is not present or not relevant to this specific device:

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

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

• Filtration Efficiency: Not explicitly stated, but implies lab testing.
• Human Test (System test): The document mentions "Human subjects performed a FVL test session". The number of subjects is not specified.
• Data Provenance: Not specified, but given the manufacturer is based in Switzerland, it's likely to be European or internationally sourced lab/human data. The tests are general performance tests for a physical device, not tied to specific patient populations or retrospective/prospective clinical data in the way an AI diagnostic would be.

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 filter, not a diagnostic tool requiring expert interpretation or ground truth establishment in the context of diagnostic accuracy. The tests are based on established engineering and medical device standards (e.g., ISO, ATS/ERS).

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

• Not applicable.

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 is not an AI-assisted diagnostic device. Its function is to filter exhaled air. The "human test" was to confirm the device doesn't negatively impact spirometry measurements, not to assess human diagnostic performance with/without AI.

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

• Not applicable. This is a physical filter, not an algorithm.

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

• The "ground truth" for this device exists in the form of established engineering and medical standards (e.g., ISO 10993 for biocompatibility, ISO 18562 for gas path emissions, ATS/ERS standards for spirometry). The performance of the filter is measured against specified physical and biological parameters. Not ground truth from medical diagnoses.

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI model requiring a training set.

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

• Not applicable.

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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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The Pal® Ultipor® U55/U55N Filter is a single use bacterial/viral filter and heat and moisture exchanger (HME) for patient side or machine side installation in breathing systems. It is designed to reduce bacterial/viral transmissions between the patient, the equipment and the environment and to reduce the loss of patient heat and humidity. The Ultipor® U55/U55N breathing circuit filter has >99.999% bacterial and >99.995% viral efficiency.

The filter is for single patient use for adult patients, and is intended for use within breathing systems in healthcare and home environments where ventilation is required and for a maximum duration of 24 hours.

The Pall® Ultipor®U55/U55N Breathing Circuit Bacterial Filter and Heat and Moisture Exchanger is a disposable, highly efficient, bi-directional bacterial/viral filter for patient ventilation solutions and is comprised of the following components:

• . Filter housing - Is comprised of two molded halves, an inlet housing and an outlet housing that are joined and sealed together. The finished filter housing holds the pleated hydrophobic filter media and provides conical (tapered) fittings on opposing sides of the finished housing to provide connection to the conventional equipment used in the breathing circuit. One side of the finished housing has a coaxial conical fitting, with a conical fitting located on the opposing side.
• Hydrophobic filter media Provides airborne bacterial removal efficiency of >99.999%, . airborne viral removal efficiency of >99.995% and waterborne microbial contaminant removal efficiency of 100%. If the filter is used at the patient end, the filter media also acts as a heat and moisture exchanger (HME) by conserving a proportion of the heat and humidity present in the patient's exhaled air and returning it to the patient on the next inspiration.

The provided text is a 510(k) summary for a medical device called the Pall® Ultipor® U55/U55N Breathing Circuit Bacterial Filter and Heat and Moisture Exchanger. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive comparative effectiveness study against human readers or specific clinical outcomes in the way an AI diagnostic device might.

Therefore, many of the requested categories are not applicable to the information contained in this document.

Here's the information extracted from the provided text, addressing your questions where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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Bact Trap filter is a breathing system filter which is designed to reduce possible airborne or liquid-borne cross contamination with micro-organisms and particulate matter via anaesthetic or ventilator breathing systems. The Bact Trap filter may either be used on the patient side of the ventilator anaesthetic device.

The Bact HME/Bact-HME Midi/Pharma Mini is a breathing system filter and a Heat and Moisture Exchanger. The combination of a filter and a Heat and Moisture offer the benefit of both product features. Heat and Moisture Exchangers are used as a conditioning system for mechanically ventilated patients whose uppassed. In almost all cases of mechanical ventilation they are a fully valid alternative to heated humidifiers. The Bact-HME Midi/Pharma Mini should be used with patients who have a Tidal Volume between 50 - 1500 ml.

The Pharma Mini™HME/Filter, Bact-HME™ filter/HME and Bact-HME™ Midi HME/Filter should be used with patients who have a Tidal Volume as follows:

• Pharma Mini™ and Bact-Trap™ Mini 50-900ml
• · Bact-HME™ Midi and Bact-Trap™ Midi between 100-1200 ml
• · Bact-HMETM and Bact-Trap™ between 250-1500 ml

The products mentioned above are designed as disposable single patient use and should be changed at least every 24 hours

The device is a standard breathing circuit bacterial filter used for respiratory management. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit. The function of any breathing circuit is to deliver oxygen and anesthetic gases, and eliminate carbon dioxide. These devices can be placed at the following locations on a breathing circuit:

• At the inhalation port of the CO2 absorber of the anesthesia gas machine ●
• At the exhalation port of the CO2 absorber of the anesthesia gas machine
• At the patient end - at the mask or ET tube
• These placements are also common on critical ventilator circuits

The Bact-Trap™ filter is a breathing filter which can be used on the patient's side or on the device side of the ventilator/anesthetic device. It is used as a hygienic measure to decontaminate the breathing circuit.

The Pharma Mini™ HME/Filter , Bact-HME™ HME/Filter and Bact-HME™ Midi HME/Filter is a breathing system filter and a Heat and Moisture Exchanger (HME).

Heat and Moisture Exchangers and HME Filters (HMEF) are designed for patients with a compromised upper airway. HME and HMEFs are used with intubated or tracheostomized patients to collect moisture and heat from the expired gases and return the inhalation cycle. HME and HMEF contain either plastic fibers or open cell polyurethane foam which offer sufficient surface area to mimic or replace the patient's upper airways while intubated. HMEFs have an additional bacterial/viral filter to help prevent the transmission of bacteria and viruses. Bacterial/Viral filter media consists of electrostatically charged fibers and water repellent cover web on both sides. They also work to prevent cross infection to and from the patient during mechanical ventilation of lungs.

The proposed devices listed below are single patient use and should be changed every 24 hours in the environment of use. The patient population applicable to these devices are specified by the tidal volumes for the filter/Heat and Moisture Exchanger.

The Pharma Mini™HME/Filter, Bact-HME™ filter/HME and Bact-HME™ Midi HME/Filter should be used with patients who have a Tidal Volume as follows:

• Pharma Mini™ and Bact-Trap™ Mini 50-900ml
• · Bact-HME™ Midi and Bact-Trap™ Midi between 100-1200 ml
• · Bact-HMETM and Bact-Trap™ between 250-1500 ml

The Pharma Mini, Bact-HME Midi and Bact-HME HME Filters and Bact-Trap Mini, Bact-Trap Midi and Bact-Trap filters are offered in several housing configurations, all of which are typical of filters. These configurations include:

• All have standard conical 15 mm / 22 mm fittings for connections ●
• Some models have a port version Female luer lock port for gas sampling for end-tidal . CO2
• Some models have a straight version .
• Some models have an angled version eliminates the need for a mask elbow .
• Straight version packaged with a standard mask elbow for convenience of the user ●

The provided document (K202459) does not describe a study involving an AI/algorithm or human readers in the loop. Instead, it's a 510(k) premarket notification for a breathing circuit bacterial filter and HME (Heat and Moisture Exchanger). The acceptance criteria and the study proving the device meets these criteria relate to the physical and biological performance of the filter/HME devices, not an AI diagnostic tool.

Therefore, many of the requested items (e.g., sample size for test set/training set, expert qualification for ground truth, adjudication methods, MRMC study, standalone algorithm performance, AI effect size) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the acceptance criteria and the non-clinical studies conducted for this device.

Acceptance Criteria & Device Performance (Non-AI Device)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are based on established international standards and relate to their physical, mechanical, and biological filtration performance. The "performance" column indicates whether the device passed these criteria.

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

The document does not specify the exact sample sizes for each non-clinical test (e.g., how many filters were tested for BFE/VFE or burst strength). It refers to "tests performed" and their summary results.

• Data Provenance: The location of the testing is not explicitly stated, but it's generated by the manufacturer or a contracted lab to support the submission. This is prospective testing designed to demonstrate compliance with standards for the specific device being submitted.

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

N/A. This information is not relevant as the studies are laboratory-based non-clinical performance tests of a physical device, not an AI model that requires expert human interpretation for establishing ground truth (e.g., for image diagnosis). The "ground truth" here is defined by physical measurements and microbiological testing standards.

4. Adjudication Method for the Test Set

N/A. Adjudication is typically used in human reader studies or to resolve discrepancies in AI model outputs where subjective interpretation is involved. For physical device testing, the results are objectively measured according to specified test protocols.

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

No. An MRMC study is relevant for diagnostic devices (often AI-assisted) to assess reader performance. This submission is for a physical breathing circuit filter device, not a diagnostic tool.

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

N/A. This device is a physical filter, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of these filters is established through:

• Standardized Test Methods: Adherence to established ISO, ASTM, and EN standards for medical device testing.
• Physical Measurements: Objective measurements of parameters like gas leakage, pressure drop, and burst strength.
• Microbiological Efficiency Testing: Quantitative measurement of bacterial and viral particle removal.
• Chemical/Biological Component Analysis: Ensuring biocompatibility and absence of harmful leachables/VOCs.

8. The Sample Size for the Training Set

N/A. This device does not involve machine learning or a "training set."

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

N/A. As above, no training set is involved for this type of device.

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Flexicare's HepaShield Bacterial Viral Breathing System Filters are intended to reduce the transmission of bacteria and viruses to/from a patient during anesthesia. For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired.

Flexicare's HepaShield Bacterial Viral Breathing System Filters are single patient for use on a single patient for up to 24hrs and are available in Adult size. FlepaShield Bacterial Viral Breathing System Filters are designed to be used in hospital environments by trained personnel.

Flexicare's HepaShield Bacterial Viral Breathing System Filters are designed to reduce the transmission of bacteria and viruses to and from a patient who requires aesthesia, artificial respiration or other types of assisted respiration

Flexicare's HepaShield Bacterial Viral Breathing System Filters consist of a top/bottom housing, pleated paper filter pack and a luer port cap. The Female luer-lock port allows connection of a luer-terminating monitoring line for monitoring of patient exhaled CO2 & is supplied with a tethered cap to seal port when not in use.

The patient side of the Flexicare's HepaShield Bacterial Viral Breathing System Filters feature a 22mm Male and a 15mm Female conical. The machine side features a 22mm Female and a 15mm Male conical.

All conical connectors comply with dimensions stated within BS EN ISO 5356-1 standard.

Flexicare's HepaShield Bacterial Viral Breathing System Filters are available in Adult sizes.

Flexicare's HepaShield Bacterial Viral Breathing System Filters are available in a both Sterile and non-sterile state, packaged in individually sealed polybags, or blister trays (if sterile).

The provided text describes the acceptance criteria and study results for the Flexicare HepaShield Bacterial Viral Breathing System Filter, which is a medical device.

1. Table of acceptance criteria and the reported device performance:

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