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The Intersurgical In-line single patient use manometer is intended to be used for monitoring the patient's airway pressure during ventilation. The manometer is to be used with resuscitation systems and Mapleson C breathing circuits.

The Intersurgical 7160030 Manometer is an inline manometer for monitoring the pressure delivered to patients via resuscitation systems and Mapleson C breathing circuits. The 7160030 manometer has an operating range of 0 - 60 mbar and a stated accuracy. of +/- 10mbar. The pressure is read where the internal red indicator disk lines up with the pressure indication mark on the outside of the transparent manometer cylinder. The 7160030 manometer specify the patient pressure via a brightly colored indicator. The indicator moves in one axis along a transparent cylinder. The diameter of the indicator is similar to that of the cylinder. A balance of the force exerted by the air in the system and the force exerted by a calibrated spring defines the indicator position. The display on each manometer is a similar size and the pressure is specified where the indicator lines up with number marked on the outside of the transparent cylinder. The Manometer connects to the resuscitator / Mapleson C system via a 3 way, 15mm Female/22mm Male - 22mm Female connector. The 3-way connector tapers are compliant with ISO 5356-1. The manometer can be rotated to the desired orientation for ease of use via a friction fit elastomeric elbow. The 7160030 Manometer is single patient use.

The Intersurgical 7160030 Manometer's acceptance criteria and performance are detailed in the provided document.

1. Acceptance Criteria and Reported Device Performance:

Note: The document only provides "stated accuracy" for the predicate at 10, 20, & 30 cmH2O as ± 2 mbar (singular value). It's assumed for clarity in the table that this applies individually. Similarly, "measured accuracy" for the predicate at 10, 20, & 30 cmH2O is also given as ± 2 mbar.

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

The document does not explicitly state the sample size used for the test set regarding the accuracy measurements. It mentions "Nonclinical tests submitted to demonstrate substantial equivalence for the Manometers include Vertical and Horizontal Pressures, Weight and Size and Tapers when compared to the legally marketed device." However, the number of devices or measurements taken during these tests is not specified.

The data provenance is not explicitly mentioned as a country of origin or whether it was retrospective or prospective. It is implied to be from internal testing conducted by Intersurgical Incorporated.

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

Not applicable. The ground truth for device performance (e.g., pressure accuracy, physical dimensions) is established through instrument-based measurements and compliance with engineering standards, not through expert consensus.

4. Adjudication Method for the Test Set:

Not applicable. As the testing concerns objective device performance metrics, adjudication by experts for discrepancies is not relevant.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or interpretive devices that involve human analysis of output (e.g., imaging devices with radiologists). The Intersurgical Manometer is a physical measurement device, so such a study would not be applicable.

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

Yes, a standalone performance assessment was done. The "Summary of Testing" section describes nonclinical tests for Vertical and Horizontal Pressures, Weight, Size, and Tapers, as well as biocompatibility and connector compliance, all demonstrating the device's inherent performance.

7. The Type of Ground Truth Used:

The ground truth used for performance validation was based on established measurement standards (e.g., pressure calibrations), physical measurements, and regulatory standards (ISO 10993-1 for biocompatibility, ISO 5356-1 for connectors).

8. The Sample Size for the Training Set:

Not applicable. The Intersurgical 7160030 Manometer is a mechanical device, not an AI/algorithmic system. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable, as there is no training set for this device.

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The CO2 monitoring lines are intended to connect from a CO2 sampling port to the expired gas monitor.

The monitoring line tubing is single use, small diameter tubing intended to be connected to a port on a face mask or breathing circuit to allow for gas sampling from a patient's breath by gas sampling equipment. When used with a face mask the line connects between the female luer lock connector on the mask and a capnograph or similar gas monitoring device. The gas monitoring device will have a pump which pulls air from inside mask, along the monitoring line and into the gas monitoring equipment. The monitoring line is available with or without a hydrophobic filter, which prevents the transfer of water down the monitoring line and into the gas sampling equipment.

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

Disclaimer: This document describes a medical device called "C02 Monitoring Line and C02 Monitoring Line with Filter." The "study" described is a submission for 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device, rather than a clinical study establishing efficacy or a standalone algorithm performance study. Therefore, some of the requested categories (like MRMC studies, human reader improvement, and training set details) are not applicable or cannot be extracted from this type of regulatory document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds in this document, but rather implied by the comparison to a predicate device. The performance is reported by comparing the new device's characteristics to those of the predicate device (K946044). The "acceptance criteria" here implicitly mean that the new device's performance for these characteristics should be comparable or substantially equivalent to the predicate device to justify market clearance.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (which in this context is "substantial equivalence") is the nonclinical testing described in the document, specifically the "Summary of Testing" section.

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

• Sample Size for Test Set: The document does not specify exact sample sizes (e.g., number of lines tested) for each physical characteristic (resistance to flow, leakage, etc.). These are typically described in detailed test reports, not usually summarized in the 510(k) filing itself beyond stating that the tests were performed.
• Data Provenance: The data appears to be prospective testing conducted by the manufacturer, Intersurgical Incorporated, on their new devices. The country of origin for the data is not specified, but the manufacturer is based in Liverpool, NY, USA. However, given the predicate is from "Catheter Research Inc.," it implies the predicate data is also likely from the US, or at least from a study accepted by the FDA.

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

This information is not applicable and not provided in this document. The "ground truth" for nonclinical performance characteristics like resistance to flow or leakage is established by validated testing methodologies and metrology, not by expert consensus. This is a technical device characteristic evaluation, not an diagnostic or interpretative one.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are relevant for studies where human interpretation of data (e.g., medical imaging, clinical symptoms) is involved, and discrepancies among observers need to be resolved to establish ground truth. For physical device performance tests, the outcome is typically measured objectively and does not require adjudication.

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

This information is not applicable. This document describes a C02 monitoring line, which is a physical accessory for gas monitoring equipment, not an AI-powered diagnostic or interpretive device. Therefore, MRMC studies, AI assistance, and human reader performance are not relevant to this submission.

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

This information is not applicable. As stated above, this is a physical medical device accessory, not an algorithm or software-as-a-medical-device (SaMD).

7. Type of Ground Truth Used

The "ground truth" for the performance characteristics like resistance to flow, leakage, dimensions, and biocompatibility is established through objective physical measurements and standardized laboratory testing (e.g., in accordance with ISO standards) using established metrology and chemical/biological analysis. It is not based on expert consensus, pathology, or outcomes data in the traditional sense.

8. Sample Size for the Training Set

This information is not applicable and not provided. As this is not an AI/machine learning device, there is no "training set."

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

This information is not applicable and not provided. There is no training set for this type of device.

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The Intersurgical Flo - Guard Breathing Filter is for use at machine end connections in home and hospital breathing system applications. It is designed to reduce bacterial/viral transmissions in order to protect the patient and respiratory equipment. The filter is single patient use for an adult target patient population, is intended for use within breathing systems in healthcare and home environments where ventilation is required and a maximum duration of 24 hours.

The breathing filer is classified as "Breathing Circuit Bacterial Filters" according to 21 CFR 868.5260. They are all in Regulatory Class II and have a product code of CAH. The Flo-Guard breathing filter is designed to be placed at the machine end of a breathing system to protect the patient and machine against cross contamination while maintaining a low resistance across a wide range of flow rates. The gas flow path is simple, the pathway is through the 22F to the 22M connection on the inspiratory breath and should the filter be used on the expiratory side, from the 22M to the 22F on the expired breath. The Flo-Guard is a single use product. The low resistance makes it an ideal filter for use in both the hospital and the home where high flow rates may potentially be used; this includes CPAP, BIPAP and cough assist applications. The filter has been designed to protect between the machine and breathing circuit interfaces. The 1690030 is a Bacterial/viral filter capable of delivering low resistance values at high flows. It is designed to accompany BiPAP circuits and cough assist circuits for systems and is an expiratory silencer kit for neonatal ventilators also to be available as a stand alone low resistance product.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Intersurgical Flo-Guard Breathing Filter:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document establishes substantial equivalence by comparing the proposed device to a predicate device (Respironics Breathing Filter K973797). Therefore, the predicate device's specifications serve as the de facto "acceptance criteria" for the new device to demonstrate similar performance. The "Reported Device Performance" column shows how the new device compares.

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

The document does not explicitly state the sample size for any specific "test set" in the traditional sense of a clinical or lab study involving a human population. Instead, the comparison is made on characteristics of the device filters themselves.

• Sample Size: Not specified in terms of number of devices tested for each characteristic. It refers to "the Flo-Guard" as a general type.
• Data Provenance: The testing for characteristics like resistance, filtration efficiency, and volume was conducted internally or at an external test house. The country of origin of the data is not specified, but the applicant company is based in Liverpool, NY, USA. The testing appears to be prospective in nature, performed specifically for regulatory submission.

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

• This information is not applicable to this type of device submission. The "ground truth" for a breathing filter is not established by expert consensus on clinical findings or images. Instead, it's based on objective, measurable physical and functional characteristics of the device (e.g., bacterial filtration efficiency, resistance to flow).
• The document implies that established laboratory methods (e.g., "Henderson rig" for filtration efficiency) are used, which are standard, objective measurements rather than subjective expert interpretations.

4. Adjudication Method for the Test Set

• Not applicable. Since the "ground truth" is determined by objective physical and functional measurements, there is no need for expert adjudication. The tests produce quantitative results that are then compared against established standards or predicate device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is typically performed for diagnostic devices where human readers interpret medical images or data, and AI assistance might improve their accuracy. This submission is for a medical device (breathing filter) with objective performance metrics, not an AI-based diagnostic tool. Therefore, human-in-the-loop performance with or without AI assistance is not relevant or reported.

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

• Not applicable. This device is a physical breathing filter, not an algorithm or AI system. Its performance is inherent to the device itself, not an independent algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective physical and functional measurements using standardized laboratory test methods. These include:

• Bacterial Filtration Efficiency (BFE) and Viral Filtration Efficiency (VFE): Determined by specialized external testing (e.g., using a "Henderson rig").
• Resistance to Flow: Measured by applying rated flow and recording pressure increase.
• Approximate Volume: Calculated using internal pressure recordings and gas laws.
• Weight: Measured using a calibrated balance.
• Leakage: Tested by maintaining internal pressure and measuring air flow.
• Maximum Duration of Use: Verified through conditioning tests (e.g., 24 hours on a ventilator, 24 hours on moisture return rig).

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI algorithm or a machine learning model, so there is no "training set" in the context of data-driven model development.

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

• Not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply here.

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Breathing system heaters are defined as a device that is intended to warm breathing gases before they enter a patient's airway.
Humidification chambers are intended for use to hold water required to humidify the air being delivered to patients.

The 2026 and 2026-CH dual heated wire breathing circuits are classified as "Breathing System Heater" according to 21 CFR 868.5270. The breathing circuits form part of the respiratory humidification system in which the inspiratory limb delivers humidified gas to the patient and the expiratory limb carries the expired gas away from the patient. Heater wires in the inspiratory and expiratory limb minimizes the formation of condensate.

The 2310 Auto-Fill Humidification Chamber, 2320 Manual Fill Humidification Chamber and the 2330 Low Volume Manual Fill Humidification Chamber are classified as accessories to "Breathing System Heater" according to 21 CFR 868.5270. Chambers are an integral part of the breathing system and allow the system to interface with the heated humidifier base. Chambers are commonly used with heated wire breathing systems. The chamber simply slides into position on the hot plate of the base controller allowing the inspiratory gas to pass over the heated water. This provides optimum humidification to the patient.

The 2310 Auto-Fill Chamber offers a fixed level of water within the chamber, ensuring a constant system volume. The float mechanism along with the webs inside the chamber and baffles at the base of the 22mm male connectors, ensure that the chamber gives maximum humidity output without compromising resistance to flow.

The 2320 Manual-Fill Chamber is supplied with a complete fill set and clamp in order to manually control the water level in the chamber.

The 2330 Low-Volume Chamber is suitable for use with high frequency ventilation and many neonatal applications. The chamber is supplied with a fill set and clamp in order to manually control the water level in the chamber.

The provided document describes a 510(k) submission for Interurgical Inc.'s heated wire breathing systems and humidification chambers, demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria through a traditional clinical study. The "acceptance criteria" are implicitly defined by the performance characteristics of the predicate devices and relevant industry standards. The "study" refers to nonclinical tests performed to show comparability.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document presents performance characteristics of the proposed devices (Intersurgical 2026, 2310, 2320, 2330) and compares them to their respective predicate devices. The "acceptance criteria" can be inferred as being similar to or meeting the performance of the predicate devices and complying with relevant standards.

For the 2026 Heated Wire Breathing Circuit:

For the 2310 Auto-Fill Humidification Chamber:

For the 2320 Manual Fill Humidification Chamber:

For the 2330 Low Volume Manual Fill Humidification Chamber:

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

The document does not explicitly state sample sizes for individual tests. It refers to "Test Results" and "Summary Conformance" with numerous page numbers (e.g., "See Pages 19 to 44 for Summary Conformance," "See Pages 45 to 86 for test reports"). The provenance of the data is retrospective, as the comparisons are made against existing predicate devices and in-house testing. The country of origin for the data is implied to be internal testing by Intersurgical Incorporated and Nelson Laboratories (for biocompatibility), likely in the USA where the company address is located, but it's not explicitly stated for all tests.

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

This type of information is not applicable to this submission. The "ground truth" here is based on objective measurements and compliance with established industry standards (ISO 5367, ISO 9360, ISO 8185, ISO 10993, ISO 5356, EN 12342), not expert consensus on qualitative data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for subjective assessments where expert agreement is needed to establish ground truth, which is not the case for these objective performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is a technical device performance study, not an AI-assisted diagnostic study.

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

Not applicable. This document describes the performance of a physical medical device (breathing circuit and humidification chambers), not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for the device evaluation is based on:

• Established Industry Standards: ISO 5367, ISO 9360, ISO 8185, ISO 10993, ISO 5356, EN 12342.
• Performance Metrics of Legally Marketed Predicate Devices: The specific values for characteristics like volume, resistance to flow, weight, leakage, moisture output, etc., of the Fisher & Paykel predicate devices (RT210, MR 290, MR 210, MR 225).
• Laboratory Testing: For properties like biocompatibility (per ISO 10993) by Nelson Laboratories, and various electrical, mechanical, chemical, and thermal safety tests.

8. The Sample Size for the Training Set

Not applicable. This document pertains to a physical medical device and its performance testing, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device submission.

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The Intersurgical Hydro-Guard Mini Filter and Heat and Moisture Exchanger is for use at the patient and equipment connections. It is designed to reduce bacterial/viral transmissions between the patient and equipment and to reduce the loss of patient heat and humidity.

The Intersurgical Air- Guard Breathing Filter is for use at the equipment connections. It is designed to reduce bacterial/viral transmissions in order to protect oxygen concentrator machines and respiratory equipment.

Both filters are single patient use for an adult target patient population, are intended for use within breathing systems in healthcare and home environments where ventilation is required and a maximum duration of 24 hours.

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I am sorry, but based on the provided document excerpts, there is no information available regarding the acceptance criteria, study details, or performance of the described medical device. The document is a 510(k) clearance letter from the FDA, which primarily states that the device is substantially equivalent to a predicate device and can be marketed. It outlines regulatory requirements but does not include the technical study details or acceptance criteria for the device itself.

Therefore, I cannot provide the requested table and information about the acceptance criteria and the study that proves the device meets them.

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The Intersurgical Clear-Therm Micro Filter is for use at the patient connection on the patient and equipment and is designed to reduce bacterial/viral contamination between patient and equipment and to reduce the loss of patient heat and humidity. It is for use in the breathing circuit. Federal law restricts this device to sale by or on the order of a physician.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "Clear-Therm Micro HME, Model 1441" and mostly discusses regulatory compliance and the device's indications for use. It does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as typically found in a clinical study report or a more detailed technical submission.

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1544, 1544-T & 1544-F: For use at the equipment or patient connection. Designed to reduce bacterial/viral transmission to and from patient, equipment. CAUTIONS: When used in the exhalation limb in conjunction with a water bath humidifier, a water trap should be placed between the filter and the patient;

1541, 1541-T & 1541-F: For use at the patient connection. Designed to reduce bacterial/viral transmission and to reduce the loss of patient heat and humidity. CAUTIONS: This product is not suitable for patients with thick or copious secretions; Do not use this product in conjunction with other humidification sources.

1544, 1544-T, 1544-F, 1541, 1541-T, 1541-F: ISO connections: When assembling any connections use a push and twist action to ensure a secure fit. Single patient use. Non conductive. Non sterile. Do not autoclave. CAUTIONS: Never position any filter on the inspiratory limb downstream of a water bath humidifier. Do not use this product between the patient and a source of nebulized drugs: When nebulized drugs are administered, resistance should be monitored and the product should be exchanged following standard hospital procedure; All ports should remain capped when not in use; Replace every 24 hours or more frequently if visible deterioration is observed, following standard hospital procedure: Federal law restricts this device to sale by or on the order of a physician.

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I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a medical device (breathing circuit bacterial filter and HMEF). It states that the device is substantially equivalent to legally marketed predicate devices, but it does not contain any information about acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement in a study.

The document primarily focuses on the regulatory aspects of the device's clearance for market.

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1844 & 1844-P: For use at the equipment connection. Designed to reduce bacterial/viral transmission to and from patient, equipment and environment. CAUTIONS: When used in the exhalation limb in conjunction with a water bath humidifier, a water trap should be placed between the filter and the patient; 1841 & 1841-T: For use at the patient connection. Designed to reduce bacterial/viral transmission and to reduce the loss of pattent heat and humidity. CAUTIONS: This product is not suitable for patients with thick or copious secretions; Do not use this product in conjunction with other humidification sources. 1844, 1844-P, 1841, 1841-T: ISO connections: When assembling any comnections use a push and twist action to ensure a secure fit. Single patient use. Non conductive. Non sterile. Do not autoclave. CAUTIONS: Never position any filter on the inspiratory limb downstream of a water bath humidifier; Do not use this product between the patient and a source of nebulized drugs; When nebulized drugs are administered, resistance should be monitored and the product should be exchanged following standard hospital procedure; All ports should remain capped when not in use; Replace every 24 hours or more frequently if visible deterioration is observed, following standard hospital procedure; Pederal law restricts this device to sale by or on the order of a physician.

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The provided text is a 510(k) premarket notification approval letter for several medical devices (Clear-Therm HMEF, Clear-Therm HME W/Flextube, Clear-Guard II Filter, and Clear-Guard II Filter w/CO2 Monitoring Port).

This document does not contain information regarding detailed acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment for AI-based medical devices.

The letter states that the devices are "substantially equivalent" to legally marketed predicate devices, meaning they have similar indications for use, technological characteristics, and safety and effectiveness. This determination is based on a comparison to existing devices rather than a de novo study with specific performance metrics against a defined standard.

Therefore, I cannot provide the requested information from the given text. The information requested typically comes from a separate summary of safety and effectiveness or a clinical study report, which is not part of this 510(k) approval letter.

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1644 & 1644-T: For use at the equipment connection. Designed to reduce bacterial transmission to and from patient, equipment and environment. CAUTIONS: When used in the exhalation limb in conjunction with a water bath humidifier, a water trap should be placed between the filter and the patient; 1831 & 1831-T: For use at the patient connection. Designed to reduce bacterial/viral transmission and to reduce the loss of patient heat and humidity. CAUTIONS: This product is not suitable for patients with thick or copious secretions: Do not use this product in conjunction with other humidification sources. 1644, 1644-T, 1831, 1831-T: ISO connections: When assembling any connections use a push and twist action to ensure a secure fit. Single patient use. Non conductive. Non sterile. Do not autoclave. CAUTIONS: Never position any filter on the inspiratory limb downstream of a water bath humidifier; Do not use this product between the patient and a source of nebulized drugs; When nebulized drugs are administered, resistance should be monitored and the product should be exchanged following standard hospital procedure; All ports should remain capped when not in use; Replace every 24 hours or more frequently if visible deterioration is observed, following standard hospital procedure; Federal law restricts this device to sale by or on the order of a physician.

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This document is a 510(k) clearance letter from the FDA for "Breathing Filters Models 1644, 1644T, 1831 and 1831T." It does not provide details about acceptance criteria or a study proving device performance. This letter merely states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval and classification, not on the technical performance data or specific studies conducted.

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