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The Inter-Therm Mini Pediatric HMEF Sterile is for use at the patient connections. The device is to be attached between the breathing circuit and patient connection. It is designed to reduce bacterial/viral transmission between the patient and equipment and to reduce the loss of patient heat and humidity. The filter is for single patient use only and therefore must be disposed of after a single patient usage and/or after its maximum duration of use at 24 hours. The device is a single use device that is required to be changed daily when used with devices (i.e. long-term ventilators) that are design to have patient body contact between 24 hours to

The Inter-Therm Mini Pediatric is a sterile HMEF used for passive humidification in pediatric patients under mechanical ventilation or anesthesia. The HMEF contains a HME paper and electrostatic filter pad incased in a plastic housing. The HME paper traps heat and moisture from the patient's exhaled air which is then returned in the inspiratory air to the patient. Therefore the patient receives heated, humidified air. The electrostatic filter pad prevents bacterial and viral cross-contamination between the breathing system and the patient. The HMEF has an additional luer lock port for CO2 monitoring with a retainable luer port cap to block the port when it is not in use. The HMEF has a 22F/15M connector at the machine end and a 22M/15F connector at the patient end.

The Inter-Therm Mini Pediatric angled HMEF is a sterile HMEF used for passive humidification in pediatric patients under mechanical ventilation or anesthesia. The HMEF contains a HME paper and electrostatic filter pad incased in a plastic housing. The HME paper traps heat and moisture from the patient's exhaled air which is then returned in the inspiratory air to the patient. Therefore the patient receives heated humidified air. The electrostatic filter pad prevents bacterial and viral cross-contamination between the breathing system and the patient. The HMEF has an additional luer lock port for CO2 monitoring with a retainable luer port cap to block the port when it is not in use. The HMEF has an angled 15M machine connecter end, eliminating the need to use an elbow in the breathing circuit. The patient end is a straight 22M/15F connector.

This document describes the safety and effectiveness summary for two medical devices: the Inter-Therm Mini Pediatric HMEF sterile (Product # 1331030S) and the Inter-Therm Mini Pediatric angled HMEF sterile (Product # 1332030S). Both are Heat and Moisture Exchanger Filters (HMEFs) designed for passive humidification and bacterial/viral filtration in pediatric patients under mechanical ventilation or anesthesia. The submission seeks substantial equivalence to the Covidien 355U5430 DAR Infant - Pediatric Electrostatic Filter HME (Small - K941381- Hygroboy).

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparison table against a predicate device. For the purpose of this analysis, the "Acceptance Criteria" are implicitly defined by the performance characteristics of the predicate device (DAR Infant - Pediatric Electrostatic Filter HME - K941381), signifying that the new devices should perform similarly or better. The "Reported Device Performance" refers to the values for the new Intersurgical devices.

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

The document explicitly states: "Non-clinical test results are submitted to confirm product safety and substantial equivalence to predicate device." and "Nonclinical tests submitted to demonstrate substantial equivalence for moisture return, resistance to flow, weight, tapers and filtration efficiency."

• Sample Size for Test Set: Not explicitly stated as a number of devices tested. The data presented in the comparison table are performance metrics, implying that testing was conducted on a sufficient number of units to obtain these typical or representative values.
• Data Provenance: The tests are "non-clinical," meaning they were likely conducted in a laboratory or engineering environment. The country of origin for the data is not specified. It is a prospective evaluation as these tests were conducted on the new devices to demonstrate equivalence.

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 in this context. The document describes a 510(k) submission for substantial equivalence based on non-clinical, performance testing of a medical device, not an AI or diagnostic tool where expert ground truth interpretation would be required. The "ground truth" here is objective physical and performance measurements (e.g., moisture return, resistance to flow, weight) as per established international standards.

4. Adjudication method for the test set:

This information is not applicable. As stated above, this is non-clinical performance testing against objective standards and comparison with a predicate device, not a study involving human interpretation of medical data that would require an adjudication method.

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:

This information is not applicable. This is a 510(k) submission for a physical medical device (HMEF) and not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI improvement metrics are provided or relevant.

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

This information is not applicable. This submission is for a physical medical device (HMEF) and does not involve an algorithm or AI.

7. The type of ground truth used:

The "ground truth" for this submission are the performance specifications and measurements obtained through standardized non-clinical testing. These include:

• Objective physical measurements (e.g., compressible volume, weight).
• Functional performance measurements according to international standards (e.g., moisture return per ISO 9360-1:1992, resistance to flow, filtration efficiency).
• Compliance with connector standards (ISO 5356-1:2004, ISO 594-2:1998).
• Biocompatibility testing against a regulatory memo (Bluebook Memo, G95-1).

The ground truth is established by these objective, reproducible tests and comparison to a legally marketed predicate device.

8. The sample size for the training set:

This information is not applicable. This medical device submission does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable. As explained above, there is no "training set" for this device submission.

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The exhalation valves are used to control Inspiratory pressure and expel the expired air from a patient being ventilated via a single limb breathing system. The exhalation valve and single limb breathing systems are used with adults/pediatrics and prescribed by a physician. A pediatric is defined as 10 kg in weight. The product is not for use in neonates. The device can be used within hospitals and for home care use. It is a single patient use device and can be used for a maximum of 30 days.

Double limb breathing systems comprising of an inspiratory and expiratory limb is commonly used for respiratory care. To reduce waste and clutter single limb breathing systems can be used with an exhalation valve to dispel exhaled air from the patient. Some ventilator designs or specifications do not require proximal pressure monitoring; airway pressure is monitored inside the ventilator. There are three variants of the exhalation valve in this submission.

Exhalation valve with proximal pressure port (1924501 &1924504): A single breathing tube connects the patient to the ventilator allowing the patient to receive respiratory care. The exhalation valve is connected at the patient end onto the breathing tube. A pressure monitor line and exhalation valve control line directly connects the valve to the ventilator. Via exhalation valve control line, the ventilator applies a pressure which controls the balloon valve. During the Inspiratory phase the balloon is inflated to close off the exhalation port in the valve body. During the expiratory phase the pressure is released in the valve chamber and the balloon deflates allowing air to be expelled to the surrounding environment via the exhalation port. This prevents the patient rebreathing exhaled gases yet allowing for a single limb breathing system to be used instead of a double limb system. The pressure line monitors the pressure in the valve body. The patient end of the exhalation valve has a swivel connector end.

Exhalation valve without proximal proximal prossure port (1923500): A single breathing tube connects the patient to the ventilator allowing the patient to receive respiratory care. The exhalation valve is connected at the patient end onto the breathing tube. An exhalation valve control line directly connects the valve to the ventilator. Via the exhalation valve control line, the ventilator applies a pressure which controls the balloon valve. During the Inspiratory phase the balloon is inflated to close off the exhalation port in the valve body. During the expiratory phase the pressure is released in the valve chamber and the balloon deflates allowing air to be expelled to the surrounding environment via the exhalation port. This prevents the patient rebreathing exhaled gases vet allowing for a single limb breathing system to be used instead of a double limb system. The patient end of the exhalation valve has a swivel connector end.

Different ventilators require valves which work with different pressure ratios. The MKIII exhalation valve (1923500 and 1924501) has a 1:1.5 pressure ratio which caters for the majority of ventilators. However, there are markets which have applications for ratio of 1:1, and 1:2. The MK3b exhalation valve (1924504) has a 1:2 pressure ratio. The pressure ratio is the pressure difference between the control line pressure and the pressure that will be generated on the patient side of the valve.

This K132143 submission describes the Intersurgical Exhalation Valve (MK3 and MK3b models) and demonstrates its substantial equivalence to a predicate device (Intersurgical 1922500 exhalation valve) through non-clinical testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" in a numerical format that would typically be seen for a device like software. Instead, it presents a comparison of key performance characteristics between the new devices and the predicate, implying that performance comparable to the predicate is the acceptance criteria for substantial equivalence. The "Acceptance Criteria" below are inferred from the predicate's performance or internal requirements.

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The FaceFit Ported Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system. This is a disposable mask. It is intended to be used for 24 hours of treatment of a single patient only, and then discarded. The masks are intended to be used in hospitals.

The Intersurgical FaceFit Ported NIV Mask provides a seal such that air flow from a positive pressure source is directed to the patient's nose or mouth. The mask is held in place with adjustable headgear that straps the mask to the face. The Intersurgical Face Fit Mask is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. FaceFit Ported Mask with a CO2 port for use with BIPAP and CPAP machines. The FaceFit Ported Mask features an anti-asphyxiation valve that will allow patients using a CPAP or BIPAP machine to breathe spontaneously through the mask in the event of a machine failure or system disconnection. The FaceFit ported mask is available in small, medium and large sizes.

The Intersurgical FaceFit Ported NIV Mask (K121747) was cleared based on substantial equivalence to the Resmed Mirage Full Face Mask (K063011). The device is a non-invasive ventilation mask intended to channel airflow from a positive airway pressure device to a patient.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The acceptance criteria are implicitly defined by demonstrating similar performance characteristics to the predicate device. The following table summarizes key performance characteristics compared between the proposed device and the predicate device:

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

The document does not specify a "sample size" in terms of number of patients or masks tested for the performance evaluations. Instead, the testing appears to be based on a comparison of technical specifications and measured physical characteristics of the device and its predicate.

The data provenance is not explicitly stated, but as this is a premarket notification to the FDA, it is expected that the testing was conducted by the manufacturer (Intersurgical Incorporated) likely in the country of origin of the manufacturer or in accredited testing facilities. The specific type of study (retrospective or prospective) is not applicable here as these are laboratory/bench tests, not clinical evaluations on human subjects for performance comparison against the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The "ground truth" for this device's performance metrics (CO2 rebreathing, respiratory resistance, valve function, volume) is established through standardized engineering and laboratory testing, not through expert clinical consensus or interpretation as would be the case for diagnostic imaging AI.

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

This information is not applicable as the "test set" in this context refers to laboratory performance measurements, not clinical interpretation or diagnostic outcomes 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human interpretation, not for physical medical devices like NIV masks.

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

This information is not applicable. The device is a physical medical device, not an algorithm, so "standalone performance" in the context of AI does not apply. The performance data provided are inherent to the device's physical design and function.

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

The "ground truth" for the performance characteristics of the NIV mask is derived from objective, quantitative measurements in a laboratory setting based on established engineering and physiological testing standards (e.g., measuring CO2 rebreathing as a percentage, respiratory resistance in millibars, and valve flow rates). This is analogous to "bench testing" data rather than clinical ground truth obtained from patients or experts.

8. The sample size for the training set

This information is not applicable. This device is a physical product and does not involve machine learning or AI algorithms with "training sets."

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

This information is not applicable as there is no training set for this device.

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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.

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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:

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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.

Not Found

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.

Not Found

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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