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The demand valve is used for the application of 100 vol% oxygen during manual ventilation with the resuscitator bag, as well as during direct non-invasive inhalation with the resuscitator mask in spontaneously breathing patients.

The valve, non - rebreathing QualityFlow O2 demand valve is a medical device to deliver medical oxygen or a medical air - oxygen mixture to a patient on demand. Unlike continuous oxygen systems, the demand valve only supplies medical gas when the patient inhales, reducing oxygen consumption and ensuring the patient receives gas only when needed. The QualityFlow O2 Demand Valve from DEHAS consists of a membrane that is activated by negative pressure during inspiration and a valve mechanism that controls gas flow. During inspiration, the valve opens due to the movement of the membrane, while during expiration it is closed by a return spring. The function of the demand valve is based on providing gas only when a negative pressure is applied to the membrane, e.g. by the patient inhaling with a connected mask or suction of the resuscitator when connected (expansion after previous compression of the resuscitator). The valve therefore ensures that gas only flows when it is needed.

The provided document is a 510(k) Premarket Notification for a medical device called "QualityFlow O2 Demand Valve". This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, and thus does not require clinical studies in many cases.

Based on the provided text, the device in question (QualityFlow O2 Demand Valve) is a mechanical device, not an AI/software-driven one. Therefore, the questions related to AI/MRMC studies, training/test sets, ground truth establishment by experts, and adjudication methods are not applicable to this submission. The "acceptance criteria" discussed in this document refer to the device's ability to meet various engineering, safety, and performance standards, rather than diagnostic accuracy metrics common for AI/ML devices.

Here's an analysis based on the information relevant to this type of medical device submission:

1. Table of Acceptance Criteria (Relevant Standards) and Reported Device Performance:

The document summarizes non-clinical tests performed according to international standards to demonstrate substantial equivalence and that the device performs as intended.

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This product is intended for use as an in-line pressure relief device, designed to limit the system pressure within the limits of its stated technical specifications.
This product is indicated for patients in a hospital for use by appropriately qualified healthcare professionals.

The F&P Optiflow Flow Diverter is intended for use as an in-line pressure relief device, designed to limit the system pressure when used with the compatible F&P Optiflow Oxygen Kits and nasal interfaces.
The F&P Flow Diverter is placed between the flow meter and the dryline during use. It is a multi-patient use prescription-only device, provided in a non-sterile state. It operates at flow rates between 5 to 70 L/min and is intended to be used by appropriately qualified healthcare professionals in hospitals.
When an anesthesia mask is applied over the Optiflow Switch interface, the respiratory gas no longer has a pathway to flow through the nasal interface to the patient. This will trigger respiratory gas flow to be diverted into the atmosphere.

The medical device in question is the "F&P Optiflow™ Flow Diverter", a nonrebreathing valve (Product Code: CBP).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly provide a table of acceptance (performance) criteria with numerical targets. Instead, it states that "Performance testing of the Flow Diverter was completed and confirms the subject device does not raise new questions of safety and effectiveness." It implies that the device met the safety and performance standards outlined in the listed ISO and IEC standards.

However, based on the comparison table with the predicate device, we can infer some key performance characteristics. The document emphasizes equivalence to the predicate device, the "OJR215 Pressure Relief Manifold (K173770)".

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

The document does not explicitly state a sample size for a "test set" in the context of a clinical performance study. The testing described is non-clinical performance testing against standards. Therefore, concepts like sample size for clinical test data, country of origin, or retrospective/prospective data are not applicable here. The testing would have involved multiple units of the device under various conditions described by the cited standards.

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

Not applicable. This is not a clinical study involving expert interpretation or "ground truth" establishment in a diagnostic context. The performance is assessed against engineering and safety standards.

4. Adjudication Method for the Test Set:

Not applicable. There's no human interpretation or diagnostic assessment that would require an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a mechanical pressure relief valve, not an AI-powered diagnostic tool.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used:

The "ground truth" for this device would be its performance against the objective criteria defined in the referenced industry standards (e.g., ISO 80601-2-74:2017 for respiratory humidifying equipment, IEC 60601-1 for basic safety and essential performance, ISO 80601-2-90:2021 for respiratory high-flow therapy equipment). This includes measurements such as maximum pressure relief, flow rates, temperature tolerances, and mechanical integrity, as well as adherence to design principles and safety features.

8. The sample size for the training set:

Not applicable. This is a medical device, not a machine learning model requiring a training set.

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

Not applicable.

In summary:

The document describes a 510(k) submission for a non-AI, mechanical medical device. The "acceptance criteria" are primarily established by compliance with recognized international and national standards for medical devices and respiratory equipment (ISO, IEC, CGA), as well as demonstrating substantial equivalence to a predicate device. The "study" proving this is a series of non-clinical performance and safety tests conducted in accordance with these standards. The concepts of clinical test sets, ground truth by experts, and training sets for algorithms are not relevant to this type of device submission.

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The exhalation valves are intended to be used in ventilator circuits consistent with the indicated use of the ventilator to which they are attached.

The single limb model directs flow and allows for pressure monitoring and may be used within hospitals and for home care use.

The dual limb model regulates flow and is for use in hospitals and for home care use.

The exhalation valve are used with adults, pediatrics, and neonates.

The exhalation valves are for single patient use and can be used for a maximum of 30 days.

The Altech® Exhalation Valves (Single Limb) are available in 2 configurations intended for use in Single and Dual Limb ventilator circuits. The difference between the configurations is location of exhaust of the expired gas to the room. In the Single limb, the valve is integrated to the limb and expired gas exhausts through the opening below the valve whereas in the valve is attached to the end of the exhalation limb and the expired gas exhausts through device end of the valve.

The Altech® Exhalation Valves (Single Limb and Dual Limb) underwent non-clinical performance testing to demonstrate substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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This device is used as a physical barrier for mouth to mouth resuscitation. The use of this device does not guarantee complete protection from disease transmission.

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the "CPR Face Shield" (K192285) does not contain any information about a study proving the device meets acceptance criteria.

The document is a standard FDA clearance letter, which confirms that the device is "substantially equivalent" to legally marketed predicate devices. It discusses regulatory matters such as registration, listing, manufacturing practices, and adverse event reporting.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

The document details:

• The device name: CPR Face Shield
• Regulation Number: 21 CFR 868.5870 (Nonrebreathing Valve)
• Regulatory Class: Class II
• Product Code: CBP
• Indications for Use: "This device is used as a physical barrier for mouth to mouth resuscitation. The use of this device does not guarantee complete protection from disease transmission."

None of these sections imply or describe performance studies with acceptance criteria as one would expect for an AI/software as a medical device (SaMD) or other complex diagnostic/therapeutic device. For a simple physical barrier like a CPR face shield, the "acceptance criteria" for FDA clearance primarily revolve around substantial equivalence to existing devices, safety considerations inherent to its material and design, and its stated intended use. A formal "study" with the characteristics you outlined (test sets, experts, MRMC, etc.) would not typically be required or relevant for this type of device.

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The OJR215 Pressure Relief Manifold is designed to protect neonates, infants and children from excessive inspiratory pressure in the event of a downstream occlusion occurring in continuous flow breathing gas delivery systems via nasal cannula.

The device is intended for use with flow rates greater than 0.5 L/min up to, and including. 36 L/min. The OJR215 is fitted upstream of the patient. The OJR215 is single use only and is prescription only.

Not Found

I am sorry, but I cannot answer the question with the provided context. The document is an FDA 510(k) clearance letter and Indications for Use statement for a medical device called the "OJR215 Pressure Relief Manifold." This document explains the device's intended use and regulatory classification but does not include information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. These details would typically be found in the 510(k) submission itself or related study reports, which are not part of this document.

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The CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask with Oxygen Port is intended for prescription use.

The CPR Mask without Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask without Oxygen Port is intended for over-the-counter use.

The Infant CPR Mask without Oxygen Port is designed to provide immediate life support (mouth to mask ventilation) to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. The Infant CPR mask is indicated for use on infants with body weight up to 10 kg (22 lbs). The Infant CPR Mask is intended for over-the-counter use.

The Non-Rebreathing Valve is a single-use, non-sterile device intended to be used with a ventilation mask to provide mouth-to-mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. It is intended for over-the-counter use.

Compower Emergency CPR masks with non-rebreathing valves are designed to assist in providing immediate life support to health emergency victims requiring oxygen support and cardiopulmonary resuscitation rescue techniques. The devices subject to this 510(k) include the following: CPR Mask with Oxygen Port, CPR Mask without Oxygen Port, Infant CPR Mask without Oxygen Port, Non-Rebreathing Valve (15mmOD), Non-Rebreathing Valve (18.5mm).

CPR Mask with Oxygen Port: comprised of an air cushion, foldable mask cover with oxygen port, a non-rebreathing valve and an elastic head strap. Constructed of transparent polyvinyl chloride. Provided non-sterile and is intended for single use only.

CPR Mask without Oxygen Port: comprised of an air cushion, foldable mask cover, a non-rebreathing valve and an elastic head strap. Constructed of transparent polyvinyl chloride. Provided non-sterile and is intended for single use only.

Infant CPR Mask without Oxygen Port: comprised of an air cushion, mask cover and non-rebreathing valve. Constructed of transparent polyvinyl chloride. Provided non-sterile and is intended for single use only.

Non-Rebreathing Valve: a non-sterile, single-use device designed with a rigid styrene-butadiene copolymer housing, a silicone valve plate and polypropylene filter. Compatible for use with 22mm connectors used in standard ventilation masks. Designed with 15mmOD and 18.5mm ports.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents performance data primarily in the context of comparison to predicate devices, rather than explicit acceptance criteria with pass/fail values. The "acceptance criteria" are implied by meeting or falling within ranges comparable to the predicate devices and adherence to relevant standards.

Comparison of Compower CPR Mask (with/without Oxygen Port) to KYOLING CPR Mask (Predicate)

Comparison of Compower Infant CPR Mask to EMS Child/Infant Mask (Primary Predicate) & Laerdal Paediatric Pocket Mask (Reference)

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The Seal Rite Non-Rebreathing Valve is a single-use, non-sterile device intended to be used with a ventilation mask (without oxygen port) to provide mouth-to-mask ventilation to health emergency victims requiring cardiopulmonary resuscitation ("CPR") rescue techniques. It is intended for over-the-counter use.

The Seal Rite™ Non-Rebreathing Valve ("Seal Rite Valve") is a resuscitation valve designed for resuscitation using expired air for ventilation. It has fittings on the grooved patient end that will adapt to standard masks (22 mm ID) used for resuscitation. The Seal Rite Valve allows the rescuer to blow air into a mask through its silicone one-way valve and directs the patient's exhaled air away from the rescuer via a rigid one-way valve and multiple exhaust ports. The Seal Rite Valve helps protect the rescuer from potential patient contamination. The Seal Rite Valve does not have an oxygen port.

The provided text is a 510(k) summary for the Seal Rite Non-Rebreathing Valve (K152521). It describes the device, its intended use, and the testing conducted to establish its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device was tested to ensure conformance with the FDA Recognized AS 4259-1995 standard ("Ancillary devices for expired air resuscitation") and passed all testing requirements. The table below summarizes the key performance parameters tested and the reported results. The explicit acceptance criteria (e.g., maximum allowable resistance values per the standard) are not fully detailed in the provided text, but the text states that the device "passed all testing requirements" and "performs as intended and meets the requirements of the AS 4259-1995 standard." I've extracted specific quantitative performance values where available and indicated "Pass" for qualitative tests.

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

The document does not explicitly state the sample sizes for the non-clinical tests (biocompatibility and bench testing). It mentions that the testing was conducted according to recognized standards (FDA Blue Book Memo G95-1, ISO 10993 series, AS 4259-1995, ISTA Procedure 2A). Typically, these standards specify the number of samples required for each test. The data provenance is implied to be from laboratory testing as mandated by these standards, not from human subjects or real-world use. It is retrospective in the sense that the testing was performed to support the 510(k) submission.

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

This information is not applicable as the evaluation relies on a non-clinical, benchtop and laboratory testing against established engineering and biocompatibility standards, not on expert interpretation of medical data.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation relies on a non-clinical, benchtop and laboratory testing against established engineering and biocompatibility standards. There is no human adjudication process described.

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. The Seal Rite Non-Rebreathing Valve is a mechanical medical device, not an AI or imaging diagnostic tool. Therefore, an MRMC study with human readers (or AI assistance) would not be relevant.

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

This information is not applicable as the device is a mechanical non-rebreathing valve, not an algorithm or AI system. The performance evaluated is the standalone performance of the physical device according to engineering and biocompatibility standards.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on established engineering standards and biocompatibility standards. Specifically:

• AS 4259-1995: "Ancillary devices for expired air resuscitation"
• FDA Blue Book Memo G95-1: Guidance for biocompatibility testing.
• ISO 10993-5: Biocompatibility testing (Cytotoxicity)
• ISO 10993-10: Biocompatibility testing (Irritation)
• ISO 10993-12: Biocompatibility testing (Sensitization)
• ISTA Procedure 2A: Shipping testing.

These standards define the acceptable performance parameters and test methods for such devices.

8. The Sample Size for the Training Set

This information is not applicable. The device is a mechanical non-rebreathing valve, not a machine learning model. Therefore, there is no "training set."

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

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

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The CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask with Oxygen Port is for prescription use.

The CPR Mask without Oxygen Port is designed to assist in providing immediate life support (mouth to health emergency victims requiring cardiopulmonary resuscitation (CPR) resuscitator without oxygen port is for overthe-counter use.

The KYOLING CPR mask is used during cardiopulmonary resuscitation procedures, which are used in emergency situations to supply oxygen and produce blood flow in the heart and lungs.

The CPR mask is made of PVC and one-way valve made of medical grade K-resin, the mask is used for mouth-to-mask breathing, it provides a physical barrier between the rescuer and victim, eliminating direct contact of the rescuer's lips with the unknown subject; and also it promotes an airtight seal to the face allowing ventilation through both the mouth and nose simultaneously. The KYOLING CPR Mask includes transparent dome, universal breathing tube, one-way filtered valve, head strap, and with Oxygen Port or without Oxygen Port.

The provided document describes the acceptance criteria and a study to prove that the KYOLING CPR mask with and without an oxygen port meets these criteria.

Here's a breakdown of the requested information:

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

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The BigEasy™ Non-Rebreathing Valve is intended to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support or cardiopulmonary resuscitation (CPR) rescue techniques.

The BigEasy™ Non-Rebreathing Valve is a resuscitation valve designed for resuscitation using expired air for ventilation. It has fittings on the patient end that will adapt to standard masks (22mm ID) or endotracheal tubes (15mm OD) used for resuscitation. It provides a path for a rescuer to blow expired air into a mask or endotracheal tube through a silicone valve in the device and has a rigid one-way valve that directs exhaled air from the patient away from the rescuer. It also incorporates an oxygen inlet port on the rescuer's side of the valve for the adding of supplemental oxygen without requiring a separate adapter.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the BigEasy™ Non-Rebreathing Valve.

Here's the breakdown of the information requested:

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

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 explicitly state the sample sizes for each specific test or the data provenance (country of origin, retrospective/prospective). The studies are described as "Non-clinical test results" and "Bench Tests," which typically implies laboratory testing rather than human subject data.

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 provided. Given that the tests are primarily "Bench Tests" and "Biocompatibility Testing," they typically involve objective measurements against established standards, rather than expert interpretation for ground truth.

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

This information is not provided. The tests appear to be objective measurements against predefined standards, thus not requiring an adjudication method by human experts.

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

No MRMC comparative effectiveness study was done. This device is a non-rebreathing valve, which is a physical medical device, not an AI-powered diagnostic tool. The "performance testing" focuses on physical and material properties, not diagnostic accuracy with or without AI.

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

A standalone performance evaluation was done, but it was for the physical device itself, not an algorithm. The device was tested independently against various physical, material, and operational standards.

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

The "ground truth" for the performance tests was based on established industry standards and regulations, such as:

• AS 4259-1995 (Ancillary devices for expired air resuscitation)
• ISO 13544-2:2002 (Respiratory Therapy Equipment – Part 2: Tubing and Connectors)
• ISO 5356-1:2004 (Anaesthetic and Respiratory Equipment – Conical Connectors - Part 1: Cones and Sockets)
• BS EN ISO 10651-4:2009 (Lung Ventilators – Part 4: Particular requirements for operator-powered non-rebreathing valves)
• ISTA-2A:2011 (Packaged-Products weighing 150 lbs (68 kg) or Less)
• ISO 10993-1:2009 COR 1 2010 (Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process)
• FDA Guidance Document (Draft) (Reviewer Guidance on Face Masks and Shield for CPR)
• BS EN ISO 15223-1:2012 (Medical Devices – Symbols to be used with Medical Devices Labels, Labelling and Information to be supplied– Part 1: General Requirements)
• EPA-453/R-98-008B (Method TO-15, Determination Of Volatile Organic Compounds (VOCs) In Air)

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm requiring a 'training set.'

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

Not applicable. There is no training set for this type of device.

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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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