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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 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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