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Heat and passive humidification with filtration between patient and circuit. Designed for use with all ISO compliant airway management systems including ventilators, respirators, and open flow systems where filtration of inspired or expired gases is required such as in hospitals, surgical centers, long term healthcare facilities and the home utilizing anesthesiology or respiratory equipment. Place at anytime on the inspiratory and/or expiratory side of the patient circuit. For single patient use only. For sale by or on the order of a physician.

The Series 1 Breathing Circuit Filter is a filter device intended to remove microbiological and particulate matter from the gases in a breathing circuit similar to the SIMS Portex, Inc. Breathing Filter and Filtered HME. The Series 1 Breathing Circuit Filter features include the following: Hydrophobic filter media, Hydrophilic filter media, Sonic welded housing, ISO compliant.

The provided text is a 510(k) Summary for the "Series 1 Breathing Circuit Filter." It describes the device, its intended use, and claims substantial equivalence to another marketed device. However, it does not contain the detailed information necessary to complete a table of acceptance criteria, reported device performance, or details of a study proving the device meets those criteria as requested in your prompt.

Specifically, the document states:

• "Substantial equivalence is based on independent laboratory testing performed at Nelson Laboratories and the University of Cincinnati. The Series 1 Breathing Circuit Filter met all standards for filtration and humidity control consistent with industry standards."
• "Clinical Data: Not available."

This means:

• There's no explicit table of acceptance criteria within this document. The criteria are only broadly referred to as "standards for filtration and humidity control consistent with industry standards."
• There are no specific performance metrics provided (e.g., filtration efficiency percentages, pressure drop values).
• No details about the "independent laboratory testing" are given (e.g., sample size, ground truth, expert involvement).
• There was no clinical study, which would typically involve human subjects or human readers (MRMC, standalone).

Therefore, I cannot provide a complete answer to your request based on the provided text.

To illustrate what a potential answer would look like if the information were available, here's a template, but the fields will be marked as "Not provided in the text" for this specific document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
Not provided in the text. The document refers to "independent laboratory testing" but does not specify sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not provided in the text. The testing was laboratory-based, and human expert consensus on ground truth is not applicable for this type of performance testing on a breathing filter.

4. Adjudication method for the test set
Not applicable. The testing was laboratory-based performance testing of a physical device, not an assessment requiring human adjudication of results in the traditional sense (e.g., medical image interpretation).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a physical breathing circuit filter, not an AI diagnostic tool. No human reader study was conducted, and the document explicitly states "Clinical Data: Not available."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical breathing circuit filter, not an algorithm. Performance testing was done on the physical product in a laboratory setting.

7. The type of ground truth used
For the laboratory testing, the ground truth would have been established by standardized laboratory methods and measurements for filtration efficiency and humidity output, not expert consensus, pathology, or outcomes data. Specifics of these ground truth methods are "Not provided in the text."

8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML algorithm. Therefore, there is no "training set."

9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical breathing filter.

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RespAide™ is designed to be used in an emergency situation where CPR assistance is required. RespAide™ offers to the administrator of CPR the comfort that the risk of transmission of various pathogens is greatly reduced and, therefore, the hesitancy factor for providing CPR is overcome. RespAide™ should be made available to all consumers for office, automobiles, boats, swimming pools, industry, airlines, and anywhere an incident of respiratory or cardiac arrest may occur.

Non Re-Breathing Valve, 73 CBP, Class II under CFR 868.5870 Respiratory assisted device - used in cardiac or respiratory arrest to assist in cardiopulmonary resuscitation (CPR).

Emergency Filtration Products, Inc. wishes to introduce to the market the RespAide™ air filtering CPR assistance mask, a device similar to the Laerdal pocket mask. Both products are one way valve, CPR assistance masks.

RespAide™ features include the following:

• One Way Valve with Hydrophobic and Hydrophilic Filters .
• Pillow Mask
• ISO Fittings
• Nylon Stuff Sack .
• Mouthpiece .
• Latex Gloves ●
• Antiseptic Wipe ●
• Biohazard Bag for disposal after use

The provided document is a 510(k) summary for the RespAide™ Valve for CPR Assistance. It describes the device, its intended use, and its substantial equivalence to a predicate device.

Based on the document, here's an analysis of the acceptance criteria and study information:

Description of the Study:

The study conducted was a bench test at Nelson Laboratories to demonstrate substantial equivalence to existing predicate devices. This type of study primarily focuses on performance specifications rather than clinical outcomes with human subjects.

Acceptance Criteria and Reported Device Performance:

Detailed Study Information:

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

   • Sample Size: Not explicitly stated. The document refers to "independent laboratory testing," suggesting a series of tests were performed on a sample of RespAide™ devices.
   • Data Provenance: The testing was performed at Nelson Laboratories, an independent laboratory. The country of origin for the data is not explicitly stated but is likely the United States, given the context of the FDA submission. This was a retrospective analysis of the device's performance against established standards.

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

   • This question is not applicable in the context of this study. The "ground truth" here is objective physical standards and criteria for filtration and airflow, rather than expert interpretation of medical data (e.g., imaging, pathology). The laboratory tests themselves establish the performance against these objective standards.

3. Adjudication Method for the Test Set:

   • Not applicable. Since the "ground truth" is objective performance against physical standards measured by laboratory equipment, there is no need for expert adjudication in the traditional sense (e.g., 2+1 physician review).

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

   • No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical Data: Not available." This indicates that no studies involving human readers or clinical outcomes were conducted or provided for this submission. The focus was solely on the physical performance characteristics of the device.

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

   • Not applicable. This device is a physical medical device (CPR mask) and not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

6. The Type of Ground Truth Used:

   • The ground truth used was objective physical performance standards for filtration and differential air flow, consistent with industry standards. These are measurable physical properties, not clinical outcomes, pathology, or expert consensus on medical findings.

7. Sample Size for the Training Set:

   • Not applicable. This device is not an AI/ML algorithm that requires a training set. The study pertains to a physical product.

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

   • Not applicable. As the device is not an AI/ML algorithm, there is no training set or corresponding ground truth to be established in that context.

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