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Indicated as an accessory to provide positive end expiratory pressure breathing capabilities to manual resuscitators, therapeutic CPAP systems and ventilator circuits. Available in 19mm, 22mm and 30 mm fittings. Pressure range from 0 to 20 cm H2O

The EMS PEEP valve is a adjustable valve which is placed in circuit and provides for positive end expiratory pressure for the patient. It is a spring actuated valve which adjusts from 0 to 20 cm H2O.

The provided document does not contain details about acceptance criteria, device performance, or related studies that would typically be found in a medical device submission beyond a comparison to predicate devices, which suggests substantial equivalence, rather than new performance criteria being established or met.

The document is a 510(k) premarket notification for the EMS Adjustable PEEP Valve. Such notifications primarily aim to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing new performance criteria through detailed studies as might be found in a De Novo submission or a PMA application.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria or detailed performance data from a study. Instead, it relies on a comparison to predicate devices to demonstrate substantial equivalence. The "Performance Standards / Specifications" section explicitly states "None required under Section 514," indicating that specific performance standards were not mandated for this device at the time of submission.

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.

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

No information regarding a test set sample size or data provenance is provided. The submission focuses on comparison to predicate devices, not on a new testing study with a specific test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The document does not describe a study involving expert review to establish ground truth.

4. Adjudication Method

Not applicable. No study involving adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. This type of study would typically assess the improvement in human reader performance with AI assistance, which is not relevant to a PEEP valve.

6. Standalone Performance Study (Algorithm Only)

Not applicable. The device is a mechanical PEEP valve, not an algorithm-based device. Therefore, no standalone algorithm performance study was done.

7. Type of Ground Truth Used

Not applicable. The submission does not describe a study that required establishing 'ground truth' in the context of expert consensus, pathology, or outcomes data. The basis for approval is substantial equivalence to physically existing predicate devices, not a diagnostic or prognostic performance claim needing extensive clinical validation.

8. Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as the device is a mechanical device, not one requiring machine learning or substantial data training.

9. How Ground Truth for the Training Set Was Established

Not applicable for the same reasons as above.

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