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The Hsiner PEEP Valve is used in conjunction with manual resuscitators and other ventilatory support equipment to provide positive end expiratory pressure.

The PEEP valve is an adjustable, spring actuated valve which when placed into a circuit provides positive end expiratory pressure for the patient. The PEEP vale is provided in two pressure ranges and several connector sizes complying wit ISO 5356-1 "Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets".

The provided text is a 510(k) summary for the Hsiner Company Resuscitator/PEEP Valve. It details the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain a detailed study report with acceptance criteria, reported device performance, sample sizes, ground truth establishment, or human-in-the-loop studies.

Instead, the submission states that the Resuscitator complies with ASTM and ISO standards, and the PEEP valve complies with ISO standards for conical connectors, implying that the acceptance criteria are adherence to these established standards. The basis for clearance is substantial equivalence to existing legally marketed devices, not a de novo study proving new performance metrics.

Therefore, many of the requested details about a specific study and its acceptance criteria cannot be extracted from this document, as such a study (in the sense of defining new performance metrics and testing against them) was not the basis for this 510(k) submission.

Here's an attempt to answer the questions based solely on the provided text, highlighting what is not available:

Acceptance Criteria and Device Performance

Study Information (Based on Substantial Equivalence, not a de novo performance study)

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

   • Test set sample size: Not applicable or not specified. The submission relies on adherence to established international standards and substantial equivalence, not a new test set generation with a specific 'sample size' of patients or cases.
   • Data provenance: Not applicable. The "study" here is demonstrating compliance with existing standards and comparing to predicate devices.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. Ground truth in the context of clinical expert consensus is not part of this 510(k) submission. The "ground truth" for the device's performance is defined by the ASTM and ISO standards themselves and the performance of the predicate devices.

3. Adjudication method for the test set:

   • Not applicable. There was no explicit "test set" in the context of expert review for clinical performance.

4. 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. This device is a manual medical instrument (resuscitator, PEEP valve), not an AI/software device.

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

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

6. The type of ground truth used:

   • For the Resuscitator: Adherence to ASTM 940-93 and ISO 8382:1988 performance specifications.
   • For the PEEP Valve: Adherence to ISO 5356-1 connector standards and the established performance of predicate devices.

7. The sample size for the training set:

   • Not applicable. This device does not use an AI or machine learning model that requires a training set.

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

   • Not applicable. No training set was used.

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