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This is a 'T' containing a single check valve in each of two side ports causing inhaled gas to be delivered through proximal port and exhaled gas to be released through distal port. The reusable BE 117 Non-Rebreathing 'T' is designed for use with a spontaneously breathing patient where "back flow" must be avoided The 'T's are designed to prevent the flow of gas back toward the source and ensure unilateral breathing. The BE 117 'T' is intended to be used with a spirometer.

This is a 'T' containing a single check valve in each of two side ports causing inhaled gas to be delivered through proximal port and exhaled gas to be released through distal port.

This 510(k) summary does not contain sufficient information to answer the request. The document is primarily concerned with the FDA's clearance of the BE 117 Non-Rebreathing 'T' device based on substantial equivalence to a predicate device, rather than providing details of a study that proves the device meets specific acceptance criteria based on performance metrics.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study, or how human readers improve with AI assistance.
• Information on standalone (algorithm-only) performance.
• Type of ground truth used.
• Sample size for a training set.
• How ground truth for a training set was established.

The document states the device's function: "This is a 'T' containing a single check valve in each of two side ports causing inhaled gas to be delivered through proximal port and exhaled gas to be released through distal port. The reusable BE 117 Non-Rebreathing 'T' is designed for use with a spontaneously breathing patient where "back flow" must be avoided. The 'T's are designed to prevent the flow of gas back toward the source and ensure unilateral breathing. The BE 117 'T' is intended to be used with a spirometer." This describes the intended function and design principles, but not performance metrics or studies proving acceptance criteria.

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