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The Vapotherm 2000h (5000) can mix air with oxygen from an external source and adds heat and moisture to the gas. The Vapotherm 2000h (5000) is for use in home, hospital or sub-acute institutional settings.

The Vapotherm 2000i, predicate, and the Vapotherm 2000h (5000) are identical and share the concept of humidification by transpiration of water vapor across a membrane. Both produce a high flow of highly humidified air (relative humidity >95%), virtually free of droplets, at body temperature or above. The water content at 41°C is 40-50 mg/liter, about fourfold higher than can be achieved by humidification at room temperature. The unique combination of high flow and high vapor-phase humidity allow an unusually wide range of clinical applications. Applications previously considered impractical because of limited patient tolerance for high nasal flow can now be routine because of the comfort provided by warmth and high humidity.

The Vapotherm 2000h (5000) is an unmodified Vapotherm 2000i but with an internal air compressor and external oxygen source, wall or cylinder oxygen. There is a single inlet fitting. like the 2000i for connection to an external oxygen source, if desired.

The provided text describes a 510(k) premarket notification for the Vapotherm 2000h (5000), a humidifier for respiratory gas. This submission focuses on demonstrating substantial equivalence to a predicate device (Vapotherm 2000i) rather than presenting a study with specific acceptance criteria and performance data in the context of AI/machine learning.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission and the information provided. This is a medical device, not an AI/ML-based diagnostic system, and thus does not involve "ground truth" derived from expert consensus on images or pathology in the way an AI study would.

Here’s the information that can be extracted and a clear explanation for the N/A categories.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k), the "acceptance criteria" is demonstrating substantial equivalence to the predicate device (Vapotherm 2000i). The "reported device performance" is essentially a comparison of attributes to show similarity.

Conclusion of Substantial Equivalence: The document states that the Vapotherm 2000h (5000) is "substantially equivalent" to the predicate device because:

• They have substantially equivalent intended uses.
• They have the same environments for use.
• They are similar in design.
• They employ the same technology.
• "There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• N/A: This document pertains to a 510(k) submission for a non-AI medical device (a humidifier). The submission relies on a comparison of device specifications and an assessment of technical and functional equivalence to a predicate device, as opposed to performance studies on a "test set" in the context of diagnostic accuracy or AI/ML. No clinical or performance data from a "test set" is presented in this summary in the way it would be for an AI device.

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)

• N/A: Not applicable for a non-AI device demonstrating substantial equivalence. There is no concept of "ground truth" established by experts for this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• N/A: Not applicable for this type of device and submission.

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

• N/A: Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was performed or is relevant.

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

• N/A: Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• N/A: Not applicable. The "ground truth" concept as defined for AI/diagnostic studies is not relevant here. The device's performance is gauged by meeting physical and functional specifications compared to a predicate.

8. The sample size for the training set

• N/A: Not applicable. This document does not describe an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

• N/A: Not applicable. This document does not describe an AI/ML device that requires a training set.

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