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The Chad Therapeutics Bonsai (modified Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511) is intended for use in the same manner as the unmodified device, i.e., for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen in their home and for ambulatory use.

The Chad Therapeutics Bonsai a pneumatic-controlled device, which is a combination of r the Onad Therapoulator and an oxygen conserver, designed for use with ambulatory a low probute regulativers boluses of oxygen that is equivalent to 1 to 7 liters per minute, depending on the flow rate setting.

The provided text describes a 510(k) submission for the Chad Therapeutics Bonsai Model 800, which is a modified oxygen conserver. However, the document does not contain an acceptance criteria table or a study report detailing specific performance metrics against acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device through general statements about design verification and validation activities.

Therefore, many of the requested sections below cannot be populated from the provided text.

Here's an attempt to answer the questions based on the available information:

1. A table of acceptance criteria and the reported device performance

The document states that "The Bonsai passed all of the test criteria established in the Bonsai design verification and validation tests." However, it does not provide a table with specific acceptance criteria or the reported performance data for each criterion. It only mentions one specific safety test the regulator passed.

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

This information is not provided in the document. The document only generally states "All risk assessment, design verification and validation activities were conducted in accordance with approved product requirements to demonstrate that the Chad Therapeutics Bonsai would perform as intended."

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)

This information is not applicable as this device is an oxygen conserver and the document describes engineering verification and validation, not studies requiring expert visual assessment or ground truth establishment in a medical imaging or diagnostic context.

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

This information is not applicable for the type of device and testing described.

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

This information is not applicable as this device is an oxygen conserver and does not involve human readers interpreting images or data with or without AI assistance.

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

This information is not applicable as this is a mechanical medical device, not an algorithm or AI system.

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

For this type of device (oxygen conserver), "ground truth" would generally refer to established engineering standards, specifications, and physical measurements. The document implies that the "ground truth" for the tests involved verifying the device's performance against predefined "product requirements" and industry standards like ASTM G 175-03.

8. The sample size for the training set

This information is not applicable as this is a mechanical medical device, not an algorithm or AI system that requires a "training set."

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

This information is not applicable for the same reason as above.

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