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This 510(k) is to convert existing Invacare IHO 100 Complete Home Oxygen Systems to proprietary type cylinder fittings.

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I am sorry, but the provided text does not contain the detailed information about acceptance criteria and the study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called "Venture Homefill Retrofit Kit," dated December 18, 1998.

It states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. This letter allows the applicant to market the device, subject to general controls provisions of the Act.

The document does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample size, data provenance, or the nature of a test set.
• Information on experts used for ground truth or adjudication methods.
• Details of a multi-reader multi-case (MRMC) study or the effect size of AI assistance.
• Results of a standalone algorithm performance.
• The type of ground truth used or the sample size and establishment of ground truth for a training set.

Therefore, I cannot provide the requested information based on the given input text.

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