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For Inhalation and Humidification by way of Sterile Water in a closed system during Inhalation Therapy.

This product is Sterile Water with Saline for Inhalation Therapy. It is packaged in a closed system and it is disposable after one use. The water is sterile and endotoxin free according to the USP. The product is used for Inhalation and Humidification during Inhalation Therapy.

The provided text describes a 510(k) summary for the RESPIFLO/S device, which is a "Sterile Water with Saline for Inhalation Therapy." However, the document does not contain information relevant to the acceptance criteria or study design for an AI/algorithm-based medical device as requested in the prompt.

The document discusses:

• The product name and classification.
• A legally marketed device to which substantial equivalence is claimed (Hudson RCI AQUAPAK/S).
• A description and intended use of the RESPIFLO/S device (Sterile Water with Saline for Inhalation Therapy).
• A summary of technological characteristics, stating it's "the exact same in nature and design as a currently marketed" product.
• A summary of test data, mentioning sterile water with saline according to USP, endotoxin-free, 3-year and 5-year stability testing, and a closed/disposable system. It refers to "Confidential Testing, Methods and Results" in Section 11, which is not provided.

Therefore, I cannot provide the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as the document pertains to a physical medical product (sterile water with saline) and not an AI or algorithm-based device.

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For Inhalation and Humidification by way of Sterile Water in a closed system during Inhalation Therapy.

This product is Sterile Water for Inhalation Therapy. It is packaged in a closed system and it is disposable after one use. The water is sterile and endotoxin free according to the USP. The product is used for Inhalation and Humidification during Inhalation Therapy.

This 510(k) summary describes a device that is Sterile Water for Inhalation Therapy. The "tests" mentioned are for product specifications (sterility, endotoxin levels, stability), not for AI/ML performance. Therefore, the questions related to AI/ML device performance, expert review, training/test sets, and ground truth are not applicable to this submission.

Here's a breakdown of the relevant information provided:

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

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

   • Not applicable as this is not an AI/ML device. The "test set" refers to product samples tested for quality control. Specific sample sizes for stability or sterility testing are not provided in this summary but would be part of the detailed "Confidential Testing, Methods and Results" in Section 11. Data provenance for such product testing is typically internal to the manufacturer.

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)

   • Not applicable. This is not an AI/ML device. "Ground truth" for this product is defined by established pharmacopeial standards (USP for sterility and endotoxins).

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

   • Not applicable. This is not an AI/ML device. Adjudication methods are not relevant for product specification testing.

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

   • Not applicable. This is not an AI/ML device.

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

   • Not applicable. This is not an AI/ML device.

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

   • For the product specifications (sterility, endotoxin, etc.), the "ground truth" is defined by established regulatory and pharmacopeial standards (USP - United States Pharmacopeia).

8. The sample size for the training set

   • Not applicable. This is not an AI/ML device.

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

   • Not applicable. This is not an AI/ML device.

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