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The Baxter Healthcare Corporation's Nebulizer Cap is for use with Sterile Water for Inhalation, USP, in 500 ml, 1000 ml, and 1500 ml plastic bottles, for inhalation therapy only.

All blueprints dimension and specifications are exactly the same in this device as found in the predicate device. The only change is the aluminum alloy and the coating. The rest of the device remains the same as currently marketed.

Here's a breakdown of the information requested, based on the provided 510(k) summary:

This document is a 510(k) summary for a Baxter Nebulizer Cap. It describes a device that is substantially equivalent to a previously cleared predicate device (Baxter Healthcare Corporation K780406). The key takeaway is that no new performance studies or clinical trials were conducted for this 510(k) submission because the device is essentially identical to the predicate, with only minor material changes (aluminum alloy and coating).

Therefore, many of the requested details about acceptance criteria and studies are not applicable in this specific context.

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

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

• Not Applicable. No new test set data was generated for this 510(k) submission.

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. No new test set requiring expert ground truth was created.

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

• Not Applicable. No new test set requiring adjudication was created.

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 a medical device (nebulizer cap), not an AI diagnostic or assistance tool. Therefore, MRMC studies are not relevant.

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

• Not Applicable. This is a medical device (nebulizer cap), not an algorithm.

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

• Not Applicable. No new ground truth was established as no new performance studies were conducted. The "ground truth" for showing safety and effectiveness relies on the previously cleared predicate device.

8. The sample size for the training set

• Not Applicable. No machine learning or AI training set was involved.

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

• Not Applicable. No machine learning or AI training set was involved.

Summary Explanation for this Specific Submission:

This 510(k) submission for the Baxter Nebulizer Cap falls under the "Special 510(k)" or "Abridged 510(k)" pathway, or a similar approach emphasizing substantial equivalence. The core argument for clearance is that the device is exactly the same in dimensions and specifications as the predicate device (K780406), with the only changes being the aluminum alloy and its coating.

Because the device is substantially equivalent to a previously cleared device, the FDA does not require new clinical performance studies or extensive testing that would establish new acceptance criteria and report performance statistics. The burden of proof shifts to demonstrating that the material change does not alter the fundamental safety or effectiveness of the device, which is typically done through material compatibility testing, biocompatibility assessments (if applicable), and showing that the new materials meet relevant standards. The provided summary does not contain details of such material testing; it only states that these are the changes.

Therefore, for this specific 510(k) summary, most of the questions related to clinical study design, performance metrics, ground truth, and AI-related assessments are not applicable. The "study" that proves the device meets acceptance criteria is primarily the comparison to the predicate device and the assertion of substantial equivalence regarding design and intended use, with an implicit understanding that the material changes do not negatively impact the known performance of the predicate.

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