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Excelsior Sterile Field Saline Flush Syringes and Heparin Lock Flush Syringes are intended for flushing IV catheters and IV tubing.

The modification which is the subject of this Special 510(k) is substitution of the current dust cover packaging with Sterile Field packaging. All other aspects of the product design remain unchanged.

The provided text describes a 510(k) submission for Excelsior Sterile Field Saline Flush and Heparin Lock Flush Syringes. However, it does not provide acceptance criteria and detailed study information as requested. The submission is for a modification involving a change in packaging (from dust cover to Sterile Field packaging), with all other aspects of the product design remaining unchanged.

The document highlights that the "technological characteristics... do not differ" from the predicate device and that "The results of testing conducted to verify the design modifications demonstrate acceptable performance of the device." This implies that the acceptance criteria would be based on demonstrating that the new packaging maintains sterility and does not compromise the device's existing performance, but specific quantified criteria and a detailed study report are not present in this document.

Therefore, I cannot populate the requested table and answer many of the questions directly from the provided text.

Here is what I can glean and what is missing:

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

Missing: Specific, quantifiable acceptance criteria (e.g., sterility assurance level, packaging integrity test results, shelf-life data with new packaging).

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified.
• Data Provenance: Not specified, but likely from Excelsior Medical Corporation's internal testing. The tests are "Non-Clinical Tests," so they would not involve human participants or specific geographic data provenance in the way clinical studies do.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This is a packaging/device modification submission, not a diagnostic or AI-driven device. Therefore, the concept of "experts to establish ground truth" (in the medical diagnostic sense) is not applicable to the non-clinical tests mentioned. The "ground truth" here would be established by validated test methods and passing criteria for physical and performance characteristics.

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

• Not applicable as this is not a diagnostic study requiring expert adjudication of cases.

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-assisted device or a diagnostic device involving human readers.

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

• Not applicable. This is not an algorithmic device.

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

• For the non-clinical tests, the "ground truth" would be objective measurements against pre-defined specifications (e.g., sterility test results, material strength tests, leak tests, etc.). The document only states "acceptable performance."

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable.

In summary: The provided 510(k) summary is for a minor device modification (packaging change) and focuses on demonstrating substantial equivalence. It does not contain the detailed study results, acceptance criteria, or specific methodologies that would be presented for a novel device or a device with clinical efficacy claims, especially those involving AI or human interpretation. The "tests conducted to verify the design modifications" are described as "non-clinical tests," implying laboratory or engineering evaluations.

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