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Flushing of IV catheters and IV tubing only. Solution is intended for maintenance of patency of intravenous injection devices. Prior to and after administration of intermittent medication, entirely flush the intravenous injection device (catheter and or tubing) with Heparin Lock Solution, USP. Use in accordance with any warnings or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy.

Excelsior Medical's Heparin Lock Flush, USP devices are provided as terminally sterilized, single-use, pre-filled, pre-packaged products. The products contain a solution of heparin sodium, USP and 0.9% sodium chloride, USP. The solution is delivered through the luer lock of a venous access device to maintain catheter patency (lock catheters) between treatments. Typically, the venous access device is flushed with normal saline before and after the administration of intermittent medication therapy, blood sampling, total parenteral nutrition, or hemodialysis.

This document does not contain information about acceptance criteria and device performance in the context of a study. The provided text is a 510(k) summary for the Heparin Lock Flush, USP, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a specific study with performance metrics against pre-defined acceptance criteria.

The 510(k) summary outlines the following:

• Device Description: The Heparin Lock Flush, USP
• Intended Use/Indications for Use: Flushing of IV catheters and IV tubing for maintaining patency.
• Technological Characteristics: A comparison table with predicate devices (K061497 and K023740) highlighting similarities in solution, concentrations, single-use nature, sterility, barrel material, plunger rod material, piston, tip cap material, tip cap colorants, and packaging.
• Purpose of Submission: To add alternate suppliers of the heparin sodium (USP) raw material.
• Non-Clinical Testing: A list of studies performed or relied upon:
  • Raw material qualification
  • Biocompatibility (ISO 10993-1)
  • Stability Studies
  • Sterilization validation (ISO 17665-1 and -2)
  • Extractables/Leachables
  • Testing of final product to Heparin Lock Flush Solution USP Monograph
• Conclusion: The change in heparin source is supported by the cited studies, and no new questions of safety and effectiveness are raised, leading to the conclusion of substantial equivalence.

The document does NOT include the following information, which would be necessary to answer the prompt:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for any test set or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for training set.
• How ground truth for the training set was established.

This is expected as 510(k) submissions for devices like a Heparin Lock Flush typically rely on demonstrating equivalence to existing devices through material characterization, manufacturing controls, and non-clinical testing rather than clinical performance studies with specific acceptance criteria as one might see for an AI/ML diagnostic device.

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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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