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Excelsior Medical Heparin Lock Flush Syringes (1Unit/ml and 2 Units/ml) are indicated for use in maintaining patnecy of vascular access devices designed for intermittent or infusion therapy. Prior to and after administration of intermittent medication, entirely flush the vascular access device with Heparin Lock Flush 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 Heparin Lock Flush Syringes are polypropylene latex-free syringes which contains a labeled volume of a sterile, non-pyrogenic solution of Heparin Lock Flush Solution, USP derived from porcine intestinal mucosa in 0.9 sodium chloride USP with a pH range of 5.0 - 7.5.

This is a 510(k) summary for a medical device: Excelsior Medical Heparin Lock Flush Syringes. The document focuses on establishing substantial equivalence to predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria in the typical clinical study format.

Therefore, many of the requested sections about clinical study details (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training data) cannot be fully answered from the provided text.

Here is an analysis based on the information available:

Acceptance Criteria and Reported Device Performance

The document states that the device was tested according to "specifications documented in Design Verification Testing Reports and independent laboratory testing." It concludes that the device "functioned as intended and met all pass criteria as expected." However, the specific acceptance criteria and the detailed performance results are not provided in this 510(k) summary. The summary focuses on comparing the new device's characteristics to its predicate devices to establish substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance:

Study Information:

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

   • Sample Size: Not specified. The document refers to "Design Verification Testing Reports and independent laboratory testing" but does not provide details on sample sizes for these tests.
   • Data Provenance: Not specified, but likely from laboratory testing (e.g., sterility, chemical analysis, functional tests) rather than human clinical data.

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

   • This information is not applicable or not provided. This type of detail is typically associated with clinical studies involving interpretation (e.g., imaging devices), not physical device performance testing for a syringe and its contents. The ground truth would be established by validated analytical methods, not expert consensus.

3. Adjudication method for the test set:

   • This information is not applicable or not provided. Adjudication methods like "2+1" or "3+1" are used in clinical studies where human interpretation of results is involved (e.g., radiologists reading scans). This document describes performance testing for a physical device, where results are typically objective measurements.

4. 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:

   • No, an MRMC study was not done. This type of study is relevant for diagnostic devices, especially those using AI, that assist human readers in interpreting clinical data. This device is a pre-filled syringe, not a diagnostic tool assisted by AI.

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

   • Not applicable. This section is for AI/algorithm-based devices. The Excelsior Medical Heparin Lock Flush Syringe is a physical medical device.

6. The type of ground truth used:

   • Laboratory Testing Parameters/Specifications: The ground truth for this device's performance would be established by predefined quality and functional specifications (e.g., sterility, pH range of the solution, heparin concentration, syringe integrity, flush volume). These are determined through established scientific and manufacturing standards for medical devices and pharmaceuticals.

7. The sample size for the training set:

   • Not applicable. This pertains to AI/machine learning models. For a physical device, there isn't a "training set" in the AI sense.

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

   • Not applicable. See point 7.

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