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· PICC Convenience Kit with Xcela® Hybrid with PASV® Valve Technology: for short or long-term peripheral access to the central venous system for intravenous therapy. including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid PICC with PASV Valve Technology is 6 mL/sec.
· PICC Convenience Kit with NMI PICC II; or with NMI PICC; or with BSC PICC: for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

• · PICC Convenience Kit with Vaxcel® PICC with PASV® Valve Technology: for use in establishing peripheral access to the central venous system for administration of fluids including, but nor limited to hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. The product is intended for central venous access in adults, children, and infants who require intravenous (IV) therapy.

The PICC Convenience Kit includes packaging configurations that will accommodate a specified NMI PICC and other legally marketed procedural aides typically used during clinical placement.

This is a 510(k) summary for a medical device called the "PICC Convenience Kit." It is not a study that proves the device meets specific acceptance criteria in the way a clinical study for an AI algorithm would. Instead, it demonstrates substantial equivalence to predicate devices based on regulatory compliance and standard testing.

Here's an analysis of the provided text in the context of your request:

Acceptance Criteria and Reported Device Performance

The "PICC Convenience Kit" is a collection of existing, legally marketed components (PICC catheters and procedural aides) bundled for convenience. The "performance" described here relates to its packaging and sterilization, not to a new功能 of the PICC catheter itself that would require clinical performance metrics like sensitivity or specificity.

Study Information (as applicable to a 510(k) for a Convenience Kit)

This document describes a regulatory submission (510(k)), not a clinical trial or a study of an AI algorithm. Therefore, many of your requested points are not applicable.

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

   • Not Applicable in the context of an AI algorithm's test set. The "testing" here refers to packaging and sterilization validation. The document does not specify sample sizes for these tests, which would typically be determined by relevant ISO standards and internal validation protocols for manufacturing and quality control.
   • Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective for these specific validation tests. However, the standards cited are international.

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

   • Not Applicable. There is no "ground truth" in the sense of expert annotation for image analysis or clinical diagnosis. The "ground truth" for packaging and sterilization is defined by the technical specifications of the standards (e.g., a package must maintain sterility, ethylene oxide residuals must be below a certain threshold).

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

   • Not Applicable. This concept relates to expert consensus in interpreting ambiguous data (e.g., medical images). The testing described here involves physical and chemical property measurements against pre-defined thresholds.

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, not done. This device is a physical medical kit, not an AI algorithm. Therefore, an MRMC study is irrelevant.

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

   • No, not done. This is not an algorithm.

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

   • Technical Specifications/Standard Compliance: The "ground truth" for the packaging and sterilization tests is regulatory compliance and adherence to established international and national standards (e.g., ISO, AAMI, FDA guidance documents). For example, if a package must maintain sterility for five years, the "ground truth" is that it either does or does not, as determined by accelerated aging and bacterial ingress tests.

7. The sample size for the training set:

   • Not Applicable. This is not an AI algorithm, so there is no training set. The "training" in the context of medical devices relates to manufacturing processes and personnel, not machine learning.

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

   • Not Applicable. Since there is no training set, there is no ground truth establishment for one.

In summary, this 510(k) submission for a "PICC Convenience Kit" focuses on demonstrating substantial equivalence to already cleared predicate devices by showing that the new packaging configuration meets mandated safety and performance standards for sterilization and packaging integrity. It is not a clinical study of a novel device or an AI application with corresponding performance metrics like accuracy, sensitivity, or specificity.

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