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The Peripherally Inserted Central Vein Access catheters are designed for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For central venous pressure monitoring (CVP), it is recommended that catheter lumen of 20 gauge or larger be used.

The Midline catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sampling. (See Contraindications). For blood therapy it is recommended that a 4French or larger catheter be used.

The Vascu-PICC® and Midline Catheters are designed for peripheral vein catheterization. The lumen is an open-ended design comprised of a soft radiopaque polyurethane material with barium sulfate for radiopacity. The lumen is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration.

The catheters are available in a range of French sizes in single, double and triple lumen. The outside diameter of the lumen has a reverse taper increasing gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen has depth marks every centimeter and numerical marks every 5th centimeter and are available in 20cm for Midline placement and a trimmable 60cm for PICC's.

The Vascu-PICC® and Midline Catheters product line is packaged sterile with the necessary accessories to facilitate catheter insertion.

This document describes the design and performance of the Vascu-PICC® and Midline Catheters by MEDCOMP. The information provided is for a 510(k) premarket notification to the FDA.

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

Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to predicate devices rather than defining novel acceptance criteria for absolute performance. The acceptance criteria for the Vascu-PICC® and Midline Catheters are implicitly tied to meeting the performance of existing, legally marketed predicate devices and conformity with relevant ISO standards through in-vitro testing.

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of in-vitro (bench/performance) tests and biocompatibility testing.

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

   • Sample Size: The document does not specify exact sample sizes for each in-vitro test (e.g., how many catheters were tested for air leakage, tensile strength, etc.). It only states that "The following in-vitro testing was performed on the Vascu-PICC® and Midline Catheters."
   • Data Provenance: The tests are in-vitro (bench tests) conducted by the manufacturer, MEDCOMP, as part of their design verification process. The country of origin for the data is implicitly the USA, where MEDCOMP is located. It is retrospective in the sense that the testing was completed before the 510(k) submission.

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

   • This question is not applicable to the type of safety and performance testing described. The "ground truth" for these tests are technical specifications and ISO standards, which are objective measurements rather than subjective expert interpretations. For example, air leakage isn't adjudicated by an expert; it's measured according to a standard protocol.

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

   • This is not applicable. The tests are objective measurements against predefined ISO standards and internal specifications, not subjective assessments requiring expert adjudication.

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:

   • This is not applicable. This document is for a medical device (catheter), not an AI-powered diagnostic or interpretive system. Therefore, MRMC studies involving human readers or AI assistance are irrelevant.

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

   • This is not applicable. As stated above, this is a physical medical device, not a standalone algorithm.

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

   • The ground truth for the in-vitro performance tests are established ISO standards and test protocols. For biocompatibility, it's the criteria set forth in ISO 10993. For substantial equivalence, the "ground truth" is the performance, design, and intended use characteristics of the cited predicate devices.

7. The sample size for the training set:

   • This is not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

   • This is not applicable for the same reason as above.

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