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The catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary. Placement is routinely achieved from peripheral venous site, but the catheter may be placed via subclavian cutdown as well. The catheter may be used to administer fluids for hydration and parenteral nutrition, as well as other commonly used intravenous medications.

The Argyle™ Peripherally Inserted Central Catheter is a sterile, single use indwelling catheter inserted into a venous access site for the infusion of fluids, medications and/or nutritional products.

The provided document K132567 is a 510(k) premarket notification for Peripherally Inserted Central Catheters (PICCs). It describes modifications to existing devices and seeks to demonstrate substantial equivalence to previously cleared predicate devices.

Acceptance Criteria and Device Performance:

The document primarily focuses on non-clinical performance data to support substantial equivalence, rather than setting specific clinical performance acceptance criteria for a new device. The acceptance criteria for the modified devices are that they "continue to meet the requirements of the product specifications" and "support the determination of substantial equivalence" to the predicate devices.

The study that proves the device meets these criteria is a series of laboratory tests.

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

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

The document does not specify the sample size used for the non-clinical laboratory tests. The data provenance is laboratory testing conducted by Covidien. The source of the data is non-clinical (laboratory).

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

This information is not applicable. For non-clinical laboratory testing, the "ground truth" is established by adherence to documented test methodologies and physical measurements/observations, rather than expert interpretation of medical images or patient data.

4. Adjudication method for the test set:

This information is not applicable for non-clinical laboratory testing. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving expert review 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:

No MRMC comparative effectiveness study was done. This document is for a physical medical device (PICC), not an AI-assisted diagnostic or imaging device.

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

This is not applicable as the device is a physical medical device and not an algorithm or AI.

7. The type of ground truth used:

For the non-clinical laboratory testing, the "ground truth" is based on engineering specifications, material properties, and established testing standards. For example, tensile strength measured against a specified limit, or biocompatibility assessed against established material standards.

8. The sample size for the training set:

This information is not applicable. There is no "training set" as this is not a machine learning or AI device.

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

This information is not applicable. There is no "training set" for a physical medical device.

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