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“The Urethane PICC Lines will be indicated for intravenous administration of nutrient fluids, chemotherapeutic agents and other drugs for therapy.”

“Used for venous pressure monitoring, blood sampling and administration of drugs and fluids.”

The Urethane PICC Line is comprised of five components which can be further described as follows:

• Catheter: The catheter is constructed of polyurethane and is available in 4 Fr and 5 Fr single lumen configurations. The catheter is 60 cm in length.
• Winged Manifold: The winged manifold is constructed of polyurethane.
• Extension Tubing: The extension tube is constructed of polyurethane.
• Clamp: A plastic clamp is provided around the external surface of the extension tube.
• Luer Lock Hub: The luer lock hub is constructed of polyurethane and is stamped on either side with the following information: 1) COOK 4 FR/.9 CC LUM VOL, or 2) COOK 5 FR/1.3 CC LUM VOL.

The Urethane PICC Line will also be available in a set or tray that incorporates legally marketed accessories. These accessories are identical to those currently sold in COOK's Silicone PICC Line sets and trays.

The provided document is a 510(k) premarket notification for a medical device, specifically a Urethane PICC Line. It describes the device, its intended use, and its substantial equivalence to predicate devices. It also lists the types of tests performed to assure its design and performance. However, this document does not contain explicit acceptance criteria with numerical targets or detailed study results that "prove" the device meets them in the way modern AI/ML medical devices are assessed.

This document is from 1999 and reflects the regulatory landscape of that time for a relatively simple medical device. The "studies" mentioned are primarily engineering and performance tests, not clinical efficacy trials with human subjects or complex statistical analyses often associated with AI/ML device evaluations.

Here's a breakdown of the requested information based on the provided text, with notes on what is not present in this type of submission for this device:

Acceptance Criteria and Reported Device Performance

Study Details (Based on the document's content)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size: Not specified in the provided text. The tests are industrial/engineering in nature (tensile, flow, burst, etc.), and the sample sizes would typically be determined by internal quality control protocols, but these numbers are not disclosed in this 510(k) summary.
   • Data Provenance: Not specified. These are laboratory-based engineering tests, likely conducted by COOK INCORPORATED internally or by an accredited testing lab. Country of origin not mentioned but generally implied to be within the US, as COOK INCORPORATED is based in Bloomington, IN.
   • Retrospective or Prospective: These would be considered prospective tests performed on newly manufactured devices or device components as part of the design validation process.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not Applicable. For a medical device like a PICC line, "ground truth" typically refers to objective physical measurements or established engineering standards. There are no clinical images or diagnostic interpretations requiring expert consensus in these types of performance tests. The "experts" would be engineers and quality control personnel following standardized test methods.

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

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation (e.g., image reading) where disagreement among observers needs a resolution process. The tests listed are objective physical measurements or functional tests of the device.

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. This is a traditional medical device (a PICC line), not an AI/ML device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

   • No. This is a hardware medical device, not an algorithm.

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

   • Engineering Specifications/Standards and Physical Measurements. The "ground truth" for each test would be the predetermined engineering specifications (e.g., minimum tensile strength, maximum leak rate, acceptable flow rate) derived from industry standards (e.g., ISO, ASTM, or internal validated standards) or predicate device performance. Device samples are then tested against these objective criteria.

7. The sample size for the training set:

   • Not Applicable. This is a hardware medical device, not an AI/ML device. There is no "training set" in the context of machine learning.

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

   • Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

In summary: The provided document is a 510(k) notification for a conventional medical device. It successfully demonstrates "substantial equivalence" based on materials, intended use, and a series of engineering performance tests against predicate devices. However, it does not involve AI/ML technology or clinical studies with human image interpretation, so many of the requested elements regarding acceptance criteria and study design for AI/ML devices are not present or applicable.

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