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Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for shortor long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The Turbo-Ject PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for Power Injectors used with the Turbo-Ject PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.

The subject Turbo-Ject® PICCs are radiopaque polyurethane peripherally inserted central venous catheters for short- or long-term use, and can be inserted through a Peel-Away® introducer, or over-thewire. The subject devices are minimally tapered 5.0 Fr single and double lumen catheters. The set components may include the PICC. obturator. Peel-Away® introducer, entry needles, wire guide, and other convenience components. The set is supplied sterile and is intended for one-time use.

The provided text (K132883) describes the testing and acceptance criteria for the "Turbo-Ject® Peripherally Inserted Central Venous Catheter Set". This is a medical device, and the testing described here relates to its mechanical performance and safety, not an AI/ML-driven diagnostic or image analysis device. As such, many of the requested categories (e.g., number of experts, adjudication method, MRMC study, training set ground truth) are not applicable to this type of device and study.

However, I can extract the relevant information regarding the acceptance criteria and the performance studies as described in the document.

Summary of Device Acceptance Criteria and Performance Study for a Medical Device (Turbo-Ject® PICC Set):

The device is a non-AI/ML medical device (a catheter set). The acceptance criteria and testing focus on physical and mechanical performance to ensure safety and effectiveness, not diagnostic accuracy or human-AI interaction.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• The document does not specify the exact sample sizes (number of units tested) for each mechanical test.
• The data provenance is not explicitly stated in terms of country of origin for the data or whether it was retrospective or prospective. These are typically laboratory-based engineering tests conducted by the manufacturer (Cook Incorporated, U.S.A.).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. This is a mechanical device, not one requiring expert human interpretation for ground truth. Ground truth for these tests is established by physical measurement and engineering standards (e.g., ISO standards, pressure gauges, leakage detection methods).

4. Adjudication Method for the Test Set:

• Not Applicable. As mentioned above, these are objective mechanical tests, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is relevant for AI/ML diagnostic devices where human readers interpret medical images. This device is a catheter set, and its performance is assessed through laboratory mechanical testing.

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

• Not Applicable. This is a physical medical device, not an algorithm. The "standalone" performance is the mechanical test results themselves.

7. The Type of Ground Truth Used:

• The ground truth for these tests is based on engineering standards, physical measurements, and objective pass/fail criteria derived from the device's intended physical performance and safety requirements (e.g., a certain tensile strength, absence of leakage, ability to withstand pressure).

8. The Sample Size for the Training Set:

• Not Applicable. This device development did not involve a "training set" in the context of machine learning. The design and manufacturing process would involve internal development and validation, but not a distinct machine learning training set.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. See point 8.

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Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The Turbo-Ject PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for Power Injectors used with the Turbo-Ject PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.

The proposed Turbo-Ject® PICCs are radiopaque polyurethane peripherally inserted central venous catheters for short- or long-term use, and can be inserted through a Peel-Away introducer, or over-the-wire. The proposed devices are minimally tapered 4.0 Fr single and double lumen catheters. A taper is a design element meant to help "wedge" the catheter into the tract by having a transition from a larger Fr size to the labeled Fr size. The proposed minimal taper design provides the same wedge feature only a △1 Fr versus Δ2 Fr from the manifold to the labeled Fr size of the catheter. The primary advantage of the 1 Fr size minimal taper is ease of insertion.

The set components may include the PICC, obturator, Peel-Away® introducer, entry needles, wire guide and other convenience components. The set is supplied sterile and is intended for one-time use.

This document describes the 510(k) summary for the Cook Turbo-Ject® Peripherally Inserted Central Venous Catheter Set (K132334). The submission primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K072625) through design modifications and performance testing, rather than a clinical study involving human readers or extensive ground truth establishment.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance testing to support substantial equivalence. The "acceptance criteria" are implied by conformance to standards and successful test outcomes.

2. Sample Size Used for the Test Set and the Data Provenance

The document primarily describes bench testing for physical and mechanical properties of the device.

• Sample Size: The document does not specify the exact number of units or samples used for each test (e.g., how many catheters were tested for tensile strength).
• Data Provenance: The data provenance is from laboratory bench testing of the manufactured device. There is no information regarding country of origin for data or whether it's retrospective or prospective, as this is laboratory testing, not clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This submission relies on engineering and laboratory performance testing, not expert-adjudicated clinical data requiring ground truth establishment by healthcare professionals for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. As this is bench testing of physical properties, there is no adjudication method in the context of clinical interpretation or diagnostic performance. Test results are objective measurements against predefined criteria.

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

Not applicable. This is a submission for a medical device (PICC catheter), not an artificial intelligence (AI) or imaging diagnostic device. Therefore, no MRMC study or AI-assisted assessment of human readers was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device; there is no algorithm or standalone performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests described would be the physical and mechanical properties of the catheter as measured in a controlled laboratory environment against established engineering and international performance standards (e.g., ISO 10555-1:1995).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth establishment for it.

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