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The Arch-Flo CT Midline is indicated for Short-Term peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. This catheter may be inserted via basilic, cephalic, or median cubital vein.

The Arch-Flo'™ CT Midline is available in a 4F Single Lumen configuration. The catheter lumen terminates through an extension to a female luer-lock connector. The extension has an in-line clamp to control fluid flow and is marked POWER INJECTABLE MIDLINE along with the lumen gauge size. The transition between lumen and extension is housed within a molded hub. The hub is marked MIDLINE to identify that the catheter is not centrally placed. The tip of the lumen is notched to increase the exposed area of the lumen. The outside diameter of the lumen increases gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen is marked with depth marks every centimeter.

The provided text describes a 510(k) premarket notification for a medical device called "Arch-Flo CT Midline." This document primarily focuses on establishing substantial equivalence to a predicate device through comparison and performance testing. It does not contain information about acceptance criteria and studies related to the performance of an AI/algorithm-based device.

The device in question is an "Intravascular Catheter," which is a traditional medical device, not an AI or software-based application. Therefore, the specific questions regarding AI device performance (like the number of experts for ground truth, MRMC studies, standalone performance with AI, training set details, etc.) are not applicable to the content provided.

However, I can extract the general "acceptance criteria" (or performance data) for the physical device based on the bench/performance data and comparison to the predicate device.

Here's the information that can be extracted, interpreted based on the context of a traditional medical device submission:

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

The document describes performance data for the Arch-Flo CT Midline and compares it to the predicate device, CT Midline (K141151). The "acceptance criteria" are implied by the standards the device was tested against and by demonstrating similar or superior performance to the predicate device.

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

• Test Set Sample Size: Not explicitly stated in terms of a specific number of devices for each test. The document mentions "performance testing" was performed according to various ISO and ASTM standards. These standards typically define the sample sizes required for validation studies.
• Data Provenance: The testing was "bench / performance data / non-clinical testing" conducted by the manufacturer, Medcomp®. There is no mention of country of origin for data (as it's bench testing, not patient data) or whether it was retrospective or prospective (which applies to patient studies).

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

This question is not applicable. The device is a physical intravascular catheter. Its performance is evaluated through objective physical and chemical tests against established international standards (e.g., ISO, ASTM) and comparison to a predicate device, not by expert interpretation of data points in the way an AI model would be validated.

4. Adjudication method for the test set:

Not applicable, as the evaluation is based on objective measurements and comparison to standards, not human interpretation requiring adjudication.

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 traditional medical device, not an AI device.

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

Not applicable. This is a traditional medical device.

7. The type of ground truth used:

The "ground truth" used for this device is based on:

• International Standards: e.g., ISO 10555-1, ISO 11607-1, ISO 10555-3, ANSI/AAMI/ISO 11135-1, AAMI TIR 28, ANSI/AAMI ST72, ISO 10993 series, ASTM F 756-08, ASTM F 619-03.
• Predicate Device Performance: The performance of the legally marketed predicate device (CT Midline K141151) serves as a benchmark for substantial equivalence.
• Objective Measurements: Physical and chemical measurements (e.g., flow rates, volumes, material properties, sterility levels) are the "ground truth" for compliance.

8. The sample size for the training set:

Not applicable. This is a traditional medical device, not an AI device that requires a training set.

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

Not applicable.

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