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The TERUMO® SURFLO® FLEX I.V. Catheters and the TERUMO® SURFLASH™ I.V. Catheters are devices consisting of a slender, flexible, radio-opaque, plastic catheter with a hub that is inserted into the patient's vascular system for short term use to withdraw samples, administer fluid intravenously or through which to place monitoring equipment such as blood pressure monitors. The stainless steel cannula, placed in the catheter to maintain rigidity, is withdrawn after the catheter is placed in the vascular system.

The TERUMO SURFLO FLEX I.V. CATHETER AND THE TERUMO SURFLASH I.V. CATHETER are sterile, single use devices consisting of a slender tube (catheter) made of polyurethane. The devices are inserted into the patient's vascular system for short-term use to withdraw samples, administer fluids intravenously, or through which to place monitoring equipment such as blood pressure monitors.

Each device consists of a catheter assembly-catheter, caulking pin, catheter hub; a needle assembly-cannula, needle hub; and a filter cap with an air filter

The catheters are made of polyurethane, which allows appropriate stiffness for proper insertions into the vein, and flexibility during retention in the vein. Each catheter contains barium sulfate radio-opaque stripes along the length of the catheter to allow radio detectability. A stainless steel caulking pin fastens the catheter to the catheter hub.

Each catheter hub is color coded according to the outside diameter as specified in ISO 10555-5, "Sterile, single-use intravascular catheters - Part 5: Over-needle peripheral catheters".

The needle assembly has the same specifications as the Terumo® Surflo® I.V. Catheter, which is the subject of K891087. The transparent needle hubs permit flashback detection when the cannula enters the vessel.

The filter cap with an air filter is provided as a vent fitting.

The Terumo Surflo Flex I.V. Catheter is available in 14 sizes with different combinations of 6 catheter diameters and 5 catheter lengths (see following specifications table). The Terumo Surflash I.V. Catheter is available in 24G by 19mm currently. Additional sizes will be implemented at a later date.

The cannula of the Surflash I.V. Catheter are grooved from the heel of the cannula tip bevel to the end of the catheter tip, which allows flashback detection at the catheter tip after the catheter tip enters the vessel.

The only difference between the TERUMO SURFLO FLEX and the TERUMO SURFLASH I.V. catheters is the grooved cannula feature of the SURFLASH. All other specifications are the same.

The provided text is a 510(k) summary for a medical device (intravascular catheters) seeking substantial equivalence to already cleared devices. This type of submission does not typically involve the kind of elaborate clinical studies or AI performance metrics that the requested questions imply.

Therefore, many of the requested sections about acceptance criteria, detailed study designs, expert involvement, and AI performance cannot be answered from the provided document. The purpose of this 510(k) is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, primarily through performance testing and material comparisons, rather than a comparative clinical trial with human and AI readers.

Here's an attempt to answer the questions based only on the provided text, and explicitly noting when information is not present:

Description of Acceptance Criteria and Device Performance Study

The TERUMO® SURFLO® FLEX I.V. Catheters and TERUMO® SURFLASH™ I.V. Catheters demonstrated substantial equivalence to predicate devices (Becton Dickinson (B-D®) Insyte® I.V. Catheter, B-D Insyte (N) I.V. Catheter, and Terumo® Surflo® I.V. Catheter) through a series of performance tests. The acceptance criterion for these tests was that the performance of the proposed devices be equivalent to that of the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted to demonstrate equivalence. However, it does not provide specific quantitative acceptance criteria or detailed numerical results for the proposed device's performance, nor does it explicitly detail the predicate device's performance for direct comparison in the format below. The "reported device performance" is implicitly stated as meeting the equivalence standard.

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

The document does not specify the sample sizes used for each of the performance tests. The data provenance is implied to be from laboratory testing conducted by Terumo Medical Corporation (USA). The nature of these tests suggests they are prospective laboratory bench tests rather than retrospective or prospective clinical studies involving patient data from a specific country of origin.

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 to this type of device and submission. The "ground truth" here is based on engineering specifications and physical property measurements, not expert interpretation of clinical data or images.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in image interpretation or clinical outcomes, which is not relevant to the physical performance tests conducted for this device.

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

There was no MRMC comparative effectiveness study and no AI component mentioned in this 510(k) submission. This device is a physical medical instrument (catheter), not an AI-powered diagnostic or assistive tool.

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 instrument and does not involve an algorithm or AI.

7. The type of ground truth used

The "ground truth" for the performance tests would be established through defined physical and chemical measurement standards and established engineering specifications for parameters like tensile strength, flow rate, stiffness, and chemical residue levels. For biocompatibility, it's adherence to the recommended tests in FDA G95-1 (AAMI/ANSI/ISO 10993-1). For sterility, it's achieving an SAL of 10^-6 based on the EN 550 standard.

8. The sample size for the training set

This is not applicable as there is no AI or algorithm involved in this device, and thus no "training set."

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

This is not applicable as there is no AI or algorithm involved in this device, and thus no "training set."

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