Search Results

The SURFLASH® Plus Safety I.V. Catheter is inserted into the patient's vascular system for short term use (

The SURFLASH® Plus Safety I.V. Catheter is manually operated and contains a passive safety feature that automatically activates as the needle is withdrawn from the catheter. The devices consist of catheter assembly (catheter, caulking pin and catheter hub containing valve, seal component and plug), needle assembly (needle, needle housing, transparent flash chamber with filter and needle protector) and a passive needle-shielding mechanism (shutter and needle shaft cover consisting of inner cylinder, outer cylinder, junction cylinder). The SURFLASH® Plus Safety I.V. Catheter has a valve and a seal component inside the catheter hub to minimize the possibility of blood leakage at catheter hub after needle removal. The catheter hub is also provided with a plug inside which penetrates the valve to create a fluid path when a connector is inserted in the catheter hub. The fluid path is permanently opened once a secure luer connection is made. The devices are an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term (

The provided text is a 510(k) summary for the Terumo SURFLASH® Plus Safety I.V. Catheter. It outlines the device's description, intended use, non-clinical tests, and substantial equivalence to predicate devices. However, it does not describe an AI/ML-based medical device. Therefore, the information required to answer your questions regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not present in the provided document.

To directly answer your request, here's what can be extracted from the document regarding the device (the I.V. catheter) meeting its intended performance, even though it's not an AI/ML device:

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

The document states that "Performance testing was conducted to ensure the safety and effectiveness of the SURFLASH® Plus Safety I.V. Catheter throughout the shelf life, to verify conformity to the applicable part of ISO standards and demonstrate substantial equivalence to the predicate devices." It also lists various performance tests conducted.

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

• Simulated Use Study: "study participants" (number not specified). "Healthcare workers who use these types of safety I.V. catheters."
• Other Performance Tests: Sample sizes are not explicitly stated for the enumerated tests (e.g., burst pressure, tensile strength).
• Data Provenance: The tests were conducted by Terumo Corporation, presumably within their facilities or via third-party labs on their behalf. The country of origin of the data is not specified beyond the manufacturer's location in Japan, with regulatory affairs in the US. The studies are prospective as they are tests performed on the device to demonstrate conformity.

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 and therefore not provided in the document as this is a physical medical device, not an AI/ML-based device requiring expert annotation for ground truth. For the simulated use study, "healthcare workers who use these types of safety I.V. catheters" were participants, but their role was to evaluate usability and safety activation, not to establish a "ground truth" in the AI/ML sense.

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

Not applicable in the context of a physical device's performance testing. The simulated use study reported that "All participants were able to read and activate the catheter safety feature without further explanation or training." This implies a very high level of consistent success, not requiring an adjudication method.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device. The "simulated use study" evaluates the human-device interaction, confirming the safety feature's activation.

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

For the safety function, the "ground truth" is the successful activation of the sharps injury prevention feature and prevention of needle stick injuries during simulated use. This is determined by observation of the device's physical function and user interaction. For other performance tests, the "ground truth" is the established engineering and materials standards (ISO standards and internal standards) for the properties being measured.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device that requires a training set.

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

Not applicable, as this is not an AI/ML device.

Ask a specific question about this device