Search Results

Use for temporary cannulation non-implantable, less than 30 days) to vascular access for extra corporeal blood treatment. The device is intended for single use only and has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries

SysLoc® MINI (V4) is intended as non-implanted blood access device, which consists of flexible tube and needle with integrated sharp safety features as described in 21 CFR 876.5540. SysLoc® MINI (V4) comes with a rotational feature and the needle is retracted with the wing sheath after deliberate release of secured external lock, and final locking is assured by an audible 'click' sound when the hub/tube is pulled rearwards.

The provided text describes a 510(k) premarket notification for a medical device (JMS SysLoc® MINI A.V. Fistula Needle Set (V4) and JMS SysLoc® MINI Apheresis Needle Set (V4)). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria through a traditional clinical study with performance metrics in terms of sensitivity, specificity, or similar.

Therefore, the requested information elements related to diagnostic performance (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission and the information provided. The "acceptance criteria" here refer to testing to ensure the device performs as intended and is safe, similar to the predicate, not diagnostic accuracy.

Here's a breakdown of the available information based on your request, with an emphasis on what is not present in this type of document:

1. Table of acceptance criteria and the reported device performance

The document does not specify "acceptance criteria" in terms of diagnostic performance metrics. Instead, it refers to "Performance Specification" and "Bench testing" to demonstrate that the new device (V4) performs as intended and is safe and effective, similar to the predicate (V3).

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

• Not Applicable. This document describes bench testing to demonstrate substantial equivalence, not a clinical study to evaluate diagnostic performance. Therefore, there is no "test set" in the context of diagnostic data. The number of devices tested in bench testing is not specified.

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

• Not Applicable. Ground truth for diagnostic accuracy is not relevant here.

4. Adjudication method for the test set

• Not Applicable.

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 medical device (fistula needle set), not an AI-powered diagnostic tool.

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

• Not Applicable. This is not an algorithm.

7. The type of ground truth used

• Not Applicable. Ground truth for diagnostic accuracy is not relevant here. The "ground truth" for this device would be its physical and functional specifications meeting design requirements and demonstrating safety and effectiveness through mechanical and material testing, as well as biocompatibility, which are confirmed to be similar to the predicate.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device.

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

• Not Applicable.

Summary of focus (based on the provided document):

This 510(k) submission primarily focuses on demonstrating that the modified device (V4) is substantially equivalent to a legally marketed predicate device (V3). This is achieved by showing that the V4 device has:

• The same intended use as the V3.
• Similar technological characteristics (e.g., anti-stick feature, physical specifications, performance specifications) to the V3.
• Passed bench testing to verify that it performs as intended as a safe and effective medical device.
• Satisfied biocompatibility and sterilization requirements comparable to the V3.

The "study" that proves the device meets (implicit) acceptance criteria is the bench testing and other evaluations (biocompatibility, sterilization) which concluded that the "SysLoc® MINI (V4) device is performing as intended to be a safe and effective medical device" and is "substantially equivalent" to the predicate. Specific details about the methodology and sample sizes of this bench testing are not provided in this summary document.

Ask a specific question about this device