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Use for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal 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.

SysLoo® MINI (V3) is intended as non-implanted blood access device, which consists of flexible tube and needle with integrated sharps safety features as described in 21 CFR 876.5540.

SysLoc® MINI (V3) 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 modifications stated for SysLoc® MINI (V3) included in this 510(k) are to have an additional packaging configuration and an alternative Polycarbonate Grade to component (lupilon EB30001R). The modification of the packaging is done accordingly to the device packing, and the modification of polycarbonate grade is evaluated accordingly with the Safety Hub and other components such as wing in order to realize the intended device. The review of modifications is documented within this submission document.

The provided document describes a 510(k) premarket notification for a medical device, the JMS SysLoc® MINI A.V. Fistula Needle Set / Apheresis Needle Set (V3). This submission aims to demonstrate substantial equivalence to a predicate device, the SysLoc® MINI (V2), for two modifications: a new packaging configuration and an alternative polycarbonate grade for a component.

The document does not describe a study involving device performance, clinical outcomes, or human interaction that would typically involve acceptance criteria and a detailed study report. Instead, it focuses on bench testing to verify that the modified device performs as intended and is safe and effective. The acceptance criteria mentioned are primarily related to compliance with various ISO standards and USP requirements, which are typical for medical device manufacturing and material safety.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth for test set, training set details) are not applicable or cannot be extracted from this type of regulatory submission, as it does not detail a clinical or performance study of that nature.

Here's a summary of the available information:

1. Table of Acceptance Criteria and the Reported Device Performance

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

The document only states that "Bench testing was conducted" and "data and reports are enclosed within this submission document." It does not specify the sample size for any test set in the context of a performance study on a specific population or data set. The testing described is primarily laboratory-based (bench testing) and compliance-based (ISO standards). Data provenance is internal to the manufacturer (JMS Singapore Pte Ltd).

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

Not applicable. This type of information is not relevant for the bench and compliance testing described for a 510(k) submission regarding material and packaging changes.

4. Adjudication method for the test set

Not applicable. No expert review or adjudication method for a test set is described.

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 device is a physical medical needle set, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant.

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

Not applicable. This refers to an AI algorithm performance, which is not relevant to this device. However, the bench testing conducted can be considered "standalone" in the sense that the device's functional performance was evaluated independent of human use context, but within a laboratory setting.

7. The type of ground truth used

For the bench testing and compliance, the "ground truth" is defined by the requirements and specifications of the referenced international standards (ISO, USP) and the device's own design specifications for its intended function (e.g., proper Luer taper fit, successful sterilization, lack of cytotoxicity, safe sharps retraction).

8. The sample size for the training set

Not applicable. This refers to an AI training set, which is not relevant to this device.

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

Not applicable. This refers to an AI training set, which is not relevant to this device.

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