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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.

SysLoc® MINI V2 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. Almost identical to the predicate device, SysLoc® MINI V2 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. SysLoc® MINI V2 included in this 510(k) is a modification from the legally marketed device, JMS SysLoc® MINI A.V. Fistula Needle Set & JMS SysLoc® MINI Apheresis Needle Set. SysLoc® MINI V2, is the same version of the predicate device (SysLoc® MUSL ) with modification made to re-position the external lock, so that the device is more user/patient friendly. Modifications are done accordingly to the other components such as wing and huh in order to realize the intended device.

The provided text is a 510(k) summary for a medical device called "JMS SysLoc® MINI V2 A.V. Fistula Needle Set & JMS SysLoc® MINI V2 Apheresis Needle Set." It describes the modifications made to a previously cleared device, the predicate device, and argues for substantial equivalence.

However, the document does not contain information regarding detailed acceptance criteria tests, study designs to prove device performance against those criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The document focuses on establishing substantial equivalence by stating that the modified device has the "same intended usage, same materials used in the blood-contact components, and adopts identical fundamental scientific technology" as the predicate device. It vaguely mentions that "data and reports are enclosed within this submission document" to demonstrate the device is performing as intended, but these details are not present in the provided text.

Therefore, I cannot fulfill your request for specific details on acceptance criteria and study designs based only on the provided input. The document is essentially a cover letter and summary for a regulatory submission, not a detailed technical report of performance studies.

Here's an explanation of why I cannot complete the table and answer your questions with the given information:

• No detailed acceptance criteria or performance data: The summary states the device performs "as intended" and that "data and reports are enclosed," but it does not list specific acceptance criteria (e.g., "sharps injury rate Y ml/min") nor does it provide the results of any tests against such criteria.
• No study design information: The document doesn't describe any studies conducted to validate the device's performance, let alone details like sample sizes, data provenance, ground truth establishment, or expert involvement.
• No mention of AI/ML components: The device described is a physical needle set. There is no indication of any AI or machine learning components, which are typically associated with performance metrics like accuracy, sensitivity, specificity, and MRMC studies.

In summary, the provided text does not contain the information needed to answer your questions about acceptance criteria, study details, or AI performance.

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