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JMS Harmony® A.V.Fistula Needle Set is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment and for the removal of scabs that have developed over the constant site prior to cannulation. The device is intended for single use only and is used on 'developed constant site' access sites. This device is for use on developed 'constant site' access sites

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This document is a 510(k) premarket notification for a medical device called the JMS Harmony® A.V. Fistula Needle Set. It aims to demonstrate substantial equivalence to legally marketed predicate devices. The document explicitly states that "Performance Specification: Met established acceptance criteria" for the modified device and both predicates.

However, the document does not provide details about the specific acceptance criteria themselves, nor does it describe the study that proves the device meets these criteria. It only makes a general statement that the criteria were met.

Therefore,Based on the provided text, I cannot extract the detailed information requested in your prompt. The document is a regulatory submission for a medical device, and while it states that "Performance Specification: Met established acceptance criteria" for the modified device and its predicates, it does not elaborate on what those acceptance criteria are or describe the specific study (or studies) used to demonstrate that the device meets them.

The information requested, such as sample sizes, data provenance, number and qualifications of experts, adjudication methods, details of comparative effectiveness studies, standalone performance, type of ground truth, and training set information, is not present in this document. This kind of detailed study information is typically found in a separate section of a 510(k) submission, often within a "Performance Testing" or "Bench Testing" report, which is not provided in this extract.

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