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Use for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended to single use only and is for temporary catheterization less than 30 days. The safety feature (foldable wing and WingEater guard) aids in prevention of needlestick injuries when removing and discarding needle after dialysis session.

JMS A.V. Fistula Needle Set "WingEater®V2 is a device whereby an antineedlestick feature (WingEater guard) is assembled with predicate device under 510(k), K000845. Needlestick injury can be prevented when removing needle so as to encapsulate the whole needle within the WingEater guard. Modifications to JMS A.V. Fistula Needle Set "WingEater®V2 in this special 510(k) are: a) Additional new polypropylene (PP) materials used for WingEater guard, needle cover, luer lock cover and clamp (non fluid pathway)

The provided text describes a 510(k) premarket notification for a medical device (JMS A.V. Fistula Needle Set "WingEater®V2") and does not contain information about acceptance criteria, device performance, or a study explicitly proving the device meets acceptance criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (JMS A.V. Fistula Needle Set "WingEater®V1") through bench testing and adherence to various ISO standards and USP guidelines. These standards and guidelines likely contain performance criteria, but the document does not explicitly state them as "acceptance criteria" for the device, nor does it present the results in a comparative table.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or the details of a study proving the device meets these criteria as the information is not present in the provided text.

Specifically, the following requested information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: The document lists various ISO standards and USP guidelines that bench testing was conducted against, but it does not detail specific acceptance criteria derived from these standards or the quantitative performance results of the JMS A.V. Fistula Needle Set "WingEater®V2" against those criteria.
2. Sample size used for the test set and the data provenance: No information on sample sizes for any tests is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This type of information is generally not relevant for a 510(k) submission for this type of medical device, which relies heavily on bench testing against established standards rather than clinical outcomes or diagnostic accuracy studies involving expert interpretation.
4. Adjudication method: Not applicable/not provided.
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 fistula needle set, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not explicitly stated as "ground truth" in the context of diagnostic accuracy. Performance is assessed against established engineering and biological standards.
8. The sample size for the training set: Not applicable. This is not
9. How the ground truth for the training set was established: Not applicable.

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