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Use for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended for single use only and is for temporary catheterization of less than 30 days. The device has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries when withdrawing and discarding the needle after treatment.

Needle, Fistula

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Plume Safety AVF Needle." This document grants market clearance based on substantial equivalence to a predicate device, rather than providing details about an acceptance criteria study as typically conducted for novel AI/software devices.

Therefore, most of the information requested in your prompt regarding acceptance criteria, study design, expert involvement, and performance metrics is not available in this type of regulatory document.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Not Available. This document does not describe specific performance acceptance criteria or report performance data. It is a regulatory clearance letter based on substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Available. No test set or data provenance details are provided as this is not a study report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Available. No experts or ground truth establishment are mentioned as this is not a study report.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Available. No adjudication method is mentioned.

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, not an AI/software device. Therefore, an MRMC study or AI assistance is not relevant.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Available. Ground truth is not relevant or mentioned for this type of device clearance.

8. The sample size for the training set

• Not Available. No training set is relevant or mentioned.

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

• Not Available. No training set or ground truth establishment is relevant or mentioned.

Information that is available (though not directly addressing your specific questions about study criteria):

• Device Name: Plume Safety AVF Needle
• Indications For Use: "Use for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended for single use only and is for temporary catheterization of less than 30 days. The device has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries when withdrawing and discarding the needle after treatment."
• Regulatory Classification: Class II
• Predicate Device Equivalence: The clearance is based on the device being "substantially equivalent" to legally marketed predicate devices. This means the FDA found that the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. The specifics of the predicate device are not included in this extract, but would have been part of the 510(k) submission.

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