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The JMS Blunt AV Fistula Needle Set with Site Preparation Tool 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. The JMS AV Fistula Blunt Needle Set is for use on developed 'constant site' access sites.

JMS A.V. Fistula Blunt Needle Set with Site Preparation Tool is a modification of the previously cleared JMS A.V. Fistula Blunt Needle Set (K082882). The modification is the replacement of the standard needle cover with a site preparation tool "scraper" feature that removes the scabs that have developed over the constant site prior to cannulation.

Here's an analysis of the provided 510(k) summary regarding the JMS Blunt A.V. Fistula Needle Set with Site Preparation Tool, focusing on acceptance criteria and supporting studies.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (JMS A.V. Fistula Blunt Needle Set, K082882) by showing that the new device shares similar technical and performance characteristics, with the key difference being the addition of a "site preparation tool" (scraper) on the needle cover.

The summary states:

Note: The document does not provide specific numerical or qualitative acceptance criteria (e.g., "tear strength must be X N", "cytotoxicity must be scale Y or less"). Instead, it states that established criteria were met, or refers to adherence to international standards. The 510(k) process often relies on demonstrating compliance with recognized standards or equivalency to a predicate for which such standards were previously deemed met.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions a "Clinical Usability Study" but does not specify the sample size for this study. It also does not explicitly state the data provenance (e.g., country of origin, retrospective/prospective). However, given that it's a medical device for use in dialysis, it's highly probable it would involve prospective data collection in a clinical setting relevant to dialysis treatment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document does not provide this information. For a "clinical usability study," the "ground truth" might be subjective user feedback or objective observations by trained personnel, but the number and qualifications of evaluators are not detailed.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the clinical usability study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This question is not applicable. The device described (JMS Blunt A.V. Fistula Needle Set with Site Preparation Tool) is a physical medical device (a needle set), not an AI-powered diagnostic or assistive tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study involving AI assistance would not be relevant.

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

This question is not applicable. As explained above, the device is a physical medical tool, not an algorithm.

7. The Type of Ground Truth Used

For the "Clinical Usability Study," the "ground truth" would likely be based on:

• User feedback: Direct qualitative and quantitative feedback from healthcare professionals (nurses, technicians) on the device's ease of use, functionality of the scraper, and overall performance in a real or simulated clinical setting.
• Observational data: Assessment by trained observers of how efficiently and effectively users performed tasks with the device, and whether the scraper feature successfully removed scabs as intended.
• Label Comprehension: Verification that users understood instructions and warnings on the device labeling.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical product and does not involve a "training set" in the context of machine learning or AI models. The design and testing are based on engineering principles, material science, and clinical evaluation.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as point 8.

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