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The Medisystems Hemodialysis Fistula Needle Securement Device, SiteGuard, is intended for use to secure the fistula needle to the patient's skin.

The SiteGuard needle securement device has the following features:
a. It allows the needle to be held at a consistent angle during treatment;
b. It secures wing/hub to the patient's skin and helps prevent movement and/or dislodgement of the needle during use; and,
c. It helps to immobilize the patient's vein or access during cannulation so that it is not necessary for caregivers to hold the vein or access with their fingers.

The subject of this 510(k) is a removable, rigid plastic securement device that is attached to the AVF needle set by the care giver. The SiteGuard securement device will be included in the unit packaging pouch with the Medisystems AVF needle set and also will be available for purchase as an individually packaged accessory.

Because the tape, the AVF wing, and the patient's skin are flexible, the needle may dislodge or move within the patient's access during treatment due to this inherent flexibility. The securement device adds a rigid structure to increase the ability of the tape to prevent the needle from accidentally dislodging or moving within the patient's vascular access.

This accessory also will immobilize the patient's vein during insertion of the cannula so that it is not necessary for caregivers to hold the vein or access with their fingers. The channel along the bottom of the securement device is designed to immobilize the patient's vein during insertion. This feature is especially helpful for patients who have newly created fistulas or implanted grafts because new accesses tend to move during cannulation.

This 510(k) summary does not contain the information requested regarding acceptance criteria and a study proving device performance against those criteria.

Instead, this document focuses on establishing substantial equivalence to legally marketed predicate devices rather than demonstrating performance against specific acceptance criteria through a comparative study.

Here's a breakdown of why the requested information is absent and what the document does provide:

• Acceptance Criteria and Reported Device Performance: These are not mentioned. The document states that "all finished products are tested and must meet all required release specifications before distribution" and that "The required testing is defined by written and approved procedures that conform to the product design specifications." However, what these specifications or acceptance criteria are, or the quantitative results of such testing, are not provided in this 510(k) summary.

• Study That Proves the Device Meets Acceptance Criteria: No such specific study is described. The document refers to "risk analysis, test and design considerations, and verification and validation testing processes" as part of product development, but it doesn't detail a study designed to demonstrate performance against acceptance criteria.

Let's address the specific points you asked for, indicating where the information is not present in this document:

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

   • Not present. The document mentions "required release specifications" and "product design specifications" but does not enumerate them or report specific performance metrics against them.

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

   • Not present. No specific test set or data from a performance study is described.

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 present. There is no mention of ground truth establishment or experts for a test set.

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

   • Not present. No test set or adjudication method is described.

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 present. This device is a physical securement device, not an AI or imaging device, so an MRMC study is not relevant and not discussed.

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

   • Not present. As this is a physical device, this concept does not apply.

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

   • Not present. No ground truth type is mentioned as no performance study is detailed.

8. The sample size for the training set:

   • Not present. There is no mention of a training set, as this is not an AI/machine learning device.

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

   • Not present. Not applicable, as there's no training set mentioned.

Summary of what the document does convey regarding "Safety and effectiveness":

The document states:

• "To assure that the devices are safe and effective, all finished products are tested and must meet all required release specifications before distribution."
• "The required testing is defined by written and approved procedures that conform to the product design specifications."
• "The potential hazards have been studied and controlled as part of the product development process, including risk analysis, test and design considerations, and verification and validation testing processes."
• The primary justification for safety and effectiveness is "substantial equivalence" to legally marketed predicate devices (TNT Moborg Intl., LTD, Immobile Non-sterile and Immobile A/C t non-sterile (K941850); and, TNT Immobile sterile and Immobile A/C sterile (K941940)). The document explicitly states, "There are no new issues of safety or effectiveness resulting from the inclusion of this accessory in the legally marketed needle set."

In essence, this 510(k) relies on the argument that the SiteGuard device is similar enough to already approved devices that it shares their established safety and effectiveness profile, without needing to conduct new, explicit performance studies detailed in this summary.

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