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The Medisystems Dual Lumen Needle is indicated for use as a vascular access device for dialysis procedures. The Medisystems Dual Lumen Buttonhole Needle is indicated fo use as a vascular access device for dialysis procedures using a constant-site or "buttonhole" method of needle insertion.

The proposed devices are to be used as a vascular access device for dialysis procedures using either a standard needle insertion technique (for Dual Lumen Needle) or a constant-site or "buttonhole" method of insertion (for Dual Lumen Buttonhole Needle).

This document is a 510(k) premarket notification for a medical device -- a dual lumen needle for dialysis. Based on the provided text, this is not an AI/ML medical device. Therefore, the questions related to AI/ML device performance criteria, training sets, expert review, MRMC studies, and ground truth establishment are not applicable to this document.

The document discusses the substantial equivalence of the proposed devices (Medisystems Dual Lumen Needle and Medisystems Dual Lumen Buttonhole Needle) to predicate devices already on the market (Medisystems Buttonhole Needles cleared under K990803 and Cordis Corp. Bionics Bi-Flo double lumen needle cleared under K801355).

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical bench testing for a physical medical device, not a software algorithm.

Here's the relevant information that can be extracted from the document:

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

The document broadly states:

Note: The document itself does not provide the specific "predetermined acceptance criteria" or the detailed "results of this testing" for the bench tests. It only states that they were conducted and met.

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

• Sample Size: Not specified in the provided text. The document refers to "Performance, verification and validation testing," which implies a test set, but the size is not mentioned.
• Data Provenance: Not applicable in the context of this type of testing for a physical device. It would involve laboratory bench testing, not patient data.

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 applicable. This is a physical medical device, not an AI/ML algorithm requiring expert annotation for ground truth.

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

• Not applicable. This relates to expert review of data for AI/ML, not bench testing of a physical device.

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 is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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

• Not applicable. For a physical device, "ground truth" would relate to engineering specifications, material properties, and functional performance metrics established through bench testing, rather than medical "ground truth" like disease presence.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device; there is no "training set" in the AI/ML sense.

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

• Not applicable. Again, this is for AI/ML devices.

Summary based on the document:

The document serves as an FDA 510(k) clearance letter and summary for a physical medical device. It attests that "Performance, verification and validation testing was conducted to characterize performance of the proposed devices and the predetermined acceptance criteria was met." However, it does not provide the specifics of these tests, such as sample sizes, detailed criteria, or specific results, as this information would typically be contained in the full 510(k) submission, not the summary letter itself.

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