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The NIPRO BioHole Needle with CAPICK Scab Remover is intended for use as a blood access device for dialysis procedures using a constant-site cannulation technique of needle insertion with an established, mature constant-site also known as a buttonhole access site.

The NIPRO BioHole Needle with CAPICK Scab Remover is a sterile, single-use device that consists of a hollow, winged needle, a flexible tube, mini clamp, locking connector and scab remover. This device is provided in four design types: fixed wing type A and B, and rotating wing type A and B. Needles are available in two lengths, 1″ and 1½″, as well as four gauges (14-17), with and without back eye. The flexible tubing comes in lengths of 150mm and 300mm. The NIPRO BioHole Needle with CAPICK Scab Remover is packaged individually in a plastic pouch with paper backing, which contains labeling that adequately defines indications for use and warnings. Each BioHole Needle is provided with a sterile CAPICK scab remover attached to the cap of the needle. The CAPICK is intended to aid the clinician in the removal of the scab on the constant-site tunnel tract prior to cannulation with BioHole Needle.

These devices operate on the principles of a blood access device. They are sterile, single use only, non-toxic and non-pyrogenic.

The provided text describes a 510(k) summary for the NIPRO BioHole Needle with CAPICK Scab Remover. It outlines the device's purpose and compares it to predicate devices. However, the document does not contain the detailed information requested regarding specific acceptance criteria, study data, sample sizes (for test or training sets), expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.

The document states:

• "Performance testing was conducted to verify that the device is safe and effective for its intended use. Those reports along with associated data are included in this submission."
• "The results of the performance testing and the comparison of technological characteristics demonstrate that the NIPRO BioHole Needle with CAPICK performs equivalent to the predicate device and is safe and effective when used as intended."

This indicates that internal performance tests were conducted and submitted to the FDA, but the details of these tests are not provided in this summary. The FDA's letter (Page 2-3) confirms substantial equivalence based on the provided information, but again, does not detail the specific study results.

Therefore, I cannot fulfill your request for the specific table and study details as that information is not present in the provided text.

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