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Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site or "buttonhole" method of needle insertion.

The Medisystems Buttonhole Needle Set consists of a hollow, rigid needle/cannula, a flexible tube, and locking connector to provide access through the skin at a constant or "buttonhole" site. Different degrees of point sharpness are offered to accommodate creation of the buttonhole site and cannulation through an established buttonhole site.

1. Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the exact sample size used for the test set of the Medisystems Buttonhole Needle Sets. It mentions that "all finished products are tested," implying a 100% inspection for release testing, but does not detail the size of any specific sample for formal effectiveness or safety studies.

The data provenance is from Medisystems Corporation, with the testing described as part of their Device Master Records which define "required testing." This suggests that the testing was conducted internally by the manufacturer. The document does not specify the country of origin of the data, but the submitter is based in Washington, DC, USA. The nature of the testing (manufacturing release testing) indicates it is prospective for each batch produced.

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

The document does not describe the use of external experts or the establishment of a "ground truth" in the context of clinical or performance evaluation for the test set. The acceptance criteria are related to manufacturing release specifications (sterility, pyrogenicity, physical testing, visual examination) rather than clinical efficacy or diagnostic accuracy. Therefore, this section is not applicable based on the provided information.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the criteria are manufacturing release specifications, not clinical outcomes requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not completed for the Medisystems Buttonhole Needle Sets. The document focuses on the substantial equivalence of the device to predicate devices based on design, materials, and indicated use, and manufacturing release testing. It does not describe any studies involving human readers or comparative effectiveness in a clinical setting. Therefore, there is no information on the effect size of human readers with or without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. The device is a physical medical needle set, not an algorithm or AI-driven system. Therefore, a standalone (algorithm only) performance study against human-in-the-loop performance is not relevant.

7. Type of Ground Truth Used

The "ground truth" in this context refers to established manufacturing and product quality standards. The types of "ground truth" used are:

• Sterility: Absence of viable microorganisms, confirmed by validated methods.
• Pyrogenicity: Absence of fever-inducing substances (endotoxins), confirmed by validated tests.
• Physical Testing: Conformance to specified physical properties (e.g., tensile strength, dimensional accuracy, needle sharpness, cannula integrity), confirmed by engineering measurements and tests.
• Visual Examination: Absence of defects, verified by inspection against defined visual standards.

These are objective, measurable criteria directly related to the product's design specifications and defined by "written and approved procedures."

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not a machine learning model. Therefore, there is no concept of a "training set" for an algorithm. The manufacturing process and quality control procedures are based on established engineering principles and standards, not data-driven machine learning training.

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

Not applicable due to the device not being an AI/ML algorithm.

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