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The Mini-Midline™ Extended Dwell Safety Catheter is inserted into a patient's vascular system for short term use (< 30 days) to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure.

The Mini-Midline Extended Dwell Safety Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device provides peripheral vascular access and administration of fluids, medications and nutritional therapy as prescribed. The device consists of an introducer needle, passive safety mechanism and single lumen catheter. The Mini-Midline Extended Dwell Safety Catheter is 20 gauge.

The provided text describes a medical device, the "Mini-Midline™ Extended Dwell Safety Catheter," and its substantial equivalence to predicate devices, but does not include acceptance criteria for a study demonstrating AI/algorithm performance. The document focuses on regulatory approval (510(k) submission) for a physical medical device, not a software algorithm.

Therefore, most of the requested information regarding AI/algorithm performance (acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, MRMC studies, standalone performance) cannot be extracted from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

This information is not present for an AI/algorithm-based device. The document lists "Technical Characteristics" and "Performance Data" for the physical catheter.

However, the document does list technical characteristics and performance data for the physical device:

Technical Characteristics and Performance Data (for the physical catheter):

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

Cannot be determined. This information pertains to a study evaluating an AI/algorithm, which is not described. The document mentions "test units representative of finished devices" for physical testing, but not a dataset for an algorithm.

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):

Cannot be determined. This information pertains to a study evaluating an AI/algorithm, which is not described.

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

Cannot be determined. This information pertains to a study evaluating an AI/algorithm, which is not 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:

No. An MRMC study was not done, as this document describes a physical medical device, not an AI or algorithm.

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

No. This document describes a physical medical device, not an AI or algorithm, so standalone performance for an algorithm is not applicable.

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

Cannot be determined. This information pertains to a study evaluating an AI/algorithm, which is not described. For the physical device, "ground truth" would relate to its physical properties meeting design specifications through the listed performance tests.

8. The sample size for the training set:

Cannot be determined. This information pertains to an AI/algorithm development, which is not described.

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

Cannot be determined. This information pertains to an AI/algorithm development, which is not described.

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