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The PowerGlide Pro™ Midline 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 PowerGlide Pro™ Midline Catheter is suitable for use with power injectors.

Bard Access Systems, Inc.'s PowerGlide Pro™ Midline Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device is intended for short term use (<30 days) to sample blood and administer fluids intravenously, and employs a placement technique similar to the cited predicate device. The subject device consists of an introducer needle with a passive safety mechanism, guidewire, and single lumen catheter rated for power injection. The PowerGlide Pro™ Midline Catheter features device housings and insertion mechanisms that are different from the predicate device. The PowerGlide Pro™ Midline Catheter is offered in 18, 20, and 22 gauge sizes. The 18 and 20 gauge devices are offered in 8 cm or 10 cm lengths. The 22 gauge device is offered in only an 8 cm length.

The provided document is a 510(k) premarket notification for the C. R. Bard, Inc. PowerGlide Pro™ Midline Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria in the manner typically seen for novel diagnostic or AI devices.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details, ground truth types) are not applicable or derivable from this type of regulatory submission. The document emphasizes mechanical and biological performance tests that are standard for this class of medical device.

Here's the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The subject device met all predetermined acceptance criteria derived from the above listed tests and demonstrated substantially equivalent performance as compared to the cited predicate device." However, the exact numerical acceptance criteria for each test are not explicitly detailed. The tests performed are as follows:

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

Not applicable for this type of device and regulatory submission. The document describes engineering and biological performance tests, not a clinical study on a patient test set.

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

Not applicable. Ground truth as typically defined for diagnostic or AI algorithm studies is not relevant here. The "ground truth" for these performance tests would be the established engineering and biocompatibility standards.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is not relevant for the performance testing of an intravascular catheter to demonstrate substantial equivalence based on mechanical and biological properties.

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

Not applicable. This device is an intravascular catheter, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's acceptable performance is based on International Organization for Standardization (ISO) standards for sterile, single-use intravascular catheters and biological evaluation of medical devices, along with internal predetermined acceptance criteria for mechanical and biocompatibility tests.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable.

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