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The PowerGlide Pro™ Midline Catheter is inserted into a patient's vascular system for short-term use (

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 (

The provided FDA 510(k) clearance letter for the PowerGlide Pro™ Midline Catheter specifies that no new performance tests, including verification and validation activities, were conducted because the modifications were limited to labeling updates (specifically, changes to the Indications for Use and associated Instructions for Use/labeling), with no changes to the device's design, materials, performance, or risk profile.

Therefore, based on the provided document, the typical information requested for acceptance criteria and study details (such as sample size, provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details) is not available as no new studies were deemed necessary due to the nature of the submission. The acceptance criteria essentially rely on the previously established performance of the legally marketed predicate device (K162377), which the subject device is substantially equivalent to.

However, I can extract the comparison table that highlights the differences between the subject device and the predicate device, which implicitly states that the performance criteria for the subject device are considered to be the same as the predicate device due to the lack of design or performance changes.

Here's a summary based on the provided document, addressing the points where information is available or where the document indicates why it's not applicable:

1. A Table of Acceptance Criteria and the Reported Device Performance

Since no new performance studies were conducted for this 510(k) submission, there are no new specific acceptance criteria or reported device performance metrics beyond those previously established for the predicate device. The document explicitly states:

"The results of the risk analysis determined that no verification or validation activities were required because the subject device modifications to the Indications for use and resulting modifications to the instructions for use and labeling do not include any changes to the design, materials, performance, or risk profile of the cited predicate device. Therefore, it is not necessary to conduct additional performance tests including verification and validation."

The "reported device performance" would therefore implicitly be identical to the predicate device, K162377, for all functional aspects. The acceptance criteria for this submission were that the labeling changes do not introduce new questions of safety or effectiveness and do not introduce any new or significantly modified risks. The document claims this was met for each change.

Summary of Device Comparison (Implicit Acceptance of Predicate Performance)

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The PowerGlide Pro™ Midline Catheter is inserted into a patient's vascular system for short-term use (

The 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 (

The provided document describes the PowerGlide Pro™ Midline Catheter, which is an intravascular catheter intended for short-term use (

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The PowerGlide Pro™ Midline Catheter is inserted into a patient's vascular system for short-term use (

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 (

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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