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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 adult and pediatric patients, 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. The device consists of an introducer needle with a passive safety mechanism, guidewire, and single lumen, radiopaque, body-softening polyurethane catheter rated for power injection.

Midline catheters, including the PowerGlide Pro, may be considered in patients with difficult IV access as clinically indicated.

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)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No new test set was used as no new performance studies were conducted.

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)
Not applicable. No new test set required ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set required adjudication.

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
Not applicable. This device is a medical catheter and does not involve AI assistance or human reader interpretation for its function.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No new ground truth was established for this submission. The substantial equivalence is based on the predicate device's established safety and effectiveness.

8. The sample size for the training set
Not applicable. No training set was used as no new algorithm or performance study was conducted.

9. How the ground truth for the training set was established
Not applicable. No training set was used.

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