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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.

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 (<30 days) to sample blood and administer fluids intravenously, and employs an identical placement technique 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 subject PowerGlide Pro™ Midline Catheter features a catheter with a reinforced tip to support patency of the catheter during aspiration or blood draw. 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 describes the PowerGlide Pro™ Midline Catheter, which is an intravascular catheter intended for short-term use (<30 days) to sample blood or administer fluids intravenously. The submission is a 510(k) premarket notification, indicating substantial equivalence to a previously cleared predicate device (K153280). The key modification to the new device is a "reinforced catheter tip."

Here is an analysis of the acceptance criteria and the study performed, based on the provided text:

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

The document describes several performance tests conducted to demonstrate substantial equivalence of the modified PowerGlide Pro™ Midline Catheter to its predicate. The acceptance criteria are generally framed as "less than or equal to the predicate device," "not swell beyond twice the size of the labeled OD," "not collapse under a vacuum," "remains in the same orientation... and does not kink," and "be greater than maximum use pressure." The reported performance is summarized as the device "met all predetermined acceptance criteria." Specific numerical values for criteria or performance are not explicitly provided in this summary for most tests, but rather stated as meeting the internal standards or predicate performance.

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

The document does not specify the sample sizes used for the test sets for any of the performance tests. It also does not provide information regarding the provenance of the data (country of origin, retrospective or prospective). These tests appear to be laboratory-based engineering performance tests rather than clinical studies with patient data.

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):

This type of information is not applicable to the studies described. The studies are engineering performance tests of a medical device, not clinical studies requiring expert interpretation or ground truth establishment in a medical context.

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

This information is not applicable to the studies described, as they are engineering performance tests and not clinical studies requiring adjudication of medical findings.

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:

This information is not applicable. The device is an intravascular catheter, not an AI-powered diagnostic or assistive technology. No MRMC study or AI-related effectiveness study was performed or is relevant to this submission.

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

This information is not applicable. The device is a physical medical instrument, not an algorithm or AI system.

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

The "ground truth" for the performance tests listed are the established physical and mechanical properties (e.g., force, swelling, flow rate, kink resistance, burst pressure) as defined by Bard's internal standards, FDA guidance, and international standards (ISO 10555-1:2013, ISO 10993 series). These are objective measurements against defined standards, not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

This information is not applicable. There is no "training set" as this is not an algorithm or AI system being developed or evaluated.

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

This information is not applicable, as there is no training set.

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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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