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The PowerGlide® Midline Catheter is intended to be inserted in the patient's vascular system for short term use (less than 30 days) to sample blood or administer fluids intravenously.
The PowerGlide® Midline Catheter is inserted into a patient's vascular system for short-term use (

Bard Access Systems, Inc.'s PowerGlide® 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 text does not contain information about an AI/ML device or a study proving its performance through clinical trials or a specific test set with ground truth established by experts.

The document is a 510(k) summary for the PowerGlide® Midline Catheter, a medical device that received clearance in January 2014. This is a traditional medical device, not an AI/ML product.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or types of ground truth used, as these details are specific to the evaluation of AI/ML software.

The document states that:

• "Verification and validation activities were designed and performed in accordance with Design Controls as per 21 CFR §820.30."
• Various guidance documents and standards were used to determine appropriate evaluation methods (listed in section {2}).
• "The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device."
• Substantial equivalence was determined "Based on the indications for use, technological characteristics, and safety and performance testing".

This indicates that the device met pre-defined engineering and performance specifications based on established medical device standards and comparisons to a predicate device (K121073), which is the standard pathway for 510(k) clearance of non-AI/ML devices. There is no information about a "study that proves the device meets the acceptance criteria" in the context of an AI/ML product's performance evaluation.

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The PowerGlide™ Midline Catheter is intended to be inserted in the patient's vascular system for short term use (less than 30 days) to sample blood or administer fluids intravenously.

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

Bard Access Systems, Inc.'s PowerGlide™ 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 (

Here's a breakdown of the acceptance criteria and study information for the PowerGlide™ Midline Catheter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the safety and performance testing for the PowerGlide™ Midline Catheter. It states that the device "met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate devices." However, it does not provide a specific table with numerical acceptance criteria and corresponding device performance values. Instead, it refers to compliance with various industry standards and guidance documents.

Here's a summary of the areas of performance verification mentioned:

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set for performance validation studies. It only mentions that "Verification and validation tests have been performed in accordance with Design Controls as per 21 CFR §820.30."

The data provenance (country of origin, retrospective/prospective) is also not mentioned. The testing appears to be primarily bench testing and in-house validation based on compliance with international standards, rather than clinical data from human subjects.

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

This information is not provided in the document. Given that the testing appears to be primarily bench and laboratory-based, the concept of "experts establishing ground truth for a test set" in a clinical sense (e.g., radiologist consensus) does not directly apply here. Performance was likely evaluated against engineering specifications derived from the referenced standards.

4. Adjudication Method for the Test Set

This information is not applicable and not specified. Adjudication methods are typically used in clinical studies where multiple reviewers interpret data, which is not described here.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document describes engineering and biocompatibility testing for substantial equivalence, not a clinical trial comparing human reader performance.

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

This question is not applicable as the device is a physical medical catheter, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the PowerGlide™ Midline Catheter was established through compliance with recognized international and national standards and guidance documents. These standards define measurable requirements (e.g., material properties, dimensional tolerances, flow rates, tensile strength, biocompatibility limits, sterilization efficacy, luer connection integrity, sharps protection effectiveness). The device's performance was measured against these predefined specifications.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical catheter, not an AI algorithm. There is no "training set."

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

This question is not applicable as the device is a physical medical catheter, not an AI algorithm. There is no "training set" or corresponding ground truth establishment for it.

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