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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 (<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® Midline Catheter is suitable for use with power injectors.

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 (<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 catheter rated for power injection. The PowerGlide® Midline Catheter is available in 18 and 22 gauge sizes. The 18 gauge size is available in 8cm or 10cm lengths and the 22 gauge size is available in only an 8cm length.

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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