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The Power Groshong™ PICC is intended for short or long-term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. The maximum recommended infusion rate is 4 ml/sec for power injection of contrast media.

Device Description

The PowerGroshong™ PICC catheters are valved, long-term peripheral access catheters. The catheters are made of silicone material to which a blue and purple colorant have been added. Blue colorants were added to the catheter materials to allow the users to identify the catheter as a Groshong distally valved catheter. Purple colorants were added to the catheter materials to provide the catheter with an appearance that allows the end user to differentiate Bard's power injectable catheters from other manufacturers' power injectable catheters. The PowerGroshong™ PICC catheters are available in 5 Fr single lumen catheter configuration. The catheters are packaged in basic and full with microintroducer kits that incorporate kit components designed to meet the needs of the respective placer.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device (5 Fr Single Lumen (SL) PowerGroshong™ PICC Catheter) and a determination of its substantial equivalence to predicate devices. It does not contain information about acceptance criteria and a study that proves the device meets those criteria in the typical format of a clinical trial or performance study with detailed metrics like accuracy, sensitivity, specificity, or F1-scores.

Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed devices, which is a different regulatory pathway than proving novel performance. The "acceptance criteria" in this context refer to meeting the relevant standards and guidance documents to show that the new characteristics of the device do not raise new safety or effectiveness questions and that its performance is comparable to the predicates.

Here's a breakdown of the information that is present, interpreted in the context of a 510(k) submission, and where information typically found in an AI/diagnostic study is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category (Type of Test)	Acceptance Criteria (Implied by Standards)	Reported Device Performance (Summary)
Intended Use Equivalence	The intended use and indications for use of the new device should be a combination of or substantially similar to the indications from the predicate devices. The new characteristic (power injection) should be supported by performance data and not introduce new safety concerns.	The intended use of the 5 Fr SL PowerGroshong is stated to be the same as the predicate devices, with the addition of power injection capability. "The PowerGroshong™ PICC is intended for short or long-term peripheral access to the central venous system for intravenous therapy and blood sampling," and "power injection of contrast media. The maximum recommended infusion rate is 4 ml/sec for power injection of contrast media." The submission asserts that the intended use and indications for use are a combination of the predicate Groshong® nXt and PowerPICC® catheters. Performance testing specifically addressed the new characteristic of power injection to ensure safety and effectiveness.
Technological Characteristics	Principles of operation and basic design should be the same as predicate devices, or differences should be justified and shown not to affect safety or effectiveness negatively.	The principles of operation and basic design are stated to be the same as the predicate devices. The main difference is the addition of power injection to a valved catheter. This was identified as potentially affecting safety or effectiveness, thus requiring testing.
Safety and Effectiveness	New characteristics should not raise new types of safety and effectiveness questions. Accepted scientific methods (standards, guidance) must exist to assess effects, and performance data must be available to assess these effects.	The submission states that the new characteristics (power injection) do not raise new types of safety and effectiveness questions, but rather questions that are "the same as for the predicate devices." Bench testing was performed based on applicable standards and an FDA guidance document to assess these new characteristics. The conclusion states, "All test results confirm that the subject device is substantially equivalent to the predicate devices." And subsequently, "The 5 Fr SL PowerGroshong™ PICC met all the performance criteria of the tests performed and, based on FDA's decision tree, is substantially equivalent to its predicate devices."
Compliance with Standards	Device must meet the requirements of specified industry standards and FDA guidance for intravascular catheters (e.g., ISO 10555 series for catheters, ISO 594-2 for Luer fittings, ASTM F640 for radiopacity, ISO 11135 for sterilization, ISO 10993-1 for biocompatibility).	Bench testing was based on the following: * Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95 * BS/EN/ISO 10555-1: 1997, Sterile, single-use intravascular catheters, Part 1. General requirements * ISO 10555-1:1995, Sterile, single-use intravascular catheters, Part 1. General requirements, Amendment 1:1999 * BS/EN/ISO 10555-3:1997, Sterile, single-use intravascular catheters, Part 3. Central venous catheters * ISO 594-2: 1998. Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings * ASTM F640-79 (reapproved 2000), Standard Test Methods for Radiopacity of Plastics for Medical Use * AAMI/ANSI/ISO 11135:1994, Medical Devices Validation and Routine Control of Ethylene Oxide Sterilization * AAMI/ANSI/ISO 10993-1:2003, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile. The conclusion states all performance criteria of the tests performed were met.

Regarding "AI" and "Study" Specifics:

The provided document is for a traditional medical device (a catheter), not a software-as-a-medical-device (SaMD) or an AI-powered diagnostic tool. Therefore, the concepts of "AI," "test set," "training set," "ground truth experts," "MRMC study," "standalone algorithm," and "data provenance" (in the context of clinical images/data for AI inference) are not applicable to this submission.

Here's why and where those elements would typically appear if it were an AI device:

No AI Component: There is no mention or indication of artificial intelligence, machine learning, or any computational algorithm for analysis or decision-making. This is a physical plastic device.
No Test/Training Sets (in the AI sense): The "testing" involved bench testing of the physical properties and performance of the catheter (e.g., flow rates, material compatibility, strength, radiopacity, sterilization effectiveness), not an evaluation of an algorithm's classification or detection performance on a dataset.
No Experts for Ground Truth: No experts were needed to establish ground truth for an AI model because there is no AI model. The "ground truth" here is adherence to engineering specifications and performance benchmarks derived from industry standards.
No Adjudication Method: Not applicable for a physical device's bench testing.
No MRMC Comparative Effectiveness Study: An MRMC study compares human reader performance (with and without AI assistance). Since there's no AI, this is irrelevant.
No Standalone Algorithm Study: There is no algorithm to study in standalone mode.
Type of Ground Truth: For this device, the "ground truth" is defined by the specifications for the device itself and the requirements outlined in the referenced standards. For example, a catheter either meets a certain radiopacity standard or it doesn't; its luer lock either conforms to ISO 594-2 or it doesn't.
No Training Set Sample Size/Ground Truth: Not applicable. Device components are manufactured to specifications and tested against those specifications, rather than "trained" on data.

In summary, while the document confirms that the device met all performance criteria of the tests performed and was deemed "substantially equivalent" to its predicates based on established scientific methods and standards, this is fundamentally different from the kind of performance validation expected for an AI/ML-driven device.

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