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The PowerPICC Catheter is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. The maximum infusion flow rate is 5mL/second for power injection of contral venous pressure monitoring, it is recommended that a catheter lumen of 20gauge or larger be used.

A family of peripherally inserted central catheters made from specially formulated and processed medical grade materials. Each PowerPICC® catheter has a kink resistant, reverse tapered design. Catheters are packaged in a tray with accessories for reliable long (greater than 30 days) or short (less than 30 days) term vascular access.

The provided document is a 510(k) summary for the PowerPICC Catheter. It focuses on demonstrating substantial equivalence to a predicate device through various performance tests, rather than providing details of a study with acceptance criteria for an AI/ML powered device. Therefore, much of the requested information (sample sizes, ground truth establishment, MRMC studies, standalone performance, training set details) is not applicable or available in this document.

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the successful completion of the listed tests, indicating that the device performed as expected under the specified conditions. The document states that the performance tests were conducted "in determining substantial equivalence" and that "the subject PowerPICC Family Catheters have been demonstrated to be substantially equivalent to the cited predicate and reference devices." This implies that the device met the acceptance criteria derived from these tests.

2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each test. It refers to "testing" in general. The data provenance is not mentioned, as these are in vitro and in vivo performance tests on the device itself, rather than studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These are physical and biological performance tests, not clinical studies requiring expert ground truth for interpretation of outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is for physical and biological performance testing, not interpretation of data by experts.

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 is not an AI/ML device, and no MRMC study was performed.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for these tests are the established scientific and engineering principles, material properties, and regulatory standards (e.g., ISO 10993-1, ISO 10555-1, ASTM F640-12, ISO 10555-3, FDA Guidance on Premarket Notification for Intravascular Catheters, ISO 80369-7, USP 788). The device's performance is measured against these defined benchmarks.

8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.

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The PowerMidline™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerMidline™ Catheters are suitable for use with power injectors.

The dual lumen PowerMidline™ catheters are a family of peripherally placed catheters made from radiopaque body-softening polyurethane materials. Each dual lumen PowerMidline™ catheter is designed with kink-resistant, reverse taper design. The dual lumen PowerMidline™ catheters are offered in a 4 F dual lumen (DL) and 5 F dual lumen (DL) configuration for reliable short term (less than 30 days) vascular access. These catheters are offered in 20 cm trimmable lengths. The dual lumen PowerMidline™ catheters are suitable for use with power injectors.

This document is a 510(k) summary for the PowerMidline Catheter (K162900) by Bard Access Systems, Inc. It describes the device, its intended use, indications for use, and a comparison to its predicate device (K153393). The document primarily focuses on demonstrating substantial equivalence to a previously cleared device, rather than defining and proving new acceptance criteria for an innovative device feature or algorithm.

Therefore, the requested information about acceptance criteria and a study proving a device-specific, newly established acceptance criteria cannot be fully extracted from this document in the way it's usually applied to a new AI/medical device. The document explicitly states: "The performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate device." and "when technological characteristics between the subject and predicate device were found to be identical, results of the performance testing conducted on the predicate device were applied to the subject device."

The "acceptance criteria" here are essentially "meets the performance requirements of the predicate device" or "meets the requirements of the specified ISO/FDA guidance documents."

However, I can extract the types of performance tests conducted and the standards/guidances used, which implicitly define what was considered acceptable performance.

1. Table of Acceptance Criteria and Reported Device Performance

Instead of explicit numerical acceptance criteria, the document states that the device "met all predetermined acceptance criteria" derived from various performance tests. The "reported device performance" is the confirmation that these implicit criteria were met, leading to a determination of substantial equivalence.

• 4 F DL = 4 mL/s
• 5 F DL = 7 mL/s
  (as implied by the statement "the subject device met all predetermined acceptance criteria" and the values provided in the comparison table.) |
  | Biocompatibility: The device materials must be biocompatible as per ISO 10993-1:2009. (Implicit criterion: The device must not cause adverse biological reactions when in contact with the body). | "Per ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process, a biocompatibility evaluation was performed based upon the modifications made to develop the subject device." - Met. |
  | Risk Management: The device must comply with risk management procedures as per BS EN ISO 14971:2012. (Implicit criterion: Identified risks must be acceptably managed and mitigated). | "Risk management, including a failure modes and effects analysis (FMEA), of the subject device was conducted in accordance with BS EN ISO 14971:2012, Medical Devices – Application of Risk Management to Medical Devices." - Met. |

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify an exact "sample size" for the performance tests in terms of number of catheters tested for each criterion. It simply states that "performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence."

• Sample Size: Not explicitly stated as a numerical count for each test. The tests were performed on "the subject device" which includes 4 F DL and 5 F DL configurations.
• Data Provenance: The tests were conducted internally by Bard Access Systems, Inc. ("BAS Internal Protocols/Procedures"). This implies the data is prospective in nature, generated specifically for this submission, rather than retrospective clinical data. The country of origin is implicitly the USA, where the manufacturer is located.

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

Not applicable in the context of this device. This is a physical medical device (catheter), and the "ground truth" for its performance is established through objective engineering and biological performance testing against recognized standards (ISO, FDA guidance). There is no "ground truth" derived from expert interpretation of data in the way one would for an AI diagnostic algorithm.

4. Adjudication Method for the Test Set

Not applicable. This concept is relevant for studies involving human interpretation or clinical outcomes where discrepancies need to be resolved. Performance testing of a physical device against standards does not typically involve adjudication in this sense. The acceptance relies on the measured performance meeting the predefined (or implicitly defined by the standard) thresholds.

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 is a physical medical device (catheter), not an AI algorithm intended for interpretation by human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance is not relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance is established by:

• Compliance with recognized international standards (e.g., ISO 10555-1:2013, ISO 10993-1:2009, BS EN ISO 14971:2012).
• Compliance with FDA Guidance documents (e.g., "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995").
• Internal protocols and procedures developed by the manufacturer, which would be designed to ensure the device meets its design specifications and is safe and effective for its intended use.

Essentially, the "ground truth" is adherence to established engineering, materials, and biological performance specifications and regulatory requirements.

8. The sample size for the training set

Not applicable. This is a physical device submission; there is no "training set" in the context of machine learning or AI models. The design and manufacturing processes are analogous to a training process, leading to the final device design.

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

Not applicable. As there is no training set in the AI sense, there is no ground truth establishment for it. The development of the device's design (analogous to "training") is guided by medical necessity, engineering principles, material science, regulatory requirements, and feedback from previous predicate devices. The "ground truth" for the predicate device would have been its demonstrated safety and effectiveness in previous clearances.

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The PowerPICC Provena Catheters are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

Bard Access Systems, Inc.'s PowerPICC Provena Catheters are sterile, single use devices designed to provide access to the patient's vascular system. The devices are intended for short- or long-term use (>30 days) to sample blood and administer fluids intravenously. The catheters are capable of central venous pressure monitoring, and can withstand power injection of contrast media. The catheters are peripherally inserted central catheters (PICC) and utilize the same placement technique as the predicate devices.

The subject devices included in this notification are of varying French size and catheter configuration types, as summarized in the table below.

Summary of Subject Devices
French size (Number of Lumens)
Catheter Configuration
PowerPICC Provena Catheters
3 French Single Lumen (SL)
4 French Dual Lumen (DL)

The following device descriptors apply to all French sizes and configurations of the subject catheters:

• Catheters are open-ended, radiopaque polyurethane;
• Catheters have a reverse taper design;
• Catheter shaft tubing is marked with depth indicators, with "0" indicated to serve as a reference for the catheter insertion point;
• Purple colorant is included in the catheter material 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; and
• Catheter extension leg, luer hub, junction, and clamp ID tags are printed with markings to identify the catheter as PowerPICC Provena Catheters, and include information to facilitate proper use of the device.

The subject devices are provided sterile in basic interventional radiology (IR) as well as basic, full, and max barrier nursing PICC kits with legally marketed components to assist in the placement procedure. These kits are available in both standard and small patient versions.

The provided document describes the acceptance criteria and a detailed study for the C.R. Bard, Inc. PowerPICC Provena Catheters (K162443). This is a medical device, and the study involves a series of performance tests to demonstrate substantial equivalence to a predicate device, rather than a clinical study evaluating AI performance.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comprehensive list of verification/validation methods and their corresponding risk acceptability criteria. The reported performance for all these tests is a general statement that the device met all predetermined acceptance criteria.

The document explicitly states: "The subject devices met all predetermined acceptance criteria derived from the above listed references and demonstrated substantial equivalence as compared to the cited predicate device."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (number of devices tested) for each individual test. It generally references "Bard internal standards and procedures" and relevant ISO standards (e.g., ISO 10555-1:2013) for the testing methodology. These standards typically define acceptable sample sizes for device testing.

The data provenance is implied to be from in-house testing conducted by Bard Access Systems, Inc. There is no mention of country of origin for data if it were to be from external sources, nor does it specify if the data is retrospective or prospective, as this is a device performance study rather than a clinical trial.

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

This type of information (number and qualifications of experts) is not relevant for this device performance study. The ground truth for these tests is established by objective, measurable engineering and material science standards and physical properties, not by expert interpretation.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1, none) are typically used in clinical studies or studies involving human assessment of data. This document describes a battery of engineering and material science tests. Therefore, no adjudication method as described for clinical data interpretation is applicable or mentioned. The "adjudication" is inherent in the objective measurement against established criteria.

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

No, a multi-reader multi-case comparative effectiveness study was not done. This document describes the safety and performance testing of a medical device (intravascular catheter), not an AI system. Therefore, there is no mention of human readers, AI assistance, or effect sizes related to AI.

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

No, a standalone algorithm performance study was not done. This document pertains to the physical performance of a medical catheter, not an algorithm or AI system.

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

The "ground truth" for the tests described is based on objective, measurable engineering and material properties, and established industry standards. Examples include:

• Physical measurements: OD, ID, length, flow rates, burst pressure, tensile strength.
  • Reference: Dimensional Test, Implantable Length, Extension Leg Length, Burst Test, Hydraulic Catheter Burst Test, Extension Leg Burst Test, Power Injection Maximum Flow Rate, Assembly Tensile Test, Shaft Tensile Test, Suture Wing Integrity Test, Priming Volume, Gravity Flow, Pump Flow, Kink Diameter Test, Taper Length.
• Chemical/Biological properties: Biocompatibility outcomes (e.g., absence of biological hazard, lack of sensitization, cytotoxicity, irritation, hemolysis).
  • Reference: Biocompatibility Testing, Mechanical Hemolysis Test.
• Functional performance: Absence of leaks, tip stability during power injection, ability to remove stylets easily, adherence of printing.
  • Reference: Clamp Engagement, Leak Test, Catheter Collapse Test, Power Injection Conditioning, Tip Stability Test, Stylet Drag Test, Catheter Printing.
• Compliance with published standards: ISO 10555-1:2013 and FDA guidance documents.

8. The sample size for the training set

This is not applicable. This is a device performance study, not an AI model development or validation study. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for an AI model in this document.

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