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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.

Ask a specific question about this device

The PowerPICC Provena Catheters with SOLO² Valve Technology 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.

Catheter Size Maximum Flow Rate
3 F Single Lumen 3 mL/sec
4 F Dual Lumen 5 mL/sec

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.

Catheter Size Maximum Flow Rate
3 F Single Lumen 3 mL/sec
4 F Dual Lumen 5 mL/sec

The PowerPICC Provena Catheters and PowerPICC Provena Catheters with SOLO2 Valve Technology 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, as clinically indicated, 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 device. The SOLO2 versions of the subject devices include a silicone valve on the proximal end.
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.

This document, K180548, is a 510(k) premarket notification for a medical device, specifically PowerPICC Provena Catheters and PowerPICC Provena Catheters with SOLO2 Valve Technology. The purpose of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials like a PMA. Therefore, the information provided focuses on comparative testing against established standards and the predicate device, rather than a clinical study with human patients, AI integration, or expert consensus on a test set in the traditional sense of an AI/ML clinical study.

Given the nature of this 510(k) submission for a non-AI/ML device, many of the requested criteria regarding AI/ML performance studies, such as multi-reader multi-case studies, ground truth establishment for clinical data, and training/test set sizes for algorithms, are not applicable.

However, we can extract information regarding acceptance criteria for the device's physical and functional performance and the study (testing) methods used to demonstrate that the device meets these criteria as part of the substantial equivalence determination.

Here's an interpretation based on the provided document:

Acceptance Criteria and Device Performance for PowerPICC Provena Catheters

Since this is a physical medical device (catheter) and not an AI/ML diagnostic or therapeutic system, the "acceptance criteria" listed here are for the device's physical and functional performance specifications. The "study" refers to the engineering and bench testing performed to verify these specifications, primarily comparing them to predicate devices and relevant ISO standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance tests conducted due to a material change in the extension leg (from Polycarbonate Polyurethane to Polyether Polyurethane). The acceptance criteria are generally "Risk Acceptability Criteria" as defined by internal standards (BAS) and ISO standards. The reported device performance is that the "subject devices met design requirements and demonstrated substantial equivalence." Specific numerical results are not provided in this summary, but the type of performance demonstrated is indicated.

• Test to demonstrate the peak tensile force of each test piece exceeds the minimum peak tensile force.
• Standard: ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters – Part 1: General requirements | Device "met design requirements and demonstrated substantial equivalence" to predicate device, implying the tensile strength criteria were met. |
  | Dimensional Characterization
• Test to demonstrate that the new material formulation conforms correctly to design tolerances of the extension legs.
• Standard: BAS internal standards and procedures | Device "met design requirements and demonstrated substantial equivalence," implying dimensional conformity. |
  | Leak Decay Testing
• Testing performed to evaluate that the catheter assembly will not leak when the distal end of the catheter is occluded.
• Standard: BAS internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters - Part 1: General requirements | Device "met design requirements and demonstrated substantial equivalence," implying no leaks or leaks within acceptable limits. |
  | Hydraulic Burst Testing
• Testing performed to evaluate that the catheter burst pressure exceeds the peak use pressure at maximum flow conditions.
• Standard: BAS internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters - Part 1: General requirements | Device "met design requirements and demonstrated substantial equivalence," implying burst pressure exceeded requirements. |
  | Biocompatibility Evaluation
• Evaluation conducted based upon the specific modification per ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process.
• Utilized information from reference device PowerPICC SOLO (K072230) which uses the same material for extension legs as subject devices. | Biocompatibility evaluation concluded device "met design requirements and demonstrated substantial equivalence." |
  | Risk Management
• Conducted in accordance with BS EN ISO 14971:2012, Medical Devices – Application of Risk Management to Medical Devices. | Risk management activities confirmed substantial equivalence. |

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

• Sample Size for Test Set: The document does not specify the exact number of units/parts tested for each performance test (e.g., Assembly Tensile Testing, Leak Decay Testing). Standard engineering practices for medical devices typically involve statistically significant sample sizes, but these are not disclosed in the 510(k) summary.
• Data Provenance: The testing appears to be in-house bench testing conducted by the manufacturer, Bard Access Systems, Inc. The document does not indicate country of origin for test data beyond the manufacturer's location in Salt Lake City, UT, USA. The testing is prospective in the sense that it was conducted specifically for this regulatory submission to demonstrate performance of the modified device.

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

This question is not applicable in the context of this device. "Ground truth" in this scenario refers to established engineering specifications and compliance with ISO standards (e.g., tensile strength minimums, leak limits). These are determined by published standards and internal design requirements, not by expert human interpretation of data in the way radiologists interpret images.

4. Adjudication Method for the Test Set

This question is not applicable. As the "test set" involves physical and functional performance testing against objective criteria (e.g., burst pressure, tensile strength), there is no need for human adjudication of results in the way image interpretation might require. The results are quantitative measurements compared against predefined thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This question is not applicable. This device is a physical catheter, not an AI-assisted diagnostic or therapeutic system. Therefore, an MRMC study related to human reader performance with or without AI assistance was not performed.

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

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

7. The Type of Ground Truth Used

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

• International Standards: e.g., ISO 10555-1:2013 (for intravascular catheters), ISO 10993-1:2009 (for biocompatibility), BS EN ISO 14971:2012 (for risk management).
• Internal Manufacturer Specifications and Procedures: ("BAS internal standards and procedures").
• Comparison to Predicate Device Performance: The primary method for 510(k) clearance is demonstrating substantial equivalence to a predicate device that has previously met these standards.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of a physical medical device. This is not an AI/ML product.

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

This question is not applicable. As there is no training set, there is no ground truth for it.

Ask a specific question about this device

The PowerPICC Provena Catheters with SOLO² Valve Technology 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 with SOLO² Valve Technology are sterile, single use devices designed to provide access to the patient's vascular system. The devices are intended for long or short-term use, as clinically indicated, 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 device. The subject devices include a silicone valve on the proximal end. 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
Catheter Configuration | French size (Number of Lumens)
PowerPICC Provena Catheters with SOLO² Valve Technology | 3 French Single Lumen (SL)
PowerPICC Provena Catheters with SOLO² Valve Technology | 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 incorporate a silicone valve on the proximal end;
● 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;
● Catheter extension legs, luer hubs, and junction are printed with markings to identify the catheter as PowerPICC Provena Catheters with SOLO² Valve Technology, and include information to facilitate proper use of the device.

The subject devices are provided sterile in basic interventional radiology (IR) kits, 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 text describes specific performance tests conducted for the PowerPICC Provena Catheters with SOLO² Valve Technology to demonstrate substantial equivalence to predicate devices, rather than an AI/ML medical device. Therefore, the information provided does not align with the request to describe acceptance criteria and a study proving an AI/ML device meets those criteria.

However, based on the provided text, I can infer the "acceptance criteria" from the "Risk Acceptability Criteria (Acceptance Criteria of Test)" column and the reported performance from the "Verification / Validation Method" column. The study described is a series of in-house and standard-based performance tests, not an MRMC or standalone AI study.

Here's an interpretation based on the provided content, acknowledging its limitations regarding AI/ML:

This document describes the testing and verification of a medical catheter, not an AI/ML-driven device. Therefore, many of the requested criteria specific to AI/ML systems (sample size for test/training sets, data provenance, expert ground truth, MRMC studies, effect size, standalone performance) are not applicable or cannot be extracted from the provided text.

However, I can extract the acceptance criteria and stated performance for the catheter device as presented:

1. Table of Acceptance Criteria and Reported Device Performance

The document 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."

AI/ML Specific Questions (Cannot be answered from the provided text as it's not an AI/ML device)

2. Sample sizes used for the test set and data provenance: Not applicable. This is a physical device.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth for a physical device is established through physical and mechanical testing against standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this physical device is established through meeting material, mechanical, and functional performance specifications defined by internal standards, ISO standards (e.g., ISO 10555-1:2013), and FDA guidance documents.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI model.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

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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The PowerPICC® EtOH Catheter is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy including prolonged exposure to intraluminal solutions containing up to 70% ethanol, power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapy, use a 4 French or larger catheter. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

The PowerPICC SOLO® EtOH Catheter is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy including prolonged exposure to intraluminal solutions containing up to 70% ethanol, power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapy, use a 4 French or larger catheter. 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® EtOH and PowerPICC SOLO® EtOH 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 compatible with intraluminal solutions containing up to 70% ethanol, 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
Catheter Configuration | French size (Number of Lumens)
PowerPICC® EtOH | 4F (Single Lumen (SL))
| 5F (Dual Lumen (DL)) FT
| 5F (Triple Lumen (TL))
PowerPICC SOLO®2 EtOH | 4F (Single Lumen (SL))
| 5F (Dual Lumen (DL)) FT
| 5F (Triple Lumen (TL))

The subject catheters will be packaged with legally marketed components used in the placement procedure.

The following device descriptors apply to all French sizes and configurations of the subject Bard Access PowerPICC® EtOH and PowerPICC SOLO®2 EtOH Catheters:

• The catheters are open-ended, radiopaque polyurethane;
• The catheters have a reverse taper design;
• Each catheter configuration has one power injectable lumen;
• Catheter shaft tubing is marked with depth indicators, with "0" indicated to serve as a reference for the catheter insertion point;
• Catheters are provided sterile in basic interventional radiology (IR), and basic, full, and max barrier nursing PICC configurations with legally marketed kit components;
• 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;
• Yellow colorant was added to the catheter junction material to provide the catheter with an appearance that allows the end user to differentiate Bard's ethanol compatible catheters from other catheters not compatible with ethanol;
• The catheter extension leg, luer hub, junction, and clamp ID tags are printed with markings to identify the catheter as PowerPICC® EtOH or PowerPICC SOLO®2 EtOH, and include information to facilitate proper use of the device; and
• The PowerPICC® EtOH catheter clamp and PowerPICC SOLO®2 EtOH luer are labeled with EtOH to indicate ethanol compatibility.

The following device descriptors apply to all French sizes of the subject Bard Access Systems PowerPICC® EtOH Catheters:

• Yellow colorant was added to the catheter extension leg clamp material to provide the catheter with an appearance that allows the end user to differentiate Bard's ethanol compatible catheter from other catheters that are not compatible with ethanol.

The following device descriptors apply to all French sizes of the subject Bard Access Systems PowerPICC SOLO®2 EtOH Catheters:

• The PowerPICC SOLO®2 EtOH catheter is a clampless, proximally valved catheter, and
• Yellow colorant was added to the lower portion of the luer hub to identify the catheter as a PowerPICC SOLO®2 EtOH catheter that is ethanol compatible.

The following device descriptors apply to specific French sizes of the subject Device Bard Access Systems PowerPICC® EtOH and PowerPICC SOLO®2 EtOH Description Catheters:

• The 5F TL catheter product labeling warns against power injection procedures through the two small lumens,
• The 5F TL catheter's usable length is 50 cm,
• The 5F DL FT and 4F SL catheter's usable length is 55 cm,
• The 5 F DL FT catheter has a double taper design, and
• The 5 F DL FT catheter product labeling warns against trimming the catheter in the "No Trim Zone" to maintain product functionality.

The provided FDA submission for the PowerPICC® EtOH and PowerPICC SOLO®2 EtOH Catheters does not contain a table of acceptance criteria and reported device performance in the typical format one might expect for a detailed performance study. Instead, it states that "The subject devices met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate devices."

The submission describes the types of tests performed and the standards referenced, implying that the acceptance criteria are linked to these standards and the performance of the predicate device. However, it does not explicitly list the specific numerical acceptance criteria (e.g., "burst pressure > X psi") or the exact reported performance values.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned above, a direct table is not present. The document generally states that "The subject devices met all predetermined acceptance criteria... and demonstrated substantially equivalent performance." The acceptance criteria would have been derived from the referenced standards and safety/performance tests.

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated for any of the tests. The document mentions "Verification and validation tests have been performed," but does not provide specific sample quantities (e.g., number of catheters tested for burst pressure).
• Data Provenance: The tests are referred to as "in-house protocols" performed by Bard Access Systems. The country of origin is not specified but implicitly would be the USA given the company's address and FDA submission. The nature of these tests (retrospective or prospective) is not discussed but for device performance tests, they would inherently be prospective (i.e., conducted on newly manufactured devices).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information (expert review for ground truth) is typically relevant for AI/ML device submissions, particularly those involving image analysis or diagnostic interpretation. For a physical medical device like a catheter, "ground truth" is established by direct physical, chemical, and biological testing against established standards and validated methods. Therefore, this section is not applicable in the context of this device and submission. The "experts" would be the engineers, scientists, and technicians conducting and evaluating the performance and safety tests, and their qualifications are not detailed in this submission.

4. Adjudication method for the test set

Similarly, adjudication methods (like 2+1 or 3+1 consensus) are typically for subjective interpretations, such as clinical reads in AI/ML performance studies. For physical device performance tests, the results are generally objective and quantitative (e.g., a burst pressure value). Therefore, an explicit adjudication method is not applicable to the performance and safety tests described here. Results are evaluated against predetermined acceptance 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

An MRMC study is relevant for AI-assisted diagnostic devices. This submission pertains to a physical intravascular catheter. Therefore, an MRMC study was not conducted, and this section is not applicable.

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

This refers to the performance of an AI algorithm without human involvement. Since this is a physical medical device, not an AI/ML algorithm, a standalone algorithm performance study was not applicable and therefore not done.

7. The type of ground truth used

For this physical medical device, the "ground truth" for showing it meets acceptance criteria is established through:

• Engineering Specifications: Conformance to dimensional tolerances, material composition, etc.
• Validated Test Methods: The results of performance tests (e.g., burst pressure, flow rate, tensile strength) conducted according to recognized industry standards (ISO, ASTM) and internal protocols.
• Biocompatibility Standards: Assessment against the criteria outlined in the ISO 10993 series for biological safety.
• Predicate Device Performance: The primary comparison for substantial equivalence relies on demonstrating that the new device performs similarly to or better than legally marketed predicate devices, especially for existing functionalities. For new functionalities (like ethanol compatibility), dedicated tests (e.g., material degradation after ethanol exposure, though not explicitly detailed here) would establish its ground truth against the claim.

8. The sample size for the training set

This question relates to the development of AI/ML models. Since this submission is for a physical medical device and does not involve AI/ML, there is no training set in this context, and thus no sample size for a training set.

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

Again, this is applicable to AI/ML device development. As there is no AI/ML component, there is no training set and therefore no ground truth established for a training set in this context.

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An extension set to be used as an extension to the intravascular administration set used for fluid delivery through Bard proximally valved catheters. The extension set will connect the IV administration set to the catheter.

The Extension Set is designed for Bard proximally valved catheters and attaches to the end of the catheter hub for use in the administration of fluids. The Extension Set opens the valve to facilitate central venous pressure monitoring and/or blood sampling. Extension Sets are packaged individually for single use for a period no longer than 96 hours.

The provided submission describes non-clinical performance testing for the "Extension Set for Bard® Proximally Valved Catheters." This is a medical device for fluid administration, not an AI/ML powered device, therefore many of the requested categories are not applicable.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for each specific test. The testing is described as "bench performance testing," which implies laboratory-based testing of manufactured devices. There is no information regarding the country of origin of data or whether it was retrospective or prospective, as no human data was involved.

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

Not applicable. This device is an extension set for catheters, and the testing involved bench performance criteria, not medical image interpretation or clinical outcomes requiring expert ground truth.

4. Adjudication Method for the Test Set

Not applicable. There was no expert adjudication process described as the testing was non-clinical bench testing against predetermined engineering specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML device, and no MRMC study or human reader performance evaluation was conducted or is relevant for this type of device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not an algorithmic device. The performance evaluation focuses on the physical properties and functionality of the extension set itself.

7. Type of Ground Truth Used

The "ground truth" for this device's acceptance criteria are established engineering, mechanical, and safety standards and internal protocols (e.g., ISO standards for infusion equipment, Luer fittings, tensile strength requirements, leak integrity, and flow rates).

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As there is no training set mentioned.

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The PowerPICC® SV catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
The PowerPICC® SV 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. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

The subject PowerPICC® SV catheters are members of Bard Access Systems' PowerPICC® series of power injectable catheters. The PowerPICC® SV catheters are available in 3F single lumen and 4F dual lumen configurations. The catheter extension leg, luer hub and junction are printed with description markings to facilitate proper use of the device. The PowerPICC® SV catheters are provided in sterile kit configurations.

The provided text does not contain information about an AI device or a study comparing human readers with and without AI assistance. The document is a 510(k) summary for a medical device called the PowerPICC® SV Catheter, a peripherally inserted central catheter (PICC). It details the device's characteristics, intended use, indications for use, and a summary of verification and validation activities demonstrating substantial equivalence to predicate devices, but does not involve AI, image analysis, or multi-reader studies.

Therefore, I cannot fulfill most of your request regarding AI-related performance metrics and study details. However, I can extract the general acceptance criteria and the type of study conducted for the physical medical device as described.

Here's the information that can be extracted from the provided text:

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

• ISO 10555-1:2009, Sterile, single-use intravascular catheters, Part 1. General requirements
• BS/EN/ISO 10555-3:1996/Cor 1:2002, Sterile, single-use intravascular catheters, Part 3. Central venous catheters | "The subject PowerPICC® SV catheters met all predetermined acceptance criteria derived from the above mentioned references." |
  | Biocompatibility | - AAMI/ANSI/ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile | Implied to meet criteria, as stated "met all predetermined acceptance criteria." |
  | Sterilization | - AAMI/ANSI/ISO 10993-7:2008, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Results
• AAMI/ANSI/ISO 11135:2007, Sterilization of Healthcare Products Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | Implied to meet criteria, as stated "met all predetermined acceptance criteria." |
  | Design Validation | In-house protocols and design validation activities | "Design validation was conducted on the subject PowerPICC® SV configuration and yielded acceptable results." |
  | Risk Management | ISO 14971:2007, Medical Devices - Risk Management for Medical Devices (Failure Modes and Effects Analysis - FMEA) | "No new types of safety or efficacy questions were identified for the subject PowerPICC® SV catheters." (This indicates acceptable risk profile within regulatory norms) |
  | Flow Rate (Indications for Use) | Not a test, but stated as part of the intended use parameters. | 3 F Single Lumen: 1 mL/sec
  4 F Dual Lumen: 2.5 mL/sec |

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 states, "Tests were performed on sterilized, finished devices." However, it does not specify the sample size for the test set or the data provenance.

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)

Not applicable. This is a submission for a physical medical device, not an AI or diagnostic imaging device requiring expert ground truth for classification.

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

Not applicable. This is a submission for a physical medical device, not an AI or diagnostic imaging device requiring adjudication.

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 MRMC study was done, as this is not an AI device.

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

Not applicable. This is not an AI algorithm. The performance described is for the physical PowerPICC® SV Catheter itself.

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

For a physical device like a catheter, "ground truth" generally relates to adherence to physical specifications, material properties, sterility, and functional performance benchmarks (e.g., flow rates, tensile strength, biocompatibility). The document indicates performance was evaluated against "predetermined performance specifications" derived from various international standards (ISO, AAMI/ANSI) and FDA guidance documents. This can be considered the "ground truth" or benchmark against which the device's physical and functional attributes were measured.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this traditional medical device submission.

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

Not applicable, as there is no training set.

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The PowerPICC SOLO™ catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
The PowerPICC SOLO™ catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media and allows for central venous pressure monitoring. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

The PowerPICC SOLO™ catheter is a clampless proximally valved catheter. The PowerPICC SOLO™ catheters are open-ended radiopaque polyurethane. The PowerPICC SOLO™ catheters are offered in 4 Fr Single Lumen (SL), 5 Fr Single Lumen (SL), 5 Fr Dual Lumen (DL), 6 Fr Dual Lumen (DL), and 6 Fr Triple Lumen (TL) configurations. Catheter usable length is 55 cm. The catheter has 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. Catheters are provided sterile in basic and full PICC configurations with legally marketed kit components. 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' catheters. Lower portion of luer hub is blue to identify the catheter as PowerPICC SOLO™ catheter. The catheter extension leg, luer hub and junction were printed with markings to identify the catheter as PowerPICC SOLO™ and to include information to facilitate proper use of the device.

This document describes the premarket notification (510(k)) for the PowerPICC SOLO™ Catheter, specifically addressing its substantial equivalence to previously cleared predicate devices. The information provided heavily focuses on regulatory compliance, device description, and safety testing rather than a clinical study evaluating specific performance metrics against acceptance criteria that are typically found in AI/ML-based device submissions.

Therefore, many of the requested sections (e.g., acceptance criteria, test set details, expert ground truth, MRMC study, training set details) are not directly applicable or available from the provided text for this non-AI/ML device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This section is largely Not Applicable in the way it's typically understood for AI/ML device performance. For this medical device (a catheter), "acceptance criteria" and "performance" are framed in terms of meeting established industry standards and demonstrating substantial equivalence to predicate devices, rather than achieving specific numerical targets on a test set.

• FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995
• BS/EN/ISO 10555-1: 1997, Sterile, single-use intravascular catheters, Part 1. General requirements
• ISO 10555-1:2004, Sterile, single-use intravascular catheters, Part 1. General requirements, Amendment 2
• ASTM F640-79 (reapproved 2000), Standard Test Methods for Radiopacity of Plastics for Medical Use
• 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
• AAMI/ANSI/ISO 11135:1994, Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
• IEC 60601-2-34: 2000-10, Medical electrical equipment - Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
• AAMI TIR9: 1992, Evaluation of Clinical Systems for Invasive Blood Pressure Monitoring
• ANSI/AAMI BP22: 1994, Blood Pressure Transducers | Met. Performance testing was conducted in accordance with the listed documents and standards, yielding "acceptable safety & performance outcomes." (Study type: Laboratory testing against numerous specific standards). |
  | Substantial Equivalence | Demonstration of substantial equivalence in design, materials, sterilization, principles of operation, and indications for use to current commercially available/cited predicate devices. | Achieved. The device "met the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates." (Study type: Comparison to predicate devices and documentation of compliance with standards). |

2. Sample size used for the test set and data provenance

Not Applicable (N/A) for this type of device submission. The provided text details engineering and biocompatibility testing against established standards and predicate devices, not a test set of data (e.g., medical images for an AI algorithm). The provenance of data refers to the source of materials or components used in the device, rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable (N/A). This concept is for AI/ML models that rely on expert annotations for ground truth. This is a physical medical device.

4. Adjudication method for the test set

Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling for AI/ML ground truth.

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 (N/A). This is not an AI-assisted device, and thus, no MRMC study involving human readers with/without AI assistance was conducted or reported.

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

Not Applicable (N/A). This is a physical catheter, not an algorithm.

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

Not Applicable (N/A) in the context of clinical "ground truth" for diagnostic or prognostic endpoints. The "ground truth" for this device's performance is its adherence to established international and FDA medical device performance standards and its physical and material properties, as demonstrated through laboratory testing.

8. The sample size for the training set

Not Applicable (N/A). This device does not involve a "training set" in the context of machine learning.

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

Not Applicable (N/A). As there is no training set for an AI/ML algorithm, this question is not relevant.

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The PowerPICC® Catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

The PowerPICC® catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media and allows for central venous pressure monitoring. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

The 4 Fr SL PowerPICC® Catheters are open-ended radiopaque polyurethane. Catheter usable length is 55 cm. The catheter has 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. Catheters are provided sterile in basic and full PICC configurations with legally marketed kit components. 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 catheter extension leg, junction and clamp ID tag were printed with markings to identify the catheter as PowerPICC® and to include information to facilitate proper use of the device.

The provided text is for a 510(k) premarket notification for a medical device called the "4 Fr SL PowerPICC® Catheter." This is a regulatory submission for a medical device and not a study proving device performance against acceptance criteria in the way a clinical or AI performance study would.

Therefore, the requested information elements such as a table of acceptance criteria and reported device performance, sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models are not applicable to this document.

Instead, this document details the substantial equivalence of the 4 Fr SL PowerPICC® Catheter to predicate devices. Substantial equivalence means the device is as safe and effective as a legally marketed device (predicate device) and does not raise new questions of safety or effectiveness.

Here's a breakdown of what is contained in the document, which can be interpreted in relation to "acceptance criteria" for a regulatory submission of this type:

1. "Acceptance Criteria" (Regulatory Context) and "Reported Device Performance" (Substantial Equivalence Claims):

In the context of a 510(k), "acceptance criteria" are not reported as specific performance metrics against a threshold for a new study, but rather that the new device meets established standards and is substantially equivalent to predicates.

• Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995
• ISO 10555-1:1997, Sterile, Single-Use Intravascular Catheters, General requirements and Amendment 1
• ISO 10555-3:1997, Sterile, Single-Use Intravascular Catheters, Central venous catheters
• 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
• IEC 60601-2-34: 2000-10, Medical electrical equipment Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
• AAMI TIR9: 1992, Evaluation of Clinical Systems for Invasive Blood Pressure Monitoring
• ANSI/AAMI BP22: 1994, Blood Pressure Transducers
  Subject product testing yielded acceptable safety & performance outcomes. |
  | Sterilization (Meets standards) | EO sterilization adoption tests yielded acceptable results. |
  | Overall Substantial Equivalence (Regulatory Outcome) | The device "meets the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates." |

2. Sample size used for the test set and the data provenance:

• N/A. This is not a study reporting on a "test set" in the context of an AI/algorithm. Performance testing was done against established standards for medical devices, but specific sample sizes for these tests (e.g., how many catheters were mechanically tested) are not provided in this summary. The data provenance would be from laboratory and engineering testing, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• N/A. This refers to expert consensus for ground truth, which is not relevant for this type of medical device submission. The "ground truth" here is compliance with recognized engineering, biocompatibility, and sterilization standards, which are evaluated by technical experts and regulatory bodies.

4. Adjudication method for the test set:

• N/A. Not applicable, as there is no "test set" in the context of human expert review as in an AI study.

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:

• N/A. This device is a catheter, not an AI or imaging diagnostic tool. An MRMC study is not relevant.

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

• N/A. This device does not have an "algorithm-only" performance to assess.

7. The type of ground truth used:

• For the performance claims made:
  • Engineering/Laboratory Test Standards: Compliance with international and national standards (ISO, AAMI, IEC) for physical performance (e.g., flow rates, pressure resistance), biocompatibility, and sterilization.
  • Predicate Device Compliance: The "ground truth" for substantial equivalence is that the new device shares fundamental characteristics and performance with previously cleared, legally marketed predicate devices.

8. The sample size for the training set:

• N/A. This is not a machine learning or AI device, so there is no training set.

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

• N/A. Not applicable, as there is no training set.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a physical medical device. It relies on compliance with established regulatory standards and comparison to predicate devices, rather than the types of clinical or AI performance studies described in the prompt's questions.

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The PowerPICC® Catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

The PowerPICC® catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi.

The 6 FR TL PowerPICC® Catheters are open-ended radiopaque polyurethanc. . Catheter usable length is 55 cm. The catheter has 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. Catheters are provided sterile in basic radiology and nursing PICC configurations. 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 catheter has one power injectable lumen. The product labeling warns against power injection procedures through the two small lumens. The catheter extension legs, junction and clamp ID tags were printed with markings to identify the catheter as PowerPICC® and to include information to facilitate proper use of the device.

This document is a 510(k) Summary for the 6 Fr TL PowerPICC® Catheter, indicating it's a premarket notification for a medical device. The focus of the summary is on demonstrating substantial equivalence to predicate devices rather than proving specific device performance against detailed acceptance criteria from a comprehensive study.

Based on the provided text, the document states:

• Acceptance Criteria and Reported Device Performance: General statements are made that "The 6 Fr TL PowerPICC® catheter meets all the prodetermined performance acceptance criteria of the testing performed" and that "Performance data gathered in design verification testing demonstrated that the 6 Fr TL PowerPICC® catheter is substantially equivalent to the predicate devices." However, specific quantitative acceptance criteria or detailed reported performance metrics are not provided in this summary. The summary refers to compliance with various ISO standards and FDA guidance documents, implying that performance was evaluated against the requirements outlined in those documents.

A table of acceptance criteria and reported device performance cannot be generated from the given text because the specific criteria and corresponding performance metrics are not explicitly listed.

Here's an analysis of the other requested information based on the text:

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

• Sample size used for the test set: Not specified in the provided text.
• Data provenance: Not specified in the provided text. The testing was "in-house," implying it was conducted by Bard Access Systems, Inc.

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 information is not applicable and not provided. The study described is a device verification and validation study, not a study involving human interpretation of data where "ground truth" would be established by experts in the typical clinical sense (e.g., in an AI diagnostic device).

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

• Not applicable and not provided. This type of adjudication is relevant for studies involving human reviewers or AI interpretations, which is not the nature of this device's performance testing.

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, an MRMC comparative effectiveness study was not done. This document describes the 510(k) submission for a physical medical device (PICC catheter), not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant.

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

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

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

• Not applicable in the conventional sense of establishing ground truth for diagnostic accuracy. The "ground truth" for this device would be established by direct physical measurements and engineering tests to ensure the catheter meets design specifications (e.g., flow rates, pressure resistance, material compatibility, strength). The text mentions performance data was gathered from "design verification testing" based on international standards (ISO) and FDA guidance for intravascular catheters. This implies the "ground truth" was derived from predefined engineering and material science specifications and test methodologies rather than clinical outcomes or expert consensus on clinical images/data.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

• Not applicable, as there is no training set for a physical device.

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