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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.

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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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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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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

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.

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

The Power PICC 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 Power PICC catheter may not exceed 300 psi.

The PowerPICC " Catheters are open-ended radiopaque polyurethane catheters. .
. Catheter size is 5 Fr DI, with 55 cm usable length.
. 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 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 the PowerPICC from other PICC 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 describes a 510(k) submission for the 5 Fr DL PowerPICC® Catheter, comparing it to a predicate device, the 6 Fr DL PowerPICC® Catheter. This is a medical device submission, primarily focused on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study or specific acceptance criteria with performance data in the typical sense of an AI/software as a medical device (SaMD) study.

Therefore, many of the requested points, especially those related to AI/SaMD specific studies (like MRMC studies, standalone algorithm performance, training set details), are not applicable to this 510(k) submission for a physical medical catheter.

However, I can extract information related to the performance data and the conclusion of substantial equivalence.

Here's a breakdown of the relevant information:

Acceptance Criteria and Device Performance

The document states that the new device (5 Fr DL PowerPICC® Catheter) underwent "Verification and validation testing...according to protocols based on the above referenced guidance document recommendations and standards, as well as in accordance with in-house protocols." It then concludes, "Performance data gathered in design verification testing demonstrated that the 5 Fr DL PowerPICC® catheter is substantially equivalent to the predicate 6 Fr DL PowerPICC catheter, and the risks associated with use of the new device were found acceptable when evaluated by FMEA."

And, "The 5 Fr DL PowerPICC® catheter meets all the predetermined performance acceptance criteria of the testing performed..."

Since this is a 510(k) for a physical medical device, the "acceptance criteria" are related to mechanical, material, and biocompatibility performance as outlined in the cited standards and guidance documents. The document does not list specific quantitative acceptance criteria values in a table, nor does it provide a table of reported device performance values. Instead, it provides a qualitative statement of meeting these criteria and substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

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

   • The document does not specify sample sizes for individual tests (e.g., how many catheters were tested for flow rate, burst pressure, etc.).
   • Data provenance is not explicitly mentioned (e.g., country of origin). The testing was done at Bard Access Systems, Inc.
   • The testing appears to be retrospective in the sense that it evaluates a manufactured device against established standards, rather than a prospective clinical trial.

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

   • This question is not applicable in the context of this 510(k) for a physical medical device. "Ground truth" established by experts is typically for diagnostic devices or AI, where a human expert provides the definitive diagnosis or assessment. For a catheter, the "ground truth" is defined by the physical and material specifications and performance against industry standards.

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

   • This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials, especially for evaluating diagnostic accuracy where multiple reviewers assess a case and consensus or a tie-breaker is needed. For product verification, performance is measured objectively against defined physical parameters.

4. 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. This is not applicable. An MRMC study is relevant for diagnostic devices, particularly those involving human interpretation of images or other data, often with AI assistance. This submission is for a physical intravascular catheter.

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

   • No. This is not applicable. This refers to AI algorithm performance.

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

   • The "ground truth" for this medical device submission is the engineering specifications, material properties, and performance requirements outlined in international standards (ISO, AAMI/ANSI) and FDA guidance documents, along with the demonstrated performance of the predicate device. Compliance is tested against these objective benchmarks.

7. The sample size for the training set:

   • This is not applicable. There is no "training set" in the context of a physical medical device 510(k) submission. This term relates to machine learning models.

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

   • This is not applicable, as there is no training set for this type of device submission.

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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. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

The Poly Per-Q-Cath PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling and allows for central venous pressure monitoring. For blood therapy, it is recommended that a 4 French or larger catheter be used. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

The Poly Per-O-Cath® Triple Lumen PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling and allows for central venous pressure monitoring. For blood therapy, it is recommended that a 4 French or larger catheter be used. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

PowerHohn and PowerLine Catheters are indicated for short or long term access to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, power injection of contrast media and allow for central venous pressure monitoring. The maximum recommended infusion rate is 5mL/sec. The maximum pressure of power injectors used with the PowerHohn and PowerLine catheters may not exceed 300 psi. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

Subject devices:

• Catheters range in French size from 3-5 Fr SL; 4-6 Fr DL and 6 Fr TL .
• Catheter usable length ranges from 40 -60 cm. .
• Catheters are open-ended catheters extruded from polyurethane material containing barium ● sulfate for radiopacity.
• The catheter extension legs are polyurethane extrusions. Extension legs are minimum 2.2 in. . in length to promote easy application of occlusive dressings. Each extension leg has a thumb clamp.
• The luer hub base material is Isoplast polyurethane. .
• The catheter has a reverse taper design .
• The user is informed of the gage size in product labeling and it is printed on the luer hub. .
• The 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 and are packaged with legally marketed kit components that are . preferred by clinicians

The provided document describes a 510(k) premarket notification for Central Venous Pressure Monitoring (CVPM) capability in various catheter devices, rather than a standalone device with extensive acceptance criteria and a study demonstrating its performance in a clinical setting against a ground truth.

The document focuses on demonstrating substantial equivalence to existing predicate devices for an expanded indication for use: "allows for central venous pressure monitoring." The key point is that the catheters themselves are not new, but their indicated use now includes CVPM. Therefore, the "acceptance criteria" and "study" are geared towards proving that the existing or slightly modified catheters are suitable for this additional function, specifically focusing on the catheter lumen size for effective CVPM.

Here's the breakdown of the information requested, 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 describe a test set in the traditional sense of a clinical trial with a specific number of patients or samples. The "testing" mentioned is bench testing (laboratory studies). Therefore, there is no information on:

• Sample size used for a clinical test set.
• Country of origin of data for a clinical test set.
• Retrospective or prospective nature of a clinical test set.

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

This information is not applicable as the document describes bench testing and design verification, not a clinical study involving human readers or expert consensus to establish a clinical "ground truth."

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on the device's capability for CVPM, not on human reader performance with or without AI assistance.

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 submission is for physical catheter devices, not AI algorithms.

7. The Type of Ground Truth Used

The "ground truth" used for evaluating the central venous pressure monitoring capability was based on recognized and un-recognized standards for invasive blood pressure monitoring equipment and transducers, likely involving physical measurements and comparisons in a controlled bench setting. This is best described as bench test performance against established engineering or medical device performance standards. It is not clinical pathology, expert consensus on images, or patient outcomes data.

8. The Sample Size for the Training Set

This information is not applicable. The document describes physical medical devices (catheters) and their expanded indications, not a machine learning model that would require a "training set."

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

This information is not applicable for the same reason as #8.

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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 5cc/sec. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi.

The PowerPICC Catheters are open-ended radiopaque polyurethane catheters. Catheter size is 5 Fr SL with 50 cm usable length. 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 PICC configurations. Purple colorants were added to the catheter materials to provide the catheter with an appearance that allows the end user to differentiate the PowerPICC from other PICC catheters. The catheter extension leg, junction and clamp ID tag were printed with markings to identify the catheter as Power PICC and to include information to facilitate proper use of the device.

The provided text is a 510(k) premarket notification for a medical device (PowerPICC™ Catheters) and does not describe an AI/ML powered device or a study involving such a device. Therefore, I cannot extract the requested information about acceptance criteria and studies related to AI/ML technology from this document.

The document discusses the substantial equivalence of the PowerPICC™ Catheter to a predicate device, focusing on its intended use, technological characteristics, and conformance to existing medical device regulations and standards. It mentions "verification testing" for performance but does not provide details on specific acceptance criteria, study methodologies, or AI/ML performance metrics.

For me to provide the requested information, the input text would need to describe a medical device that utilizes AI/ML, along with a study detailing its performance and acceptance criteria.

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