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The Vector 4 " PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arterio-venous dialysis fistulae.

The Vector Catheter is not indicated for use in the coronary arteries or for placement of or post dilatation of stents.

The Vector" PTA Balloon Catheter is a high pressure, non-compliant balloon catheter with a radio-opaque coating on the balloon. The radio-opaque coating on the working length of the balloon minimizes or eliminates the need for using contrast solution to inflate the balloon. The radio-opaque coating delineates the working length of the balloon and provides continuous fluoroscopic visibility during balloon placement. Saline may be used to inflate the balloon without affecting visualization. Contrast mixture may be used at the discretion of · the physician.

It is a coaxial dual lumen over the wire balloon dilatation catheter. The central lumen, accommodates guide wires up to 0.035 inches in diameter while the outer lumen is the inflation'lument or the balloon. The catheter includes an atraumatic tip to ease advancement of the catheter, to and through the stenosis. The distal tip is visible under fluoroscopy.

The balloon is a high pressure composite balloon with a radio-opaque coating on the working length to help visualize placement within the lesion during both placement and inflation; without the use of contrast. The balloon's rated burst pressure is 30 atm.

The catheter is supplied sterile and non-pyrogenic. Different balloon sizes (5 mm to 10 mm) and catheter lengths (50 to 135 cm) are available. The proximal end of the catheter contains a hub with two female luer locks.

The device is compatible with 6-7F introducers. The introducer compatibility for each device size is listed on the device label itself. The materials used in the construction are biocompatible and latex free.

The modifications to the Vector TM PTA Balloon Dilatation Catherer are as follows.

• 1. The balloon will be coated with Parylene C coating, referred to throughout as Parylene, providing a natural lubricity for insertion and withdrawal through the introducer.
• 2. Each balloon catheter hub will be laser marked to include the balloon and introducer size, rated burst pressure and the product name, Vector" PTA. Balloon Catheter for customer convenience.
• 3. The balloon protector ID for the 5x40mm balloon was increased slightly.

There are no changes in the balloon catheter dimensions or significant changes in weight with these modifications ..

The provided text describes a 510(k) summary for the Vector4™ PTA Balloon Dilatation Catheter. The document outlines device modifications and performance testing but does not contain the detailed information requested regarding specific acceptance criteria values, sample sizes for test sets (beyond stating "all devices met"), ground truth establishment methods, expert involvement, or multi-reader multi-case studies.

Therefore, I cannot fully complete the requested table and answer all questions with the provided input. However, I can extract the available information and indicate where details are missing.

Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The specific numerical or qualitative thresholds for "performance specifications" for each test are not provided in the document.

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

• Sample Size for Test Set: The document states "All devices met the performance specifications" for the various tests. However, the exact sample size (number of devices) used for each test set is not specified.
• Data Provenance: The tests are described as "bench testing" and conducted on "the modified Vector™ PTA Balloon Dilatation Catheter." This implies the data is prospective (generated specifically for this submission) and likely from an in-house or contracted lab, representing a controlled testing environment, not clinical data provenance (country, retrospective/prospective).

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

• Not Applicable: This device is a medical catheter undergoing bench testing for physical and material performance, not an AI or diagnostic device that requires expert-established ground truth for image interpretation or diagnosis. Therefore, no experts for establishing ground truth are mentioned or applicable in this context.

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

• Not Applicable: As this is bench testing of a physical device, not a diagnostic interpretation or clinical outcome, adjudication methods for ground truth establishment are not relevant. Test results would be objectively measured against predefined engineering specifications.

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: This is a physical medical device (catheter), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not applicable and was not performed.

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

• Not Applicable: This is a physical medical device, not an algorithm.

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

• Not Applicable in the traditional sense: For a physical medical device's bench testing, "ground truth" refers to predefined engineering specifications, regulatory standards (e.g., ISO 10993-1 for biocompatibility), and design requirements. The device's performance is measured against these objective criteria.

8. The sample size for the training set

• Not Applicable: This submission describes the testing of a physical medical device, not the development or validation of an AI algorithm that would require a training set.

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

• Not Applicable: There is no training set for a physical medical device.

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The Vector " Thi PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arterio-venous dialysis fistulae.

The Vector Catheter is not indicated for use in the coronary arteries or for placement of or post dilatation of stents

The Vector" PTA Catheter is a high pressure, non-compliant balloon catheter with a radiopaque coating on the balloon. The radio-opaque coating on the working length of the balloon minimizes or eliminates the need for using contrast solution to inflate the balloon. The radioopaque coating delineates the working length of the balloon and provides continuous fluoroscopic visibility during balloon placement. Saline may be used to inflate the balloon without affecting visualization. Contrast mixture may be used at the discretion of the physician.

The Vector4™ PTA Balloon Dilatation Catheter is a coaxial dual lumen over-the-wire balloon dilatation catheter. The central lumen accommodates guide wires up to 0.035 inches in diameter while the outer lumen is the inflation lumen for the balloon. The catheter includes an atraumatic tip to ease advancement of the catheter to and through the stenosis. The distal tip is visible under fluoroscopy.

The balloon is a high pressure composite balloon with a radiopaque coating on the working length to help visualize placement within the lesion during both placement and inflation without the use of contrast. The balloon's rated burst pressure is 30 atm.

The catheter is supplied sterile and non-pyrogenic. Different balloon sizes (5 mm to 10 mm) and catheter lengths (50 to 135 cm) are available. The proximal end of the catheter contains a hub with two female luer locks.

The device is compatible with 6-7F introducers. The introducer compatibility for each device size is listed on the device label itself. The materials used in the construction are biocompatible and latex free.

Here's a breakdown of the acceptance criteria and the study information for the Vector™ PTA Balloon Dilatation Catheter, based on the provided text:

Acceptance Criteria and Reported Device Performance

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The r4 Duraspan™ and the Duraspan™ Ultra long-term dialysis catheter is indicated for attaining short and long term (>30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters 40 cm and longer are for femoral vein insertion. The ability of the Biomimetic Coating to reduce platelet adhesion and thrombus accumulation is supported exclusively by in-vitro and animal testing.

The Duraspan™ Dialysis Catheter is designed for patients with End Stage Renal Disease needing chronic hemodialysis. The catheter is inserted percutaneously through the Subclavian or Jugular veins and placed in the venous system of the patient. Once in place, the catheters two proximal luer connectors are connected to a hemodialysis machine's blood lines. The machine's pump draws blood through the proximal lumen, indicated with the red connector, removing blood from the patient. The blood is processed in the hemodialysis filter or apheresis centrifuge. The blood is then returned through the lumen, marked by a blue connector, exiting out the most distal tip. The tip of the catheter is staggered to reduce recirculation of the blood.

The catheters include female luer locking adapters and a tissue ingrowth cuff for fixing the catheters in a subcutaneous tunnel. The Duraspan™ kit includes a catheter and introduction components. The catheter is supplied sterile.

The Duraspan 114 product line has catheters in a 15.5 Fr dual lumen. The catheters come in a variety of lengths (24-55cm) for patient specificity and access preference.

The Duraspan 104 is similar to the Duraspan ™ Ultra with a reduced tip stagger to address the variability of the dimensions of the vena cava in patients allowing for appropriate positioning of the arterial and venous lumens within the vena cava and right atrium.

The provided text does not describe a study that uses AI or machine learning technology. It is a 510(k) summary for a medical device called the Duraspan™ Long-Term Hemodialysis Catheter. The document focuses on the substantial equivalence of this catheter to a predicate device, based on design, materials, sterilization, principles of operation, and performance testing against existing standards and test methods.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies, as these concepts are specifically relevant to AI/ML device evaluations and are not present in this document.

The document states:

• "The Duraspan ™ was thoroughly tested with tests based on existing standards and test methods and demonstrates that the Duraspan ™ is substantially equivalent to the listed predicates."
• "Based on indications for use, technological characteristics and performance testing the Duraspan™ catheters met the requirements for its intended use and the Duraspan™ is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates."

These statements indicate that the device met pre-defined requirements or standards, usually involving bench testing and potentially animal studies for physical and biological characteristics, to demonstrate substantial equivalence to a predicate device. However, specific acceptance criteria and performance metrics for an AI/ML system are not applicable here.

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The r4 Duraspan"10 long-term dialysis catheter is indicated for attaining short and long term (>30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters 40 cm and longer are for femoral vein insertion. The ability of the Biomimetic Coating to reduce platelet adhesion and thrombus accumulation is supported exclusively by in-vitro and animal testing.

The Duraspan™ Dialysis Catheter is designed for patients with End Stage Renal Disease needing chronic hemodialysis. The catheter is inserted percutaneously through the Subclavian or Jugular veins and placed in the venous system of the patient. Once in place, the catheters two proximal luer connectors are connected to a hemodialysis machine's blood lines. The machine's pump draws blood through the proximal lumen, indicated with the red connector, removing blood from the patient. The blood is processed in the hemodialysis filter or apheresis centrifuge. The blood is then returned through the lumen, marked by a blue connector, exiting out the most distal tip. The tip of the catheter is staggered to reduce recirculation of the blood.

The catheters include female luer locking adapters and a tissue ingrowth cuff for fixing the catheters in a subcutaneous tunnel. The Duraspan" kit includes a catheter and introduction components. The catheter is supplied sterile.

The Duraspan 114 product line has catheters in a 15.5 Fr dual lumen. The catheters come in a variety of lengths (24-55cm) for patient specificity and access preference.

The Duraspan 10 is similar to the Bard HemoGlide Star Series and the tip stagger is similar to the Arrow Step-Tip with the addition of a Biomimetic Coating that is identical to the coating on the Zeus Catheter.

The provided text describes a 510(k) premarket notification for a medical device, the Duraspan™ Long-Term Hemodialysis Catheter. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a diagnostic AI device typically would.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices for regulatory approval. This is a different type of evaluation.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance because this information is not present in the provided text. The document's purpose is to show the device is similar enough to already approved devices, not to establish novel performance metrics against a defined ground truth.

Here's an explanation of what the document does describe in relation to the prompt:

• Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in terms of quantitative metrics or a table of performance. The "acceptance criteria" for a 510(k) submission are that the device is "substantially equivalent" to predicate devices and raises "no new questions regarding safety or efficacy." The reported "performance" is that it "met the requirements for its intended use" through testing based on existing standards and test methods, demonstrating substantial equivalence.

• Sample Size Used for the Test Set and Data Provenance: Not applicable. The document refers to "testing" and "performance testing" but does not detail a specific "test set" of patient data in the way an AI diagnostic study would. The testing would likely involve bench testing, biocompatibility, and perhaps animal studies, but not a human subject "test set" for a diagnostic algorithm.

• Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts: Not applicable. There is no concept of "ground truth" establishment by experts in this context, as it's not an AI diagnostic device being evaluated for its accuracy.

• Adjudication Method for the Test Set: Not applicable.

• If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done: No. This type of study is for evaluating human performance with and without AI assistance for interpretation tasks, which is not relevant to a hemodialysis catheter.

• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is not an algorithm-based device.

• The Type of Ground Truth Used: Not applicable. For this catheter, the "ground truth" would be successful function and safety in a physiological environment, assessed through various engineering tests, biocompatibility tests, and potentially animal studies.

• The Sample Size for the Training Set: Not applicable. This is not an AI device that uses a "training set."

• How the Ground Truth for the Training Set was Established: Not applicable.

Summary based on the provided text:

The document outlines the regulatory basis for the Duraspan™ Long-Term Hemodialysis Catheter. It claims that the device:

• Met the requirements for its intended use.
• Is substantially equivalent in design, materials, sterilization, principles of operation, and indications for use to current commercially available catheters/cited predicates.
• Was thoroughly tested with tests based on existing standards and test methods.
• Raises no new questions regarding safety or efficacy.

The "study" or evaluation performed was a series of engineering and biocompatibility tests designed to demonstrate substantial equivalence to legally marketed predicate devices (HemoGlide Star Series, Zeus CT PICC, Arrow Step-Tip). The basis of approval is this demonstrated equivalence, not a direct measurement of diagnostic accuracy against a "ground truth" in human patients as would be expected for an AI diagnostic device.

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The r4 Pherocious 14 apheresis triple lumen catheter is designed for short and long term (>30 days) apheresis, intravenous infusion, blood sampling and CECT via the jugular veins or subclavian vein. The maximum recommended flow rate is 5 ml/sec for power injection of contrast media. The maximum pressure of the power injector utilized should not exceed 300 psi.

The r4 Vascular, Inc Pherocious™ is a family of apheresis triple lumen catheters designed to perform apheresis, intravenous infusion, blood sampling and power injection. The catheters, made of radiopaque polyurethane tubing are inserted via jugular, subclavian or femoral veins. Pherocious™ has a kink resistant, atraumatic, staggered tip design. The lumen with the purple connector, extension leg, and clamp may be used for CT injection as denoted by the text, "power injectable," printed on the extension leg. The remaining lumens with the red and blue connectors and blue and red or white clamps are for blood products. The catheters include female luer locking adapters and a tissue ingrowth cuff for fixing the catheters in a subcutaneous tunnel. The Pherocious™ kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic. The Pherocious 110 product line has catheters in 10.5 Fr and 12.5 Fr triple lumen. The catheters come in a variety of lengths for patient specificity. The Pherocious 10 is similar to Bard TriFusion with the addition of the ability to CECT inject that is substantially equivalent to the Zeus.

The provided text describes a 510(k) premarket notification for the r4 Vascular, Inc. Pherocious™ intravascular catheter. The submission asserts substantial equivalence to predicate devices and includes information about performance testing.

However, the provided text does not contain the specific details required to fully address all parts of your request, particularly regarding acceptance criteria and a detailed study report for AI/machine learning device performance. This document is for a medical device (catheter), not specifically an AI/ML diagnostic or prognostic tool. Therefore, the questions related to AI device performance (MRMC studies, standalone performance, training set, experts for ground truth) are not applicable or cannot be answered from this text.

Here's the information that can be extracted and a clear indication of what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states:

Missing Information:

• Specific numerical acceptance criteria for each test performed (e.g., tensile strength, flow resistance, leakage rates, etc.).
• Detailed quantitative results of the device performance against each specific criterion. The document only provides a high-level qualitative statement that criteria were met.

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

The document mentions "Performance testing was generated in accordance with the above referenced guidance document and standards."
However, no specific sample size for a test set (e.g., number of catheters tested) is provided.
No information on data provenance (e.g., country of origin, retrospective/prospective) is available, as this is a physical medical device, not a data-driven diagnostic.

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

Not applicable. This document describes a physical medical device (catheter) evaluation, not a study involving expert-established ground truth for an AI/ML algorithm.

4. Adjudication Method for the Test Set:

Not applicable. As above, this is for a physical device, not an AI/ML algorithm requiring expert adjudication of results.

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 section describes a physical medical device. No AI component is mentioned, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or reported.

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

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

7. The Type of Ground Truth Used:

For a physical device like a catheter, "ground truth" typically refers to established engineering principles, material science specifications, and performance requirements outlined in recognized standards (e.g., ISO, FDA guidance documents). For instance, burst pressure, tensile strength, flow rates, and biocompatibility are measured against predefined acceptable limits. The document states:

• "Testing was based on FDA guidance documents and recognized standards to evaluate the devices' performance."
• Referenced standards include: FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, ISO 10555-1:1997, ISO 594, ISO 10993 Part 1.

8. The Sample Size for the Training Set:

Not applicable. This relates to AI/ML devices. The Pherocious™ is a physical catheter, not an AI model requiring a training set.

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

Not applicable. As above, this is for a physical device, not an AI/ML algorithm.

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The Zeus™ CT PICC is indicated for short or long-term (less than or greater than 30 days) peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and central venous pressure monitoring. The maximum recommended infusion rate is 5 ml/sec for power injection of contrast media. The maximum pressure of the power injector utilized should not exceed 300 psi.

The r4 Vascular. Inc. Zeus™ CT PICC is a family of peripherally inserted central venous catheters designed to perform infusion, intravenous therapy, blood sampling, power injection of contrast media studies and central venous pressure monitoring. The catheters, made of radiopaque polyurethane tubing, are inserted peripherally. Each Zeus™ CT PICC has a kink resistant reverse tapered catheter design. The Zeus™ CT PICC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.

The Zeus™ CT PICC product line has catheters in 4 Fr and 5 Fr single lumen and 5 Fr and 6 Fr dual lumen.

The Zeus™ CT PICC is similar to HDC's V-Cath (Polyurethane) Power PICC (Power-V), with the addition of a Biomimetic Coating that is similar in performance to the Tyco Palindrome Emerald.

The provided text is a 510(k) summary for a medical device (Zeus™ CT PICC), which focuses on demonstrating substantial equivalence to predicate devices rather than detailing specific acceptance criteria and a comprehensive study report with the requested elements. Therefore, many of the requested details are not explicitly present in the provided document.

However, based on the information that is available, here's an attempt to answer your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that the device "met all established acceptance criteria for performance testing and design verification testing." However, specific quantitative acceptance criteria and their corresponding reported device performance values are not explicitly detailed in the provided text. The document refers to various standards (e.g., ISO 10555-1:1997, ISO 594, AAMI/ANSI/ISO 11135:1994, ISO 10993) that would contain these criteria, but doesn't list them or the specific results.

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

The document states, "Performance testing was generated in accordance with the above referenced guidance document and standards." However, the sample size used for the test set is not specified, nor is the data provenance (e.g., country of origin, retrospective or prospective). This type of detail is typically found in a full study report, not a 510(k) summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the given text. The evaluations mentioned are performance testing based on established standards, likely involving engineering or lab-based assessments rather than human expert opinion for ground truth.

4. Adjudication Method

This information is not provided. Given the nature of the testing described (performance testing against standards), formal adjudication methods like 2+1 or 3+1 by human experts would not typically apply.

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

No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence for a medical device (PICC catheter), not on evaluating the improvement of human readers with AI assistance. Therefore, no effect size of human improvement with AI is provided.

6. Standalone (Algorithm Only) Performance Study

No standalone algorithm performance study is mentioned. This device is a physical medical catheter, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance testing of this device would be the physical and chemical specifications outlined in the referenced international and FDA standards (e.g., ISO 10555-1 for intravascular catheters, ISO 594 for Luer taper, ISO 11135 for sterilization, ISO 10993 for biocompatibility). The device's performance was measured against these established standards to ensure safety and effectiveness.

8. Sample Size for the Training Set

This information is not applicable and not provided. The Zeus™ CT PICC is a physical medical device, not an AI algorithm that requires a training set.

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

This information is not applicable and not provided. As mentioned above, this is not an AI device.

In summary, the provided 510(k) summary focuses on regulatory compliance and demonstrating substantial equivalence through adherence to recognized standards and guidance documents for a medical device. It does not contain the detailed study information typically requested when evaluating an AI/ML algorithm or a diagnostic tool that relies on human interpretation.

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THE R4 VASCULAR INC. PEGASUS CT PICC IS INDICATED FOR SHORT TERM AND LONG-TERM PERIPHERAL ACCESS TO THE CENTRAL VENOUS SYSTEM FOR INTRAVENOUS THERAPY AND POWER INJECTION OF CONTRAST MEDIA. FOR BLOOD SAMPLING, INFUSION, OR THERAPIES, USE A 4F OR LARGER CATHETER. THE MAXIMUM PRESSURE OF INJECTORS USED WITH THE 5F AND 6F PEGASUS CT PICC CATHETER MAY NOT EXCEED 300PSI. MAXIMUM RECOMMENDED INFUSION RATE IS 5CC/SEC FOR 5F AND 6F CATHETER. THE MAXIMUM PRESSURE OF INJECTORS USED WITH THE 4F PEGASUS CT PICC CATHETER MAY NOT EXCEED 200PSI. MAXIMUM RECOMMENDED INFUSION RATE IS 4CC/SEC FOR A 4F CATHETER.

• The Pegasus CT PICC catheters are radiopaque polyurethane.
• Catheter usable length is 55 to 60 cm in length. It is available in a 4F/5F single lumen and 5F/6F dual lumen version.
• The catheter has a reverse taper design.
• Catheter lumen tubing is marked with depth markings for proper placement of the catheter during insertion.
• Catheters are provided sterile in basic radiology and nursing PICC configurations.
• The catheter has one power injectable lumen.
• Purple colorant was added to the catheter materials to distinguish it from other nono power injectable catheters and recognize it as a power injectable catheter.
• The catheter extension, ID rings are printed to identify the catheter as a Power Injectable Catheter to ensure proper use of the device.

The provided text describes the 510(k) summary for the r4 Vascular Inc. Pegasus CT PICC. It states that clinical studies were not considered necessary, because the device's substantial equivalence to a predicate device (Medcomp Pro-Line CT Power Injectable CVC Catheter, K053345) was demonstrated through in vitro testing. Therefore, there is no explicit study described that proves the device meets specific acceptance criteria as would be found in a clinical trial.

However, the document does list the standards and guidelines followed for verification and validation testing, implying that these standards contain the acceptance criteria for device performance. Since no direct performance values are given from such tests in the provided text, I will describe the type of acceptance criteria implied by the cited standards and the reported device characteristics that are intended to meet these criteria.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Pegasus CT PICC are implied by the conformance to the listed international and AAMI/ANSI/ISO standards. These standards typically set requirements for:

• Sterility: Ensuring the device is free from viable microorganisms.
• Biocompatibility: Ensuring the materials used are safe for contact with the human body.
• Physical and Chemical Properties: Requirements related to material strength, durability, patency, flow rates, and pressure limits under specified conditions.
• Labeling Accuracy: Ensuring critical information like power injection limits, catheter size, and intended use is clearly marked.

Since the submission relies on substantial equivalence to a predicate device and states that "The technological characteristics such as design and materials are identical to the predicate device," the reported performance is essentially that it meets the requirements of the predicate and the general standards.

No information regarding clinical study design elements like sample size, data provenance, expert consensus, adjudication methods, MRMC studies, or standalone algorithm performance is present, as no clinical studies were deemed necessary.

Here's why based on the document:

1. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used for a human-centric study. In vitro testing was performed. The data provenance for the materials is that they were "previously cleared for similar applications."
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth was established through in vitro testing against standards, not expert consensus on human data.
3. Adjudication method for the test set: Not applicable.
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: Not applicable. This device is a medical catheter, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical catheter, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the device's performance is compliance with international and AAMI/ANSI/ISO standards (e.g., ISO 10555, ISO 10993, AAMI/ANSI/ISO 11135), established through in vitro testing.
7. The sample size for the training set: Not applicable. This device is a medical catheter and was not developed using machine learning.
8. How the ground truth for the training set was established: Not applicable. This device is a medical catheter and was not developed using machine learning.

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