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The Trio-CT® Triple Lumen Catheter is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis and apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring.
• The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.

The Trio-CT® Triple Lumen Catheter is a short-term (less than 30 days) dialysis catheter made of thermosensitive polyurethane. The catheter has three separate lumens allowing continuous blood flow. The venous (blue) and arterial (red) lumens may be used for hemodialysis and apheresis treatments. The middle (purple) lumen is independent from the two dialysis lumens, and may be used for intravenous therapy, power injection of contrast media, central venous pressure monitoring, blood draws and infusion of medications. The catheter is available with straight or curved extensions in a variety of lengths to accommodate physician preference and clinical needs. The attachable suture wing can be used to provide additional catheter securement and to minimize movement at the exit site.

The provided text describes the submission of a medical device, the "Trio-CT® Triple Lumen Catheter w/ Curved Extensions," for FDA 510(k) clearance, asserting its substantial equivalence to a predicate device, the "Trio-CT™ Triple Lumen Catheter." The document focuses on regulatory compliance and does not detail a study proving the device meets specific acceptance criteria in the context of an AI/human-in-the-loop performance study.

Therefore, many of the requested elements for an AI evaluation study, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity, AUC), sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI training sets, are not applicable to this document. This document pertains to the regulatory clearance of a physical medical device, not an AI software component.

However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish its substantial equivalence.

Here's the relevant information based on the provided text:

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

The document doesn't explicitly state "acceptance criteria" in the format typically used for performance studies (e.g., sensitivity, specificity thresholds). Instead, it compares the technical specifications and performance characteristics of the subject device to its predicate to demonstrate substantial equivalence. The "acceptance criteria" are implied to be that the subject device's performance is comparable to or better than the predicate device across various technical and performance specifications.

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

This information is not applicable. The document describes non-clinical testing for a physical medical device, not a test set for an AI algorithm. The performance testing was "Design validation performance testing... leveraged from the predicate device manufactured by Medical Components, Inc." and "Design verification performance testing was completed to confirm performance criteria of the subject device." No specific sample sizes for these tests are mentioned in the provided text, nor is data provenance in the context of patient data described.

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 as this document does not concern an AI/algorithm where human expert ground truth would be established.

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

This information is 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:

This information is not applicable.

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

This information is not applicable.

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

The "ground truth" for this device's performance comes from adherence to established technical specifications and performance characteristics, and the results of various non-clinical tests. These include:

• Biocompatibility Evaluation: This involved specific tests like ISO Muscle Implantation, USP Rabbit Pyrogen, ASTM Hemolysis, SC5b-9 Complement Activation Assay, ISO Guinea Pig Maximization Sensitization, ISO Intracutaneous, Cytotoxicity Study, ISO Acute Systemic Toxicity, ISO Systemic Toxicity in Rat, Bacterial Reverse Mutation, Genotoxicity: Mouse Lymphoma Assay, Infrared Spectroscopy, Mechanical Hemolysis Testing, and In Vivo GLP 30 Day Thromboresistance Study. These tests provide "ground truth" regarding the material's safety and biological interactions.
• Performance Testing: This refers to design verification tests to confirm the device meets its specified technical characteristics (e.g., Catheter French Size, Inner Diameters, Priming Volume, Power Injection Pressure, Flow Rate vs. Pressure). The "ground truth" here is the direct measurement of these physical properties.

8. The sample size for the training set:

This information is not applicable. The document focuses on regulatory clearance of a physical medical device, not an AI algorithm.

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

This information is not applicable.

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The Symetrex® Long Term Hemodialysis Catheter & Symetrex® Long Term Hemodialysis Catheter with Sideholes is a symmetric tip dual lumen catheter designed for chronic hemodialysis and apheresis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral placement.

Long term, greater than 30 days, vascular access for Hemodialysis and Apheresis treatments.

The Symetrex® Long Term Hemodialysis Catheter & Symetrex® Long Term Hemodialysis Catheter with Sideholes is a chronic, 15.5 French, dual lumen, radiopaque catheter made of polyurethane. It has a polyester retention cuff and two female luer adapters. The retention cuff promotes tissue ingrowth to anchor the catheter in the subcutaneous tunnel. The luer adapters are identical in color to indicate the reversibility of this catheter. This catheter features symmetrical side channels with a distal tip configuration designed to separate the intake flow from the output flow in both directions.

The provided document is a 510(k) summary for a medical device, the Symetrex® Long Term Hemodialysis Catheter & Symetrex® Long Term Hemodialysis Catheter with Sideholes. It states that the device is substantially equivalent to a previously cleared predicate device.

However, this document does not contain the kind of detailed information requested regarding acceptance criteria and a study proving device performance, particularly related to AI/software performance metrics like sensitivity, specificity, or human reader improvement. The "performance testing" referenced in the document (Table 6.2) refers to non-clinical bench testing and adherence to standards for physical properties, materials, packaging, and biocompatibility, not a clinical study or a study involving AI with human experts.

Therefore, I cannot provide an answer to your request based on the provided text. The document focuses on demonstrating substantial equivalence through non-clinical testing of the physical catheter and its materials.

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The Duo-Flow Side x Side Double Lumen Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.

The Duo-Flow Side x Side Double Lumen Catheter is a non-implanted hemodialysis catheter with two lumens. The red adapter connects to the proximal lumen for "arterial" outflow, and the blue adapter connects to the distal lumen for "venous" return. The catheter is available in various sizes and configurations (curved or straight extensions).

This document describes the premarket notification (510(k)) for the Medcomp® Duo-Flow® Side x Side Double Lumen Catheter. It outlines the device's characteristics, its intended use, and its substantial equivalence to a predicate device.

Key Point: The provided text does not describe an AI/ML medical device. It pertains to a physical medical device (a catheter) and therefore, the concepts of AI-specific acceptance criteria, test sets, ground truth establishment by experts, MRMC studies, standalone performance, and training sets for an AI model are not applicable.

The document primarily focuses on demonstrating the substantial equivalence of the Duo-Flow® Side x Side Double Lumen Catheter to a legally marketed predicate device (Mahurkar™ Acute Dual Lumen Catheter). This is a common pathway for medical device clearance in the US, where new devices are compared to existing ones that have already been cleared for marketing.

Instead of AI-specific performance metrics, the document details:

• Indications for Use: What the device is intended for (short-term central venous access for hemodialysis, apheresis, and infusion).
• Comparison to Predicate Device: A detailed table (Table 6.1) comparing various attributes of the subject device to the predicate device, including indications for use, definition, location of use, French size, catheter configuration, lengths, duration of use, sterilization method, number of lumens, patient population, insertion site, and kit type. The goal is to show that the new device is fundamentally similar to the predicate.
• Bench/Performance Data/Non-Clinical Testing: This section (Table 6.2) lists the applicable standards and performance testing conducted on the physical device to ensure its safety and effectiveness. These are primarily engineering and material tests, not clinical performance studies comparing diagnostic accuracy.
  • ISO 10555-1: Intravascular catheters (Air Leak, Liquid Leak, Peak Tensile Force, Gravity Flow)
  • ISO 11607-1 & -2: Packaging for terminally sterilized medical devices (Transit and Shelf Life testing)
  • ISTA 3A: Packaged products for parcel delivery system shipment (Transit Testing)
  • ISO 594-1 & -2: Conical fittings (Luer) for syringes, needles, etc. (Gauging, Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding, Stress Cracking)
• Biocompatibility: Tests conducted according to ISO 10993 standards to ensure the device is safe for biological contact. These include cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, subacute toxicity, genotoxicity, implantation, and hemocompatibility.

Therefore, to directly answer your request based on the provided text, while acknowledging that it's not an AI device:

1. Table of acceptance criteria and the reported device performance:

Since this is a physical medical device and not an AI/ML diagnostic tool, the "acceptance criteria" are based on meeting established engineering and biocompatibility standards, and demonstrating substantial equivalence to a predicate device. Performance is measured by successful completion of these non-clinical tests.

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

For this type of device, a "test set" in the AI sense is not applicable. The sample sizes for the various bench/performance/biocompatibility tests are typically determined by the standards themselves (e.g., specific number of catheters for tensile strength, or material samples for biocompatibility), and these details are not provided in this summary. The data provenance is from non-clinical bench testing and laboratory studies by the manufacturer (Medcomp®) to ISO and ASTM standards. It is not patient data from clinical trials.

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

Not applicable. "Ground truth" in the context of an AI device relates to verified diagnostic labels. For a physical medical device, the "ground truth" is established by the specifications of the device, the requirements of the standards, and the physical measurements/observations during testing. No external expert panel is described for establishing a "ground truth" for these engineering and biocompatibility tests.

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

Not applicable. This concept applies to human reader consensus for labeling data, which is not relevant here. The tests are defined by standard protocols with clear pass/fail 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:

Not applicable. This is not an AI-assisted device. The "effectiveness" is demonstrated by meeting performance standards and clinical equivalence to a predicate device, not by improving human reader performance.

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

Not applicable. This is not an algorithm.

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

Not applicable in the AI sense. The "truth" for this device's performance is derived from:

• Engineering specifications and design.
• Compliance with recognized international standards (ISO, ASTM).
• Direct physical measurements and observations during bench testing (e.g., flow rates, tensile strength, Luer taper dimensions).
• Laboratory analysis for biocompatibility endpoints.

8. The 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.

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The Trio-CT™ Triple Lumen Catheter is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis and apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring.

The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.

The Trio-CT™ Triple Lumen Catheter is a short-term (less than 30 days) dialysis catheter made of thermosensitive polyurethane. The catheter has three separate lumens allowing continuous blood flow. The venous (blue) and arterial (red) lumens may be used for hemodialysis and apheresis treatments. The middle (purple) lumen is independent from the two dialysis lumens, and may be used for intravenous therapy, power injection of contrast media, central venous pressure monitoring, blood draws and infusion of medications. The attachable suture wing can be used to provide additional catheter securement and to minimize movement at the exit site.

The provided text describes a medical device, the Trio-CT™ Triple Lumen Catheter, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria for a study proving device performance in the context of an AI/algorithm-based medical device.

The document is a 510(k) summary for a physical medical device (a catheter) and discusses its non-clinical testing, biocompatibility, and comparison to a predicate device. It lacks the specific details requested regarding acceptance criteria, study design for AI evaluation, ground truth establishment for AI, or sample sizes related to AI performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/algorithm. Based on the provided text, such a study was not conducted or reported for this device.

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The 12F Tri-Flow Triple Lumen Catheter is indicated for use in attaining Short-Term vascular access for Hemodialysis and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include subclavian vein as required. The 12F Tri-Flow Triple Lumen Catheter is intended to be used less than (30) days.

The 12F Tri-Flow Triple Lumen Catheter is a short term dialysis catheter made of thermosensitive polyurethane. The catheter has three separate lumens allowing continuous blood flow. The venous (blue) and arterial (red) lumens may be used for hemodialysis and apheresis treatments. The middle (clear) lumen is independent from the two dialysis lumens, and may be used for intravenous therapy, blood draws and infusion of medications.

The provided text describes a 510(k) premarket notification for a medical device, the "12F Tri-Flow Triple Lumen Catheter." It focuses on demonstrating substantial equivalence to a predicate device, not on proving that the device meets specific acceptance criteria through a clinical study or performance data akin to what would be provided for an AI/CADe device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a device performance study based on AI or CADe functionality cannot be extracted from this document, as the document details a traditional medical device submission based on comparison to a predicate device and bench/non-clinical testing.

The document's "Bench/Performance Data/Non-Clinical Testing" section (page 5-6) lists various ISO and ASTM standards and the "Performance Testing" conducted against them. These are primarily related to the physical, chemical, and biological properties of the catheter, such as:

• Air Leak, Catheter Leak, Extension-Hub, Extrusion-Hub, Gravity Flow (against ISO 10555-1)
• Shipping and Shelf Life testing (against ISO 11607-1, ISO 11607-2)
• Gauging (against ISO 594-1)
• Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding Stress Cracking (against ISO 594-2)
• Biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Subchronic Toxicity, Genotoxicity, Implantation, Hemocompatibility against ISO 10993 series and USP/OECD guidelines).

These are not "device performance" in the context of an AI-powered diagnostic or therapeutic device where sensitivity, specificity, accuracy, or human reader improvement are measured.

In summary, none of the specific questions regarding acceptance criteria, study design, sample sizes, expert involvement, or ground truth for an AI/CADe device performance study can be answered from the provided text. The document pertains to a K181175 submission for a physical medical device (catheter) based on substantial equivalence and non-clinical bench testing.

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