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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 Power Acute Triple Lumen Hemodialysis Catheter is indicated for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring and pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

The Power Acute Triple Lumen Hemodialysis Catheter is manufactured from a thermally reactive polyurethane material known for its rigidity at room temperature and softness at body temperature. This reactivity allows bedside insertion, while minimizing the risk of vein perforation and providing an overall improvement of patient comfort after insertion. The catheter cannula is radiopaque and incrementally marked to indicate the effective insertion length of the device in centimeters (cm). This cannula is extruded with three independent, non-communicating inner lumens. The lumens are made accessible within the cannula via luer-fitted silicone extension legs on the proximal end of the device, alongside a rigid polyurethane hub marked with the catheter's size in French (Fr) and effective insertion length that is fitted with a freely rotating suture wing. The clear outer extension legs are fitted with red and blue occlusion clamps, which are marked on either face with the lumen's priming volume in milliliters (mL), and respectively identify arterial and venous lumens. The medial, colored, extension leg is fitted with a purple occlusion clamp that is similarly marked with priming volume on its dorsal face, and marked with the maximum flow rate (in cubic centimeters [cc]) and injection pressure (in pounds per square inch [psi]) recommended for power-injected fluids on its ventral face. The distal end of the device is thermally bonded to a flexible, symmetrically tapered tip, which allows for direct outflow, and is skived on the radial and ulnar sides of the cannula.

The provided text is a 510(k) Premarket Notification Submission for a medical device: the "Power Acute Triple Lumen Hemodialysis Catheter." This document is primarily focused on demonstrating "substantial equivalence" of the new device to existing predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study or a study directly assessing AI performance.

Therefore, many of the specific details requested in your prompt regarding acceptance criteria, AI performance, ground truth establishment, expert adjudication, and MRMC studies are not available in this document because it describes a traditional medical device submission, not an AI/ML-enabled medical device submission.

However, I can extract information related to the device's performance testing and validation as described for a non-AI/ML device.

Here's an analysis based on the provided text, addressing what can be found and noting what is not applicable/present:

Acceptance Criteria and Study for Power Acute Triple Lumen Hemodialysis Catheter

This submission pertains to a traditional medical device (hemodialysis catheter), not an AI/ML-enabled device. As such, the "acceptance criteria" discussed are primarily related to general device performance and safety benchmarks, rather than specific AI performance metrics like sensitivity, specificity, or AUC, or human reader improvement with AI assistance. The "study" refers to bench testing and biocompatibility testing to ensure the device performs as intended and is safe.

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

The document lists various tests performed to ensure the device's safety and performance, demonstrating "substantial equivalence" to a predicate device. The acceptance criteria are implicitly the successful completion of these tests in accordance with recognized standards, showing that the new device performs comparably to or better than the predicate. The "reported device performance" is that it "met the minimum requirements" for these tests.

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

The document describes bench testing and biocompatibility testing. This type of data does not typically involve a "test set" in the context of patient data for AI model validation. The sample sizes for these engineering and biological tests (e.g., number of catheters tested for flow rate, number of samples for chemical tolerance) are not specified in this summary document.

• Data Provenance: Not applicable in the sense of country of origin for clinical data. The tests are laboratory-based and conducted on the manufactured device.
• Retrospective or Prospective: Not applicable for bench/biocompatibility testing.

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

This is not applicable as the document describes a traditional medical device, not an AI/ML device relying on expert-established ground truth from medical images or clinical data. Ground truth for these tests is established by standardized measurements and laboratory methods (e.g., measuring flow rates, observing material reactions).

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

Not applicable. This concept applies to human expert review of medical data, typically for AI model validation, not for the engineering and biocompatibility testing described.

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 not applicable. This document describes a traditional hemodialysis catheter, not an AI-assisted device. Therefore, no MRMC study, human reader improvement, or AI effect size would be relevant or performed.

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

No. This is not applicable. There is no algorithm mentioned in this device submission.

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

The "ground truth" for the device's performance is established by physical and chemical measurements conducted according to internationally recognized standards (e.g., ISO standards) and FDA-recognized consensus standards. This includes:

• Measured flow rates
• Measured burst pressures
• Observational results of material integrity (kinking, clamping)
• Biological reactions in biocompatibility tests (e.g., cell culture, animal studies for toxicity, hemolysis)

8. The sample size for the training set

Not applicable. This document describes the testing of a physical medical device, not an AI/ML model that requires a "training set" of data.

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

Not applicable. As there is no training set mentioned, there is no ground truth establishment for it.

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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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The device is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, apheresis, rapid fluid administration, intravenous therapy, blood sampling, pressure injection of contrast media, and central venous pressure monitoring. The catheter may also be used in a variety of renal replacement therapies, such as hemofiltration and hemoperfusion. The catheter may be inserted into the jugular, subclavian, or femoral veins. The maximum pressure injection flow rate is 6 mL / sec.

The Multi-Lumen Acute Hemodialysis Catheter for High Volume (hereafter referred to as the 3-L AHDC) is a short-term, single use catheter designed to provide access to the central venous system in a healthcare facility environment. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter is available in a 12 Fr. triple-lumen configuration with usable lengths of 16-25 cm. The catheters can be used for the injection of contrast media. The maximum recommended pressure injection flow rate is 6 mL/sec.

The catheters are packaged sterile with various components to facilitate insertion.

This document is a 510(k) summary for a medical device called the "Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions," not a study describing AI algorithm. It details the device's indications for use, its substantial equivalence to predicate devices, and non-clinical testing performed.

Therefore, I cannot provide the requested information about acceptance criteria and studies related to an AI device's performance because the provided text is about a physical medical device (a catheter) and does not mention any AI component or algorithm.

Specifically, there is no mention of:

• Acceptance criteria table and reported device performance for an AI algorithm.
• Sample size for a test set, data provenance, ground truth establishment, or expert qualifications for an AI study.
• Adjudication methods for an AI test set.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone performance of an AI algorithm.
• Ground truth types for an AI algorithm.
• Training set sample size or ground truth establishment for an AI algorithm.

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The Power-Trialysis Slim-Cath Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

Power-Trialysis™ Slim-Cath™ Short-Term Dialysis Catheters are made of thermosensitive polyurethane, which softens when exposed to body temperature. The catheter is divided into three separate lumens permitting continuous blood flow. Both the venous (blue) and the arterial (red) lumens may be used for hemodialysis, hemoperfusion, and apheresis treatments. The distal (purple) lumen is completely independent from the two dialysis lumens and may be used for intravenous therapy, power injection of contrast media, and central venous pressure monitoring. The distal lumen can also be accessed for blood draws and infusion of medications.

The provided document is a 510(k) Premarket Notification for a medical device (Power-Trialysis Slim-Cath Short-Term Dialysis Catheter). It lists the device's characteristics, intended use, and a summary of performance testing done to establish substantial equivalence to a predicate device.

However, the document does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The tests described are engineering and material performance tests for a physical catheter, not algorithmic performance evaluations. Specifically, there is no mention of:

• AI/Machine Learning algorithms
• Test sets for AI models
• Data provenance for AI models
• Expert review for ground truth establishment for AI models
• Adjudication methods for AI ground truth
• MRMC studies
• Standalone algorithm performance
• Training sets for AI models

Therefore, I cannot extract the requested information about acceptance criteria for an AI device or a study proving its performance against expert-defined ground truth from this document. The "acceptance criteria" discussed in this document refer to engineering specifications for the physical catheter.

If you have a document related to an AI/ML medical device, please provide that.

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The Power-TrialysisTM Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

Power-Trialysis™ Short-Term Dialysis catheters are made of thermosensitive polyurethane, which softens when exposed to body temperature. The catheter is divided into three separate lumens permitting continuous blood flow. Both the venous (blue) and the arterial (red) lumens may be used for hemodialysis, hemoperfusion, and apheresis treatments. The distal (purple) lumen is completely independent from the two dialysis lumens and may be used for intravenous therapy, power injection of contrast media, and central venous pressure monitoring. The distal lumen can also be accessed for blood draws and infusion of medications.

The provided text describes a 510(k) premarket notification for a medical device called the Power-Trialysis Short-Term Dialysis Catheter (K133456). This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K083675) rather than establishing novel performance criteria for a new type of device. As such, the structure of the provided information does not perfectly align with a typical AI/software device study seeking to establish performance against defined acceptance criteria.

The "acceptance criteria" here are generally that the new device performs as safely and effectively as the predicate device. The study described is a series of engineering and performance tests comparing the subject device to the predicate device to confirm this substantial equivalence.

Here's an attempt to structure the information based on your request, with clarifications where the provided text doesn't directly map to the question:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a physical medical catheter, the "acceptance criteria" are generally based on meeting the performance established by the predicate device and relevant industry standards. The reported performance confirms these criteria were met.

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

The document does not explicitly state the sample sizes for each specific test (e.g., how many catheters were tested for hemolysis or burst strength). It refers to "verification and validation activities" and "performance data" but does not quantify the number of units tested.

• Sample Size for Test Set: Not explicitly stated for each individual test. Implied to be sufficient for engineering validation studies following design controls (21 CFR §820.30).
• Data Provenance: The studies were conducted by Bard Access Systems, Inc. in the US, as part of their 510(k) submission. These are prospective engineering and performance tests on manufactured devices, not retrospective clinical data.

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

This type of information is generally not applicable to a 510(k) submission for a physical device like a catheter. The "ground truth" for the performance tests (e.g., flow rate, burst pressure, tensile strength) is based on measurable physical properties and objective engineering standards (e.g., ISO, ASTM). The "experts" involved would be the engineers, technicians, and quality control personnel conducting and reviewing these tests, whose qualifications would be in engineering, materials science, or related fields. The document does not specify the number or specific qualifications of these individuals.

4. Adjudication Method for the Test Set

Not applicable in the context of physical performance testing against objective standards. The results of tests like burst pressure or hemolysis are quantitative and compared directly to predetermined specifications or standards, without the need for expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems where human reader performance is being evaluated with and without AI assistance. The Power-Trialysis Short-Term Dialysis Catheter is a physical medical device, not a diagnostic AI tool.

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

The "ground truth" for the device's performance is based on:

• Objective Engineering Standards: Adherence to established international and national standards (e.g., ASTM F1841, ISO 10555-1, ISO 10993-7).
• Predicate Device Performance: Performance data from the legally marketed predicate device (K083675) serves as a benchmark for substantial equivalence.
• Design Specifications: Internal design requirements and specifications for the catheter's physical and functional properties.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, and the concept of a "training set" is generally used for machine learning models, not for engineering validation of a catheter. The manufacturing process for these devices would involve process validation and quality control, which are distinct from machine learning training.

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

Not applicable. As there is no "training set" in the machine learning sense, there is no ground truth established for it.

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The Medcomp® T3 T catheter is a triple lumen catheter indicated for use in attaining short-term vascular access for hemodialysis, 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 T3 CT is a triple lumen catheter with a designated lumen for power injection, infusion or pressure monitoring. Each catheter lumen terminates through an extension to a female luer- lock connector. Each extension has an in-line clamp to control fluid flow and the clamp I.D. Ring is marked with the priming volume plus power injection rate is printed on the center clamp. The transition between lumen and extension is housed within a molded hub. The hub is marked with the catheter French size, lumen length and both the company and catheter design name. The outer extensions are clear and marked with "Do Not Power Inject" and the center extension is a translucent purple pigment printed with "Power Injectable". The catheter is available with either straight or curved out extensions.

The catheter lumen is composed of a soft, thermo-sensitive, polyurethane material with barium sulfate for radiopacity. At bodv temperature the catherer lumen becomes softer to reduce the risk of vessel trauma.

The catheter hub and extensions are molded from soft pliable polyurethane to increase patient comfort. The suture wing is flexible with suture holes for catheter securement.

The provided document does not contain a study demonstrating acceptance criteria or device performance in the way typically expected for a medical device efficacy or performance study. This document is a 510(k) summary for a hemodialysis catheter (T3 CT).

Instead of a clinical study or performance data against specific acceptance criteria, the submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices. This means that instead of proving the device meets certain performance metrics through a new study, the applicant argues that the new device is as safe and effective as devices already on the market because it has the same intended use, materials, anatomical location, basic design, performance, labeling, manufacturing process, and method of sterilization.

Here's an analysis based on the information provided, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, there is no explicit table of acceptance criteria and reported device performance from a specific study presented in this 510(k) summary. The submission asserts that the device "meets the performance criteria of design verification as specified by ISO standards, guidance documents and test protocols." However, the details of these criteria or the test results are not included.

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

Not applicable. No new clinical or performance test set (as in a study to evaluate efficacy or performance against specific metrics) is described. The submission relies on equivalence to predicate devices and adherence to design verification standards (ISO, guidance documents, test protocols), but details of these tests are not provided.

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

Not applicable. No ground truth establishment for a test set is described as part of this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring an adjudication method is described.

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

Not applicable. This is a medical device 510(k) summary for a catheter, not an AI software or imaging device that would typically undergo an MRMC study.

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

Not applicable. This is a medical device 510(k) summary for a catheter, not an algorithm or AI system.

7. Type of Ground Truth Used

Not applicable in the context of a new efficacy/performance study. The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the identified predicate devices, based on their prior clearance and market history.

8. Sample Size for the Training Set

Not applicable. This is a medical device 510(k) summary for a catheter. The concept of a "training set" is relevant for machine learning algorithms, which is not what this submission is about.

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

Not applicable. See point 8.

Summary of the Acceptance Criteria and "Study":

The "acceptance criteria" for the Medcomp® T3 CT catheter, as presented in this 510(k) summary, are primarily based on:

• Substantial Equivalence: The device is considered substantially equivalent to legally marketed predicate devices (K033570, K083675, K102605 as primary, and several others as secondary). This is the core "study" or justification for its market clearance. The argument is that "there are no differences that raise new issues of safety and effectiveness."
• Design Verification: The submission states that the "proposed device meets the performance criteria of design verification as specified by ISO standards, guidance documents and test protocols." While the specific tests and their results are not detailed, this implies that the device underwent engineering and materials testing to ensure it meets established specifications for medical catheters (e.g., strength, flow rates, material compatibility, etc.).
• Biocompatibility: The materials used meet the requirements of ISO 10993, and all materials have been cleared under past approved 510(k)s. This demonstrates the materials are biologically safe.

Conclusion:

The Medcomp® T3 CT 510(k) submission (K123292) for a hemodialysis catheter does not describe a clinical study to prove device performance against specific efficacy or performance acceptance criteria. Instead, it relies on demonstrating substantial equivalence to existing predicate devices and adherence to established design verification standards and biocompatibility requirements. This is a common pathway for medical device clearance, especially for devices that are modifications or improvements upon existing technologies rather than entirely novel ones.

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The MAHURKAR™ Triple Lumen Catheter is intended for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring and pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

The MAHURKAR™ Triple Lumen Dialysis Catheter is a 12 Fr radiopaque polyurethane catheter with two large lumens (arterial and venous) and one smaller medial lumen running longitudinally along the length of the catheter shaft. The two large lumens either have curved or straight extensions and the smaller medial lumen have a straight extension. At the distal end of the catheter there is a tapered green, soft radiopaque catheter tip. Each lumen terminates at a separate location along the catheter shaft, designated as the arterial, venous, or medial outlets. The catheter is available in four implantable lengths (13 cm, 16 cm, and 24 cm) with two clear silicone catheters extensions and three internal lumina distinguished by color coded adapters

The provided text describes a 510(k) summary for the MAHURKAR™ Triple Lumen Dialysis Catheter, focusing on its substantial equivalence to predicate devices and performance testing. However, it does not contain information typically associated with acceptance criteria and study details for an AI/ML powered device, specifically due to the device being a physical medical product (catheter) rather than a software-as-a-medical-device (SaMD).

Therefore, a significant portion of your requested information (sample size for test/training, number of experts, adjudication, MRMC, standalone performance, ground truth types) is not applicable to this physical device submission.

Here's a breakdown of what can be extracted and what cannot:

Acceptance Criteria and Device Performance

The submission focuses on demonstrating substantial equivalence to predicate devices through performance data related to physical and functional aspects of the catheter. The "acceptance criteria" are implied by the successful testing showing equivalence and mechanical integrity.

Study Details for a Physical Medical Device (Catheter)

The following details are not relevant or available for this physical device as they typically apply to AI/ML software evaluations.

1. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical catheters subjected to various engineering tests (tensile, leak, burst, CVP). Data provenance would be from materials testing and physical experiments, not country of origin of data in a clinical sense.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical catheter's mechanical integrity is established by engineering standards and measurement equipment, not expert consensus.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This method is used for resolving discrepancies in expert labeling or diagnoses, not for physical product testing.
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 is for AI-assisted diagnostic tools, not a physical medical device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device is based on engineering specifications, physical measurements from testing (e.g., pressure readings, force measurements during tensile tests, observation of leaks/bursts), and comparison to the established performance of predicate devices.
7. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of what is present:

The study described is a series of engineering verification and validation tests aimed at demonstrating the MAHURKAR™ Triple Lumen Dialysis Catheter's performance characteristics (mechanical integrity, pressure monitoring capability) and its substantial equivalence to predicate devices (Mahurkar™ Triple Lumen Dialysis Catheter K020089 and Bard Power-Trialysis Triple Lumen Dialysis Catheter K083675). The data provenance is from laboratory testing of the physical device. The "ground truth" for this context is the adherence to engineering standards and comparison against the known performance of the predicate devices.

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The Power-Trialysis™ Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 ml/sec for power injection of contrast media.

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Here's an analysis of the provided text regarding the Power-Trialysis™ Short-Term Dialysis Catheter, extracting information about acceptance criteria and supporting studies:

This document is a 510(k) summary for a medical device seeking premarket notification clearance. For such submissions, the primary "study" is often a comparison to a predicate device, focusing on substantial equivalence in design, materials, manufacturing, and performance characteristics rather than a clinical trial with specific acceptance criteria in the same way a new drug would have.

Based on the provided text, the device is cleared based on substantial equivalence to previously marketed predicate devices, not on meeting specific, quantifiable acceptance criteria established by a clinical study. The "performance testing" mentioned is likely bench testing to demonstrate that the new device performs similarly to the predicate, especially for its new features (like power injection).

Here's the breakdown based on your requested information:

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

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

The document does not mention a specific sample size or test set in the context of a clinical study. The clearance is based on the concept of substantial equivalence, which primarily relies on comparison to existing predicate devices through engineering, material, and performance testing (benchtop, rarely clinical for 510(k)s unless there are significant changes).

Therefore, details like data provenance or retrospective/prospective studies are not provided because a clinical test set in the traditional sense was not performed for this 510(k) submission. "Performance testing" is mentioned, which refers to engineering and bench testing, not human clinical trials.

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 device clearance is based on substantial equivalence to predicate devices, supported by engineering and laboratory testing. There is no mention of a human-read test set or expert consensus to establish ground truth for clinical performance.

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

Not applicable. As there is no clinical test set involving human judgment described, there is no adjudication method.

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 device is a physical medical catheter, not an AI or imaging diagnostic device. Therefore, a MRMC study or AI assistance is irrelevant.

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

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

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

The ground truth in this context is the established safety and effectiveness of the predicate devices. The new device's equivalence in design, materials, intended use, and performance characteristics (demonstrated through bench testing) serves as the basis for its perceived "ground truth" of substantial equivalence. There is no mention of clinical outcomes data, pathology, or expert consensus specific to the new device's performance that would serve as ground truth in a clinical study.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable. No training set is involved.

Summary of 510(k) Clearance Approach:

The clearance for the Power-Trialysis™ Short-Term Dialysis Catheter is achieved through the 510(k) pathway by demonstrating substantial equivalence to existing predicate devices. This involves showing that the new device has:

• The same intended use.
• Similar technological characteristics (design, materials, principles of operation).
• No new questions of safety or efficacy.

Performance testing typically refers to non-clinical (benchtop) tests (e.g., flow rates, material compatibility, strength, pressure resistance for power injection) to ensure the device performs as expected and is comparable to the predicate for critical parameters. The document explicitly states: "Based on the indications for use, technological characteristics, and safety and performance testing, the subject Power-Trialysis™ catheters met the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates."

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