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The L-Cath Single and Dual Lumen Catheters and the L-Cath Midline Catheters are indicated for short or long term peripheral access to the central venous system for the administrations, and nutrients; the sampling of blood; and monitoring blood pressure and temperature intravenously.

The L-Cath™ Single and Dual Lumen and L-Cath™ Midline Catheters are sterile, single use devices, sold as standalone devices which includes the following accessories:
• Trim Tool
• Tape measure
• Stylet (include in the final catheter assembly as applicable)
• Polyurethane catheter
These catheters are also sold as a component in a Basic Kit (catheter and introducer packaged together) which includes the following:

• BD Introsyte Autoguard Introducer or Splittable Introducer ●
• Stylet (include in the final catheter assembly as applicable)
• Trim Tool
• Tourniquet
• Tape measure

The provided text describes a 510(k) premarket notification for Argon Medical Devices' L-Cath™ Single and Dual Lumen Catheters and L-Cath™ Midline Catheters. This document focuses on demonstrating substantial equivalence to an existing predicate device (BD L-Cath™ Midline Catheter, BD Cath™ Single Lumen, BD Cath™ Dual Lumen Peripherally Inserted Central Catheters PICC, K091670), rather than proving the device meets clinical acceptance criteria based on studies involving AI or human readers.

Therefore, many of the requested criteria in your prompt (e.g., acceptance criteria for device performance in terms of AI metrics, sample sizes for test/training sets in an AI study, number of experts, adjudication methods, MRMC studies, standalone AI performance, ground truth establishment) are not applicable to this type of regulatory submission. This document details the engineering and biocompatibility aspects of the device to show it functions safely and effectively similarly to devices already on the market.

However, I can extract the relevant information from the provided text regarding the performance testing conducted to support the substantial equivalence claim.

Here's a breakdown of the requested information based on the provided text, highlighting what is applicable and what is not:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This submission is a 510(k) for substantial equivalence, not a clinical study proving performance against AI-related metrics. The "acceptance criteria" here refer to engineering, biocompatibility, and sterilization performance standards, demonstrating the modified device is as safe and effective as its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The subject device met all the predetermined acceptance criteria derived from the above listed reference standards and internal test protocols and demonstrated substantially equivalent performance compared to the predicate device." While specific numerical acceptance criteria (e.g., "pressure burst must exceed X psi") are not explicitly detailed in a table, the document lists the types of performance tests conducted and confirms successful completion.

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

• Sample Size: Not explicitly stated in terms of number of units tested for each criterion, but implied to be sufficient for demonstrating compliance with ISO standards and internal protocols.
• Data Provenance: The tests were conducted internally by Argon Medical Devices, as indicated by the company providing the summary. The regulatory context implies these are laboratory tests, not clinical data from patients. They are likely prospective bench and lab tests.

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

• Not Applicable. This is a medical device 510(k) submission based on engineering and biocompatibility testing, not an AI performance study requiring human expert ground truth for image or diagnostic interpretation. The "ground truth" here is established by validated test methods and reference standards.

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

• Not Applicable. See point 3.

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 diagnostic device. Clinical testing (human studies) was explicitly stated as "not required for the determination of substantial equivalence."

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

• Not Applicable. See point 5.

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

• Engineering and Biocompatibility Test Standards: The "ground truth" for the device's performance is established by recognized international standards (e.g., ISO 10993 series for biocompatibility, ISO 80369-7 for luer connectors, ISO 11135 for sterilization) and internal validated test protocols designed to assess the device's physical properties and safety characteristics.

8. The sample size for the training set

• Not Applicable. This document describes a medical device, not an AI algorithm. There is no "training set."

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

• Not Applicable. See point 8.

Summary of the Study Proving Acceptance:

The study presented in this 510(k) summary is a series of bench testing, laboratory analyses (biocompatibility), and sterilization validations designed to demonstrate that the modified L-Cath™ catheters are substantially equivalent to the previously cleared predicate devices. The primary change was the material used in the Luer Lock assembly.

The "study" involved:

• Performance Testing: Assessing mechanical characteristics like leak integrity, dimensions, pressure burst, durometer, radiopacity, retaining force, pull force, particulates, and material durability. These tests were stated to be the "SAME as K091670" (the predicate's testing) with additional supplemental testing specific to the Luer Lock material change (Luer Integrity, ISO 80369-7 Compliance).
• Biological Comparison (Biocompatibility Testing): Evaluation of potential biological risks including pyrogenicity, cytotoxicity, hemocompatibility, irritation/sensitization, systemic toxicity, ethylene oxide residuals, and local effects after implantation. Supplemental testing (Systemic Toxicity, Genotoxicity) was performed due to the Luer Lock material change.
• Sterilization Validation: Confirmation that the device can be consistently sterilized to meet a sterility assurance level (SAL) of 10-6, in accordance with ISO 11135:2014 and AAMI TIR28:2016.

The conclusion is that the modified device "met all the predetermined acceptance criteria derived from the above listed reference standards and internal test protocols and demonstrated substantially equivalent performance compared to the predicate device." This means the tests confirmed the new device performs within acceptable limits, similar to the predicate, and does not raise new questions of safety or effectiveness.

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Each Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.

The Langston dual lumen catheters have two lumens, both with distal sideholes, to allow simultaneous pressure measurements from two sites. The high-pressure inner lumen, which extends the entire length of the catheter, can be used for pressurement and rapid delivery of contrast medium. The outer lumen ends proximal to the distal end of the catheter and is used for pressure measurement only. A side port fitted with an extension tube and a stopcock assembly is used for fluid flow and pressure measurement within the outer lumen. The Langston dual lumen catheter will accommodate a standard ≤ 0.038" diameter guidewire and is supplied with a single use pigtail straightener. The Langston dual lumen catheter is sterilized with ethylene oxide.

This document describes the FDA's 510(k) clearance for the Langston dual lumen catheter (K221470). It's a medical device submission, not a study proving the device meets acceptance criteria for an AI or diagnostic algorithm. Therefore, the questions related to AI/algorithm performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable to this document.

However, I can extract the acceptance criteria and performance data for the physical device based on the provided text.

Here's the breakdown of what can be found and what cannot:

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

Study that proves the device meets the acceptance criteria:

The study was a series of bench tests and biocompatibility evaluation to demonstrate substantial equivalence to a predicate device, focusing on a design modification to the strain relief to hub bond.

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

• Sample Size: Not specified in the document for any of the bench tests.
• Data Provenance: The tests were performed internally by Vascular Solutions LLC ("Performance Data" section). The country of origin and retrospective/prospective nature of data collection for these specific tests are not detailed, but they are generally considered prospective bench tests performed for regulatory submission.

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

• Not Applicable. This document concerns a physical medical device (catheter) and its design validation via bench testing and biocompatibility, not an AI or diagnostic algorithm requiring expert "ground truth" for interpretative accuracy.

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

• Not Applicable. As above, this is about physical device performance, not diagnostic interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is not an AI-assisted diagnostic device.

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 consensus, pathology, outcomes data, etc):

• For Bench Testing: The "ground truth" was defined by the specified acceptance criteria for each individual physical performance test (e.g., a minimum tensile strength, a maximum leak rate). These criteria are objective measurements, not subjective expert interpretations or biological outcomes.
• For Biocompatibility: Compliance with ISO 10993-1 is the standard used, which involves a series of tests to assess biological safety.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. There is no "training set."

In summary, this document is a regulatory clearance for a physical medical device. The "acceptance criteria" and "performance data" provided relate to the manufacturing and physical characteristics of the catheter, not to the diagnostic accuracy of an algorithm or the improvement of human readers with AI assistance.

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Indicated for short-or long-term peripheral access to the central venous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media.

Rated for maximum power injection flow rate of 3.5ml/s

The HydroPICC peripherally inserted central catheter (PICC) is a 5 French, dual lumen catheter comprised of a radiopaque hydrophilic catheter material with a suture wing, Luer lock hubs, and extension tubes made from materials commonly used in the manufacture of catheters are provided packaged in kit configurations with the appropriate accessories for placement in the appropriate clinical environments. The maximum power injection flow rate for each lumen is indicated on each extension tube clamp.

HydroPICC has been shown to be effective in reducing thrombus accumulation. Reduction of thrombus accumulation was evaluated using in vivo models. Pre-clinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

This document is a 510(k) summary for the HydroPICC 5F Dual Lumen Catheter. It indicates that the device has undergone performance testing to demonstrate substantial equivalence to a predicate device. However, the document does not contain details about acceptance criteria, reported device performance, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.

The provided text focuses on the physical and technological characteristics of the medical device and its predicate, along with the regulatory and biocompatibility testing performed to establish substantial equivalence. It does not describe an AI/ML device or its performance study in the way the request specifies.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's the breakdown of what can be extracted:

1. A table of acceptance criteria and the reported device performance: Not available in the provided text. The document refers to conformance with recognized standards but does not list specific acceptance criteria or performance metrics for the device in a study context.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not available in the provided text.

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 available in the provided text.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not available in the provided text.

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 available in the provided text. This device is not an AI/ML product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available in the provided text. This device is not an AI/ML product.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available in the provided text. For the type of device (intravascular catheter), "ground truth" would typically refer to physical and mechanical properties, not diagnostic categories.

8. The sample size for the training set: Not available in the provided text. This device is not an AI/ML product.

9. How the ground truth for the training set was established: Not available in the provided text. This device is not an AI/ML product.

What can be extracted from the document regarding "performance testing" related to the device:

The document lists various performance tests conducted to demonstrate conformance with FDA-recognized standards for intravascular catheters. These tests are primarily focused on the physical, mechanical, and safety aspects of the catheter, rather than diagnostic or AI-driven performance.

Study Details (as much as can be inferred/is stated):

• Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth (for diagnostic AI/ML): Not applicable or not provided. The study mentioned for "reducing thrombus accumulation" used "in vivo models," but specific details like sample size, provenance, control groups, or exact endpoints are not given.
• Training Set Sample Size/Ground Truth: Not applicable for this type of medical device submission.

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The MC3 Crescent™ Jugular Dual Lumen Catheter is a single use, dual lumen catheter that provides both venous drainage and reinfusion of blood via the jugular vein and is indicated for use in adult and pediatric patients with acute respiratory failure requiring Veno-Venous Extracorporeal Membrane Oxygenation, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

The MC3 Jugular Dual Lumen Catheters are dual lumen catheters supplied with an introducer to facilitate wire guided placement into the vasculature via percutaneous (Seldinger type) vascular access methods. The introducer is designed to follow a prepositioned standard guide wire (not included) or obturator (blunt end closed tip introducer) when following a surgical placement. The catheter is wire reinforced for flexibility and kink-resistance and includes depth marks. Both the introducer and catheter are made of radiopaque materials and the catheter also includes tantalum radiopaque markers at the infusion port, proximal and distal drainage holes, and the catheter tip. The catheter body contains an integrated suture site for use during securement. An optional suture collar is provided and can be used for supplemental securement only. A dilator is also included. The dilators are the same diameter of the catheter and are designed to be used for dilation of the vessel. These catheters are provided in a variety of sizes ranging from 13Fr (8.9 cm insertable length) to 32Fr (34 cm insertable length).

This document is a 510(k) Summary for the MC3 Crescent™ Jugular Dual Lumen Catheter. It outlines the device's indications for use, description, comparison to a predicate device, and how it conforms to Class II Special Controls.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets alongside "reported device performance" in the way one might expect for diagnostic accuracy or clinical outcomes. Instead, it discusses conformance to "Special Controls" and mentions various types of testing to demonstrate "substantial equivalence."

Based on the information provided, the "acceptance criteria" can be inferred from the "Class II Special Controls" and the general requirements for substantial equivalence. The "device performance" is described qualitatively as meeting these controls.

Important Note: The document focuses on demonstrating substantial equivalence to a predicate device (Jugular Dual Lumen Catheter K180151) rather than proving novel clinical efficacy or diagnostic accuracy as might be seen for AI-driven diagnostic devices. The performance metrics are related to safety, material compatibility, and engineering design rather than clinical outcome improvements attributable to the device itself beyond its function in ECMO.

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

The document describes various types of testing but does not provide specific sample sizes for each test mentioned (e.g., "non-clinical performance," "in vivo evaluation," "biocompatibility").

• Non-clinical Performance: Mentions "bench" testing, "mechanical integrity," and "30-day durability." No specific sample size is given.
• In vivo Evaluation: Mentions "7-day in vivo thrombogenicity evaluation." No specific sample size is given, nor is the species used.
• Biocompatibility: Refers to ISO 10993-1:2009 and GLP (21 CFR 58). These are standards for testing, but they don't specify the sample size used in this particular submission.

Data Provenance: The data is generated from various tests (bench, in vivo, etc.) conducted by the manufacturer (MC3 Incorporated). The document does not specify the country of origin for the data or if it's retrospective or prospective, as these are typically controlled laboratory and animal studies, not patient data in the context of this device.

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

This information is not provided in the document. The tests described are laboratory and animal studies, not typically involving human expert adjudication for "ground truth" in the way a diagnostic AI would.

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

This information is not provided and is not applicable to the types of engineering and biocompatibility tests described for this medical device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices, not for a physical medical device like a catheter.

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

This question is not applicable as the device is a physical catheter, not an algorithm or AI system.

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

The concept of "ground truth" in the context of diagnostic accuracy is not directly applicable here. For the various tests performed, the "truth" is established through:

• Bench Test Results: Measured physical and mechanical properties against pre-defined specifications.
• Biocompatibility Standards: Adherence to established ISO and GLP guidelines.
• In vivo Evaluation: Biological responses (e.g., thrombogenicity) observed in an animal model, measured against expected safety profiles.

8. The sample size for the training set

This is not applicable. The MC3 Crescent™ Jugular Dual Lumen Catheter is a physical medical device, not an AI/ML algorithm that requires a training set.

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

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

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The Mahurkar(TM) Acute Single Lumen Catheters provides temporary access for acute hemodialysis. The flexible tubing permits percutaneous insertion into subclavian, jugular, and femoral veins.

The Mahurkar(TM) Acute Dual Lumen Catheters are intended for short-term central venous access for hemodialysis. apheresis, and infusion.

The Mahurkar(TM) Acute Triple Lumen Catheters are intended for short-term central venous access for hemodialysis. apheresis, and infusion.

The Mahurkar(TM) Acute High Pressure Triple Lumen Catheters are intended for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

The Mahurkar™ Acute Single Lumen Catheter is a radiopaque, polyurethane tube that features a single-lumen design on the proximal end. A rotatable suture wing, for securing the catheter to the patient, is attached to the hub and five outflow holes are arranged in a spiral near the tapered tip. The single lumen catheter is available in 8.0 Fr outer diameter and in implant lengths 15 cm and 19.5 cm. An optional, disposable Y-adapter can be used to convert the single extension to a dual.

The Mahurkan™ Acute Dual Lumen Catheter is a radiopaque, polyurethane tube that features a two-lumen design on the proximal end. The color-coded adapters on each lumen indicate arterial and venous flow. The adapters are connected to extension tubes which are available in curved or straight configurations. The extension tubes are connected, by a hub, to a dual lumen shaft that is available in pre-curved and straight configurations. The shaft extends to side slots near the distal tip. The dual lumen catheter is available in 8.0 Fr. 10.0 Fr. 11.5 Fr. or 13.5 Fr outer diameters and a variety of implant lengths ranging from 9 cm to 24 cm. It is offered as a single device or as convenience kits.

The Mahurkar™ Acute Triple Lumen Catheter and the Mahurkar™M Acute High Pressure Triple Lumen Catheter are radiopaque, polyurethane tubes that features a three-lumen design on the proximal end. The color-coded adapters on each lumen indicate arterial flow, venous flow, and medial infusion. The adapters are connected to extension tubes which are available in curved or straight configurations. The extension tubes are connected, by a hub, to a triple lumen shaft that extends to side slots near the distal tip. The triple lumen catheter is available in 12 Fr outer diameter and a variety of implant lengths ranging from 13 cm to 24 cm. They are offered as a single device or as convenience kits.

The FDA 510(k) summary for the Mahurkar™ Acute Single, Dual and Triple Lumen Catheters does not describe acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical trial for diagnostic performance.

This submission is for modifications to an already cleared device, primarily regarding changes to priming volumes on labels and instructions for use, and an update to static flow rate tables for the triple lumen catheter to align with ISO 10555-1. Therefore, the "acceptance criteria" and "device performance" are focused on demonstrating that these changes do not negatively impact the device's substantial equivalence to its predicate and that the updated information is accurate and compliant with relevant standards.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" and "reported device performance" as one might expect for a new diagnostic or AI device. Instead, the performance data provided is focused on demonstrating that the modified aspects of the existing device are substantially equivalent to the predicate device and meet relevant regulatory standards.

• Note: No changes to materials were made for this submission, so previous biocompatibility data was referenced. |
  | Performance Testing (Engineering): | |
  | - Priming Volumes: Demonstrate accuracy of new priming volume labels | - "Engineering testing analysis were performed... to establish the equivalence with the predicate devices."
• "The test regimen evaluated the devices for priming volumes and cleaning agent compatibility."
• Conclusion: Supported the update to the priming volumes printed on the label, IFU and device. |
  | - Cleaning Agent Compatibility: Ensure compatibility with common agents | - "The test regimen evaluated the devices for priming volumes and cleaning agent compatibility."
• Specific results not detailed, but implied as satisfactory to support equivalence. |
  | - Static Flow Rates (Triple Lumen): Align with ISO 10555-1 (minimum flowrates)| - "Additionally, the triple lumen catheter has been evaluated for static flow rates of the medial lumens."
• Conclusion: Supported the update to the static flow rates of the triple lumen's medial lumen to align with ISO 10555-1. |
  | Substantial Equivalence: | |
  | - Demonstrate that material, design, and principle of operation remain the | - "No material, design or principle of operation changes have been made to the Mahurkar™ Acute Catheters, Kits and Trays for the purposes of this submission."
• "The Mahurkar™ Acute Single, Dual and Triple Lumen Catheters, kits and trays have equivalent design, materials and principles of operation and technology when compared to the predicate device."
• This is the overarching conclusion of the 510(k) summary. |

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

• Test Set Sample Size: Not explicitly stated with specific numbers for each test. The document mentions "the Mahurkar™ Acute Catheters" as the subject of biocompatibility tests and "the devices" for engineering tests. Given this is an engineering and labeling change, the "sample" would likely refer to a certain number of manufactured catheters used for physical testing, rather than patient data.
• Data Provenance: The biocompatibility testing was conducted previously and references "Good Laboratory Practice (GLP)." The engineering tests were likely conducted in-house by Covidien, LLC. There is no mention of country of origin for any data or whether it was retrospective or prospective, as these are not relevant for this type of submission focused on engineering changes to an existing device.

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

This information is not applicable to this 510(k) submission. "Ground truth" established by experts, as typically seen in AI/diagnostic device submissions, would involve clinical interpretations or medical diagnoses. This submission pertains to physical device characteristics (priming volumes, flow rates, material compatibility) and regulatory compliance.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for clinical interpretive tasks, especially with ambiguous cases, to establish a definitive "ground truth." This is not relevant for the engineering and biocompatibility testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance

No. This is not an AI device, nor is it a diagnostic device that would typically undergo MRMC studies. This submission concerns physical catheters.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

For the biocompatibility tests, the "ground truth" would be established by validated laboratory assays and adherence to international standards (ISO 10993). For the priming volumes and flow rates, the "ground truth" would be the physically measured values according to established and validated engineering test methods, with the alignment of flow rates to ISO 10555-1 serving as a standard for accuracy.

8. The Sample Size for the Training Set

Not applicable. This isn't an AI/machine learning device that requires a training set.

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

Not applicable. As above, no training set is involved.

In summary: This 510(k) is for minor modifications (labeling and a standard alignment) to an already cleared medical device (catheters). The "study" described focuses on demonstrating that these changes do not alter the substantial equivalence of the device, primarily through engineering performance testing (priming volumes, flow rates, cleaning agent compatibility) and by referencing prior biocompatibility testing. It is not an AI/diagnostic device submission, so many of the requested categories are not relevant.

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The MC3 Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in patients with acute respiratory failure requiring Veno-Venous Extracorporeal Membrane Oxygenation, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

The MC3 Jugular Dual Lumen Catheters are bi-caval dual lumen catheters supplied with an introducer to facilitate wire guided placement into the vasculature via percutaneous surgical methods (Seldinger type approach). The introducer is designed to follow a prepositioned standard 0.038" (0.97 mm) or 0.035" (0.89 mm) guide wire (not included). The introducer hub provides an area for grasping the introducer during insertion and when fully seated, indicates that the introducer is fully inserted. The catheter is wire reinforced for flexibility and kink-resistance and includes depth marks. Both the introducer and catheter are made of radiopaque materials and the catheter also includes tantalum radiopaque markers at the infusion port, proximal and distal drainage holes, and the catheter tip. The catheter body contains an integrated suture site for use during securement. An optional suture collar is provided and can be used for supplemental securement only. A dilator is also included. The dilators are the same diameter of the catheter and are designed to be used for dilation of the vessel. The catheters remain intact throughout the duration of use and withstand the forces associated with insertion, securement, connection to perfusion line, clamping, blood pressures, and removal.

This document describes the premarket notification for a medical device and provides information on its performance evaluations, but it does not contain acceptance criteria or a study proving the device meets those criteria in the context of diagnostic or AI-driven performance.

The document is a 510(k) summary for the MC3 Jugular Dual Lumen Catheter, which is a physical medical device (a catheter) used for Veno-Venous Extracorporeal Membrane Oxygenation (ECMO). The "performance evaluations" mentioned are for the physical characteristics and safety of the catheter itself (e.g., durability, flow, kink resistance, biocompatibility, sterility), not for a diagnostic algorithm or AI system's output.

Therefore, I cannot provide the requested information from the provided text, as it pertains to a different type of device and different evaluation criteria than what your questions imply (e.g., questions about ground truth, expert consensus, MRMC studies, standalone algorithm performance, training/test sets are relevant for AI/diagnostic devices, not for a physical catheter's mechanical performance).

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

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The Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressurement is useful in determining transvalvular, intravascular, and intraventricular pressure gradients.

The Langston dual lumen catheter consists of a coaxial tube (outer lumen) mounted over a braided catheter shaft (inner lumen) and an extension line with a 3-way stopcock. The extension line with stopcock connects to the outer lumen. The outer lumen, and extension line are joined by an over molded manifold. The manifold also includes a luer that connects to the inner lumen. The manifold is printed with the Langston catheter length, French size, maximum guidewire diameter, and product logo ("Langston"). The Langston dual lumen catheter tip terminates in either a pigtail or multipurpose tip configuration.

The provided text describes a medical device, the Langston Dual Lumen Catheter, and its substantial equivalence to predicate devices, but it does not contain details about acceptance criteria or a study designed to prove the device meets specific performance criteria in the context of an AI/ML model for diagnosis or prediction.

The document is a 510(k) summary for a medical device (a catheter) seeking FDA clearance, demonstrating substantial equivalence to already cleared predicate devices. The "studies" mentioned are bench tests and biocompatibility tests to show that the new device's modifications (e.g., in manufacturing, materials) do not negatively impact its safety and performance compared to the previously cleared versions. These are not clinical studies in the sense of evaluating diagnostic accuracy or predictive performance through human reader evaluations or ground truth comparisons.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML model's performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for training sets, because this information is not present in the provided text.

The closest relevant information from the document is related to the performance verification of the physical medical device, not an AI component.

Here's a breakdown of what is available in the document, framed in the context of device performance, but noting its irrelevance to AI/ML model evaluation:

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

The document broadly states: "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues." It does not provide a table with specific quantitative acceptance criteria or detailed reported performance figures for each test. Instead, it lists the types of tests performed.

The following points are explicitly NOT present in the provided text, as they relate to AI/ML model evaluation, which is not the subject of this 510(k) summary:

2. Sample size used for the test set and the data provenance: Not applicable, no AI/ML test set mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no AI/ML ground truth mentioned.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: "Clinical testing was not performed to validate the performance of the subject device." Therefore, no MRMC study for AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no algorithm.
7. The type of ground truth used: Not applicable, no AI/ML ground truth mentioned.
8. The sample size for the training set: Not applicable, no AI/ML training set mentioned.
9. How the ground truth for the training set was established: Not applicable, no AI/ML training set mentioned.

In summary, the provided document details the regulatory clearance process for a physical medical catheter through non-clinical bench and biocompatibility testing, not the evaluation of an AI-powered diagnostic or predictive device.

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The MC3 26 Fr. QuickFlow™ Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the femoral vein, that is indicated for use for up to 72 hours in patients with acute respiratory failure requiring partial Veno-Venous Extracorporeal Membrane Oxygenation (full hemodynamic support is not required and predicted flows needed to maintain adequate oxygenation do not exceed 31/min) where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

The MC3 28 Fr. QuickFlow™ Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the femoral vein, that is indicated for use for up to 72 hours in patients with acute respiratory failure requiring partial Veno-Venous Extracorporeal Membrane Oxygenation (full hemodynamic support is not required and predicted flows needed to maintain adequate oxygenation do not exceed 3.5l/min) where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

The MC3 QuickFlow Dual Lumen Catheters are dual lumen catheters supplied with an introducer to facilitate wire guided placement into the vasculature by normal access techniques. The introducer is designed to follow a pre-positioned standard 0.038" (0.97 mm) or 0.035" (0.89 mm) guide wire (not included). The catheter is wire-reinforced for flexibility and kink-resistance and includes depth marks. Both the introducer and catheter are made of radiopaque materials and the catheter has radiopaque markers at the tip and most proximal set of drainage holes.

The devices are comprised of two separate thin-walled catheters made of silicone and polyurethane polymer and reinforced with a spring wire. The dual lumen design involves two catheters of different diameters joined together in a co-axial configuration. An arrangement of side holes in the outer (drainage) catheter allows for egress of blood. An open tip on the inner (return) catheter allow s for blood ingress. Unreinforced tube extensions with barbed connectors, allowing clamping and connection to the extracorporeal circuit, are joined to the wye junction. A tapered tip introducer is included to facilitate placement of the catheter into the blood vessel over a standard guide wire (not included). Securement of the device may be accomplished via a groove designed in the Y-connector to accept a suture and a suture around a 3/8" barb connector.

The provided text describes the MC3 QuickFlow Dual Lumen Catheter and its equivalency to a predicate device, focusing on its physical characteristics, intended use, and performance evaluations. However, it does not contain information related to an AI/ML device, nor does it present acceptance criteria or a study proving an AI/ML device meets such criteria.

The document is a 510(k) premarket notification for a medical device (a catheter), and the performance evaluations listed are typical for such hardware devices (durability, pressure/flow, kink resistance, etc.). There is no mention of "AI", "algorithm", "human readers", "MRMC", "ground truth" in the context of an AI-driven study, or any other terms that would suggest an AI/ML component.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving an AI/ML device meets those criteria based on the provided text, as the text pertains to a non-AI medical device.

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The ELITE-i Dual Lumen Catheter is indicated for use as a single catheter for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures.

The Elite-i (RA) Dual Lumen (short lengths), Elite-i (Bi) Dual Lumen (standard) and Elite-i (BiX) Dual Lumen (extra-long lengths) are wire-reinforced catheters with a one-piece, dual lumen construction. The Dual Lumen Catheter is a single catheter with two separate lumens within the catheter body to collect and to return the blood. The product is offered in a range of sizes to address varying patient size requirements. The catheters are intended to be inserted via the internal jugular vein into the superior vena cava, the right atrium and the inferior vena cava (except for the short lengths which only reach the right atrium). The catheter's dual lumen construction allows for both venous drainage and reinfusion of blood during extracorporeal life support procedures. The catheters are designed for use by physicians trained in and experienced with venous catheterization and extracorporeal life support in a hospital setting. Each catheter is supplied with a tapered tip introducer to facilitate placement into the vasculature using a guide wire and following normal access techniques. In addition to the standard introducer, the Elite-i (RA) Dual Lumen Catheter (short lengths) is supplied with an extra, blunt tip introducer to accommodate user preference for placement into the right atrium. Both the catheter and introducers are radiopaque and include depth or location marks. The standard introducer is designed to follow a prepositioned standard 0.038" (0.97 mm) guide wire (which is not included). The blunt tip introducers do not require or accommodate a guide wire. The device is supplied sterile and non-pryogenic in a peel pouch and carton. It is intended for single use.

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

The document describes a medical device, the Elite-i Dual Lumen Catheter family, which is a modification of a previously cleared predicate device. Instead of acceptance criteria and reported device performance in the traditional sense of AI/software performance metrics, this submission focuses on demonstrating substantial equivalence through nonclinical testing.

Here's a table based on the provided text, outlining the tests performed and the general performance conclusions:

Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a nonclinical testing program, building upon the original 510(k) submission for the predicate device. The core argument for substantial equivalence is that the new devices utilize the "same technological characteristics (design and materials)" as the predicate device.

For modifications, additional testing was conducted:

• Flow curves for the new configurations: These were generated to confirm consistency with the predicate device.
• Verification of Biocompatibility for the colored caps and tantalum dots: This addressed new materials.
• Verification of Sterilization for blunt tipped introducers and modified lengths: This addressed new components and lengths.
• Design verification of spring and reinforcement modifications including kink resistance and tensile strength testing: This addressed minor structural changes.

The conclusion is that the modified catheters are "equivalent to the predicate devices in all key areas of features and performance that affect safety and effectiveness based on a Risk Assessment of the modifications made."

The subsequent questions (2-9) are typically relevant for AI/ML device submissions, where statistical performance of an algorithm against a ground truth is evaluated. This document describes a traditional medical device (catheter) and its 510(k) submission based on substantial equivalence to a predicate device, not an AI/ML device. Therefore, questions 2 through 9 are not directly applicable to this particular submission.

Here's why each question is not applicable in this context:

2. Sample size used for the test set and the data provenance: This relates to data used to test an algorithm's performance. No such "test set" of data (e.g., images, patient records) is mentioned for this physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no diagnostic or interpretive "ground truth" being established by experts for algorithmic performance.
4. Adjudication method: Not applicable as there's no expert review of algorithmic outputs.
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 is specific to AI-assisted diagnostic devices. There is no AI component mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as there is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as there's no algorithmic output to compare against a ground truth. The "ground truth" for the catheter's performance is adherence to engineering specifications and safe physiological function shown through nonclinical tests.
8. The sample size for the training set: Not applicable as there is no AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable as there is no AI model requiring a training set.

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The OriGen Reinforced Dual Lumen cannula is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.

The OriGen Reinforced Dual Lumen catheter (RDLC) is the same design as the OriGen Dual Lumen Catheter (the predicate device), but with the addition of a wire reinforcement layer on the tip of the device. Both are dual lumen catheters with unequal lumen areas for drainage and reinfusion. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position. Other characteristics of the catheter are the same.

This is not an AI/ML medical device. It is a dual-lumen catheter used for extracorporeal life support. Therefore, the questions related to AI/ML device studies are not applicable.

However, I can extract the acceptance criteria and the summary of the study performed for this device:

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

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

• Sample Size: Not explicitly stated. The document mentions "applicable tests were carried out," but does not specify the number of units tested for each in vitro test.
• Data Provenance: The tests were conducted "in accordance with the requirements of ISO 10993-1 and the FDA 1995 memorandum." These are non-clinical, in-vitro tests, not involving human data (retrospective or prospective).

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

• Not applicable. This is a medical device (catheter), not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from images or other patient data. The "ground truth" for this device's performance is established by objective engineering and material science standards as per ISO 10993-1 and FDA guidelines.

4. Adjudication method for the test set:

• Not applicable. As this is not an AI/ML device assessing patient data, no adjudication method for a test set by human experts is relevant.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• For this device, the "ground truth" can be considered the established engineering and performance specifications and safety standards defined by ISO 10993-1 and FDA guidance for medical device biocompatibility, structural integrity, and functional performance (e.g., flow rates). These are objective, measurable criteria.

8. The sample size for the training set:

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

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

• Not applicable. This is a physical medical device, not an AI/ML model.

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