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The Duo-Flow® Side X Side double lumen catheter is intended for short-term central venous access for hemodialysis, apheresis and infusion.

The Duo-Flow® Side X Side double lumen catheter is a radiopaque, polyurethane tube with two D-shaped lumina. The lumina can be distinguished by the color-coded luers:

• Red Adaptor = proximal lumen
• Blue Adaptor = distal lumen
  The proximal lumen provides "arterial" outflow from the patient; the distal lumen provides "venous" return.
  The catheter comes in a variety of sizes and is offered with curved or straight extensions.
  The Duo-Flow® Side x Side Catheter removes and returns blood through two segregated lumen passages. Each lumen is connected to an extension line with color-coded female luer connectors. The transition between lumen and extension is housed within a molded hub. Both arterial and venous lumens contain side-holes. The catheter incorporates Barium Sulphate to facilitate visualization under fluoroscopy or Xray. All sizes of the Duo-Flow® Side x Side Catheter are available in a Basic Set intended to be used in an Interventional Radiology or Operating Suite. The Set includes primary insertion componentry for the Modified Seldinger Insertion Technique.

The provided FDA 510(k) clearance letter describes the 14F Duo-Flow® Side X Side Double Lumen Catheter and its substantial equivalence to a predicate device. However, this document does not detail an AI/algorithm-based medical device performance study.

The submission is for a physical medical device (a catheter) and focuses on demonstrating substantial equivalence through non-clinical (bench) testing and comparison of technical specifications with a previously cleared predicate device. Therefore, many of the requested details regarding AI/algorithm performance (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable to this particular FDA clearance.

Here's an analysis based on the information provided, highlighting the acceptance criteria and how the device meets them within the context of a physical device submission and not an AI/algorithm study:

Acceptance Criteria and Reported Device Performance (Non-AI/Algorithm Device)

The acceptance criteria for this physical medical device are derived from establishing substantial equivalence to a predicate device (Duo-Flow® Side x Side Double Lumen Catheter, K192807) through a combination of identical intended use, similar technological characteristics, and satisfactory non-clinical performance testing. The "performance" here refers to physical and mechanical attributes, not diagnostic or predictive accuracy.

Table of Acceptance Criteria and Reported Device Performance (Focus on Substantial Equivalence and Bench Testing):

Details Not Applicable to this Submission (as it's not an AI/Algorithm Device):

The following information requested in the prompt is not applicable to this 510(k) submission, as it pertains to AI/algorithm-based medical devices or clinical studies that were explicitly stated as "not required nor performed":

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device clearance based on bench testing. No "test set" in the context of diagnostic data was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No diagnostic ground truth was established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No diagnostic test set or adjudication was involved.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device. The document explicitly states "Clinical testing was not required nor performed to support the substantial equivalence of these devices."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" concept does not apply to the physical and mechanical performance testing of a catheter.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI model.
9. How the ground truth for the training set was established: Not applicable. This is a physical device, not an AI model.

In summary, the FDA 510(k) K250836 clearance for the 14F Duo-Flow® Side X Side Double Lumen Catheter is for a physical medical device. The "acceptance criteria" and "study" described in the document are focused on demonstrating substantial equivalence to a predicate device through comparison of intended use, technological characteristics, and comprehensive non-clinical (bench) performance testing. There is no information regarding AI/algorithm performance or clinical studies in this submission.

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The Acute Dual Lumen Hemodialysis Catheter is indicated for short-term central venous access for hemodialysis, apheresis, and infusion.

The Acute Dual Lumen Hemodialysis Catheter is manufactured from thermal reactive polyurethane material known for its rigidity at room temperature which allows bedside insertion, and softness at body temperature minimizing the risk of vein perforation and improving patient comfort after insertion. The catheter shaft is made of radiopaque polyurethane with two independent, non-communicating inner lumens, where the distal end of the catheter, with arranged outflow eyelets, extends to a symmetrical tip configuration. The proximal end of the catheter shaft joins to a polyurethane hub assembly having each inner lumen connected to individual extension tubes. The extension tubes are made of silicone material and are identified by color coded occlusion clamps. The red clamp identifies the lumen which provides "arterial" outflow from the patient, the blue clamp identifies the lumen which provides "venous" inflow return when used for hemodialysis, apheresis and infusion. Lumen priming volume is printed on each ID tag clamp insert, and catheter size and length are printed in the hub. Centimeter markings are placed along the length of the indwelling portion of the catheter body to facilitate proper positioning.

Here's a breakdown of the acceptance criteria and study information for the Acute Dual Lumen Hemodialysis Catheter, based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document lists various performance characteristics that were tested. While specific numerical acceptance criteria (e.g., "flow rate must be > X mL/min") are not explicitly detailed in the summary, the general statement indicates the device "met the minimum requirements that are considered adequate for its intended use." This implies that for each test, there was an established benchmark or range that the device successfully achieved.

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

The document does not specify the exact sample sizes used for each individual performance test (e.g., how many catheters were tested for flow rate or tensile strength). It only states that "Bench testing was conducted."

Regarding data provenance:

• Country of Origin: Not specified.
• Retrospective or Prospective: The testing described is prospective, as it involves the evaluation of the subject device's performance before market approval.

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 document describes bench testing and biocompatibility testing against established standards (FDA recognized standards, ISO standards), rather than studies involving human experts establishing "ground truth" on clinical cases. The "ground truth" here is the adherence to these engineering and biocompatibility standards.

4. Adjudication Method for the Test Set:

This is not applicable as the described testing does not involve human expert adjudication of clinical cases. The "adjudication" is essentially the determination by a testing facility or qualified personnel that the device either passed or failed the specified test criteria based on the relevant standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was mentioned. The device is a physical medical device (catheter), not an AI algorithm or a diagnostic tool that would typically involve human readers.

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

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

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance evaluation of this medical device is based on established engineering standards, international standards (ISO), and regulatory requirements for the safety and performance of such devices. For example:

• Bench Testing: Engineering specifications and performance limits for properties like flow rate, tensile strength, leakage, etc.
• Biocompatibility Testing: Standards outlined in ISO 10993-1, which define acceptable levels of biological response to medical devices.
• Sterilization and Shelf Life: Standards like ISO 11135 and ISO 11607-1.

8. The Sample Size for the Training Set:

Not applicable. This document describes the evaluation of a physical medical device, not a machine learning algorithm that would have a "training set."

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

Not applicable. As above, no training set is relevant for this type of device submission.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Not applicable. This is not an algorithm.

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

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

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

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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The 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.

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 Zenysis™ Short-Term Dialysis Catheter, 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.

Zenysis™ Short-Term Dialysis Catheters are made of thermosensitive polyurethane, which softens when exposed to body temperature. The catheter is divided into two 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 Attachable Suture Wing and Attachable Suture Wing Fastener will be used to support the Zenysis™ Short-Term Dialysis Catheter, as securement devices to fixate the exposed portion of the catheter shaft to the patient's skin. The subject device included in this submission will be offered in varying French size and catheter configuration types, as summarized in the table below: Straight Extension Legs and Precurved Extension Legs with Insertion Lengths of 12.5 cm, 15 cm, 20 cm, and 24 cm. The subject catheters will be packaged with legally marketed components used in the placement procedure.

The provided text describes the Zenysis™ Short-Term Dialysis Catheter and its substantial equivalence to a predicate device. However, it does not contain a study that proves the device meets specific acceptance criteria in the way a clinical or performance study with detailed statistical results would.

Instead, the document outlines the acceptance criteria by referencing various guidance documents and standards that the device was tested against. The study itself is a series of verification tests performed in accordance with Design Controls (21 CFR §820.30) and the listed standards. The "reported device performance" is simply stated as "The subject device met all predetermined acceptance criteria".

Here's the information extracted and formatted to answer your request, with "N/A" for information not present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the "subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device." It does not provide specific numerical results for each test.

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin). The testing would typically be performed in a laboratory setting by the manufacturer (Bard Access Systems, Inc. in Salt Lake City, UT).
• Retrospective or Prospective: N/A (these are bench tests, not clinical studies on patients).

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

• Number of Experts: N/A. Ground truth for these types of bench tests is established by adhering to widely accepted engineering and medical device standards (e.g., ISO, ASTM) and internal protocols, rather than expert consensus on medical images or diagnoses.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: N/A. The evaluation methods for these bench tests are typically predefined by the relevant standards and protocols, not requiring an adjudication process like clinical expert review.

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

• N/A. This document describes a medical device (dialysis catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

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

• N/A. This document describes a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Established definitions and metrics based on engineering principles and international standards (e.g., ISO 10555, ASTM F640, ISO 10993-1) for device performance, safety, and material properties.

8. The Sample Size for the Training Set

• N/A. This is a physical medical device; there is no "training set" in the context of machine learning or AI.

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

• N/A. As there is no training set, this is not applicable.

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The Cook Turbo-Flo® HD Acute Hemodialysis Catheter Set/Tray is intended for acute hemodialysis, apheresis and hemofiltration via percutaneous insertion into the subclavian, jugular, or femoral veins. The device is a short-term use catheter (less than 30 days).

The Cook Turbo-Flo® HD Acute Hemodialysis Catheter Set/Tray is a short-term, 12 Fr, radiopaque polyurethane central venous catheter with two independent, noncommunicating lumens. Lengths of 15, 20, and 25 cm are available based on the anatomical needs of the patient.

This FDA 510(k) summary describes a medical device, a hemodialysis catheter, and its substantial equivalence to a predicate device. It does not contain information about an AI/ML-based device or a study proving its performance against specific acceptance criteria in the manner requested.

However, I can extract the information provided about the Cook Turbo-Flo® HD Acute Hemodialysis Catheter Set/Tray and frame it as if it were describing a device's performance against acceptance criteria, using the available data. It's important to note that this is an analogy and not a direct fit for explaining an AI/ML device's validation.

Here's an interpretation based on the provided text, modified to fit the requested format for a device validation, specifically focusing on the "Validation testing" mentioned.

The document describes the Cook Turbo-Flo® HD Acute Hemodialysis Catheter Set/Tray and its validation testing, which ensures reliable design and performance. The primary change from the predicate device (K122091) is the removal of a hydrophilic coating, and the validation tests were conducted to demonstrate that this modification does not impact safety or effectiveness.

1. Acceptance Criteria and Reported Device Performance

The device underwent "Validation testing" to ensure reliable design and performance. The acceptance criteria and reported performance for specific parameters were as follows:

Study Details:

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

   • Sample Size: The document states "When tested in an animal model that simulates clinical use." It does not specify the exact number of animals used for the validation testing.
   • Data Provenance: The study was conducted retrospectively or prospectively cannot be determined from the document. The country of origin for the animal model data is not specified.

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

   • This document describes a physical medical device and its performance in an animal model, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. Therefore, the concept of "experts" to establish ground truth in this context is not directly applicable as it would be for an AI/ML study. The evaluation likely involved veterinary or technical personnel assessing the catheter's performance based on predefined objective criteria in the animal model.

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

   • Adjudication methods like 2+1 or 3+1 are typical for human-in-the-loop or expert consensus studies for AI/ML. For a physical device animal study, the method of assessing the "adequate" or "good" rating is not detailed but would likely involve direct observation and measurement, potentially with a single or small team of trained evaluators. No specific adjudication method is mentioned.

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 study is for a physical medical device and does not involve AI assistance, human readers, or an MRMC study design.

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

   • No. This study pertains to the physical performance of a medical catheter in an animal model, not an algorithm.

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

   • The "ground truth" for this device's performance was established through direct observation and qualitative assessment ("rating scale... 'adequate' or 'good'") within an animal model simulating clinical use. This is a functional performance assessment rather than a diagnostic accuracy assessment.

8. The sample size for the training set:

   • This concept is not applicable for a physical medical device's validation testing described here. No "training set" for an algorithm is mentioned or implied. Design control activities and pre-clinical testing would have informed the device's design, but not in the sense of an algorithm training set.

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

   • Not applicable, as there is no training set for an algorithm in this context. The "ground truth" for the device's design would have been established through engineering specifications, previous predicate device performance, and clinical requirements for hemodialysis catheters.

Summary of Limitations based on the Document:

The provided text is a 510(k) summary for a physical medical device, not an AI/ML algorithm. Therefore, many of the requested details about AI/ML study design (e.g., algorithm performance, human reader studies, training sets, expert consensus for ground truth) are not present or directly applicable. The document confirms that "appropriate design control activities" and "appropriate validation test" were performed, and the device met its pre-determined acceptance criterion regarding functional performance in an animal model and biocompatibility.

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The Zenysis™ Short-Term Dialysis Catheter, 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.

Zenysis™ Short-Term Dialysis Catheters are made of thermosensitive polyurethane, which softens when exposed to body temperature. The catheter is divided into two 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 Attachable Suture Wing and Attachable Suture Wing Fastener will be used to support the Zenysis™ Short-Term Dialysis Catheter, as securement devices to fixate the exposed portion of the catheter shaft to the patient's skin. The subject device included in this submission will be offered in varying French size and catheter configuration types, as summarized in the table below: Straight Extension Legs with Insertion Lengths of 15 cm, 20 cm, 24 cm and Precurved Extension Legs with Insertion Lengths of 12.5 cm, 15 cm, 20 cm, 24 cm. The subject catheters will be packaged with legally marketed components used in the placement procedure.

The provided document is a 510(k) premarket notification for the Zenysis™ Short-Term Dialysis Catheter. It does not describe a study involving an AI/algorithmic device or human readers. Instead, it focuses on demonstrating substantial equivalence to a predicate device through technological characteristic comparisons and performance testing to ensure safety and effectiveness.

Therefore, most of the information requested in your prompt (acceptance criteria tables, sample sizes for test/training sets for AI, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, type of ground truth used for AI) is not applicable to this document.

However, I can extract the acceptance criteria and performance related to the device itself from the safety and performance testing section.

Here's the relevant information that can be extracted from the provided document:

Study Type: This is a medical device substantial equivalence submission (510(k)), not a study on an AI/algorithmic medical device. It involves bench testing of the physical catheter, not evaluation of a diagnostic algorithm's performance with human readers.

Acceptance Criteria and Device Performance for Zenysis™ Short-Term Dialysis Catheter

Details from the document that are not applicable to the AI prompt but are included for context:

• Sample size used for the test set and the data provenance: Not applicable to an AI device. The testing here refers to physical product testing (bench tests) on the Zenysis™ catheter. The document does not specify the number of catheters tested for each metric, but mentions "Verification tests were designed and performed in accordance with Design Controls as per 21 CFR §820.30."
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI and expert consensus are not relevant here.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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 device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI device. For this physical medical device, "ground truth" would be established by physical measurements, material properties, and functional performance testing against established engineering and medical standards.
• The sample size for the training set: Not applicable. This is not an AI device that requires a training set.
• How the ground truth for the training set was established: Not applicable.

Relevant Guidance Documents and Standards Used for Testing:

• Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995
• Draft Guidance for Industry and Food and Drug Administration Staff: Implanted Blood Access Devices for Hemodialysis, June 28, 2013
• ISO 10555-1:2013, Sterile, single-use intravascular catheters – Part 1: General requirements
• ISO 10555-3:2013, Sterile, single-use intravascular catheters – Part 3: Central Venous catheters
• ASTM F640:2012, Standard Test Methods for Determining Radiopacity for Medical Use
• ASTM F756:2013, Standard Practice for Assessment of Hemolytic Properties of Materials
• ASTM F1841:1997 (R2013), Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
• ISO 10993-1 CORR1:2010. Biological Evaluation of Medical Devices: Part 1 - Evaluation and Testing
• ISO 14971:2012, Medical Devices - Risk Management for Medical Devices (for Risk Management/FMEA)

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The Cook Turbo-Flo® HD Acute Hemodialysis Catheter is intended for acute hemodialysis, apheresis and hemofiltration. It is intended for percutaneous insertion into the subclavian, jugular or femoral veins. The device is a short-term use catheter (less than 30 days).

The Cook Turbo-Flo® HD Hemodialysis Catheters are short-term, 12 Fr., hydrophilically coated, radiopaque polyurethane central venous catheters with two independent, non-communicating lumens. Lengths of 15, 20 and 25 cm are available based on the anatomical needs of the patient. Various components may be included that are associated with placement of the device.

Here's a breakdown of the requested information based on the provided document:

The provided document is a 510(k) summary for the Cook Turbo-Flo® HD Acute Hemodialysis Catheter. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance metrics for a novel AI device. Therefore, much of the requested information (especially points 2-9 related to AI/algorithm studies) is not applicable or not found in this type of regulatory submission.

However, I can extract the relevant information from the document that aligns with your request for device performance and the study that proves it meets criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of "acceptance criteria" with quantitative targets and corresponding "reported device performance" in the way one might see for an AI diagnostic device. Instead, it lists various tests conducted to ensure reliable design and performance, concluding that the results support substantial equivalence to the predicate. The implicit acceptance criterion for each test is that the device performs comparably to or within acceptable limits for a hemodialysis catheter.

Study Details:

The "study" described here is a series of bench and possibly non-clinical (e.g., in vitro, animal) tests conducted on the Cook Turbo-Flo® HD Acute Hemodialysis Catheter to demonstrate its safety and effectiveness relative to a legally marketed predicate device (K993933, Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip® ARROWg+ard Blue).

• Type of Study: This is not a clinical trial or an AI algorithm performance study. It is a design verification and validation study comprised of various engineering and biological tests typical for medical device clearance via the 510(k) pathway.

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

• Sample Size: Not specified in the provided summary. These would typically be a statistical sample of devices for the bench tests.
• Data Provenance: Not specified, but generally refers to in-house laboratory testing (Cook Incorporated, USA).
• Retrospective or Prospective: These are prospective tests performed on newly manufactured devices.

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 type of information is irrelevant for bench testing of a physical medical device. Ground truth for these tests is established by objective physical and chemical measurements against design specifications and industry standards.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review in diagnostic studies. For physical device performance, results are typically objective measurements.

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 an AI device.

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

• No. This is not an AI device.

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

• The "ground truth" for the tests listed (tensile, flow rate, burst pressure, etc.) are objective physical and chemical properties and measurements against established engineering specifications, industry standards, and biocompatibility criteria.

8. The sample size for the training set

• Not Applicable. This is not an AI device. There is no "training set" in the context of this 510(k) submission.

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

• Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.

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The Mahurkar™ Elite Acute Dual Lumen Catheter is indicated for short-term central venous access for hemodialysis, apheresis, and infusion.

The Mahurkar™ Elite Acute Triple Lumen 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 Mahurkar™ Elite Acute Dual Lumen Catheter features a two lumen design. The proximal end has color-coded adapters to 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 to the hub which is joined to a dual lumen shaft available in pre-curved and straight configurations. The shaft extends to side slots near the distal tip. The dual lumen catheter is available in 12.0 Fr or 13.5 Fr outer diameters and a variety of implant lengths ranging from 13 cm to 30 cm. It is offered as a single device or as convenience kits.

The Mahurkar™ Elite Acute Triple Lumen Catheter features a three lumen design. The proximal end has color-coded adapters to 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 to the hub which is joined to a triple lumen shaft that extends to side slots near the distal tip. The triple lumen catheter is available in 12.5 Fr outer diameter and a variety of implant lengths ranging from 13 cm to 30 cm. It is offered as a single device or as convenience kits.

This document describes a 510(k) submission for new catheter devices and not a study for AI/ML device. Therefore, I cannot extract the requested an AI/ML device study information from this document.

However, I can provide available information about the device's performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify the sample sizes used for each of the bench-top functional and performance tests.
• The data provenance is from bench-top functional and performance testing and biocompatibility testing, which are laboratory-based tests. There is no information about country of origin in the context of data.

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

• This information is not applicable as the document describes physical device performance tests, not clinical studies involving expert interpretation.

4. Adjudication method for the test set:

• This information is not applicable for the type of testing described (bench-top and biocompatibility).

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 as this document describes a medical device (catheter) and not an AI/ML device.

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

• This information is not applicable as this document describes a medical device (catheter) and not an AI/ML device.

7. The type of ground truth used:

• The ground truth for the performance testing was based on "relevant product specifications". This implies pre-defined engineering and safety standards for catheter performance.
• For biocompatibility, the ground truth was adherence to ISO 10993: Biological Evaluation of Medical Devices.

8. The sample size for the training set:

• This information is not applicable as this document describes a medical device (catheter) and not an AI/ML device that requires a training set.

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

• This information is not applicable as this document describes a medical device (catheter) and not an AI/ML device that requires a training set.

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Indicated for acute hemodialysis and apheresis. They may be inserted perculaneously and are idealy placed in the internal jugularyon and apricless. They may be inserted percuraneously and an the internal jugular is the preferred site the preferred site.

"Amecath" and "Amecath UniQath Soft" short term dual hemodialysis catheterization kits

The provided text is related to a 510(k) premarket notification for "Amecath" and "Amecath UniQath Soft" short term dual hemodialysis catheterization kits. It includes details about the device's indications for use and classification.

However, the document does not contain any information regarding acceptance criteria, device performance metrics, study details (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or any comparative effectiveness studies (MRMC or standalone).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided input.

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