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

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

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

Here's a breakdown of the acceptance criteria and study information for the Symetrex™ Long Term Hemodialysis Catheter with Sideholes, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily demonstrated through equivalence to the predicate device and compliance with various ISO and ASTM standards. The document doesn't explicitly state quantitative acceptance criteria in all cases, but rather reports the device performance against established standards through "performance testing."

Key performance aspects are outlined in the comparison to the predicate device and in the performance standards section.

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

The document does not specify the sample sizes used for the performance testing (test set) for the device. It also does not provide information on data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned are primarily in vitro (Recirculation) or bench/laboratory testing (physical, mechanical, packaging, luer fittings, biocompatibility).

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

This information is not provided in the document. The studies described are non-clinical, benchtop, and in vitro tests governed by engineering and scientific standards, rather than clinical trials requiring expert-established ground truth in the medical diagnostic sense.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable and therefore not provided in the document. The studies are non-clinical hardware tests.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document pertains to a physical medical device (catheter), not an AI-powered diagnostic system. Therefore, the concept of "human readers improve with AI" is not relevant here.

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

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

7. The Type of Ground Truth Used

For the non-clinical performance testing and biocompatibility studies, the "ground truth" is established by:

• Engineering and Scientific Standards: Compliance with relevant ISO and ASTM standards (e.g., ISO 10555-1 for intravascular catheters, ISO 11607-1 for packaging, ISO 594-1/2 for luer fittings, and various ISO 10993 parts for biocompatibility).
• Measurement and Comparison: Direct measurement of physical properties (e.g., priming volumes) and comparison to the predicate device.
• Established Test Methods: In vitro testing for recirculation rates.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" in the context of this physical medical device. The device is not learning-based.

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

This information is not applicable as there is no "training set" for this physical medical device.

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The C3 Wave System is indicated for use in the positioning of Peripherally Inserted Central catheters (PICC). The C3 Wave provides real-time catheter tip location by displaying changes in the patient's cardiac electrical activity. The C3 Wave is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

Note: Limiting, but not contrindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-Wave: Atrial fibrillation Atrial flutter Severe tachycardia Pacemaker-Driven Rhythm Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to PICC insertion. Use of additional method is necessary to confirm catheter tip location.

C3 Wave is designed to provide a continuous display of electrocardiograph [ECG] waveform to be used as a guide in placement of peripherally-inserted central catheters [PICC] in the lower third of the Superior Vena Cava [SVC] of a patient. The principle for operation of this system uses three ECG leads placed on the patient's chest and generates a third ECG lead by switching from RA to PICC stylet. The ECG waveform is wirelessly transmitted to a tablet which allows the operator to view and record changes to the ECG waveform as the tip of the catheter approaches the heart. As the PICC catheter approaches the atrium of the heart, the P wave in the ECG waveform shows substantial changes. This system is designed to aid the visualization of changes in P wave amplitude.

The C3 Wave system must only be operated by a skilled nurse, physician, or trained medical professional who has been qualified in placement of PICC's and trained in the proper use of this device.

This document details the substantial equivalence review for the Medcomp C3 Wave System (K180567), which is an update to a previously cleared device (K170934). The current submission focuses on expanding accessory pack offerings, specifically adding a larger drape and revising the packaging system. Therefore, the "study" described relates to the testing performed to ensure the safety and effectiveness of these modifications, rather than a clinical efficacy study of the core device functionality.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "All testing was completed and is the subject of this submission" and concludes that the device raises "no new questions of safety or effectiveness compared to the predicate device." This implies that all acceptance criteria for the non-clinical testing performed on the modified accessory pack were met. Specific numerical performance metrics for each test (beyond the EO residuals) are not detailed in this summary.

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

The provided text describes non-clinical laboratory testing performed on the modified accessory pack. It does not mention a "test set" in the context of patient data or clinical performance. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or not provided for this specific submission, as it focuses on accessory modifications rather than the primary device's clinical performance.

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

This information is not applicable or not provided as the submission focuses on non-clinical testing of device accessories (drape and packaging), not on clinical performance requiring expert ground truth for interpretation of patient data.

4. Adjudication Method for the Test Set

This information is not applicable or not provided for the same reasons as 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

An MRMC comparative effectiveness study was not performed or described in this document. The C3 Wave System is an ECG-based positioning aid for PICC lines, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. This submission specifically addresses modifications to accessory packs.

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

A standalone performance study of an algorithm is not discussed or applicable to this submission. The C3 Wave System is a device that provides real-time data to a human operator (skilled nurse, physician, or trained medical professional) to aid in PICC placement. The submission pertains to modifications to non-electronic accessories.

7. The Type of Ground Truth Used

For the non-clinical testing of accessories, the "ground truth" would be established by standardized laboratory testing procedures and the specifications of relevant international and national consensus standards (e.g., ISO 10993 for biocompatibility, ANSI/AAMI/ISO 11135 for sterilization, ASTM F1929 and F1140 for packaging). This is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable or not provided. Since the submission refers to modifications of accessories and non-clinical testing, there is no "training set" in the context of machine learning or AI algorithms.

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

This information is not applicable or not provided as there is no "training set" in the context of this submission.

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The CT Midlines are indicated for Short-Term peripheral access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

The CT Midline Catheter is designed for peripheral vein catheterization and power injection of contrast media. The lumen is an open-ended design comprised of a soft radiopaque polyurethane material with barium sulfate for radiopacity. The lumen is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid contamination. Female luer connectors provide the connection for intravenous administration.

The CT Midline Catheter is available in a 4Fx20cm single-lumen, or 5Fx20cm double-lumen configuration. The outside diameter of the lumen has a reverse taper increasing gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen has depth marks every centimeter and numerical marks every fifth centimeter. The CT Midline is packaged sterile with the necessary accessories to facilitate insertion.

The provided document is a 510(k) premarket notification for a medical device (CT Midline) and primarily discusses its substantial equivalence to a predicate device, rather than presenting a study of the device's performance against specific acceptance criteria.

The submission states that the purpose of this particular 510(k) is to "remove a contraindication that was once cited in the Journal of Infusion Nursing but has since been revised." This is a change to the labeling, not a new performance claim or a new device design that would necessitate a comprehensive performance study with acceptance criteria and reported results.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

Here's a breakdown of why each point cannot be thoroughly answered from the provided text:

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

   • The document implies that the device's performance (e.g., flow rates for power injection) is identical to the predicate device K141151.
   • Table 5.1 "Design Comparison Matrix" lists "Performance Testing" with "Power Injection: 5cc/sec (4F), 7cc/sec (5F)" for both the proposed and predicate devices, stating "Identical, no change." This indicates the expected performance, but not explicit acceptance criteria, nor the results of a new study designed to meet those criteria for this specific submission. It's a statement of equivalence.

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

   • No test set is described for evaluating new performance. The comparison is based on the predicate device's existing performance data.

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 as no new performance test set requiring expert ground truth is described.

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

   • Not applicable.

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

   • Not applicable. This device is an intravascular catheter, not an AI-powered diagnostic tool.

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

   • Not applicable.

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

   • Not applicable. The "ground truth" here is the established performance of the predicate device, against which the proposed device is declared equivalent.

8. The sample size for the training set:

   • Not applicable as this is a physical medical device, not an algorithm requiring a training set.

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

   • Not applicable.

Summary from the document:

The submission explicitly states under "Bench / Performance Data / Non-Clinical Testing":
"No performance testing was required for the revision to the instructions in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, CT Midline, is equivalent to the predicate device, CT Midline (K141151)."

The basis for equivalence is that the "Proposed CT Midline is substantially equivalent to the predicate device. CT Midline (K141151), in all aspects, including but not limited to, indications for use, intended use, anatomical location, basic design, dimensions, lengths performance, biocompatibility, materials, manufacturing process and method of sterilization." The only difference is a "revision to the instructions for use (labeling)" to remove a contraindication.

Therefore, for this specific 510(k) submission (K170770), no new study was conducted to prove the device meets performance acceptance criteria, because the device itself and its performance characteristics are deemed identical to a previously cleared predicate device. The change is solely in the labeling information, specifically removing a contraindication.

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THE MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER IS INDICATED FOR USE IN ATTAINING LONG-TERM VASCULAR ACCESS FOR HEMODIALYSIS AND APHERESIS. IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARILY PLACED IN THE INTERNAL JUGULAR VEIN. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN. CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN INSERTION.

The Medcomp 14.5F Double Lumen Hemodialysis Catheter is a polyurethane, double lumen catheter used to remove and return blood through two-segregated lumen passages. Both lumens open at the distal tip, each with a series of side holes. The distal venous lumen is tapered and extends beyond the arterial lumen to reduce recirculation. The lumens are connected to the extensions via a molded hub. The arterial and venous extensions are identified by red and blue luer connectors and clamps. Priming volume information is printed on the clamps for ease in identification. A removable suture wing is provided for securing the catheter after initial placement. The fixed polyester cuff allows for tissue ingrowth for long term placement. The Medcomp 14.5F Double Lumen Hemodialysis Catheter is available in varied implantable lengths, with straight or pre-curved configurations to be determined by the prescribing physician based on insertion site and patient anatomy.

This document describes the Medcomp 14.5F Double Lumen Hemodialysis Catheter and its substantial equivalence to a predicate device (K981994 Bard Opti-Flow).

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document states that clinical studies were not deemed necessary. All performance data was generated through in vitro testing.
• The specific sample size (number of catheters tested) for each in vitro test is not explicitly stated in the provided document.
• The data provenance is in vitro laboratory testing, directly related to the manufactured device, and therefore not tied to a specific country of origin in terms of patient data. It is inherently prospective in the sense that the device was manufactured and then tested.

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 clinical studies were not conducted, and the ground truth was not established by human experts for patient outcomes. The acceptance criteria were based on engineering and material science principles, against which the in vitro performance was compared.

4. Adjudication method for the test set:

• This information is not applicable as clinical studies were not conducted, and there was no expert adjudication process for patient cases.

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 performed. This device is a medical catheter and does not involve AI for diagnostic or interpretive purposes.

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

• No, this refers to an AI algorithm's performance, which is not applicable to this medical device.

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

• The "ground truth" for this device, in the context of its substantial equivalence determination, was based on established performance characteristics of legally marketed predicate devices (K981994 Bard Opti-Flow) and industry standards for catheter performance and material properties. This is typically determined through engineering specifications, previous regulatory approvals, and documented performance of equivalent devices.

8. The sample size for the training set:

• This information is not applicable as this device does not involve a machine learning algorithm that requires a training set.

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

• This information is not applicable as this device does not involve a machine learning algorithm that requires a training set.

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The Medcomp Hemo-Flow Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site is the subclavian vein as required.

The Medcomp Hemo-Flow Catheter is a polyurethane, double lumen catheter used to remove and return blood through two-segregated lumen passages. Both lumens are "D" shaped, open at the distal tip, with two side holes. The distal venous lumen is tapered and extends beyond the arterial lumen to reduce recirculation. The fixed polyester cuff allows for tissue ingrowth for long term placement.

The lumens are connected to the extensions via a soft pliable hub with suture wing. The arterial and venous extensions are identified by red and blue luer connectors and clamps. Priming volume information is printed on the extensions for ease in identification.

The provided text describes the Medcomp Hemo-Flow Catheter and its substantial equivalence to a predicate device. However, it does not explicitly detail acceptance criteria or a study design for a specific performance metric with quantitative results. Instead, it generally states that in vitro performance data "demonstrates that this device is substantially equivalent to legally marketed devices."

Given the information provided, I can infer the acceptance criteria are implicitly defined by the performance of the predicate device and relevant industry standards. The "study" described is a comparison demonstrating substantial equivalence through in vitro testing and biocompatibility assessments.

Here's an attempt to structure the information based on your request, with significant limitations due to the level of detail in the original document:

Acceptance Criteria and Performance Data for Medcomp Hemo-Flow Catheter

The Medcomp Hemo-Flow Catheter's acceptance criteria are implicitly based on demonstrating substantial equivalence to its predicate device, the Medcomp Ash Split-Cath (K972207), and compliance with relevant standards for hemodialysis catheters.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific numerical thresholds or target values for these metrics. The acceptance is based on demonstrating "substantial equivalence" to legally marketed devices and compliance with ISO 10993.

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

The document states "In Vitro performance data," indicating laboratory testing.

• Sample Size: Not specified.
• Data Provenance: In vitro testing, likely conducted in a laboratory setting. No country of origin is specified for the data, nor whether it was retrospective or prospective (as it's in vitro, these terms aren't directly applicable in the same way as clinical data).

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

N/A. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical diagnosis). The performance data mentioned for the Medcomp Hemo-Flow Catheter is in vitro (tensile strength, leakage, recirculation, flow performance), which relies on standardized testing methods rather than expert consensus on ground truth in the same way clinical studies would.

4. Adjudication Method (for the test set)

N/A. As the performance data is from in vitro testing of mechanical and hemodynamic properties, an adjudication method for establishing ground truth (like 2+1 or 3+1 for expert review) is not applicable.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on in vitro performance and biocompatibility to demonstrate substantial equivalence, not on human reader performance with or without AI assistance.

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

N/A. This question is relevant for AI/algorithm-based devices. The Medcomp Hemo-Flow Catheter is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

For the in vitro performance data (tensile strength, joint strength, leakage, recirculation, and flow performance), the "ground truth" would be established by:

• Standardized measurement protocols: Following established test methods and specifications for each performance characteristic.
• Predicate device performance: Comparing the results against the known performance characteristics of the legally marketed predicate device (Medcomp Ash Split-Cath) to establish substantial equivalence.
  For biocompatibility, the ground truth is established by meeting the requirements of ISO 10993 standards.

8. The Sample Size for the Training Set

N/A. The concept of a "training set" is relevant for machine learning or AI models. This device is a physical catheter, and thus, a training set for an algorithm is not applicable.

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

N/A. See point 8.

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The Medcomp Safety Slide Clamp is intended to provide a secondary extension tube clamp on the Medicomp Ash Split-Cath, Duo-Flow 400XL and Duo-Split Catheters to prevent leakage during connection or disconnection of the bloodlines.

Medcomp selected a standard "off the shelf" slide clamp designed to pinch or occlude a variety of medical tubing. This slide clamp is widely used throughout the medical device industry to prevent air or fluid communication.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medcomp Safety Slide Clamp:

Unfortunately, the provided text does not contain a detailed table of acceptance criteria or specific performance data with numerical metrics. It focuses more on the problem the device addresses (faulty original clamps) and the fact that a "simulated use testing" was performed, which is referred to as "Performance Data (Simulated Use Testing V-1026)". There are no explicit performance metrics, target values, or reported device performance against those targets.

However, based on the information provided, we can infer some aspects:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document mentions "52-week simulated use testing." While the specific number of devices or tests performed is not explicitly stated as a sample size, the duration (52 weeks) indicates a prolonged test. It also refers to "performance data (Simulated Use Testing V-1026)", which implies a specific test protocol.
• Data Provenance: The study was conducted by Medcomp ("Medcomp confirmed the complaints and determined the root cause... Medcomp has determined that to prevent possible leakage..."). It is a retrospective analysis in the sense that the need for the device arose from existing complaints. The testing itself (simulated use) would be considered prospective for the new clamp design. The country of origin for the data is not explicitly stated, but Medcomp is a US-based company (Harleysville, PA).

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

• The document does not mention the use of external experts to establish ground truth for the simulated use testing. The "ground truth" for the effectiveness of the clamp seems to be based on the direct observation during the simulated use testing and the conclusion of Medcomp's internal assessment that the clamp prevented the target failure mode.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method involving multiple reviewers for establishing ground truth within the simulated use testing. The evaluation appears to be a direct assessment of the clamp's function during the simulated use.

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

• No, an MRMC comparative effectiveness study was not conducted or mentioned. This approval is for a device modification (a clamp), and the "study" described is a simulated use test, not a comparative human reader study. Therefore, there's no discussion of human reader improvement with or without AI assistance.

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 medical device (a clamp), not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

• The ground truth for the simulated use testing was direct observation of physical performance and absence of failure modes (e.g., no leakage, no damage to the extension tube). It is performance-based ground truth derived from a physical test.

8. The Sample Size for the Training Set

• This question is not applicable as the device is a physical medical device (a clamp), not an AI algorithm. There is no concept of a "training set" in this context.

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

• This question is not applicable as the device is a physical medical device and does not involve a training set.

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The MedComp® Duo-Coat Catheter is indicated for use in attaining short term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion sites are the subclavian or femoral vein.

The MedComp® DUO-COAT Catheter Double Lumen combines the MEDCOMP Duo-Flow Catheter with a dual purpose surface coating. Bound heparin reduces thrombus formation on the catheter outer surface and at arterial and venous ports, in 4-hour invitro-studies'. The round catheter design and lubricious surface may aid in catheter insertion by reducing friction on the outer surface. The fixed circular tube within a tube allows for a 360 arterial uptake and provides consistent flows from 350 to 400 ml/min. The catheter lumen is fabricated from a soft, thermo-sensitive, polyurethane material that is rigid upon insertion, but which becomes soft upon reaching body temperature to reduce vessel trauma. The external lumen surface incorporates heparin to reduce the risk of thrombus. The catheter hub is molded from soft pliable polyurethane to increase patient comfort. The soft radiopaque tip reduces vessel trauma and aids in confirmation of tip placement. Extensions are color coded with a red luer and clamp for the arterial lumen and a blue luer and clamp for the venous lumen for easy identification.

Here's a breakdown of the acceptance criteria and study information for the MedComp® DUO-COAT Catheter Double Lumen, based on the provided text:

Important Note: This submission is a 510(k) Pre-market Notification, which primarily focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" and "study" described are often comparisons to the predicate and performance tests to ensure safety and effectiveness, rather than extensive clinical trials with human subjects as might be seen for novel devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a number of devices or subjects in the provided text. The testing mentioned refers to "comparative evaluation against uncoated control catheters" and "hemodynamic testing under strenuous simulation testing." It implies in vitro testing, not human trials.
• Data Provenance:
  • Country of Origin: Not specified, but generally assumed to be within the US or compliant with US regulatory standards for a US FDA submission.
  • Retrospective or Prospective: The reported tests ("4-hour in-vitro-studies", "hemodynamic testing under strenuous simulation testing," "comparative evaluation") are presented as prospective in vitro bench tests conducted specifically for this submission.

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

This information is not provided in the text. The evaluation method described is primarily in vitro laboratory testing and comparison to an uncoated control, not an expert-driven ground truth assessment for a diagnostic or imaging device.

4. Adjudication Method for the Test Set

None. The testing described is in vitro laboratory performance evaluation (e.g., thrombus formation, drag reduction, consistent flow rates, biocompatibility, mechanical integrity) against a control, not a subjective assessment requiring adjudication.

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

No. An MRMC study is typically performed for diagnostic imaging or AI devices where human readers interpret cases. This device is a medical catheter, and its evaluation focuses on physical and biological performance characteristics, not diagnostic interpretation. Therefore, there is no mention of human readers or effect size of AI assistance.

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

Not Applicable. This is a physical medical device (catheter), not an AI algorithm. Its performance is inherent to its design and materials, not learned from data.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims appears to be established through:

• Quantitative In Vitro Measurements: Direct measurement of parameters like flow rates (350-400 ml/min), thrombus formation (reduction in 4-hour studies), and drag reduction (marked reduction).
• Comparative Assessment: Performance compared against "uncoated control catheters" for thrombus formation and drag.
• Predicate Device Performance: Substantial equivalence claims often benchmark against the known safety and effectiveness of the predicate.
• Biocompatibility Standard Tests: Implied adherence to established biocompatibility screens.
• Mechanical Integrity Tests: Implied adherence to established tests for device durability and function.

8. The Sample Size for the Training Set

Not Applicable. This device 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

Not Applicable. As this is not an AI/ML device, there is no training set and therefore no ground truth established for it.

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