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DualView Catheter is intended for the intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

The DualView Catheter is a catheter consisting of two assemblies: the catheter sheath and the imaging core (consisting of lens and transducer). During imaging, the imaging core rotates inside the catheter sheath to obtain a 360°image of the surface layer of the vessel wall by irradiating with near-infrared light and ultrasound. By pulling back the imaging core inside the catheter sheath, an image in the long axis direction can be obtained.

This is a rapid exchange (RX) design (short monorail) catheter, which is used with a 0.014" (0.36 mm) guidewire. The catheter is 2.6 Fr (0.86 mm) in the imaging window section and 3.0 Fr (1.01 mm) in the shaft section with an effective length of 137 cm. The catheter has a 100 cm hydrophilic coating starting from the distal end, which becomes highly lubricious when wet. The catheter has a telescoping section, and the telescoping length is 155 mm. When connected to the OPUSWAVE, the imaging core can be pulled back 150 mm in the catheter sheath. There are two radiopaque markers. The distal radiopaque marker is located 7 mm from the distal end of the catheter sheath, and the sensor radiopaque marker is located where the near-infrared light and ultrasound are emitted. Those markers allow a user to confirm the positional relationship between the distal end of the catheter and the sensor position (imaging point). There are two depth markers, one at 90 cm and the other at 100 cm from the distal end of the catheter sheath, which serves as a guide for insertion.

The transducer has an IPX7 ingress rating in accordance with IEC 60529.

The catheter is stored in the holder tube and is secured to the catheter holder. The catheter comes with the Motor Drive Unit (MDU) Cover and accessories. The MDU Cover consists of an adapter and a plastic cover sheet to maintain the sterility of the catheter and clean field. The catheter accessories consist of a connection tube with a three-way stopcock, a priming syringe, and a reservoir syringe for priming the catheter lumen with heparinized saline solution.

The provided FDA 510(k) Clearance Letter concerns the DualView Catheter, a diagnostic intravascular catheter. This document is a Summary of a Traditional 510(k) submission, which primarily focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance testing.

Therefore, the submission does not include a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, standalone algorithm performance, or extensive details on ground truth establishment involving human expert consensus for a clinical test set as would be typical for an AI/ML-based device. The clearance is based on direct device performance and safety, primarily through bench testing and animal studies, not a human reader study.

Here's an analysis of the provided information, specifically addressing the questions as much as possible given the nature of this particular 510(k) (a medical device clearance, not an AI/ML algorithm clearance):

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):

Since this is a non-clinical device clearance, the "acceptance criteria" are the successful completion of the listed performance and safety tests, demonstrating the device meets its design specifications and is suitable for its intended use. The "reported device performance" is that it successfully met these criteria.

Detailed Study Information (Where Applicable for this Device Type):

1. Sample sizes used for the test set and the data provenance:

   • Test Set (Non-Clinical): The document refers to various non-clinical tests (e.g., performance testing, software V&V, electrical safety, biocompatibility, sterilization). The "sample size" for these tests would correspond to the number of catheters or test articles subjected to each specific test. This specific number is not provided in the summary but is assumed to be sufficient for each test type according to relevant standards.
   • Animal Study: A "swine model" was used for both safety and performance animal studies. The specific number of animals is not provided in this summary.
   • Data Provenance: The document does not explicitly state the country of origin for the data (e.g., test labs, animal facilities). This is a traditional 510(k) submission, and the manufacturer is Terumo Corporation (Japan), with manufacturing in Japan. Animal studies were likely prospective.

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

   • Not Applicable in the context of this 510(k). This clearance is for a medical device (catheter), not an AI/ML algorithm that requires human expert consensus for image interpretation ground truth. The "ground truth" for this device's performance is established by direct physical measurements, engineering validations, and physiological outcomes in animal models against predefined specifications and safety standards.

3. Adjudication method for the test set:

   • Not Applicable. Since there's no human interpretation component needing adjudication for ground truth establishment. Test outcomes are determined by objective measurements against acceptance criteria.

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

   • No, an MRMC study was NOT done. The document explicitly states: "This 510(k) does not include data from clinical tests." MRMC studies are typically used to assess the impact of AI algorithms on human reader performance, which is not relevant for this device's non-clinical clearance pathway.

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

   • No, not in the sense of an AI algorithm. This device does not appear to involve an AI algorithm whose performance would be assessed in a standalone manner for image interpretation or diagnosis. It is a diagnostic imaging catheter that generates images for human interpretation.

6. The type of ground truth used:

   • Engineering Specifications, Physical Measurements, and Physiological Outcomes (Animal Model):
     • For non-clinical performance tests (e.g., tensile strength, dimensions, imaging quality, etc.), the ground truth is the device's adherence to pre-defined engineering specifications and measurable performance characteristics.
     • For biocompatibility and sterilization, the ground truth is established by adherence to relevant ISO standards and successful completion of validated tests.
     • For animal studies, the "ground truth" relates to the physiological effects observed (e.g., absence of tissue injury, thrombus formation) and the successful performance of the device in a living system as intended by design, compared to predicate devices.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device that requires a training set of data.

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

   • Not Applicable. As no training set for an AI/ML algorithm is involved.

Summary:

The DualView Catheter received 510(k) clearance based on demonstrating substantial equivalence to predicate devices primarily through rigorous non-clinical performance testing and animal studies. This type of submission relies on showing that the new device meets established safety and performance standards equivalent to existing legally marketed devices, rather than a clinical study evaluating an AI algorithm's interpretive accuracy and its impact on human readers. Therefore, many of the questions pertinent to AI/ML device clearances (e.g., human expert ground truth, MRMC studies) are not applicable to this traditional medical device submission.

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The Gentuity® HF-OCT Imaging System with Vis-Rx® Prime Micro-Imaging Catheter is intended for intravascular imaging and is indicated for use in coronary arteries in patients who are candidates for transluminal interventional procedures. The Vis-Rx Prime Micro-Imaging Catheter is intended for use in vessels 1.3 to 6.0 mm in diameter. The Vis-Rx Prime Micro-Imaging Catheter is also intended for use prior to or following transluminal interventional procedures. The Vis-Rx Prime Micro-Imaging Catheter is not intended for use in a target vessel that has undergone a previous bypass procedure.

The Gentuity® HF-OCT Imaging System provides images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The system utilizes fiber-optic technology to deliver near-infrared light and receive light reflected from coronary tissue to produce high resolution, real-time images. The Gentuity HF-OCT Imaging System consists of the following components:

1. The Gentuity Imaging Console: A mobile system that houses the Optical Engine, the Computer and application software, and the Probe Interface Module (PIM). It also includes two monitors, keyboard, mouse, and cord storage as well as external interfaces to the system. The PIM provides the interconnection between the Gentuity Imaging System and the Vis-Rx® Prime Micro-Imaging Catheter.
2. Vis-Rx Prime Micro-Imaging Catheter: The Vis-Rx Prime Micro-Imaging Catheter is a sterile, single-use catheter that consists of an external sheath and an optical imaging core. The external sheath facilitates placement of the device into the coronary artery and houses the optical imaging core. An optical fiber and lens assembly rotates inside the optical imaging core. The optical fiber and lens deliver near-infrared light to the tissue and receive reflected light. The Vis-Rx Prime Micro-Imaging Catheter is a rapid exchange design, compatible with an 0.014" guidewire. The catheter attaches to the PIM, which is mounted outside the sterile field on the table bed rail. A sterile 3 ml purge syringe is provided with the Vis-Rx Prime Micro-Imaging Catheter.
3. Optional Gentuity Review Station: The Gentuity Review Station (GRS) is an optional standalone computer with the Gentuity application software that provides analysis and review capabilities similar to what may be performed on the Gentuity Console. The GRS allows physicians to review images for research, presentation and publication preparation outside the catheterization lab without the Gentuity Console.

This FDA 510(k) summary does not contain the detailed performance study information typically found in acceptance criteria and validation studies for medical devices, particularly those involving AI or imaging interpretation. This document primarily describes the device, its intended use, and substantial equivalence to a predicate device based on bench and animal testing.

Therefore, many of the requested points cannot be answered from the provided text.

Here is what can be extracted and what cannot:

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

The document does not provide a table of acceptance criteria with corresponding reported device performance metrics. Instead, it lists the types of performance testing conducted and states that "All [type of test] validation results met applicable acceptance criteria." without specifying what those criteria or results were.

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

The document mentions an "Animal Study" which was a GLP (Good Laboratory Practice) nonclinical laboratory study. It does not specify the sample size (number of animals) used, nor does it detail the specific data collected from this study in a way that would relate to device performance metrics, image quality, or diagnostic accuracy. There's no information about human test sets, data provenance, or retrospective/prospective nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided. The document does not describe any studies involving human experts interpreting images or establishing ground truth.

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

This information is not provided.

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

There is no mention of an MRMC study and no indication that this device involves AI assistance for human readers in its primary function as described in this 510(k) summary. The device is an imaging system (Optical Coherence Tomography) for intravascular imaging.

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

This information is not provided. The document focuses on the hardware and basic system functionality, not on advanced algorithmic performance or automated interpretation.

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

For the animal study, the "ground truth" would likely be the direct physiological and histological findings from the animals, but the document does not specify this or link it to any performance claims. For other tests (biocompatibility, particulate, sterilization), the ground truth is against established standards and validated methods.

8. The sample size for the training set

This is not applicable as the document does not describe any machine learning or AI components requiring a training set.

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

This is not applicable.

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The pNOVUS 21 Microcatheter is indicated for use with compatible accessories, such as guidewires and guide catheters, in the delivery of interventional devices and infusion of diagnostic agents, such as contrast media, into the neuro vasculature during diagnostic and/or therapeutic procedures. It is not intended for use in peripheral or coronary vasculature.

The pNOVUS 21 Microcatheter (pNOVUS 21) is a single use microcatheter, supplied sterile using ethylene oxide (EtO), in a packing hoop, within a sealed pouch and shelf carton configuration. An introducer sheath and shaping mandrel are supplied on a backing card inside the pouch. The packaging is designed to facilitate ease of handling and aseptic presentation of the device.

The pNOVUS 21 Microcatheter is a variable stiffness single lumen catheter. The pNOVUS 21 has a radiopaque marker on the distal end to facilitate fluoroscopic visualization, and a luer hub on the proximal end to facilitate the infusion of diagnostic agents and the smooth transfer of other devices (e.g., guidewires) into the inner lumen of the microcatheter. The distal end of the microcatheter's external surface has a hydrophilic coating applied for increased lubricity during use. The pNOVUS 21 has a straight tip. Steam shaping of the distal tip allows for one-time customizing of the tip shape. There are two models of the pNOVUS 21 Microcatheter, the device model # are:

• PNOV-21-160
• PNOV-21-150

The pNOVUS 21 Microcatheter is intended for use with compatible accessories, such as guidewires and guide catheters, in the delivery of interventional devices and infusion of diagnostic agents, such as contrast media, into the neuro vasculature during diagnostic and/or therapeutic procedures. pNOVUS 21 is generally inserted either through a sheath or guide-catheter.

The provided text is a 510(k) summary for the pNOVUS 21 Microcatheter. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (bench testing and biocompatibility), rather than a study involving an AI/software component with specific acceptance criteria related to accuracy, sensitivity, or human-in-the-loop performance.

Therefore, many of the requested elements for describing the acceptance criteria and study that prove an AI/software device meets acceptance criteria are not present in this document. This document describes a traditional medical device (microcatheter), not an AI-powered diagnostic or therapeutic software.

However, I can extract the general "acceptance criteria" and "reported device performance" in the context of this traditional device clearance, which are primarily based on meeting defined specifications and demonstrating comparable performance to a predicate device through bench testing.

Here's an attempt to answer the prompt based on the provided text, acknowledging the limitations due to the nature of the device:

This document describes the 510(k) clearance for the pNOVUS 21 Microcatheter, which is a physical medical device, not an AI software. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating the device's physical and functional performance and biocompatibility through non-clinical testing, rather than metrics like sensitivity, specificity, mAP, FROC, or human reader improvement with AI assistance.

The overarching acceptance criterion for substantial equivalence for this device is that it performs as intended and is as safe and effective as a legally marketed predicate device. This is demonstrated through a comprehensive suite of bench tests and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes numerous bench tests conducted to ensure the pNOVUS 21 Microcatheter performs as intended and is substantially equivalent to its predicate. The "acceptance criteria" for each test are typically that "All samples met the acceptance criteria," "performance is comparable to the predicate," or "conforming to specifications." The "reported device performance" is essentially that these criteria were met.

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

The document does not explicitly state the numerical sample size for each specific non-clinical bench test. It consistently reports "All samples met the acceptance criteria," indicating that a sufficient number of devices were tested to provide statistical confidence for the relevant acceptance criteria and demonstrate performance.

• Data Provenance: The tests were conducted internally by phenox Ltd or by their designated testing partners (e.g., sterilization in Trier, Germany by Rose GmbH). The data is prospective in the sense that it was generated specifically for this regulatory submission through controlled bench testing and laboratory studies.

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

This section is not applicable as this submission is for a physical medical device (microcatheter) and does not involve AI software requiring expert-established ground truth for image interpretation or similar diagnostic tasks. The "ground truth" for these tests are objective, measurable physical properties and performance characteristics (e.g., leak/no leak, pass/fail for specific forces, material properties).

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described because the testing involves objective measurements against predefined specifications, not subjective interpretations requiring consensus from adjudicators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Reader Improvement

No MRMC study was done. This is a physical medical device, not an AI software intended to assist human readers. Therefore, there is no discussion of human reader improvement.

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

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective physical and functional measurements and performance specifications, as defined by relevant ISO standards, ASTM standards, and FDA guidance documents. Examples include:

• Absence of cytotoxic effect, sensitization, irritation, systemic toxicity.
• Measured burst pressure, friction force, particulate count, torque strength, flow rate.
• Visual inspection for defects, kinks, or damage.
• Confirmation of specific dimensions (ID, OD, length).
• Compliance with standard requirements for luer fittings, packaging, etc.

These are not "expert consensus" or "pathology" in the sense of a diagnostic interpretation, nor are they "outcomes data" from clinical trials, as clinical trials were not deemed necessary.

8. The Sample Size for the Training Set

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

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

Not applicable. As this is not an AI model, there is no training set or ground truth in that context.

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The Impress Angiographic Catheter is designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. Angiographic catheters with marker bands may also be used for anatomical measurements.

The Merit Impress Angiographic Catheters with/without hydrophilic coating are intravascular diagnostic catheters that are intended for the administration of contrast for conducting fluoroscopic studies. The catheters are available in a variety of 4F and 5F wire-braided and non-braided configurations ranging in length from 40cm to 125cm. The device may include a marker band to assist anatomical measurements. The devices are available in a variety of tip shapes to cater to variations in physician preference and patient anatomy.

The catheters consist of a shaft with a molded hub assembly. It is the shaft that may be offered with or without a wire-braided reinforcement. The distal tip of the device is tapered for efficient volume flow and dispersion of the contrast media. The distal tip is flexible so as to minimize the potential for vessel trauma.

The provided text is a 510(k) premarket notification summary for the Impress Angiographic Catheter. It outlines the device's characteristics, indications for use, comparison to predicate devices, and the testing conducted to demonstrate its safety and performance. However, this document does not contain information about an AI/algorithm-based medical device study.

The device in question, the "Impress Angiographic Catheter," is a physical medical device used for delivering radiopaque media in the vascular system. The testing described (design verification, design validation, and biocompatibility studies) are standard for physical medical devices and do not involve AI or software performance evaluation against an acceptance criterion that would be typical for an AI/ML product.

Therefore, I cannot provide the requested information regarding acceptance criteria and study proving an AI device meets those criteria based on the provided text. The document focuses on the substantial equivalence of a physical catheter, primarily due to changes in its material composition.

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The Zoom 6F Insert Catheters are indicated for use in delivering radiopaque media to selected sites in the peripheral vascular system in conjunction with routine diagnostic procedures.

The Imperative Care Zoom™ 6F Insert Catheters are single lumen, braid reinforced, variable stiffness catheters. The catheters feature a standard luer hub on the proximal end, a radiopaque distal shaft and tip, and a tapered distal tip provided pre-shaped with various curve configurations. The curve configurations are designed to selectively engage arteries from the access sites such as the femoral, radial, and brachial arteries. The Zoom 6F Insert Catheter outer diameter is 0.082" (2.08 mm), the inner diameter is 0.041" (1.04 mm), and the tapered distal tip outer diameter is 0.061" (1.55 mm). The catheters are offered in working lengths of 137 cm, 139 cm, 140 cm, and 143 cm and come in three different tip configurations: VRT, SIM and VTK. The Zoom 6F Insert Catheters are compatible with standard luer lock devices (e.g., syringes), ≤ 0.038" diameter guidewires, ≥ 180 cm length guidewires, ≥ 6F introducer sheaths and ≥ 0.088" inner diameter guide catheters.

The provided text describes the submission for a medical device called the "Zoom 6F Insert Catheter." This is a regulatory submission to the FDA, demonstrating "substantial equivalence" to a legally marketed predicate device, the "Impress Angiographic Catheter."

Crucially, this document does not describe an AI/ML device. It describes a physical medical device (a catheter) and its performance through bench and laboratory (in-vitro) testing against physical specifications, not algorithm performance. Therefore, many of the requested items related to AI/ML device testing (e.g., sample size for AI test sets, expert consensus for ground truth, MRMC studies, training set details) are not applicable to this document.

However, I can extract the acceptance criteria and performance data for the physical device as presented.

Description of Acceptance Criteria and Study (for this physical device)

The submission details the design verification and validation testing performed on the Zoom 6F Insert Catheter to demonstrate its substantial equivalence to a predicate device. The "study" here refers to a series of in-vitro bench and laboratory tests, not a clinical trial or an AI/ML model validation.

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a table (Table 2) summarizing the performance specifications (acceptance criteria) and the results ("Pass") for the Zoom 6F Insert Catheter.

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The Soldier Microcatheter is indicated for use in the blood vessels of the peripheral vasculature. It is intended to assist in the delivery of diagnostic agents and therapeutic agents into the target treatment area.

The Soldier Microcatheter is intended for Prescription Use Only.

The Soldier is a single lumen catheter designed to access small, tortuous vasculature. It is available in a variety of outer and inner diameters. Each configuration has a hydrophilic coating to provide lubricity for navigation of vessels. The inner lumen is lined with lubricious PTFE to facilitate movement of guidewires and other devices. The distal tip of the catheter is radiopaque to aid in visualization under fluoroscopy.

This document is a 510(k) summary for the Embolx Soldier Microcatheter, seeking substantial equivalence to a predicate device (Progreat catheter). As such, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device through non-clinical testing. It does not contain information about an AI/ML-driven device or a study involving human readers and AI assistance. Therefore, I am unable to provide information on acceptance criteria and study details for an AI/ML device from this document.

The document primarily details the acceptance criteria and the study that proves the device meets the acceptance criteria for a medical device through bench testing and biocompatibility assessments, rather than an AI/ML study.

Here's an analysis of the provided text, focusing on the available information regarding the "Soldier Microcatheter" as a non-AI/ML medical device:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML context):

The document does not present a formal table of "acceptance criteria" versus "reported device performance" in the typical sense of numerical thresholds met by specific metrics from a study. Instead, it lists various non-clinical tests performed and states that "Results from each test met the defined acceptance criteria" for biocompatibility and "All tests met the pre-defined performance criteria" for shelf-life. For design verification, it states "Performance testing was conducted to ensure the safety and effectiveness of the Soldier Microcatheter and to demonstrate substantial equivalence to the predicate device: Progreat catheter."

Below is a summary of the types of tests conducted and the general performance statement, as the specific numerical acceptance criteria and results are not detailed in this public summary.

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

The document describes non-clinical bench testing. Therefore, the concept of "test set" in the context of data (images, records) for an AI/ML algorithm is not applicable. The sample sizes would refer to the number of physical devices tested for each bench-top, biocompatibility, and sterilization test. These specific numbers are not provided in this summary.

• Data Provenance: Not applicable in the context of this non-AI/ML device. The "data" comes from laboratory bench testing of physical devices, not from patient-derived data (e.g., medical images). The testing was for a physical medical device (microcatheter).

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

This is not applicable for a physical medical device. Ground truth, in the context of AI/ML, refers to expert-labeled data for training and evaluating algorithms. For this microcatheter, performance is evaluated through objective physical and chemical tests, not human expert interpretation of data.

4. Adjudication Method for the Test Set:

This is not applicable as there is no human review of "data" from the test set for an AI/ML system. The tests are bench-top, objective measurements.

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

No, an MRMC comparative effectiveness study was not done. This document pertains to a physical medical device (microcatheter), not an AI/ML-driven device or diagnostic tool that would involve human readers interpreting cases.

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

No, this is not applicable. The Soldier Microcatheter is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

For this physical device, "ground truth" doesn't refer to clinical outcomes or expert consensus on patient data. Instead, it refers to:

• Established laboratory standards and validated test methods (e.g., ISO 10993, ASTM F1980) for evaluating physical and chemical properties.
• Engineering specifications and design requirements for the device, against which performance is measured (e.g., burst pressure, flow rate, dimensions).

8. The Sample Size for the Training Set:

This is not applicable. There is no software algorithm or "training set" for a physical microcatheter.

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

This is not applicable as there is no training set for a physical microcatheter.

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Cordis catheters are indicated for enabling diagnosis of various pathologies by facilitating of diagnostic devices within the coronary and peripheral vasculature.

The INFINITI Ambi Catheter is a 0.038" guidewire compatible catheter with a 3-staged braided nylon construction. The body is a braided nylon intended for torque responsiveness and stability. The proximal segment is a non-braided nylon for flexibility and shape retention. The Distal Tip is a soft, radiopaque nylon for minimal vessel cannulation. The INFINITI Ambi product line comes in 5F and 6F size and various curve style configurations. The device is a disposable intended for single use only. It is individually packaged and sterilized by ethylene oxide gas.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called the "INFINITI™ Ambi Angiographic Catheter." It is not a study proving the device meets acceptance criteria for an AI/ML medical device.

The document states that the device is a catheter and its purpose is for "enabling diagnosis of various pathologies by facilitating the positioning of diagnostic devices within the coronary and peripheral vasculature." It is a physical medical device, not a software device or an AI/ML algorithm.

Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, ground truth establishment, sample sizes for training/test sets, expert adjudication methods, and MRMC studies are not applicable to this document. This submission is for demonstrating "substantial equivalence" of a physical medical device to a predicate device, based on bench testing and biocompatibility testing, not AI/ML performance metrics.

The document explicitly states:

• "No clinical data was required in support of the proposed change to the predicate device cleared under K970854." (Page 9, Section VII. CLINICAL PERFORMANCE)
• The performance data section details Biocompatibility Testing, Sterilization, Packaging, and Bench Testing, which are standard for physical medical devices. (Page 7-8, Section VII. PERFORMANCE DATA)

Since the prompt asks for information about AI/ML device performance and this document concerns a traditional physical medical device, I cannot extract the requested information from the provided text.

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The Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter is intended for intravascular imaging and is indicated for use in coronary arteries in patients who are candidates for transluminal interventional procedures. The Vis-Rx Micro-Imaging Catheter is intended for use in vessels 1.3 to 6.0 mm in diameter. The Vis-Rx Micro-Imaging Catheter is not intended for use in a target vessel that has undergone a previous bypass procedure.

The Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter (herein the "Gentuity Imaging System") provides images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The system utilizes fiber-optic technology to deliver near-infrared light and receive light reflected from coronary tissue to produce high resolution, real-time images. The Gentuity Imaging System consists of the Gentuity Imaging Console, Vis-Rx Micro-Imaging Catheter, and Optional Gentuity Review Station.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only discusses the device performance for the AI feature designed to identify "B-Mode with Stent & Guide Catheter." It specifies performance targets and the achieved performance within a table. Note that the other new software features (Stent Expansion View Mode, Longitudinal Zoom & Zoom Indicator, Training Mode, Image Display Speed Optimization, and Angle measurement tool) are verified and validated but their specific performance metrics are not explicitly detailed as acceptance criteria in the same way as the AI feature.

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

• Test Set Sample Size: The text indicates that the test set included 25 patients. The "Patient population included the following" table shows age, sex, and BMI distribution for 25 patients in the test set.
• Data Provenance: The HF-OCT images used for the AI training and test data sets included "clinical data acquired with the Gentuity HF-OCT Imaging System and Vis-Rx catheters." The study population consisted of participants "already scheduled for a visit to the catheterization laboratory and were candidates for transluminal interventional procedures." This strongly suggests the data is retrospective clinical data from an unspecified country, likely where the Gentuity system is used.

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

The document does not explicitly state the number of experts used or their specific qualifications (e.g., "radiologist with 10 years of experience") for establishing the ground truth on the test set.

4. Adjudication Method for the Test Set

The document does not describe the adjudication method used for the test set. It mentions "ground truth for the test data was established by expert consensus," but no details on the consensus process (e.g., 2+1, 3+1) are provided.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focused on the performance of the AI algorithm in isolation (standalone). There is no mention of comparing human readers with and without AI assistance or any effect size for human improvement.

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

Yes, a standalone performance study was done for the AI feature. The acceptance criteria and reported performance metrics (Accuracy, Sensitivity, Specificity for B-Mode with Stent & Guide Catheter detection, and overall image annotation accuracy) are for the algorithm's performance without direct human intervention in the interpretation phase for these specific AI tasks.

7. The Type of Ground Truth Used

The ground truth for the test set was established by expert consensus. The text states: "The ground truth for the test data was established by expert consensus."

8. The Sample Size for the Training Set

The training set included 20 patients. The "Patient population included the following" table shows age, sex, and BMI distribution for 20 patients in the training set.

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

The document states, "The ground truth for the training data was established by expert consensus." No further details on the specific experts or the consensus method are provided.

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The Drakon™ and SeQure® microcatheters are intended for the infusion of contrast media into all peripheral vessels. The Drakon™ and SeQure® microcatheters are also intended for drug infusion in intra-arterial therapy and infusion of embolic materials. The Drakon™ and the SeQure® microcatheters should not be used in cerebral vessels.

The Drakon™ and Sequre® microcatheters are single use microcatheters primarily comprised of a luer lock hub, a strain relief cover and tube, central shaft, and a distal tip with radiopaque markers for visualization. The two models differ only in the design of the distal tip. The Sequre®'s distal end has side holes and two radiopaque markers while the Drakon™'s distal end has no side holes and one radiopaque marker. These markers allow for the fluoroscopic visualization of the distal tip of the microcatheters. The inner lumen is made of PTFE (polytetrafluoroethylene), which allows for the smooth passage of fluids, embolic agents and devices such as guide wires. The distal section of the shaft in both models is coated in a hydrophilic polymer layer, which ensures high lubricity when wet with saline or blood. The Drakon™ and Sequre® microcatheters are sterile single lumen devices and are available in varying configurations of length (105 cm, 130 cm, 150 or 155 cm, 180 cm), diameters (1.7 Fr., 1.9 Fr., 2.4 Fr. 2.7 Fr., 2.8Fr. and 3.0 Fr.) and tip shape (straight, SP1, SP2).

The provided text is a 510(k) summary for the Drakon™ and Sequre® microcatheters, and it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving those criteria.

Specifically, this document describes a device modification (addition of sizes and tip shapes) to previously cleared predicate devices, rather than an initial market clearance study with detailed performance metrics against specific disease detection criteria. The performance data presented are bench tests conducted to demonstrate that the modified device remains substantially equivalent to the predicate device, not a formal clinical efficacy study in the sense typically associated with AI/diagnostic device performance.

Therefore, many of your questions, particularly those related to clinical performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies, cannot be effectively answered from this document.

However, I can extract the available information related to the acceptance criteria and the type of studies conducted:

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

The document states that the modified devices met "predetermined acceptance criteria" for various bench tests, but it does not explicitly list the quantitative acceptance criteria or detailed numerical results. It only reports that the devices "met the predetermined acceptance criteria."

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. The document lists "bench tests," which typically involve a set number of physical samples of the device. The specific number of devices tested for each bench test is not provided.
• Data Provenance: Not applicable in the context of clinical data. These are laboratory/bench tests, not patient data trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. These are bench tests for a microcatheter, not an AI/diagnostic device requiring expert interpretation for ground truth.

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

• Not applicable. These are bench 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, an MRMC study was not done. This device is a microcatheter, not an AI diagnostic tool.

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

• No, this is a physical medical device, not an algorithm.

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

• For bench tests, "ground truth" generally refers to validated measurement standards, engineering specifications, and established limits for physical properties (e.g., tensile strength, burst pressure, leak rates). The document implies that these standards were used for the "predetermined acceptance criteria."

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

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The Dragonfly OpStar™ Imaging Catheter with the OCT imaging system is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragong Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OpStar Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The Dragonfly OpStar Imaging Catheter is a sterile, single-use intravascular catheter consisting of a catheter body external sheath and an internal rotating fiber optic imaging core. The external sheath serves two primary functions: 1) to facilitate placement of the device into the coronary artery and 2) to cover and protect the internal rotating fiber optic imaging core. The inner rotating fiber optic imaging core emits near infrared light to tissues and receives reflected light. It is driven by a stainless-steel torque wire visible under fluoroscopy and pulled back through the window tube of the external sheath by the Drive-motor and Optical Controller (DOC). The emitted and returned reflected light are combined and processed by the OPTIS System software to construct an Optical Coherence Tomography (OCT) image. The patient is never exposed to moving parts as the external sheath completely covers the rotating imaging core.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dragonfly OpStar™ Imaging Catheter.

Important Note: The provided document is an FDA 510(k) clearance letter and summary. It focuses on demonstrating substantial equivalence to a predicate device, not on detailed clinical or standalone performance studies against specific acceptance criteria for a novel AI/software component. The "device" in this context refers to the physical imaging catheter, not an AI or software algorithm that provides diagnostic interpretations. Therefore, many of the requested items (like AI performance, ground truth establishment, expert adjudication, MRMC studies) are not applicable or not present in this type of submission.

Let's break down what information is available and what is not for the "device" (the catheter itself).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria and reported performance for the Dragonfly OpStar™ Imaging Catheter in the way one would for an AI diagnostic algorithm. Instead, it relies on demonstrating substantial equivalence to a predicate device (K192019). The "performance" assessment is qualitative, focusing on meeting design specifications and not raising new safety or effectiveness concerns.

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

• Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of a diagnostic test set. The testing performed was "Design verification and validation bench tests." These typically involve testing individual catheter units, components, and system functionalities.
• Data Provenance: Not applicable in the context of clinical data for a diagnostic algorithm. The tests were "bench tests," meaning they were conducted in a laboratory or simulated environment, not on human patients or derived from patient data.

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

This information is not applicable to this submission. The device is an imaging catheter that produces images, not an AI algorithm that interprets them to make a diagnosis requiring expert ground truth for validation. The "ground truth" for bench testing would be engineering specifications and measurements (e.g., catheter diameter, image resolution, material strength).

4. Adjudication Method for the Test Set

This is not applicable. Since there's no diagnostic interpretation requiring expert consensus, no adjudication method was used.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing is provided in this pre-market notification." This type of study would be relevant for evaluating AI-assisted interpretation, which is not the subject of this 510(k) (it's for the physical catheter).

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

No, a standalone performance study was not done. This question is relevant for AI algorithms. The device's "performance" described relates to its physical and functional capabilities as an imaging tool, not its interpretive accuracy.

7. The Type of Ground Truth Used

The ground truth for the "Design verification and validation bench tests" would be engineering specifications and measurements. For example, if a test was to verify the catheter's diameter, the ground truth would be the specified diameter in the design documents, and the test would confirm that measured catheters fall within acceptable tolerances of that specification.

8. The Sample Size for the Training Set

This information is not applicable. This question is for AI/machine learning algorithms. The Dragonfly OpStar™ Imaging Catheter is a physical medical device.

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

This information is not applicable. As above, this pertains to AI/machine learning training, which is not described for this device.

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