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The Cora Microcatheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions of diagnostic contrast.

The CoraFlex and CoraForce Microcatheters (Cora Microcatheters) are single lumen catheters designed to access the peripheral and coronary vasculature. Each configuration has a hydrophilic coated coiled catheter with a braided support matrix, radiopaque distal tip, proximal luer, and "spin-friendly" strain relief. The Cora Microcatheters will also allow for the exchange of guidewires and provide a conduit for delivery diagnostic or therapeutic agents.

This document is a 510(k) clearance letter for medical microcatheters, not an AI/ML device. Therefore, the requested information about acceptance criteria, study data, ground truth, and expert involvement for AI device performance is not applicable to this submission.

The FDA clearance is based on non-clinical (bench) testing demonstrating substantial equivalence to a predicate device, as indicated by the following sections:

1. A table of acceptance criteria and the reported device performance:
This information is not provided in a table format. The document states:
"The Cora Microcatheters met all specified criteria and did not raise new questions regarding safety and effectiveness compared to the predicate."
And
"Based on the performance testing, the Cora Microcatheters were found to be substantially equivalent to the predicate."

The specific criteria and direct performance metrics are not detailed in this summary, but the types of tests performed indicate the areas of performance evaluated:

• Simulated Use
• Dimensional Verification
• Radiopacity
• Leak Testing
• Kink Resistance
• Corrosion Resistance
• Component Integrity
• Bond Integrity
• Particulate Testing
• Torque Testing
• Burst Testing
• Lubricity and Coating Integrity Testing
• Design Validation/Usability
• Sterility Testing
• Biocompatibility Assessment

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not explicitly stated in the provided document. The study was non-clinical (bench testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this is a non-clinical device clearance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this is a non-clinical device clearance.

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, as this is a non-clinical device clearance and does not involve AI or human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a non-clinical device clearance and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" for this device would be established by engineering specifications and industry standards for medical device performance, as evaluated through bench testing.

8. The sample size for the training set:
Not applicable, as this is a non-clinical device and does not involve a training set as in AI/ML.

9. How the ground truth for the training set was established:
Not applicable, as this is a non-clinical device and does not involve a training set as in AI/ML.

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SINC Support Catheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices, and provide a conduit for delivery of saline solutions or diagnostic/ therapeutics agents.

The SINC™ (Selective Interventional Navigation Catheter) Support Catheters are single lumen catheters designed to access peripheral vasculature. These catheters are available in a variety of lengths and offer a side port. Each configuration has a braided support matrix and hydrophilic coating on the distal segment of the catheter. The distal tip is clearly distinguished by a radiopaque gold coated tip.

The SINC Support Catheters will also allow for exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic contrast.

The provided text is a 510(k) summary for the Reflow Medical SINC Support Catheter. It outlines the device description, indications for use, and a comparison to a predicate device. However, it does not include information about a study proving the device meets acceptance criteria related to a standalone AI algorithm's performance, human-in-the-loop performance, or the nuances of AI model development (training/test sets, ground truth establishment, expert adjudication).

The document focuses on the physical and mechanical performance of the catheter itself, demonstrating substantial equivalence to a predicate device through non-clinical laboratory testing. The types of tests mentioned are:

• Simulated Use Testing
• Dimensional Verification
• Leak Testing
• Bond Integrity
• Component Integrity
• Corrosion Testing
• Kink Resistance
• Torque Testing
• Particulate
• Catheter Flow Rate and Burst Testing
• Lubricity Characterization
• Packaging Testing
• Design Validation

These tests are standard for medical devices like catheters to ensure their mechanical safety and functionality, not for AI/ML performance.

Therefore, I cannot provide accurate answers to most of your questions as they pertain to an AI/ML device study, which is not described in the given text.

However, I can extract information relevant to the device's mechanical performance to show what "acceptance criteria" and "performance" are mentioned for this type of device:

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

The document states: "The SINC™ Support Catheter met all specified criteria and did not raise new safety and performance questions." While specific quantitative acceptance criteria and reported values for each test (e.g., "Kink Resistance: Passed 1N force without kinking") are not detailed in this summary, the general statement indicates successful performance against pre-defined criteria for each test listed.

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

This information is not applicable to the non-clinical, mechanical testing described. The "test set" here refers to the physical units of the SINC Support Catheter used for the various lab tests (e.g., a certain number of catheters were subjected to torque testing, burst testing, etc.). The document does not specify the number of units tested for each category, nor is "data provenance" (country/retrospective/prospective) relevant to lab-based mechanical tests.

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 is not applicable. "Ground truth" in this context refers to the successful completion or failure of mechanical tests according to engineering specifications, not expert interpretation of medical images or patient outcomes. The "experts" would be the engineers and technicians conducting and evaluating the specified physical/mechanical tests according to established international standards (like ISO 10555-1, referenced in the document). Their qualifications would be in engineering, materials science, or related fields, not medical imaging.

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 establishing consensus on medical image interpretations or clinical outcomes, typically when ground truth is subjective or challenging to obtain. For mechanical tests, the results (e.g., pass/fail, measurable physical properties) are typically objective and determined by the test protocol itself.

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. No MRMC study was performed as this is a medical device (catheter), not an AI-assisted diagnostic tool.

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

Not applicable. No standalone algorithm performance was assessed as this is a medical device (catheter), not an AI algorithm.

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

For the mechanical tests listed, the "ground truth" is defined by the pass/fail criteria of the specified engineering and performance tests, often based on international standards (like ISO 10555-1 mentioned in the document) and the device's design specifications. For example, a "kink resistance" test would have an objective threshold for what constitutes a "kink" and the maximum force the catheter must withstand without kinking.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the machine learning sense. The "training" for such a device involves its design, manufacturing processes, and quality control.

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

Not applicable.

In summary, the provided document details the regulatory clearance of a physical medical device (a catheter) and its mechanical performance testing. It does not describe an AI/ML device or a study involving AI performance metrics or human-AI interaction.

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The coraCross Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewire and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic contrast.

The coraCross Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature. The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic contrast.

This document is an FDA 510(k) Premarket Notification summary for the coraCross Catheter. It focuses on demonstrating substantial equivalence to a predicate device, not on proving performance against specific acceptance criteria for an AI/ML-based device or diagnostic study.

Therefore, the requested information regarding acceptance criteria, study design parameters (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), and ground truth establishment for a device performance study (especially one involving AI/ML) is not available in the provided text.

The document primarily describes:

• Device Name: coraCross Catheter
• Intended Use: Used with steerable guidewires to access peripheral/coronary vasculature, facilitate placement/exchange of guidewires/interventional devices, and provide a conduit for saline/contrast.
• Predicate Device: Wingman 14C Crossing Catheter (K190393)
• Technological Comparison: States the coraCross Catheter is "nearly identical" to the predicate, listing identical technological elements (over-the-wire, through lumen, smooth inner lumen, polymer catheter shaft) and minor differences (inner catheter leveraged from another device, beveled tip attachment method, hydrophilic coating length).
• Nonclinical Tests: Lists various performance tests conducted (Simulated Use Testing, Leak, Kink Resistance, Corrosion, Bond, Component Integrity, Particulate, Torque, Catheter Flow/Burst, Lubricity Testing).
• Conclusion: The device "met all specified criteria and did not raise new safety or performance questions" and "was found to be equivalent to the predicate device."

In summary, there is no information in this document that directly addresses the specific points requested for a study proving a device meets acceptance criteria related to AI/ML or diagnostic performance. The submission is for a medical device (catheter) based on substantial equivalence to an existing predicate, and the "acceptance criteria" referred to are likely engineering and performance specifications for the catheter itself, rather than diagnostic accuracy metrics.

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Cora Catheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic contrast.

The coraForce and coraFlex Support Catheters are devices intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and coronary vasculature. The device consists of a support catheter body with a luer end and a polymer tip (coraFlex) or metallic tip (coraForce). The through-lumen of the device can serve as a conduit for the delivery of diagnostic contrast.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria, as it relates to performance metrics like sensitivity, specificity, or F1-score which are typically found in AI/ML device studies. The document describes a medical device called "coraForce and coraFlex Support Catheters" and its substantial equivalence to predicate devices, focusing on technological characteristics and bench testing.

Therefore, I cannot provide the requested table or details about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies.

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The speX LP Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.

The speX LP Support Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature. The device consists of a support catheter body with a luer end. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.

Based on the provided text, the acceptance criteria and study information for the speX LP Support Catheter are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Simulated Use Testing" and "design testing."

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

The document does not provide information about experts, their number, or their qualifications for establishing ground truth. The testing appears to be nonclinical, focusing on device performance rather than clinical diagnostic accuracy.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method, as the testing described is nonclinical.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The device is a support catheter, not an AI or diagnostic tool that would typically involve human readers.

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

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

7. Type of Ground Truth Used

The "ground truth" for this device appears to be defined by engineering and performance specifications related to its function as a support catheter, as opposed to a diagnostic ground truth like pathology or outcome data. The stated goal was to meet "specified criteria" and have "performance equal to the legally marketed predicate devices."

8. Sample Size for the Training Set

Not applicable, as this is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable, as this is a physical medical device.

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The Wingman Crossing Catheters (14/14C/18/3) are intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices, including facilitation of the intraluminal placement of diagnostic/ interventional devices beyond peripheral stenotic lesions (including chronic total occlusions [CTOs]) and provide a conduit for delivery of saline solutions or diagnostic/therapeutic agents.

The Wingman 14C Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic/therapeutic agents.

The Wingman 14, 18, & 35 Crossing Catheter is contraindicated for use in the coronary and cerebral vasculature. The Wingman 14C Crossing Catheter is contraindicated for use in the cerebral vasculature.

The Wingman Crossing Catheter (14/18/35) is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral vasculature.
The Wingman Crossing Catheter (14C) is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the coronary vasculature and peripheral vasculature.

The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.

The provided text describes a 510(k) summary for the Wingman Crossing Catheters. The summary includes information about the device, its intended use, and a brief discussion of a clinical study conducted to demonstrate the safety and effectiveness of the device for crossing Chronic Total Occlusions (CTOs) in infrainguinal arteries.

Here's a breakdown of the requested information based on the provided text, focusing on the clinical study that proves the device meets the acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: 85 subjects with 86 CTO lesions.
• Data Provenance: The study was "non-randomized, prospective, multi-center, single-arm." It was conducted "both in the United States and outside the United States in Germany and Austria."

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

The provided text does not specify the number of experts used to establish ground truth or their qualifications. The study focused on objective endpoints (successful CTO crossing, MAE rates) rather than subjective expert consensus on image interpretation.

4. Adjudication Method for the Test Set

The provided text does not specify an adjudication method. Given the objective nature of the primary effectiveness endpoint (successful crossing of the CTO) and the safety endpoint (occurrence of specific adverse events), a formal adjudication method by experts beyond clinical reporting might not have been implemented in the way it would for, say, image review.

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

The provided text indicates this was a "non-randomized, prospective, multi-center, single-arm study." It does not describe an MRMC comparative effectiveness study comparing human readers with and without AI assistance. The study evaluated the device's performance in crossing CTOs, not its impact on human reader performance.

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

The device is a physical medical device (catheter), not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in this context. The study evaluates the catheter's ability to facilitate CTO crossing.

7. The Type of Ground Truth Used

The ground truth for the effectiveness endpoint was the objective observation of successful CTO crossing during the interventional procedure. For the safety endpoint, the ground truth was the occurrence of specific clinical events (MAE, perforation, embolization, or dissection) within 30 days, likely determined by clinical follow-up and medical records. This falls under outcomes data and clinical observation.

8. The Sample Size for the Training Set

The provided text describes a clinical study evaluating the device's performance. It does not mention a "training set" in the context of machine learning or AI models. This study is an evaluation of the device itself.

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

As the device is a physical catheter and not an AI algorithm, the concept of a "training set" and its associated ground truth establishment is not applicable. The study evaluates the device's clinical performance.

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The speX 14/18 Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.

The speX Support Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature.

The device consists of a support catheter body with a luer end. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.

The provided text is a 510(k) premarket notification for a medical device called the "speX Support Catheter." This document is a regulatory submission to the FDA for market clearance, arguing that the new device is substantially equivalent to a previously cleared predicate device.

Crucially, this document focuses on demonstrating substantial equivalence to a predicate device, not on proving that an AI/ML powered device meets specific performance criteria through a clinical study where AI assists human readers or performs standalone analysis.

Therefore, most of the requested information regarding acceptance criteria, study design (sample sizes, ground truth, experts, adjudication methods, MRMC studies, standalone AI performance), and training set details for an AI-powered device is not applicable to this document.

The document discusses performance data in general terms for a physical medical device (catheter), not a digital health/AI product. The "performance data" mentioned (Simulated Use Testing, Particulate Testing) are engineering and biocompatibility tests typical for physical medical devices, not clinical performance studies for an AI algorithm.

Here's what can be extracted and what cannot:

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

• Acceptance Criteria (Implicit for a medical device approval): The device must demonstrate a safety and effectiveness profile similar to the predicate device and meet "specified criteria" in performance testing. The text states: "The speX Support Catheter met all specified criteria and did not raise new safety or performance questions."
• Reported Device Performance:
  • "Simulated Use Testing" was performed.
  • "Particulate Testing" was performed.
  • Result: "The speX Support Catheter met all specified criteria and did not raise new safety or performance questions."
  • Conclusion: "Based on the performance testing the speX Support Catheter was found to have a safety and effectiveness profile that is similar to the predicate device." And "The design testing performed for the speX Support Catheter demonstrated that the performance of the device is equal to the legally marketed predicate devices."

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

• Not applicable. This document describes testing for a physical medical device (catheter), not an AI algorithm. The "test set" concept in the context of AI (i.e., a dataset of images/cases for algorithm evaluation) is not relevant to this submission. The "Simulated Use Testing" likely involved a certain number of tests on physical prototypes, but specific sample sizes and data provenance (country of origin, retrospective/prospective) are not detailed because they are not required for this type of submission for a physical device.

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 medical images or diagnostic AI systems is not relevant for this physical device.

4. Adjudication method for the test set:

• Not applicable. No adjudication method for a test set is mentioned, as it's not an AI study.

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. No MRMC study was done, as this is not an AI-powered device.

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

• Not applicable. No standalone AI algorithm performance was evaluated.

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

• Not applicable. Ground truth for diagnostic accuracy is not relevant for this physical device. The "ground truth" for a physical device's performance would be engineering specifications and safety standards, which are implicitly met.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of AI for this physical device.

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

• Not applicable. There is no "ground truth for the training set" for this physical device.

In summary, the provided document is a regulatory filing for a physical medical device (a catheter) demonstrating substantial equivalence to a predicate device, not an AI/ML powered device. Therefore, the specific details requested about AI model validation and performance criteria are not present in this document.

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The Wingman 14C Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic agents.

The Wingman 14C Crossing Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature.

The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.

The provided text is a 510(k) summary for the ReFlow Medical, Inc. Wingman 14C Crossing Catheter. It describes the device, its intended use, and comparison to a predicate device, as well as a list of performance tests conducted.

However, the document does not contain the kind of information requested in the prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, or details about a multi-reader multi-case (MRMC) study for an AI/device. The device described here is a physical medical catheter, not an AI-powered diagnostic device.

Therefore, I cannot fulfill the request using only the provided text. The questions posed are specifically for a study that proves an AI medical device meets acceptance criteria, which this document does not describe.

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The Wingman 35 Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.

The Wingman 35 Crossing Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral vasculature.

The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.

I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the format you requested.

Here's why:

• This document is an FDA 510(k) clearance letter and its summary. It primarily focuses on demonstrating "substantial equivalence" of a new device (Wingman 35 Crossing Catheter) to a previously cleared predicate device.
• The "Performance Data" section (VII) lists categories of tests but explicitly states: "The Wingman 35 Crossing Catheter met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the Wingman 35 Crossing Catheter was found to be substantially equivalent to the predicate device." It does not provide details about specific acceptance criteria or the numerical results of these tests.
• The document is about a mechanical catheter, not an AI/ML-driven device. Therefore, concepts like "AI assistance," "human readers," "ground truth," "training set," "test set," "number of experts," and "adjudication methods" as they pertain to AI development and validation are irrelevant to this specific device and are not mentioned in the text.

The information you are asking for (acceptance criteria and study details with respect to AI/ML performance) would typically be found in a more detailed clinical study report or a specific section of a regulatory submission for an AI/ML medical device, not a 510(k) summary for a mechanical catheter.

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