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The Aristotle 14 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Aristotle 18 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Aristotle 24 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Zoom Wire 14 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Aristotle Colossus Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Scientia Vascular's Aristotle 14, Aristotle 18, Aristotle 24, Zoom Wire 14, and Aristotle Colossus Guidewires ("the guidewires") are steerable guidewires with a shapeable tip to aid in accessing the neuro and peripheral vasculatures. The guidewires are supplied sterile, for single use only.

The distal portion of each guidewire's tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. All guidewires have a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels.

The guidewires are provided with an accessory kit consisting of an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve), a torque device (to attach to the proximal portion of the guidewire to facilitate gripping and manipulation of the guidewire during use), and a shaping mandrel (to aid in shaping the flexible tip of the guidewire). These accessory devices are included to facilitate use of the guidewires and are not intended to contact the patient's body.

This document describes a 510(k) clearance for several guidewire devices, not an AI/ML medical device. Therefore, the information requested about acceptance criteria and studies related to AI/ML device performance (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, etc.) is not applicable and cannot be extracted from this document.

The document primarily focuses on establishing substantial equivalence for physical medical devices—guidewires—by comparing their technological characteristics and performing non-clinical performance tests (biocompatibility, sterilization, bench performance).

Here's a breakdown of why this document does not contain the requested information about an AI/ML device:

• Device Type: The clearance is for "Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire" which are physical catheter guide wires. These are traditional medical devices, not software or AI/ML devices.
• Study Types: The studies described are "Biocompatibility," "Sterilization," and "Bench Performance Testing" (Visual Inspection, Coating Integrity, Corrosion Resistance, Agent Compatibility, Simulated Use, Particulate). These are mechanical and biological tests relevant to physical devices, not algorithmic performance.
• Missing Information: All points you requested regarding AI/ML performance are absent because they are not relevant to this type of device clearance:
  • No acceptance criteria for AI performance metrics (e.g., sensitivity, specificity, AUC).
  • No test or training set sample sizes for AI data.
  • No information about experts establishing ground truth for images or data used by an AI.
  • No adjudication methods.
  • No MRMC comparative effectiveness studies.
  • No standalone algorithm performance.
  • No ground truth type related to AI (e.g., imaging labels, pathology).

The document explicitly states:

• "No animal testing was deemed necessary to support the substantial equivalence of the subject devices."
• "No clinical testing was deemed necessary to support the substantial equivalence of the subject devices."

This indicates that the clearance relies on non-clinical data and comparison to predicate devices, which is common for guidewires, especially when the changes are minor (like a different PTFE coating).

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The Socrates™ 38 Catheter is indicated for use in facilitating the insertion and guidance of an appropriate microcatheter or diagnostic agents into a selected blood vessel in the peripheral or neuro vasculature. The Socrates™ 38 Catheter is not intended for use in the coronary vasculature.

Scientia Vascular's Socrates™ 38 Catheter is a single lumen, variable stiffness, open-ended catheter designed to track through a guide catheter using a steerable guidewire and microcatheter. The catheter shaft design includes nitinol, polymers of varying durometer, and an internal lubricious liner. To reduce friction during manipulation, a hydrophilic coating is applied to the distal exterior section of the catheter shaft. A single radiopaque tip marker provides visualization under fluoroscopy. The proximal end of the catheter includes a clear hub with luer lock and a stainless-steel strain relief. The catheter is supplied sterile, for single use only and is packaged with a rotating hemostasis valve (RHV).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Socrates™ 38 Catheter:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary provided does not explicitly state numerical acceptance criteria for each test. Instead, it indicates that all tests either "Pass" or that the "subject device met all acceptance criteria." The acceptance criteria are implicitly defined by the test methods referenced (e.g., ISO standards, comparison to predicate).

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

The document does not specify the exact sample sizes (number of devices tested) for the individual functional tests. It only states that "performance testing was conducted." The data provenance is non-clinical performance data, primarily from laboratory testing. It does not mention country of origin for the data, nor whether it's retrospective or prospective, as these are non-clinical studies. Many tests were "leveraged" from a previous submission (K223913) for a similar device, implying consistency in design and testing methodologies.

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

For the "Usability and Radiopacity Validation" test, it states "Physicians evaluated various performance characteristics...in a human cadaver."

• Number of experts: Not specified (plural "Physicians" implies more than one).
• Qualifications of experts: "Physicians" (likely interventional neuroradiologists or neurosurgeons given the device's indications) are mentioned, but specific qualifications (e.g., years of experience, subspecialty) are not provided.
• This specific test involved evaluation in a "human cadaver," which serves as a realistic test environment.

For all other functional tests, the "ground truth" (acceptance criteria) was established by engineering specifications, relevant ISO standards, and comparisons to the predicate device, not by expert consensus on a test set in the traditional sense of a clinical or image-based study.

4. Adjudication Method for the Test Set

For the "Usability and Radiopacity Validation" involving physicians, an adjudication method is not specified. For the other non-clinical functional tests, adjudication is not applicable as the results are quantitative measures against pre-defined engineering or standard-based acceptance criteria.

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 done. The document explicitly states: "Therefore, no clinical study was conducted." The device being reviewed is a physical medical device (catheter), not an AI or software device that would typically undergo MRMC studies to evaluate human-in-the-loop performance with AI assistance.

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

No, a standalone study was not done. This device is a physical catheter, not an algorithm or software. Therefore, the concept of "algorithm only without human-in-the-loop performance" does not apply.

7. The Type of Ground Truth Used

The ground truth for the device's performance is established through:

• Engineering specifications and design requirements: For dimensional, mechanical, and functional aspects.
• International Standards (ISO): Such as ISO 10555-1:2014 for catheters and ISO 80369-7 for luer connectors, which define test methods and performance requirements.
• Comparison to a legally marketed predicate device: Many tests established performance relative to the "Modified HD Guide Catheter (K133177)" or "Socrates Aspiration System (K223913)."
• Expert Observational Consensus: For the "Usability and Radiopacity Validation" test, physicians' evaluations (though specific methodology is not detailed).
• Leveraged Data: Much of the data was leveraged from the previous K223913 submission, indicating that the design, components, and manufacturing processes are sufficiently similar to pre-validate certain aspects.

8. The Sample Size for the Training Set

This question is not applicable. The Socrates™ 38 Catheter is a physical medical device. There is no "training set" in the context of machine learning or AI algorithms, as no algorithm is being developed or trained.

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

This question is not applicable for the same reason as above. There is no training set for this physical medical device.

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As part of the Socrates Aspiration System, the Socrates 38 Aspiration Catheter with a compatible suction pump is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral -M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

As part of the Socrates Aspiration System, the Socrates Aspiration Tubing is indicated to connect the Socrates 38 Aspiration Catheter to a compatible suction pump.

The Scientia Vascular Socrates Aspiration System is composed of two components: the Socrates 38 Aspiration Catheter, designed to aid in accessing vasculature, and the Socrates Aspiration Tubing, designed to connect the aspiration catheter to a compatible suction pump and control flow between them. When used with a compatible vacuum pump, these components facilitate the aspiration and removal of thrombus from the neurovasculature. Both components are supplied sterile for single use only.

The Socrates 38 Aspiration Catheter is a single lumen, variable stiffness catheter designed to be advanced over a steerable guidewire. The catheter shaft design includes nitinol, polymers of varying durometer, and an internal lubricious liner. To reduce friction during manipulation, a hydrophilic coating is applied to the distal exterior section of the catheter shaft. A single radiopaque tip marker provides visualization under fluoroscopy. The proximal end of the catheter includes a clear hub with Luer lock and a stainless-steel strain relief. The catheter is supplied sterile, for single use only and is packaged with a rotating hemostasis valve (RHV).

The Socrates Aspiration Tubing is designed to connect the Socrates 38 Aspiration Catheter to a compatible vacuum pump and control flow between them. The aspiration tubing consists of tubing attached to a suction connector on one end and a male Luer lock on the other with an intermediate on/off fluid flow control device and is supplied sterile and for single use only.

The provided FDA 510(k) summary for the Socrates Aspiration System does not contain information related to an AI/ML-enabled device or its performance criteria specific to AI/ML applications. The document describes a medical device for revascularization in acute ischemic stroke and its non-clinical performance data (biocompatibility, functional testing, and an animal study) to support substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study that proves an AI-enabled device meets those criteria based on the provided text. The document clearly states:

• "The non-clinical performance data presented were determined to be sufficient to support the substantial equivalence of the Socrates Aspiration System. Therefore, no clinical study was conducted."
• There is no mention of an AI/ML component, a test set, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

If you have a document pertaining to an AI/ML medical device, please provide that.

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The Plato 17 Microcatheter is intended for the introduction of therapeutic devices, infusion of diagnostic agents, such as contrast media, and delivery of embolization materials to the peripheral and neuro vasculature systems. The Plato 17 Microcatheter is not intended for use in the coronary vasculature.

Scientia Vascular's Plato® 17 Microcatheter is a single lumen, open-ended catheter designed to be flexible and axially stable, to aid the physician in the accessing of the distal neuro and peripheral vasculature. The Plato® 17 Microcatheter is supplied sterile and is for single use only. The Plato® 17 Microcatheter is supplied in various tip configurations, including straight and pre-shaped (45° and 90°). The microcatheter shaft design includes nitinol, polymers of varying durometer, and an internal liner providing lubricity for therapeutic device, diagnostic agent, and embolization material delivery. The distal exterior section of the catheter shaft is hydrophilic coated to reduce friction during manipulation in vessels. The microcatheter includes two radiopaque tip markers to facilitate fluoroscopic visualization and a clear hub with luer lock and a strain relief.

The microcatheter is provided with a steam shaping mandrel, peel-away introducer, and a ruler. The shaping mandrel, peel-away introducer, and ruler are accessories included to facilitate use of the microcatheter and are not intended to contact the patient's body.

The provided document is a 510(k) summary for the Scientia Vascular, Inc. Plato® 17 Microcatheter. It does not contain information about studies related to AI/ML device performance, human reader improvement with AI assistance, or standalone algorithm performance. The device described is a microcatheter, a physical medical device, not a diagnostic imaging or AI-powered solution.

Therefore, I cannot populate the table or provide information for points 2 through 9 as they are specific to AI/ML device evaluations.

Here is the acceptance criteria and the (non-AI/ML related) study details as provided in the document:

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

Since the provided document is for a physical medical device (microcatheter) and not an AI/ML-powered device, the following points are not applicable and cannot be answered from the given text:

2. Sample size used for the test set and the data provenance: Not applicable for a physical medical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a physical medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical medical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI-powered algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a physical medical device; ground truth refers to labels/diagnoses in AI/ML performance evaluation. For this device, "ground truth" would relate to confirming physical properties and functional performance against standards.
8. The sample size for the training set: Not applicable as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML device that requires a training set.

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The Aristotle 18 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional device is not intended for use in the coronary vasculature.

The Aristotle 24 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Scientia Vascular's Aristotle 18 Guidewire and Aristotle 24 Guidewire are steerable guidewires with a shapeable tip to aid in accessing the neuro and peripheral vasculatures. The guidewires are supplied sterile, for single use only, in the following diameters, stiffness profiles, and lengths:

Aristotle 18 Guidewire
Diameter: 0.018"
Stiffness Profiles: Soft, Standard, Support
Length: 200 cm, 300 cm

Aristotle 24 Guidewire
Diameter: 0.024"
Stiffness Profiles: Soft, Standard, Support
Length: 200 cm, 300 cm

The distal portion of each guidewire's tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. All guidewires have a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels.

The guidewires are provided with an accessory kit consisting of an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve), a torque device (to attach to the proximal portion of the guidewire to facilitate gripping and manipulation of the guidewire during use), and a shaping mandrel (to aid in shaping the flexible tip of the guidewire). These accessory devices are included to facilitate use of the guidewires and are not intended to contact the patient's body.

The provided text is a 510(k) summary for the Aristotle 18 Guidewire and Aristotle 24 Guidewire. This type of submission to the FDA focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through a full clinical study with a defined test set and ground truth.

Therefore, many of the requested details about acceptance criteria, test set, expert adjudication, MRMC studies, standalone performance, and ground truth establishment (which are typical for AI/ML device clearances or more complex clinical effectiveness studies) are not applicable to this 510(k) submission.

This submission relies on:

1. Similarities in indications for use, intended use, operating principles, design, materials, packaging, and sterilization processes to predicate devices.
2. Bench testing data from predicate/reference devices to support the performance of the new models, particularly noting that the added length (100 cm) is at the proximal end and does not impact the distal end's features or dimensions.
3. Biocompatibility and sterilization data from reference devices which are deemed applicable due to material and process commonality.
4. A risk assessment (ISO 14971) concluding that no new questions of safety or effectiveness are raised and no additional testing is necessary.

Since this is a guidewire, the "performance" typically refers to physical characteristics rather than diagnostic accuracy like an AI/ML product.

Here's a breakdown based on the information provided, highlighting what is and is not present:

1. Table of acceptance criteria and the reported device performance

No explicit acceptance criteria table is provided as this is a substantial equivalence claim, not a de novo or PMA where specific performance targets might be set and then measured against. The "performance" is implicitly demonstrated through the similarity to predicate devices and the lack of new safety/effectiveness concerns due to the minor modification (increased length at the proximal end).

The document states:

• "The subject devices have the following similarities to the previously cleared predicate devices:
  • The same indications for use,
  • The same intended use,
  • The same operating principle,
  • The same basic guidewire design,
  • The same materials, and
  • The same packaging materials and sterilization processes."
• "The bench performance testing conducted for the reference devices (K222347, K173235) and the predicate 200 cm long models of the subject guidewires cleared under K183608 and K192783, support the performance of the subject devices (300 cm) because they use the same materials, processes, components, and dimensions within the range of the previously cleared predicate and reference devices."
• "Following the risk assessments conducted in accordance with ISO 14971, no additional testing was deemed necessary to support the substantial equivalence of the subject device models."

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

• No specific "test set" in the context of an AI/ML model for diagnostic accuracy is described. The studies referenced are bench performance testing, biocompatibility, and sterilization, which are standard for guidewire manufacturing and safety.
• The provenance of data for the bench testing and biocompatibility is not explicitly stated (e.g., country of origin) but would typically be from the manufacturer's internal testing.
• The studies were retrospective in the sense that they relied on pre-existing data from predicate and reference devices (K222347, K173235, K183608, K192783) and did not generate new clinical data for this specific submission.

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

• Not applicable. This submission does not involve diagnostic interpretation or human reader performance, so there's no "ground truth" establishment by experts in the sense of image annotation or disease diagnosis. The "ground truth" for guidewire performance comes from engineering specifications and bench testing.

4. Adjudication method for the test set

• Not applicable. No human adjudication of results is mentioned or required for this type of device and submission.

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 a guidewire, a physical medical instrument, not an AI/ML diagnostic or image-assisted tool for human readers. No MRMC study was performed.

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

• Not applicable. This device is a guidewire, not an algorithm.

7. The type of ground truth used

• For the performance assessment, the "ground truth" for the guidewire's characteristics (e.g., diameter, stiffness, coating, radiopacity) is based on engineering specifications, material science properties, and established bench testing methods to ensure the physical device meets its design intent and functions as expected within the vasculature. This is not a "ground truth" in terms of disease presence or absence like in diagnostic studies.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set" or corresponding ground truth to establish for this type of device.

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The Aristotle Colossus Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

Scientia Vascular's Aristotle Colossus Guidewire is a modification of Scientia Vascular's Aristotle 24 Guidewire. It is a 0.035" diameter, steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a single stiffness profile (standard) and is available in a range of lengths from 150 cm to 300 cm. The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in tortuous vessels.

The guidewire is provided with a shaping mandrel, an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a rotating hemostasis valve (RHV)), and a torque device (to attach to the proximal portion of the guidewire to facilitate gripping and manipulation of the guidewire during use). The shaping mandrel, introducer, and torque device accessories are included to facilitate use of the guidewire and are not intended to contact the patient's body.

The provided text describes a medical device, the Aristotle Colossus Guidewire, and its clearance process with the FDA. It details a comparison to a predicate device and reports on non-clinical performance tests. However, the document does NOT contain information about any study involving human readers, AI assistance, or the establishment of ground truth by experts for such a study. It specifically focuses on the physical and functional characteristics of a guidewire.

Therefore, I cannot provide the detailed information requested regarding acceptance criteria and studies that prove the device meets those criteria in the context of an AI/human-in-the-loop performance evaluation. The document describes a traditional medical device clearance process based on material properties, functional performance, and biocompatibility.

Here's a breakdown of why I cannot fulfill your request based on the provided text, and what is present:

Information NOT present in the document which your request asks for:

• A table of acceptance criteria and reported device performance related to AI/human reader performance.
• Sample size used for a test set in the context of AI/human reader performance.
• Data provenance (country of origin, retrospective/prospective) for AI/human reader performance data.
• Number of experts used to establish ground truth for an AI/human reader test set or their qualifications.
• Adjudication method for an AI/human reader test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study (effect size of human readers with/without AI).
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data) in the context of AI interpretation.
• Sample size for a training set (for an AI model).
• How ground truth for a training set was established (for an AI model).

Information that IS present in the document (but is for a physical medical device, not an AI/Software as a Medical Device):

The document describes the acceptance criteria and performance study for the Aristotle Colossus Guidewire, which is a physical medical device (a guidewire for vascular procedures). The studies described are non-clinical (laboratory and simulated use) to demonstrate the device's physical and biological safety and effectiveness.

1. Acceptance criteria and reported device performance (for the physical guidewire):

The document states: "Results of tests performed on the Aristotle Colossus Guidewire demonstrate that it met the test acceptance criteria and meets the requirements of relevant standards and FDA guidance documents."

The "Table 3: Summary of Subject Device Functional Testing" lists the tests performed and consistently reports: "The Aristotle Colossus Guidewires met test acceptance criteria."

Here's a summary of the stated "acceptance criteria" through the lens of successful test outcomes for the physical guidewire:

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

• Sample Size: Not specified quantitatively for each test, but it refers to the physical guidewires tested. Standard engineering and biocompatibility testing typically involves a specific number of units per lot or batch, but these numbers are not detailed in this summary.
• Data Provenance: The studies are non-clinical performance tests conducted in a laboratory setting, likely by or for the manufacturer, Scientia Vascular, Inc. (West Valley City, Utah). They are simulations or bench tests rather than data derived from patients. The studies are prospective in the sense that they were designed and executed to evaluate this specific device for regulatory submission.

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 applicable in the context of this device's testing. The "Usability Evaluation" involved "Physicians [who] evaluated subject and predicate guidewires for various performance characteristics in a human cadaver." The number and specific qualifications of these physicians are not provided. This is a usability assessment, not an expert panel for establishing ground truth for diagnostic accuracy.

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

Not applicable. This is for a physical device, and the "usability evaluation" doesn't describe a ground truth adjudication process in the manner seen for diagnostic AI.

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 a guidewire, not an AI diagnostic tool.

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

Not applicable. This device is a guidewire, not an AI algorithm.

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

The "ground truth" for this device's performance is established by engineering specifications, material science standards, and in vitro/ex vivo (cadaver) performance. For biocompatibility, it's established via standardized biological assays. There is no "ground truth" in the clinical diagnostic sense with expert consensus or pathology involved.

8. The sample size for the training set:

Not applicable. This device does not use a "training set" in the context of machine learning or AI.

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

Not applicable.

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