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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 Volo 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 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 Scientia Vascular's Aristotle 14, Aristotle 24, Volo 14, and Zoom Wire 14 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, in the following diameters, stiffness profiles, and lengths:

Aristotle 14 Guidewire: Diameter 0.014", Stiffness Profiles Soft, Standard, Lengths 200 cm, 300 cm
Aristotle 18 Guidewire: Diameter 0.018", Stiffness Profiles Soft, Standard, Support, Length 200 cm
Aristotle 24 Guidewire: Diameter 0.024", Stiffness Profiles Soft, Standard, Support, Length 200 cm
Volo 14 Guidewire: Diameter 0.014", Stiffness Profiles Soft, Standard, Lengths 200 cm, 300 cm
Zoom Wire 14 Guidewire: Diameter 0.014", Stiffness Profiles Support, Extra Support, Lengths 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.

This document concerns the 510(k) premarket notification for five guidewires: Aristotle 14 Guidewire, Aristotle 18 Guidewire, Aristotle 24 Guidewire, Volo 14 Guidewire, and Zoom Wire 14 Guidewire. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

1. Acceptance Criteria and Reported Device Performance:

The acceptance criteria are not explicitly stated as numerical thresholds for performance metrics. Instead, the document indicates that the devices "met acceptance criteria" or "passed" various tests, implying successful adherence to pre-defined standards for each test. The study's focus is on demonstrating similar performance and safety to predicate devices, particularly given a change in the PTFE coating.

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

• Test Set Sample Size: The document does not explicitly state the numerical sample sizes for each specific test (e.g., number of guidewires tested for coating integrity). It only mentions that "performance testing was performed on the subject devices" and "testing and evaluation... of the subject devices has been performed".
• Data Provenance: The data provenance is internal to the manufacturer (Scientia Vascular, Inc.) and is prospective testing conducted specifically for this 510(k) submission. There is no mention of country of origin for the data other than it being part of an FDA submission from a U.S.-based company.

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

• This submission pertains to a medical device's physical and biological performance, not an AI/software device that requires expert-established ground truth for diagnostic or interpretative tasks. Therefore, these details are not applicable. The "ground truth" for the tests mentioned (biocompatibility, sterilization, bench performance) is based on established, standardized test methods (e.g., ISO standards, FDA guidance documents).

4. Adjudication method for the test set:

• Not applicable, as this is not a diagnostic AI/software study involving human interpretation that requires adjudication of expert opinions. The performance is assessed against objective technical specifications and standards.

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

• Not applicable. This is not an AI/software device that involves human readers or an AI assistance component.

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

• Not applicable. This is a hardware medical device (guidewire) and does not involve an algorithm or AI.

7. The type of ground truth used:

• The "ground truth" for the various tests conducted is based on:
  • Standardized Test Methods: Adherence to defined protocols from ISO 10993 series, ISO 14971:2019, ISO 11070:2014, and FDA guidance documents.
  • Objective Measurements: E.g., cell culture observations for cytotoxicity, temperature rise for pyrogenicity, measurement of physical dimensions, observation of material integrity.
  • "Pass/Fail" Criteria: Compliance with established thresholds or qualitative assessments as defined by the standard test methods (e.g., "Non-cytotoxic," "Non-hemolytic," "Acceptance criteria met").

8. The sample size for the training set:

• Not applicable. As this is not an AI/software device, there is no "training set" in the context of machine learning.

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

• Not applicable, as there is no training set for an AI/software algorithm.

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The Plato 17 Microcatheter is intended for the introduction of embolic coils and infusion of diagnostic agents, such as contrast media, 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 distal vasculature. The Plato 17 Microcatheter is supplied sterile and is for single use only. The Plato 17 Microcatheter is packaged with 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 intraluminal delivered embolic coils and contrast media: the distal exterior section of the catheter shaft is hydrophilic coated to reduce friction during manipulation in vessels. The working length of the catheter is 160 cm. The microcatheter includes two radiopague tip markers to facilitate fluoroscopic visualization and a clear hub with luer lock and a strain relief. The Plato 17 Microcatheter is compatible with 0.014 inch guidewires or embolic coils.

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 Scientia Vascular, LLC's Plato® 17 Microcatheter was evaluated through non-clinical performance tests, including biocompatibility and functional testing, to demonstrate substantial equivalence to the predicate device, the Excelsior™ SL-10 Pre-Shaped Microcatheter (K042568) and reference device Excelsior XT-17 Microcatheter (K142565).

1. Table of Acceptance Criteria and Reported Device Performance:

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 does not explicitly state the specific sample sizes for each functional test performed. However, it mentions "study animals" for some biocompatibility tests (e.g., sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity) and "catheter samples" for corrosion resistance. For the Catheter Usability Study, it mentions a "cadaver study." The provenance of the data (country of origin, retrospective/prospective) is not specified.

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)

For the "Catheter Usability Study," it states "Physician evaluation of the microcatheter in a cadaver study." The number of physicians and their specific qualifications are not provided. For other functional and biocompatibility tests, "ground truth" is established by adherence to recognized standards and objective measurements, not necessarily expert consensus in the clinical sense.

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

The document does not describe any specific adjudication method for establishing ground truth, as most tests are bench-top or animal studies with objective pass/fail criteria or comparisons to predicate devices/standards. For the "Catheter Usability Study" involving physician evaluation, the method of aggregation or adjudication of physician opinions is not detailed.

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

No MRMC comparative effectiveness study was done as this device is a microcatheter, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

This refers to a physical medical device (microcatheter), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.

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

For biocompatibility tests, the ground truth is based on the biological responses observed in study animals or in vitro tests, evaluated against established scientific principles and standards (ISO 10993-1:2018). For functional tests, the ground truth is based on physical measurements, mechanical performance, and adherence to engineering standards (ISO 80369-7, ISO 80369-20, ISO 10555-1), as well as comparison to the predicate device where applicable. For the usability study, "acceptable use" by physicians in a cadaver study serves as a form of expert assessment.

8. The sample size for the training set

This device is a physical microcatheter, not a machine learning or AI model. Therefore, the concept of a "training set" is not applicable.

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

As described in point 8, the concept of a "training set" and its associated ground truth is not applicable to this device submission.

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The Zoom 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 Zoom 14 Guidewire is a modification of Scientia Vascular's Aristotle 14 Guidewire. It is a 0.014" 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 range of stiffness profiles: support and extra support. The product is provided in lengths of 200cm or 300cm. 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 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 hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The mandrel, introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.

The provided text describes the Zoom 14 Guidewire, a modification of Scientia Vascular's Aristotle 14 Guidewire. The submission is a 510(k) premarket notification, which means the manufacturer seeks to prove "substantial equivalence" to a legally marketed predicate device, rather than entirely new safety and effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical or qualitative "acceptance criteria" are not explicitly detailed in the document but are implied by the statement "met testing acceptance criteria" for each test. The tests were performed in accordance with ISO 11070:2014 and the FDA Guidance Document "Coronary, Peripheral and Neurovascular Guidewires – Performance Tests and Recommended Labeling (2019)."

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

The document does not explicitly state the sample size used for each functional test. The tests are non-clinical (bench testing and model evaluation) rather than human studies. Therefore, the concept of "country of origin of the data" and "retrospective or prospective" for a test set in the traditional sense of clinical data does not apply here. The data provenance is from the manufacturer's internal testing.

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

This information is not applicable. The functional tests described are objective engineering and performance tests, not subjective evaluations requiring expert consensus for "ground truth" in the way clinical images or diagnoses would.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are objective functional tests, not subjective evaluations requiring adjudication.

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

No MRMC comparative effectiveness study was done. This is a 510(k) submission for a guidewire, which relies on non-clinical performance data and substantial equivalence to a predicate device, not a comparative clinical study with human readers assessing diagnostic accuracy.

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

This information is not applicable. The device is a physical medical guidewire, not an algorithm or AI system. The "performance" described relates to its physical and mechanical properties.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical performance tests is based on:

• Engineering specifications and drawings: For visual and dimensional verification.
• International standards (ISO 11070:2014): For tensile testing and other general guidewire performance.
• FDA Guidance Document "Coronary, Peripheral and Neurovascular Guidewires – Performance Tests and Recommended Labeling (2019): Guiding the types of tests and likely acceptable ranges for performance.
• Risk assessment (EN ISO 14971:2012): To determine which tests were necessary.
• Anatomical models: For torqueability, torque strength, and simulated use evaluation.

Essentially, the ground truth is established by objective, verifiable technical standards and engineering benchmarks.

8. Sample Size for the Training Set

This information is not applicable. The "Zoom 14 Guidewire" is a physical medical device, not an AI or machine learning model that requires a training set. The device's design is based on the predicate device (Aristotle 14 Guidewire) and engineering principles, not statistical learning from a data set.

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

This information is not applicable for the reasons stated above.

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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 Aristotle 24 Guidewire is a modification of Scientia Vascular's Aristotle 18 Guidewire. It is a 0.024" 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 range of stiffness profiles: soft, standard, and support. The product is provided in one overall length of 200cm. 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 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 hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The mandrel, introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.

The provided text describes the 510(k) premarket notification for the Aristotle 24 Guidewire. This document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (Aristotle 18 Guidewire) rather than acting as a traditional clinical study report with detailed acceptance criteria and performance data for a novel AI/software device.

Therefore, many of the requested details, such as those related to AI algorithm performance (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details), are not applicable to this document as it pertains to a physical medical device (guidewire) and its mechanical/biocompatibility testing, not an AI/ML algorithm.

However, I can extract the relevant information regarding the acceptance criteria and the "study" (functional and non-clinical performance tests) that prove the device meets these criteria as described in the provided text for this specific medical device.

Here's an interpretation based on the provided document, addressing the applicable points and noting where information is not relevant to this specific clearance:

Acceptance Criteria and Device Performance for Aristotle 24 Guidewire (Based on 510(k) K192783)

The Aristotle 24 Guidewire is a physical medical device, and its "acceptance criteria" are demonstrated through non-clinical performance and design characteristic comparisons to a predicate device. The goal is to show substantial equivalence, not to prove clinical efficacy through a comparative effectiveness study involving human readers or AI algorithms.

1. Table of Acceptance Criteria and Reported Device Performance

For a traditional medical device like a guidewire, the "acceptance criteria" are implicitly met when the device successfully passes a battery of functional, dimensional, and biocompatibility tests, demonstrating performance consistent with its intended use and safety profile, and comparable to a predicate device. The tables below outline the tests conducted and their general "results" as stated in the document.

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

For the functional testing of the guidewire, specific sample sizes are not explicitly stated in the document. The testing involves physical samples of the Aristotle 24 Guidewire. The provenance of this "data" is the non-clinical bench testing conducted by Scientia Vascular LLC. This is not a retrospective or prospective clinical study, but rather laboratory testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The concept of "experts establishing ground truth" in the context of an AI algorithm is not applicable here. For a physical device like a guidewire, "ground truth" is established by adherence to engineering specifications, national/international standards (e.g., ISO 11070), and validated test methods.

However, for the "Usability Evaluation," it states "Physicians evaluated subject and predicate guidewires."

• Number of experts: Not specified (plural "Physicians" indicates more than one).
• Qualifications of experts: Explicitly stated as "Physicians." No further details on their years of experience or specialization are provided within this document.

4. Adjudication Method for the Test Set

This concept (e.g., 2+1, 3+1) is typically relevant for expert review of images or data in AI/diagnostic studies to establish a consensus ground truth. It is not applicable to the functional and mechanical testing of a physical medical device. The "adjudication" for mechanical tests is whether the device passes or fails predefined engineering specifications.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed to evaluate the impact of an AI system on human reader performance, which is not relevant for the clearance of a guidewire.

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

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

7. The Type of Ground Truth Used

For the functional and biocompatibility testing, the "ground truth" is defined by:

• Adherence to internal engineering specifications and design parameters.
• Compliance with recognized industry standards (e.g., ISO 11070:2014 for guidewires, EN ISO 14971:2012 for risk management, AAMI TIR 28:2016 for sterilization).
• Equivalence to the performance characteristics of the predicate device (Aristotle 18 Guidewire) as established by its clearance and prior testing.

For the "Usability Evaluation," the "ground truth" was likely subjective feedback and performance metrics collected from the evaluating physicians using the device in a cadaver model.

8. The Sample Size for the Training Set

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

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

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

Summary of the Study Proving Acceptance Criteria:

The "study" conducted for the Aristotle 24 Guidewire was a series of comprehensive non-clinical performance tests, including:

• Biocompatibility Testing: Confirmed the safety of the device's materials by assessing blood compatibility and cytotoxicity. This was supported by the fact that the materials are identical to those used in the cleared predicate device.
• Sterilization Validation: Demonstrated the effectiveness of the Ethylene Oxide (EO) sterilization process to achieve a required sterility assurance level (SAL).
• Functional Testing: Evaluated various mechanical and physical properties of the guidewire (e.g., dimensional accuracy, tensile strength, flexibility, torqueability, tip retention, particulate generation, coating lubricity/integrity) in accordance with ISO 11070:2014 and FDA guidance. These tests were stated to "meet testing acceptance criteria," implying successful performance against pre-defined engineering and performance specifications.
• Simulated Use Model Testing: Used an anatomical model to simulate tortuous neurovasculature for assessing device performance and compatibility during simulated use.
• Usability Evaluation: Involved physicians evaluating the device in a human cadaver model for performance characteristics.

The overarching goal of these tests was to demonstrate that the Aristotle 24 Guidewire is substantially equivalent to the predicate Aristotle 18 Guidewire, despite minor technological differences (larger O.D., two centering coils, one bushing). The document explicitly states that these differences "do not result in new materials used or new questions of safety or effectiveness, nor do they result in new risks for the subject device," and that "testing of the subject device has been performed, demonstrating the safety and effectiveness of the device."

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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 devices. The guidewire is not intended for use in the coronary vasculature.

The Aristotle 18 Guidewire is a modification of Scientia Vascular's Aristotle 14 Guidewire. It is a 0.018" 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 range of stiffness profiles: soft, standard, and support. The product is provided in one overall length of 200cm. 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 vessels. The guidewire is provided with an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.

This document describes the safety and performance testing for a medical device called the "Aristotle 18 Guidewire" to demonstrate its substantial equivalence to a predicate device, the "Aristotle 14 Guidewire." This is a 510(k) premarket notification, not a clinical study of an AI/ML device, therefore many of the requested criteria are not applicable.

Here's an analysis of the provided text in relation to your request:

Key Takeaway: The provided document is a 510(k) summary for a guidewire, which is a physical medical device, not an AI/ML diagnostic or treatment device. Therefore, many of the questions related to AI/ML device performance (such as MRMC studies, training/test sets, ground truth establishment by experts, and adjudication methods) are not applicable to this submission. The "study" described herein refers to non-clinical performance and biocompatibility testing of a physical product.

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

The document provides a table summarizing functional tests and their results. The "acceptance criteria" are implied by the "Results" column, indicating that the device "met," "demonstrated acceptable," or "showed acceptable" performance according to relevant standards (ISO 11070, AAMI TIR 28:2016, ASTM D 4169:16) and internal specifications.

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: The document does not specify the exact number of guidewires tested for each functional test. It refers to "All Aristotle 18 guidewires" (e.g., for tensile strength, torqueability, flexibility), implying that the entire batch or lot tested passed. For biocompatibility, it states "new biocompatibility testing was conducted" but does not give sample sizes.
• Data Provenance: The tests are non-clinical, laboratory-based functional and material tests. There is no "country of origin" for patient data as no patient data was used. These tests are prospective, meaning they were performed specifically for this 510(k) 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)

• Not Applicable. This is a physical device testing summary. "Ground truth" in the context of AI/ML diagnostic studies (where experts typically label images) is not relevant here.
• However, for usability and radiopacity evaluations, "physicians" were used in a simulated use (cadaver) model. The number and qualifications of these physicians are not specified.

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

• Not Applicable. This concept is for resolving discrepancies in expert labeling or diagnoses in AI/ML performance studies. It is not relevant to the functional testing of a physical guidewire.

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

• Not Applicable. This is specific to AI/ML software. The submission describes a physical medical device.

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

• Not Applicable. This is specific to AI/ML software.

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

• Ground Truth (for this type of device): The "ground truth" for a physical medical device like a guidewire is established by adherence to engineering specifications, validated test methods (e.g., ISO, ASTM standards), and risk assessments. For biocompatibility, the "ground truth" is that the materials are safe for human contact and do not induce adverse biological responses, often confirmed through standardized in vitro and in vivo tests. For functional performance, the "ground truth" is that the device performs reliably according to its design parameters and intended use.
• For the usability and radiopacity assessments, the "ground truth" was physician evaluation in a simulated (cadaver) environment, where they determined "acceptable performance" and "acceptable radiopacity."

8. The sample size for the training set

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

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

• Not Applicable. As above, no training set was used.

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The Volo 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 Volo 14 Guidewire is a modification of Scientia Vascular's Aristotle 14 Guidewire. It is a 0.014" 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 range of stiffness profiles, from soft to standard. The product is provided in 200cm and 300cm lengths.

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 vessels.

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

The provided text is a 510(k) summary for the Volo 14 Guidewire, and it details the device's characteristics, indications for use, and a comparison to a predicate device (Aristotle 14 Guidewire). This document focuses on demonstrating substantial equivalence to an already cleared predicate device, rather than proving a device meets specific performance acceptance criteria for a novel AI/ML device.

Therefore, the information required to answer your request (acceptance criteria, study details for AI/ML device performance, sample sizes, expert ground truth establishment, MRMC studies, etc.) is not present in the provided text. The document describes functional testing for a medical device (guidewire), not the performance of an AI/ML algorithm.

The testing described in the document is for the physical and functional aspects of the guidewire, such as:

• Biocompatibility: Assessed by material equivalence to the predicate device.
• Sterilization: Confirmed by method and process equivalence to the predicate.
• Functional Testing: This includes:
  • Tip Shape/Retention
  • Torqueability
  • Torque Strength
  • Tip Flexibility
  • Simulated Use Model Testing and Product Compatibility (e.g., torqueability in tortuous vasculature, lubricity, microcatheter support & tracking, compatibility with introducer, torque device, and microcatheter).

These tests are standard for a guidewire to demonstrate its physical and operational safety and efficacy, and its comparability to a predicate device. They do not involve AI/ML performance evaluation.

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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 Scientia Vascular Aristotle 14 Guidewire is a 0.014" 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 range of stiffness profiles, from soft to support, The product is provided in 200cm and 300cm lengths. 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 vessels. The guidewire is provided with an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.

The provided text is a 510(k) summary for the "Aristotle 14 Guidewire". This document summarizes non-clinical performance tests to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific performance acceptance criteria for a new clinical claim or an AI algorithm.

Therefore, many of the requested elements for an AI algorithm study (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this submission.

However, I can extract the acceptance criteria and reported device performance from the Non-Clinical Performance Tests section, focusing on the functional and biocompatibility tests.

Acceptance Criteria and Reported Device Performance for the Aristotle 14 Guidewire

The provided document details non-clinical performance tests for the Aristotle 14 Guidewire to demonstrate substantial equivalence to a predicate device (PVS 1300 Synchro® 0.014" Guidewire, K032146). The study is based on a series of laboratory and simulated use tests rather than a clinical trial with human subjects or an AI algorithm performance evaluation.

Here's a summary of the acceptance criteria (implied by the test objective and relevant standards) and the reported device performance.

1. Table of Acceptance Criteria and Reported Device Performance

Biocompatibility Tests

Functional Testing

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The Plato MICROCATH 27B Microcatheter is intended for the introduction of interventional devices and infusion of diagnostic agents to the peripheral and neurovascular systems. The catheter is also intended for the introduction of therapeutic agents to the peripheral system. The catheter is not intended for use in the coronary vasculature.

The Plato MICROCATH® 27B Microcatheter is a single lumen microcatheter with a flexible polymer shaft of varying stiffness to aid in navigation of the neurovasculature. The catheter is designed to be used with a guide catheter and a steerable guidewire. The proximal end of the catheter has a diameter of 3.4F tapering to a distal OD of 3.2F. The catheter can be inserted into a 5F guide catheter. The inner diameter is constant over the entire length of the catheter shaft and accommodates guidewires up to 0.025" in diameter. The catheter is 150 cm in length with a straight tip configuration which can be shaped, using steam heat and the provided mandrels, to the users' preferred shapes. A steam shaping mandrel is included in the packaging. The microcatheter has a hydrophilic coating on the outer distal shaft to reduce friction during catheter manipulation in the vasculature and has one radiopaque tip marker at its distal tip to facilitate fluoroscopic visualization.

The subject microcatheter is identical with respect to its technological characteristics, design and materials to Scientia's currently marketed Plato MICROCATH 27B Microcatheters cleared under K143398. This 510k was prepared to expand the indications for use of the device to include its use in the neurovasculature.

The provided document describes the acceptance criteria and a study demonstrating that the Plato MICROCATH® 27B Microcatheter meets these criteria.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

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 does not explicitly state the sample sizes for each test in a numerical format (e.g., "n=X catheters"). Instead, it generally refers to "all catheters," "all samples," or "test and predicate catheters." The provenance of the data is primarily non-clinical, involving in-vitro testing and simulated use in anatomical models and human cadavers.

• Data Provenance: Predominantly non-clinical laboratory testing (in-vitro) and human cadaver studies.
• Country of Origin: Not specified, but generally assumed to be carried out by the manufacturer (Scientia Vascular LLC) or their contracted labs.
• Retrospective or Prospective: All tests described are prospective, conducted specifically to demonstrate substantial equivalence for this 510(k) 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)

For the human cadaver testing and radiopacity evaluation, "physicians" were used to evaluate the devices. No specific number or qualifications (e.g., years of experience, specialization) of these physicians are provided in the document.

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

The document does not describe any formal adjudication method (like 2+1 or 3+1) for establishing ground truth or evaluating performance, beyond "physicians" performing evaluations in the cadaver study. The non-clinical tests rely on meeting specified standards (e.g., ISO, ASTM, internal specifications).

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 MRMC comparative effectiveness study and no AI component mentioned in this document. This is a traditional medical device (microcatheter) and the testing is purely for physical and functional performance, not diagnostic accuracy with AI.

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

There is no standalone algorithm performance study as this device does not involve any algorithm or AI.

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

For most functional and biocompatibility tests, the ground truth is defined by established industry standards (ISO, ASTM), FDA guidance documents, and internal engineering specifications which are based on acceptable performance limits for medical devices. For the cadaver studies, the "ground truth" for performance was based on physician evaluation and comparison to a predicate device's performance in a similar setting. There is no pathology or patient outcomes data as it's a pre-market submission for a physical device.

8. The sample size for the training set

There is no training set as this device does not incorporate machine learning or AI.

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

Not applicable, as there is no training set for this device.

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The Plato MICROCATH 27B Microcatheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents to the peripheral system. The cather is not intended for use in cither the coronary or neuro vasculature.

The Plato MICROCATH® 27B Microcatheter is a single lumen microcatheter constructed with a flexible polymer shaft of varying stiffness to aide in accessing vasculature. The catheter is designed to be used with a guide catheter and a steerable guidewire for accessing the vasculature. The proximal end of the catheter has a diameter of 3.4F, tapering to a distal OD of 3.2F, which can be inserted into a 5F guide catheter. The inner diameter is constant throughout the shaft length and accommodates up to a 0.025" guidewire. The catheter is 150 cm in length with a straight tip configuration which can be steam-shaped to the doctor's preferred shape. A steam shaping mandrel is included in the packaging. The microcatheter has hydrophilic coating on the outer distal shaft to reduce friction during manipulation in vessels and has one radiopaque tip marker to facilitate fluoroscopic visualization.

The provided document describes the FDA 510(k) summary for the Plato MICROCATH® 27B Microcatheter, focusing on demonstrating substantial equivalence to predicate devices, not on proving effectiveness for a new diagnostic or interventional AI device. Therefore, the traditional acceptance criteria, study design parameters, and concepts like 'human readers improve with AI' are not applicable to this submission.

Instead, the document details performance data collected from non-clinical testing to show that the new microcatheter is as safe and effective as existing, legally marketed predicate devices. The acceptance criteria essentially derive from established standards for medical devices and comparisons to the predicate devices.

Here's an adaptation of your requested table and information, tailored to the context of this medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document primarily reports on non-clinical bench and lab testing, and some limited biological/simulated use testing. The "test set" here refers to the number of devices or samples tested for each specific non-clinical performance attribute.

• Sample Sizes: Not explicitly stated for each test, but implied by the nature of bench testing where multiple samples are typically used to ensure reliability. For example, "all catheters" met specifications implies multiple catheters were tested. For animal studies (thrombogenicity) and cadaver studies, the sample size would be small (e.g., number of dogs, cadavers). For Radiopacity and Simulated Use, "physicians," plural, suggests more than one device per observer.
• Data Provenance: The data is primarily from bench-top laboratory testing and in vitro studies, in accordance with ISO and ASTM standards. Some tests involve animal models (e.g., thrombogenicity in dogs) and human cadavers. The context implies these studies were conducted by the manufacturer or their contracted labs. No specific country of origin for the data is mentioned, but the submission is to the U.S. FDA, and the company is US-based. This is all prospective testing, specifically designed to demonstrate compliance for the 510(k) submission.

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

• Experts: The document mentions "physicians" evaluated radiopacity and participated in cadaver testing. For simulated use, "physicians" also provided Likert scores.
• Number: Not explicitly stated how many physicians were involved in these evaluations. The plural "physicians" indicates more than one.
• Qualifications: Not explicitly stated in terms of years of experience or specific subspecialty (e.g., interventional radiologist), but given the context of medical device evaluation, it is implied that these are qualified medical professionals with expertise relevant to microcatheters and their use.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly detailed. For tests involving "physicians" (Radiopacity, Simulated Use, Cadaver Testing), it is stated that comparisons were made or scores obtained. The document does not specify if there was a formal adjudication process (e.g., 2+1, 3+1), rather it presents the aggregate findings or an overall determination of "comparable" or "acceptable."

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

• No, an MRMC comparative effectiveness study was not done. This type of study (often used for diagnostic imaging AI) is not applicable to a premarket notification for a physical medical device like a microcatheter. The comparison is primarily against established performance standards and a predicate device's existing characteristics. The "simulated use" and "cadaver testing" involve human readers/users (physicians) providing feedback, but this is to assess usability and performance in a simulated environment, not an MRMC study comparing AI with and without human assistance.
• Effect Size of Human readers with/without AI: Not applicable, as this is not an AI device.

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

• Not applicable. This submission is for a physical medical device (microcatheter), not an algorithm or AI product. The performance evaluations are intrinsic to the device itself and its interaction with biological and simulated environments.

7. The Type of Ground Truth Used

The concept of "ground truth" as it applies to diagnostic or AI studies is not directly applicable here. Instead, the basis for comparison and acceptance is:

• Established Industry Standards: ISO 10993 (biocompatibility), ISO 10555 (intravascular catheters), ASTM standards.
• FDA Guidance: FDA guidance for Short-Term and Long-Term Intravascular Catheters, FDA Special Controls Document for PTCA Catheters.
• Predicate Device Performance: Direct comparison to the ev3 Marksman™ Catheter (K111490, K091559) and the Scientia Vascular, LLC Plato MICROCATH 27 (K121734). The goal is to demonstrate that the new device is "substantially equivalent" in safety and effectiveness.
• Expert Observational Consensus: For aspects like radiopacity and simulated use feedback from physicians.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device, so there is no "training set." The device design and materials are based on engineering principles and prior device knowledge.

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

• Not applicable. As there is no training set for an AI model, this question does not apply. The "ground truth" for the device's design and expected performance comes from established engineering principles, regulatory standards, and the performance characteristics of predicate devices.

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The Plato MICROCATH® 27 Microcatheters are intended to assist in the delivery of diagnostic and/or therapeutic agents to the peripheral and neurovascular systems.

The Plato MICROCATH® 27 Microcatheters are single lumen catheters designed to be used with a guiding catheter and a steerable guidewire for accessing the vasculature. The microcatheter contains a metal hypotube reinforced shaft with a maximum diameter of 3.7F, tapering to a distal end of 3.3F, which can be inserted into a 6F guide catheter. The inner diameter is constant throughout the shaft length and accommodates up to a 0.025" guidewire. The catheter is 150 cm in length with two tip configurations; straight and 45°. All have steam shapeable tips, hydrophilic coating and a radiopaque marker at the distal tip. The devices are marketed with an accessory mandrel which allows the catheter tips to be steam-shaped to the doctor's preferred shape when desired.

The provided text describes the "SCIENTIA VASCULAR LLC PLATO MICROCATH® 27 MICROCATHETER". It does not describe a study involving acceptance criteria related to an AI/ML device, but rather the non-clinical performance data for a microcatheter device. Therefore, I will extract information relevant to the device's performance against non-clinical acceptance criteria.

Here's the breakdown of the information as per the request, adapted for a non-AI/ML medical device:

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

The document lists "Non-Clinical Performance Data" which served as the basis for demonstrating substantial equivalence. These can be considered the acceptance criteria for functional and safety aspects of the device.

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:
  • For the non-clinical bench testing, specific sample sizes are not provided in the document. The tests likely involved multiple units of the Plato MICROCATH 27 Microcatheter.
  • For the simulated use testing, an "anatomical model" was used. The number of models or tests conducted is not specified.
  • For the human cadaver model, the term "a human cadaver model" is used, implying at least one but the exact number of cadavers or trials is not specified.
• Data Provenance: The tests are explicitly described as "Non-Clinical Performance Data" and include "bench testing," "simulated-use testing," and testing in a "human cadaver model." This indicates the data is from controlled laboratory and simulated environments. The country of origin of the testing is not specified, but the submission is to the FDA (United States). This testing would be considered prospective, as it was conducted specifically to evaluate the device.

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 section is not applicable as the document describes non-clinical and simulated-use testing of a physical medical device, not an AI/ML system requiring expert ground truth for interpretation. The evaluation was based on engineering specifications, standardized test methods (ISO 10993, ISO 10555-1), and performance in physical models.

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

This is not applicable. The device's performance was evaluated against physical and functional criteria, not expert interpretations requiring adjudication.

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

This is not applicable. The document describes a physical medical device (microcatheter), not an AI-assisted diagnostic or therapeutic system that would involve human readers.

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

This is not applicable. This document is about a physical medical device, not an algorithm.

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

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

• Compliance with international standards (ISO 10993, ISO 10555-1).
• Demonstration of expected functional performance in various bench tests (e.g., kink resistance, tensile strength, burst pressure, coating lubricity).
• Comparative performance to a predicate device in simulated anatomical and human cadaver models for key operational aspects like maneuverability and advancement.

8. The sample size for the training set

This is not applicable. This document describes a physical medical device, not an AI/ML system that requires a training set.

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

This is not applicable. This document describes a physical medical device, not an AI/ML system.

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