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

Scientia Cardio Access's CrossTorg™ 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 with the 4 different tip loads, or tip stiffnesses: 1 gram. 10 gram, and 15 gram. These tip stiffnesses are referred to as Soft, Standard, Support, and Extra Support. respectively. The product is offered in lengths of 200cm and 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 (to shape the flexible tip of the guidewire), 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 shaping 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 a 510(k) premarket notification for the "CrossTorq 14 Guidewire". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or clinical superiority. Therefore, the acceptance criteria and study described are geared towards demonstrating this equivalence through non-clinical performance and functional testing.

Here's a breakdown based on your requested information:

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

The document lists various tests with associated "Results." For substantial equivalence, the "acceptance criteria" are implicitly that the new device performs "as well as the predicate devices and/or meets requirements of relevant standards" or that any differences "do not raise different questions of safety and effectiveness."

2. Sample sized 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 explicitly state the numerical sample size (n-value) for each specific test, nor does it detail multiple test sets. The functional and biocompatibility tests generally refer to "Guidewires" or "All guidewires" or "All samples" in the results, implying that a sufficient number were tested to satisfy the testing standards (e.g., ISO 11070). For "Radiopacity," it mentions "Guidewires evaluated by physicians in human cadaver" without specifying the number of guidewires or cadavers.
• Data Provenance: The document states that "Results for following tests, performed on the reference Aristotle 14 Guidewires and reference Aristotle 18 Guidewires, were included in Scientia Vascular LLC's premarket notifications K173235 and K183608..." This indicates some data was leveraged from previous submissions for reference devices. For the CrossTorq 14 Guidewire, the tests performed appear to be prospective (i.e., new tests done for this submission), although the location where they were performed is not specified. There is no information about country of origin.

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)

• The only mention of "experts" is for the "Radiopacity" test, stating "Guidewires evaluated by physicians in human cadaver." No specific number or qualifications of these physicians are provided.
• For other functional tests (e.g., simulated use, torqueability), the methods describe objective measurements or observations ("acceptable torque responses," "no defects or damage"), implying expert judgment primarily in setting the testing parameters and interpreting compliance with established standards, but not necessarily in adjudicating a "ground truth" for classification purposes.

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

• No formal adjudication method (like 2+1 or 3+1 consensus) is described. The tests are primarily objective measurements or evaluations against defined standards (ISO 11070, ASTM standards). The "Radiopacity" test mentions physician evaluation, but the decision process is not detailed as an 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

• No MRMC comparative effectiveness study was done.
• This device (a guidewire) is a physical medical device, not an AI-assisted diagnostic tool or software. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

• This question is not applicable. The CrossTorq 14 Guidewire is a physical interventional medical device, not an algorithm or AI system.

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

• For this type of device and submission (510(k) for a guidewire), "ground truth" is established through adherence to recognized performance standards (e.g., ISO 11070), engineering specifications, and comparative non-clinical testing against predicate devices. It relies on objective physical measurements and empirical demonstrations of performance characteristics like tensile strength, torqueability, flexibility, and biocompatibility, rather than clinical outcomes or diagnostic classifications requiring expert consensus.

8. The sample size for the training set

• This question is not applicable. This device is not an AI/ML model that requires a "training set." The development of the guidewire involves design, materials selection, and manufacturing processes, supported by engineering principles and testing.

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

• This question is not applicable, as there is no "training set" for this physical 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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