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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.

Device Description

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.

AI/ML Overview

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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K Number

K231954

Device Name

Aristotle 18 Guidewire; Aristotle 24 Guidewire

Manufacturer

Scientia Vascular, Inc.

Date Cleared

2023-08-01

(29 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K222437,K173235,K183608,K192783

Intended Use

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.

Device Description

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

AI/ML Overview

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:

Similarities in indications for use, intended use, operating principles, design, materials, packaging, and sterilization processes to predicate devices.
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.
Biocompatibility and sterilization data from reference devices which are deemed applicable due to material and process commonality.
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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K Number

K220398

Device Name

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire

Manufacturer

Scientia Vascular, LLC

Date Cleared

2023-03-10

(392 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K173235,K183608,K192783,K181828,K201760

Intended Use

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.

Device Description

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

AI/ML Overview

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.

Test Category	Test	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Cytotoxicity	Non-cytotoxic	Pass: Non-cytotoxic
	Pyrogenicity	Non-pyrogenic	Pass: Non-pyrogenic
	Sensitization	Non-sensitizing	Pass: Non-sensitizing
	Irritation	Non-irritant	Pass: Non-irritant
	Acute Systemic Toxicity	No evidence of toxicity	Pass: No evidence of acute systemic toxicity
	Hemocompatibility	Non-hemolytic	Pass: Non-hemolytic
	Complement Activation of SC5b-9	Similar to comparator device	Pass: The test article complement activation was similar to the comparator device.
	Partial Thromboplastin Time	Similar to comparator device	Pass: The test article clotting time was similar to the comparator device.
	In Vitro Thrombogenicity	Thromboresistant	Pass: Thromboresistant
	Latex Detection	Latex not detected	Pass: Latex was not detected
Sterilization	Sterilization Assurance Level (SAL), EO/ECH residuals, Bacterial Endotoxin Levels	SAL of 10^-6, acceptable residual levels	Achieved SAL of 10^-6, appropriate levels of residuals and endotoxins confirmed (implied from "existing validated sterilization cycle uses 100% EO to achieve a sterilization assurance level (SAL) of 10-").
Bench Performance	Visual Inspection and Dimensional Verification	Met ISO 11070 requirements	Acceptance criteria met
	Coating Integrity Assessment	Met ISO 11070 and FDA guidance	Acceptance criteria met
	Corrosion Resistance	Met ISO 11070 requirements	Acceptance criteria met
	Agent Compatibility	Met ISO 11070 requirements	Acceptance criteria met
	Simulated Use	Met performance in anatomical model	Acceptance criteria met
	Particulate	Acceptable particulate count	Acceptance criteria met

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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K Number

K183608

Device Name

Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile

Manufacturer

Scientia Vascular LLC

Date Cleared

2019-03-22

(86 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K173235

Why did this record match?

Device Name :

Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle
18 Guidewire, 200cm, Support Profile

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

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.

AI/ML Overview

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.

Test	Test Method Summary	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	In vitro blood flow loop thrombogenicity, MEM elution, toxicological risk assessment, ASTM hemolysis (direct/extract), PTT, complement activation	Equivalent to predicate device	Established that the biocompatibility profile of the subject device is equivalent to the predicate device due to identical materials and no increased thrombogenic potential from increased surface area. New testing was conducted to specifically address the increased diameter.
Sterilization	100% Ethylene Oxide (EO) to achieve SAL of at least 10^-6, evaluated per AAMI TIR 28:2016	SAL of at least 10^-6	The device was adopted into an EO sterilization processing group, and review indicates similarity between Aristotle 18 and Aristotle 14 regarding characteristics affecting sterilization.
Functional Testing	Per ISO 11070:2014 & FDA Guidance Document Coronary and Cerebrovascular Guidewire Guidance (Jan 1995)
Visual Inspection	For extraneous matter, process/surface defects, trauma-causing defects.	No defects observed	No extraneous matter, surface defects or visible droplets of coating are present on the Aristotle 18 Guidewires.
Dimensional Verification	Per engineering drawings.	Met dimensional specifications	All Aristotle 18 guidewires met dimensional specifications.
Tensile Strength	Per ISO 11070.	Met minimum force breakage	All Aristotle 18 guidewires meet minimum force breakage requirements specified in ISO 11070.
Flexing Test	Inspection for defects, damage, or flaking of coating after flexing.	No defects or damage	No defects or damage / flaking of the coating were observed after flexing.
Fracture	Inspection for fracture, loosening, or failure after wrapping around mandrel.	No fracture, loosening, or failure	No Aristotle 18 guidewires showed signs of fracture, loosening, or failure after wrapping them 8 times around a mandrel.
Torqueability	Measurement of torque response (avg input to output lag) in anatomical model.	Acceptable, comparable to predicate	All Aristotle 18 guidewires demonstrated acceptable torque responses. The torque response of the subject device was comparable to that of the predicate device.
Torque Strength	Torque turns to failure in anatomical model.	Acceptable, comparable to predicate	All Aristotle 18 guidewires demonstrated acceptable torque strength. The torque strength of the subject device was comparable to that of the predicate device.
Tip Flexibility	Measure force to deflect guidewire tips to 45 & 90 deg at 5mm, 10mm, 20mm.	Acceptable, comparable to predicate	The forces required to deflect the Aristotle 18 guidewire tips were acceptable. The flexibility of the tips of all subject devices was comparable to the tip flexibility of the predicate guidewire.
Tip Shape, Retention	Must be shapeable and retain shaped angle after simulated use.	Met requirements	All tips met shaping and shape retention requirements after simulated use.
Particulate	Particulates of various size ranges counted after simulated use in tortuous path.	Comparable to predicate	A comparable number of particulates was recovered from subject and predicate device following simulated use.
Coating Lubricity & Durability	Frictional force determined after simulated use in tortuous path.	Met specified requirements	All Aristotle 18 guidewires met specified frictional force requirements.
Coating Integrity	Uniformity/integrity visually examined on dyed samples after simulated use in tortuous path.	Acceptable coverage	All Aristotle 18 guidewires showed acceptable coating coverage after simulated use.
Simulated Use Model Testing & Product Compatibility	Anatomical model (neurovasculature) for simulated use testing.	Acceptable performance	Aristotle 18 Guidewires and predicate devices were found to perform acceptably in evaluations of: Torqueability in tortuous vasculature, Lubricity, Microcatheter Support & Tracking, Compatibility with Introducer, Compatibility with Torque Device, and Compatibility with Microcatheter.
Usability Evaluation	Physicians evaluated subject/predicate guidewires for various characteristics in human cadaver.	Acceptable performance	Subject and predicate guidewires both exhibited acceptable performance.
Radiopacity	Physicians evaluated during simulated use in human cadaver.	Acceptable radiopacity	Both subject and predicate guidewires exhibited acceptable radiopacity.
Corrosion Resistance	Per ISO 11070, after soaking in typical end-use solutions.	No signs of corrosion	There were no signs of corrosion on guidewires after soaking in typical end-use solutions.
Compatibility with Agents	Exposed to saline, contrast agents, DMSO, then examined for degradation.	No degradation, corrosion, decomp.	All Aristotle 18 guidewires showed no signs of degradation, corrosion or physical decomposition after exposure.
Packaging	Simulated transportation test per ASTM D 4169:16.	Product secured, labeling legible	Following exposure to typical storage and transportation conditions, product remained secured and labeling remained affixed and legible.

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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