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The R2P Radifocus Glidewire Advantage is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

The subject device, R2P Radifocus Glidewire Advantage, and the predicate device, Radifocus Glidewire (K152740), are both operated through a manual process. The subject device, R2P Radifocus Glidewire Advantage, and the predicate device, Radifocus Glidewire (K152740), exhibit some differences in design and construction. Terumo has confirmed that these differences don't introduce any new concerns in safety and performance compared to the predicate device.

The provided text is a 510(k) summary for a medical device (guide wire) and does not contain any information about an AI/ML-driven device or study results related to acceptance criteria for such a device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/ML-driven device meets those criteria based on this document. The document describes traditional performance and biocompatibility testing for a physical medical device.

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This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. Do not use the guide wire in neurovascular.

The CROSSLEAD Tracker is steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 100cm, 200cm, 235cm and 300cm length. This Guide Wire consists of a hybrid Ni-Ti and stainless-steel core wire with a Pt-Ni inner coil and Pt-Ni and stainless-steel outer coil is soldered to the core wire with Ag-Sn solder. The coil has radiopacity to achieve visibility and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. A hydrophobic coating is applied to proximal portion. The basic structure, construction, and material of the CROSSLEAD Tracker are similar to that previously described in the predicate Regalia XS 1.0 (K083146/K163426) and reference devices MINAMO (K190176), ASAHI Gaia Next(K192599) and ASAHI Gladius (K150445/K163426).

The provided text is a 510(k) Summary for a medical device (CROSSLEAD Tracker, a guide wire) and does not contain information about a study proving the device meets acceptance criteria related to AI/ML performance or human reader improvement.

The document details non-clinical laboratory testing performed to demonstrate substantial equivalence to predicate and reference devices, focusing on physical and material properties of the guide wire. These tests are standard for medical devices and are not related to AI/ML or a comparative effectiveness study involving human readers.

Therefore, I cannot provide the requested table and information as it pertains to AI/ML performance and human reader studies because this information is not present in the provided document.

The "Non-clinical testing/performance data" section (Page 8) lists various physical tests:

• Tensile Strength
• Torque Strength
• Torqueability
• Tip Flexibility
• Coating Integrity
• Catheter Compatibility
• Visual Inspection
• Corrosion Resistance
• Kink Resistance
• Radio-Detectability
• Dimensional Verification
• Coating Integrity / Acute Particulate Characterization

And "Biocompatibility" tests:

• Cytotoxicity
• Sensitization
• Intracutaneous Irritation
• Systemic Toxicity
• USP Rabbit Pyrogen, Material Mediated
• Hemolysis
• Partial Thromboplastin Time
• In Vivo Thromboresistance
• Sc5b-9 Complement Activation

The document states: "The in vitro bench tests demonstrated the CROSSLEAD Tracker met all acceptance criteria and performed similarly to the predicate and reference devices." However, it does not provide the specific numerical acceptance criteria or the reported performance for each of these physical and biocompatibility tests. It also does not discuss any computational or AI-driven aspects, nor does it mention a study involving human readers, sample sizes for test/training sets, or expert ground truth establishment for such studies.

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This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures.

The CROSSLEAD Penetration Peripheral Guide Wire (hereafter "CROSSLEAD Penetration") is steerable guide wire with a maximum diameter of 0.014" (0.36 mm) and 0.018" (0.46 mm) and available in 200 cm, 235 cm and 300 cm length. The guide wire is constructed from a stainless steel core wire with a Pt-Ni-Au alloy coil. The coil is soldered to the core wire with Au-Sn solder. The coil has radio - detectability to achieve visibility and can be made to bend with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. A hydrophobic coating is applied to proximal portion. The basic structure, construction, and coating of the CROSSLEAD Penetration are similar to that previously described in the predicate ASAHI Peripheral Guide Wire ASAHI Astato XS 40 (K153443) (hereafter "ASAHI Astato XS 40") and reference CROSSLEAD Peripheral Guide Wire (K213315) (hereafter "CROSSLEAD").and ASAHI Peripheral Guide Wire ASAHI Halberd (K150445) (hereafter "ASAHI Halberd")..

The provided document describes the FDA's 510(k) clearance for the CROSSLEAD Penetration Peripheral Guide Wire. This is a medical device, not an AI/ML powered device, so many of the requested fields are not applicable. However, I can extract information related to its non-clinical testing and acceptance criteria as provided.

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

The document states that the CROSSLEAD Penetration met all acceptance criteria in its bench testing. Specific acceptance criteria are not detailed in the summary, but the categories of tests performed are listed. The reported performance is generally stated as "performed similarly to the predicate devices" and "functions as intended."

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

The document describes non-clinical bench testing and biocompatibility testing. It generally refers to "bench testing" and "in vitro bench tests." There is no mention of a "test set" in the context of patient data, as this is a device clearance for a physical medical guide wire, not a diagnostic or prognostic algorithm. Therefore, information on sample size for a test set or data provenance (country of origin, retrospective/prospective) is not applicable or provided in this document.

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 medical device. "Ground truth" in the context of expert consensus on data is not relevant here. The "ground truth" for the performance of the device is established by meeting specified physical and biological performance criteria during bench and biological compatibility testing, per established international standards (e.g., ISO 10993).

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

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring adjudication of a test set based on expert opinion.

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 a physical medical device, not an AI/ML device, and therefore no MRMC study or AI assistance assessment was conducted.

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

Not applicable. This is a physical medical device, not an AI/ML algorithm.

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

The "ground truth" for this medical device is established through compliance with recognized performance standards and validated test methods for physical characteristics and biocompatibility. This includes:

• Compliance with FDA guidance document: "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling, 15JUN2018."
• Compliance with ISO 10993 series for biocompatibility: This involves specific laboratory tests with predefined acceptance criteria. For example, for cytotoxicity, the ground truth is established by observing no signs of cellular reactivity (Grade 0) for controls. For sensitization, no evidence of delayed dermal contact sensitization in guinea pigs. For pyrogenicity, no increase in rectal temperature by more than 0.5 degrees Celsius.

8. The sample size for the training set

Not applicable. This is a physical medical device, 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 a physical medical device, not an AI/ML algorithm.

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This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The VASSALLO GT 018 Peripheral Guide Wire in this submission is a steerable guide wire with a maximum diameter of 0.018" (0.45mm) and available in lengths of 190cm and 300cm. The device has a solid core with a hydrophilic coated coil-type distal end. The coil is partly or entirely radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy. The core shaft surface is coated with Polytetrafluoroethylene (PTFE). About 2cm of the distal end can be shaped. A detachable extension wire (hereafter "extension wire") is available to connect with the proximal end of the quide wire with a length of less than 300 cm. A Torque device is included in the same package.

The provided document describes the VASSALLO GT 018 Floppy peripheral guide wire. It does not describe an AI/ML powered device, but rather a medical device that facilitates the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. Therefore, many of the requested elements for AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this submission.

However, I can provide information based on the non-clinical testing performed for the device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The in vitro bench tests demonstrated that the VASSALLO GT 018 met all acceptance criteria and performed similarly to the predicate and reference devices." However, specific quantitative acceptance criteria and their corresponding reported device performance values are not detailed in this document. The document only lists the types of tests performed.

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

The document does not specify the sample sizes used for each non-clinical bench test. The data provenance is not explicitly stated in terms of country of origin for the testing, but the applicant company, FILMECC CO., LTD., is based in Japan. These would be considered prospective tests conducted specifically for this submission.

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

Not applicable. This is a medical device and the tests are non-clinical bench tests (e.g., tensile strength, corrosion resistance). "Ground truth" in the context of expert consensus is not relevant here; the tests have objective physical or chemical measurements.

4. Adjudication method for the test set

Not applicable, as this refers to expert review processes for complex diagnostic outputs, not physical device performance tests.

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 not an AI/ML diagnostic tool.

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

Not applicable. This device is not an AI/ML algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is established by standard engineering and biocompatibility testing protocols and specifications. For example, for "Tensile Strength," the ground truth would be a pre-defined range of acceptable tensile forces according to relevant standards for guide wires. For biocompatibility, the ground truth is the absence of cytotoxicity, irritation, etc., according to recognized international standards (e.g., ISO 10993).

8. The sample size for the training set

Not applicable. This device does not involve machine learning and therefore has no "training set."

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

Not applicable. There is no training set for this device.

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This product is intended for use in the percutaneous introduction of catheters. Not for use in the coronary arteries or intracranial vessels.

The ASAHI Silverway consists of a one-piece core wire and a coil assembly that extends the entire length of the device. The coil assembly consists of an inner coil and an outer coil, soldered to the core wire. In addition, coatings are applied on the surface of the ASAHI Silverway. The distal and proximal sections are coated with silicone. The intermediate section is coated with hydrophilic coating. The ASAHI Silverway has a nominal outer diameter of 0.89mm (0.035in) and is available in various lengths from 150cm to 300cm and tip shapes.

This document describes the premarket notification (510(k)) for the ASAHI® Silverway® guidewire. The acceptance criteria and study details are focused on non-clinical performance given the type of device and the 510(k) pathway, which establishes substantial equivalence rather than independent safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

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

The document states that the ASAHI Silverway "met all acceptance criteria" and "performed similarly to the predicate devices." While specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons, maximum torque to twist in degrees) are not explicitly listed in the public summary, the general categories of tests performed indicate the areas for which acceptance criteria would have been established.

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 explicitly state the specific number of units tested for each non-clinical test. It generally refers to "non-clinical laboratory testing."
• Data Provenance: The tests were "non-clinical laboratory testing" presumably conducted by or for ASAHI INTECC CO., LTD. Given the company's address (Japan), the testing was likely performed in Japan or by a qualified lab contracted by them. The studies are by nature prospective in that new guidewires were manufactured and then tested according to predefined protocols.

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

This section is not applicable to this type of regulatory submission. For a guidewire, "ground truth" is typically defined by engineering specifications, material properties, and performance benchmarks established through industry standards (e.g., ISO, ASTM) and comparison to predicate devices, rather than expert human interpretation of complex data (like medical images).

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

Not applicable. As this is non-clinical laboratory testing against pre-defined engineering and material standards, there is no need for expert adjudication in the way it might be applied to, for example, classifying medical images. Test results are objective measurements.

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 medical guidewire, not an AI/imaging device. Therefore, no MRMC study or AI assistance evaluation would be relevant or expected.

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

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

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

The "ground truth" for this device's performance is based on:

• Engineering specifications and design requirements: Did the device meet its designed dimensions, material properties, and functional characteristics?
• International standards: Adherence to relevant ISO (e.g., ISO 11070 for catheter guidewires, ISO 10993 for biocompatibility) and ASTM standards.
• Performance of predicate devices: Substantial equivalence is demonstrated by performing "similarly to the predicate devices." The predicates themselves would have established a benchmark for acceptable performance.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set in the AI sense. The "training" in manufacturing comes from process validation and quality control, but not a data-driven model training.

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

Not applicable for the same reason as point 8.

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ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

The ASAHI® PTCA Guide Wire ASAHI Gladius Mongo consists of a one-piece core wire and a distal coil assembly. The coil assembly consists of an inner coil and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of the ASAHI® PTCA Guide Wire ASAHI Mongo. The coil and distal portion of the quide wire are coated with polyurethane and then covered with hydrophilic coating. The proximal portion of the guide wire is coated with PTFE only. The ASAHI® PTCA Guide Wire ASAHI Mongo is available in various lengths. The shorter length device is designed for use with a commercially available ASAHI INTECC extension, wire.

The provided text describes the 510(k) premarket notification for the "ASAHI® PTCA Guide Wire ASAHI Gladius Mongo 14 and ASAHI Gladius Mongo 14 ES." This document pertains to a medical device (a guide wire), not an AI algorithm or a diagnostic tool. Therefore, the questions regarding acceptance criteria and studies for an AI/ML powered device, specifically those requiring information on human readers, ground truth establishment for AI training/test sets, and expert adjudication, are not applicable to this document.

The document focuses on demonstrating substantial equivalence of the new guide wire to a legally marketed predicate device (ASAHI® Fielder XT-A). It primarily relies on non-clinical testing/performance data to show that the new device functions as intended and has a similar safety and effectiveness profile.

Here's a breakdown of the relevant information provided, responding to the spirit of the request where applicable to a traditional medical device:

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

The document lists the following non-clinical tests performed, implying that internal acceptance criteria were met. However, the specific quantitative acceptance criteria and the exact reported performance results (e.g., specific tensile strength values or torque strength ranges) are not detailed within this public summary. The statement is qualitative: "met all acceptance criteria and performed similarly to the predicate device."

Regarding the other questions, they are not directly applicable to this type of device submission:

• 2. Sample sized used for the test set and the data provenance: This refers to data for an AI model. For this physical device, "sample size" would refer to the number of devices tested for each non-clinical test. This specific number is not provided in the summary. Data provenance is not relevant for a physical device's bench testing.
• 3. Number of experts used to establish the ground truth... and qualifications: This is for AI performance evaluation. Not applicable.
• 4. Adjudication method... for the test set: This is for AI performance evaluation. Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: This is for AI performance evaluation. Not applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is for AI algorithm performance. Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This is for AI ground truth. For this device, "ground truth" would be established by validated test methods and engineering specifications.
• 8. The sample size for the training set: This is for AI model training. Not applicable.
• 9. How the ground truth for the training set was established: This is for AI model training. Not applicable.

In summary, the provided document is a 510(k) summary for a physical medical device (a guide wire), and the questions posed are primarily designed for the evaluation of AI/ML-powered medical devices. Therefore, most of the specific details requested regarding AI acceptance criteria, ground truth, and study design are not found within this document. The core of this submission is demonstrating substantial equivalence through a comparison of technological characteristics and non-clinical bench testing.

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To facilitate the placement of devices during diagnostic or interventional procedures.

The Mandril Wire Guide, subject of this submission, is a Class II device according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The subject device consists of a stainless steel or nitinol mandril design with a stainless steel, palladium, or platinum distal spring coil anchored over the distal portion of the mandril. The Mandril Wire Guide is available with outside diameters ranging from 0.015 inches to 0.018 inches and lengths ranging from 25 centimeters (cm) to 180 cm. The tip portion of the subject device is either straight or angled. The Mandril Wire Guide is a packaged, sterile device intended for single patient use.

The provided text describes the 510(k) premarket notification for the Cook Incorporated Mandril Wire Guide (K171997). The document outlines the device description, intended use, comparison to a predicate device, and the technological characteristics demonstrated through various tests.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not provide specific sample sizes for any of the individual tests. It states that "All test articles evaluated" for the Acute Performance Evaluation met the criteria, implying all samples used in that test.

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective for most tests. However, the Acute Performance Evaluation was conducted in an animal model, which is a prospective study design to simulate clinical use.

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

This information is not provided in the document. The tests described are primarily engineering and performance tests on the device itself, not assessments requiring human expert interpretation for "ground truth" in the way a diagnostic AI might.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The tests described are objective measurements of the device's physical properties and performance against pre-defined criteria, not subjective assessments requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically for diagnostic devices that involve human interpretation of images or data, often comparing AI-assisted performance to unassisted human performance. The Mandril Wire Guide is a physical medical device (guidewire), and its evaluation focuses on its mechanical, material, and functional properties.

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

This question is not applicable. The Mandril Wire Guide is a physical medical device, not an algorithm or software that operates in a standalone manner. Its performance is inherent to its physical design and construction.

7. The Type of Ground Truth Used

For the various engineering and performance tests (biocompatibility, corrosion, flexing, fracture, tensile, tip flexibility, torqueability, torque strength, radiopacity, surface examination, dimensional measurement, catheter compatibility), the "ground truth" is defined by established engineering and medical device standards (e.g., ISO, ASTM) and FDA guidance documents, along with an "approved study protocol" for dimensional measurements. These standards and protocols define the expected performance characteristics.

For the Acute Performance Evaluation, the ground truth is based on the device's performance in an animal model under simulated clinical conditions, against pre-determined acceptance criteria for various performance parameters. This is effectively an in-vivo performance assessment.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. A "training set" refers to data used to train machine learning algorithms. The Mandril Wire Guide is a physical device, and its development and testing do not involve machine learning training sets.

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

This information is not applicable for the same reasons as point 8.

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