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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 Crossing14 Peripheral Guide Wire in this submission is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) in available lengths of 190cm and 300cm. The outer coil wire diameter has been modified to 0.072 mm. The devices have a solid core with a hvdrophilic coated coil-type distal end. The coil is 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 2 cm 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 300cm. A Torque device is included in the same package.

Here's an analysis of the provided text regarding acceptance criteria and device performance:

It's important to note that the provided document is a 510(k) summary for a medical device (a guide wire), not a publication about an AI/ML medical device. Therefore, many of the requested elements for AI/ML device studies (e.g., ground truth methods, expert qualifications, effect size for human readers with AI assistance) are not applicable to this document. This summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and biocompatibility assessments, not on the performance of a diagnostic or assistive AI system.

Here's the information that can be extracted from the document, with explanations for what cannot be:

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

The document states that "The in vitro bench tests demonstrated that the VASSALLO GT Crossing14 met all acceptance criteria and performed similarly to the predicate devices." However, the specific quantitative acceptance criteria for each test and the corresponding precise device performance values are not explicitly detailed in this 510(k) summary. It only lists the tests performed.

Non-clinical tests performed (details on specific criteria and results are not provided):

• Dimensional Verification
• Visual Inspection
• Tensile Strength / Tip Pull
• Torque Strength
• Torqueability
• Coating Adhesion/Integrity
• Catheter Compatibility / Lubricity
• Corrosion Resistance
• Kink Resistance
• Tip Flexibility
• Radiopacity

Biocompatibility tests performed (details on specific criteria and results are not provided; leveraged from predicate):

• Cytotoxicity
• Sensitization
• Intracutaneous Irritation
• Acute Systemic Toxicity
• Material Mediated Pyrogenicity
• Hemolysis
• Partial Thromboplastin Time
• In Vivo Thromboresistance
• Complement Activation (SC5b-9)

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 refers to "non-clinical laboratory testing" and "in vitro bench tests." It does not specify sample sizes for these tests (e.g., how many guidewires were tested for tensile strength). Since these are bench tests, "data provenance" in terms of patient data (country of origin, retrospective/prospective) is not applicable. The tests were performed to support a device manufactured by FILMECC CO., LTD. in Japan.

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 is not applicable as this is not an AI/ML medical device or a clinical study requiring expert ground truth for interpretation. The "ground truth" for these non-clinical tests would be the physical and chemical properties measured against established engineering and material standards.

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

Not applicable, as this is not an AI/ML medical device or a clinical study involving subjective interpretation 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

Not applicable. This document describes a traditional medical device (guide wire) and does not involve AI assistance or human readers.

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

Not applicable. This document describes a traditional medical device (guide wire) and does not involve an algorithm.

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

For non-clinical bench testing, the "ground truth" is defined by established engineering standards, material specifications, and physical/chemical measurements. For biocompatibility, it's defined by biological responses according to ISO standards for biocompatibility testing. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

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

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

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

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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 G12 and G30 Peripheral Guide Wires in this submission are a steerable guide wire with a maximum diameter of 0.018 inches (0.45mm) in available lengths of 190cm and 300cm. The devices have a solid core with a hydrophilic coated coil-type distal end. The entire coil is 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 2 cm of the distal end can be shaped. A detachable extension wire (hereafter "extension wire") is available to connect with the proximal end of the guide wire with a length of less than 300 cm. A Torque device is included in the same package.

The provided document is a 510(k) summary for the VASSALLO® GT 018 G12 and G30 Peripheral Guide Wires. This type of submission is for medical devices that claim substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information typically requested regarding AI/human reader studies, ground truth establishment for training, and detailed performance metrics as one might find for an AI-powered diagnostic device, is largely not applicable here.

The document describes non-clinical testing performed to demonstrate that the device meets acceptance criteria and performs similarly to its predicate device.

Here's the information extracted from the document:

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

The document states that the VASSALLO GT 018 G12 and G30 met all acceptance criteria for the non-clinical tests performed. Specific acceptance values are not provided in this summary, but the types of tests and the conclusion that the device met the criteria are listed.

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

The document does not specify sample sizes for each non-clinical test. This is typically found in the detailed test reports, not the summary. The tests are non-clinical laboratory tests, meaning they were performed in a controlled lab environment and are not based on human or animal data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not applicable as the tests are non-clinical, mechanical, and material property evaluations. There is no "ground truth" to be established by human experts in the context of diagnostic interpretation.

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

This information is not applicable as there is no diagnostic image or data interpretation by experts that would require an adjudication method. The tests are objective measurements of physical properties.

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 information is not applicable. This device is a physical medical device (peripheral guide wire), not an AI diagnostic or assistance tool. Therefore, MRMC studies are not relevant.

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

This information is 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.)

This information is not applicable for the non-clinical tests described. The "ground truth" for these tests would be the established engineering specifications, material properties, and performance benchmarks that the device is designed to meet.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of this physical medical device.

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

This information is not applicable.

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