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Boston Scientific JUDO 1, JUDO 3, and JUDO 6 Guidewires are intended to facilitate the placement of balloon dilatation catheters or other interventional therapeutic devices during percutaneous transluminal coronary angioplasty (PTCA) or other intravascular interventional procedures. These guidewires are not intended for use in the cerebral vasculature.

The Boston Scientific JUDO 1, JUDO 3, and JUDO 6 Guidewires are available with a nominal diameter of 0.014 inches (0.37 mm) and in nominal lengths of 190 cm or 300 cm. The guidewires are composed of a stainless steel core wire which tapers at the distal end. The tapered distal end of the guidewire is covered with a proximal stainless steel coil and a distal platinum/nickel radiopaque coil that allows for visualization while using fluoroscopy. The proximal end of the guidewire contains a polytetrafluoroethylene (PTFE) coating and the distal portion of the wire is coated with a hydrophilic coating. The guidewires are available in a straight tip shape only.

The 190 cm guidewires are designed with a 2.1 cm friction fit extension section for exchange of Over-the-Wire systems by using the Stretch Extension Wire (K151840). The 300 cm guidewire allows exchange of therapeutic devices without the use of an extension wire or exchange system.

This FDA 510(k) summary describes a guidewire device and its substantial equivalence to a predicate device, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML studies are not applicable.

Here's the information extracted from the document:

1. A 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)

• Sample Size: Not specified for the "Tip Flexibility" test.
• Data Provenance: Not specified. This is bench testing, not clinical data, so country of origin or retrospective/prospective don't directly apply in the same way.

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 as this is bench testing of a physical medical device, not an AI/ML algorithm requiring expert ground truth for interpretation.

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

• Not applicable as this is bench testing of a physical medical device.

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 is for a physical guidewire device, not an AI/ML powered device.

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

• Not applicable. This document is for a physical guidewire device, not an AI/ML powered device.

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

• For "Tip Flexibility", the ground truth would be established by physical measurement and evaluation standards relevant to guidewire function, likely against pre-defined engineering specifications. The document doesn't detail these specific standards.

8. The sample size for the training set

• Not applicable. This is not an AI/ML powered device, so there is no training set in that context.

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

• Not applicable. This is not an AI/ML powered device.

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