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The Savion DLVR and Savion FLX Guidewires are intended to facilitate the placement of balloon dilaters or other interventional therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. They are not intended for use in the cerebral vasculature.

The Boston Scientific Savion DLVR and Savion FLX Guidewires with ICE® Hydrophilic Coating are available with a nominal diameter of 0.014 in (0.37 mm) and in nominal lengths of 182 cm, 185 cm, or 300 cm. These guidewires contain a metal core wire. Varying tapers along the core wire and differing tip materials (spring coil or polymer) provide combinations of rail support and tip flexibility to address user requirements. The proximal core wire section of all models is coated with polytetrafluoroethylene (PTFE) for lubricity.

The 182 cm and 185 cm guidewires are designed with an extension section for exchange of Over-the-Wire systems by using the AddWire™ Extension Wire (K030617). The 300 cm guidewires allow exchange of therapeutic devices without the use of an exchange system.

This document describes a 510(k) premarket notification for guidewires, which are physical medical devices, not AI/ML software. Therefore, many of the requested categories related to AI/ML software studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) are not applicable.

Here's the information that can be extracted or deduced from the provided text for a medical device that is not AI/ML:

1. Table of Acceptance Criteria and Reported Device Performance

Details of the Study:

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

  • The document states "Nonclinical testing per FDA Guidance for Coronary and Cerebrovascular Guide Wires (1995) supports a determination of substantial equivalence." This refers to laboratory and bench testing, not human patient data sets. The specific sample sizes for each nonclinical test are not provided in this summary.
  • Data Provenance: Not applicable in the context of human data. These are laboratory test results.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for nonclinical performance tests is established by adhering to standardized test methods and measuring physical properties, not by expert consensus on clinical data.

• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for nonclinical, physical performance testing.

• 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, as this is a physical medical device, not an AI/ML software.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI/ML software.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is derived from standardized laboratory measurements and physical property evaluations as outlined in the FDA Guidance for Coronary and Cerebrovascular Guide Wires (1995).

• 8. The sample size for the training set: Not applicable, as this is a physical medical device and does not involve AI/ML training.

• 9. How the ground truth for the training set was established: Not applicable for the same reason as above.

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