Search Results

KinetixTM Guidewires are intended to facilitate placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or PTA or other intravascular interventional procedures. The KinetixTM Guidewires are not intended for use in the cerebral vasculature. The devices are provided non-pyrogenic, sterile, and intended for one procedure only.

The Kinetix™ Guidewires are two 0.014" PTCA guidewires utilizing a micro-slotted nitinol sleeve that replaces the traditional spring coil. The Kinetix Guidewires are similar in design and manufacture to the spring-coil IQ™ Guidewires (K040140 on February 12, 2004). The two distinct models are: Kinetix™ Guidewire - A guidewire with a soft, a-traumatic tip and a moderate rail support. Kinetix™ Plus Guidewire - A guidewire with a stiffer tip than the moderate support version and an intermediate rail support.

The provided text describes the Kinetix™ Guidewire and its substantial equivalence to a predicate device but does not detail specific acceptance criteria or an explicit study proving the device meets those criteria in the way typically expected for a detailed performance study with quantitative results. Instead, it focuses on demonstrating equivalence through non-clinical testing.

Here's an attempt to extract and infer the requested information based on the provided text, while acknowledging limitations due to the nature of the available document (a 510(k) summary).

Guidewire Acceptance Criteria and Performance (Inferred from Non-Clinical Testing Summary)

Study Information:

1. Sample Size Used for the Test Set and Data Provenance:

   • The document states "Testing and evaluation of the Kinetix™ Guidewires included..." followed by a list of tests. It does not specify the sample size for each test.
   • The data provenance is non-clinical (in vitro) testing conducted by Boston Scientific Corporation, likely in their laboratory in Maple Grove, MN, USA. It is prospective testing designed to evaluate the new device.

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

   • This question is not applicable in the context of the provided document. The "ground truth" for non-clinical performance tests is typically established by engineering specifications, industry standards, and predicate device performance, not by expert consensus in the same way clinical ground truth (e.g., disease diagnosis) is established. The "experts" would be the engineers and scientists conducting and analyzing the tests against established criteria.

3. Adjudication Method for the Test Set:

   • This question is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for clinical studies involving human interpretation or decision-making, where there might be disagreement among reviewers. For physical product testing, the results are typically quantitative and assessed against predefined pass/fail criteria.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices or decisions support systems. The Kinetix™ Guidewire is a physical medical device (catheter guidewire), not an AI system.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • No, a standalone algorithm performance study was not done. As mentioned above, this device is a physical guidewire, not a software algorithm.

6. The Type of Ground Truth Used:

   • For the non-clinical tests, the "ground truth" refers to the pre-defined engineering specifications, performance standards, material properties, and the performance characteristics of the predicate device (IQ™ Guidewire). The tests verified that the Kinetix™ Guidewires met these minimum requirements.

7. The Sample Size for the Training Set:

   • This question is not applicable as the device is not an AI model or a system that requires a "training set." The testing described is for a physical medical device.

8. How the Ground Truth for the Training Set Was Established:

   • This question is not applicable for the same reason as point 7.

Ask a specific question about this device