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The IQ™ Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. The IQ™ Guide Wires are not intended for use in the cerebral vasculature.

The IQ™ Guide Wires are silicone-coated, steerable, spring-coil guide wires available in a nominal diameter of 0.014 inches (0.36 mm) and nominal lengths of 185 and 300 centimeters with Brachial and Femoral marks at 90cm and 100cm respectively. The tip has Floppy flexibility, while the rail offers Moderate Support (MS). The distal two centimeters of all models are radiopaque and available in either a straight shapeable or a pre-formed J-Tip. The IQ™ Guide Wires will be available with and without a lesion length marker system. The 185-centimeter version is designed with a proximal extension section that allows connection to the AddWire™ Extension Wire.

This 510(k) summary (K052783) is for a medical device called the "IQ™ Guide Wire," a catheter guide wire used in interventional procedures. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device rather than presenting new clinical study data with acceptance criteria based on performance. As such, the requested information elements related to clinical study design, acceptance criteria, and performance metrics are not applicable in the way they would be for a device requiring de novo clinical validation.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided 510(k) summary, specific numerical acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) and corresponding reported device performance are not applicable. This submission relies on "substantial equivalence" to a predicate device, meaning the new device is demonstrated to be as safe and effective as a legally marketed device without requiring new clinical performance metrics to be established against specific criteria.

The general "acceptance criterion" for this type of submission is the demonstration that the device's technological characteristics, materials, and intended use are similar enough to the predicate device such that it raises no new questions of safety or effectiveness.

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

Not applicable, as a clinical "test set" with associated ground truth for performance evaluation (e.g., sensitivity, specificity) was not conducted or reported in this 510(k) submission. The evaluation was primarily based on non-clinical (bench) testing.

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

Not applicable, as a clinical test set requiring expert ground truth establishment for performance metrics was not conducted or reported.

4. Adjudication Method for the Test Set:

Not applicable, as a clinical test set requiring adjudication was not conducted or reported.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This type of study assesses how AI assistance impacts human reader performance. The IQ™ Guide Wire is a physical medical device, not an AI software system aiding interpretation, and the submission is focused on substantial equivalence based on non-clinical testing.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. The IQ™ Guide Wire is a physical medical device, not an algorithm. Its performance is evaluated through bench testing and comparison to a predicate device, not standalone algorithmic output.

7. Type of Ground Truth Used:

For the non-clinical tests mentioned ("Bench, product shelf life, and biocompatibility test results"), the "ground truth" would be established by:

• Bench Testing: Engineering specifications, industry standards, and established physical/mechanical properties of materials.
• Product Shelf Life: Accelerated aging studies and real-time stability studies, with the "truth" being the device meeting its performance specifications over time.
• Biocompatibility Testing: International standards (e.g., ISO 10993) and established toxicological profiles, with the "truth" being the device not eliciting adverse biological responses.

8. Sample Size for the Training Set:

Not applicable, as this device is not an AI/ML algorithm that requires a "training set." The evaluation is based on non-clinical testing of physical device samples.

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

Not applicable, as there is no "training set" for this type of device submission.

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