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510(k) Data Aggregation
(62 days)
GTX 12 GIDEWIRE
Medtronic GTX guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.
The Medtronic GTX 12 guidewires are available in nominal 180cm length and 300cm exchange length. They are available with PTFE, silicone or hydrophilic coatings. A portion of the distal length is opaque to allow for visualization under fluoroscopy and markers are etched on the proximal segment of the guide wire to aid in gauging guide wire position relative to the guiding catheter tip.
Here is an analysis of the provided 510(k) summary regarding the acceptance criteria and study information for the Medtronic GTX 12 Guidewire:
Please note: This 510(k) summary describes an in-vitro bench study and animal study for a medical device (guidewire), not an AI/ML powered medical device for which acceptance criteria typically refer to performance metrics like sensitivity, specificity, or AUC. Therefore, much of the requested information (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets, training set sample size) are not applicable or extractable from this type of regulatory document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are qualitative, focusing on similarity to predicate devices and meeting established safety and performance benchmarks for guidewires, rather than specific quantitative performance metrics typical of AI/ML algorithms. The document emphasizes that the GTX 12 guidewire "met the acceptance criteria and performed similarly to the predicate devices." No specific numerical acceptance criteria (e.g., minimum diameter, maximum tortuous torque) are provided, nor are the exact numerical results for each test. Instead, the document states successful completion ("met the acceptance criteria").
| In-vitro Bench Testing Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dimensional—Diameter | Similar to predicate devices (GTX 1 (K091582) and GTX 15) | Met acceptance criteria, performed similarly to predicates |
| Dimensional—Overall Length | Similar to predicate devices (GTX 1 (K091582) and GTX 15) | Met acceptance criteria, performed similarly to predicates |
| Dimensional—Radiopaque Length | Similar to predicate devices (GTX 1 (K091582) and Medtronic GTX 15) | Met acceptance criteria, performed similarly to predicates |
| Tip Column Stiffness | Acceptable performance for guidewire function | Met acceptance criteria |
| Tortuous Torque Energy Transfer | Acceptable performance for guidewire function | Met acceptance criteria |
| Tip Integrity-Torsional | Similar to predicate devices (GTX 1 (K091582) and GTX 15) | Met acceptance criteria, performed similarly to predicates |
| Tip Integrity-Strength | Similar to predicate devices (GTX 1 (K091582) and GTX 15) | Met acceptance criteria, performed similarly to predicates |
| Radiopacity-Distal & Proximal | Similar to predicate devices (GTX 1 (K091582) and GTX 15) | Met acceptance criteria, performed similarly to predicates |
| PTFE Coating Adhesion | Acceptable performance (similar to Medtronic Cougar XT (K032899)) | Met acceptance criteria, performed similarly to predicates |
| Lubricity/ Durability | Acceptable performance (similar to Medtronic Cougar XT (K032899)) | Met acceptance criteria, performed similarly to predicates |
| DOC Insertion and Extraction Force (180 cm only) | Acceptable performance (similar to Medtronic GT1 (K983927)) | Met acceptance criteria, performed similarly to predicates |
| DOC Crimp Wire Stiffness (180cm only) | Acceptable performance (similar to Medtronic GT1 (K983927)) | Met acceptance criteria, performed similarly to predicates |
| Biocompatibility | Meeting ISO 10993-1 and specific test standards | All specified tests performed, no new issues reported |
| Simulated Use Testing (Animal Study) | Acceptable performance | Performed, no new safety or effectiveness issues raised |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for each in-vitro test. The document mentions that "a bracketing sample strategy was chosen to support the test requirements" in some cases. For the animal study, the sample size is not specified.
- Data Provenance: The studies are in-vitro bench tests and an animal study. This type of data does not typically have "country of origin" in the same way human clinical data would. It is retrospective in the sense that the testing was performed on manufactured devices, not derived from observations of devices in clinical use over time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is an engineering and biocompatibility evaluation of a medical device, not a diagnostic AI/ML algorithm that relies on expert interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable. This is an engineering and biocompatibility evaluation; no human interpretation or adjudication of results in the traditional sense is mentioned. The tests are designed to yield objective, measurable outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. MRMC studies are specific to diagnostic AI/ML algorithms to assess human reader performance with and without AI assistance. This document pertains to a guidewire, which is a physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI algorithm. The performance described is inherently "standalone" in that it refers to the physical device's characteristics in bench and animal testing.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on engineering specifications, established industry standards (e.g., ISO guidance, ASTM), and performance of legally marketed predicate devices. For example, for dimensional tests, the ground truth would be the specified dimensions of the device itself and comparison to predicate dimensions. For biocompatibility, the ground truth is defined by the toxicological and biological response criteria outlined in standards like ISO 10993-1. For functional tests like Tip Column Stiffness or Torque Energy Transfer, the ground truth is established by acceptable performance parameters typical for such devices, often benchmarked against predicate devices.
8. The Sample Size for the Training Set
Not applicable. This device is evaluated through engineering and biocompatibility testing, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved for this type of device evaluation.
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