(115 days)
The EASYTRAK® 2 Stylet is intended to aid in the placement of a Guidant THE EXS FIRAK® 2 implantable venous lead in the coronary venous vasculature.
The EASYTRAK® 2 Stylet is designed for delivery of the EASYTRAK® 2 lead in the coronary veins. The stylets come in three lengths corresponding to the lengths of the EASYTRAK® 2 leads.
The EASYTRAK® 2 Stylet consists of a stainless steel wire with a polypropylene hub at the proximal end. The distal end of the wire has a stop-coil designed to prevent the stylet from exiting through the distal end of the lead.
Here's an analysis of the provided 510(k) summary regarding the EASYTRAK® 2 Stylet, focusing on acceptance criteria and study information:
Based on the provided document (K052965), the information about acceptance criteria and the study that proves the device meets them is very limited. This is typical for 510(k) submissions, especially for devices seeking substantial equivalence where extensive clinical trials with detailed performance metrics are often not required if the device is sufficiently similar to a predicate.
Here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Testing demonstrated that the EASYTRAK® 2 Stylet met the acceptance criteria." |
| Not specified | "No new safety or effectiveness issues were raised during the testing program." |
Explanation: The document states that testing was performed and the device met the acceptance criteria. However, it does not explicitly list what those acceptance criteria were or provide specific quantitative results for the device performance beyond a general statement of compliance. This typically means the tests related to engineering performance (e.g., tensile strength, flexibility, material compatibility, dimensional accuracy) and possibly simulated use, which are usually compared against internal design specifications derived from the predicate devices.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. Given the nature of a 510(k) for a stylet, the testing would almost certainly be internal, non-clinical (benchtop) testing. There is no indication of clinical data, animal studies, or data from specific countries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the studies described are not clinical studies requiring expert ground truth for interpretation (e.g., image reading, disease diagnosis). The testing would have focused on engineering specifications and physical properties.
4. Adjudication method for the test set
This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials involving human interpretation of data, where discrepancies need to be resolved. This document describes non-clinical engineering and 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
This is not applicable. MRMC studies are related to evaluating diagnostic devices, often AI-driven, and involve multiple human readers interpreting cases. The EASYTRAK® 2 Stylet is a mechanical accessory, not a diagnostic or AI-powered device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used
This is not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). For engineering testing, "ground truth" would be established by validated test methods and reference standards against which the device's physical and functional properties are measured. For example, a "pull test" might have an acceptance criterion of "withstands X Newtons of force," and the ground truth for whether the device passes is an objective measurement of the force it withstood.
8. The sample size for the training set
This is not applicable as this is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 870.1380 Catheter stylet.
(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(b)
Classification. Class II (performance standards).