(126 days)
AVE 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. AVE guide wires are not intended for use in the cerebral vasculature. AVE steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.
The GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support 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. The GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support Guide Wires are not intended for use in the cerebral vasculature.
The provided text describes a 510(k) submission for the GT1 Guide Wires, comparing them to the predicate Commander Series guide wires. The submission focuses on demonstrating substantial equivalence, primarily through material changes and subsequent bench testing and biocompatibility assessments, rather than clinical studies or evaluations of diagnostic accuracy typically associated with AI/ML devices. Therefore, much of the requested information (e.g., sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable here.
Here's an analysis of the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of specific acceptance criteria with numerical targets and corresponding performance values in the way one might expect for a diagnostic or AI device. Instead, it states that the GT1 guide wires were evaluated against the "performance requirements" of their Commander Series counterparts and that their performance was either:
- Statistically equivalent to
- Better than
- Between the performances of the currently sold Commander Series guide wire counterparts
- Or was found to meet specification (i.e. the performance was clinically acceptable) in every case.
For biocompatibility, the acceptance criterion was "biocompatible."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical properties equivalent or superior to predicate devices | "Performance of the GT1 Floppy and GT1 Hi-Per Flex guide wires was statistically equivalent to, better than, or between the performances of the currently sold Commander Series guide wire counterparts or was found to meet specification." |
| Biological safety (biocompatibility) | "GT1 guide wires were shown to be biocompatible." |
| Meeting established specifications (clinical acceptability) | "Performance was clinically acceptable in every case." |
2. Sample Size for the Test Set and Data Provenance:
The document mentions "bench testing" was conducted on the GT1 Floppy and GT1 Hi-Per Flex guide wires as "representative samples." It does not specify the exact sample size (number of guide wires tested, or number of tests performed per guide wire) used for this bench testing.
- Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting, not with human or animal subjects. The origin of the data is internal to the manufacturer (Arterial Vascular Engineering Massachusetts, Inc.). The data is prospective in the sense that the tests were conducted specifically for this submission, but it's not a clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not applicable as the study was not a clinical or diagnostic study involving human subjects or expert interpretations. The "ground truth" for mechanical properties would be defined by the physical measurements and established engineering standards, rather than expert consensus on medical images or diagnoses. Biocompatibility assessment relies on standardized laboratory tests.
4. Adjudication Method for the Test Set:
This information is not applicable as the study was not a clinical or diagnostic study requiring adjudication of expert opinions.
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 information is not applicable as the device is a guide wire, not an AI/ML diagnostic or assistive tool, and no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a guide wire, not an AI algorithm. Its performance is inherently "standalone" in its mechanical function, but this is not the context of AI standalone performance.
7. The Type of Ground Truth Used:
- Mechanical Performance: The ground truth for mechanical performance was based on established performance requirements and specifications for guide wires, and comparative measurements against the predicate Commander Series guide wires. This is analogous to engineering specifications and comparative testing.
- Biocompatibility: The ground truth for biocompatibility was established through standardized biocompatibility testing conducted according to recognized protocols (mentioned in NAMSA reports in Appendix 1, though not detailed in the provided text). This is based on scientific assay results.
8. The Sample Size for the Training Set:
This information is not applicable as the device is a guide wire and does not involve AI/ML requiring a training set.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as the device does not involve AI/ML requiring a training set.
§ 870.1370 Catheter tip occluder.
(a)
Identification. A catheter tip occluder is a device that is inserted into certain catheters to prevent flow through one or more orifices.(b)
Classification. Class II (performance standards).