(29 days)
The Eagle Eye® Platinum ST catheters are designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels.
The Eagle Eye Platinum ST ultrasound imaging catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
The Eagle Eye Platinum ST Catheter incorporates a cylindrical ultrasound transducer array. The array radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the coronary and peripheral vessels.
The Eagle Eye Platinum ST Catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36 mm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The catheter is introduced percutaneously or via surgical cutdown into the vascular system.
Three 1 mm-long radiopaque markers are incorporated on the internal lumen positioned 10 mm apart from distal edge to distal edge, starting 10 mm from the proximal edge of the portion of the scanner marker tube normally visible under fluoroscopy.
The Eagle Eye Platinum ST Catheter may only be used with the In-Vision Imaging System, Volcano s5 or Volcano s5i Imaging System. These systems use Volcano VH IVUS system software v1.2 or higher. This catheter will not operate if connected to any other imaging system.
The provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The document is a 510(k) summary for the Eagle Eye Platinum ST Catheter, which is a submission to the FDA requesting clearance to market a medical device. It focuses on demonstrating "substantial equivalence" to a predicate device (the Eagle Eye Platinum Digital IVUS Catheter), rather than providing detailed performance data against specific acceptance criteria.
Here's what the document does say regarding performance:
- "Performance Data: Applicable testing was performed in accordance with the Design Verification Plan including a Risk Analysis addressing the impact of enhancements to the device and components. The test results indicate the Eagle Eye Platinum ST Catheter is comparable to the predicate device."
This is a very high-level statement and does not provide quantified acceptance criteria or the specific results of any performance studies. It primarily asserts comparability to the predicate device.
Therefore, I cannot fill out the requested table or answer most of the questions based on the provided text.
Here's what I can state based on the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (e.g., Sensitivity, Specificity, Accuracy, Imaging Resolution, Measurement Accuracy) | Reported Device Performance |
|---|---|
| Not specified in the provided text. | Not specified in the provided text, beyond a general statement of "comparable to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified.
- Data Provenance: Not specified.
- Retrospective/Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable/Not specified, as no details of a ground truth creation process are provided for a specific test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified, as no details of a ground truth creation process are provided for a specific test set.
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:
- No. The document describes an intravascular ultrasound (IVUS) catheter, which is a diagnostic imaging device, not an AI-powered image analysis system or a device intended to assist human readers in image interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's regulatory submission as described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware device (catheter) for generating real-time images. It is not an algorithm that performs standalone analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not specified, as no specific performance study details are provided. The "performance data" mentioned is broadly stated as indicating comparability to the predicate device, likely through engineering and bench testing rather than clinical ground truth validation.
8. The sample size for the training set:
- Not applicable. This is a hardware device. The "Volcano VH IVUS system software v1.2 or higher" is mentioned, implying software for image processing, but no details regarding machine learning or a "training set" are provided.
9. How the ground truth for the training set was established:
- Not applicable, as no training set is mentioned for this device.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).