(49 days)
IC-PRO, an image acquisition and processing modular software package, is indicated for use as follows:
- Assists in the evaluation of coronary lesions by enabling the creation of 3D images of coronary vessel segments based on two to three 2D angiography images obtained from single plane angiography. Provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image.
- Performs quantitative analysis of the left ventricle based on left ventricular angiograms.
- Enhances visualization of the stent deployment region and provides quantitative data based on manual stent tracings
- To be used in-procedure in the catheterization lab and off-line for postprocedural analysis
The IC-PRO System is an image acquisition and processing modular software package designed as an add-on to conventional X-ray angiography systems. This system improves the output of cardiovascular angiography by providing software modules that assist in diagnosis, procedure planning and post deployment analysis. IC-PRO enhances visualization and provides quantitative data of vessel, left ventricular and stent dimensions.
Here's an analysis of the provided text regarding the acceptance criteria and study for the IC-PRO System, structured according to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific, quantifiable acceptance criteria (e.g., "accuracy greater than X%", "precision within Y mm"). Instead, it describes performance in general terms relative to validation and predicate devices.
| Acceptance Criteria (Stated Implicitly/Generally) | Reported Device Performance |
|---|---|
| Accuracy within predetermined specifications | Produced accuracy within predetermined specifications |
| Precision within predetermined specifications | Produced precision within predetermined specifications |
| Performance comparable to marketed predicate devices | Comparable to results obtained by the marketed predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified (e.g., 2+1, 3+1, none). The document only mentions "performance evaluation."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: Not explicitly mentioned as a comparative effectiveness study with human readers. The wording "comparable to results obtained by the marketed predicate devices" suggests a comparison, but it doesn't specify if human readers were part of an MRMC study comparing AI-assisted vs. non-AI-assisted performance.
- Effect Size: Not provided.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- The document implies that "performance testing was performed to evaluate the IC-PRO System" and produced "accuracy and precision results." This suggests a standalone evaluation of the algorithm's output (e.g., derived measurements) against a ground truth, rather than being solely a human-in-the-loop study. However, it doesn't definitively exclude human interaction during the acquisition or initial parameter setting that might influence the reported performance.
7. The Type of Ground Truth Used
- The document does not explicitly state the specific type of ground truth used (e.g., expert consensus, pathology, phantom measurements, or another form of reference standard). It mentions comparison to "predetermined specifications" and "marketed predicate devices," which implies that the ground truth would have been established measurements for the same anatomical structures.
8. The Sample Size for the Training Set
- The document does not mention a training set or its sample size. This is common for older 510(k)s, especially for systems that might not rely on machine learning in the modern sense (e.g., rule-based algorithms, advanced image processing) for their primary function, or if the training data details were not deemed essential for the summary.
9. How the Ground Truth for the Training Set Was Established
- Since a training set is not mentioned, the method for establishing its ground truth is also not provided.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.