Search Results

The LipiScan Coronary Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. The System is intended for the detection of lipid-core-containing plaques of interest. The System is intended for the assessment of coronary artery lipid core burden.

The LipiScan Coronary Imaging System is comprised of the catheter, catheter accessories, pull-back and rotation device and laser console with accessories.

The provided text describes a 510(k) summary for the LipiScan Coronary Imaging System. However, it does not contain specific acceptance criteria or details of a study that directly proves the device meets such criteria. The document focuses on establishing substantial equivalence to a predicate device, highlighting similar intended use, operating principles, catheter design, shelf life, packaging, and compliance with general safety and performance standards.

Here's an analysis based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in the document. The 510(k) summary states, "Further preclinical testing has shown that the product can function as intended and meets all internal design specifications," but it does not list these specifications or acceptance criteria. There are no quantitative performance metrics (e.g., sensitivity, specificity, accuracy for detecting lipid-core-containing plaques) presented as acceptance criteria or reported device performance.

2. Sample Size Used for the Test Set and Data Provenance

Not explicitly provided for any specific performance study. The document mentions "Ex vivo and in vivo data is presented to support expanded indications for use," but no details about the sample size, type of test set, or data provenance (e.g., country of origin, retrospective/prospective) are given for these studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not explicitly provided. Since no specific performance study with a test set is detailed, information about experts, their number, or their qualifications for establishing ground truth is absent.

4. Adjudication Method for the Test Set

Not explicitly provided. As no specific performance study is detailed, there is no information about any adjudication methods (e.g., 2+1, 3+1).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not mentioned and likely not performed or reported in this summary. The document focuses on demonstrating substantial equivalence, not on comparative effectiveness with or without AI assistance. The device is for imaging, and there's no mention of AI assistance for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable/not described. The LipiScan Coronary Imaging System is presented as an imaging system that provides an image of the artery wall. It's a diagnostic tool intended for use by clinicians, not an autonomous AI algorithm. Therefore, a "standalone algorithm only" performance study is not relevant in the context described.

7. Type of Ground Truth Used

Not explicitly stated for specific performance evaluations. The summary does not detail the nature of the ground truth for any studies supporting "expanded indications for use." For such devices, ground truth might involve histology, pathology, or correlative imaging modalities, but this is not specified here.

8. Sample Size for the Training Set

Not applicable/not provided. The device is an imaging system, not explicitly an AI/machine learning algorithm that requires a training set in the conventional sense. The "preclinical testing" and "ex vivo and in vivo data" likely refer to validation and verification testing for safety and performance, not training data for a learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable/not provided. As explained in point 8, there's no mention of a training set or an AI algorithm that would necessitate establishing ground truth for training.

In summary, the provided 510(k) summary serves to demonstrate substantial equivalence to predicate devices and adherence to general safety and performance standards. It mentions "preclinical testing" and "ex vivo and in vivo data" to support its expanded indications, but it lacks the detailed information about specific acceptance criteria and the comprehensive study methodology asked for in the prompt. This level of detail is often found in the full 510(k) submission, not typically in the public summary.

Ask a specific question about this device