(48 days)
In-Vision™ Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also incicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.
ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vaculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.
The JOMED Inc. In-Vision™ Imaging System consists of the imaging catheter, the patient interface module, and the system console. The system console gathers and displays high-resolution intra'uminal images that can be analyzed both qualitatively and quantitatively. In addition to supplying diagnostic information, the In-Vision™ Imaging Systems can be adjunct to interventional therapies, such as balloon angioplasty. With ChromoFloTM, a two-dimensional color map of relative blood flow is overlaid on the grayscale image, providing a ditional information for vessel analysis. The In-Line Digital™ option displays a two-dimensional, 360° rotations, and longitudinal view of the vessel.
Here's an analysis of the provided text regarding the In-Vision™ Imaging System's acceptance criteria and studies:
Based on the provided 510(k) summary, the document does not contain specific acceptance criteria tables or detailed performance study results in the manner requested. The submission is a "Special 510(k)" for a software modification (version upgrade to V4.1) of an existing device. For such submissions, the focus is often on demonstrating that the changes do not raise new questions of safety or efficacy, rather than presenting extensive de novo performance data.
Therefore, many of the requested fields cannot be filled directly from this document. However, I can extract the available information and highlight what is missing.
Acceptance Criteria and Device Performance
Not explicitly stated in the document. The document states: "Applicable testing was performed to evaluate the modifications to the In-Vision™ Imaging System. The test results were found to be acceptable as required by the respective test plans and protocols."
This indicates that internal acceptance criteria and protocols were used, but the specific metrics and performance values are not disclosed in this 510(k) summary.
Study Details (Based on Available Information)
Since detailed performance data is not provided, many of these sections will indicate "Not specified in document."
| # | Feature | Description |
|---|---|---|
| 1 | A table of acceptance criteria and the reported device performance | Not specified in document. The document states "Applicable testing was performed... The test results were found to be acceptable as required by the respective test plans and protocols," but no specific criteria or performance values are provided. |
| 2 | Sample size used for the test set and data provenance | Not specified in document. The document does not mention sample sizes for any test sets or the origin (country, retrospective/prospective) of any data. |
| 3 | Number of experts used to establish the ground truth for the test set and qualifications | Not specified in document. No information on expert involvement or ground truth establishment is provided for any testing. |
| 4 | Adjudication method (e.g., 2+1, 3+1, none) for the test set | Not specified in document. No information on adjudication methods is present. |
| 5 | If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size | Not specified in document. The document does not mention an MRMC study or any comparison of human readers with vs. without AI assistance. This device is an imaging system, not an AI-assisted diagnostic tool in the modern sense. |
| 6 | If a standalone (i.e. algorithm only without human-in-the loop performance) was done | Not specified in document. While "performance data" is mentioned, there's no detail on whether this involved standalone algorithm performance, or if the "device" implicitly includes a human operator for interpretation. Given the era and device type, it's highly likely human interpretation is integral. |
| 7 | The type of ground truth used (expert consensus, pathology, outcomes data, etc.) | Not specified in document. |
| 8 | The sample size for the training set | Not specified in document. It's unlikely a "training set" in the modern machine learning sense was employed given the context of a software modification to an intravascular ultrasound system in 2003. "Training" would more likely refer to system configuration or calibration. |
| 9 | How the ground truth for the training set was established | Not specified in document. |
Summary of Information from the Document:
- Device Name: In-Vision™ Imaging System
- Purpose of Submission: Software modification (version upgrade to V4.1) to an existing intravascular ultrasound imaging system.
- Comparison: Claims substantial equivalence to predicate devices based on fundamental scientific technology, intended use, and clinical applications.
- Performance Data Statement: "Applicable testing was performed to evaluate the modifications... The test results were found to be acceptable as required by the respective test plans and protocols." This indicates internal testing was done and met predefined criteria, but the specifics are not public in this summary.
- Conclusion: The software modification "raises no new questions about safety and efficacy."
This 510(k) summary focuses on demonstrating that a software update to an already cleared device does not alter its fundamental safety or effectiveness profile, rather than providing a detailed performance study as might be expected for a novel device or an AI/ML product today.
§ 870.2330 Echocardiograph.
(a)
Identification. An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners.(b)
Classification. Class II (performance standards).