(29 days)
The IntraSight System is used for the qualitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated 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 vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.
The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.
Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and the wall structures. The Pullback feature of the imaging core within the protective sheath for a maximum of 15 cm.
The FFR Modality is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.
The iFR Modality is intended to be used in conjunction with currently marketed Volcano pressure wires. In the coronary anatomy, the iFR modality has a diagnostic cut-point of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic catheterization procedure. When used as for a pullback assessment, the iFR modality is intended as a visual aid in decision the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.
The IntraSight Mobile System provides qualitative and quantitative evaluation of vascular morphology in the coronary arteries and peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. The IntraSight Mobile System interfaces with Volcano Intravascular Ultrasound (IVUS) Imaging Catheters and pressure wires.
When operating in the IVUS mode, the IVUS catheter uses a transducer near the distal tip to emit and receive high frequency sound waves. The system is then able to analyze the signal that is received by the transducer to differentiate between vessel structures and produce a 360° cross-sectional, tomographic image. When operating in the pressure mode, the system acquires intraluminal data from pressure guide wire while simultaneously taking aortic pressure data from the established catheterization lab equipment. Catheters and guide wires are connected to the system via the Patient Interface Module (PIM).
The provided text describes a 510(k) premarket notification for the "IntraSight Mobile" system, which is a modification of an already cleared device, "IntraSight System" (K190078). This document primarily focuses on establishing substantial equivalence to the predicate device due to a functional modification (making it mobile). As such, it does not contain the kind of detailed information about acceptance criteria for AI/ML-enabled device performance and the extensive clinical study data (sample sizes, expert qualifications, MRMC studies, ground truth establishment) typically required for novel AI device submissions.
The "Performance Data" section lists various engineering and software verification and validation activities, but these are general product development tests and not specific to AI/ML performance. The "Conclusion" statement, "All device acceptance criteria were met," refers to these engineering and usability tests, not to a clinical AI/ML performance study.
Therefore, many of the requested details about acceptance criteria and study proving device performance for an AI/ML device cannot be extracted from this document, as it is a 510(k) for a modified hardware platform rather than a new AI/ML software feature.
However, I can extract the available information:
1. A table of acceptance criteria and the reported device performance:
Based on the provided text, the acceptance criteria are implicitly that the device performs as intended and meets safety and effectiveness standards, demonstrating substantial equivalence to the predicate. The performance data listed are general engineering and validation tests, not specific quantitative AI/ML performance metrics.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| EMC and Electrical Safety | Met |
| Environmental Testing | Met |
| Design Verification | Met |
| Software Verification and Validation | Met |
| Packaging Validation | Met |
| Simulated Use / Usability Validation | Met |
| Image Validation | Met |
2. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any clinical or AI/ML performance testing, as it's a hardware modification submission. The listed tests are engineering/software verification.
- Data Provenance: Not applicable/specified for AI/ML performance data, as such data is not detailed in this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The submission focuses on device modifications and substantial equivalence to a predicate, not novel AI/ML algorithm performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. This level of detail on clinical study methodology is not present, as the submission is for a device modification.
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 MRMC study information is provided. This submission is for a hardware modification, not a new AI-assisted workflow.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance data is provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- No specific ground truth type is mentioned as no AI/ML performance study is detailed. The "Image Validation" likely refers to ensuring image quality is comparable to the predicate.
8. The sample size for the training set:
- Not applicable/specified, as this submission concerns a hardware modification of an existing device, not the development or training of a new AI/ML model.
9. How the ground truth for the training set was established:
- Not applicable/specified, as this submission does not detail the training of an AI/ML model.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.