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510(k) Data Aggregation
(112 days)
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
The Ultreon™ 1.0 Software is intended to be used only with compatible OPTIS™ Next Imaging Systems. The OPTIS Next Imaging System with a compatible Dragonfly™ OPTIS™ Imaging Catheter or Dragonfly OpStar™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OPTIS Imaging Catheter or Dragonfly OpStar Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OPTIS Imaging Catheter or Dragonfly OpStar Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The OPTIS Next Imaging System is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if thervention is indicated.
The OPTIS™ Mobile Next and OPTIS™ Integrated Next with a compatible Dragonfly™ OPTIS™ or Dragonfly™ OpStar™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OPTIS or Dragonfly OpStar Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OPTIS or Dragonfly OpStar Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The OPTIS Mobile Next and OPTIS™ Integrated Next is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if therapeutic intervention is indicated.
The OPTIST™ Next Imaging System is comprised of two devices providing the same set of features:
• The OPTIST™ Mobile Next Imaging System is comprised of a cart-mounted personal computer, imaging engine, and power supply that are placed inside an ergonomically designed mobile cart. This system includes a keyboard, display monitors, mouse, tableside controller, and a Drive-motor and Optical Controller (DOC).
• The OPTIST™ Integrated Next is comprised of a PC, imaging engine, and power supply that are housed in stationary cabinet which is located in the clinic/hospital equipment closet of a catheter lab. The tableside controller, DOC and DOC Holster are located in the procedure room, and the keyboard, display monitor, and mouse are located in the control room.
With the Ultreon™ 1.0 software application, these systems perform Optical Coherence Tomography (OCT) imaging of coronary arteries using compatible Dragonfly imaging catheters. Resting Full-cycle Ratio (RFR), Fractional Flow Reserve (FFR), and Pd/Pa at rest physiological waveforms are also measured by the system to assess the severity of a coronary lesion by measuring the pressure drop across the lesion (distal vs proximal pressure). The physician may use the RFR or FFR parameter, along with knowledge of patient history, medical expertise, and clinical judgment to determine if therapeutic intervention is indicated.
The provided document is a 510(k) summary for the OPTIS™ Mobile Next Imaging System, OPTIS™ Integrated Next Imaging System with Ultreon™ Software 1.0. It primarily focuses on demonstrating substantial equivalence to a predicate device (K192019: Dragonfly Opstar™ Imaging Catheter, AptiVue™ Software version E.5.1) rather than detailing specific acceptance criteria for AI performance and a study proving those criteria are met for the Ultreon™ Software 1.0's automated morphology assessment features.
The document states that modifications to the Ultreon 1.0 software include:
- Automated morphology assessment of External Elastic Lamina (EEL) and calcium.
- Display of live angiography imagery.
- User interface guided workflows.
- Updates to existing features: OCT image color map, OCT pullback auto-trigger, Angio co-registration, Vessel sizing, Stent analysis, Stent expansion, Cybersecurity.
However, the "Summary on Non-Clinical Testing" section does not provide details for the acceptance criteria and the study that proves the device meets the acceptance criteria specifically for the automated morphology assessment of EEL and calcium. It only generally states: "Software design verification and validation testing have been performed which concludes these modifications demonstrate claims of substantial equivalence to the AptiVue E.5.1 software." No specific quantitative metrics (like sensitivity, specificity, accuracy, dice score etc.) or study methodologies for the automated morphology assessment are described.
The document does mention "Human Factors - Summative Usability Study" and "Hardware/System/packaging Verification," but these are general safety and performance tests, not specific to the performance of the AI-driven automated morphology assessment.
The section "Summary of Clinical Testing" discusses the Resting Full-cycle Ratio (RFR) and its interpretation, referencing clinical studies used to support a labeling change for the RFR cut-off. This RFR functionality appears to be a physiological parameter measurement and interpretation, which is distinct from the "automated morphology assessment" mentioned earlier. The RFR discussion relies on published literature for its validation, not a de novo study conducted for this 510(k) submission to evaluate the Ultreon software's performance in automatically assessing EEL and calcium.
Therefore, based solely on the provided text, the specific information requested about the acceptance criteria and the study proving the device meets those criteria for the "automated morphology assessment of External Elastic Lamina (EEL) and calcium" is NOT detailed.
If we were to infer based on the provided text, and assuming the question is about the overall device and not just the AI component (which is not explicitly elaborated upon in sufficient detail for the AI-specific performance), here's what can be extracted, acknowledging the limitations for AI-specific performance:
Based on the provided document, detailed acceptance criteria and a study proving the device meets these criteria for the automated morphology assessment features of the Ultreon™ Software 1.0 are not explicitly stated. The document primarily focuses on demonstrating substantial equivalence to a predicate device through general software and hardware verification and validation, and literature-based validation for RFR.
The document indicates that the Ultreon™ 1.0 Software includes "automated morphology assessment of External Elastic Lamina (EEL) and calcium," but the specifics of how this particular AI component's performance was evaluated against quantitative acceptance criteria are not present.
However, if we are to interpret the request as broadly as possible within the confines of the provided text, particularly focusing on the stated "design verification and validation testing" for software modifications and the comparison to the predicate device, here is a breakdown. Please note that the AI-specific performance metrics and study details for the automated morphology assessment are absent in this document.
Inferred Study Overview and Acceptance Criteria (with significant caveats as explicit details for AI performance are missing):
The submission relies on a demonstration of substantial equivalence to a predicate device (K192019). The "acceptance criteria" appear to be broadly defined by ensuring the modified device (including the Ultreon 1.0 software with its new features like automated morphology assessment) performs as intended, does not raise new questions of safety or effectiveness, and maintains the same indications for use and operational characteristics as the predicate.
The "study" encompasses general Software Verification and Validation and Hardware/System/packaging Verification. The qualitative outcome of these tests is that they "conclude these modifications demonstrate claims of substantial equivalence."
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from Substantial Equivalence and V&V) | Reported Device Performance (General Outcome) |
|---|---|
| Software Functionality & Safety: | |
| - Meets requirements and functions as intended. | - Design verification and validation (including for automated morphology assessment) performed. |
| - Does not trigger serious harm based on use error/problems. | - Summative Usability Study performed, showing no serious harm from use error or problems, and no patterns requiring further modification of UI, labeling, or training. |
| - Does not raise new questions of safety or effectiveness. | - Software V&V concludes modifications (including automated morphology assessment) demonstrate substantial equivalence, implying no new safety/effectiveness concerns. |
| Hardware/System Performance & Safety: | |
| - Meets specifications. | - Hardware/System/packaging Verification performed, concluding products and packaging meet specifications. |
| - Appropriate for intended use. | - Hardware/System/packaging Verification performed. |
| - Does not raise new questions of safety or effectiveness. | - Hardware/System V&V (including for computational speed, display, electrical compliance, cybersecurity, TPM chip, ferrites) concludes modifications demonstrate substantial equivalence, implying no new safety/effectiveness concerns. |
| Physiological Parameter Accuracy (RFR): | |
| - RFR interpretation matches established clinical cut-offs. | - RFR validated for clinical accuracy and outcomes in >2,500 patients through published literature. |
| - RFR equivalence to other NHPRs. | - Multiple peer-reviewed publications demonstrate equivalence of RFR to other NHPRs; studies like IRIS-FFR and 3V FFR-FRIENDS concluded broad equivalence in diagnostic and prognostic performance, supporting RFR-guided treatment at 0.89 cut-off being equivalent to FFR 0.80. This supports the clinical utility of the RFR measurement displayed by the device. |
Missing specific quantifiable acceptance criteria related to the accuracy or performance of the "automated morphology assessment of External Elastic Lamina (EEL) and calcium" (e.g., sensitivity, specificity, Dice score, etc.). The document does not elaborate on the specific "design verification and validation" tests for these AI features.
2. Sample Size for the Test Set and Data Provenance:
- For "automated morphology assessment" or AI features: Not specified. The document mentions "Software design verification and validation testing," but provides no details on the size or characteristics of the dataset used for these tests, nor its provenance (country of origin, retrospective/prospective).
- For RFR validation: The document refers to "over 2,500 patients" across multiple peer-reviewed publications (e.g., VALIDATE RFR, IRIS-FFR, 3V FFR-FRIENDS studies). This data provenance would be from various clinical studies, likely international and retrospective/prospective depending on the specific study design cited.
3. Number of Experts and Qualifications for Ground Truth:
- For "automated morphology assessment" or AI features: Not specified. The document does not describe how ground truth was established for the "automated morphology assessment of External Elastic Lamina (EEL) and calcium."
- For RFR validation: Ground truth for RFR (and FFR) studies is typically established by consensus of interventional cardiologists based on invasive physiological measurements and clinical outcomes, though the specific number and qualifications of experts for the studies cited are not detailed in this 510(k) summary.
4. Adjudication Method for the Test Set:
- For "automated morphology assessment" or AI features: Not specified.
- For RFR validation: Not described for the referenced clinical studies in this document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC study is explicitly mentioned or detailed for the Ultreon™ Software 1.0, specifically regarding how human readers improve with or without AI assistance for the "automated morphology assessment" features. The focus is on substantial equivalence and verification/validation, not a clinical effectiveness trial for the AI component's impact on human performance.
6. Standalone (Algorithm Only) Performance:
- Not explicitly detailed for the "automated morphology assessment" features. While "Software design verification and validation testing" implies evaluation of the algorithm, specific standalone performance metrics (e.g., sensitivity, specificity, accuracy of EEL/calcium detection/segmentation) and the methodology for assessing these are not provided in this summary. The RFR discussion refers to the validated performance of the RFR parameter itself, not the software's ability to automatically interpret it.
7. Type of Ground Truth Used:
- For "automated morphology assessment": Not specified. Presumable an "expert consensus" or "pathology" (histology/ex-vivo) ground truth would be ideal for morphological assessments, but it is not mentioned.
- For RFR validation: The ground truth for RFR (and FFR) would be based on invasive physiological measurements (e.g., pressure wire readings) and clinical outcomes data from the referenced studies.
8. Sample Size for the Training Set:
- Not specified. The document does not provide any information regarding the training dataset used for the development of the Ultreon™ software's "automated morphology assessment" features.
9. How Ground Truth for Training Set was Established:
- Not specified. As the training set size is not mentioned, neither is the method for establishing its ground truth.
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