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510(k) Data Aggregation
(105 days)
The ILUMIEN OPTIS with Dragonfly DUO or Dragonfly OPTIS Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly DUO or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly DUO or Dragonfly OPTIS 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 ILUMIEN OPTIS will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.
The ILUMIEN OPTIS is a cart-mounted computer and Imaging Engine (or optical engine) placed inside an ergonomically designed mobile cart with the cable underground. It also includes the Drive-motor and Optical Coupler (DOC), which provides the interconnection between the ILUMIEN OPTIS System and the Dragonfly Catheter. The cart is equipped with two display monitors (one for the console operator, and the other for the physician), as well as a keyboard and mouse. The cart also contains an isolation transformer for electrical safety.
The cart includes two USB mounted FFR receivers which provide wireless reception of distal intracoronary and aortic pressure signals originating at the PressureWire® Aeris and the aortic pressure transducer (AIU). These signals are used to calculate and display the patient's Fractional Flow Reserve (FFR) on the system monitor.
The provided text is a 510(k) summary for the ILUMIEN OPTIS device, which is an ultrasonic pulsed echo imaging system. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to set and meet specific acceptance criteria in the same way a de novo or PMA submission might.
Therefore, the document focuses on demonstrating that the new device shares similar technological characteristics and performance to its predicate. It does not contain specific "acceptance criteria" presented as quantitative clinical performance metrics, nor does it describe a detailed "study that proves the device meets the acceptance criteria" in the way one might expect for a new clinical claim. Instead, the performance testing described is primarily focused on safety, fundamental functionality, and compliance with general medical device standards.
Here's an attempt to answer your request based on the available information, noting the limitations of a 510(k) summary for this type of request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for clinical performance (e.g., sensitivity, specificity for a specific diagnostic task) or quantitative clinical performance metrics alongside reported device performance. It primarily focuses on compliance with general standards and demonstrating equivalence to the predicate device.
| Acceptance Criterion (Compliance) | Reported Performance |
|---|---|
| IEC 62304:2006 (Software) | In compliance; software verification and validation conducted to FDA regulations, standards, and guidance document requirements. Results conclude software met requirements. |
| IEC 60601-1:2005+CORR.1(2006)+CORR.2(2007) (Basic Safety/Essential Performance) | In compliance. |
| IEC 60825-1:2nd Ed. 2007 (Laser Safety) | In compliance. |
| 21 CFR 1040.10 (Light Emitting Products) | In compliance (sections b5 and b15). |
| IEC 60601-1-2 Ed.3 (EMC) | In compliance (Electromagnetic emissions and immunity requirements for medical electric equipment-Group 1 Equipment, Class A for non-life supporting equipment). |
| Hardware and OCT Imaging Parameter Performance | Bench testing and design verification/validation performed in compliance with internal design control procedures, including engine hardware design verification and OCT Imaging Parameter testing. Results conclude the ILUMIEN OPTIS is safe and effective and substantially equivalent to the predicate device. |
| FFR Measurement Accuracy | Not explicitly defined as a separate acceptance criterion with a specific threshold. The device acquires RF signals from pressure transducers to "determine" FFR, and the physician uses this parameter. The document implies its functionality is equivalent to the predicate by virtue of being an "upgrade" to the engine. |
2. Sample size used for the test set and the data provenance
The document does not mention a "test set" in the context of clinical data for performance evaluation (e.g., in vivo patient data). The testing described is primarily bench testing, software verification/validation, and compliance with electrical/safety standards. Therefore, information regarding sample size and data provenance (country of origin, retrospective/prospective) for a clinical test set is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The testing described does not involve human experts establishing ground truth for a clinical test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided. There is no mention of a test set requiring adjudication in the context of clinical performance.
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 such study is described in the document. The device, ILUMIEN OPTIS, is an imaging system and FFR measurement device, not an AI-assisted diagnostic tool that aids human readers in interpreting images in the context of this 510(k). The document states it is an upgrade to an existing imaging system with improved performance through a modified engine design and updated software to accommodate FDML laser support. Its purpose is to acquire and display OCT images and FFR parameters. The physician uses these outputs.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not relevant to the described device as an imaging and FFR measurement system. The device produces images and FFR parameters for physician interpretation and use. No standalone algorithmic diagnostic performance is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance testing mentioned, the "ground truth" would be related to the specifications and expected outputs of the system (e.g., accurate optical coherence tomography images, correct calculation of FFR based on input pressure signals, compliance with safety and electrical standards, accurate software functionality). This is not a clinical ground truth like pathology or expert consensus on a diagnosis.
8. The sample size for the training set
This information is not applicable and not provided. The device is not described as using machine learning or AI that requires a "training set" in the conventional sense for clinical performance. The software upgrade is to "accommodate FDML laser support," which implies hardware and data processing adjustments, not AI model training.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as no training set for an AI/ML model is mentioned.
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(103 days)
The C7 XR™ Imaging System with C7 Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The C7 Dragonfly™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 Dragonfly™ 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 C7 XR™ Imaging System will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.
The C7 XR™ Imaging System K093857 (C7 XR) and Dragonfly™ Imaging Catheter (Dragonfly Catheter or DF) provide images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The system utilizes fiber-optic technology to emit near infrared light and receive light reflected from coronary tissue in order to produce high resolution, real-time images. The C7 XR will include two USB receivers to accept radiofrequency signals from a distal intracoronary pressure transducer and a proximal aortic pressure transducer and display the acquired pressure waveforms and calculated Fractional Flow Reserve on the C7 XR system monitor.
The C7 with FFR system consists of the following components:
C7 XR Imaging System (K093857): A cart-mounted computer and optical engine control the device and function as user interface, display and data storage. It includes the Drive-motor and Optical Coupler (DOC). The DOC is an optical-electro-mechanical device that provides the optical interconnection between the C7 XR and Dragonfly Catheter, and controls the rotational and axial motion of the fiber-optic core within the catheter and will include two USB receivers to accept radiofrequency signals from the distal intracoronary pressure transducer and a proximal aortic pressure transducer.
The provided text describes a 510(k) submission for the C7 XR™ Imaging System with Fractional Flow Reserve (FFR) and primarily focuses on its substantial equivalence to predicate devices and adherence to various standards. While it mentions "Clinical performance evaluation (Usability Testing)" for equivalence, it does not provide detailed information about specific acceptance criteria for system performance regarding FFR calculations or a study proving those criteria are met.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for the test set and data provenance.
- Number of experts used to establish ground truth.
- Qualifications of those experts.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study details.
- Standalone (algorithm only) performance study details.
- Type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
The text is a regulatory submission for a device modification, focusing on safety, effectiveness, and substantial equivalence, not a detailed clinical performance study report.
Information Extracted from the Text (as relevant to the request, even if it highlights missing information):
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of performance metrics for FFR accuracy or any other quantitative measure. The submission relies on "Usability Testing" and compliance with standards for substantial equivalence.
- Reported Device Performance: No specific performance metrics (e.g., accuracy, sensitivity, specificity, or numerical concordance for FFR values) are reported in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The clinical performance evaluation is referred to as "Usability Testing," which typically focuses on user interaction rather than extensive FFR accuracy testing against a gold standard.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified.
4. Adjudication method for the test set
- Not specified.
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 is mentioned. The device provides "Fractional Flow Reserve (FFR)" which is a physiological parameter calculated from pressure transducers, not an AI interpretation of images requiring human reader comparative effectiveness. The text indicates that "The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated," implying FFR (the output of the device) is an input to human clinical judgment, rather than the device assisting human readers in interpreting complex images directly.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device calculates FFR based on pressure transducer signals and displays it. It is inherently a "standalone" calculation, as it's an automated measurement. However, there are no reported performance metrics for this calculation within this document. The FFR calculation itself is well-established in cardiology. The submission focuses on the incorporation of this functionality into the C7 XR system and its equivalence to predicate FFR devices (RadiAnalyzer® Xpress and Pressure Wire®).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified. For FFR, the ground truth would typically be the measurement itself using an established reference method, but no such comparison data is presented. The "Usability Testing" mentioned would not typically establish this kind of ground truth.
8. The sample size for the training set
- Not applicable, as this is a device incorporating a known physiological measurement technique (FFR) and not a machine learning algorithm requiring a training set in the conventional sense. The "algorithm" for FFR calculation is based on principles of fluid dynamics.
9. How the ground truth for the training set was established
- Not applicable (see point 8).
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(135 days)
The C7 XR™ Imaging System with C7 Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The C7 Dragonfly™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 DragonflyTM 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 C7 XR™ Imaging System (C7 System) and C7 Dragonfly™ Imaging Catheter (Dragonfly Catheter) provide images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The system utilizes fiber-optic technology to transmit and receive light reflected from coronary tissue in order to produce high resolution, real-time images. The system consists of the C7 XR™ Imaging System (cart-mounted computer and optical engine), the C7 Dragonfly™ Imaging Catheter and Disposable Accessories (sterile, single-use catheter with fiber optic imaging core and external sheath), and the Off-line Review Workstation (personal computer with software to import, maintain and review images).
The provided text describes the C7 XR™ Imaging System and C7 Dragonfly™ Imaging Catheter. Here's an analysis of its performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Endpoint | Device Performance (C7 System & Dragonfly Catheter) |
|---|---|
| Efficacy Endpoint: Median Clear Image Length | 44.0 mm (statistically significant, close to 50 mm system limit) |
| Primary Hypothesis: True, population median Clear Image Length exceeded 24 mm | Met (44.0 mm observed) |
| Intra-observer reliability (Clear Image Length & cross-sectional lumen area) | Lin Concordance Correlation Coefficients ≥ 0.95 (Very good or excellent agreement) |
| Inter-observer reliability (Clear Image Length & cross-sectional lumen area) | Lin Concordance Correlation Coefficients ≥ 0.95 (Very good or excellent agreement) |
| Safety Endpoint: Incidence of predefined safety events (during procedure) | 0% (0/59 subjects) |
| Measurement Accuracy (Diameter) | 3.7% error (upper 95th percentile limits) |
| Measurement Accuracy (Area) | 8.6% error (upper 95th percentile limits) |
| Biocompatibility | Successfully passed ISO 10993:1 and ISO 10993:4 |
| Software Verification & Validation | Passed all requirements |
| International and Performance Standards (Electrical, Electromagnetic, Laser Safety) | Met EN 60601-1, 60601-2-18, 21 CFR Part 1040, IEC 60825 |
| Bench (Performance) Testing | Met performance specifications |
2. Sample Size Used for the Test Set and Data Provenance
The clinical study was a prospective, multi-center study.
The provided text does not explicitly state the specific country of origin for the clinical study data, but it was conducted under a "Significant Risk IDE application", suggesting it was likely conducted in the US.
- Clinical Study Test Set:
- Number of imaged subjects: 59
- Bench Testing (Measurement Accuracy): The sample size for arterial phantoms of different sizes is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document mentions "intra- and inter-observer reliability (variability) of cross-sectional lumen area measurements and Clear Image Length measurements were evaluated," and these analyses "concluded that both intra- and inter-reader agreements were very good or excellent." This implies at least two readers were involved in reading the clinical images.
The qualifications of these readers/experts are not specified in the provided text.
4. Adjudication Method for the Test Set
The document mentions "intra- and inter-observer reliability (variability)" and "intra- and inter-reader agreements were very good or excellent. Lin Concordance Correlation Coefficients were all 0.95 or greater." This suggests that multiple readers independently evaluated the images, and their agreement was assessed. However, it does not explicitly describe a specific adjudication method (e.g., 2+1, 3+1 consensus) for resolving discrepancies or establishing a single "ground truth" for the test set from the readers' interpretations. The high concordance coefficients suggest strong agreement, potentially rendering a formal adjudication process unnecessary for the reliability analysis itself.
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, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human readers with vs. without AI assistance was not performed or described in this document. The study assessed the device's standalone performance in providing clear images and the reliability of human measurements using the device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is an "Imaging System" with a catheter, so "standalone" in the traditional sense of an AI algorithm would not apply. However, the performance assessment described is essentially the standalone performance of the imaging system to produce images that are "suitable for the measurement of lumen diameter and cross-sectional area." The efficacy endpoints (Clear Image Length, measurement accuracy) and reliability analyses assess the quality of the output that human readers then use for diagnosis and measurement. There's no mention of an algorithm autonomously making diagnoses or measurements without human input; rather, the device provides the images for human interpretation.
7. The Type of Ground Truth Used
- Clinical Study (Efficacy): The ground truth for "Clear Image Length" was established by human readers/observers (implied from the intra- and inter-observer reliability analysis). For safety, adverse events were "adjudicated," but the specific type of ground truth beyond clinical observation and expert judgment is not detailed.
- Bench Testing (Measurement Accuracy): For diameter and area measurements, the ground truth was established using a simulated model of the coronary vasculature (arterial phantoms) with known sizes.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This submission is for an imaging system, not explicitly an AI/machine learning algorithm that requires a distinct training phase.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned for an AI/machine learning algorithm, the establishment of ground truth for a training set is not applicable based on the provided text.
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