(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.
§ 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.