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The OPTIS Integrated System 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 OPTIS Integrated 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 OPTIS Integrated System performs optical coherence topography (OCT) and fractional flow reserve (FFR) procedures and provides images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The device 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 imaging engine generates wavelength scanning light, which is guided to the DOC and the catheter. The reflection is collected and sent back to the engine. The engine processes the optical signal and converts it to electrical signal, which is then fed into the Host PC. The software application processes the signal and generates OCT images. The device is compatible with Dragonfly OPTIS, Dragonfly Duo and PressureWire Aeris.

The OPTIS Integrated System configuration has the following components integrated into a single catheterization lab.

The OPTIS Integrated System Mobile Workstation (MWS) is an accessory for the OPTIS Integrated System. The MWS is a mobile terminal that mirrors the functionality of the control room monitor, keyboard and mouse that is part of the OPTIS Integrated System. The Control room monitor, keyboard and mouse of OPTIS Integrated System is a desktop setup located in the control room for operating system controls.

The MWS consists of two major subassemblies:

• MWS console is comprised of a cart, keyboard, mouse, monitor, wireless . Keyboard/Video/Mouse (KVM) receiver, cabling, branding labels and compliance label.
• MWS transmitter is comprised of a wireless KVM transmitter, video splitter, power supplies and cabling. All items are shipped together in a single carton.

The provided text is a 510(k) premarket notification for the OPTIS Integrated System Mobile Workstation. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does NOT provide the level of detail requested for acceptance criteria and a study proving the device meets those criteria, particularly regarding AI performance or human reader improvement with AI.

Here's an analysis based only on the provided text, highlighting what information is and is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in the document. The document states that performance testing was conducted according to various IEC standards and internal design control procedures, and that the device "met these requirements." However, no specific acceptance criteria or quantitative performance metrics are listed for the core functionality of imaging or FFR determination. The testing primarily focuses on electrical safety, usability, and design verification of the Mobile Workstation accessory, not the clinical performance of the entire OPTIS system.

2. Sample Size Used for the Test Set and Data Provenance

Not provided in the document. The document mentions "Hardware Design Verification, System Level Design Verification and Transport & Storage Conditions Verification," but does not specify any sample sizes for these tests, nor does it refer to a "test set" in the context of clinical data or algorithm performance. The device is for imaging coronary arteries, but no patient data is mentioned in relation to testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable/Not provided. The document describes a medical device (OPTIS Integrated System) for imaging and FFR measurement. It does not mention any AI component or a need for expert-established ground truth for algorithm performance in the way a diagnostic AI would.

4. Adjudication Method for the Test Set

Not applicable/Not provided. As there's no mention of a test set requiring ground truth, no adjudication method is discussed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable/Not provided. The document does not describe an AI component within the OPTIS Integrated System that would assist human readers, nor does it discuss any MRMC studies comparing human readers with and without AI assistance. The focus is on the device's ability to acquire images and FFR data.

6. Standalone (Algorithm Only) Performance Study

Not applicable/Not provided. The device is an integrated system (hardware and software) for medical imaging and physiological parameter measurement. There is no mention of a standalone algorithm or a study evaluating its performance in isolation.

7. Type of Ground Truth Used

Not applicable/Not provided. Given the device's function (imaging and FFR measurement), the “ground truth” would likely be related to the accuracy of the physical measurements (e.g., FFR values against a gold standard manometer, image resolution/clarity against known phantoms). However, the document does not specify what ground truth was used for assessing the device's core performance, only that "Design Verification activities demonstrate that OPTIS Integrated System and the Mobile Workstation comply with the defined design and performance specifications."

8. Sample Size for the Training Set

Not applicable/Not provided. The document does not mention any machine learning or AI components that would require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not provided. As there's no mention of a training set, the method for establishing its ground truth is not discussed.

Summary of Device Performance Information Provided in the Document:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K141769) for the OPTIS Integrated System, with the addition of a Mobile Workstation accessory. The "Performance Testing" section states:

• The OPTIS Integrated System Mobile Workstation has been tested and is in compliance with:
  • IEC 60601-1:2005 + A1: 2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
  • IEC 60601-1-6:2010 + A1: 2013 (Medical electrical equipment - Part 1-6: General requirements for safety - Collateral Standard: Usability)
  • IEC 60601-2-18:2009 (Medical equipment - Part 2: Particular requirements for the basic safety and essential performance of endoscopic equipment)
  • IEC 60601-1-2 Ed. 3 (Electromagnetic emissions and immunity requirements for medical electrical equipment - Group 1 Equipment. Class A for non-life supporting equipment)
• Additionally, Hardware Design Verification, System Level Design Verification, and Transport & Storage Conditions Verification were conducted in accordance with FDA regulations, standards, guidance documents, and internal design control procedures.
• Reported Conclusion: "The results of this testing conclude the OPTIS Integrated System and Mobile Workstation have met these requirements. The Design Verification activities demonstrate that OPTIS Integrated System and the Mobile Workstation comply with the defined design and performance specifications. The addition of Mobile Workstation does not affect the safety, efficacy and performance of OPTIS Integrated System. The results of this testing concludes the OPTIS Integrated System with Mobile Workstation is determined to be safe and effective and is substantially equivalent to the OPTIS Integrated System predicate device."

In essence, the document confirms that the device (including its new mobile workstation accessory) meets safety and performance standards as determined by its design verification, but it does not detail specific, measurable clinical acceptance criteria nor the results of a study demonstrating these criteria are met with quantitative data. The focus is on the substantial equivalence and the compliance of the new accessory with regulatory standards.

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