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The OPUSWAVE System with DualView Catheter is intended for the intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

The OPUSWAVE Dual Sensor Imaging System consists of a wheeled console with monitor, keyboard, mouse, a software graphical user interface and a Motor Drive Unit (MDU) protected by an MDU cover. The MDU is connected to a DualView Catheter capable of imaging both, Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IVUS) modalities, either simultaneously or asynchronously, without removing the catheter from the imaging site. The system allows image data to be exported and stored on external media (USB, DVD), and for integration with Cath Lab imaging technologies (angio, ECG).
The sterile operator (physician) is able to control image acquisition by manually positioning the imaging sensor as well as performing pullback (automatically or manually) for defined regions of interest. The system provides analysis tools such as area and linear measurements.

The provided FDA 510(k) Clearance Letter for the OPUSWAVE Dual Sensor Imaging System focuses on establishing substantial equivalence to predicate devices, primarily through engineering and regulatory compliance testing. While it mentions various verification and validation activities, it does not contain the detailed clinical study data typically found when a device’s performance against specific acceptance criteria is being proven, especially for AI-enabled devices requiring human reader studies or detailed standalone performance metrics.

Based on the information given, here's an analysis of what can be extracted or inferred, and what cannot be answered:

Acceptance Criteria and Study for OPUSWAVE Dual Sensor Imaging System

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating equivalence to predicate devices for imaging capabilities (OCT and IVUS modalities), safety (electrical safety, EMC, laser output, acoustic output), and software functionality. There are no specific quantitative performance metrics or acceptance criteria reported similar to what would be found for an algorithm that provides diagnostic outputs (e.g., sensitivity, specificity, accuracy).

However, based on the provided text, we can infer the "acceptance criteria" were met through various tests that showed compliance with standards and equivalence to predicates.

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

• Test Set Sample Size: Not specified. The document mentions "animal testing" and "simulated use testing" for design validation. For software, general "verification and validation testing" is mentioned, but specific test set sizes (e.g., number of test cases, images, patients) are not provided.
• Data Provenance:
  • Animal Study: Animal data. Details on geographic origin or whether it was retrospective/prospective are not provided.
  • Simulated Use Testing: Implies a controlled environment, likely within the manufacturer's facility, but specifics are not given.
  • Software V&V: Internal testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• Not Applicable / Not Provided: The document does not describe the establishment of a "ground truth" in the clinical sense (e.g., for diagnostic accuracy) as it's not a device focusing on automated interpretation or diagnosis. The studies mentioned (animal, simulated use, software V&V) would have their own internal verification against design specifications or a recognized standard, but not a human expert-adjudicated ground truth as would be typical for AI/CADx devices.

4. Adjudication Method for the Test Set:

• Not Applicable / Not Provided: As there's no mention of expert-established ground truth for a diagnostic test set, there's no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

• No: The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the OPUSWAVE Dual Sensor Imaging System to the predicate devices and is not included as part of this premarket notification." Therefore, an MRMC study demonstrating human reader improvement with AI assistance was not conducted or reported. This device is an imaging system, not an AI interpretation tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not Applicable (in the classic AI sense): This device is an imaging system, not an AI algorithm designed to provide standalone diagnostic outputs. Its "performance" would be related to image quality, system functionality, and safety parameters. While the system's software underwent "verification and validation testing," this is to ensure the software itself functions correctly and safely within the imaging system, not to assess its diagnostic accuracy as a standalone algorithm.

7. The Type of Ground Truth Used:

• Design Specifications, Regulatory Standards, and Animal Models:
  • For electrical safety and EMC: Compliance with IEC 60601-1 and IEC 60601-1-2.
  • For software: Compliance with FDA Software Guidance ("Enhanced" level), suggesting verification against defined requirements.
  • For design: Compliance with "defined design input requirements."
  • For clinical equivalence/imaging capabilities: Demonstrated equivalence in "animal testing," implying that normal anatomy and pathology in animal models served as a reference.

8. The Sample Size for the Training Set:

• Not Applicable / Not Provided: This device is not described as an AI/machine learning device that requires a "training set" in the context of model development. The verification and validation activities are for the entire system, not for training a specific algorithm.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable / Not Provided: As there is no mention of a training set for an AI algorithm, there is no ground truth establishment process described for one.

Summary of Device and Evidence Focus:

The OPUSWAVE Dual Sensor Imaging System is an intravascular imaging system (OCT and IVUS). The 510(k) clearance relied on demonstrating substantial equivalence to existing predicate devices, rather than proving novel clinical efficacy or superior diagnostic accuracy through large-scale human clinical trials or AI performance evaluations. The "studies" primarily referenced are engineering verification and validation testing, animal studies for equivalence, and compliance with recognized safety and software standards. The document does not suggest that the device incorporates AI in a way that requires AI-specific performance criteria (e.g., sensitivity, specificity, MRMC studies) for its clearance.

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