(57 days)
The CORE M2 Vascular System is used for the qualitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.
The CORE M2 Vascular System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. The system utilizes the acoustic impedance of vascular structures to provide cross sectional images from inside the vessel. The IVUS catheter uses a transducer near the distal tip to emit and receive high frequency sound waves. The system is then able to analyze the signal that is received by the transducer to differentiate between vessel structures to produce a 360° cross sectional image.
The CORE M2 Vascular System consists of a cart mounted touchscreen PC Console, a patient interface module (PIM) for connecting the IVUS Imaging Catheter to the PC Console, and an optional Control Console as an alternative to the touchscreen for control of the CORE M2 System.
The provided text describes the Volcano CORE M2 Vascular System, an ultrasonic pulsed echo imaging system. The performance data section outlines the design verification, software verification and validation, simulated use/usability validation, and image validation conducted to support the substantial equivalence claim to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Design Verification | |
| Electrical safety & EMC | Compliance with ANSI/AAMI ES60601-1:2005 + A2(R2012) + A1, IEC 60601-2-37:2007 (safety) and IEC 60601-1-2:2014 (EMC). |
| Environmental Testing | System remains functional under defined environmental conditions (humidity, temperature, shock, vibration). |
| Packaging Testing | Sufficient for transit conditions per ASTM D4332-14 and ASTM D4169-16. |
| Hardware Verification | CORE M2 System and subassemblies (Panel PC, Image Acquisition PCA, Mobile Cart, fully assembled system) meet relevant product specifications. |
| Software Verification & Validation | Software meets defined software requirements. Considered "Moderate" level of concern. |
| Simulated Use / Usability Validation | System meets user needs, satisfies intended use, and users can use the device safely and effectively. |
| Image Validation | Images acquired and displayed are clinically acceptable for end users. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for test sets in most categories.
- Design Verification: Details are general about testing performed on "the CORE M2 system" or "each of its subassemblies" or "each of the CORE M2 System packages." Specific numbers of units tested are not provided.
- Software Verification and Validation: Mentions "Unit, integration, and system level software testing was conducted on the CORE M2 v4.1 software." No specific number of test cases or cycles is provided.
- Simulated Use / Usability Validation: The text implies testing with users ("demonstrates that users are able to use the device safely and effectively"), but does not state the number of users or scenarios.
- Image Validation: The text states "An Image Validation was also conducted to confirm that the images acquired and displayed by the CORE M2 System are clinically acceptable for end users." No specific number of images or patients for this validation is provided.
Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be internal verification by Volcano Corporation rather than external clinical data. The studies described are likely prospective in nature, as they involve testing the device against predefined specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number or qualifications of experts specifically used to establish ground truth for the test set in the same way one might describe a clinical study comparing diagnostic accuracy.
- For Image Validation, it mentions "clinically acceptable for end users," implying clinical judgment, but does not specify how many clinicians or what their qualifications were.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for any of the performance data tests. The evaluations described are primarily engineering and software verification against specifications, or general statements about clinical acceptability.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
No, the document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The performance data focuses on validating the device's technical specifications and image quality, not its impact on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
The device itself is an "Ultrasonic Pulsed Echo Imaging System" which provides images for a human to interpret. Therefore, the concept of a "standalone" algorithmic performance (without human-in-the-loop) in the context of an imaging system's primary output is not directly applicable in the way it would be for an AI diagnostic algorithm. The system itself (hardware + software for image generation) is being evaluated for its standalone ability to acquire and display clinically acceptable images. The section "Image Validation" could be interpreted as evaluating the standalone image quality generated by the system.
7. The Type of Ground Truth Used
- Design Verification: Ground truth for these tests (electrical safety, EMC, environmental, packaging, hardware) would be the engineering specifications and industry standards (e.g., ANSI/AAMI, IEC, ASTM) that the device must meet.
- Software Verification and Validation: Ground truth would be the defined software requirements.
- Simulated Use / Usability Validation: Ground truth would be user needs and safety requirements.
- Image Validation: Ground truth appears to be expert consensus on "clinical acceptability" of the images, although the specifics are not detailed.
8. The Sample Size for the Training Set
The document does not describe any machine learning components that would require a distinct "training set." The CORE M2 Vascular System is an ultrasonic imaging system, and its development and validation are described in terms of engineering, software, and image quality verification, not in terms of training an AI model on a dataset.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of machine learning, this question is not applicable.
§ 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.