Search Results

The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.

The Integrated Innova - s5i system option is indicated for use in conjunction with single plane and biplane angiographic X-ray systems.

The Integrated Innova - s5i system option simplifies the clinical workflow associated with the use of Volcano s5i systems by:
(1) automatically synchronizing the patient demographic and medical exam information (patient name, date of birth, etc.) from angiographic X-ray systems with Volcano s5i systems,
(2) providing a remote access to commonly used Volcano s5i system functions from the angiographic X-ray systems user interface,
(3) displaying the Volcano s5i systems output on the monitor display solutions of the angiographic X-ray systems.

The integrated INNOVA - s5i system option provides enhanced connectivity with Volcano's intravascular imaging and pressure system.

The provided 510(k) summary for the "Integrated Innova - s5i system option" indicates that no clinical studies were performed to support substantial equivalence. Therefore, there is no detailed information available regarding acceptance criteria based on clinical performance, a study proving device performance against such criteria, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies related to AI performance.

The submission primarily focuses on demonstrating substantial equivalence based on non-clinical tests and technological similarity to its predicate device.

Here's a breakdown of the information that can be extracted from the provided text based on your request, with an emphasis on what is not available from this specific document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Note: The acceptance criteria for this device, as implied by the submission, revolve around its functional performance in integrating with the Volcano s5i system and maintaining the safety and effectiveness profile of the predicate device. This is assessed through non-clinical means like software validation, risk analysis, and verification/validation testing.

2. Sample size used for the test set and the data provenance:

• Not applicable: No clinical "test set" in the context of diagnostic or AI performance was used, as no clinical studies were conducted. The device's integration and functional aspects were likely tested using internal data or simulated environments, but details are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable: As no clinical studies or test sets requiring expert ground truth were submitted, this information is not available.

4. Adjudication method for the test set:

• Not applicable: No clinical test set to adjudicate.

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: No MRMC study was conducted. This device is not an AI algorithm for diagnostic interpretation; rather, it's an integration option for existing medical equipment to simplify workflow. Therefore, "human readers improve with AI vs without AI assistance" is not a relevant metric for this specific device.

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

• Not applicable: This device is not a standalone algorithm. It's an integration option for an existing X-ray system with an IVUS system, aiming to streamline workflow and display information.

7. The type of ground truth used:

• Not applicable: No clinical ground truth was used for performance evaluation in this 510(k) submission. For the non-clinical tests, the "ground truth" would be against design specifications and established functional requirements.

8. The sample size for the training set:

• Not applicable: This device is not described as utilizing machine learning or AI that would require a "training set" in the conventional sense for diagnostic algorithm development. Its function is connectivity and display.

9. How the ground truth for the training set was established:

• Not applicable: As no training set was used in the context of AI/ML, this information is irrelevant for this specific device.

Summary from the document regarding meeting acceptance criteria:

The document explicitly states: "The subject of this premarket submission, integrated Innova - s5i system option, did not require clinical studies to support substantial equivalence."

Instead, the device's substantial equivalence was determined based on:

• Compliance with voluntary standards: (Detailed in Section 9 of the premarket submission, though not included in this excerpt).
• Quality assurance measures applied during development:
  • Risk Analysis
  • Software Requirements Specifications
  • Requirements Reviews
  • Software design specification document
  • Design Reviews
  • Traceability between requirements & hazards towards their associated mitigations
  • Testing on unit level (Module verification)
  • Integration testing (System verification)
  • Performance testing (Verification)
  • Safety testing (Verification)
  • Simulated use testing (Validation)

The implied acceptance criteria are that these non-clinical tests demonstrate the integrated system performs its intended functions (patient data synchronization, remote access to IVUS functions, display of IVUS output) reliably, safely, and effectively without introducing new safety concerns or compromising the performance of the predicate device. The "study" proving this would be the compilation of results from the various verification and validation activities listed above.

Ask a specific question about this device