(60 days)
The iLab™ Ultrasound Imaging System is intended for ultrasound examinations of intravascular pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.
The iLab Ultrasound Imaging System is designed for real time viewing of intravascular anatomies and is intended to be a basic diagnostic tool for imaging and evaluation of patients who are candidates for transluminal procedures.
The iLab™ Ultrasound Imaging System submission (K123535) is for a modification to an existing device, not a new device. Therefore, the information provided focuses on demonstrating substantial equivalence to the predicate device, rather than comprehensive new acceptance criteria and studies.
Here's a breakdown of the available information regarding acceptance criteria and supporting studies for the modified iLab™ Ultrasound Imaging System (version 2.7.1), acknowledging the limitations of this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a modification and not a new device requiring extensive clinical trials, the acceptance criteria are primarily focused on software verification and validation relative to the predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Software Unit and System Level Verification: All requirements in the Software Requirements Specifications are met. | "iLab 2.7.1 update meets the acceptance criteria as noted in the iLab System Software Unit and System Test Plans. All requirements in the Software Requirements Specifications have been verified by the system level testing." |
| Software Validation (Clinical Experience): iLab 2.7.1 image quality is equivalent or better than the predicate device. | "Validation passed its acceptance criteria in that a majority of the validation test results demonstrate that iLab 2.7.1 image quality is equivalent or better than the predicate device." |
2. Sample Sizes Used for the Test Set and Data Provenance
- Software Verification: The document states "Software unit and system level verification testing." The specific sample sizes for test cases or environments are not explicitly provided in this summary.
- Software Validation: The summary mentions "Validation was performed by testers with clinical experience evaluating IVUS images." The specific number of cases or images used for validation is not explicitly provided.
- Data Provenance: The document does not specify the country of origin of the data used for testing or validation. It is implied to be laboratory/internal testing performed by the manufacturer. The studies are retrospective in the sense that they are conducted on pre-existing software and images (or simulated scenarios), rather than a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- For software validation, the document states, "Validation was performed by testers with clinical experience evaluating IVUS images." The number of experts is not specified, nor are their detailed qualifications (e.g., specific clinical roles, years of experience).
4. Adjudication Method for the Test Set
- The document does not specify an adjudication method. Given the nature of a software verification and validation report for a modification, a formal adjudication process between independent experts as seen in clinical trials is unlikely to have been documented in this summary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "The modified iLab Ultrasound Imaging System did not require clinical studies to support substantial equivalence."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- The software verification and validation activities described are inherently a form of standalone testing, as they focus on the software's performance against its requirements and its image quality relative to a predicate device. However, the term "standalone" in the context of an AI-powered diagnostic device often implies a specific evaluation against a ground truth without human intervention during diagnosis. While the software generates images, its ultimate interpretation in a clinical setting still involves a human reader. The described "validation" focuses on image quality equivalence for human interpretation.
7. The Type of Ground Truth Used
- For Software Verification: The "ground truth" for software verification is adherence to the Software Requirements Specifications. The 'truth' is whether the software performs as designed.
- For Software Validation: The "ground truth" for image quality validation was based on the performance of the predicate device. The goal was to demonstrate that the image quality of the modified iLab 2.7.1 was "equivalent or better" than the predicate device, as evaluated by testers with clinical experience. This is a comparative ground truth rather than an absolute truth (e.g., pathology).
8. The Sample Size for the Training Set
- This information is not provided. This being a software update, the underlying core algorithms for image processing and display would have been developed and trained using data not described in this document, which focuses only on the modifications. If the update involved new machine learning components, details about their training set would typically be required, but this summary doesn't suggest that kind of fundamental change.
9. How the Ground Truth for the Training Set Was Established
- This information is not provided, as details about a "training set" for the underlying algorithms are outside the scope of this particular submission for a software modification. If new machine learning models were introduced as part of the update, this information would be critical. However, the description suggests an update to existing software functionalities.
§ 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.