(29 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 provided document states that no clinical studies were required for the modified iLab™ Ultrasound Imaging System to support substantial equivalence. Therefore, the device's acceptance criteria and performance are not discussed in the context of clinical studies.
The document explicitly states:
- "Summary of Clinical Tests: The modified iLab Ultrasound Imaging System did not require clinical studies to support substantial equivalence."
Instead, the determination of substantial equivalence was based on non-clinical data, including:
- Functional/performance testing
- Interoperability testing
- Electrical Safety testing
The document notes that:
- "Design verification testing demonstrates that the modified device meets the acceptance criteria."
However, the specific acceptance criteria and the reported device performance from these non-clinical tests are not detailed in the provided text.
Given this, I cannot provide the information requested in your numbered list, as the study details, sample sizes, expert involvement, and ground truth information are not present for clinical performance.
§ 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.