(64 days)
iSR'obot Mona Lisa is intended for use by a trained urologist or physician to perform the computerassisted transperineal prostate biopsy under transrectal ultrasound guidance. The device serves as a biopsy needle guide only. It shall be used in conjunction with a third party ultrasound machine and endorectal probe that supports BMode, and a third party prostate biopsy gun and needle. The insertion of biopsy needle will be done by urologist.
iSR'obot Mona Lisa is a platform-hosted motorized device integrating a probe-driving system for 3-D image collection and a precise biopsy guidance mechanism (biopsy needle platform) to control the orientation of needle insertion and depth of puncture to assist the surgeon perform targeted transperineal prostate biopsy in conjunction with the guidance of transrectal ultrasound. The device serves as a needle quide only.
The device has a graphics user interface (GUI) that can provide a complete view of the 3D prostate to the physicians by hands-free image acquisition. The prostate segmentation tool allows a manual or automatic surface detection from the 3D image, based on which the prostate volume is calculated and the systematic biopsy plan is generated. This plan can be customized and the approved plan will be used to control the biopsy needle platform to guide the needle positioning for the manual puncture.
The provided text is a 510(k) summary for the iSR'obot Mona Lisa device. It describes the device, its intended use, and substantial equivalence to a predicate device. However, it explicitly states:
"Clinical Performance: No clinical data is submitted in support of this submission."
Therefore, the document does not contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for clinical performance.
The submission focuses on demonstrating substantial equivalence through non-clinical testing (bench and simulated use testing, including phantom testing) and comparison of regulatory and technical characteristics with its predicate device (iSR'obot Mona Lisa K111347).
As such, I cannot create the requested table or answer the specific questions about clinical study details based on the provided text.
§ 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.