(91 days)
iSR'obot Mona Lisa is intended for use by a trained urologist or physician to perform the computer-assisted 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 B-Mode, 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 guide 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 describes the iSR'obot Mona Lisa device and its 510(k) submission but does not include specific acceptance criteria or an explicit study proving performance against those criteria. The document states that "No clinical data is submitted in support of this submission." and that substantial equivalence is based on "comparison of the regulatory characteristics, product technical characteristics, and performance." It primarily highlights non-clinical testing.
Therefore, for many of your questions, the information is not available in the provided text.
Here's what can be extracted based on the given document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified directly in the document. The submission focuses on substantial equivalence to predicate devices and non-clinical testing. | Bench and simulated use testing, including phantom testing, confirm that the subject device performs as intended and is substantially equivalent to the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable/Not provided. The document states, "No clinical data is submitted in support of this submission." and refers to "bench and simulated use testing, including phantom testing." The sample size for these non-clinical tests is not specified.
- Data provenance: Not applicable/Not provided. Since no clinical data was submitted, there is no information on country of origin or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. As no clinical data with human expert-adjudicated ground truth was submitted, this information is not available.
4. Adjudication method for the test set
- Not applicable/Not provided. No clinical test set requiring adjudication is mentioned.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states, "No clinical data is submitted in support of this submission."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The document implies that non-clinical testing (bench and simulated use, including phantom testing) was performed to assess the device's performance "as intended." However, it doesn't explicitly describe a "standalone" algorithmic performance in the context of image analysis (e.g., sensitivity/specificity of an automated detection system), but rather the mechanical and functional performance of the robotic system as a biopsy guide. The "prostate segmentation tool allows a manual or automatic surface detection from the 3D image" suggesting an algorithmic component, but no performance metrics for this specific function are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical "bench and simulated use testing, including phantom testing," the ground truth would typically be established by the known physical properties and design specifications of the phantoms and the expected mechanical outputs of the device. This is generally a physical truth rather than a clinical one. No clinical ground truth (like pathology or outcomes) was used as no clinical data was submitted.
8. The sample size for the training set
- Not applicable/Not provided. No information is given about a "training set" in the context of machine learning. While the device has an "automatic surface detection" tool, no details about its development or training data are provided.
9. How the ground truth for the training set was established
- Not applicable/Not provided, as no information on a training set or its ground truth establishment is given.
§ 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.