(140 days)
iSR'obot Mona Lisa 2.0 is a user-controlled, stereotaxic accessory intended to guide physicians in the planning and positioning of insertion tools, such as a third-party needle or a probe, during image-guided diagnostic and interventional procedures in conjunction with the guidance of transrectal ultrasound involving the prostate gland in a clinical setting. Examples of such procedures include, but are not limited to, image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, and soft tissue ablations.
The iSR'obot Mona Lisa 2.0 system consists of a workstation, robotic navigation module (comprising of a motorized mechanical robotic arm, bed rail stabilizer or floor stand stabilizer) and disposables. The workstation is installed with application software that provides functions for image processing, image segmentation, 2D/3D visualization to support urologists or physicians in planning needle positions for procedures. The application software (UroBiopsy / UroTherapy) interfaces and controls the robotic arm to position its needle guidance mechanism at a trajectory to allow needle insertion by the physician. Another application software (UroFusion) provides an interface for users to perform contouring of the prostate gland and marking of suspected lesion regions, which can be imported into UroBiopsy or UroTherapy for image fusion during the procedure. The physician is able to review procedural data such as prostate information and model, needle positioning plan and trajectories, number of needles executed, etc., using a utility software (UroReview). A utility software (UroConnect) provides the connectivity solution to a picture archiving and communication system (PACS) server for downloading/uploading DICOM-compatible data. The bed rail stabilizer and floor stand stabilizer provide support for the robotic arm. They are to be attached to the bed rail or mounted on the floor respectively. Sterile disposables are used with iSR'obot Mona Lisa 2.0 during prostate procedures.
The system is compatible with commercially available ultrasound systems, transrectal ultrasound bi-plane probes, and commercially available needle devices.
The provided document indicates that the Biobot Surgical Pte Ltd iSRobot Mona Lisa 2.0is being submitted for 510(k) clearance based on its substantial equivalence to a legally marketed predicate device,iSRobot Mona Lisa 2.0 (K213411). The submission does not include clinical data, and therefore, no study proving device meets acceptance criteria based on clinical performance with human subjects. Instead, it relies on non-clinical testing to demonstrate that modifications to the device do not raise new questions of safety or effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria for specific performance metrics of the device as if it were a new device seeking initial clearance. Instead, it states that
All verification and validation activities were performed, and the results demonstrated substantial equivalence.
The acceptance criteria are implicitly tied to meeting the specifications and intended purpose of the modified components and software, and ensuring safety and effectiveness as compared to the predicate.
The reported device performance is described as:
The technological characteristics such as intended use, indications for use, method of operation, general function, and application of the subject device iSR 'obot Mona Lisa 2.0 are equivalent to the cleared predicated device iSR 'obot Mona Lisa 2.0 ([K213411](https://510k.innolitics.com/search/K213411)).
Specific non-clinical testing performed includes:
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Design and System Verification (Meet specifications and intended purpose) | Ensure new modification meets the specifications and its intended purpose |
| Software Verification and Validation (Meet specifications and intended purpose; IEC 62304:2006+A1:2015 Ed 1.1 compliant) | Ensure all software updates meets the specifications and the intended purpose. Software life cycle process is in accordance with IEC 62304:2006+A1:2015 Ed 1.1 |
| Cybersecurity Testing (Compliance with ANSI UL 2900-1 and ANSI UL 2900-2-1) | Testing conducted in accordance with ANSI UL 2900-1 and ANSI UL 2900-2-1 |
| Non-clinical System Performance Testing (Accurate needle positioning with new components) | Testing conducted to demonstrate that system is able to accurately position the needle with the new needle guide holder and iSR’obot Biopsy Kit. |
| Biological Evaluation and Biocompatibility Testing (Compliance with ISO 10993-1:2018) | Evaluation and testing conducted in accordance with ISO 10993-1:2018 |
| Sterilization Validation (Compliance with ISO 11135:2014) | Validation conducted in accordance with ISO 11135:2014 |
| Compatible Evaluation for New Ultrasound Transducers (Image quality, acoustic output, physical integrity) | Compatibility evaluation conducted with the new ultrasound transducers (e.g., image quality, acoustic output, physical integrity with the holder) |
| Accelerated Aging (To demonstrate 2-year shelf life, compliance with ASTM standards) | Accelerated aging, post-packaging and functional test conducted for the kit to demonstrate shelf life of 2 years (ASTM F1980-21, ASTM F1886/F1886M-16, ASTM F2906-11 (2019), ASTM F1929-15, ASTM F88/F88M-21) |
| Other Non-Clinical Tests (Compliance with ISO 14971:2019, ISTA 3A 2018) | ISO 14971:2019, ISTA 3A 2018 |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The submission explicitly states:
No clinical data is submitted in support of this submission.
Therefore, there is no clinical test set, sample size, or data provenance provided from human subjects. The non-clinical testing was performed on physical components (e.g., phantom for system performance, materials for biocompatibility, packaging for aging) and software. The document does not specify the sample sizes of these non-clinical tests (e.g., how many phantoms were used, how many samples of materials were tested).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Since no clinical data was submitted, there was no human-established ground truth for a clinical test set in this submission. The ground truth for non-clinical testing would typically be engineering specifications, established scientific principles, or recognized standards. The document does not specify if external experts were used for these non-clinical tests or their qualifications, beyond stating that testing was done using "well-established methods based on FDA recognized standards."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring expert adjudication was used.
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
Not applicable. No clinical studies, including MRMC studies, were conducted or submitted. The device is a "user-controlled, stereotaxic accessory" for guidance during procedures, not a diagnostic AI tool that assists human readers in image interpretation for which an MRMC study would typically be conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is not an algorithm-only device. It is a "user-controlled" system intended "to guide physicians." Its performance is inherently linked to human interaction. The non-clinical system performance testing used a phantom, which could be considered a form of standalone technical performance evaluation of the robot's accuracy in positioning, but it's not a standalone diagnostic algorithm performance as typically meant in AI contexts.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical system performance testing, the "ground truth" would have been the known, precise target locations within the phantom or the expected trajectory accuracy as per engineering specifications. The document states: Testing conducted to demonstrate that system is able to accurately position the needle with the new needle guide holder and iSR’obot Biopsy Kit. This implies comparison against a predefined accurate position.
For other non-clinical tests (biocompatibility, sterilization, aging, cybersecurity, software), the ground truth is adherence to the specified technical standards (e.g., ISO 10993-1:2018, ISO 11135:2014, IEC 62304:2015, ANSI UL 2900-1, etc.) or internal design specifications.
8. The sample size for the training set
Not applicable in the context of this 510(k) submission. While the device involves "software updates" and "application software" with functions like "segmentation" and "image registration" (which often use machine learning requiring training data), the document does not discuss the development of new AI algorithms or models that would necessitate a training set in this submission. The modifications described are primarily mechanical (needle guide holder material, stabilizer), software updates for existing functionalities, and compatibility expansions, rather than the introduction of new AI-driven diagnostic or analytical capabilities that would typically require a training set discussion.
9. How the ground truth for the training set was established
Not applicable, as no training set details were provided.
§ 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.