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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:

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.

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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 provides 2D and 3D visualization of Ultrasound images and the ability to fuse and register these images with those from other imaging modalities such as Magnetic Resonance, etc. It also provides the ability to display a simulated image of an insertion tool on a computer monitor screen, the target organ, and the current and projected future path of the insertion tool taking into account patient movement. Other software features include multiplanar reconstruction, segmentation, image measurements, 2D/3D image registration, and reporting.

The iSR'obot Mona Lisa 2.0 is user-controlled, stereotaxic accessory intended to guide physicians in the planning and positioning of insertion tools, such as a needle or a probe, during image-guided diagnostic and interventional procedures involving the prostate gland in a clinical setting. The device displays the 2D live image feeds from commercially available ultrasound systems and constructs 3D ultrasound image stacks. The system allows the importation of an MRI image to create a model of patient prostate by providing fusion between Ultrasound and Magnetic Resonance Imaging (MRI). The system is compatible with commercially available ultrasound systems, transrectal ultrasound bi-plane probes, and commercially available needle devices. Other software features include multi-planar reconstruction, segmentation, image measurements and 2D/3D image registration.

The provided text for iSR'obot Mona Lisa 2.0 (K213411) focuses on demonstrating substantial equivalence to a predicate device and details non-clinical testing. It explicitly states, "There is no pre-market clinical investigation submitted for iSR'obot Mona Lisa 2.0." Therefore, there is no information available in this document regarding acceptance criteria for clinical performance, the results of a clinical study proving the device meets these criteria, or details related to human readers, sample sizes for test/training sets, or ground truth establishment in a clinical context.

However, the document does describe non-clinical system performance testing using phantoms. I can extract information related to those non-clinical tests.

Non-Clinical System Performance Testing (using phantom)

1. Acceptance Criteria and Reported Device Performance (Non-Clinical)

Note: The document only states that these tests were "conducted to demonstrate" the listed functionalities. It does not provide specific numerical results or quantitative acceptance thresholds for these non-clinical tests in the provided summary. A "Pass / Meets criteria implied" is inferred based on the submission being cleared and the statement that "successful verification and non-clinical testing" was performed.

2. Sample Sizes Used for the Test Set and Data Provenance:

• Sample Size (Test Set): Not specified in the provided text. The tests were conducted using a "phantom."
• Data Provenance: The tests were non-clinical, using a "phantom." Therefore, there is no patient data provenance (country, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Number of Experts: Not applicable for non-clinical phantom testing.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable for non-clinical phantom testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Was an MRMC study done? No. The document explicitly states, "There is no pre-market clinical investigation submitted for iSR'obot Mona Lisa 2.0."
• Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm only without human-in-the-loop performance) Study:

• Was a standalone study done? Not explicitly mentioned as a separate formal study, but the "Non-clinical System Performance Testing" on a phantom would represent an algorithm/system-only performance test in a controlled environment, demonstrating the device's capabilities without direct human clinical intervention during the specified tasks (e.g., automated positioning accuracy). However, the device is marketed as "user-controlled, stereotaxic accessory intended to guide physicians," implying a human-in-the-loop for its clinical use.

7. Type of Ground Truth Used:

• Ground Truth Type: For the non-clinical phantom testing, the ground truth would typically be the precisely known or measured locations/trajectories within the phantom, established by engineering specifications, physical measurements, or other metrology techniques. The document refers to the system's "ability to accurately position the needle" and "adjustment... to compensate for the patient movement," which suggests a known target or reference from which accuracy/adjustment can be measured against.

8. Sample Size for the Training Set:

• Sample Size (Training Set): Not applicable or not specified in the provided text, as this document focuses on regulatory submission for a marketed device based on non-clinical testing and substantial equivalence, not detailing the development or training of specific AI components if they exist within the system beyond the mechanical guidance.

9. How the Ground Truth for the Training Set was Established:

• Ground Truth Establishment (Training Set): Not applicable or not specified.

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iSR'obot Mona Lisa 1.0 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 thirdparty prostate biopsy gun and needle. The insertion of biopsy needle will be done by urologist. The patient is administered general anesthesia and placed in a lithotomy position.

The iSR'obot Mona Lisa 1.0 is able to display the 2D live image feeds from commercially available ultrasound systems and also construct 3D ultrasound image stacks. The system allows the importation of an MRI image to create a model of patient prostate by providing fusion between Ultrasound and Magnetic Resonance Imaging (MRI). The system is compatible with commercially available ultrasound systems, transrectal ultrasound bi-plane probes, and commercially available needle devices. Other software features include multi-planar reconstruction, segmentation, image measurements, and 2D/3D image registration. The device is a user-controlled, stereotaxic accessory intended to guide the urologist or physician in the planning and positioning of a needle during ultrasound-guided transperineal prostate procedures such as biopsies in the operating room.

The iSR'obot Mona Lisa 1.0 comprises a workstation, robotic navigation module (comprising of robotic arm and bed rail stabilizer), and disposables.

The Biobot Surgical Pte Ltd iSR'obot Mona Lisa 1.0 device did not

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The iSR'obot Biopsy Kit (consisting of a needle guide, a probe sheath and a drape) is intended to be used with the iSR'obot Mona Lisa (K130944) for performing image guided transperineal biopsies of the prostate.

The iSR'obot Biopsy Kit is a consumables pack consisting of three (3) separate singleuse items designed to be used with the iSR'obot Mona Lisa (K130944).
Contents of the Biopsy Kit:
Probe Sheath: Non-active invasive device made of medical grade TPX (polymethylpentene). The open end of the sheath is intended to be connected to the end of the probe platform of Mona Lisa and its closed end is to be inserted into the patient's rectum for transient use (

The provided text describes the 510(k) submission for the iSR'obot Biopsy Kit, which consists of a needle guide, a probe sheath, and a drape. It establishes substantial equivalence to predicate devices rather than presenting a study proving performance against acceptance criteria for an AI-powered device. Therefore, a direct answer to the request regarding acceptance criteria and a study proving an AI device meets them cannot be fully provided from the given text.

However, I can extract the information related to the device itself and its testing, and then explain why a full answer to your prompt is not possible with the provided document.

Based on the provided document, here's what can be extracted regarding acceptance criteria and device testing:

This document is a 510(k) premarket notification, which seeks to demonstrate "substantial equivalence" to existing legally marketed predicate devices, rather than proving performance against specific acceptance criteria for a novel AI device through a clinical study with detailed statistical outcomes.

The testing described is primarily for the physical components of the iSR'obot Biopsy Kit (probe sheath, needle guide, drape) and their functionality, biocompatibility, and sterility, which are typical for consumable medical devices. It does not describe an AI device, an AI-powered component, or an MRMC study.

Here's a breakdown of the requested information, adapted to what is (and isn't) available in the text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format typically seen for AI device performance (e.g., sensitivity, specificity, AUC thresholds). Instead, it discusses the functional and safety requirements for a physical medical device kit and reports on non-clinical tests to meet these.

• Effective ultrasound imaging through the sheath
• Biocompatibility (ISO 10993-01)
• Environmental, packaging, shipping, shelf-life, and sterilization requirements | - Laboratory stress tests demonstrated mechanical safety.
• Performance testing showed effective ultrasound imaging of the prostate gland through the probe sheath using a phantom.
• Reviewed images obtained during the clinical trial of the main device (iSR'obot Mona Lisa, K130944) for imaging effectiveness.
• Met biocompatibility requirements specified by ISO 10993-01.
• Environmental, packaging, shipping, shelf-life, and sterilization requirements were met through validations performed by a certified laboratory. |
  | Needle Guide | - Allow 18-gauge needle passage
• Needle deflection within specified tolerance
• Biocompatibility (ISO 10993-01)
• Environmental, packaging, shipping, shelf-life, and sterilization requirements | - Physical dimensions were verified to ensure an 18-gauge needle can pass through.
• Any deflection of the needle was within the specified tolerance.
• Met biocompatibility requirements specified by ISO 10993-01.
• Environmental, packaging, shipping, shelf-life, and sterilization requirements were met through validations performed by a certified laboratory. |
  | Drape | - Sterility maintenance over shelf-life | - Microbial barrier test on the Tyvek film pouch showed it can maintain sterility for the 3-year shelf-life if packaging integrity is not compromised. |
  | Overall Kit| - Designed and manufactured under Quality System Regulations (21 CFR 820 and ISO 13485) | - Risk Analysis conducted
• Requirements Reviews completed
• Design Reviews completed
• Usability Analysis performed
• Performance testing (Verification) completed |

2. Sample size used for the test set and the data provenance:

• Test Set: The document does not specify a "test set" in the context of an AI algorithm's performance validation.
  • For the probe sheath, testing involved a phantom and a "review of images obtained during the clinical trial conducted for the main device - iSR'obot Mona Lisa (K130944)". The sample size for this review is not specified.
  • For the needle guide, "physical dimensions were verified," implying a small sample or inspection.
• Data Provenance: Not applicable as this is not a study on a data-driven AI device. The images reviewed for the probe sheath came from the clinical trial of the associated Mona Lisa device, but no further details on origin (e.g., country) or retrospective/prospective nature are provided for those images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is a submission for a physical medical device kit, not an AI device requiring expert-established ground truth for a diagnostic task.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. No such adjudication method is mentioned or relevant for this type of device submission.

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, an MRMC study was NOT done. This document pertains to a physical medical device kit, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable in the context of AI device ground truth. The "ground truth" for this device's performance relates to its physical properties:
  • Mechanical safety: Direct observation against stress.
  • Imaging effectiveness: Comparison of ultrasound images (with and without the sheath) using a phantom and potentially clinical images from the associated device's trial.
  • Sterility: Microbial barrier tests.
  • Biocompatibility: Adherence to ISO 10993-01 standards.

8. The sample size for the training set:

• Not applicable. This is not an AI device.

9. How the ground truth for the training set was established:

• Not applicable. This is not an AI device.

In summary: The provided document is a 510(k) premarket notification for a physical medical device kit. It focuses on demonstrating substantial equivalence to predicate devices through functional and safety testing of its components (probe sheath, needle guide, drape), rather than detailing the performance metrics or clinical study results of an AI-powered diagnostic system. Therefore, most of the questions pertaining to AI device validation (e.g., acceptance criteria for AI, training/test set details, expert ground truth, MRMC studies) are not addressed in this document.

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