(99 days)
The Anovo Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMS during single site, natural orifice transvaginal benign laparoscopic-assisted surgical procedures listed below. The Anovo Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment.
The representative uses of the Anovo Surgical System are indicated for the following benign procedures:
- Total benign hysterectomy with salpingo-oophorectomy
- Total benign hysterectomy with salpingectomy
- Total benign hysterectomy
- Salpingectomy
- Oophorectomy
- Adnexectomy
- Ovarian cyst removal
The Anovo Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMS during single site, benign laparoscopic-assisted surgical procedures. The system consists of two (2) Anovo Instrument ARMS, Anovo Surgeon Console, Anovo Robotic Control Unit (RCU), and accessories (Anovo Pedestal, Anovo Access Kit and Anovo Sterile Drape for Robotic Control Unit).
The Instrument ARMS are connected to the RCU, which is attached to the Pedestal. The physician sits at the Anovo Surgeon Console and controls the Instrument ARMS by manipulating the ARMS Controllers. While manipulating the Instrument ARMS, the physician views the surgical site through a standard OR visualization system using a laparoscopic camera inserted through an abdominal port. The Anovo Surgical System Surgeon Console is located outside of the sterile zone.
The Anovo Surgical System is a modification of the Anovo Surgical System Model 6Ne ("Predicate Device" K242157), including software update and Surgeon Console hardware modifications to support the use of an Off-the-Shelf FDA-cleared Endoscope Arm, SOLOASSIST II by AKTORmed (K233312) as an optional accessory (without the SOLOASSIST II hand-held joystick and Voice Control features). The Endoscope Arm can be connected to the Surgeon Console and controlled by the Surgeon through the ARMS Controllers. The annotation feature was removed, and the annotation pedal was replaced with the Endoscope control pedal. There are no differences in the system RCU, Instruments, and accessories.
The provided FDA 510(k) clearance letter for the Anovo Surgical System (6Ne) describes various performance evaluations conducted. However, it does not provide specific acceptance criteria or quantitative performance metrics for the device itself or a study demonstrating these criteria were explicitly met in a table format as requested.
The document focuses on demonstrating substantial equivalence to a predicate device (Anovo Surgical System Model 6Ne K242157) through various tests, primarily related to safety, functionality, and technological characteristics, rather than establishing new, specific quantitative performance criteria for the device's surgical capabilities.
Therefore, many sections of your request cannot be fully answered with the information provided in the given text.
Here's a breakdown of what can be extracted and what information is missing:
Acceptance Criteria and Reported Device Performance
The document states that "The Anovo Surgical System 6Ne met all the predefined specific requirements related to clinical compatibility, performance, and safety." However, it does not detail what these specific quantitative requirements or acceptance criteria were for the device beyond general statements of successful performance of surgical tasks.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Compatibility, Performance, and Safety Requirements (specific details not provided) | The System can successfully perform all surgical tasks to complete transvaginal laparoscopic-assisted surgical procedures. All relevant use-related risks were found to be acceptable and there is no residual use-related risk. The device demonstrated compliance with electrical safety, EMC, and human factors standards. |
| Bench Testing Design Output Requirements (specific details not provided) | Subject device's design output meets the design input requirements; testing included dimensional measurements and mechanical and functional verification. |
| Software Development Process and Testing Standards (IEC 62304, FDA Guidance "Content of Premarket Submissions for Device Software Functions") | Software development process and testing, including verification and validation, were performed according to these standards. |
| Cybersecurity Standards (Section 524B of the FD&C Act, FDA Guidance: "Cybersecurity in Medical Devices") | Implements robust security controls; testing demonstrates compliance with these standards. |
| Electrical Safety and EMC Standards (IEC 60601-1, IEC 60601-1-6, IEC 80601-2-77, IEC 60601-1-2, IEC 60601-4-2, IEC 60601-2-2) | Testing conducted in accordance with these standards. |
| Human Factors and Usability Engineering Standards (ISO/IEC 62366-1:2015, FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices") | Human Factors and Usability Engineering Process performed according to these requirements. |
Study Details
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Description: The letter refers to a "Pre-Clinical Cadaver Study" and a "Human Factors" study.
- Sample Size (Cadaver Study): "A female cadaver model was chosen for this study..." (implies n=1 cadaver model or a very small, unspecified number of cadavers).
- Sample Size (Human Factors): "Representative US Surgeons evaluated the Anovo Surgical System..." (number of surgeons/evaluation sessions not specified).
- Data Provenance:
- Cadaver Study: The study used "female cadaver models." No country of origin is specified for the cadavers themselves, but the study was performed as part of a submission by an Israeli company (Momentis Surgical Ltd.).
- Human Factors: "Representative US Surgeons" were used, implying the study was conducted with US clinicians.
- Study Type: Both studies mentioned appear to be prospective evaluations (i.e., new data generated for this submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Cadaver Study: The study "demonstrated that the System can successfully perform all surgical tasks". This implies an evaluation by the study team or expert oversight, but the number and qualifications of experts directly establishing "ground truth" (e.g., successful task completion, surgical outcomes on cadavers) are not specified.
- Human Factors Study: "Representative US Surgeons evaluated the Anovo Surgical System... by performing predefined critical tasks." These surgeons act as the evaluators, but their number and specific qualifications (beyond "US Surgeons") are not detailed. It's not clear if there was an independent "ground truth" established or if the surgeons' performance was the evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not specify any formal adjudication method for either the cadaver study or the human factors study. It describes the conduct and outcomes but not the process of resolving potential disagreements or confirming "ground truth" if multiple evaluators were involved.
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 MRMC comparative effectiveness study was done as described in the context of human readers + AI vs. human readers alone. The device is a surgical system, not an AI-powered diagnostic tool. The document describes a "Human Factors" study where surgeons evaluated the system's interface, implying a usability and safety assessment, not a comparative effectiveness study involving AI assistance for interpretive tasks.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / No standalone algorithmic performance study was done. The Anovo Surgical System is an "endoscopic instrument control system" that assists human surgeons. It's not an AI algorithm performing diagnostic tasks independently. The software testing mentioned is for the control system's functionality and adherence to software development standards, not for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cadaver Study: "The results of the study demonstrated that the System can successfully perform all surgical tasks to complete transvaginal laparoscopic-assisted surgical procedures." This suggests "ground truth" was established by expert observation/evaluation of surgical task completion and clinical compatibility in a cadaver model environment. There is no mention of pathology or long-term outcomes data from cadavers.
- Human Factors Study: The "ground truth" here relates to the usability and safety of the system. This was established through observation and analysis of representative US Surgeons' performance of predefined critical tasks in a simulated OR environment, aiming to identify use-related risks.
8. The sample size for the training set
- Not applicable. The document describes a medical device, not an AI/ML algorithm that requires a separate training set. The "Software Testing" referred to is for the device's control software, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 878.4961 Mountable electromechanical surgical system for transluminal approaches.
(a)
Identification. A mountable electromechanical surgical system for transluminal approaches is a software-controlled, patient bed- and/or operating table-mounted electromechanical surgical system with human/device interfaces that allows a qualified user to perform transluminal endoscopic or laparoscopic surgical procedures using surgical instruments attached to an electromechanical arm.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
(2) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(3) The device manufacturer must conduct and complete post-market surveillance, including an impact of the training program on user learning, behavior, and performance, in accordance with an FDA-agreed-upon protocol. The device manufacturer must submit post-market surveillance reports that contain current data and findings in accordance with the FDA-agreed-upon protocol.
(4) The device manufacturer must submit a report to FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling or device-specific use training program, which did not require submission of a premarket notification during the reporting period.
(5) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness of the device has not been evaluated for outcomes related to the treatment or prevention of cancer, including but not limited to risk reduction, overall survival, disease-free survival and local recurrence, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A detailed summary of the post-market surveillance data collected under paragraph (b)(3) of this section and any necessary modifications to the labeling to accurately reflect outcomes based upon the post-market surveillance data collected under paragraph (b)(3) of this section.
(6) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use.
(7) Human factors validation testing must be performed and must demonstrate that the user interfaces of the system support safe use in an operating room environment.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and precision;
(ii) System testing;
(iii) Instrument reliability;
(iv) Thermal effects on tissue;
(v) Human-device interface;
(vi) Mounting hardware testing;
(vii) Workspace access testing; and
(viii) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed. Software documentation must include an assessment of the impact of threats and vulnerabilities on device functionality and end users/patients as part of cybersecurity review.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.