(93 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 and transabdominal 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
- Ventral hernia
The Anovo™ Surgical System is a mountable electromechanical surgical system used in single-site surgical procedures through a transvaginal or transabdominal access point. The system consists of two (2) Anovo™ Instrument ARMS, Anovo™ Surgeon Console, Anovo™ Robotic Control Unit, 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 and views the main user interface at the Anovo™ Surgical System Surgeon Console. The Anovo™ Surgical System Surgeon Console is located outside of the sterile zone.
The system is designed to be used with an Electrosurgical Generator. The Anovo™ Surgical System is operated in conjunction with standard commercially available laparoscopic surgery visualization systems.
The provided text describes the Anovo Surgical System and includes information about its performance evaluation, but it does not explicitly list pre-defined acceptance criteria in a table format with corresponding device performance values for each criterion. Instead, it presents the results of various studies that collectively aim to demonstrate the device's safety and effectiveness for its expanded indications, particularly for ventral hernia repair.
However, based on the information provided, we can infer some criteria and reported performance:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit acceptance criteria are not tabulated in the document, I will infer them from the reported study objectives and outcomes.
| Acceptance Criterion (Inferred from Study Objectives) | Reported Device Performance |
|---|---|
| Clinical Performance (Primary Endpoint): | |
| No instances of conversion to open surgery. | Met: No instances of conversion to open surgery were observed for all 30 subjects. |
| No instances of conversion to laparoscopy approach. | Met: No instances of conversion to laparoscopy approach were observed for all 30 subjects. |
| Clinical Safety (Intraoperative): | |
| No Adverse Events (AEs). | Met: 0% intraoperative AEs (intraoperative). |
| No Adverse Device Events (ADEs). | Met: 0% intraoperative ADEs (intraoperative). |
| No Serious Adverse Events (SAEs). | Met: 0% intraoperative SAEs (intraoperative). |
| Clinical Safety (Postoperative/Perioperative): | |
| No Adverse Device Events (ADEs). | Met: 0% ADEs (postoperative). |
| No Serious Adverse Events (SAEs). | Met: 0% SAEs (postoperative). |
| Complications (not device related) within acceptable limits. | Reported: 3.33% complications (post-procedure) - indicated as "Not device related." One wound seroma reported, also "not device related." |
| Adverse Events (not device related) within acceptable limits. | Reported: 16.66% AEs (post-procedure) - indicated as "Not device related." |
| Clinical Efficacy (Secondary Endpoints): | |
| 100% Procedure completion. | Met: 30 (100%) procedure completion. |
| No unplanned surgical activities. | Met: None reported. |
| No additional ports used. | Met: None reported. |
| Acceptable Average Operative Time. | Reported: 64.1 minutes (range 33-124). (No specific criterion was given for what is "acceptable" but the inference is that this range was acceptable). |
| No bowel injury. | Met: 0 bowel injuries. |
| No surgical site infection. | Met: 0 surgical site infections. |
| Acceptable blood loss. | Reported: 0 blood loss. (No specific criterion was given for what is "acceptable" but 0 is excellent). |
| Acceptable length of hospital stays. | Reported: 1 day (range 1-2). (No specific criterion was given for what is "acceptable" but this is a very short stay, implying acceptance). |
| No mortality. | Met: 0% mortality. |
| Cadaver Study Performance: | |
| Successful access and reach of anatomical structures. | Met: Anovo™ Surgical System can successfully access and reach anatomical structures during execution of transabdominal laparoscopic ventral hernia procedures. |
| Ability to perform all surgical tasks. | Met: Anovo™ Surgical System can perform all surgical tasks to complete transabdominal laparoscopic ventral hernia repair. |
| Met specific requirements related to clinical compatibility, performance, and safety. | Met: Anovo™ Surgical System met all predefined specific requirements related to transabdominal clinical compatibility, performance, and safety. |
| Human Factors/Usability Performance: | |
| Support safe and effective use by representative users. | Met: Demonstrated that the Anovo™ Surgical System supports safe and effective use by representative users during the performance of laparoscopic transabdominal general surgery procedures. |
| All relevant use-related risks found acceptable. | Met: Analysis of results demonstrated all relevant use-related risks were found to be acceptable and there is no residual use-related risk. |
| Bench Testing Performance: | |
| Design output meets design input requirements. | Met: Bench testing demonstrates that the subject device's design output meets the design input requirements (mechanical and functional verification). |
| Software Performance: | |
| Compliance with IEC 62304 and FDA Guidance. | Met: Software development process and testing performed according to IEC 62304 and FDA's Guidance for Industry and FDA Staff "Content of Premarket Submissions for Device Software Functions." |
| Cybersecurity Performance: | |
| Assurance of integrity and security. | Met: Implements robust security controls to safeguard the integrity and security of the system's operation, and tested in compliance with FDA Guidance: Cybersecurity in Medical Devices and section 524B of the FD&C Act. |
| Electrical Safety and EMC: | |
| Compliance with relevant IEC standards. | Met: Testing conducted in accordance with IEC 60601-1, IEC 60601-1-6, IEC 60601-1-2, and IEC 60601-2-2. |
| Biocompatibility: | |
| Compliance with ISO 10993-1. | Met: All patient-contacting components classified and evaluated per ISO 10993-1:2018 and FDA guidance. |
| Sterilization: | |
| Effectiveness, consistency, and reproducibility of sterilization processes. | Met: Sterilization validation study conducted to demonstrate the effectiveness, consistency, and reproducibility of the EtO and Steam sterilization processes for the Instrument ARM and Access Kit respectively. |
2. Sample Size Used for the Test Set and Data Provenance
-
Clinical Study (Test Set):
- Sample Size: 30 subjects (N=30).
- Data Provenance: Multi-center, single-arm, prospective study. Conducted in two sites outside the United States (Belgium and Israel).
-
Cadaver Study (Test Set):
- The document does not specify the sample size (number of cadavers) used for this study.
- Data Provenance: Not specified, but generally cadaver studies are retrospective use of donated human remains.
-
Human Factors Study (Test Set):
- The document mentions "Representative users" but does not specify the number of users in the sample size.
- Data Provenance: Conducted in a "simulated OR environment."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not explicitly state the number of experts used to establish a "ground truth" in the traditional sense (e.g., for diagnostic accuracy).
- For the Clinical Study: The "ground truth" is derived from the actual surgical outcomes, complications, operative times, etc., observed by the surgical teams and follow-up clinicians at the study sites. These would be trained physicians in an operating room environment, as the device is intended for use by "trained physicians."
- For the Cadaver Study: The "ground truth" of successful access, reach, and task completion would have been assessed by experienced surgeons or surgical residents performing the procedures on the cadavers.
- For Human Factors: The "ground truth" for usability and safety was established by "representative users" (presumably surgeons or surgical staff) performing predefined critical tasks and experts evaluating use-related risks.
4. Adjudication Method for the Test Set
- The document does not specify an explicit adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth, as would be common for diagnostic imaging studies where agreement on subtle findings might be required.
- For the Clinical Study, outcomes like conversion rates, adverse events, and procedure completion are generally objective metrics observed and recorded by the treating physicians and study coordinators/monitors, rather than requiring an explicit adjudication process for interpreting findings.
- The complications and adverse events were categorized as "not device related," implying a clinical judgment was made (presumably by the investigators/clinicians at the sites or a clinical events committee), but no formal adjudication committee or process is described.
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 comparative effectiveness study was not done.
- This device is an electromechanical surgical system (robotics system), not an AI-based diagnostic imaging tool that would involve "human readers" interpreting images. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable in this context. The study focused on the performance of the surgical system itself.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- This question is not applicable to the Anovo Surgical System. As a surgical robot, it inherently requires a "human-in-the-loop" (the surgeon operating the console). There is no "algorithm-only" performance for such a device; its function is always to assist the surgeon. The "standalone" performance if considered would be the system's mechanical and software reliability in performing the surgeon's commands, which is assessed through bench testing and software validation.
7. The Type of Ground Truth Used
-
Clinical Study: The ground truth for the clinical study was based on clinical outcomes and observations during and after surgery, including:
- Procedure completion (objective observation).
- Conversion rates (objective observation).
- Occurrence and type of adverse events, adverse device events, and serious adverse events (clinical diagnosis/observation).
- Operative time (objective measurement).
- Blood loss (objective measurement/estimation).
- Hospital stay duration (objective record).
- Mortality (objective record).
- These are forms of outcomes data and expert clinical observation/diagnosis.
-
Cadaver Study: The ground truth was based on direct observation and assessment by surgeons of the device's ability to access, reach, and perform tasks on anatomical structures within the cadaveric model. This is a form of expert observation/assessment in a simulated setting.
-
Human Factors Study: The ground truth for usability and safety was established by observing "representative users" interacting with the system and experts identifying and assessing use-related risks. This is based on expert observation and assessment of user performance and risk analysis.
8. The Sample Size for the Training Set
- The document does not mention a "training set" in the context of device performance validation testing for the Anovo Surgical System for its expanded indications.
- For electro-mechanical systems, the "training" typically refers to the engineering design, simulation, and bench testing phases where parameters are refined and models are iterated, but not in the same sense as an AI model's training data.
- The "training" of the physicians using the system in the human factors study is mentioned, but this is user training, not data training for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- As a "training set" for an algorithm or data-driven model is not mentioned in this submission, this question is not applicable. The validation studies (clinical, cadaver, human factors, bench, software, etc.) are evaluating the final device's performance against its design requirements and safety/effectiveness goals, not training an underlying model.
§ 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.