(29 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 laparoscopic-assisted transvaginal and transabdominal benign 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 Instrument ARM Curved Scissors is indicated for use for tissue manipulation including cutting, dissecting, and coagulating and cutting using monopolar energy.
The Anovo Instrument ARM Hook Electrode is indicated for use for tissue manipulation including dissecting, and coagulating and cutting using monopolar energy.
The Anovo Instrument ARM Curved Scissors and the Anovo Instrument ARM Hook Electrode are intended for use with the Anovo Surgical System.
The Anovo Surgical System model 6Ne (6N enhanced) was the subject of the Premarket Notification K242157, which was cleared on October 21, 2024, for use based on the Anovo 6N (predicate) Indication for Use cleared at the time the Anovo 6Ne was submitted. A subsequent 510(k) clearance (K250591) addressed the addition of the Endoscope Arm as an off-the-shelf accessory.
The Anovo Surgical System Model 6N was the subject of the Premarket Notification K241907 for expanding the Indication for use to include transabdominal access and Ventral Hernia procedure, which was cleared on October 2, 2024.
The Instrument ARM Hook and Scissors were evaluated and found safe and effective for use with the Anovo model 6N (K243182) and with model 6Ne (K251056).
Under the scope of this submission, the Anovo Surgical System Model 6Ne, including Instrument ARM Curved Scissor and Hook Electrode, are the subject of labeling unification to include Ventral Hernia through transabdominal access.
The Anovo Surgical System model 6Ne (6N enhanced) 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 laparoscopic-assisted benign surgical procedures.
The Anovo Surgical System Model 6Ne ("Subject Device") is an enhanced configuration of the Anovo Surgical System 6N ("Predicate Device"). The Anovo Surgical System Model 6Ne enhances the experience by incorporating Off-the-Shelf controllers to the Surgeon Console, including minor modifications in the Robotic Control Unit to support those controllers and allowing the use of an Off-the-Shelf Endoscope Arm as an optional accessory. Those modifications were performed mainly for commercialization and user experience and do not impact the key functionalities of the device. The system enhancements do not impact the system Instruments or accessories.
No changes were made to the Anovo Surgical System or its accessories for the scope of this submission. Additionally, there are no differences in the procedure for use of the system; the surgeon and surgical teams perform system set-up in the same manner as performed with the cleared Anovo 6Ne, where the only difference is transabdominal versus transvaginal access and the entry of the Instrument ARMs through these access ports, which is performed in the same manner as performed with the cleared Anovo 6N.
The provided FDA 510(k) clearance letter for the Anovo Surgical System describes a robotically-assisted surgical device, not an AI-powered diagnostic or treatment device. Therefore, the questions related to AI device performance metrics, such as ground truth establishment by experts, adjudication methods, MRMC studies, and standalone performance, are not applicable to this submission.
The clearance focuses on demonstrating substantial equivalence to a predicate device (Anovo Surgical System model 6N) for an expanded indication for use (Ventral Hernia through transabdominal access) and the unification of labeling for existing instruments. The performance evaluation primarily involves non-clinical (cadaver) testing to confirm the system's compatibility, performance, and safety for the new indicated procedure.
Here's the breakdown of the information that can be extracted from the provided text, addressing the relevant aspects of the acceptance criteria and study, while noting the inapplicable questions:
Acceptance Criteria and Device Performance for Anovo Surgical System
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't list specific quantitative acceptance criteria and corresponding reported device performance metrics in a typical tabular format as one would expect for an AI/diagnostic device. Instead, it describes a
qualitative acceptance criteria centered on the system's successful demonstration of compatibility, performance, and safety during Design Validation for the new indication.
| Acceptance Criteria (Qualitative) | Reported Device Performance |
|---|---|
| Transabdominal clinical compatibility for Ventral Hernia Repair procedures | Met all predefined specific requirements related to transabdominal clinical compatibility. |
| Performance for Ventral Hernia Repair procedures | Met all predefined specific requirements related to performance. |
| Safety for Ventral Hernia Repair procedures | Met all predefined specific requirements related to safety; "do not present new risks." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: Design validation was performed in female cadaver models.
- Sample Size: The exact number of cadaver models used is not specified in the provided text.
- Data Provenance: The text does not specify the country of origin of the cadaver models. The study was prospective in the sense of being a planned test to validate the changes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable: This criterion relates to AI/diagnostic devices where expert consensus is used to label data. For a surgical system, "ground truth" is about the functional performance and safety observed during a surgical procedure simulation. The document mentions "trained physicians" are intended users, implying their involvement in the cadaver study, but does not specify their number or role in establishing a "ground truth" as it would be defined for an AI evaluation.
4. Adjudication Method for the Test Set
- Not Applicable: This criterion is for AI/diagnostic devices where multiple experts provide annotations, and a method (e.g., 2+1, 3+1) is used to resolve disagreements. For a surgical system validation, "adjudication" typically refers to the process of evaluating the successful completion of surgical tasks and safe operation, which would be part of the design validation protocol, but not in the sense of expert annotation adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable: An MRMC study is designed to assess how human reader performance (e.g., diagnostic accuracy) changes with or without AI assistance. This device is a surgical system, not a diagnostic AI. The study's purpose was to demonstrate the safe and effective performance of the surgical system itself.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance
- Not Applicable: This criterion refers to the performance of an AI algorithm in isolation. The Anovo Surgical System is an instrument control system that assists human surgeons. Its function is inherently human-in-the-loop, so a "standalone" performance (without human interaction) is not relevant or possible for this type of device.
7. Type of Ground Truth Used
- Functional Performance and Safety Assessment: The "ground truth" in this context is the successful and safe execution of representative surgical procedures (Ventral Hernia Repair) in cadaver models. This is assessed against predefined specific requirements for "transabdominal clinical compatibility, performance, and safety." It's not based on expert consensus on image labels, pathology, or patient outcomes data in the traditional sense of a diagnostic study.
8. Sample Size for the Training Set
- Not Applicable: This device is a mechanical/robotic surgical system, not an AI model that requires a training set of data. The "training" for such a system would involve engineering design, prototyping, and iterative testing, not the machine learning concept of a training dataset.
9. How Ground Truth for the Training Set Was Established
- Not Applicable: As there is no "training set" in the machine learning sense, this question is not applicable. The design and development of the surgical system are based on engineering principles and regulatory requirements for medical devices.
§ 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.