(90 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 Model 6Ne is an electromechanical surgical system for transluminal approaches used in single-site benign hysterectomy and salpingo-oophorectomy surgical procedures through a transvaginal access point. The system consists of two (2) Instrument ARMS, a Surgeon Console, a Robotic Control Unit Assembly, and System Accessories (Sterile Drape, Vaginal Access Kit, Cables, and Pedestal). During clinical use, surgeons operate the Instrument ARMS from the Surgeon Console with a compatible and FDA-cleared third-party standard laparoscope (transumbilical) and visual guidance system.
Anovo™ Surgical System 6Ne, including Anovo™ Surgeon Console 6Ne and Anovo™ Robotic Control Unit 6Ne, is an additional enhanced configuration of the Anovo™ 6N, with Anovo™ Surgeon Console 6N and Anovo™ Robotic Control Unit 6N ("Predicate Device") that was the subject of a De Novo request (DEN190022). There are no differences in the system instruments and accessories compared to the Anovo™ 6N, and the Surgeon Console and Robotic Control Unit Model 6Ne will be offered with the same Instrument and accessories.
This document (K242157) is a 510(k) Premarket Notification from the FDA for the Momentis Surgical Ltd. Anovo Surgical System (Model 6Ne). It outlines the device, its intended use, a comparison to a predicate device, and the testing performed to demonstrate substantial equivalence.
However, the provided text does not include specific quantitative acceptance criteria or reported device performance metrics in the format of "A table of acceptance criteria and the reported device performance." It mentions various types of testing conducted but doesn't provide the numerical results against predefined thresholds for any specific performance aspect.
Furthermore, it does not describe a study involving an AI/algorithm that requires detailed information about:
- Sample size for test set and data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study or its effect size.
- Stand-alone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document discusses tests for a surgical system (a robotic device), not an AI algorithm for diagnostic or prognostic purposes. The performance evaluation section details:
- Bench Testing: Demonstrates design output meets design input requirements (dimensional measurements, mechanical, functional verification).
- Software Testing: Covered by IEC 62304 and FDA guidance for device software functions.
- Cybersecurity: Compliance with FD&C Act and FDA guidance.
- Electrical Safety and Electromagnetic Compatibility (EMC): In accordance with various IEC standards (IEC 60601-1, IEC 60601-1-6, IEC 80601-2-77, etc.).
- Human Factors: Performed according to ISO/IEC 62366-1:2015 and FDA guidance. Representative US Surgeons evaluated the system in a simulated OR environment. The study "demonstrated that the Anovo™ Surgical System 6Ne supports safe and effective use by representative users" and that "all relevant use-related risks were found to be acceptable."
- Pre-Clinical Cadaver Study: Performed on five (5) female cadavers by two (2) trained Surgeons to evaluate the system's ability to access and reach anatomical regions and structures during surgical procedures. The conclusion was that the system "can successfully perform all surgical tasks to complete transvaginal laparoscopic-assisted surgical procedures" and "met all the predefined specific requirements related to clinical compatibility, performance, and safety."
In summary, the provided document describes the regulatory approval of a physical robotic surgical system and its associated software/controls, not an AI algorithm intended for diagnostic image analysis or similar tasks that would require the specific details requested in your prompt regarding AI model performance, ground truth establishment, expert reading, and MRMC studies.
Therefore, I cannot extract the information requested about AI performance, training sets, ground truth methodology, or MRMC studies because it is not present in this document, which pertains to a different type of medical device (a surgical robot).
§ 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.