(57 days)
The Anovo™ Pedestal is a reusable optional accessory to the Anovo™ Surgical System intended to assist in supporting and positioning the Robotic Control Unit (RCU).
The Anovo™ Pedestal, as well as the Anovo™ Surgical System, is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument Arms during indicated procedures. 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 Anovo™ Surgical System is restricted to prescription use only.
The Anovo™ Pedestal is an optional accessory for the Anovo™ Surgical System. The Anovo™ Pedestal is intended to hold the Robotic Control Unit (RCU) of the Anovo™ Surgical System, for use as an alternative to the existing Robotic Control Unit Support System (RCUSS), which was cleared as part of the Anovo™ System. The Pedestal allows the RCU to be mounted on a moveable cart instead of being bed mounted. Anovo™ Pedestal is comprised of the following components:
- Wheels Base includes four wheels enabling smooth movements of the Anovo Pedestal within the OR and hospital.
- Pedestal Main Body includes the motors of the linear, height and tilt notions, the RCU trav and adaptor, used to affix the RCU to the Pedestal, EMO button, handle to allow the user to comfortably move the Anovo™ Pedestal.
- Control panel attached to the Pedestal Handle serves as the Pedestal's User Interface and enables the user to operate all three motorized axes (height, tilt and linear), and includes enable buttons, that must be pressed by the user together with the motion buttons in order to enable motorized movement of the Anovo™ Pedestal
- Accessories include two types of cables: power supply - US power cord, 12 feet long, with locking aid to prevent unintentional disconnection connected to the main grid and provides power to the Anovo™ Pedestal; and Grounding Cable, used to connect between the Anovo™ Pedestal's equipotential pin to main grid protective earth to create potential equilibrium.
The Anovo™ Pedestal is reusable optional accessory for the Anovo™ Surgical System, intended to be covered by Sterile drape during the procedure and cleaned afterwards.
The Anovo™ Pedestal is an AC powered electrical device. Most of the Pedestal's components are connected to one main PCB board, which is powered by a 24V DC supplied from the power supply (connected to the main grid). The main PCB board consists of CPLD (Complex Programmable Logic Device) unit, which controls the vertical and tilt motions of the Pedestal, EMO, enable button and LEDs indications.
The addition of Anovo™ Pedestal does not require any changes to other components of the Anovo™ Surgical System.
This FDA 510(k) summary describes the Momentis Surgical Anovo Pedestal, an accessory for the Anovo Surgical System. It details performance testing and validation studies conducted to demonstrate its safety and effectiveness relative to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Testing | Device meets its design specifications, including compatibility with other Anovo™ System components, structural and durability requirements, performance and general dimensional/mechanical strength considerations. Labeling and training specifications conform to risk analysis. Cleaning and disinfection compliant. | "A series of bench tests were performed to verify that Anovo™ Pedestal meets its design specifications. These bench tests assessed the functionality and performance of the Pedestal with respect to its intended use, as an accessory to the Anovo™ Surgical System... The testing also assessed general dimensional and mechanical strength considerations of the components. In addition, labeling and training specification was performed, that assessed the labeling of the device and conform that all markings, symbols and content of the labeling appear according to their specifications and to the in accordance with the requirements of risk analysis process. The cleaning and disinfection process of Anovo™ was also tested as part of the bench testing and found to be compliant with the relevant requirements." |
| Life-span & Environmental | Compliant with anticipated lifespan of 7 years and environmental conditions for operation, storage, and transportation. | "Life-span and environmental conditions were evaluated through technical report, and Anovo™ Pedestal was found to be compliant with anticipated lifespan of 7 years and environmental conditions for operation, storage and transportation defined in labeling of the device." |
| Pre-Clinical Design Validation (Cadaver Study) | Safety and performance requirements met; stability of RCU and Instrument Arms ensured throughout the clinical procedure; successful evaluation of docking and undocking stages; range of motion provides adequate access to relevant anatomical regions; all surgical tasks and performance features meet pre-defined acceptance criteria (grading ≥3 on Likert scale). | "all surgical tasks and all the performance features met the pre-defined acceptance criteria (grading ≥3) with average grading ranging between 4.95 and 5, thus Anovo™ Pedestal was successfully validated for clinical use." |
| Usability (Human Factors) | All test cases meet acceptance criteria, demonstrating safe and effective use of the Anovo™ System for its indicated procedures. | "The testing results demonstrated that all test cases met their acceptance criteria as defined in the protocol. Therefore, the objectives of the study have been successfully validated and Anovo™ Pedestal was found to be able to support safe and effective use of the Anovo™ System for its indicated procedures, similar to RCUSS, its predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Cadaver Study (Pre-Clinical Design Validation):
- Sample Size: Two (2) human female cadavers.
- Data Provenance: Prospective, conducted at the Pre-clinical Research and Development Unit ("GLPigs Laboratory") of the Assaf Harofeh Medical Center in Zerifin, Israel.
- Usability Study (Human Factors):
- Sample Size: 22 users (6 for formative study, 16 for summative validation study).
- Data Provenance: Prospective, simulated operating room environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Cadaver Study: Two (2) qualified surgeons performed the procedures and evaluated the Pedestal's performance and surgical tasks (grading based on Likert scale). Specific qualifications beyond "qualified surgeons" are not provided in the document.
- Usability Study: The test cases were issued based on the Anovo™ Pedestal's critical tasks of use flow and UFMEA (Use Failure Mode and Effects Analysis). While investigators monitored and collected data, the document does not explicitly state the number or qualifications of "experts" establishing the ground truth beyond the study design protocols (IEC 62366, FDA Guidance, AAMI HE 75).
4. Adjudication Method for the Test Set
- Cadaver Study: Not explicitly stated, but the process involved two surgeons independently performing and then evaluating features, with the acceptance criterion being "grading ≥3" on a Likert scale. It concludes that "all surgical tasks and all the performance features met the pre-defined acceptance criteria." This implies an aggregate or consensus interpretation of their individual evaluations against the predefined criteria.
- Usability Study: "A test case passes if all participants eventually provided the correct response, expected by the investigator." This indicates that the "correct response" was predetermined (presumably by design experts or the investigators) and successful completion by all participants was the adjudication method for passing a test case. For any issues, an analysis was performed based on subjective input and observational data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for this device. The studies described focus on the standalone performance and usability of the Anovo™ Pedestal as an accessory, demonstrating its equivalence to a predicate device rather than comparing human reader performance with and without AI assistance. The device in question is a physical robotic pedestal, not an AI diagnostic algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
Yes, a form of standalone performance was assessed through the Bench Testing, Life-span and Environmental Evaluation, and to some extent, the Cadaver Study. These tests evaluate the physical device's functionality, durability, structural integrity, and ability to support surgical tasks without direct human cognitive input being judged (though human operators are required for its use). The "algorithm" in question is the device's inherent mechanical and electronic functioning controlled by its internal software/CPLD, not a diagnostic AI algorithm.
7. The Type of Ground Truth Used
- Bench Testing: Design specifications, risk analysis requirements, and relevant standards for device functionality, structural integrity, cleaning, and labeling.
- Life-span and Environmental Evaluation: Technical reports and specifications for anticipated lifespan and environmental conditions.
- Cadaver Study: Clinical procedures according to intended use, simulated human anatomy, and predefined acceptance criteria (Likert scale grading ≥3 by qualified surgeons) for performance features. This reflects expert consensus on what constitutes adequate performance in a simulated surgical environment.
- Usability Study (Human Factors): Predefined critical tasks and expected correct responses, derived from use flow and Use Failure Mode and Effects Analysis (UFMEA) with high severity. This is an expert-defined ground truth based on usability engineering principles.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning. This device is a physical medical accessory with internal control logic, not a machine learning model that requires a data training set. The various validations described are for assessing the device's performance, not for training it.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no machine learning training set for this device.
§ 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.