(28 days)
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 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 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
The Anovo Instrument ARM Curved Scissors and Anovo Instrument ARM Hook Electrode ("Subject Device") are optional instruments for the Anovo Surgical System.
The purpose of this submission is to update the product labeling of the Anovo Instrument ARM Curved Scissors and Anovo Instrument ARM Hook Electrode to include compatibility with the Anovo Surgical System Model 6Ne.
The Anovo Surgical System Model 6N and Model 6Ne are almost identical, with the main difference being in the user interface. Both models are endoscopic instrument control systems that are intended to assist in the accurate control of the Instrument ARMS during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures.
Both system's models comprise a Surgeon Console operated by a non-sterile surgeon, two sterile instruments (Instrument ARMS) actuated by the non-sterile, Robotic Control Unit (RCU). Both systems allow the physician to operate the Instrument ARMS from the Anovo Surgeon Console by manipulating the ARMS Controllers under visual guidance.
The provided FDA 510(k) clearance letter (K251056) for the Anovo Instrument ARM Curved Scissors and Anovo Instrument ARM Hook Electrode indicates that this submission is primarily for a labeling update to include compatibility with a new system model (Anovo Surgical System Model 6Ne), rather than a submission for a novel AI/software device requiring extensive performance studies typically associated with AI/ML-based medical devices.
Therefore, the information regarding acceptance criteria and performance study details (e.g., sample sizes, expert ground truth, MRMC studies) as requested in the prompt, are not explicitly present within this 510(k) summary letter. The letter focuses on demonstrating substantial equivalence based on the device being identical to the predicate in design and function, and that the compatibility with the new system model was validated.
However, I can extract the relevant information implied by the document and address the requested points to the best of my ability based on the provided text, while highlighting what is not present for this specific type of submission.
Device Background and Purpose of Submission (K251056):
The Anovo Instrument ARM Curved Scissors and Anovo Instrument ARM Hook Electrode are surgical instruments intended for tissue manipulation (cutting, dissecting, coagulating) using monopolar energy. They are used with the Anovo Surgical System, which is an endoscopic instrument control system for transvaginal benign surgical procedures.
The primary purpose of this specific 510(k) (K251056) is not to introduce a new device or a new AI/software component, but to update the product labeling of already cleared instruments (Anovo Instrument ARM Curved Scissors and Anovo Instrument ARM Hook Electrode, previously cleared under K243182) to include compatibility with a newer version of the Anovo Surgical System, Model 6Ne. The submitter states: "No changes were made to the Instrument ARM Curved Scissors and Anovo Instrument ARM Hook Electrode or any of the Anovo Surgical System Components for the scope of this submission."
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the validation of compatibility and continued safety/performance with the new system model, rather than the initial performance validation of an AI algorithm or a novel surgical instrument's core functionalities.
Acceptance Criteria and Study for K251056 (Compatibility Validation):
Given the nature of this 510(k) (labeling update for system compatibility), the "acceptance criteria" revolve around demonstrating that the instruments perform as intended when used with the new system model (6Ne) and remain as safe and effective as with the predicate system. The study conducted appears to be a design validation focused on this compatibility.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied for Compatibility) | Reported Device Performance (From Text) |
|---|---|
| Clinical Compatibility: Instruments perform as intended and integrate seamlessly with the Anovo Surgical System Model 6Ne during surgical procedures. | "met all the predefined specific requirements related to transvaginal clinical compatibility" |
| Performance: Instruments maintain their functional performance (cutting, dissecting, coagulating) when operated via the Model 6Ne system. | "met all the predefined specific requirements related to...performance" |
| Safety: Use of instruments with Model 6Ne does not introduce new safety concerns or adverse effects. | "met all the predefined specific requirements related to...safety" |
| Substantial Equivalence: The instruments, when used with Model 6Ne, are substantially equivalent to their use with the predicate system and to predicate devices. | "it can be concluded that the subject Anovo Instrument ARM Curved Scissors and Anovo Instrument ARM Hook Electrode, when used with the Anovo Surgical System Model 6Ne, are substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: "female cadaver models" (plural, indicating more than one, but no specific number is provided).
- Data Provenance: The study was conducted on "female cadaver models." No country of origin is specified for the cadavers themselves, but the submitter is based in Israel. The description indicates a prospective evaluation of compatibility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable / Not Specified: This validation study is for compatibility of surgical instruments with an control system, not for an AI/ML diagnostic or image analysis device where "ground truth" typically involves expert annotations or diagnoses. The "ground truth" here is the direct observation of the instruments' functional performance and compatibility during the simulated surgical procedures in cadavers. While trained physicians are mentioned as users of the system for clinical use, their role in establishing ground truth for this specific validation study is not detailed, beyond their likely involvement in conducting and assessing the simulated procedures.
4. Adjudication Method for the Test Set:
- Not Applicable / Not Specified: Given the nature of a cadaveric performance and compatibility study for surgical instruments, formal adjudication methods (like 2+1 or 3+1 used for reader studies in AI) are not typically employed or detailed in the publicly available summary for this type of submission. The successful meeting of "predefined specific requirements" implies an agreed-upon assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, not for this submission. This is not an AI/ML diagnostic device requiring an MRMC study to assess human reader improvement with AI assistance. It's a re-clearance for hardware compatibility.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- No, not applicable. This is not an algorithm, but rather surgical instruments used with a control system, inherently requiring a human "in the loop" (the surgeon).
7. The Type of Ground Truth Used:
- Direct Observation and Performance Assessment: The ground truth for this compatibility study was based on the direct observation of the instruments' performance (cutting, dissecting, coagulating, and proper function within the system) in cadaveric models. This confirms whether the system and instruments work as intended and meet safety and performance specifications.
8. The Sample Size for the Training Set:
- Not Applicable: This is a hardware compatibility validation, not an AI/ML submission. Therefore, there is no "training set" in the context of machine learning. The instruments and system were likely developed and refined through extensive R&D and previous testing, but that's not a "training set" in the AI sense.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable: As there is no training set for an AI/ML model, this question does not apply.
§ 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.