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510(k) Data Aggregation
(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.
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(99 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 is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMS during single site, benign laparoscopic-assisted surgical procedures. The system consists of two (2) Anovo Instrument ARMS, Anovo Surgeon Console, Anovo Robotic Control Unit (RCU), 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. The Anovo Surgical System Surgeon Console is located outside of the sterile zone.
The Anovo Surgical System is a modification of the Anovo Surgical System Model 6Ne ("Predicate Device" K242157), including software update and Surgeon Console hardware modifications to support the use of an Off-the-Shelf FDA-cleared Endoscope Arm, SOLOASSIST II by AKTORmed (K233312) as an optional accessory (without the SOLOASSIST II hand-held joystick and Voice Control features). The Endoscope Arm can be connected to the Surgeon Console and controlled by the Surgeon through the ARMS Controllers. The annotation feature was removed, and the annotation pedal was replaced with the Endoscope control pedal. There are no differences in the system RCU, Instruments, and accessories.
The provided FDA 510(k) clearance letter for the Anovo Surgical System (6Ne) describes various performance evaluations conducted. However, it does not provide specific acceptance criteria or quantitative performance metrics for the device itself or a study demonstrating these criteria were explicitly met in a table format as requested.
The document focuses on demonstrating substantial equivalence to a predicate device (Anovo Surgical System Model 6Ne K242157) through various tests, primarily related to safety, functionality, and technological characteristics, rather than establishing new, specific quantitative performance criteria for the device's surgical capabilities.
Therefore, many sections of your request cannot be fully answered with the information provided in the given text.
Here's a breakdown of what can be extracted and what information is missing:
Acceptance Criteria and Reported Device Performance
The document states that "The Anovo Surgical System 6Ne met all the predefined specific requirements related to clinical compatibility, performance, and safety." However, it does not detail what these specific quantitative requirements or acceptance criteria were for the device beyond general statements of successful performance of surgical tasks.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Compatibility, Performance, and Safety Requirements (specific details not provided) | The System can successfully perform all surgical tasks to complete transvaginal laparoscopic-assisted surgical procedures. All relevant use-related risks were found to be acceptable and there is no residual use-related risk. The device demonstrated compliance with electrical safety, EMC, and human factors standards. |
| Bench Testing Design Output Requirements (specific details not provided) | Subject device's design output meets the design input requirements; testing included dimensional measurements and mechanical and functional verification. |
| Software Development Process and Testing Standards (IEC 62304, FDA Guidance "Content of Premarket Submissions for Device Software Functions") | Software development process and testing, including verification and validation, were performed according to these standards. |
| Cybersecurity Standards (Section 524B of the FD&C Act, FDA Guidance: "Cybersecurity in Medical Devices") | Implements robust security controls; testing demonstrates compliance with these standards. |
| Electrical Safety and EMC Standards (IEC 60601-1, IEC 60601-1-6, IEC 80601-2-77, IEC 60601-1-2, IEC 60601-4-2, IEC 60601-2-2) | Testing conducted in accordance with these standards. |
| Human Factors and Usability Engineering Standards (ISO/IEC 62366-1:2015, FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices") | Human Factors and Usability Engineering Process performed according to these requirements. |
Study Details
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Description: The letter refers to a "Pre-Clinical Cadaver Study" and a "Human Factors" study.
- Sample Size (Cadaver Study): "A female cadaver model was chosen for this study..." (implies n=1 cadaver model or a very small, unspecified number of cadavers).
- Sample Size (Human Factors): "Representative US Surgeons evaluated the Anovo Surgical System..." (number of surgeons/evaluation sessions not specified).
- Data Provenance:
- Cadaver Study: The study used "female cadaver models." No country of origin is specified for the cadavers themselves, but the study was performed as part of a submission by an Israeli company (Momentis Surgical Ltd.).
- Human Factors: "Representative US Surgeons" were used, implying the study was conducted with US clinicians.
- Study Type: Both studies mentioned appear to be prospective evaluations (i.e., new data generated for this submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Cadaver Study: The study "demonstrated that the System can successfully perform all surgical tasks". This implies an evaluation by the study team or expert oversight, but the number and qualifications of experts directly establishing "ground truth" (e.g., successful task completion, surgical outcomes on cadavers) are not specified.
- Human Factors Study: "Representative US Surgeons evaluated the Anovo Surgical System... by performing predefined critical tasks." These surgeons act as the evaluators, but their number and specific qualifications (beyond "US Surgeons") are not detailed. It's not clear if there was an independent "ground truth" established or if the surgeons' performance was the evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not specify any formal adjudication method for either the cadaver study or the human factors study. It describes the conduct and outcomes but not the process of resolving potential disagreements or confirming "ground truth" if multiple evaluators were involved.
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 MRMC comparative effectiveness study was done as described in the context of human readers + AI vs. human readers alone. The device is a surgical system, not an AI-powered diagnostic tool. The document describes a "Human Factors" study where surgeons evaluated the system's interface, implying a usability and safety assessment, not a comparative effectiveness study involving AI assistance for interpretive tasks.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / No standalone algorithmic performance study was done. The Anovo Surgical System is an "endoscopic instrument control system" that assists human surgeons. It's not an AI algorithm performing diagnostic tasks independently. The software testing mentioned is for the control system's functionality and adherence to software development standards, not for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cadaver Study: "The results of the study demonstrated that the System can successfully perform all surgical tasks to complete transvaginal laparoscopic-assisted surgical procedures." This suggests "ground truth" was established by expert observation/evaluation of surgical task completion and clinical compatibility in a cadaver model environment. There is no mention of pathology or long-term outcomes data from cadavers.
- Human Factors Study: The "ground truth" here relates to the usability and safety of the system. This was established through observation and analysis of representative US Surgeons' performance of predefined critical tasks in a simulated OR environment, aiming to identify use-related risks.
8. The sample size for the training set
- Not applicable. The document describes a medical device, not an AI/ML algorithm that requires a separate training set. The "Software Testing" referred to is for the device's control software, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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(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.
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(126 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 are optional instruments for the Anovo™ Surgical System Model 6N. The Anovo™ Surgical System Model 6N with Instrument ARM Grasper end-effector ("Predicate Device") was the subject of a De Novo request (DEN190022) for transvaginal access to gynecological procedures and was granted a marketing authorization in February 2021. Both the Anovo™ Instrument ARM Curved Scissors and Hook Electrode are intended to be used with the Anovo™ Surgical System. The Anovo™ Surgical System comprises the Anovo™ Surgeon Console operated by a nonsterile surgeon, two sterile instruments (Instrument ARMS) actuated by the non-sterile, Anovo™ Robotic Control Unit (RCU). The system allows the physician to operate the Instrument ARMS from the Anovo™ Surgeon Console by manipulating the ARMS Controllers under visual guidance. No changes were made to the Anovo™ Surgical System for the scope of this submission.
The provided text describes a 510(k) premarket notification for new surgical instruments (Anovo™ Instrument ARM Curved Scissors and Anovo™ Instrument ARM Hook Electrode) intended for use with an existing surgical system (Anovo™ Surgical System Model 6N). The submission aims to demonstrate substantial equivalence to a predicate device (Anovo™ Instrument ARM Grasper end-effector).
However, the document does not describe the acceptance criteria and the study that proves a device meets the acceptance criteria in the context of an AI/ML medical device. Instead, it focuses on the substantial equivalence of surgical instruments to a predicate device through bench testing, pre-clinical animal studies, thermal damage testing, and biocompatibility testing.
Therefore, I cannot fulfill the request to describe the acceptance criteria and study for an AI/ML device based on the provided text. The information requested (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance) is relevant to AI/ML device evaluations and is not present in this 510(k) summary for surgical instruments.
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(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).
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(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.
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(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.
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(681 days)
The Hominis Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Hominis Arms during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures listed below. The Hominis 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 Hominis 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 Hominis Surgical System (see Figure 1) is a mountable 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) Hominis Arms, a Hominis Control Console, a Hominis Motor Units Assembly, and Hominis Surgical System Accessories (Hominis Sterile Drape, GYN Trocar Kit, Hominis System Cables, and Bed Fixation Kit). During clinical use, surgeons operate the Hominis Arms from the Hominis Control Console with a compatible and FDA-cleared third-party standard laparoscope (transumbilical) and visual guidance system.
The Hominis Surgical System is a robotic surgical system designed to assist in transvaginal laparoscopic-assisted benign surgical procedures. The acceptance criteria and the study proving the device meets these criteria are detailed through a combination of non-clinical bench testing, animal and cadaver studies, human factors testing, and a pre-market clinical study.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the "NON-CLINICAL PERFORMANCE TESTING - BENCH" section. These tests demonstrate the system's mechanical, electrical, and thermal performance, as well as its interaction with tissue. All reported results for these bench tests were marked as "Pass".
Table: Acceptance Criteria and Reported Device Performance (Bench Tests)
| Test Description | Objective | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Electromechanical arm motion accuracy | Demonstrate that the Hominis Arm is able to reach the entire intended workspace based on pre-defined acceptance criteria. | Elbow and wrist can be fully rotated 360°. Elbow flexion angle is 210° (b)(4). Shoulder flexion angle is 175° (b)(4). Shoulder can be rotated clockwise and counter clockwise no less than (b)(4). Gripper jaw range (b)(4). | Pass |
| Instrument Motion Accuracy | Demonstrate the accuracy of the surgical instruments and quantify the amount of unintended motion when under surgeon control. | Hominis Arm end-effector successfully pulls the ring through the wire without contact between both, at vertical, and horizontal orientation of the wire. | Pass |
| System latency | Determine system latency of each tested degree of freedom to ensure that it is within the pre-defined acceptable range. | Minimal calculated system latency of each tested degree of freedom is no greater than (b)(4). | Pass |
| Droop Rate | Demonstrate under single fault conditions that the end-effector of the Hominis Arm does not droop or apply force under gravity based on the pre-defined acceptance criteria. | Maximal movement of the motor unit and Hominis Arm after power cut-off shall be (b)(4). | Pass |
| System components integrity, loading and mechanical properties | Demonstrate the component's rigidity, yield strength, ability to withstand anticipated loads, tensile forces and torque application (e.g., that the Hominis Arm can withstand application of anticipated forces, that Bed Fixation Kit and sustain the load of the Motor Units Assembly with Arms assembled, etc.) and evaluate the lift and pull force of the Arm. | Arm vertical deflection (b)(4). Lift force: lift load of (b)(4). Pull force: sustain load of (b)(4). Actuation Cable: withstand max load (b)(4). Elbow Spring: withstand torque condition of (b)(4). Wrist Spring: withstand torque condition of (b)(4). Torque Cable: withstand torque condition of (b)(4). Elbow Joint: sustain bending moment of (b)(4). Shoulder Joint: sustain bending moment of (b)(4). | Pass |
| Electrosurgical compatibility | Active electrode (monopolar and bipolar) performance testing. | Supports monopolar/bipolar energy delivery (b)(4) efficiency. | Pass |
| Thermal effects on tissue | Evaluate the thermal effects on tissue caused by the electrosurgical functionalities (monopolar cutting/coagulation and bipolar coagulation) of the Hominis Arms. | Histopathologic criteria: Monopolar Cutting - Extent of necrosis (at site or adjacent) is minimal or absent. - Extent of edema is minimal or absent. - Regular margins present at site. Monopolar Coagulation - Extent of Necrosis (at site or adjacent) is moderate or less. - Extent of edema is moderate or less. - Regular Margins. Bipolar Coagulation - Extent of Necrosis (at site or adjacent) is moderate or less. - Extent of edema is moderate or less. - Regular Margins. | Pass |
| Arm simulated use testing | Demonstrate that the Hominis Arms maintain functionality for a full, worst-case surgical procedure. | Life Expectancy and Usage: Maintained full functionality and no visual damage after performing full simulated-use cycle of a hysterectomy procedure. Insulation Sleeve Strength: Insulation sleeve is intact with no holes, tear, or other forms of damage. Insulation Sleeve Position: insulation sleeve is securely at the distal end after simulated-use cycle. Bipolar Wire: - Bipolar wire is secured and maintains integrity after use of arms and full range of joint flexion. - Bipolar wire is secured and maintains integrity at full range of motion of the gripper jaws. - Bipolar wire is secured and maintains integrity after being articulated via wire protective sleeve. Gripper Screw: screw withstood maximal applied forces during usage. | Pass |
| System interfaces | Demonstrate that the system's components, when used together, are compatible and operate as expected. | Gear Interface: no noises here when Hominis Arms moved at all (b)(4). Handle Interface: Arm successfully. | Pass |
| Electrical properties | Verify system grounding, insulation, ingress protection, power controls. | Jaw Insulation: - No DC current electrical conductivity on Gripper Jaws backsides. - No AC Current electrical conductivity on test specimen. Impedance of Arm (b)(4). | Pass |
| GYN Trocar Kit bench testing | Demonstrate functional performance of the GYN Kit with respect to the vaginal access procedure, including assembly of the GYN Trocar Kit, compatibility with other components of the Hominis System, structural support for the Hominis Arms during transvaginal access, as well as the ability to maintain pneumoperitoneum. | Arm-Gyn Interface: - no damage occurred to the silicone sleeve or GYN protective sheath during insertion and extraction. - insertion and extraction force no more than (b)(4). - torque during rotation of shoulder tube through GYN protective sheath no more than (b)(4). - Insulation sleeve remained fixed and undamaged during insertion. | Pass |
| Bed Fixation Kit bench testing | Assess the physical and mechanical properties of the Bed Fixation Kit functional abilities with respect to mounting and securing the Motor Units onto the surgical bed and compatibility with interfacing components such as the Hominis Arms and sterile drape. | Load Bearing: Able to hold weight of fully extended arm with 8kg weight. Table Mounting: Bed Fixation Kit adapter able to hold (b)(4) weight without damage. | Pass |
Clinical Study Acceptance Criteria (Effectiveness & Safety):
The clinical assessment of safety and effectiveness was established if the clinical endpoints met or were more favorable than study endpoints obtained from existing clinical studies in a literature review.
Effectiveness Results:
- Conversion rate (i.e. conversion to laparotomy, laparoscopy, other): None (Acceptance: Met or more favorable than literature review)
- Procedure completion: 100% (Acceptance: Met or more favorable than literature review)
- Ports used in addition to vaginal and umbilical port): None (Acceptance: Met or more favorable than literature review)
- Average Operative Time (range) [minutes]: 57.07 (24-88) (Acceptance: More favorable than traditional vaginal hysterectomy; comparable/favorable to robotically-assisted abdominal hysterectomy per literature review)
- Average length of hospital stay (range) [days]: 3.2 (2-8) (Acceptance: More favorable than traditional vaginal hysterectomy; comparable/favorable to robotically-assisted abdominal hysterectomy per literature review)
- Re-admission rate [%]: 0 (Acceptance: More favorable/comparable to literature review)
- Re-operation rate [%]: 0 (Acceptance: More favorable/comparable to literature review)
Safety Results:
- Intra-operative Adverse Events (AEs) and Serious Adverse Events (SAEs) [%]: 0 (Acceptance: More favorable than traditional vaginal hysterectomy and robotically-assisted abdominal hysterectomy per literature review)
- Bladder injury [# of patients]: 0 (Acceptance: More favorable/comparable to literature review)
- Rectal injury [# of patients]: 0 (Acceptance: More favorable/comparable to literature review)
- Transfusion rate: 0 (Acceptance: More favorable/comparable to literature review)
- Mortality [%]: 0 (Acceptance: More favorable/comparable to literature review)
- Cuff dehiscence rate: 0 (Acceptance: More favorable/comparable to literature review)
- Vaginal cuff healing: 23% (7 of 30 subjects) had relatively delayed healing (9-14.5 weeks). All healed. (Acceptance: Within normal range for recovery, deemed acceptable)
2. Sample Size Used for the Test Set and the Data Provenance
The primary test set for demonstrating clinical safety and effectiveness was the pre-market clinical study.
- Sample Size (Clinical Study): 30 subjects
- Data Provenance: Multi-center, prospective study. The specific countries are not explicitly stated for the primary clinical study, but the "Investigators Background" mentions surgeons from Rambam hospital (Haifa, Israel) and Imelda hospital (Bonheiden, Belgium). So, the data is from Israel and Belgium, collected prospectively.
Additional test sets were used for non-clinical and human factors testing:
- Animal Study: 5 ewe models. (GLP Ewe Study)
- Cadaver Study: 5 female cadavers.
- Human Factors Study: 71 users in total (50 surgeons, 21 OR staff). This included 24 US surgeons and 16 US OR staff. The study was conducted in a simulated OR setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
For the Clinical Study:
- The clinical study involved investigators, specifically surgeons, performing the procedures and assessing outcomes. The "Investigators Background" section notes that all surgeons (total of (b)(4) from Rambam hospital and (b)(4) from Imelda hospital) underwent a device-specific training program.
- Qualifications of Experts: The surgeons' experience in robotic surgery ranged from 0 to 10 years, with three surgeons having no independent robotic experience. Experience in vaginal hysterectomies ranged from no experience to 80 procedures; (b)(4) were novice users (no prior vaginal hysterectomies) and (b)(4) performed (b)(4) or less. Experience in laparoscopic hysterectomies ranged from no experience to (b)(4) procedures; (b)(4) were novice users (no prior laparoscopic hysterectomies) and (b)(4) performed (b)(4) or less.
- The study endpoints (e.g., complications, operative time, conversion rate) were clinically assessed by these participating surgeons and likely other medical staff as part of their standard clinical practice and protocol adherence.
For the Human Factors Study:
- The study involved 71 users (50 surgeons, 21 OR staff).
- Qualifications of Experts: Surgeon participants had 0-40 years of clinical experience and 0-10 years of robotic surgical experience. US OR staff had 1-23 years of clinical experience and 0-10 years of robotic experience. These individuals acted as their own "ground truth" for usability by attempting the critical tasks.
4. Adjudication Method for the Test Set
For the Clinical Study:
- The document does not explicitly detail an independent adjudication method for clinical outcomes. The reported results appear to be direct observations and measurements from the participating sites and investigators.
- "All procedures were successfully completed, including safely and successfully performing transvaginal access with the GYN Trocar Kit. No device-related complications or adverse events occurred..."
For the Human Factors Study:
- For each critical task, "the expected and incorrect responses were pre-defined based on sub-tasks and risks associated with that critical task."
- "Task success criteria looked at expected and incorrect responses, and completion of the task safely and effectively..."
- "Each critical task was evaluated for successful completion and a test case for the critical tasks passes if all participants eventually provided the correct response."
- Ratings of "difficult" and "close call" were "analyzed for possible root-cause but were considered to be a pass." Any potential use problem observed was assessed for root cause and possible outcomes.
- This suggests an implicit adjudication based on the pre-defined success/failure criteria, rather than an explicit multi-reader adjudication panel.
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 MRMC or AI assistance study was conducted. The Hominis Surgical System is an electromechanical surgical system, not an AI-assisted diagnostic or assistive tool in the traditional sense that "improves" human readers. It is a tool for performing surgery.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The Hominis Surgical System is a human-controlled electromechanical surgical system. Its function is to assist a human surgeon in performing procedures; it is not designed to operate autonomously. The bench tests and animal/cadaver studies evaluate the system's performance, but always in the context of being operated by a user.
7. The Type of Ground Truth Used
- Bench Tests: Engineering specifications, physical measurements, and established quality control standards for mechanical, electrical, and thermal properties. Simulated use scenarios.
- Animal and Cadaver Studies: Direct observation of surgical task performance, procedure completion, hemostasis, thermal spread, and system safety by trained surgeons. Histopathological evaluation for tissue effects.
- Human Factors Study: Pre-defined "expected and incorrect responses" for critical tasks, observed performance by representative users, and expert assessment of safety and effectiveness based on task completion and identification of use errors.
- Clinical Study: Clinical outcomes (e.g., presence/absence of complications, operative time, blood loss, length of stay, conversion rates) as observed and recorded by the surgical teams and follow-up medical staff. The comparison was made against literature review data from conventional procedures, effectively using an aggregated historical control as a ground truth for comparative effectiveness.
8. The Sample Size for the Training Set
- The document does not describe a "training set" in the context of machine learning model development. This device is a robotic system, not an AI algorithm that learns from data in that manner.
- However, for the device use training program, all users (surgeons and OR Staff) in the clinical study and human factors study underwent this training. The human factors study involved 71 users (50 surgeons, 21 OR staff) who received a "condensed training program." This training program itself is subject to iterative improvement based on collected data.
9. How the Ground Truth for the Training Set Was Established
- Since there isn't a "training set" for an AI model, this question is interpreted in the context of the device use training program.
- The "ground truth" for the effectiveness of the training program is established through human factors validation testing. This testing identified "critical tasks" (tasks that, if performed incorrectly, could cause serious harm). The training program was designed to ensure users could safely and effectively perform these critical tasks.
- Establishment method: The critical tasks themselves were identified during the risk analysis process (UFMEA - Use Failure Mode Effects Analysis). The training was developed to mitigate these use-related risks. User competency after training was assessed by evaluating performance on these critical tasks during the human factors study. "All users met pre-specified success criteria before moving towards clinical cases." The human factors study verified that "all of the identified critical tasks were completed across the different user types within the surgical team, and that all test cases met their acceptance criteria...by all users." This demonstrated the effectiveness of the training in enabling safe usage. The training effectiveness will also be continuously monitored via post-market surveillance.
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