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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 ●

Device Description

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.

AI/ML Overview

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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