The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization and retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use.

Device Description

The Senhance® Surgical System (Senhance system) is a multi-arm, console-based robotic system that allows a surgical team to perform laparoscopic surgery in the abdomen and pelvis in a manner similar to a manual laparoscopic approach. The capital equipment of the Senhance system is comprised of the following three main subsystems which are powered separately and connected by means of communications cables:

Cockpit The station where the surgeon inputs information through hand and eye movements to direct the arms to move within the surgical field.
Manipulator Arm(s) - Up to three mechanized instrument support arms that produce output movements based on the instruction from the cockpit or bedside assistant. Each robotic arm can hold either a laparoscopic surgical instrument or an endoscope to facilitate a surgeon remotely operating the instrument from the cockpit.
Intelligent Surqical Unit (ISU) The ISU component, which is the communication hub that connects the cockpit inputs to the manipulator arms. The ISU contains a high-performance computer that enables the surgeon to control the endoscope using software features that apply image processing algorithms to the endoscope video signal.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Senhance Surgical System. While it details the device, its intended use, and various tests performed, it does not contain the specific information required to complete the table of acceptance criteria and the detailed study information as requested.

The document states that "Software testing and a comprehensive set of performance testing were conducted to demonstrate that the modified device is as safe and effective, and thus substantially equivalent, to the predicate," and that "Functional performance tests utilizing well-established test methodology verified that the ISU features and Senhance system performed as intended." However, it does not provide the acceptance criteria themselves, nor the quantitative results of these tests. It also lacks details on the sample sizes, expert involvement, ground truth establishment, or specific study designs (like MRMC) for proving the device meets performance criteria related to AI/image processing features.

Therefore, I cannot fill out the requested table and answer many of the questions based on the provided text. The text broadly states that tests were done and requirements were met, but it does not give the specifics of those tests or their quantitative outcomes.

Here's what I can extract and what's missing:

Acceptance Criteria and Device Performance Table:

Acceptance Criteria (e.g., Accuracy, Sensitivity, Specificity, etc. for specific tasks/features)	Reported Device Performance
NOT PROVIDED IN THE TEXT. The document states "Functional performance tests utilizing well-established test methodology verified that the ISU features and Senhance system performed as intended." However, it does not specify what those performance metrics, their thresholds (acceptance criteria), or the measured device performance were.	NOT PROVIDED IN THE TEXT.

Study Details (Based on available information and what is missing):

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: NOT PROVIDED. The document mentions "Pre-Clinical Design Validation" was conducted in a "simulated patient model," but does not specify the sample size of "cases" or "simulated procedures."
- Data Provenance (country of origin, retrospective/prospective): NOT PROVIDED. The study was a "single-center, un-blinded, observational, simulated use design validation evaluation." It doesn't specify if this involved retrospective data or prospective data collection from actual surgical procedures. The "simulated patient model" suggests synthetic or cadaveric data rather than clinical patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: NOT PROVIDED. The evaluation was conducted "with users who represented the intended primary user population," implying surgeons, but the number and specific qualifications (e.g., years of experience, subspecialty) are not mentioned.
- Qualifications of Experts: Users "represented the intended primary user population," which for the Senhance system are "trained physicians." Specific qualifications or years of experience are NOT PROVIDED.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: NOT PROVIDED. The study is described as "observational," but no details on how discrepancies (if any) in assessments were resolved are given.
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:
- MRMC Study: NOT PROVIDED/Unclear. The study describes a "single-center, un-blinded, observational, simulated use design validation evaluation." This does not suggest an MRMC comparative effectiveness study comparing human readers with and without AI assistance for specific diagnostic or performance metrics. The new features ("Follow Me," "Measurements," "Digital Tags," "Image Enhancement") are described as aids to the surgeon, but a comparative study on improved human performance is not detailed.
- Effect Size: NOT PROVIDED. Since an MRMC study is not explicitly described, the effect size is also not given.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: NOT PROVIDED. The document mentions "Functional performance tests utilizing well-established test methodology verified that the ISU features and Senhance system performed as intended." This might imply an evaluation of the algorithms' direct output (e.g., accuracy of 3D distance measurements), but it's not explicitly labeled as "standalone" and no quantitative results are provided. The "Image Characterization Verification" is a procedure for the system, which might have its own internal performance metrics.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: NOT EXPLICITLY STATED for all features. For some features, like "Measurements," the ground truth would likely be precise physical measurements in the simulated environment. For others, like the efficacy of "Image Enhancement," it might be subjective user satisfaction or objective image quality metrics, but this is not detailed. The "Pre-Clinical Design Validation" assessed "all applicable user level requirements" in a "simulated patient model," implying that the "ground truth" was whatever the expected, correct performance was in that simulated environment.
The sample size for the training set:
- Training Set Sample Size: NOT PROVIDED. The document describes software verification and validation, but provides no information on the training data for any machine learning components within the "new image processing features."
How the ground truth for the training set was established:
- Training Set Ground Truth Establishment: NOT PROVIDED. As no training set details are given, how its ground truth was established is also not mentioned.

Summary of what the document does state:

The device is a robotically-assisted surgical system (Senhance Surgical System) used for laparoscopic procedures.
The 510(k) is for a modified device with new software features related to image processing and endoscope movement (Follow Me, Measurements, Digital Tags, Image Enhancement, Image Characterization).
The software is considered a "major" level of concern.
Performance testing, electrical safety/compatibility, and software verification/validation were conducted.
A "Pre-Clinical Design Validation" was done at a single center, un-blinded, observational, in a simulated use environment with intended users.
The conclusion is that the modified device is "as safe and effective" as the predicate and "does not raise any different questions of safety and effectiveness," supporting substantial equivalence.

Without access to the actual test reports or the full 510(k) submission, the detailed quantitative information for acceptance criteria and study results cannot be provided from this letter.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Asensus Surgical, Inc. Ravi Kommineni Head of Global Quality and Regulatory 1 TW Alexander Drive, Suite 160 Durham. North Carolina 27703

Re: K212054

Trade/Device Name: Senhance Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY Dated: June 30, 2021 Received: June 30, 2021

Dear Ravi Kommineni:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part

{1}------------------------------------------------

801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark Trumbore, Ph.D. Acting Assistant Director THT4A1: Robotically-Assisted Surgical Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K212054

Device Name Senhance® Surgical System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K212054

510(k) Summary

[In accordance with 21 CFR 807.92]

1. Submitter

510(k) Sponsor:	Asensus Surgical, Inc.
Address:	1 TW Alexander Drive, Suite 160Durham, NC 27703 USA
Contact Person:	Ravi KommineniGlobal Head of Quality and Regulatory
Contact Information:	Email: rkommineni@asensus.comPhone: +1 763.227.5896Facsimile: +1 919.765.8459
Date Summary Prepared:	08/19/2021
2. Device:
Proprietary (Trade) Name:	Senhance® Surgical System
Common Name:	System, Surgical, Computer Controlled Instrument
Classification:	Class II
Classification AdvisoryCommittee:	General and Plastic Surgery
Regulation Number:	21 CFR 876.1500, Endoscope and Accessories
Product Codes:	NAY (System, Surgical, Computer Controlled Instrument)
3. Predicate and Reference Devices
Predicate Device:	Senhance® Surgical System (K202166)

{4}------------------------------------------------

4. Device Description:

Cockpit The station where the surgeon inputs information through hand and eye ● movements to direct the arms to move within the surgical field.
Manipulator Arm(s) - Up to three mechanized instrument support arms that produce output movements based on the instruction from the cockpit or bedside assistant. Each robotic arm can hold either a laparoscopic surgical instrument or an endoscope to facilitate a surgeon remotely operating the instrument from the cockpit.
Intelligent Surqical Unit (ISU) The ISU component, which is the communication hub ● that connects the cockpit inputs to the manipulator arms. The ISU contains a high-performance computer that enables the surgeon to control the endoscope using software features that apply image processing algorithms to the endoscope video signal.

5. Intended Use/ Indications for Use:

The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction. The Senhance Surqical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.

6. Summary of Technological Characteristics:

The modified device has either identical or very similar technological characteristics to the predicate. Any differences in technological characteristics do not raise different questions of safety and effectiveness. Software testing and a comprehensive set of performance testing were conducted to demonstrate that the modified device is as safe and effective, and thus substantially equivalent, to the predicate.

6.1. Capital Equipment

Like the predicate, the modified device consists of the same three main system components: cockpit, manipulator arms, and ISU. No design changes have been made to the Senhance capital equipment hardware or its accessories (i.e., surgical instruments and adapters). The surgeon controls of the modified device and predicate are the same. Compliance with EMC and safety standards was previously established for the predicate and test results are applicable to the modified device. Thus, there are no technological differences between the modified device and the predicate hardware.

{5}------------------------------------------------

6.2. Software

Software changes were made in the modified device resulting in a new version of software. The software for the modified device introduces new image processing features and improvements to existing endoscope movement features and implement updates to the graphical user interface displayed on the cockpit monitor.

6.2.1 Follow Me

In the modified Follow Me mode, the surgeon designates two surgical instruments (guide instruments) in the endoscopic view for the camera to follow.

6.2.2 Measurements

Measurements is a new feature that enables the surgeon to take accurate 3D distance measurements within the endoscopic view.

6.2.3 Digital Tags

Digital Taqs is a new feature that enables the surgeon to add virtual tags within the endoscopic view to identify and precisely locate landmarks on the tissue.

6.2.4 Image Enhancement and Illumination Indication

Image Enhancement is a new feature that increases the brightness and contrast of the endoscopic view. This feature may be used to illuminate dark areas or increase contrast of areas of interest, such as tissue vasculature.

6.2.5 Image Characterization and Verification

In order to provide accurate distance measurements, characterization of camera parameters is required. Image Characterization is performed through a new calibration procedure performed by service personnel authorized by Asensus Surgical.

Image Characterization Verification (also called calibration verification) is a new procedure that is part of the pre-operative tasks to prepare the Senhance system for a surgical procedure.

6.2.6 Graphical User Interface

Graphical user interface (GUI) changes were made to enable use of the new ISU features, update mode icons and status indicators, and to improve overall aesthetics of the overlays.

6.3. Equipment Drapes

There are no changes to the single use, sterile equipment drapes used with the Senhance system. The equipment drapes continue to be manufactured by the same manufacturer and are considered Class 2, 510(k)-exempt devices. For the drapes provided with the modified device, a sterile calibration verification card is provided with the sterile drapes which is used to verify the camera calibration parameters stored in the ISU software. The camera calibration parameters are required for use of certain ISU features.

{6}------------------------------------------------

7. Performance Data:

The following performance testing of the modified device was conducted to demonstrate substantial equivalence to the predicate.

7.1. Bench Testing:

Bench testing of the modified Senhance system evaluated the performance of the new and modified ISU features, GUI changes, and the overall use of the Senhance system. Functional performance tests utilizing well-established test methodology verified that the ISU features and Senhance system performed as intended.

7.2. Electrical Safety and Compatibility:

The modified Senhance Surgical System complies with the current versions of IEC 60601-1 (Basic safety and essential performance), IEC 60601-1-2 (Electromagnetic disturbances), IEC 60601-2-18 (Endoscopic equipment interactions), and IEC 60601-2-2 (High frequency surgical equipment).

7.3. Software Verification and Validation Testing:

The software was fully verified and validated in accordance with well-established software development processes and test methodology used for the predicate. There are no unresolved software anomalies/bugs that impact safety or effectiveness of the modified device. Documentation was provided as recommended in FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software is considered as a "major" level of concern.

7.4. Pre-Clinical Design Validation:

Design validation of the modified device was conducted to ensure that the devices perform as intended according to defined user needs and intended uses when used in a simulated use environment. A single-center, un-blinded, observational, simulated use design validation evaluation of the modified Senhance system was conducted with users who represented the intended primary user population. The design validation was conducted in a simulated patient model using well-established test methodology used for the predicate. All applicable user level requirements were assessed and found to be met.

8. Conclusions

The modified Senhance Surgical System is as safe and effective as the predicate Senhance Surgical System (K202166). The modified device has the same intended use/ indications for use and either identical or very similar technological characteristics and principles of operation as the predicate. Any differences in technological characteristics between the modified device and predicate have been addressed through a comprehensive set of testing using well-established test methods and do not raise any different questions of safety and effectiveness. Thus, the assessment and testing results support a determination of substantial equivalence to the predicate in terms of safety, efficacy, and performance.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.