The VS3 consists of the following components: Endoscope, Light source, Camera Control Unit (CCU), Camera, Display monitors, 2D Endoscope coupler. The VS3 Stereoscopic High Definition ("3DHD") system is based on the proximal HD camera concept with a stereoscopic camera block located on the proximal side of the endoscope (the handle). This allows high resolution capture of the 3D video stream. The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block containing the HD sensor module. The VS3 system allows for separation of the camera module with image sensor module and electronics from the endoscope shaft housinq optical relay components and light fibers. The VS3 system also includes 2D coupler capability that allows the VS3 system to be used with FDA-cleared, third party 2D scopes at user sites to display monocular video.

AI/ML Overview

The provided text describes a 510(k) submission for the Visionsense VS3 Stereoscopic Vision System, a Class II medical device. However, it does not contain the detailed information required to fill out the table regarding acceptance criteria, study details, and performance metrics as it is primarily focused on establishing substantial equivalence to a predicate device.

Specifically, the document states:

"No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") for endoscopes."
"However, the VS3 system and its components follow FDA recognized consensus standards for electrical safety, electromagnetic compatibility, and biocompatibility. In addition, cleaning validation, sterilization, and software validation were performed for the subject device. The completed testing listed above demonstrates that the subject device is as safe and effective as the predicate device."

This indicates that the "study" proving the device meets acceptance criteria is primarily a series of verification and validation tests against recognized consensus standards and internal quality controls, rather than a clinical performance study with specific acceptance criteria in terms of diagnostic accuracy or other performance metrics typically associated with AI/software devices. Therefore, many of the requested fields cannot be answered from the provided text.

However, based on the information provided, here's what can be extracted and what cannot be:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Specific Criteria (from text)	Reported Device Performance (from text)
Safety - Electrical	Compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2	Complies with recognized consensus standards.
Safety - Electromagnetic Compatibility	Compliance with IEC 60601-1-2	Complies with recognized consensus standards.
Safety - Biocompatibility	Compliance with recognized consensus standards	Complies with recognized consensus standards.
Safety - Sterilization	Cleaning validation, Sterilization validation	Performed; demonstrates safety and effectiveness.
Safety - Risk Management	Compliance with ISO 14971	Complies with recognized consensus standards.
Safety - Endoscopic Equipment Specific	Compliance with IEC 60601-2-18	Complies with recognized consensus standards.
Safety - Optical/Endoscopic Accessories	Compliance with ISO 8600 (Parts 1, 3, 4, 5, 6)	Complies with recognized consensus standards.
Software Validation	Software validation	Performed; demonstrates safety and effectiveness.
Functional Equivalence	Same Indications for Use, Operating Principle, Basic Design, Materials of Construction, Sterilization Method, Manufacturing Processes as predicate.	Demonstrated to be "Same" as predicate (VSi, K073279).
Performance - Visualization Capabilities	3D, High Definition (HD) viewing	Provides 3D, HD viewing (an enhancement over predicate's 3D only).

Note: The text explicitly states "No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") for endoscopes." This implies there are no specific quantitative or clinical performance acceptance criteria (e.g., sensitivity, specificity, accuracy) provided in this document as would be expected for a diagnostic AI device. The "performance" described focuses on meeting safety, electromagnetic, and material standards, and demonstrating functional equivalence to the predicate device with the added feature of HD.

Additional Information (where available or noted as unavailable):

2. Sample size used for the test set and the data provenance:

Not provided. The document describes engineering and quality assurance validation (e.g., electrical safety, sterilization validation) against consensus standards but does not detail sample sizes or data provenance for a "test set" in the context of clinical performance data or AI model evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. This information is relevant for studies validating interpretations or diagnostic outputs, typically in AI/software clinical performance studies. The provided text does not describe such a study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not provided. As above, this pertains to expert-led ground truth establishment for performance studies.

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 (or at least not described in this submission summary). The device is a stereoscopic vision system (hardware-based 3D visualization), not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable/Not provided. The device is an endoscopic system providing visualization, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable/Not provided. The device's validation focuses on engineering and safety standards, and functional equivalence to a predicate, rather than validating against a clinical "ground truth" for diagnostic accuracy.

8. The sample size for the training set:

Not applicable/Not provided. This is not an AI/machine learning device in the context of this submission. "Training set" would not apply in the conventional sense.

9. How the ground truth for the training set was established:

Not applicable/Not provided. As above, this is not an AI/machine learning device.

Summary

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K123467

510(k) Summary

Date Prepared: December 11, 2012

Submitter

' เ

Visionsense Ltd. 20 Hamagshimim Street Petach Tikva 49348 lsrael

Contact Person(s)

Azi Ben-Yishai 20 Hamagshimim Street Petach, Tikva 49348 Israel Phone: +972 (3) 9244339 Facsimile: +972 (3) 9244335

OR

Gerard J. Prud'homme Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004 Tel: 202-637-5735 Fax: 202-637-5910

Device Information

Trade name: VS3 Common name: Laparoscope, General and Plastic Surgery Classification Name: Endoscope & Accessories Review Panel: General and Plastic Surgery Product Code: GCJ Device Class: Class II Regulation: 21 CFR 876.1500.

Predicate Device Information

The predicate device is the VSir (K073279) manufactured by Visionsense Ltd.

Device Description

Intended Use/Indications for Use

・・・・

The VS3 is intended for viewing internal surgical sites during general endoscopic and laparoscopic surgical procedures

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Characteristical Characteristics

The VS3 consists of the following components:

- Endoscope
& Light source
- Camera Control Unit (CCU)
- Camera
- Display monitors
- 2D Endoscope coupler

The VS3 Stereoscopic High Definition ("3DHD") system is based on the proximal HD camera concept with a stereoscopic camera block located on the proximal side of the endoscope (the handle). This allows high resolution capture of the 3D video stream. The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block containing the HD sensor module. The VS3 system allows for separation of the camera module with image sensor module and electronics from the endoscope shaft housinq optical relay components and light fibers. The VS3 system also includes 2D coupler capability that allows the VS3 system to be used with FDA-cleared, third party 2D scopes at user sites to display monocular video.

Principles of Operation

During surgical procedures, the surgeon inserts the endoscope into the surgical site, which is illuminated using the internal or external illumination source. The optical array then functions by capturing both right and left images of the surgical site from different angles. Both images are detected by the camera and transmitted to the CCU. Once the images are received by the CCU. the VS3 generates a stereoscopic signal of both the right and left images that can be sent to the display monitor.

Substantial Equivalence

The Visionsense VS3 Stereoscopic Vision System is substantially equivalent to the Visionsense VSu Stereoscopic Vision System (K073279). Both the proposed VS3 system and the predicate VS1 system are designed for providing stereoscopic 3 dimensional (3D) viewing. Both are rigid stainless steel endoscopes with illumination indicated for 3D viewing and illumination of interior surgical sites during general surgical procedures. Both the proposed VS3 and the predicate VS1 systems utilize the same basic endoscopy and illumination principles for viewing internal locations and transmission of video to PC workstations or external display monitors for enhanced viewing or capturing. The VS3 has been developed in order to provide clinicians with High Definition (HD) viewing capabilities. The proposed device has the same intended uselindication for use as the predicate device. The addition of HD viewing capabilities in the VS3 is not intended to change the indications or intended use of the subject device.

The proposed VS3 system, like the FDA-cleared VSj, system, consists of an endoscopic insertion tube with optics and/or a camera component that detects and transmits images of the surgical site to image processing and viewing components, such as CCU, video displays, or display monitors. The principal difference between the VS and the VS consists of high definition viewing, the location of the camera mounting block being proximal on the proposed device versus distal on the predicate device, and the ability to separate the VS3 endoscope from the VS3 camera. Both devices provide rigid endoscopic insertion tubes that are inserted into the patient's body through surgically prepared access sites. An illumination source that is connected to the endoscope provides light to the surgical site. Optical units and camera systems are employed to capture images of the surgical site and transmit the images to image processing or display units. Both devices are reusable medical

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devices which are sterilized using the same methods.

	VS3	VSII (073279)
Indications for Use	Same	Same
Operating Principle	Same	Same
Basic Design	Same	Same
Materials of Construction	Same	Same
Sterilization Method	Same	Same
Visualization Capabilities	3D, HD	3D
Manufacturing Processes	Same	Same

Performance

No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") for endoscopes. However, the VS3 system and its components follow FDA recognized consensus standards for electrical safety, electromagnetic compatibility, and biocompatibility. In addition, cleaning validation, sterilization, and software validation were performed for the subject device. The completed testing listed above demonstrates that the subject device is as safe and effective as the predicate device.

Applicable Standards

. IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (1998); Amendment 1, 1991-11, Amendment 2, 1995.
IEC 60601-1-1, Medical electrical equipment Part 1-1: General requirements for safety. . Collateral standard: Safety requirements for medical electrical systems (2000).
. IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance. Collateral standard: Electromagnetic compatibility requirements and tests. (Edition 2:2001 with Amendment 1:2004; Edition 2:1 (Edition 2:2001 consolidated with Amendment 1:2004).
IEC 60601-2-18, Medical electrical equipment Part 2-18: Particular requirements for the . basic safety and essential performance of endoscopic equipment (1996). Amendment 1, 2000.
ISO 14971, Medical devices Application of risk management to medical devices (2007). .
ISO 8600, Optics and optical instruments -- Medical endoscopes and endoscopic . accessories. Part 1:2005; Part 3:1997; Part 4:1997; Part 5:2005; Part 6:2005.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Visionsense Ltd. % Hogan Lovells US LLP Gerard J. Prud'homme Columbia Square 555 Thirteenth Street. Northwest Washington, District of Columbia

Re: K123467

Trade/Device Name: VS3 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: March 27, 2013 Received: March 27, 2013

Dear Mr. Prud'homme:

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. 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

April 17, 2013

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Page 2 - Gerard J. Prud'homme

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, FOR

Peter D
Rümm-S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

K123467 510(k) Number (if known):

Device Name: Visionsense VS3 Stereoscopic Vision System

Indications for Use.

Intended for viewing internal surgical sites during general endoscopic and laparoscopic surgical procedures.

Prescription Use _ × (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use_ (Per 21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joshua C.
Nipper -S

For

(Division Sign-Off)

Division of Surgical Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

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.