The VS3-OT system is intended for viewing internal surgical sites during general surgical procedures, visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures.

Device Description

The VS3 Stereoscopic High Definition Vision System, Model VS3-OT consists of the following components:

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

The VS3 Stereoscopic High Definition ("3DHD") Vision System, Model VS3-0T 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 Stereoscopic High Definition Vision System. Model VS3-OT allows for separation of the camera module with image sensor module and electronics from the endoscope shaft housing optical relay components and light fibers. The VS3 Stereoscopic High Definition Vision System, Model VS3-OT also includes 2D coupler capability that allows the VS3 Stereoscopic High Definition Vision System, Model VS3-OT to be used with FDA-cleared, third party 2D scopes at user sites to display monocular video.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the way a typical performance study for AI/ML devices might. Instead, it focuses on general performance standards, substantial equivalence to predicate devices, and regulatory compliance.

However, based on the information provided, we can infer some "acceptance criteria" through the lens of comparison to predicate devices, particularly regarding technical specifications. The study described is a comparison of the subject device (VS3-OT) with legally marketed predicate devices, focusing on demonstrating substantial equivalence rather than a standalone performance study with a test set, ground truth, and human readers in the traditional sense.

Here's an attempt to structure the information according to your request, highlighting what is present and what is absent:

Acceptance Criteria and Study for Visionsense Ltd VS3 Stereoscopic High Definition Vision System, Model VS3-OT

The provided document describes the regulatory submission for the VS3 Stereoscopic High Definition Vision System, Model VS3-OT, focusing on demonstrating substantial equivalence to predicate devices rather than a standalone performance study with explicit acceptance criteria and corresponding performance metrics for a novel AI/ML algorithm.

The "acceptance criteria" can be inferred from the technical specifications of the predicate devices which the subject device aims to match or exceed to demonstrate substantial equivalence. The "study" refers to the comparison table provided in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like the VS3-OT (an endoscope), performance standards often relate to optical and physical characteristics. Since this is a substantial equivalence submission, the "acceptance criteria" are the performance characteristics of the predicate devices. The "reported device performance" is the VS3-OT's specifications.

Acceptance Criteria (from Predicate Devices)	Reported Device Performance (VS3-OT Subject Device)	Notes
Endoscope diameter:
- VS3 Neurosurgery: 4 - 5.5 mm	4 – 5.5 mm	Meets
- VSii Arthroscope: 4 - 5 mm
- Karl Storz C-Mount Arthroscope: 4mm
Endoscope length:
- VS3 Neurosurgery: 175 - 300 mm (±5 mm)	175 - 300 mm (±5 mm)	Meets
- VSii Arthroscope: 175 - 300 mm (±5 mm)
- Karl Storz C-Mount Arthroscope: 175 mm
Working distance range:
- VS3 Neurosurgery: 7 - 70mm	7 - 70mm	Meets
- VSii Arthroscope: 7 - 60mm
- Karl Storz C-Mount Arthroscope: 7 - 70mm
Field of view:
- VS3 Neurosurgery: 70°-95°	70°-95°	Meets
- VSii Arthroscope: 70°
- Karl Storz C-Mount Arthroscope: 95°
Direction of View:
- VS3 Neurosurgery: 0° - 70°	0° - 70°	Meets
- VSii Arthroscope: 0° - 70°
- Karl Storz C-Mount Arthroscope: 0° - 70°
Horizontal Resolution:
- VS3 Neurosurgery: >199 lpf	>199 lpf	Meets (also > VSii)
- VSii Arthroscope: >150 lpf
- Karl Storz C-Mount Arthroscope: >199 lpf
Vertical Resolution:
- VS3 Neurosurgery: >199 lpf	>199 lpf	Meets (also > VSii)
- VSii Arthroscope: >140 lpf
- Karl Storz C-Mount Arthroscope: >199 lpf
Depth of Field:
- All Predicates: 7 - 30mm and 15 - 60mm	7 - 30mm and 15 - 60mm	Meets

Note: "Meets" indicates that the subject device's reported performance is comparable to or better than the predicate devices' specifications, supporting the claim of substantial equivalence for these technical characteristics.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a "test set" in the context of an AI/ML algorithm evaluation with a specific sample size of cases or images. The "study" relies on a direct technical comparison against the published specifications of predicate devices. There is no information about data provenance (e.g., country of origin, retrospective/prospective) for a test set, as such a test set is not explicitly detailed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The document does not describe a test set that requires expert-established ground truth for an AI/ML algorithm. The comparison is based on objective technical specifications.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or expert review process described in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers with or without AI assistance was not performed or described in this submission. The device is an imaging system (endoscope), not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a surgical vision system; it is not an AI algorithm performing standalone analysis.

7. The Type of Ground Truth Used

The "ground truth" implicitly used is the published technical specifications and performance characteristics of the legally marketed predicate devices, which serve as the benchmark for demonstrating substantial equivalence. There is no explicit mention of pathology, outcomes data, or expert consensus being used as ground truth for a novel AI algorithm's performance.

8. The Sample Size for the Training Set

Not applicable. This submission is for a conventional medical device (endoscope), not an AI/ML system developed with a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there's no training set for an AI/ML algorithm, the method of establishing its ground truth is not relevant here.

Summary

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510(k) Summary K141002

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date Prepared: April 11, 2014

Applicant Visionsense Ltd 20 Hamagshimim Street Petach Tikva 49348 Israel

Contact Person Raymond Kelly Licensale Inc. 57 Lazy Brook Rd Monroe, CT 06468 USA Phone: (203) 880-4091

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

Device Information Trade name: VS3 Stereoscopic High Definition Vision System, Model VS3-OT Common name: Endoscope, Arthroscope Classification Name: Arthroscope Review Panel: General and Plastic Surgery Product Code: HRX Device Class: Class II Regulation: 21 C.F.R. §888.1100

Predicate Device Information Visionsense Ltd VS3 for Neurosurgery (K131434) Visionsense Ltd VSii Arthroscope (K082355) Karl Storz C-Mount Arthroscope (K983142)

Intended Use/Indications for Use

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Technological Characteristics

The VS3 Stereoscopic High Definition Vision System, Model VS3-OT consists of the following components:

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

Principles of Operation

During surgical procedures, the surgeon inserts the endoscope into the surgical site, which is illuminated using the internal 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 Stereoscopic High Definition Vision System, Model VS3-OT generates a stereoscopic signal of both the right and left images that can be sent to the display monitor.

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 Stereoscopic High Definition Vision System, Model VS3-OT and its components follow FDA recognized consensus standards for electrical safety, electromagnetic compatibility, and biocompatibility:

AAMI/ANSI ES60601-1:2005:A1:2012 Medical electrical equipment part 1: general requirements for basic safety and essential performance.
AAMI/ANSI/IEC 60601-1-2:2007 Medical electrical equipment part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.

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IEC 60601-2-18:2009 Medical electrical equipment part 2-18: particular requirements for the basic safety and essential performance of endoscopic equipment
ISO 14971:2007 Medical devices application of risk management to medical devices.
AAMI/ANSI/ISO 10993-1:2009 Biological evaluation of medical devices -part 1: evaluation and testing within a risk management process.

Substantial Equivalence

The Visionsense VS3 Stereoscopic High Definition Vision System, Model VS3-OT has the same intended use and similar indications, principles of operation, and technological characteristics as the cleared VS3 for Neurosurgery (K131434), VSii Arthroscope (K082355), and Karl Storz Arthroscope (K983142). Thus, the VS3 Stereoscopic High Definition Vision System, Model VS3-OT is substantially equivalent to its predicate devices.

	VS3-OT(subject device)	VS3 Neurosurgery(K131434)	VSii Arthroscope(K082355)	Karl Storz C-MountArthroscope(K983142)
Manufacturer	Visionsense Ltd.	Visionsense Ltd.	Visionsense Ltd.	Karl Storz
Classification	Arthroscope21.C.F.R. §888.1100Product code HRX	Endoscope,Neurological21 C.F.R. §882.1480Product code GWG	Arthroscope21 C.F.R. §888.1100Product code HRX	Arthroscope21 C.F.R. §888.1100Product code HRX
Indications forUse	Intended for viewinginternal surgical sitesduring surgicalprocedures	Intended for viewinginternal surgical sitesduring surgicalprocedures	Intended for viewinginternal surgical sitesduring surgicalprocedures	Intended for viewinginternal surgical sitesduring surgicalprocedures
Endoscope type	Rigid Stainless Steel	Rigid Stainless Steel	Rigid Stainless Steel	Rigid Stainless Steel
Endoscopediameter	4 – 5.5mm	4 - 5.5 mm	4 - 5 mm	4mm
Endoscopelength	175 - 300 mm(±5 mm)	175 - 300 mm(±5 mm)	175 - 300 mm(±5 mm)	175mm
Workingdistance range	7 - 70mm	7 - 70mm	7 - 60mm	7 - 70mm
Field of view	70°-95°	70°-95°	70°	95°
Direction ofView	0° - 70°	0° - 70°	0° - 70°	0° - 70°
HorizontalResolution	>199 lpf	>199 lpf	>150 Ipf	>199 lpf
VerticalResolution	>199 lpf	>199 lpf	>140 lpf	>199 Ipf
Depth of Field	7 - 30mm and15 - 60mm	7 - 30mm and15 - 60mm	7 - 30mm and15 - 60mm	7 - 30mm and15 - 60mm

The following table shows the similarities between the VS3-OT and predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

June 26, 2014

Visionsense Ltd. % Ravmond Kelly Licensale Inc. 57 Lazy Brook Road Monroe, Connecticut 06468

Re: K141002

Trade/Device Name: Vs3 stereoscopic high definition vision system Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX. GWG Dated: April 7, 2014 Received: April 18, 2014

Dear Mr. Kelly.

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 mav, 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 cither 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 801); medical device reporting (reporting of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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.

David Krause - S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K141002

Device Name

VS3 Stereoscopic High Definition Vision System, Model VS3-OT

Indications for Use (Describe)

The VS3-OT system is intended for viewing internal surgical procedures, visualization of ventricles and structures within the brain during neurological procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectorny, and shoulder and knee arthroscopic procedures.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.