The TrueVision® 3D Visualization and Guidance System is an adjunct imaging tool that provides onscreen guidance with alignment, orientation, and sizing for eye surgery. The system is intended for use as a preoperative and postoperative image capture tool with visualization and guidance provided during anterior segment ophthalmic surgical procedures, including limbal relaxing incisions, capsulorhexis and toric intraocular lens (toric IOL) positioning. The system utilizes surgeon confirmation at each step for planning and positioning of guidance templates.

Device Description

The TrueVision® 3D Visualization and Guidance System is a stereoscopic highdefinition digital video camera and workstation, which operates as an adjunct to the surgical microscope during cataract surgery and the slit lamp microscope during pre-operative and post-operative image capture. The visualization system displays real-time images during eve surgery on a flat-panel, high-definition digital 3D display device positioned for live video image viewing by the surgeon and surgical personnel in the operating room.

The Cataract and Refractive Toolset system combines the TrueVision FDAregistered Class 1 Device (TrueVision® 3D Visualization System for Microsurgery) with proprietary TrueWare™ software (controlled via remote keyboard with included touchpad mouse) to provide enhanced visualization and surgical quidance assistance to the surgeon during specific procedures such as Limbal Relaxing Incision, Capsulorhexis, and toric IOL positioning.

Using standard pre-operative clinical data, together with surgeon-driven, onscreen templates and guides, the Refractive Cataract Toolset provides graphical assistance to the surgeon as desired during the surgery. Guidance applications include incision templates to optimize the position of limbal relaxing incisions, sizing and positioning of capsulorhexis tears, and rotational alignment of toric intraocular lenses (toric IOL).

AI/ML Overview

The provided 510(k) summary for the TrueVision 3D Visualization and Guidance System (K101861) includes some details about performance testing but does not provide a table of acceptance criteria with specific numeric targets or detailed reported device performance against those targets. It also lacks granular information on some of the requested study parameters.

Here's a breakdown of the available information and what is not explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Performance verification and validation testing was completed to demonstrate that the device performance complies with specifications and requirements identified for the TrueVision® 3D Visualization and Guidance System. This was accomplished by software verification testing and a non-significant risk clinical study. All criteria for this testing were met and results demonstrate that the TrueVision® 3D Visualization and Guidance System meets all performance specifications and requirements."

However, specific acceptance criteria (e.g., minimum accuracy percentages, error margins) and the quantitative results validating these criteria are not provided. The summary only confirms that "All criteria for this testing were met."

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

Sample Size for Test Set: Not explicitly stated. The document mentions a "non-significant risk clinical study" but does not provide details about its sample size.
Data Provenance: Not explicitly stated. It's unclear if the data was retrospective or prospective, or the country of origin. Given the device's intended use in surgical settings, it's likely prospective for the clinical study aspect, but this is an inference.

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

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: Not explicitly stated. The focus is on the device's performance in providing "onscreen guidance" and assisting the surgeon, not on comparing human reader performance with and without AI assistance.
Effect Size: Not applicable, as an MRMC study is not described.

6. Standalone (Algorithm Only) Performance Study

Standalone Study Done: Yes, implicitly. The document mentions "software verification testing" to demonstrate compliance with specifications. This would typically involve testing the algorithm's performance independent of human interaction for its guidance functions. The "non-significant risk clinical study" would then likely evaluate the overall system (device + human interaction) in a real-world setting. However, specific performance metrics for the standalone algorithm are not presented.

7. Type of Ground Truth Used

Type of Ground Truth: The document states that the system "utilizes surgeon confirmation at each step for planning and positioning of guidance templates." This suggests that the ground truth for evaluating the guidance features (e.g., accuracy of incision templates, capsulorhexis sizing, IOL alignment recommendations) would be based on surgeon confirmation/expert judgment during the clinical study. It is not explicitly stated if pathology or outcomes data were used directly for ground truth establishment.

8. Sample Size for the Training Set

Sample Size for Training Set: Not mentioned or applicable. The device primarily functions as a "visualization and guidance system" with "surgeon-driven, onscreen templates and guides." There is no indication that it uses a machine learning algorithm that requires a separate "training set" in the context of typical AI device development. The software likely implements pre-defined algorithms based on known surgical parameters and anatomical measurements, rather than learning from a large dataset.

9. How Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there's no mention of a training set in the context of machine learning. The guidance templates are described as "surgeon-driven" and utilizing "standard pre-operative clinical data," implying that the accuracy of the guidance is based on established surgical principles and measurements, confirmed by the surgeon.

In summary, while the K101861 document states that performance testing, including software verification and a clinical study, was conducted and that all criteria were met, it lacks the detailed quantitative data and specific methodological descriptions required to fully populate the requested information.

Summary

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510(k): K101961

TrueVision 3D Visualization and Guidance System 7/14/2010

DEC 2 2 2010

II: 510(k) Summary

Image /page/0/Picture/5 description: The image shows the logo for TrueVision Systems, Inc. The logo consists of a globe-like graphic on the left, followed by the word "TrueVision" in a bold, sans-serif font. Below "TrueVision" are the words "SYSTEMS, INC" in a smaller, sans-serif font. The logo is black and white.

TrueVision® 3D Visualization and Guidance System

Submitter:

TrueVision Systems Inc. 114 E. Haley Suite L Santa Barbara, CA 93101 Tel: (805) 963-9700 Fax: (805) 963-9719

Official Correspondent:

A. Burton Tripathi, Ph.D. Vice President of Product Development 114 E. Haley St., Suite L Santa Barbara, CA 93101 Tel: 805-963-9700 Email: btripathi@truevisionsys.com

Date: June 30, 2010

Device Trade Name	Classification Name	Common Name
TrueVision® 3D Visualizationand Guidance System	Microscope, SurgicalClass I per 21 CFR878.4700Camera, OphthalmicClass II, per 21 CFR886.1120Picture archiving andcommunications SystemClass II, Per 21 CFR892.2050	Visualization andGuidance System

Product Codes: HKI, NFJ

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Substantial Equivalence:

The TrueVision® 3D Visualization and Guidance System is substantially equivalent to the following devices:

TrueVision® Visualization System for Microsurgery, Class 1 Device 1) TrueVision Systems, Inc. Surgical Microscope/21CFR878.4700, EPT
Optronics EPIC Color Television Camera System 2) Karl Storz Imaging Ophthalmic camera/21CFR 886.1850 K963333, HKI
1. OphthaVision Imaging System MRP Group, Inc. Ophthalmic camera/21CFR 886.1850 K980295. HKI
IMAGEnet Professional PC Software, Digital Image Management 4) Software Topcon Corporation Picture archiving and communications system/21 CFR 892.2050 K082364, NFJ

Description of the Device Subject to Premarket Notification:

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applications include incision templates to optimize the position of limbal relaxing incisions, sizing and positioning of capsulorhexis tears, and rotational alignment of toric intraocular lenses (toric IOL).

Indications for Use:

The TrueVision® 3D Visualization and Guidance System is an adjunct imaging tool that provides onscreen quidance with alignment, orientation, and sizing for eve surgery. The system is intended for use as a preoperative and postoperative image capture tool with visualization and quidance provided during anterior seqment ophthalmic surgical procedures, including limbal relaxing incisions. capsulorhexis and toric intraocular lens (toric IOL) positioning. The system utilizes surgeon confirmation at each step for planning and positioning of quidance templates.

Performance Standards:

None. There are no mandatory performance standards for this type of device.

Basis for Determination of Substantial Equivalence:

The TrueVision® 3D Visualization and Guidance System described in this submission is substantially equivalent to the predicate device(s) listed above. All of the devices are used in ophthalmic imaging applications, provide means for capture, storage, and manipulation of said images, and provide practitioners with tools to provide visualization or surgical guidance assistance. All of the devices contain similar system components (camera, processor, and display), and all are used on the same anatomical location. The minor differences between the TrueVision 3D Visualization and Guidance System and the listed predicate devices do not raise any new questions of safety or of effectiveness in comparison to the predicate devices.

Performance Data:

Performance verification and validation testing was completed to demonstrate that the device performance complies with specifications and requirements identified for the TrueVision® 3D Visualization and Guidance System. This was accomplished by software verification testing and a nonsignificant risk clinical study. All criteria for this testing were met and results demonstrate that the TrueVision® 3D Visualization and Guidance System meets all performance specifications and requirements.

Conclusions:

As described in this 510(k) Summary, all testing deemed necessary was conducted on the TrueVision® 3D Visualization and Guidance System to ensure that the device is safe and effective for its intended use and is substantially

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equivalent to legally marketed devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

TrueVision Systems, Inc. c/o Dr. A. Burton Tripathi Vice President. Product Development 114 East Haley Street, Suite L Santa Barbara, CA 93101

DFC 2 2 2010

Re: K101861

Trade/Device Name: TrueVision 3D Visualization and Guidance System Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: II Product Code: HKI, NFJ, EPT Dated: Not Dated Received: October 14, 2010

Dear Dr. Tripathi:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Malvina B. Eydelman, M.D.
Director
Division of Ophthalmic, Neurological,
and Ear, Nose and Throat Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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510(k) Number (if known): Original Premarket Notification

Device Name: TrueVision® 3D Visualization and Guidance System

Indications for Use:

DEC 2 2 2010

K101861

Prescription Use X

(Part 21 CFR 801 Subpart D)

Signature

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K101861

Regulation Number and Section

§ 886.1120 Ophthalmic camera.

(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.