The Envision 3D™: Image Guidance System is a stereotaxic image guidance system intended for the spationing and orientation of neurosurgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure can be identified.

Device Description

The 7D Surgical Envision 3D™: Image Guidance System is intended for use as a stereotaxic image guided surgical navigation system during spine surgery. The system provides image registration between preoperative scan data and data captured intraoperatively from the Envision 3D™ integrated structured light scanner and/or user selected points. The system provides guidance data by displaying the locations of wireless optically tracked Envision 3D™ Spinal Instruments (examples include pedicle probe and awl) relative to the patient. Position and orientation data of tracked Envision 3D™ Spinal Instruments are linked to the preoperative scan data using the Envision 3D™ workstation. The system is intended to be used as the primary surgical luminaire for image guided surgery.

The system is intended to be used for both image fusion and navigation for neurological applications where reference to a rigid structure can be identified relative to a preoperative image data of the anatomy.

The Envision 3D™: Image Guidance System is comprised of 5 major components:

1. Cart
1. Arm
1. Head
1. Tracked surgical Envision 3D™ Spinal Instruments
1. Software

AI/ML Overview

The provided text gives limited details about the acceptance criteria and a specific study proving the device meets them. However, it does mention non-clinical performance and accuracy testing. Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "All accuracy specifications have been met" for the "Non Clinical Accuracy" testing. However, the specific numerical acceptance criteria for accuracy are not explicitly stated. It refers to ASTM F2554-10 for the measurement method but doesn't provide the targets.

Acceptance Criteria (Explicitly Stated - limited)	Reported Device Performance (Summary)
System verification requirements	All design requirements have been fulfilled
System validation, user needs	All user needs met
Usability, reduction of use errors	Validation successful with respect to use errors
Risk control requirements	Risk Control requirements are effective and mitigate the associated risks to an acceptable level
Compliance with recognized product safety standards (IEC 60601-1, IEC 60601-1-2, etc.)	Compliance with recognized standards have been verified
Non Clinical Accuracy (based on ASTM F2554-10 and TRE)	All accuracy specifications have been met

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

Test Set Sample Size: Not explicitly stated. The "Non Clinical Accuracy" testing was performed "on phantom models." The number of phantom models or specific test cases is not provided.
Data Provenance: The Non-Clinical Accuracy tests were conducted on "phantom models" in a "clinical simulated environment." This indicates simulated, controlled environments rather than data from human patients. The country of origin of the data is not specified. It is a retrospective analysis of device performance on phantom models.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

The ground truth for accuracy testing (Target Registration Error) is described as "the error discrepancy between the position reported by the image guided surgery system and the ground truth position measured physically or otherwise." This implies a measurement-based ground truth rather than expert consensus on images.

4. Adjudication Method for the Test Set

Not applicable/Not specified. The accuracy testing described appears to be objective, measurement-based (comparing system output to physical ground truth), rather than requiring expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document states, "A clinical trial was not required to demonstrate safety and effectiveness of the Envision 3D™: Image Guidance System. Clinical validation is unnecessary as the Envision 3D™: Image Guidance System introduces no new indications for use, device features are equivalent to the previously cleared predicate device identified." Therefore, no assessment of human reader improvement with AI assistance was conducted or reported.

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

The "Non Clinical Accuracy" testing refers to the "System's accuracy" using the Envision 3D™ on phantom models. This implies a standalone evaluation of the device's accuracy without a human-in-the-loop performance assessment. The system's ability to spatially position and orient surgical instruments is the core function being tested.

7. The Type of Ground Truth Used

The ground truth used for "Non Clinical Accuracy" testing, specifically for Target Registration Error (TRE), is described as "the ground truth position measured physically or otherwise." This suggests physical measurement or pre-defined true positions on the phantom models, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not provide information about a training set specifically for an AI/algorithm component. The device is referred to as an "Image Guidance System" utilizing an "integrated structured light scanner" and "software" that "links all system components," but it does not detail any machine learning or AI models requiring a distinct training dataset. The system seems to rely on established image processing and tracking algorithms rather than a trainable AI model in the context usually meant by "training set" for AI.

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

Since no separate training set or AI model requiring traditional training data is explicitly described, this information is not applicable or provided in the document.

Summary

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

December 29, 2016

7D Surgical, Inc. Daniel Ziskind Director. Quality & Regulatory 60 Scarsdale Road, Unit 118 Toronto. Ontario M3B 2R7 Canada

Re: K162375

Trade/Device Name: Envision 3D 104: Image Guidance System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: November 29, 2016 Received: November 30, 2016

Dear Daniel Ziskind:

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 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,

Caroline Rhim -S

for

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

Enclosure

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Indications for Use

510(k) Number (if known) K162375

Device Name Envision 3D™: Image Guidance 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)

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510(k) Summary of Safety and Effectiveness Envision 3D™: Image Guidance System

This summary of safety and effectiveness information is submitted in accordance with 21CFR §807.92

1. Submitter's name, address, telephone number, contact person.

7D Surgical, Inc. 60 Scarsdale Road, Unit 118 Toronto, ON, M3B 2R7, Canada

Contact person:	Daniel Ziskind
	Quality and Regulatory, Director
	7D Surgical, Inc.
	60 Scarsdale Road, Unit 118
	Toronto, ON, M3B 2R7, Canada
Phone:	(647) 484-0079
Fax:	(647) 749-0400 (wait until you hear a message, then press 7)
Email:	daniel.ziskind@7dsurgical.com

Date prepared: August 23, 2016

1. Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

Common/usual name:	Computer-assisted surgical device
Proprietary name:	Envision 3D™: Image Guidance System

These devices are classified as follows:

Classification Name	21 CFR Section	Product Code
Stereotaxic instrument	21 CFR §882.4560	OLO

3. Substantially Equivalent Devices

7D Surgical believes the Envision 3D™: Image Guidance System is substantially equivalent to the following currently marketed devices:

Product	510(k)
Medtronic StealthStation System	K133444

The indications for use of the subject device Envision 3D™: Image Guidance System are equivalent to the predicate device K133444. Furthermore, the technological characteristics of the Envision 3D™: Image Guidance System are substantially equivalent. The differences in the technological characteristics do not raise new

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Envision 3D™: Image Guidance System

questions of safety and effectiveness. Consequently, the subject is substantially equivalent to the predicate device.

4. Device Description and Technical Comparison to Predicate Devices

The Envision 3D™: Image Guidance System is comprised of 5 major components:

1. Cart
1. Arm
1. Head
1. Tracked surgical Envision 3D™ Spinal Instruments
1. Software

The Cart of the system serves the following purposes:

Easy movement of system with secure attachment of all moveable components to the cart.
Space efficient storage of system, when not used.
Allow stable positioning of the entire system when in use. •
· Safe enclosure of the computer and electric supplies.
. Allow user interaction and data-transfer to and from the computer workstation

The Arm of the system serves the following purposes:

Link the cart and the head allowing easy positioning of the head by the sterile surgeon but is stable otherwise (no motion of the head after positioning)
・ Allow positioning of the head outside of the sterile field in all positions
・ Provides mechanisms for routing cables between the head and the cart

The Head of the system serves 3 main purposes:

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Capture 3D structured light images of the intraoperative patient anatomy to facilitate registration of patient preoperative data with the local surgical coordinate system to enable surgical navigation
To passively track the location of Envision 3D™ Spinal Instruments awl, pedicle probe) and a reference frame within the surgical field and provide intraoperative guidance to the surgeon
To illuminate the surgical field during navigated portions of the surgery. The incorporation of an illumination module into the system is driven by the fact that the use of standard surgical lighting during navigated parts of the procedure prevent the acquisition of structured light images due to saturation of cameras.

The Tracking System enables the surgeon to view the position and orientation of these Envision 3D™ Spinal Instruments relative to registered pre-operative image data while performing the surgical procedure. Each Envision 3D™ Instrument utilizes 4 commercially available passive reflective marker spheres [Manufactured by NORTHERN DIGITAL, INC.; 510(k) K033621] used to determine the position and orientation of each Envision 3D™ Instrument. Each Envision 3D™ Instrument requires a unique marker position configuration to enable the tracking system to distinguish the tools from one to the other.

The Software links all system components and displays navigational data to the surgeon. It provides methods for loading preoperative scans and guides the surgeon through the process of surface model creation, structured light acquisition, registration, registration verification and navigation.

5. Indications for Use

The Envision 3D™: Image Guidance System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure can be identified.

6. Safety Considerations

Electrical safety and EMC testing were conducted on Envision 3D™: Image Guidance System. The device complies with recognized electrical safety standards: IEC 60601-1

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Envision 3D™: Image Guidance System

standard for electrical safety and IEC 60601-1-2 standard for electromagnetic compatibility.

The biocompatibility evaluation Envision 3D™: Image Guidance System instrumentation has been conducted in accordance with ISO 10993 standards and blue book memorandum #G95-1 entitled "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing", May 1, 1995. The evaluation reveals that biocompatibility requirements are met.

7. Technological Characteristics

The literature research and the comparison to the predicate devices show that the device makes use of equivalent technological characteristics and functionality and is intended for equivalent surgical procedures as compared to the predicate devices.

8. Nonclinical Performance Data

Verification and Validation activities have been conducted to provide assurance that the device meets the performance requirements under the indications for use conditions.

7D Surgical performed the following testing to ensure the safety and effectiveness of the Envision 3D™ device:

Non-Clinical System, Software, and Instrumentation Verification and Validation
Non-Clinical Performance Surgical Simulations Conducted on Phantom Models .
Surgeon Performed Human Cadaveric Workflow Study ●
Cadaveric Porcine Study Performed on Reference Frame Clamp Stability
. Compliance Conformity Assessments
- IEC 60601-1 Medical electrical equipment. General requirements for basic safety and essential performance, 2005, Amendment 1, 2012
- . IEC 60601-1-2 Medical Electrical Equipment – Part 1-2, General Requirements for Basic Safety and Essential Performance – Collateral Standard Electromagnetic Compatibility, 2007
- . IEC 60601-2-41 Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
- IEC 60601-1-6 Medical Electrical Equipment Part 1-6, General . Requirements for Basic Safety and Essential Performance - Usability
- . IEC 60825-1 Safety of laser products - Part 1: Equipment classification and requirements
- ISO 10993-1 Biological evaluation of medical devices.

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. ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
. AAMI / ANSI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, (Consolidated Text) Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities. (Sterility)
ASTM F2554-10 Standard Practice for Measurement of Positional . Accuracy of Computer Assisted Surgical Systems

Device performance tests were performed to verify the absolute accuracy and repeatability of the accuracy of the device, and the navigation accuracy according to ASTM F2554-10. In addition, Target Registration Error has been used to evaluate the clinical accuracy of the system on phantom models in a clinical simulated environment. TRE evaluates the error discrepancy between the position reported by the image guided surgery system and the ground truth position measured physically or otherwise.

The following table contains a summary of verification and validation performed on the Envision 3D™: Image Guidance System

Verification and Validation	Description	Conclusion
System Verification	Scope of the test is to verifythe design requirementspecifications of Envision 3D™System under test caseprotocols.	Verification successful, alldesign requirements havebeen fulfilled
System Validation	Scope of the test is to validatethe Indications For Use andCustomer Requirements of theEnvision 3D™ System undersimulated use case situations.	Validation successful, all userneeds met
Usability	This test is conducted tovalidate the Envision 3D™System with respect to useerrors.	Validation successful withrespect to use errors
Safety regarding risk analysis	Implementation andeffectiveness of all risk controlrequirements specified in theEnvision 3D™ risk analysis aretested and verified.	Risk Control requirements areeffective and mitigate theassociated risks to anacceptable level.
Product Safety standards	The Envision 3D™ System andInstrumentation was tested tothe following recognizedstandards:IEC 60601-1, IEC 60601-1-2,IEC 60601-1-6, IEC 60601-2-41,IEC 60825-1, ISO 10993-1, andISO 17665-1.	Compliance with recognizedstandards have been verified

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Envision 3D™: Image Guidance System
-------------------------------------	--	--	--	--	--

Verification and Validation	Description	Conclusion
Non Clinical Accuracy	System's accuracy is tested using the Envision 3D™ on phantom models following the ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems in addition to Target Registration Error	All accuracy specifications have been met

All non-clinical tests successfully passed demonstrating that the subject device performs as safely and effectively as the predicate device and supporting substantial equivalence.

9. Clinical Data

A clinical trial was not required to demonstrate safety and effectiveness of the Envision 3D™: Image Guidance System. Clinical validation is unnecessary as the Envision 3D™: Image Guidance System introduces no new indications for use, device features are equivalent to the previously cleared predicate device identified. The clinical safety and effectiveness of Image Guided Surgery Systems are historically accepted for both the predicate and subject device.

10. Conclusion

The Envision 3D™: Image Guidance System is substantially equivalent in safety and effectiveness to the predicate devices identified above:

. The predicate devices and Envision 3D™ use essentially the same technologies
The predicate devices and Envision 3D™ are designed and manufactured to . the similar electrical and physical safety standards.

The non-clinical verification and validation performed support the safety and effectiveness of Envision 3D™: Image Guidance System. The conclusions drawn from the nonclinical tests demonstrate that the Envision 3D™ System, performs as safely and effectively as the legally marketed device According to the comparison based on the requirements of 21 CFR §882.4560 and the information provided herein, it is concluded that the Envision 3D™ System is substantially equivalent to the predicate device with respect to its indications for use, technological characteristics and performance characteristics.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).