The 7D Surgical 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 cranial surgery where reference to a rigid anatomical structure can be identified.

Device Description

The 7D Surgical System Cranial Application is intended for use as a stereotaxic image guided surgical navigation system during cranial surgical procedures. The Cranial Application software assists in guiding surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The Cranial Application software works in conjunction with 7D Surgical Machine Vision Guidance System which consists of clinical software, optically tracked surgical Pointer, a reference frame instrument and platform/computer hardware which is substantially equivalent to K162375. Image guidance, or Machine Vision, tracks the position of instruments in relation to the surgical anatomy and identifies this position on DICOM scan images or intraoperative structured light images of the patient. The Cranial software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.

The 7D Surgical System Cranial Application is comprised of 5 major components:

Cart
Arm
Head
Tracked surgical 7D Surgical System Cranial Instruments
Software

AI/ML Overview

The provided document, a 510(k) summary for the 7D Surgical System Cranial Application, outlines the device's acceptance criteria and the studies conducted to demonstrate its safety and effectiveness for FDA clearance.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed around demonstrating substantial equivalence to predicate devices and meeting established safety and performance standards for image-guided surgical systems. The document doesn't provide specific quantitative "acceptance criteria values" in the format of a typical performance table (e.g., "accuracy must be < X mm"). Instead, it states that tests were performed to verify "absolute accuracy and repeatability of the accuracy of the device, and the navigation accuracy according to ASTM F2554-10." It also mentions evaluating "Target Registration Error (TRE) and Angular Trajectory Error (ATE)" to assess clinical accuracy.

The reported performance is summarized qualitatively:

Acceptance Criterion (Test Type)	Reported Device Performance
System Verification (Design Requirement Specs)	Verification successful, all design requirements have been fulfilled.
System Validation (Indications for Use & Customer Requirements)	Validation successful, all user needs met.
Usability	Validation successful, device safe and effective with respect to use errors.
Safety regarding Risk Analysis	Risk Control requirements are effective and mitigate the associated risks to an acceptable level.
Biocompatibility (ISO 10993-1)	Compliance with recognized standards has previously been established in the predicate device K142024. (For Cranial Instrumentation)
Sterilization (ISO 17665-1)	Compliance with recognized standards have been verified in this application. (For Cranial Instrumentation)
Product Safety Standards (IEC 60601 series, IEC 60825-1)	Compliance with recognized standards have been verified in the previous application K162375. Previous test results have not been affected by this change. (For System Cart, as no substantial changes were made)
Non-Clinical Accuracy (ASTM F2554-10, TRE, ATE)	All accuracy specifications have been met. (Tested on phantom models in a clinical simulated environment)

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

Sample Size: The document does not specify a numerical sample size for the "Non-Clinical Performance Surgical Simulations Conducted on Phantom Models" or for the system verification/validation tests. It states "phantom models" but not the quantity or specific cases.
Data Provenance: The studies were non-clinical simulations conducted on phantom models. The location of the testing is not explicitly stated, but the submitter's address is in Toronto, ON, Canada, suggesting the testing likely occurred there. The studies are retrospective in the sense that they are conducted on a developed device, rather than prospective clinical trials.

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

The document does not mention the use of human experts to establish ground truth for the non-clinical phantom studies. Ground truth for accuracy tests on phantom models is typically established by precise physical measurements on the phantom or through highly accurate reference tracking systems, rather than expert consensus on medical images.

4. Adjudication Method for the Test Set

Not applicable. As the tests were non-clinical simulations on phantom models, there was no need for human adjudication of results in the traditional sense of clinical imaging studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No MRMC study was performed. The device is a computer-assisted surgical navigation system, not an AI-assisted diagnostic imaging tool. Its purpose is to guide surgeons, not to "improve human readers." The document explicitly states: "A clinical trial was not required to demonstrate safety and effectiveness of the 7D Surgical System Cranial Application. Clinical validation is unnecessary as the 7D Surgical System Cranial Application introduces no new indications for use, and device features are equivalent to the previously cleared predicate device identified."

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

Yes, the accuracy and performance tests (e.g., Non-Clinical Accuracy, System Verification, System Validation, Usability, Biocompatibility, Sterilization, Product Safety standards) are essentially standalone performance evaluations of the device and its components, without a human-in-the-loop study in a clinical setting. The "human-in-the-loop" aspect during surgery is the surgeon using the navigation system, but the testing itself evaluates the system's inherent accuracy and functionality.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the non-clinical accuracy tests (TRE and ATE on phantom models), the ground truth was established through physical measurements or highly accurate reference tracking systems on the phantom. This is inherent in the ASTM F2554-10 standard. The document states: "TRE and ATE evaluates the error discrepancy between the position reported by the image guided surgery system and the ground truth position measured physically or otherwise."

8. The Sample Size for the Training Set

Not applicable. The document describes a medical device (a navigation system), not a machine learning model that requires a "training set" in the context of deep learning for image analysis. The "software" component is described as providing "functional components" and guidance, implying a rule-based or algorithmic system, not a data-driven machine learning model.

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

Not applicable, as there was no explicit "training set" in the typical machine learning sense. The device's software and algorithms are developed and verified through engineering principles and testing against established performance requirements and standards.

Summary

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August 8, 2018

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

Re: K181041

Trade/Device Name: 7D Surgical System Cranial Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW, OLO Dated: July 9, 2018 Received: July 11, 2018

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. 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/cdrl/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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jay R. Gupta -S

For Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181041

Device Name

7D Surgical System Cranial Application

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
þ 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 7D Surgical System Cranial Application

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: April 17, 2018

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:	7D Surgical System Cranial Application

These devices are classified as follows:

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

3. Substantially Equivalent Devices

7D Surgical believes the 7D Surgical System Cranial Application is substantially equivalent to the following currently marketed devices:

Product	510(k)
Envision 3D: Image Guidance System	K162375
Medtronic StealthStation System	K133444
BrightMatter Navigation System PointerTool	K142024

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The indications for use of the subject device 7D Surgical System Cranial Application are equivalent to the predicate device K142024, K133444 including the Envision 3D: Image Guidance System Spinal Application K162375. Furthermore, the technological characteristics of the 7D Surgical System Cranial Application are substantially equivalent. The differences in the technological characteristics do not raise new questions of safety and effectiveness. Consequently, the subject is substantially equivalent to the predicate device.

4. Purpose of Submission

The purpose of this submission is intended introduce the Cranial Application for the 7D Surgical System. The technology to support the Cranial Application is fundamentally equivalent to the currently cleared spinal application K162375 as both applications utilize structured light imaging to perform registration. In addition, the scope of this submission includes the Cranial instrumentation which includes a titanium Pointer tool and a multi-face reference frame articulating arm assembly which attaches to a skull clamp. It is important to note that there have been no significant changes made to the system cart hardware from that of K162375.

The Cranial Application introduces a new workflow specific to cranial procedures which is limited to the software component and instrumentation designed for cranial clinical applications. Key functional components of the system are an optical tracking subsystem, navigated surgical tools, custom software application and external displays. The navigated surgical tools are tracked using single-use passive reflective markers that are attached to the surgical tools, which include the Cranial Pointer and Reference Frame which are mounted onto an Articulating Arm attached to skull clamp, prior to each surgical procedure.

5. Indications for Use

6. Device Description and Technical Comparison to Predicate Devices

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intraoperative structured light images of the patient. The Cranial software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.

It is important to note that the fundamental technology of the Cranial Application is equivalent to the currently cleared Spinal Application. Both applications require structured light imaging provided by the currently marketed system cart hardware. ldentical to the Spinal Application, the system provides image registration between preoperative scan data and data captured intraoperatively from the 7D Surgical System integrated structured light scanner and/or user selected points of the Cranium. The system provides guidance data by displaying the locations of wireless optically tracked 7D Surgical System Cranial Instruments (examples include Reference Frame and Pointer) relative to the patient. Position and orientation data of tracked 7D Surgical System Cranial Instruments are linked to the preoperative scan data using the 7D Surgical System 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 7D Surgical System Cranial Application is comprised of 5 major components:

1. Cart
1. Arm
1. Head
1. Tracked surgical 7D Surgical System Cranial 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

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Provides mechanisms for routing cables between the head and the cart
The Head of the system serves 3 main purposes:
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 7D Surgical System Cranial Instruments -Pointer 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 external surgical lighting can prevent the acquisition of structured light images due to saturation of cameras during registration.

The Tracking System enables the surgeon to view the position and orientation of these 7D Surgical System Cranial Instruments relative to registered pre-operative image data while performing the surgical procedure. Each 7D Surgical System 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 7D Surgical System Instrument. Each 7D Surgical System 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.

7. Safety Considerations

This change to add compatibility the Cranial application to the 7D Surgical does not impact conformity to regulatory compliance standards. The device complies with recognized electrical safety standards: IEC 60601-1 standard for electrical safety and IEC 60601-1-2 standard for electromagnetic compatibility.

The biocompatibility assessment of 7D Surgical System Cranial Application 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.

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8. 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.

9. 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 7D Surgical System device:

. Non-Clinical System, Software, and Instrumentation Verification and Validation
. Non-Clinical Performance Surgical Simulations Conducted on Phantom Models
Compliance Conformity Assessments
- ISO 10993-1 Biological evaluation of medical devices.
- 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 (TRE) and Angular Trajectory Error (ATE) has been used to evaluate the clinical accuracy of the system on phantom models in a clinical simulated environment. TRE and ATE 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 7D Surgical System Cranial Application:

System Verification	Scope of the test is to verifythe design requirementspecifications of 7D SurgicalSystem under test caseprotocols.	Verification successful, alldesign requirements havebeen fulfilled.

System Validation	Scope of the test is to validatethe Indications For Use andCustomer Requirements of the7D Surgical System undersimulated use case situations.	Validation successful, all userneeds met.
Usability	This test is conducted tovalidate the 7D SurgicalSystem with respect to useerrors.	Validation successful, devicesafe and effective with respectto use errors.
Safety regarding risk analysis	Implementation andeffectiveness of all risk controlrequirements specified in the7D Surgical System riskanalysis is tested and verified.	Risk Control requirements areeffective and mitigate theassociated risks to anacceptable level.
Biocompatibility	The 7D Surgical System CranialInstrumentation was assessedto the following recognizedstandards:ISO 10993-1	Compliance with recognizedstandards has previously beenestablished in the predicatedevice K142024
Sterilization	The 7D Surgical System CranialInstrumentation was tested tothe following recognizedstandards:ISO 17665-1.	Compliance with recognizedstandards have been verifiedin this application.
Product Safety standards	The 7D Surgical System wastested to the followingrecognized standards:IEC 60601-1, IEC 60601-1-2,IEC 60601-1-6, IEC 60601-2-41,and IEC 60825-1.	Compliance with recognizedstandards have been verifiedin the previous applicationK162375. Previous test resultshave not been affected by thischange.
Non-Clinical Accuracy	System's accuracy is testedusing the 7D Surgical Systemon phantom models followingthe ASTM F2554-10 StandardPractice for Measurement ofPositional Accuracy ofComputer Assisted SurgicalSystems in addition to TargetRegistration Error and AngularTrajectory Error	All accuracy specificationshave been met.

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

It is important to note that the following Compliance Conformity Assessments were not required as a result of design implementation of the Cranial Application, as no substantial changes were made to the system cart. The information provided in application K162375 is still applies to the current 7D Surgical System:

. IEC 60601-1 Medical electrical equipment. General requirements for basic safety and essential performance, 2005, Amendment 1, 2012

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. 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

10. Clinical Data

A clinical trial was not required to demonstrate safety and effectiveness of the 7D Surgical System Cranial Application. Clinical validation is unnecessary as the 7D Surgical System Cranial Application introduces no new indications for use, and 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.

11. Conclusion

The 7D Surgical System Cranial Application is substantially equivalent in safety and effectiveness to the predicate devices identified above:

The predicate devices and 7D Surgical System use essentially the same ● technologies.
. The predicate devices and 7D Surgical System instrumentation have essentially the same materials and performance requirements.
The predicate devices and 7D Surgical System 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 7D Surgical System Cranial Application. The conclusions drawn from the nonclinical tests demonstrate that the 7D Surgical 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 7D Surgical System is substantially equivalent to the predicate device with respect to its indications for use, technological characteristics and performance characteristics.

514 Performance Standards

There are no Sec. 514 performance standards for this device.

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).