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 posterior approach spine surgery where reference to a rigid anatomical structure can be identified.

Device Description

The 7D Surgical 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 7D Surgical System structured light scanner and/or user selected points. The system provides guidance data by tracking and displaying the position and orientation of wireless optically tracked Spinal Instruments including the 7D Surgical Pedicle Probe and Awl, now including the Medtronic Universal Drill Guide, relative to the patient. Position and orientation data of tracked Spinal 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. Similar to the Medtronic Stealth Station, the system tracks the position and orientation of the Medtronic Universal Drill Guide.

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 Tracking System enables the surgeon to view the position and orientation of 7D Surgical System Spinal Instruments relative to registered preoperative image data while performing the surgical procedure. Each of the 7D Surgical System instruments, including the Medtronic Universal Drill Guide, utilizes commercially available passive reflective marker spheres [Manufactured by NORTHERN DIGITAL, INC.; 510(k) K033621] to determine the position and orientation of instruments. Each tracked Instruments 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. lt provides methods for loading preoperative scans and guides the surgeon through the process of surface model creation, structured light acquisition, registration verification, and navigation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the 7D Surgical System, based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
System Verification: Design requirements specifications of 7D Surgical System under test case protocols.	Conclusion: Verification successful, all design requirements have been fulfilled.
System Validation: Indications For Use and Customer Requirements of the 7D Surgical System under simulated use case situations.	Conclusion: Validation successful, all user needs met.
Usability: Validate the 7D Surgical System with respect to user errors.	Conclusion: Validation successful, device safe and effective with respect to user errors.
Safety regarding risk analysis: Implementation and effectiveness of all risk control requirements specified in the 7D Surgical System risk analysis.	Conclusion: Risk Control requirements are effective and mitigate the associated risks to an acceptable level.
Product Safety standards: Compliance with recognized standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-41, IEC 60825-1, ISO 10993-1, and ISO 17665-1).	Conclusion: Compliance with recognized standards has been verified in the previous application K162375. Previous test results have not been affected by this change.
Non-Clinical Accuracy: System's accuracy tested using the 7D Surgical System on phantom models following ASTM F2554-10 Standard Practice and Target Registration Error.	Conclusion: All accuracy specifications have been met for the Medtronic Universal Drill Guide. Accuracy testing for the currently cleared Reference Frame, Awl and Pedicle Probe have been verified in previous application K162375.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical sample size. The testing was conducted on "phantom models" in a "clinical simulated environment." The number of phantom models or specific test cases performed for accuracy is not quantified.
- Data Provenance: The study was "non-clinical" and involved "phantom models." There is no indication of human patient data (retrospective or prospective) or country of origin for such data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the study was non-clinical, using phantom models. Ground truth for accuracy was established through physical measurements ("measured physically or otherwise") rather than expert consensus on medical images or clinical outcomes.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as the study was non-clinical, focusing on device accuracy measured against a physical ground truth, not requiring expert adjudication of interpretations.
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. This was a non-clinical performance study of a surgical navigation system's accuracy, not an MRMC study comparing human reader performance with or without AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The "Non-Clinical Accuracy" testing evaluated the system's accuracy (algorithm and hardware) in determining positional information against a ground truth on phantom models. While a human surgeon would ultimately use the system clinically, this specific test isolated the device's inherent navigational accuracy.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for accuracy testing involved comparing the position reported by the image-guided surgery system to the "ground truth position measured physically or otherwise." This implies a physical measurement or established reference standard on the phantom models.
The sample size for the training set:
- Not applicable. This document describes verification and validation activities for a new software compatibility feature (Medtronic Universal Drill Guide) for an existing surgical navigation system. It does not refer to a machine learning model that would require a distinct "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set for a machine learning algorithm.

Summary

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May 2, 2018

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

Re: K180352

Trade/Device Name: 7D Surgical System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 29, 2018 Received: April 2, 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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,

Mark N. Melkerson -S

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) K180352

Device Name

7D Surgical 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 7D Surgical 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: February 05, 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

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

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

The indications for use of the subject device 7D Surgical System are equivalent to the predicate device K133444 and K162375. Furthermore, the technological characteristics of the 7D Surgical System are substantially equivalent. The differences in the

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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 proposed software change for the 7D Surgical System is intended to enable compatibility with the Medtronic Universal Drill Guide Set. The Universal Drill Guide Set is part of the Medtronic Spinal Navigation Instrument product line which assists surgeons with positioning of a drill to create the canal for screw placement. Similar to the 7D Surgical System, these stereotactic instruments are optically tracked by reflective marker spheres to locate the instruments' position and orientation relative to the patient's preoperative image. The Universal Drill Guide is currently designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

5. Indications for Use

6. Device Description and Technical Comparison to Predicate Devices

The Tracking System enables the surgeon to view the position and orientation of 7D Surgical System Spinal Instruments relative to registered preoperative image data while

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performing the surgical procedure. Each of the 7D Surgical System instruments, including the Medtronic Universal Drill Guide, utilizes commercially available passive reflective marker spheres [Manufactured by NORTHERN DIGITAL, INC.; 510(k) K033621] to determine the position and orientation of instruments. Each tracked Instruments requires a unique marker position configuration to enable the tracking system to distinguish the tools from one to the other.

7. Safety Considerations

This change to add compatibility to the 7D System to include navigational tracking of the Medtronic Universal Drill Guide Set did not impact conformity to regulatory compliance standards as only the system software has been modified to support this new feature. Software and User Instructions risk control measures have been implemented to ensure all new risks associated with use of the Medtronic Universal Drill Guide Set have been adequately controlled.

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 ●
- 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

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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:

Verification and Validation	Description	Conclusion
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 usererrors.	Validation successful, devicesafe and effective with respectto user errors.
Safety regarding risk analysis	Implementation andeffectiveness of all risk controlrequirements specified in the7D Surgical System riskanalysis are tested andverified.	Risk Control requirements areeffective and mitigate theassociated risks to anacceptable level.
Product Safety standards	The 7D Surgical 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 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.	All accuracy specificationshave been met for theMedtronic Universal DrillGuide. Accuracy testing for thecurrently cleared ReferenceFrame, Awl and Pedicle Probehave been verified in previousapplication K162375.

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

10. Clinical Data

A clinical trial was not required to demonstrate safety and effectiveness of the 7D Surgical System. Clinical validation is unnecessary as the 7D Surgical System introduces no new indications for use, and device features are equivalent to the previously cleared

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7D Surgical System

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 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 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 the 7D Surgical System compatibility with the Universal Drill Guide. The conclusions drawn from the non-clinical 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).