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 Universal Tracking Clamp, 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 previously cleared 7D Surgical System and Brainlab, the system tracks the position and orientation of a Universal Tracking Clamp.

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 Universal Tracking Clamp, utilizes commercially available passive reflective marker spheres 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, registration verification, and navigation.

The 7D Surgical Universal Tracking Clamp consists of two different size tracking arrays which hold the reflective marker spheres both with a unique marker arrangement to distinguish one from the other. The tracker arrays attach to two different clamps of different sizes which attach to 30 party spinal surgical instruments. The Universal Tracking Clamp when attached to 30 party spinal instruments requires calibration in order to accurately display the position and orientation of the tool in the 7D Surgical System software.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Requirement)	Reported Device Performance (Conclusion)
System Verification	All design requirements have been fulfilled.
System Validation	All user needs met (validates Indications For Use and Customer Requirements under simulated use case situations).
Safety regarding risk analysis	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) verified.
Non-Clinical Accuracy	All accuracy specifications have been met for the Universal Tracking Clamp. Accuracy testing for the currently cleared Reference Frame, Awl, and Pedicle Probe have been verified.

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

The provided document describes non-clinical performance testing conducted on phantom models. It does not specify a numerical sample size (e.g., number of cases or runs) for the accuracy testing.

Data Provenance: The testing was conducted internally by 7D Surgical, Inc. on phantom models, simulating clinical use. There is no mention of country of origin for data as it's a simulated environment, nor whether it's retrospective or prospective, as it's not a human clinical study.

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

This information is not provided in the document. The ground truth for the non-clinical accuracy testing was established by physical measurements or "otherwise" in a simulated environment, not through expert consensus in a clinical setting.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth was established through physical measurements on phantom models, not through expert review requiring adjudication.

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

No, an MRMC comparative effectiveness study was not performed and is not mentioned. The document explicitly states: "A clinical trial was not required to demonstrate safety and effectiveness of the 7D Surgical System."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The described non-clinical accuracy testing is a form of standalone performance evaluation for the device's ability to track and display positions accurately on phantom models. While it involves a human operator using the system, the focus of the accuracy tests (Target Registration Error, Angular Trajectory Error, and ASTM F2554-10 compliance) is on the system's intrinsic measurement and navigation capabilities, separate from overall human surgical outcomes. Therefore, it implicitly evaluates the algorithm's performance in determining position and orientation.

7. Type of Ground Truth Used

For the non-clinical accuracy testing:

Physical Measurement: The document states that Target Registration Error (TRE) and Angular Trajectory Error (ATE) evaluate the error discrepancy between the position reported by the image-guided surgery system and the "ground truth position measured physically or otherwise." This indicates that a physically measured gold standard was used on the phantom models.
ASTM F2554-10 Standard: Compliance with this standard also implies a defined method for establishing ground truth for positional accuracy.

8. Sample Size for the Training Set

The document does not specify a training set sample size or details about a training set. As this is a device for image-guided surgery (navigation), rather than an AI-driven diagnostic or predictive algorithm learning from large datasets, the concept of a "training set" in the context of machine learning is not directly applicable here. The system uses algorithms for structured light scanning, image registration, and tracking, but these are typically developed and validated through engineering principles and specific test cases rather than large-scale data training.

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

Since a "training set" in the context of machine learning is not explicitly mentioned or applicable to the type of device described, this information is not provided. The device's underlying algorithms and functionalities would have been developed and tested against engineering specifications and internal validation criteria.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

November 5, 2019

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

Re: K192140

Trade/Device Name: 7D Surgical System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 7, 2019 Received: August 8, 2019

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/cdrh/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

{1}------------------------------------------------

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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K192140

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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: November 05, 2019

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 and Universal Tracking Clamp is substantially equivalent to the following currently marketed devices:

Product	510(k)
7D Surgical System	K180352
BrainLAB Vectorvision (Starlink)	K082060

The indications for use of the subject device 7D Surgical System are equivalent to the predicate device K180352. Furthermore, the technological characteristics of the 7D

{4}------------------------------------------------

Surgical System 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. It is important to note the 7D Surgical System K180352 is considered the Primary Predicate Device for this application.

It is important to note that the BrainLAB Vectorvision K082060, which consists of a Starlink Adapter Clamp, is a Reference Device to the 7D Surgical Universal Tracking Clamp as they are comparable in intended use, functional and dimensional characteristics, and overall performance.

4. Purpose of Submission

The proposed change for the 7D Surgical System is to introduce the 7D Surgical Universal Tracking Clamp. The Universal Tracking Clamp, which consists of a tracking array, is designed to clamp onto the shaft of a non-tracked spinal surgical instrument. After the system performs a calibration of the Universal Tracking Clamp when attached to a spinal surgical instrument, the system can display the position and orientation of the instrument, enabling real-time image guided navigation.

5. Indications for Use

6. Device Description and Technical Comparison to Predicate Devices

{5}------------------------------------------------

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 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 (TRE) and Angular Trajectory Error (ATE) has been used to evaluate the clinical accuracy of the system on phantom models in a clinical simulated

{6}------------------------------------------------

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:

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.
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 verified.
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 theUniversal Tracking Clamp.Accuracy testing for thecurrently cleared ReferenceFrame, Awl and Pedicle Probehave been verified.

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 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 predicate device identified. The clinical safety and effectiveness of Image Guided Surgery Systems are historically accepted for both the predicate and subject device.

{7}------------------------------------------------

10. 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 equivalent 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 Tracking Clamp. 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.

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).