The 7D Surgical System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical 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 FlashLock and Flex Rod, 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, the system tracks the position and orientation of a FlashLock and Flex Rod.

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 FlashLock and Flex Rod, 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.

AI/ML Overview

The provided text describes a 510(k) submission for the 7D Surgical System with new instruments (FlashLock and Flex Rod). It does not contain information about an AI-powered device or a multi-reader, multi-case (MRMC) comparative effectiveness study. Therefore, I cannot fully answer all aspects of your request as they pertain to AI device performance.

However, I can extract the information provided regarding the device's acceptance criteria and the study conducted, focusing on the available details.

Here's a breakdown of the information provided in the document:

1. A table of acceptance criteria and the reported device performance

The document mentions "Non-Clinical Accuracy" testing as proof that "All accuracy specifications have been met for the FlashLock and Flex Rod." However, it does not provide specific numerical acceptance criteria or the exact reported performance values (e.g., specific TRE or ATE values). It only states that the testing was performed using ASTM F2554-10 and Target Registration Error (TRE).

Acceptance Criteria	Reported Device Performance
Non-Clinical Accuracy (ASTM F2554-10 & TRE): System's accuracy testing on phantom models. Specific numerical criteria not provided in document.	"All accuracy specifications have been met for the FlashLock and Flex Rod." Specific numerical performance not provided.

2. Sample size used for the test set and the data provenance

The document mentions "phantom models" for non-clinical performance surgical simulations. It does not specify the sample size of these phantom models or their provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of experts to establish ground truth for the test set. The ground truth appears to be established by physical measurements on phantom models, as indicated by the description of TRE and ATE.

4. Adjudication method for the test set

Not applicable, as expert adjudication is not mentioned for establishing ground truth or evaluating the device's accuracy on phantom models.

5. 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a stereotaxic surgical navigation system, not an AI-powered diagnostic or assistive tool for human readers in the sense of image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The performance testing (Non-Clinical Accuracy) was conducted on the "System's accuracy... using the 7D Surgical System on phantom models." This can be considered a form of standalone performance evaluation for the navigation system, focusing on its accuracy in guiding instruments. However, it's not an "algorithm-only" performance in the context of an AI device interpreting data. The system itself is the "standalone" entity being evaluated for its navigational accuracy.

7. The type of ground truth used

The ground truth used for accuracy evaluation (TRE and ATE) was based on: "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 physically measured ground truth on phantom models, not derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

The document does not mention a "training set" as would be applicable to machine learning or AI models. This system is described as a "stereotaxic image guidance system" and its functionality seems to be based on established engineering principles of tracking and navigation, rather than a learned model.

9. How the ground truth for the training set was established

Not applicable, as a training set for an AI model is not mentioned.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The first logo on the left is the Department of Health & Human Services logo. The second logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue.

September 3, 2020

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

Re: K201966

Trade/Device Name: 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: July 13, 2020 Received: July 15, 2020

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.

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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 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/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

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Indications for Use

510(k) Number (if known) K201966

Device Name

7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array

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

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: July 06, 2020

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 FlashLock 1, 7D Surgical Flex Rod Connector
	- 5.5 mm - 150 mm, 7D Surgical Flex Array

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 FlashLock and Flex Rod is substantially equivalent to the following currently marketed devices:

Product	510(k)
7D Surgical System	K180352(primary) and K192140(secondary)

The indications for use of the subject device 7D Surgical System are equivalent to the predicate device K180352 and K192140. 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 change for the 7D Surgical System is to introduce the 7D Surgical FlashLock and Flex Rod instruments.

The 7D Surgical Flex Rod used in conjunction with the 7D Surgical Flex Array is intended to be used as a patient referencing device when attached to a pedicle screw which has been inserted into the vertebral body. It should be noted that the Flex Array has identical tracking marker sphere configuration as the currently marketed 7D Surgical Reference Clamp. The Flex Array and Flex Rod assembly is identical in intended use to the current Reference Clamp except in the way it is rigidly attached to the spine. The currently marketed 7D Surgical patient referencing device is rigidly attached to the spine by use of an Ikuta Clamp design, whereas the Flex Rod attaches to an already implanted pedicle screw.

The 7D Surgical FlashLock is a ¼" quick connect adapter that has a rotatable tracking marker sphere array. The FlashLock requires a non-tracked insert and handle to be attached to it. Examples of inserts that can be used are drill bits, taps, and screwdrivers that have a ¼" quick connect interface. Examples of handles are T-handles, ratcheting handles or surgical drills. Once calibrated using the 7D Surgical calibration device, the user can rotate the handle and insert while holding the FlashLock array stationary facing the 7D Surgical System tracking camera.

5. Indications for Use

6. Device Description and Technical Comparison to Predicate Devices

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Surgical System, the system tracks the position and orientation of a FlashLock and Flex Rod.

7. Safety Considerations

This change to add compatibility to the 7D System to include navigational tracking of the FlashLock and Flex Rod did not impact conformity to regulatory compliance standards as only the system software has been modified to support this new feature. Software, Mechanical Design, and User Instructions risk control measures have been implemented to ensure all new risks associated with use of the FlashLock and Flex Rod 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

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7D Surgical System

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:

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 verifiedin the previous application.Previous test results have notbeen affected by this change.
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 theFlashLock and Flex Rod.

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

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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 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 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 FlashLock and Flex Rod. 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).