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 IZI Pedicle Access Kit, 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.

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 IZI Pedicle Access Kit, 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. 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.

AI/ML Overview

The provided text does not contain information about an AI/ML-driven device or study. It describes a 510(k) premarket notification for the "7D Surgical System," which is a stereotaxic image guidance system intended for spatial positioning and orientation of neurosurgical instruments and as a primary surgical luminaire during image-guided surgery. This system appears to be a hardware and software system for surgical navigation, not an AI/ML diagnostic or prognostic tool.

Therefore, many of the requested details regarding acceptance criteria, training/test sets, expert ground truth, MRMC studies, and standalone algorithm performance, which are typical for AI/ML validation, are not applicable or described in this document.

However, I can extract information related to the device's performance testing and general acceptance criteria as described for this non-AI system.

Here's an attempt to answer based on the provided text, highlighting what is missing or not applicable:

1. A table of Acceptance Criteria and the Reported Device Performance:

The document describes performance in terms of verification and validation activities, particularly accuracy.

Acceptance Criteria Category for 7D Surgical System	Reported Device Performance
System Verification	Verification successful, all design requirements have been fulfilled. (Scope: verify design requirement specifications under test case protocols)
System Validation	Validation successful, all user needs met. (Scope: validate 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. (Scope: Implementation and effectiveness of all risk control requirements specified in the 7D Surgical System risk analysis are tested and verified)
Product Safety standards conformity	Compliance with recognized standards have been verified in the previous application K142344. (Tested to 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). Previous test results have not been affected by this change (addition of IZI Pedicle Access Kit compatibility).
Non-Clinical Accuracy	All accuracy specifications have been met for the IZI Pedicle Access Kit. (System's accuracy tested using the 7D Surgical System on phantom models following ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems, in addition to Target Registration Error (TRE)). Accuracy testing for the currently cleared Reference Frame, Awl and Pedicle Probe have been verified in previous application K180352. The document mentions "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 specific numerical accuracy metrics or thresholds met are not explicitly provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: The document mentions "phantom models" for non-clinical accuracy testing. It does not specify a numerical sample size (e.g., number of phantoms, number of measurements per phantom).
Data Provenance: The studies were "Non-Clinical Performance Surgical Simulations Conducted on Phantom Models" and "Non-Clinical Accuracy" tests on phantom models in a "clinical simulated environment." This indicates the data is synthetic/simulated, not from real patient cases. No information on country of origin for this simulated data.
Retrospective or Prospective: Not applicable as it's non-clinical, phantom-based testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the document. Given that the testing was "Non-Clinical Accuracy" on "phantom models" and describes "Target Registration Error (TRE)" as a comparison between the system's reported position and "ground truth position measured physically or otherwise," it's highly likely the ground truth was established through precise physical measurements using metrology tools, not human expert consensus, for this mechanical/optical navigation system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not mentioned. This concept (adjudication for discordant interpretations) typically applies to human readers interpreting medical images or data, not to the performance measurement of a surgical navigation system's mechanical/optical accuracy on phantoms.

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:

No MRMC study was performed or described. The device is a surgical navigation system, not an AI diagnostic/prognostic tool that assists human image readers. Clinical data (and thus human reader studies) were deemed "unnecessary" because the device introduces "no new indications for use" and its features are "equivalent to the previously cleared predicate device."

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

The document describes "Non-Clinical Accuracy" testing of the "System's accuracy... on phantom models." This testing measures the system's ability to accurately track and report positions relative to a physical ground truth, which can be considered a standalone performance assessment of the navigation component. The device's primary function is to provide guidance (essentially "standalone" positional data) that a human surgeon then uses. The document states, "TRE evaluates 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 direct algorithmic measurement comparison.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For "Non-Clinical Accuracy," the ground truth was established through "physical measurements" or "otherwise" on "phantom models." This is evident from the description of Target Registration Error (TRE) as comparing the system's reported position to the "ground truth position measured physically or otherwise." It is not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

Not applicable/Not mentioned. This device does not appear to be an AI/ML system that requires a "training set" in the conventional sense for model development. The system's operation is based on structured light sensing and optical tracking of physical markers.

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

Not applicable. As a non-AI/ML system, there is no "training set" for which ground truth would need to be established in the context of machine learning model training.

Summary

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August 7, 2019

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

Re: K183276

Trade/Device Name: 7D Surgical System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 24, 2019 Received: June 25, 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.

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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, MPH 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) K183276

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: November 15, 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; HAW

3. Substantially Equivalent Devices

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

Product	510(k)
7D Surgical System	K180352

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 Surgical System are substantially equivalent. The differences in the technological

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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 IZI Medical Products LLC Navigated Pedicle Access Kit.

It is important to note that the Medtronic StealthStation System (K133444) and the Medtronic HORIZON Spinal System (K153442) are considered reference devices for the proposed submission.

5. Indications for Use

6. Device Description and Technical Comparison to Predicate Devices

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7. Safety Considerations

This change to add compatibility to the 7D System to include navigational tracking of the IZI Pedicle Access Kit 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 IZI Pedicle Access Kit 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 (TRE) 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 7D Surgical System:

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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 tovalidate the Indications ForUse and CustomerRequirements of the 7DSurgical System undersimulated use case situations.	Validation successful, all userneeds met.
Safety regarding risk analysis	Implementation andeffectiveness of all riskcontrol requirementsspecified in the 7D SurgicalSystem risk analysis aretested and verified.	Risk Control requirementsare effective and mitigate theassociated risks to anacceptable level.
Product Safety standards	The 7D Surgical System andInstrumentation was testedto the following recognizedstandards: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.	Compliance with recognizedstandards have been verifiedin the previous applicationK142344. Previous test resultshave not been affected bythis change. Please seeapplication K162375 fortesting results related to the7D Surgical System.
Non-Clinical Accuracy	System's accuracy is testedusing the 7D Surgical Systemon phantom modelsfollowing the ASTM F2554-10Standard Practice forMeasurement of PositionalAccuracy of ComputerAssisted Surgical Systems inaddition to TargetRegistration Error.	All accuracy specificationshave been met for the IZIPedicle Access Kit. Accuracytesting for the currentlycleared Reference Frame,Awl and Pedicle Probe havebeen verified in previousapplication K180352.

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

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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 IZI Pedicle Access Kit. 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).