The Mazor X is indicated for precise positioning of surgical implants during general spinal and brain surgery. It may be used in either open or minimally invasive or percutaneous procedures.

Mazor X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects.

Device Description

The Mazor X hosts guidance for spine and brain procedures and intra-operative 3D image processing capabilities. It enables the surgeon to precisely position surgical instruments and/or implants (in spinal surgery). The planning of the surgical procedure and virtual placement of surgical instruments and/or implants (e.g., a screw) can be achieved through pre-operation planning based on the patient's CT scan or intraoperative planning based on Mazor X 3D Scan image or on a 3D image uploaded from an external 3D image acquiring system. The Mazor X enables accurate deployment of surgical accessories in the precise anatomical location according to predefined planning. With the imaging capabilities of the system, the user can also visualize the implants on the patients CT. The Mazor X is a device modification of the original Mazor X System cleared in 510(k) K163221.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Mazor X" device. This submission is for a modification of an existing device (Mazor X System, K163221), and therefore, the performance testing focuses on demonstrating that the modifications do not adversely affect the device's safety, effectiveness, and performance compared to the predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Limited Information on Acceptance Criteria and Studies:

It's important to note that this 510(k) summary focuses on demonstrating substantial equivalence of a modified device to a predicate device. As such, it does not detail a comprehensive study establishing novel acceptance criteria or a full clinical study with specific performance metrics (like sensitivity, specificity, accuracy) that would be typical for a new device's initial clearance or a comparative effectiveness study. The "acceptance criteria" here are primarily about demonstrating that the modified device performs as well as the predicate and meets its design requirements.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a modification submission, the "acceptance criteria" are implicitly tied to maintaining the performance and safety established by the predicate device and meeting design requirements for the modifications. Specific quantitative performance metrics are not provided in this document in a tabular format.

Acceptance Criteria (Implicit from text)	Reported Device Performance
Software Validation: Meet design requirements of the Mazor X software version.	Demonstrated compliance through validation testing for procedure simplicity, system startup, security, user interfaces, diagnostics, error handling, performance, robustness, installation, and database.
Mazor X Align Module Functionality: Maintain or improve performance of the original Align module after modifications.	Retested according to the same functionality as the original Mazor X Align module, including: Validation of changes related to updating CT-based fluoroscopy images and pre-operative registration method (CT-Xray). Validation of lateral positioning. Validation of modifications to the vertebral end-plates recognition algorithm. Integration testing of the modified system.
Safety, Effectiveness, and Performance: Modifications should not adversely affect these aspects compared to the predicate.	The performance testing and comparison to the predicate device demonstrated that the Mazor X system is as safe, as effective, and performs as well as the legally marketed Mazor X System predicate device. The Mazor X system was tested according to the aforementioned validation and performance tests and found compliant.

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

The document does not explicitly state sample sizes for tests. The descriptions focus on "validation testing" and "retesting" of specific modules and algorithms. It does not mention clinical studies with human patient data or specific "test sets" in the context of typical AI/machine learning evaluation (e.g., a set of patient images for diagnostic accuracy).

Sample Size: Not specified.
Data Provenance: Not specified. The tests are described as software validation testing and functionality testing for the modified Align module. This implies testing with internal data or synthetic data relevant to the software functionalities, rather than patient data from specific countries or retrospective/prospective studies.

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

Given the nature of the tests described (software and functionality validation), there's no indication that a "ground truth" was established by medical experts for a diagnostic or interventional task, which would typically involve human reviewers. The tests are against design requirements and algorithmic performance.

Number of Experts: Not mentioned.
Qualifications: Not mentioned.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the described tests are technical validations against specifications and functionality rather than human-interpreted diagnostic outcomes.

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

No MRMC study is mentioned. The document focuses on demonstrating that the modified device is as safe and effective as the predicate device, not on comparing human performance with and without AI assistance.

Effect Size of Human Readers Improve: Not applicable; no MRMC study reported.

6. Standalone (Algorithm Only) Performance Study

The performance tests mentioned are for the integrated "Mazor X system" and its "software version" and "Align module." While these are tests of the algorithm's functionality, the document describes the system as enabling surgeons to position instruments and implants, and its imaging capabilities provide processing and conversion of fluoroscopic projections. This suggests the algorithm's performance is tested within the context of its intended function as part of a surgical guidance system, rather than as a standalone diagnostic tool. The "algorithm only" performance is embedded within the "Software validation testing" and "retraining" of the Align module.

7. Type of Ground Truth Used

The "ground truth" for the reported tests appears to be based on:

Design requirements/specifications: For the software validation.
Established functionality of the original Mazor X Align module: For retesting the modified Align module.
Algorithmically derived correct states: For parameters like lateral positioning validation and vertebral end-plates recognition.

It is not based on expert consensus, pathology, or outcomes data as these are not clinical studies.

8. Sample Size for the Training Set

No information about a training set is provided. This 510(k) pertains to a device modification and validation, not the initial development or training of a machine learning model from scratch where a distinct "training set" would typically be detailed. The "software optimization" and "enhanced functionalities" likely involved development and testing, but the specific "training set" for any underlying machine learning components is not discussed.

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

Not applicable, as no training set is described in this document.

Summary

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April 30, 2018

Image /page/0/Picture/1 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 USA seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

Mazor Robotics Ltd. % Ahava Stein Regulatory Affairs Consultant A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as St. Kfar Saba, 44425 Isreal

Re: K180307

Trade/Device Name: Mazor X Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, HAW, LLZ Dated: March 11, 2018 Received: March 14, 2018

Dear Ahava Stein:

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,

Katherine D. Kavlock -S

for 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)

K180307

Device Name Mazor X

Indications for Use (Describe)

The Mazor X is indicated for precise positioning of surgical implants during general spinal and brain surgery. It may be used in either open or minimally invasive or percutaneous procedures.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
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☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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SUMMARY OF SAFETY AND EFFECTIVENESS

K180307 (Premarket Notification [510(k)] Number)

1. Submitter Information

Manufacturer Name and Address	Mazor Robotics Ltd.
	PO Box 3104,
	5 Shacham St.,
	Caesarea Park North 3088900,
	Israel
Official Correspondent	Ahava Stein
	A. Stein - Regulatory Affairs Consulting Ltd.
	20 Hata'as St. (Beit Hapaamon, Suite 102)
	Kfar Saba 4442520,
	Israel

1. Date Prepared: April 22, 2018
Device Name Mazor X 3.

Proprietary Name:	Mazor X
Common Name:	Combination of:1. Stereotaxic instrument; and2. System, Image Processing, Radiological
FDA Classification Name:	21 CFR 882.4560; Stereotaxic instrument

FDA Classification: Class II, Product Code OLO, HAW and LLZ

Predicate Devices 4.

The Mazor X is substantially equivalent to the following device:

Manufacturer	Device	510(k)	Date Cleared
Mazor Robotics Ltd.	Mazor X System	K163221	April 04, 2017

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5. Device Description

Indications for Use 6.

The Mazor X is indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It may be used in either open or minimally invasive or percutaneous procedures.

7. Performance Standards

There are no performance standards under the Federal Food, Drug and Cosmetic Act, for the Mazor X.

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8. Performance Testing

The following Performance tests were performed on the Mazor X system:

· Software validation testing in accordance with the FDA Guidance for the Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) and the IEC 62304 Standard for Medical Device Software - Software Life Cycle Processes. The software validation tests demonstrate that the Mazor X software version meets the design requirements. Test cases were designed for testing procedure simplicity, system startup, security, user interfaces, diagnostics and error handling, performance and robustness, installation, and database.
· The modified Mazor X Align module was retested according to the same functionality testing as the original Mazor X Align module and included the following validation testing:
- · Testing the registration algorithm to validate the changes related to updating the CT based fluoroscopy images and the pre-operative registration method (CT-Xray).
- · Validation of lateral positioning.
- · Validation of the modifications to the vertebral end-plates recognition algorithm.
- · Integration testing of the modified Mazor X System.

9. Technological Characteristics Compared to Predicate Device

The device modifications included modified software with minor software changes and a slightly modified Mazor X System (minor hardware changes). The software changes included SW optimization within the established specifications, enhanced functionalities (e.g., updating CT based fluoroscopy images and pre-operative registration method (CT-X-ray), support of lateral approach and modifications to the vertebral endplates recognition algorithm), as well as screen enhancements (graphical enhancements and enhanced information presented on screen). The modified Mazor X workstation and Surgical System are very similar to the Mazor X workstation and Surgical System with some minor technical and design improvements to allow better manufacturability during assembly process.

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The modifications do not adversely affect the safety, effectiveness and performance of the Mazor X system. The Mazor X system was tested according to the aforementioned validation and performance tests and found compliant.

The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the indications for use of the Mazor X system are substantially equivalent to the predicate device cited above.

Conclusion 10.

The performance testing and comparison to the predicate device demonstrate that the Mazor X system is as safe, as effective and performs as well as the legally marketed Mazor X System predicate device. Therefore, the Mazor X system is substantially equivalent to the Mazor X System cleared under K163221.

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).