(139 days)
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.
The Mazor X enables the surgeon to precisely position surgical instruments and/or implants (in spinal and brain surgery). The Mazor X enables guidance for spine and brain procedures and intra-operative 3D image processing capabilities. 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 intra-operative 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 Renaissance X System cleared in 510(k) K152041.
This document describes the Mazor X, a device for precise positioning of surgical implants during spinal and brain surgery, and its substantial equivalence to predicate devices. It focuses on the device's software validation and measurement comparison testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical quantitative sense for clinical metrics like accuracy, sensitivity, or specificity. Instead, it discusses performance testing related to software and measurement comparison.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software meets design requirements (per FDA Guidance & IEC 62304) | Software validation tests demonstrate modified software meets design requirements. |
| X Align module measurements comparable to Surgimap's calculations | Measurement Comparison testing showed comparison of the X Align module and the Surgimap measurement calculations. (Implies comparability, though no specific metrics are given). |
| Device is safe and effective as predicate devices | Performance testing and comparison demonstrate Mazor X is as safe, as effective, and performs as well as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified for the software validation or measurement comparison testing. The document states "software validation tests" and "measurement comparison testing" were performed, but no number of samples or cases is given.
- Data Provenance: Not specified. It's unclear if these tests involved patient data, simulated data, or a combination. The document mentions "pre-operation planning based on the patient's CT scan" and "intra-operative planning based on Mazor X 3D Scan image," suggesting potential use of imaging data, but the source (country, retrospective/prospective) for the testing itself is not detailed.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The performance testing described (software validation, measurement comparison) doesn't inherently require expert-established ground truth in the same way a clinical diagnostic study would. The "ground truth" for software validation would be its functional specifications, and for measurement comparison, it would be the accepted calculations of the predicate device (Surgimap).
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the described tests (software validation, measurement comparison), a multi-reader adjudication method would not typically apply.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case comparative effectiveness study is not mentioned in the document. The testing described focuses on standalone device performance (software and measurement capabilities) compared to a predicate device's calculations, rather than comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the described performance testing appears to be a standalone (algorithm only) assessment. The software validation tests demonstrate the modified software's adherence to design requirements, and the measurement comparison tests evaluate the X Align module's calculations against Surgimap's, implying an assessment of the algorithm's output rather than human interaction with it.
7. The Type of Ground Truth Used
- For software validation: The "ground truth" would be the design requirements and specifications of the software, as outlined in the FDA Guidance for Premarket Submissions for Software Contained in Medical Devices and the IEC 62304 standard.
- For measurement comparison: The "ground truth" for the X Align module's performance would be the measurement calculations derived from the predicate device, Surgimap.
8. The Sample Size for the Training Set
This information is not provided. The document details performance testing (validation and comparison) but does not discuss the development or training of any machine learning components, nor any associated training set sizes.
9. How the Ground Truth for the Training Set was Established
This information is not provided, as the document does not mention a training set or the establishment of its ground truth.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2017
Mazor Robotics Ltd. % Ahava Stein Regulatory Affairs Consultant A. Stein - Regulatory Affairs Consulting Ltd. 20 Hatas St., (Beit Hapaamon, Suite 102) Kfar Saba. IL 4442520
Re: K163221
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 8, 2017 Received: March 13, 2017
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Mazor X
vice Name
zor 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.
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.
| 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
K163221
(Premarket Notification [510(k)] Number)
1. Submitter Information
| Manufacturer Name and Address | Mazor Robotics Ltd. |
|---|---|
| PO Box 3104, | |
| 7 HaEshel St., | |
| Caesarea Park South 3088900, | |
| Israel | |
| Official Correspondent | Ahava Stein and Moshe Rosenberg |
| A. Stein - Regulatory Affairs Consulting Ltd. | |
| 20 Hata'as St. (Beit Hapaamon, Suite 102) | |
| Kfar Saba 4442520, | |
| Israel |
-
- Date Prepared: November 13, 2016
-
- Device Name Mazor X
| 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 |
4. Predicate Devices
The Mazor X is substantially equivalent to the following devices:
| Manufacturer | Device | 510(k) | Date Cleared |
|---|---|---|---|
| Mazor Robotics Ltd. | Renaissance X System | K152041 | November 17, 2015 |
| Nemaris Inc. | Surgimap | K111019 | September 30, 2011 |
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5. Device Description
The Mazor X enables the surgeon to precisely position surgical instruments and/or implants (in spinal and brain surgery). The Mazor X enables guidance for spine and brain procedures and intra-operative 3D image processing capabilities. 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 intra-operative 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 Renaissance X System cleared in 510(k) K152041.
6. Indications for Use
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.
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.
Performance Standards 7.
There are no performance standards under the Federal Food, Drug and Cosmetic Act, for the Mazor X.
8. Performance Testing
The following Performance tests were performed on the Mazor X:
- 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
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62304 standard for Medical Device Software - Software Life Cycle Processes. The software validation tests demonstrate that the modified software version meets its design requirements.
- Measurement Comparison testing comparison testing of the X Align module and the . Surgimap measurement calculations.
Technological Characteristics Compared to Predicate Device 9.
The differences in the software do not adversely affect the safety, effectiveness or performance of the Mazor X. The Mazor X was tested according to the aforementioned validation and performance tests (detailed in section 8) 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 are substantially equivalent to the predicate devices cited above.
10. Conclusion
The performance testing and comparison to the predicate devices demonstrate that the Mazor X is as safe, as effective and performs as well as the legally marketed Renaissance X System and Surgimap predicate devices. Therefore, the Mazor X is substantially equivalent to the predicate devices and may be cleared for marketing.
§ 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).