(30 days)
The Renaissance System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. It may be used in either open or percutaneous procedures.
Renaissance 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 Renaissance System hosts guidance for spine procedures and intra-operative 3D image processing capabilities. It enables the surgeon to precisely position surgical instruments and/or implants. 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 patients' CT scan. The "Scan-and-Plan" new feature enables intra-operative planning on the 3D Scan (formerly the C-Insight) image or on a 3D image uploaded from an external 3D image acquiring system (e.g., Medtronic O-arm). The new "Scan-and-Plan" feature replaces the need for a pre-operative CT scan and pre-operative planning, although this feature is still available in the system.
The modified Renaissance System also allows retrieving DICOM files from the hospitals' PACS system for operation planning purposes.
In addition, the modified Renaissance System enables the user to download MRI data and fuse it with CT data in order to provide the user with additional information on the patient's anatomy during the pre-operative planning stage.
The Mazor Robotics Renaissance System (K113228) is a surgical guidance system for spinal procedures. The provided documentation does not explicitly list acceptance criteria in a table format with corresponding device performance values, nor does it detail a standalone human-in-the-loop study with specific accuracy metrics. However, it mentions performance testing and a comparison to a predicate device.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide a table of acceptance criteria with quantitative performance metrics. It generally states that software validation and registration accuracy tests were performed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Validation | "The modified software version meets its design requirements." |
| Registration Accuracy | "The modified Renaissance System has maintained its accuracy, as specified in the device design requirements." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The tests mentioned (software validation and registration accuracy) appear to be internal engineering tests rather than clinical studies on patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention using experts to establish ground truth for a test set. The performance tests described are related to software and system accuracy, which would typically be verified against known specifications or physical standards rather than expert consensus on medical images.
4. Adjudication Method
Since the document does not describe the use of experts or a test set requiring ground truth adjudication, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided information does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed, or any effect size related to human reader improvement with AI assistance. The device is a surgical guidance tool, not an AI diagnostic imaging system that would typically be evaluated in an MRMC study for reader performance enhancement.
6. Standalone Performance Study (Algorithm Only)
The document does not explicitly describe a standalone (algorithm only) performance study in terms of diagnostic accuracy or precise guidance error metrics. The performance tests mentioned pertain to software functionality and maintenance of accuracy according to design requirements. The system's core function is to guide a surgeon; its "performance" is inherently linked to its integration into a surgical workflow.
7. Type of Ground Truth Used
Based on the described tests:
- Software Validation: Ground truth would likely be the defined software design requirements and expected outputs.
- Registration Accuracy: Ground truth would be the known physical coordinates or measurements of a phantom or calibrated test object against which the system's registration capabilities are verified. There's no indication of pathology, outcomes data, or expert consensus being used as ground truth for these tests.
8. Sample Size for the Training Set
The document does not provide information regarding a training set sample size. The description of the device and its capabilities (e.g., 3D image processing, planning on CT/MRI) suggests that it's a rule-based or image processing system rather than a machine learning model that requires a distinct "training set" in the conventional sense.
9. How Ground Truth for the Training Set Was Established
Since there's no mention of a traditional machine learning training set, there is no information on how ground truth for a training set was established.
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DEC - 1 2011
SECTION 7 - SUMMARY OF SAFETY AND EFFECTIVENESS
(Premarket Notification [510(k)] Number)
1. Submitter Information
Manufacturer Name & Address
| Mazor Robotics Ltd. |
|---|
| PO Box 3104, |
| 7 HaEshel St., |
| Caesarea Park South 38900, |
| Israel |
Official Correspondent Ahava Stein A. Stein – Regulatory Affairs Consulting Ltd. 20 Hata'as St., Kfar Saba 44425, Israel
-
Date Prepared: October 24, 2011
-
Device Name
| Proprietary Name: | Renaissance System |
|---|---|
| Common Name: | Combination of:1. Spinal Stereotaxic instrument; and2. System, Image Processing, Radiological |
| Device Type andClassification: | 1. 21 CFR 882.4560; Stereotaxic instrument2. 21 CFR 892.2050; System, image Processing, Radiological |
| FDA Classification: | Class II, Product Code HAW and LLZ |
Predicate Devices 4.
The Renaissance System is substantially equivalent to the following devices:
| Manufacturer | Device | 510(k) | Date Cleared |
|---|---|---|---|
| Mazor Robotics | Renaissance System | K110911 | April 28, 2011 |
| Medtronic Navigation | StealthStation System | K050438K022414 | June 2, 2005August 14, 2002 |
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5. Device Description
The Renaissance System hosts guidance for spine procedures and intra-operative 3D image processing capabilities. It enables the surgeon to precisely position surgical instruments and/or implants. 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 patients' CT scan. The "Scan-and-Plan" new feature enables intra-operative planning on the 3D Scan (formerly the C-Insight) image or on a 3D image uploaded from an external 3D image acquiring system (e.g., Medtronic O-arm). The new "Scan-and-Plan" feature replaces the need for a pre-operative CT scan and pre-operative planning, although this feature is still available in the system.
The modified Renaissance System also allows retrieving DICOM files from the hospitals' PACS system for operation planning purposes.
In addition, the modified Renaissance System enables the user to download MRI data and fuse it with CT data in order to provide the user with additional information on the patient's anatomy during the pre-operative planning stage.
Indications for Use 6.
The Renaissance System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. It may be used in either open or percutaneous procedures.
Renaissance 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.
7. Performance Standards
There are no performance standards under the Federal Food, Drug and Cosmetic Act, for the Renaissance System.
8. Performance Testing
The following Performance tests were performed on the Renaissance System:
- Software validation testing in accordance with the FDA Guidance for the . Premarket Submissions for Software Contained in Medical Devices (May 11, 2005). The software validation tests demonstrated that the modified software version meets its design requirements.
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- Multiple acquisition Methods Registration Accuracy. The registration . accuracy test demonstrated that the modified Renaissance System has maintained its accuracy, as specified in the device design requirements.
Technological Characteristics Compared to Predicate Device 9.
The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the indications for use of the modified Renaissance System are substantially equivalent to the predicate devices cited above.
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", indicating the department's name and national affiliation.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
DEC - 1 2011
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mazor Robotics Ltd. % A. Stein - Regulatory Affairs Consulting Ms. Ahava Stein Consultant 20 Hata'as Street 44425 KFAR SABA ISRAEL
Re: K113228
Trade/Device Name: Renaissance System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW and LLZ Dated: October 27, 2011 Received: November 1, 2011
Dear Ms. 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803): and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Stastel
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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SECTION 1 - INDICATIONS FOR USE
510(k) Number (if known):_K l | 3228
Device Name:
Renaissance System
Indications for Use: ·
The Renaissance System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. It may be used in either open or percutaneous procedures.
Renaissance 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.
Prescription Use V
OR
(Per 21 C.F.R. 801 Subpart D)
Over-The-Counter Use
(Optional Format Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE).
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K
8
§ 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).