(214 days)
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle serews in lumbar vertebrae with a posterior approach
ROSA Spine is a computer controlled electromechanical arm providing guidance of neurosurgical instruments during spinal surgery.
ROSA Spine assists the surgeon in planning the position of instruments relative to intraoperative images.
Adequate position of the instrument holder is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
ROSA Spine provides a stable, accurate and reproducible mechanical guidance of neurosurgical instruments in accordance with an intraoperative planning.
While the provided document is a 510(k) premarket notification for the ROSA Spine device, it primarily focuses on establishing substantial equivalence to predicate devices rather than detailing a specific clinical study with detailed acceptance criteria and ground truth establishment for a diagnostic or AI-driven medical device. The ROSA Spine is described as a computer-controlled electromechanical arm for surgical guidance, not a device that makes diagnoses or predictions based on medical images in the way an AI algorithm might.
Therefore, many of the requested details, particularly those related to "AI improvement," "multi-reader multi-case studies," "ground truth establishment," and "training sets" are not applicable or explicitly stated for this type of surgical guidance system's 510(k) submission.
However, I can extract the relevant performance data and address the questions to the best of my ability based on the provided text, making it clear where the information is not present or not applicable.
Here's an attempt to answer your questions based on the provided document:
Device: ROSA Spine (a computer-controlled electromechanical arm for spinal surgical guidance)
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly present these as "acceptance criteria" in a formal table with pre-defined thresholds the way an AI or diagnostic device might. However, it does provide performance metrics tested and reported for the device and its predicates. I will interpret "acceptance criteria" as the performance levels achieved that demonstrate equivalence and safety/effectiveness for this type of device.
| Performance Metric | Acceptance Criteria (or equivalent reported predicate performance) | Reported Device Performance (ROSA Spine) |
|---|---|---|
| Robot Absolute Accuracy | < 0.75 mm (ROSA Surgical Device predicate) | < 0.75 mm |
| Robot Repeatability | < 0.10 mm (ROSA Surgical Device predicate) | < 0.10 mm |
| Guidance Application Accuracy | < 2.00 mm (ROSA Surgical Device predicate) | < 2.00 mm |
| Navigation Accuracy | < 2.00 mm (StealthStation System predicate) | < 1.50 mm (This is better than the predicate) |
| Biocompatibility | Complies with ISO 10993 standards and blue book memorandum #G95-1 | Met |
| Electrical Safety (IEC 60601-1) | Compliant | Compliant |
| Electromagnetic Compatibility (60601-1-2) | Compliant | Compliant |
| Software Level of Concern | "Major" (failure could result in serious injury or death) | Managed with V&V testing |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Device Performance Testing: "Testing were conducted on cadaveric specimens" - The exact number of cadaveric specimens is not specified.
- Data Provenance: The document does not explicitly state the country of origin for the cadaveric specimens or if the studies were retrospective or prospective. Given it's a 510(k) for a French company, it's plausible testing occurred in Europe or the US, but this is not stated. The context implies these were laboratory/simulated clinical environment tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable in the sense of typical AI ground truth for image interpretation. For a surgical guidance robot, "ground truth" relates to physical accuracy. The device's accuracy was verified against physical measurements. The document does not specify if "experts" were involved in setting up or verifying the cadaveric tests beyond standard engineering and clinical personnel.
4. Adjudication Method for the Test Set
- Not applicable as it's not an AI model requiring human consensus for interpretation. The performance metrics are objectively measured.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC study was NOT done. This type of study is typically performed for diagnostic devices, especially those involving human interpretation of medical images with or without AI assistance. The ROSA Spine is a robotic surgical guidance system, not a diagnostic imaging device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- The "Performance Data" section describes "Device performance tests were performed to validate the absolute accuracy and repeatability of the robot arm, the application accuracy of the device, and the navigation accuracy according to ASTM F2554-10." This is essentially the standalone performance of the robot's mechanical and navigation capabilities, independent of a specific surgeon's skill in using it for the final instrument placement, although it is designed to guide human actions. It's not an "algorithm only" in the AI sense, but rather the robot's physical performance.
7. The Type of Ground Truth Used
- For the performance tests related to accuracy and repeatability, the ground truth was physical measurement against known standards or reference points (e.g., as per ASTM F2554-10) on cadaveric specimens. This is an objective measurement of the robot's mechanical and guidance precision.
8. The Sample Size for the Training Set
- Not applicable. This device is a robotic system; it is not an AI model that learns from a "training set" of data in the common machine learning sense. Its programming and algorithms are deterministic, based on physics and geometry.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the machine learning sense. The device's functionality is based on engineering principles and pre-programmed algorithms rather than data-driven learning.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 4, 2016
Medtech S.A. Ms. Colette Maurin Regulatory Affairs Director ZAC Eurêka 900 rue du Mas de Verchant 34000 Montpellier, Lamguedoc-Rousillon FRANCE
Re: K151511
Trade/Device Name: ROSA Spine Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: December 14, 2015 Received: December 16, 2015
Dear Ms. Maurin:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,
Lori A. Wiggins -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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Image /page/2/Picture/0 description: The image shows the logo for Medtech, a company that specializes in innovative surgical technology. The logo is in blue and features the company name in a bold, sans-serif font. Below the company name is the tagline "Innovative Surgical Technology" in a smaller font. The logo is simple and modern, and it conveys the company's focus on technology and innovation.
TRADITIONAL 510(K) PREMARKET NOTIFICATION ROSA SPINE
Page 7/63
4 - INDICATIONS FOR USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K151511
Device Name ROSA Spine
Indications for Use (Describe)
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle serews in lumbar vertebrae with a posterior approach
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
PSC Publishing Jhevines (1005/903-163-676) (16)
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Image /page/3/Picture/0 description: The image shows the logo for Medtech. The logo is in blue and consists of the word "medtech" in a sans-serif font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font. The logo is simple and modern.
510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part §807.92.
I SUBMITTER
Medtech S.A. ZAC Eurêka 900 rue du Mas de Verchant 34000 Montpellier, France Tel +33 (0)4 67 10 77 40 Fax +33 (0)4 67 59 74 18
Contact Person: Colette Maurin Regulatory Affairs Director c.maurin@medtechsurgical.com
Date prepared: December 31, 2015
II DEVICE
Name of device: ROSA Spine Common Name: Computer-assisted surgical device Classification name: Stereotaxic Instrument (21CFR 882.4560) Regulatory class: II Code product: OLO
III PREDICATE DEVICE
ROSA Surgical Device, manufactured by Medtech S.A., K101797, cleared September 23, 2010
StealthStation System, manufactured by Medtronic Navigation Inc., K133444, cleared July 25, 2014
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IV DEVICE DESCRIPTION
ROSA Spine is a computer controlled electromechanical arm providing guidance of neurosurgical instruments during spinal surgery.
ROSA Spine assists the surgeon in planning the position of instruments relative to intraoperative images.
Adequate position of the instrument holder is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
ROSA Spine provides a stable, accurate and reproducible mechanical guidance of neurosurgical instruments in accordance with an intraoperative planning.
V INDICATIONS FOR USE
ROSA Spine is intended for the spatial positioning and orientation of instrument holders or tool quides to be used by surgeons to quide standard neurosurgical instruments during spine surgery.
Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans.
The device is indicated for the placement of pedicle screws in lumbar vertebrae with a posterior approach
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Image /page/5/Picture/0 description: The image shows the logo for Medtech, a company that specializes in innovative surgical technology. The logo is in blue and features the company name in a bold, sans-serif font. Below the company name is the tagline "Innovative Surgical Technology" in a smaller font. The logo is simple and modern, and it conveys the company's focus on technology and innovation.
VI COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Predicate Devices | Subject Device | ||||
|---|---|---|---|---|---|
| Device | ROSA Surgical Device | StealthStation System | ROSA Spine | ||
| (K101791) | (K133444) | (Submission subject) | |||
| Device description and indications for use | |||||
| Indications for use | Intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. The system is intended to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). Indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate. | Intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone or a vertebra, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. | ROSA Spine is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumbar vertebrae with a posterior approach | ||
| Where used | Operating room | Operating room | Operating room | ||
| User | Neurosurgeon | NeurosurgeonOrthopedic surgeon | NeurosurgeonOrthopedic surgeon | ||
| General device description | Computer controlled electromechanical arm providing guidance of neurosurgical instruments | Navigation system helping the surgeon in manual guidance of navigated neurosurgical instruments | Computer controlled electromechanical arm providing guidance of neurosurgical instruments | ||
| Anatomical site | Head | Head, spine | Spine | ||
| Surgical approach | Open, minimally invasive or percutaneous | Open, minimally invasive or percutaneous | Open, minimally invasive or percutaneous | ||
| Technology | |||||
| Principle of operation | - Preoperative images;- Surgical planning;- Patient registration;- Guidance of instruments | For Spine application:- Intraoperative images;- Patient registration;- Surgical planning;- Real-time tracking of navigated instruments | - Intraoperative images;- Patient registration;- Surgical planning;- Guidance of instruments;- Real-time tracking of navigated instruments | ||
| Input images | 3D pre-operative exam | 3D pre-operative exam3D intra-operative exam2D intra-operative exam | 3D intra-operative exam | ||
| DICOM compliance | Yes | Yes | Yes | ||
| Integrated planning Software | ROSANNA (Medtech) | Synergy Spine software(Medtronic) | ROSANNA SPINE (Medtech) | ||
| Save/load planning | Yes | Yes | Yes | ||
| Merge images functionality | Yes | Yes | Yes |
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Image /page/6/Picture/0 description: The image shows the logo for Medtech, a company that specializes in innovative surgical technology. The logo is in blue and features the company name in a bold, sans-serif font. Below the company name is the tagline "Innovative Surgical Technology" in a smaller font. The logo is simple and modern, and it conveys the company's focus on technology and innovation.
| Predicate Devices | Subject Device | ||
|---|---|---|---|
| Device | ROSA Surgical Device(K101791) | StealthStation System(K133444) | ROSA Spine(Submission subject) |
| Trajectoryplanningparameters | Entry point, target point,length of the instrument,diameter | Entry point, target point, lengthof the instrument, diameter | Entry point, target point, lengthof the instrument, diameter |
| Localizationmeans | Robot arm absoluteencoders | Optical system (infraredcamera)or electromagnetic system | Robot arm absolute encoders+ optical system (infraredcamera) |
| Image-guided | Yes | Yes | Yes |
| Controller | Axis controller for each jointKinematic transformationbetween the Cartesianspace and joint spaceSupervisor module | No controller -The instrument is manuallypositioned by the surgeon | Axis controller for each jointKinematic transformationbetween the Cartesian spaceand joint spaceSupervisor module |
| Patientregistrationmethod | Fiducial markers (skin)Optical registration device | Point-to-point registration withanatomical markers | 3D registration with X-Raypattern containing radio-opaquemarkers |
| Accuracyverification onanatomicallandmarks | Yes (probe, laser beam) | Yes (probe) | Yes (probe) |
| Laser class foroptical system | Class 2 laserWavelength - 650 nm,Maximum output - 1 mW(complies with 21 CFR1040.10) | Class 2 laserWavelength - 635 nm,Maximum output - 1 mW(complies with 21 CFR1040.10) | Class 2 laserWavelength - 635 nm,Maximum output - 1 mW(complies with 21 CFR1040.10) |
| Real timedisplay of theinstrumentposition | Yes | Yes | Yes |
| Provideguidance forinstruments | Yes - Instruments aremounted onto the robotarm. The guidance isrobotized. | No - The instrument is manuallypositioned by the surgeon. | Yes - Instruments are mountedonto the robot arm. Theguidance is robotized. |
| Surgeoncarries out thefinal gesture | Yes - through theinstrument guide | Yes - the surgeon holds theinstrument | Yes - through the instrumentguide |
| Instrument | Instrument holder,endoscope holder andadaptors, optical sensor | Navigated instruments | Instrument holder, cannula,adaptors, navigatedinstruments |
| Instrumentcalibrationmethod | Factory calibration | Factory calibration | Factory calibration |
| Associatedequipment | 3D imaging system● Fiducial markers● Head holder● Endoscope● Stereovision system● 3D visualization● headset● Light source | 3D/2D imaging system● Retro-reflective sterile● spheres● Implants andinstrumentation | 3D imaging system● Retro-reflective sterile● spheres● Implants andinstrumentation |
| Patientimmobilization | Yes - The device isattached to the head holdervia an adaptor. | No - a reference is fixed in thepatient's iliac crest or clampedon the patient's spinous fortracking system | No - a reference is fixed in thepatient's iliac crest for trackingsystem |
| Devicemobility | Yes - mobile stand withwheels, immobilized withstabilization feet | Yes - mobile stands withwheels; Stands immobilizedwith wheels brakes | Yes - mobile stands withwheels; Robot standimmobilized with stabilization |
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Image /page/7/Picture/0 description: The image shows the logo for Medtech. The logo is in blue and consists of the word "medtech" in a sans-serif font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font. The logo is simple and modern.
| Predicate Devices | Subject Device | ||
|---|---|---|---|
| Device | ROSA Surgical Device(K101791) | StealthStation System(K133444) | ROSA Spine(Submission subject)feet and camera standimmobilized with wheels brakes |
| Sterility | Non-sterile and sterileinstrumentsDisposable sterile drapeson device | Non-sterile and sterileinstrumentsDisposable sterile drapes ondevice | Non-sterile and sterileinstrumentsDisposable sterile drapes ondevice |
| Power supply | 110 V | 115 V | 115 V |
| Footprint | Robot stand ≈ 91cm × 66cm | Surgeon cart ≈ 60cm x 63cmStaff cart ≈ 58cm x 61cm | Robot stand ≈ 121cm × 65cmCamera stand ≈ 81cm x 76cm |
| Performance | |||
| - Robotabsoluteaccuracy- Robotrepeatability | < 0.75 mm< 0.10 mm | Not applicable | < 0.75 mm< 0.10 mm |
| Guidanceapplicationaccuracy | < 2.00 mm | Not applicable | < 2.00 mm |
| Navigationaccuracy | Not applicable | < 2.00 mm | < 1.50 mm |
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Image /page/8/Picture/0 description: The image shows the logo for Medtech, a company that specializes in innovative surgical technology. The logo is in blue and features the company name in a bold, sans-serif font. Below the company name is the tagline "Innovative Surgical Technology" in a smaller font. The logo is simple and modern, and it conveys a sense of innovation and expertise.
PERFORMANCE DATA VII
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for ROSA Spine device has been conducted in accordance with ISO 10993 standards and blue book memorandum #G95-1 entitled "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing", May 1, 1995. The evaluation reveals that biocompatibility requirements are met by the ROSA Spine device.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on ROSA Spine. The device complies with recognized electrical safety standards: IEC 60601-1 standard for electrical safety and IEC 60601-1-2 standard for electromagnetic compatibility.
Device performance Testing
Device performance tests were performed to validate the absolute accuracy and repeatability of the robot arm, the application accuracy of the device, and the navigation accuracy according to ASTM F2554-10
Testing were conducted on cadaveric specimens in a simulated clinical environment to evaluate the device safety and effectiveness (clinical performance).
Software Verification and Validation Testing
Software tests were conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 Standard (Medical Device Software - Life Cycle Process). The software was considered as a "major" level of concern, since a failure of the software could result in serious injury or death to the patient.
Software verification activities were performed during the "Design, coding & testing" and "Verification" phases of software lifecycle. Outputs generated during these phases include:
- . Code walkthroughs
- Unit test reports ●
- . Integration test reports
- . System test reports
- Overall software test report .
- Verification test reports
- Overall software verification report ●
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Image /page/9/Picture/0 description: The image shows the logo for Medtech. The logo is in blue and consists of the word "medtech" in a sans-serif font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font. The logo is simple and modern.
Code inspections and software tests at the unit, integration and system levels were performed according to the Software Test Plan. Verification tests were performed for each software requirements according to the Software Verification Plan. Conformity of software with the user needs and intended use of the device were performed through the "Validation" phase of the ROSA Spine device.
Animal study
The 510(k) does not contain animal study test results for the ROSA Spine.
Clinical Studies
The 510(k) does not contain clinical information for the ROSA Spine.
VIII CONCLUSIONS
The non-clinical data support the safety of the device and the verification and validation demonstrate that the ROSA Spine device should perform as intended in the specified use conditions. The non-clinical data demonstrate that the ROSA Spine device performs comparably to the predicate devices that are currently marketed for the same intended use.
§ 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).