(268 days)
Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable open and minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data.
Spine & Trauma Navigation System enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system. The software offers screw and interbody device planning and navigation with surgical instruments.
The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
Spine Planning is intended for pre- and intraoperative planning of open- and minimal invasive spinal procedures. It displays digital bio imaging and allows measurement and planning of spinal implants like screws and rods.
The Subject Device Spine and Trauma Navigation System consists of the following software's and hardware.
Software:
-
- Spine & Trauma 3D Navigation 1.5
-
- Instrument Selection 1.6
-
- Fluoro 3D 1.0
-
- Registration Software Paired Point 3.5
-
- Registration Software Spine Surface Matching 1.0
-
- Spine Planning 1.0
Hardware:
The Hardware accessories for the Subject Device are Platforms and Surgical Instruments.
The provided text describes a 510(k) premarket notification for the Brainlab AG Spine & Trauma Navigation System. It outlines the device, its indications for use, and a summary of the performance data provided to the FDA. However, the document does not contain specific acceptance criteria, detailed results of a study proving the device meets these criteria, or information on aspects like sample size, expert ground truth establishment, or human reader studies.
The document states that "The verification of the Spine & Trauma Navigation System has been carried out thoroughly both at the top level and on underlying modules according to the verification plan and following internal processes. The verification was done to demonstrate that the design specifications are met." It also mentions "Bench Testing" for instruments. However, it does not provide the quantitative data necessary to populate the requested table or answer the specific questions about the study design and results.
Therefore, I cannot provide the requested information from the provided text. The output will explicitly state what information is and is not available in the input.
Information Not Found in the Provided Text:
The provided 510(k) summary does not contain the detailed performance study results, acceptance criteria, or specific aspects of a clinical or bench study needed to answer the questions comprehensively. While it mentions "Software Verification and Validation Testing" and "Bench Testing," it does not provide the quantitative data, methodology details (sample size, ground truth generation, expert qualifications, adjudication methods), or comparative effectiveness study results requested.
Therefore, the following sections will indicate where information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document states that "The verification was done to demonstrate that the design specifications are met," but the specific design specifications/acceptance criteria and the quantitative results validating them are not detailed. | Not provided in the document. The document states that "all test were passed successfully" for bench tests, but no specific performance metrics or their actual values are reported. |
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 for Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The document mentions "patient's preoperative or intraoperative 2D or 3D image data" but does not detail the origin or nature of the data used for verification/validation.
- Retrospective or Prospective: Not specified in the provided document.
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)
- Number of Experts: Not specified in the provided document.
- Qualifications of Experts: Not specified in the provided document.
- Ground Truth Establishment: The document refers to "preoperative or intraoperative scans" as the basis for navigation and planning, implying that these images serve as a form of ground truth for instrument placement relative to anatomy, but it does not describe a process involving human experts to establish ground truth for a test set to evaluate the device's accuracy against.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified in the provided document.
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
- MRMC Study: Not mentioned or described in the provided document. The device is a navigation system and planning software, not an AI-assisted diagnostic tool typically evaluated with MRMC studies focused on human reader improvement. The focus is on the system's ability to localize and guide instruments.
- Effect Size of Human Reader Improvement: Not applicable/not provided as no such study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies that the device's software components (e.g., Spine & Trauma 3D Navigation, Spine Planning) perform specific functions, and their "verification and validation testing" was conducted. However, the exact nature of "standalone" performance testing (e.g., algorithm-only accuracy on a dataset without human interaction, specifically for AI/ML components) is not explicitly detailed with performance metrics. The device is intended for human-in-the-loop surgery.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The document implies that the "acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy" serves as the reference ("ground truth") against which the navigation system operates, by linking a tracked probe to this virtual computer image space. For planning, screws are proposed and reviewed ("approved") but the ultimate ground truth for the accuracy of a plan would typically relate to anatomical landmarks on these images, often confirmed by intraoperative imaging. No mention of expert consensus, pathology, or outcomes data being used as ground truth for a performance study is made.
8. The sample size for the training set
- Training Set Sample Size: Not applicable or not specified. The document describes a "verification" process for a regulated medical device, not explicit "training" of a machine learning model. While software verification and validation would use test data, this is distinct from a "training set" for AI/ML model development. The document does not indicate that the device uses an AI/ML model that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable or not specified, for the same reasons as in point 8.
{0}------------------------------------------------
April 13, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Brainlab AG Chiara Cunico Manager, Reuglatory Affairs Olof-Palme-Str. 9 Munich, Bavern 81829 Germany
Re: K212245
Trade/Device Name: Spine & Trauma Navigation System, Spine & Trauma 3D Navigation, Navigation Software Spine& Trauma 3D, Elements Screw Planning Spine, Elements Spine Screw Planning, Spine Planning
Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 10, 2022 Received: March 14, 2022
Dear Chiara Cunico:
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.
{1}------------------------------------------------
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.
For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K212245
Device Name
· Spine & Trauma Navigation System
· Spine & Trauma 3D Navigation. Navigation Software Spine & Trauma 3D
· Elements Screw Planning Spine, Elements Spine Screw Planning, Spine Planning
Indications for Use (Describe)
Spine & Trauma Navigation System
Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable open and minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data.
Spine & Trauma Navigation System enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system. The software offers screw and interbody device planning and navigation with surgical instruments.
The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
Spine Planning
Spine Planning is intended for pre- and intraoperative planning of open- and minimal invasive spinal procedures. It displays digital bio imaging and allows measurement and planning of spinal implants like screws and rods.
| 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."
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image is a banner with a geometric design. The design is composed of triangles in varying shades of blue, with white lines separating the triangles. The triangles are arranged in a random pattern, and the shades of blue range from a dark, vibrant blue to a light, almost white blue.
Image /page/3/Picture/2 description: The image shows the word "BRAINLAB" in bold, sans-serif font. To the left of the word is a stylized graphic that appears to be a representation of the brain. The graphic is black and white and has a simple, modern design.
510(k) Summary
March 10, 2022
| General Information | |
|---|---|
| Manufacturer | Brainlab AG; Olof-Palme Str.9; 81829, Munich, Germany |
| Establishment Registration | 8043933 |
| Device Name | Orthopedic Stereotaxic Instrument |
| Trade Name | • Spine & Trauma Navigation System• Spine & Trauma 3D Navigation, Navigation Software Spine& Trauma 3D• Elements Screw Planning Spine, Elements Spine ScrewPlanning, Spine Planning |
| Product Code | OLO |
| Regulation Number | 882.4560 |
| Regulatory Class | II |
| Panel | Orthopedic |
| Predicate Devices | Primary: Spine & Trauma Navigation K183605Secondary: : Medtronic StealthStation S8 Spine Software v1.0.0;K170011 |
| Contact Information | |
| Primary Contact | Alternate Contact |
| Chiara Cunico | Regulatory Affairs Brainlab |
| Manager RA | Phone: +49 89 99 15 68 0 |
| Phone: +49 89 99 15 68 0 | Fax: +49 89 99 15 68 5033 |
| Email: chiara.cunico@brainlab.com | Email: regulatory.affairs@brainlab.com |
1. Indications for Use
Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable open and minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data.
The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, along bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
Spine & Trauma 3D Navigation
Spine & Trauma 3D Navigation enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image
{4}------------------------------------------------
acquisition system. The software offers screw and interbody device planning and navigation with surqical instruments.
Spine Planning
Spine Planning is intended for pre- and intraoperative planning of open- and minimal invasive spinal procedures. It displays digital bio imaging and allows measurement and planning of spinal implants like screws and rods.
2. Device Description
The Subject Device Spine and Trauma Navigation System consists of the following software's and hardware.
Software:
-
- Spine & Trauma 3D Navigation 1.5 Spine & Trauma 3D Navigation enables navigation of instruments using the Spine & Trauma Navigation System. Instruments that were calibrated in Instrument Selection are loaded for use with Spine & Trauma 3D Navigation.
-
- Instrument Selection 1.6 This software lists all the available instruments listing them by manufacturer, type, description and article number. The software offers functionality to select and activate navigated surqical instruments that are provided to Spine & Trauma 3D Navigation and other software components.
-
- Fluoro 3D 1.0
Registration Software Fluoro 3D enables registration of patient scans in the Spine & Trauma Navigation System.
This software establishes compatibility to integrated 3rd party 3D-Fluoroscopes. Dedicated hardware accessories allocate the fluoroscope during image acquisition. Each image acquisition in registration mode delivers registered images in 3D of the patient anatomy.
-
- Registration Software Paired Point 3.5
Registration Software Paired Point is a touchscreen-based intraoperative registration software.
- Registration Software Paired Point 3.5
The placement of surgical instruments in a three-dimensional representation overlaid on anatomical image sets, such as CT and/or XT, can support the surgeon during various surgical interventions.
Registration Software Paired Point is used to register the patient position relative to the preoperative or intraoperative scans prior to surgical navigation.
The following registration points are possible:
- Anatomical landmarks
- Screws
- Registration Software Spine Surface Matching 1.0 5.
Registration Software Spine Surface Matching is a touchscreen-based intraoperative reqistration software. The placement of surgical instruments in a three-dimensional representation overlaid on anatomical image sets, such as CT and/or XT can support the surgeon during various surgical interventions.
{5}------------------------------------------------
Registration Software Spine Surface Matching is used to register the patient position relative to the preoperative scans prior to surqical navigation.
- Spine Planning 1.0
Brainlab Elements Spine Planning of screws for surgical navigation. Depending on the region of interest, screws can be automatically proposed by the software or planned manually. These screws must be reviewed and approved before proceeding with navigated surgery.
Hardware:
The Hardware accessories for the Subject Device are Platforms and Surgical Instruments.
3. Substantial Equivalence
The Subject Device is similar to the predicate devices in terms of:
- Interbody instrument navigation: Accuracy a.
- b. Interbody instrument navigation: Imaging modalities
- Interbody instrument navigation: View (Display) Features C.
- Localization Technology d.
- Programming language e.
- Graphical User Interface f.
- Improved instrument activation methods g.
- Intra-operative planning of implants h.
- Automatic patient registration i.
- Manual Registration j.
- Implant planning k.
- -Additional compatibility to modified hardware components and instruments or accessories
The Subject Device differs from its predicate devices in terms of:
- m. Interbody instrument navigation: new instrument activation methods introduced
- n. Architecture: added compatibility to new software modules
- GUI technology 0.
- p. Added additional platform compatibility
- g. Added compatibility to instruments from 3rd party manufacturers
4. Performance Data
The verification of the Spine & Trauma Navigation System has been carried out thoroughly both at the top level and on underlying modules according to the verification plan and following internal processes. The verification was done to demonstrate that the design specifications are met.
In general, verification includes different kinds of tests like Unit Tests within the software, GUI based automatic software tests and explorative testing. Results are documented in corresponding test reports and summarized in the Verification Summary document. For hardware parts, mechanical or biocompatibility tests were performed and filed accordingly.
Electrical safety and electromagnetic compatibility (EMC)
N/A as no EMC considerations are within the scope of this 510(k).
Software Verification and Validation Testing
{6}------------------------------------------------
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern.
Biocompatibility and Reprocessing
Material properties in relation to biocompatibility and their response to cleaning, disinfection and sterilization were assessed and tested.
Bench Testing
The following tests were conducted for the instruments and all test were passed successfully.
- Array Radiolucent Cervical Clamp Stability Vibration Resistance Test ●
- Radiolucent Cervical Clamp Fixation Stability Test ●
- Array Radiolucent Cervical Clamp Fixation Stability Test ●
- . Instrument Adapter Extension - Slip Resistance Test
5. Conclusion
The comparison of the Spine & Trauma Navigation System with the predicate device shows that the Spine & Trauma Navigation System has similar functionality, intended use, technological characteristics, and typical users as the predicate devices. Other included minor changes do not affect the fundamental scientific technology of the device.
Verification and validation activities ensure that the design specifications are met and that the Spine & Trauma Navigation System does not introduce new issues concerning safety and effectiveness. Hence, the Spine & Trauma Navigation System is substantially equivalent to the predicate devices.
§ 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).