(112 days)
BrightMatter Planning's indications for use are the viewing, simulation of cranial surgical procedures and reviewing of existing treatment plans. Typical users of the software are medical professionals, including but not limited to surgeons and radiologists.
BrightMatter Planning is a treatment planning software that enables the user to view and process medical image data. The software is intended for pre-operative planning of neuro-surgical treatments based on image guided surgical systems. The planning software system provides the ability to visualize diagnostic images in 2D and 3D formats and fusion of image datasets. The software automatically segments the skull from the acquired image and generates diffusion tracts from DTI data. The user can also manually annotate regions of interest, resulting in structures which can subsequently be visualized in 3D. The end result of such processing is a set of images that can be used to develop a treatment plan for a neuronavigational procedure. The treatment plan is developed by a trained person. A trained person can use the software to segment structures, define regions of interest and establish one or more trajectories. The software, operated on a stand-alone computer workstation, is expected to be used by a Surgical Planner in an office setting, in preparation for one of several possible surgical procedures. The resulting treatment plan can be exported to a PACS for subsequent use in image guided surgery.
Here's a breakdown of the acceptance criteria and study information for the BrightMatter Planning Software, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria for the BrightMatter Planning Software. Instead, it focuses on demonstrating substantial equivalence to predicate devices and verifying software functionality. The key performance comparison is for DTI-derived image creation and tractography.
| Acceptance Criteria (Implicit/Derived) | Reported Device Performance |
|---|---|
| Equivalence in performance for DTI-derived image creation and tractography compared to a predicate system (Siemens syngo MR B17). | DTI-derived image creation and tractography results were demonstrated to be equivalent in performance to Siemens syngo MR B17 software. |
| Software functionality (load/import data, view/adjust data, registration points, image fusion, object creation, advanced object planning, fiber tracking, trajectory planning, save/export plans, 3D functionalities) | Subject device (BrightMatter Planning) provides these functionalities, similar to the predicate iPlan Cranial module. |
| Software verification and validation (unit, integration, system level for each requirement/algorithmic function) | Bench (software validation) testing was conducted for each requirement specification and algorithmic function, at unit, integration, and system levels. |
| Compliance with quality assurance measures during development | Software Development Life Cycle, Software Risk Assessment, Risk Assessment of Off-the-Shelf (OTS) Software, Software Configuration Management and Version Control, and Software issue tracking and resolution were applied. |
| Safety and effectiveness for intended use. | Design validation in actual and simulated use settings supported substantial equivalence and demonstrated safety for intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical data for performance assessment. The "testing" primarily refers to non-clinical software verification and validation.
- Sample Size for Test Set: Not specified, as it's primarily a software validation and comparison to an existing system's output, not a clinical study with patient samples.
- Data Provenance: Not applicable in the context of a "test set" for clinical performance. The comparison for DTI tractography was against the output of Siemens syngo MR B17 software, implying existing data processed by that tool.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The performance assessment is based on comparison to an existing software's output rather than expert-established ground truth on a test image set.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a test set requiring adjudication from multiple readers.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The documentexplicitly states: "This technology is not new, therefore a clinical study was not considered necessary prior to release. Additionally, there was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." Therefore, there is no information on the effect size of human improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a "standalone" evaluation of the algorithm's performance for DTI-derived image creation and tractography was done. The document states: "The DTI-derived image creation and tractography results were compared with Siemens syngo MR B17 software and were demonstrated to be equivalent in performance." This suggests an assessment of the algorithm's output directly against a benchmark, without necessarily involving a human reader in the performance metric itself.
7. The Type of Ground Truth Used
The "ground truth" for the DTI-derived image creation and tractography comparison was the output of a commercially available and cleared software: Siemens syngo MR B17. This serves as a comparative benchmark rather than an independent expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
The document does not mention a training set. This is consistent with a 510(k) submission for a software device that relies on established algorithms and demonstrates equivalence to predicate devices, rather than a new AI/ML device that requires extensive training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned or implied for this device.
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Synaptive Medical Inc. 510(k) Summary
1 510(k) Summary
| Table 5.1 510(k) Summary (As required by section 21 CFR 807.92(c)) | ||
|---|---|---|
| Submitter: | Synaptive Medical Inc.MaRS Centre, South Tower101 College Street, Suite 200Toronto, ON M5G 1L7 Canada | |
| Contact Person: | Cameron PironPresidentTelephone: 416-673-6679Email: cameron.piron@synaptivemedical.comSynaptive Medical Inc.MaRS Centre, South Tower101 College Street, Suite 200Toronto, ON M5G 1L7 Canada | |
| Date Prepared: | May 24, 2014 | |
| Trade Name: | BrightMatter Planning Software | |
| Common/Usual Name: | BrightMatter Planning Software | |
| Classification: | 21 CFR 892.2050Product Code LLZ, Class IIPicture archiving and communication system. | |
| Product Code: | LLZ, Class II | |
| Manufacturer: | Synaptive Medical Inc.MaRS Centre, South Tower101 College Street, Suite 200Toronto, ON M5G 1L7 Canada | |
| Establishment Registration: | N/A | |
| Primary Predicate Device: | Manufacturer: Meterialise NVTrade name: SurgiCase System510(k) Number: K073449Date Cleared: Apr 16, 2008 | |
| Table 5.1 510(k) Summary (As required by section 21 CFR 807.92(c)) | ||
| Secondary PredicateDevice: | Manufacturer: | BrainLab AG |
| Trade name: | iPlan Cranial | |
| 510(k) Number: | K113732 | |
| Date Cleared: | May 7, 2012 | |
| Device Description | BrightMatter Planning is a treatment planning software that | |
| enables the user to view and process medical image data. The | ||
| software is intended for pre-operative planning of neuro-surgical | ||
| treatments based on image guided surgical systems. The planning | ||
| software system provides the ability to visualize diagnostic | ||
| images in 2D and 3D formats and fusion of image datasets. The | ||
| software automatically segments the skull from the acquired | ||
| image and generates diffusion tracts from DTI data. The user can | ||
| also manually annotate regions of interest, resulting in structures | ||
| which can subsequently be visualized in 3D. | ||
| The end result of such processing is a set of images that can be | ||
| used to develop a treatment plan for a neuronavigational | ||
| procedure. The treatment plan is developed by a trained person. | ||
| A trained person can use the software to segment structures, | ||
| define regions of interest and establish one or more trajectories. | ||
| The software, operated on a stand-alone computer workstation, | ||
| is expected to be used by a Surgical Planner in an office setting, in | ||
| preparation for one of several possible surgical procedures. The | ||
| resulting treatment plan can be exported to a PACS for | ||
| subsequent use in image guided surgery. | ||
| Intended Use | BrightMatter Planning's indications for use are the viewing, | |
| simulation of cranial surgical procedures and reviewing of existing | ||
| treatment plans. | ||
| Typical users of the software are medical professionals, including | ||
| but not limited to surgeons and radiologists. | ||
| Table 5.1 510(k) Summary (As required by section 21 CFR 807.92(c)) | ||
| Summary of TechnicalComparisons | Both the predicate device and the subject device (BrightMatterPlanning Software) are software applications that import DICOM imagedata files, provide image processing fuctions such as image fusion andsegmentation, and produce output that can be used for image guidedsurgery. | |
| The primary predicate device, SurgiCase System, is a software systemthat helps transfer of images from medical scanners (MR or CT). Thesubject device also supports transfer of images from scanners but islimited to detailed visualization of MR images. Both the predicatesystem and subject system provide the ability to reformat pre-operative images, segment and select regions from the scanned imagesand visualize the images in 3D without patient contact or surgical insult.Like the predicate device, the subject device also supports simulationand evaluation of surgical treatment options using pre-operativeimages. The end result in both systems is a surgical plan that cannot besubsequently altered by other users once the plan is exported. Hence,BrightMatter Planning is substantially equivalent to SurgiCase systemfrom intended use and technological characteristics points of view anddoes not raise different questions of safety. | ||
| The predicate device (iPlan) lists these trade names: iPlan Cranial, iPlanStereotaxy, iPlan ENT, iPlan Spine, iPlan View and iPlan CMF. Thesepredicate device modules include functionality that is not part of thesubject device. The subject device is substantially equivalent to thepredicate device's iPlan Cranial module. The subject device does notinclude the following predicate device functionality:Atlas assisted visualization. Functional planning using BOLD MRI mapping.Comparison of the subject device to the predicate iPlan Cranial module,shows that the two products are very similar in features and functions. | ||
| The comparison was made using the following technical characteristicsof the two products:- Load and import data | ||
| - View and Adjustment of data- Registration points | ||
| - Image fusion- Object creation | ||
| - Advanced Object Planning- BOLD MRI mapping | ||
| - Fiber tracking | ||
| - Trajectory planning- Save and export of plans | ||
| - 3D functionalities | ||
| Table 5.1 510(k) Summary (As required by section 21 CFR 807.92(c)) | ||
| The DTI-derived image creation and tractography results werecompared with Siemens syngo MR B17 software and weredemonstrated to be equivalent in performance. | ||
| Non-Clinical Testing | The following bench (software validation) testing was conducted onBrightMatter Planning Software:Software verification and validation testing for each requirement specification. Software verification and validation testing for each algorithmic function. Software verification and validation testing at the unit, integration, and system level. | |
| The following quality assurance measures were applied during software development:Software Development Life Cycle Software Risk Assessment. Risk Assessment of Off-the-Shelf (OTS) Software. Software Configuration Management and Version Control. Software issue tracking and resolution. | ||
| Design Validation | Design validation was performed using the BrightMatter PlanningSoftware in actual and simulated use settings. The results supportsubstantial equivalence to the predicate device and demonstrate thatthe BrightMatter Planning Software is safe for its intended use. | |
| Clinical Testing | This technology is not new, therefore a clinical study was notconsidered necessary prior to release. Additionally, there was noclinical testing required to support the medical device as the indicationsfor use is equivalent to the predicate device. The substantialequivalence of the device is supported by the non-clinical testing. | |
| Table 5.1 510(k) Summary (As required by section 21 CFR 807.92(c)) | ||
| Conclusion: | We conclude that the results of testing show the BrightMatter PlanningSoftware to be substantially equivalent to the predicate devices. | |
| The BrightMatter Planning Software has the same technologicalcharacteristics as the predicate devices in that it has a similar intendeduse, same general operating principle, and same technology. Thespecific details of the predicate device may vary from those ofBrightMatter Planning Software, but testing shows that similar resultsare produced. Performance of DTI-derived image generation andtractography results were compared with Siemens syngo MR B17 andwere shown to be equivalent. | ||
| It has been shown in this 510(k) submission that the differencesbetween the BrightMatter Planning Software and the Brainlab AG iPlanCranial (K113732) do not raise any questions regarding safety andeffectiveness. The BrightMatter Planning Software, as designed andmanufactured, is substantially equivalent to, and as safe and effectiveas. the referenced predicate device. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hamoshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 2, 2014
Synaptive Medical, Inc. % Mr. Cameron Piron President MaRS Centre, South Tower 101 College Street, Suite 200 Toronto Ontario M5G IL7 CANADA
Re: K140337
Trade/Device Name: BrightMatter Planning Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 24, 2014 Received: April 28, 2014
Dear Mr. Piron:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 210(k) premained included (for the indications
referenced above and have determined the device is substantially equivalent in internate referenced above and nave determined the acrise is sedicate devices marketed in interstate for use stated in the enclosure) to legally markets producal Device Amendments, or to commerce prior to May 28, 1970, the chacinem and other provisions of the Federal Food, Drug, devices that have been reclassified in accordance with the proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarked a pproval ions of the and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the device, subject to the gently for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act theider requires against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Please note: CDRFI docs not evaluate information reast be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), ( If your device is classified (See above) into critics major regulations affecting your device can be
it may be subject to additional controls. Existing major regulation F it may be subject to additional Controls. Existing major regaring and the endition, FDA may be found in the Code of Federal Regulations, This 20, Forderal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuality of a substination with other requirements of the Act
that FDA has made a determination that your device Edgerales. You must that FDA has made a delermination that your dovice Federal agencies. You must or any Federal statures and regulations administers of cregistration and listing (21
comply with all the Act's requirements, including, but not insting of medical comply with all the Act 's requirements, including, 'or reporting (reporting of medical CFR Part 807); labeling (21 CFR Part 607); good manufacturing practice requirements as set
device-related adverse events) (21 CFR 803); good manufacturing practice requiremen device-related adverse events) (2) CFR 820); and if applicable, the electronic
forth in the quality systems (2) CFR Part 820); and if applicable, the electronic
(2010); forth in the quality systems (QS) regulation (21-51-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Mr. Piron
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 r ou may obtain other general million. 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,
Smh.7)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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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) K140337
Device Name BrightMatter Planning Software
| Indications for Use (Describe) | |
|---|---|
| -------------------------------- | -- |
mucations of Ose (25schbo) including different modules for use are the mage fusion and image segmentation, where the output can be used for image guided surgery. BrightMatter Planning and simulation of cranial surgical procedures and reviewing of existing treatment plans.
Typical users of the software are medical professionals, including but not limited to surgeons and radiologists.
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)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sanh. 7)
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 is estimated to average 79 hours per response, including the data needed and complete The burden time for this collection of nibination is estimalitian the data needed and complete
time to review instructions, search existing data sources, gather and other asp time to review instructions, search existing data sources, gamer and mate or any other aspect
and review the collection of information. Send comments regarding the burgen in and review the collection of inlormation. Golls sons for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of ol conduct of sponsor, und a percently valid OMB number."
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).