· Viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and image segmentation where the output can be used for image guided surgery.

· Planning and simulation of cranial surgical procedures.

· Reviewing of existing treatment plans.

Typical users of the software are medical professionals, including but not limited to surgeons and radiologists.

Device Description

BrightMatter Plan 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 Diffusion Tensor Imaging (DTI) data. The user can also manually annotate regions of interest, resulting in structures which can subsequently be visualized in 3D. 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 Clinician in an office or home setting, in preparation for one of several possible surgical procedures. The end of the processing is a surgical plan which can be exported to a Picture Archiving and Communication Systems (PACS) for subsequent use in image guided surgery.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for BrightMatter Plan 1.6.0, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria/Tests Performed	Reported Device Performance (Summary)
Performance Testing	Algorithm pipeline verification	Verified
	Functional verification	Verified
Unit Level Testing	Unit level verification	Verified
Integration Testing	Integration verification	Verified
System Validation	Implementation requirements verification and system integration (release testing, compatibility testing, testing of resolved anomalies, platform testing)	Validated, deemed to conform to clinical expectations
	System requirements verification (traceability from system requirements to implementation, labeling reviews)	Verified
Clinical Expectations	Evaluation of resulting plan for conformance to clinical expectations by intended user population	Conformed to clinical expectations
Usability/ Human Factors	Effectiveness of risk control measures related to usability/human factors	Evaluated and validated
Substantial Equivalence	Comparison to predicate device with equivalent intended uses and essential underlying technology	Shown to be substantially equivalent

Study Details

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of cases/patients. The document mentions "representative preoperative images" for design validation.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). It only mentions "representative preoperative images."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated. The design validation was conducted by "the intended user population," which typically implies multiple clinicians, but a specific number is not provided.
- Qualifications of Experts: The intended user population consists of "medical professionals, including but not limited to surgeons and radiologists." No specific experience level (e.g., 10 years) is mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. The document states "evaluation of resulting plan for conformance to clinical expectations," which implies a qualitative assessment by the users, but no formal adjudication method is detailed.
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:
- No MRMC comparative effectiveness study was performed. The non-clinical testing and design validation focused on the software's performance and conformance to clinical expectations, assuming the user would utilize the tool. The comparison was primarily to a previous version of the same device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The performance testing and unit/integration verification assessed the "algorithm pipeline" and "functional verification," which are inherent to standalone algorithm performance. However, the design validation explicitly involved "the intended user population," indicating a human-in-the-loop evaluation for the overall system. The focus appears to be on the device as a tool for clinicians, rather than a fully autonomous AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Expert Consensus/Clinical Expectation: The ground truth for the design validation was "conformance to clinical expectations" as determined by the "intended user population." This implies clinical assessment and consensus on the accuracy and utility of the generated plans.
The sample size for the training set:
- Not applicable/Not provided. This device is an updated version of a previous planning software (BrightMatter Plan 1.0) and primarily focuses on image viewing, processing, and surgical planning based on existing medical images. It's not described as a deep learning or machine learning model that requires a distinct "training set" in the conventional sense for a new algorithm. The "underlying technology used to process images is the same" as the predicate device.
How the ground truth for the training set was established:
- Not applicable (see point 7).

Summary

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March 9, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Synaptive Medical Inc. % Maham Ansari Director of Regulatory Affairs 555 Richmond Street West, Suite 800 Toronto, Ontario M5V 3B1 CANADA

Re: K180394

Trade/Device Name: BrightMatter Plan 1.6.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 12, 2018 Received: February 13, 2018

Dear Maham Ansari:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180394

Device Name BrightMatter Plan 1.6.0

Indications for Use (Describe) BrightMatter Plan is indicated for:

· Planning and simulation of cranial surgical procedures.

· 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)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(k) Summary

[As required by 21 CFR 807.92]

Manufacturer:Address:	Synaptive Medical Inc.555 Richmond Street West, Suite 800Toronto, ON M5V 3B1Canada
Establishment Registration:	3012075008
Contact Name:Title:Phone Number:Fax Number:Date Prepared:	Ms. Maham Ansari, MS, RACDirector, Regulatory Affairs+1 647 925 34351 888 650 523012 February 2018
Device Proprietary Name:Device Common or Usual Name:Classification Name:Product Code:Regulation Number:Regulation Class:Regulation Description:	BrightMatter PlanBrightMatter PlanSystem, Image Processing, RadiologicalLLZ21 CFR 892.2050IIPicture Archiving and CommunicationsSystem

Predicate Devices

Substantial equivalence is claimed to the following device:

Trade name	Manufacturer	510(k) Number	Date Cleared
BrightMatter PlanningSoftware 1.0	Synaptive MedicalInc.	K140337	June 02, 2014

Device Description

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Indications for Use

BrightMatter Plan is indicated for:

. Viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and image segmentation where the output can be used for image guided surgery.
. Planning and simulation of cranial surgical procedures.
Reviewing of existing treatment plans.

Typical users of the software are medical professionals, including but not limited to surgeons and radiologists.

Summary of Technological Comparisons

BrightMatter Plan is an updated version of the predicate: its previously cleared version 1.0 (K140337). The subject device is substantially unchanged from the predicate with respect to indications and performance claims. The primary difference between the proposed and predicate devices is additional or altered functionality which improve the planning workflow or the user experience of the device.

Key differences and advantages compared to the predicate are:

1. BrightMatter Plan incorporates numerous improvements to usability.
1. The new software enables manual segmentation of tractography, in a manner similar to segmenting anatomical structures. This enables the planner to deliberately reduce the amount of information displayed during planning to the most useful elements.
1. The software exports a volumetric dataset, incorporating the planned target and engagement points. This enables more efficient translation of the plan to a PACS.
1. Removal of sulcal paths workflow stage since it cannot be utilized in commercially available navigation systems and was consequently not used in practice.

There are no known disadvantages with the proposed device in comparison to the predicate device.

The essential underlying technology used to process images is the same. The intended uses are equivalent. Direct comparison of major functionality showed largely identical results. Any changes introduced in the subject device do not raise new concerns of safety and effectiveness.

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Non-Clinical Testing

The following bench (software verification) testing was conducted on BrightMatter Plan:

Performance testing – algorithm pipeline verification; functional verification
Unit level verification ●
Integration verification ●
. Implementation requirements verification and system integration - release testing, compatibility testing, testing of resolved anomalies, and platform testing
. System requirements verification – review of traceability from systems requirements to implementation; labeling reviews.

Design Validation

Device (software) was tested by the intended user population using representative preoperative images and evaluation of resulting plan for conformance to clinical expectations with production equivalent device. This was conducted to validate that the customer needs have been satisfied.

Effectiveness of risk control measures related to usability/human factors were also evaluated and validated via this activity.

Clinical Testing

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 are equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing.

Conclusion

BrightMatter Plan has been shown through comparison and testing to be substantially equivalent to the identified predicate device.

Regulation Number and Section

§ 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).

Acceptance Criteria and Device Performance

Study Details

Indications for Use

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5. 510(k) Summary

Predicate Devices

Device Description

Indications for Use

Summary of Technological Comparisons

Non-Clinical Testing

Design Validation

Clinical Testing

Conclusion

§ 892.2050 Medical image management and processing system.

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