BrightMatter Guide is intended as a planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures where the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The user should consult the "Accuracy Characterization" section of the User Manual to assess if the accuracy of the system is suitable for their needs.

The BrightMatter Pointer is intended to be used for anatomy palpation and as a pointing tool to enable spatial localization and identification by BrightMatter Guide navigational systems.

Device Description

BrightMatter Guide is a planning and image guided surgical system that enables computer assisted surgery where use of stereotactic image guidance may be considered appropriate. The BrightMatter Pointer is a handheld passive instrument which can be used for anatomy palpation using its tip. This tool can be tracked using passive reflective markers in order for BrightMatter Guide to identify and spatially track its location. There are rigid features on the subject device where the markers (passive spheres) that reflect infrared (IR) signals can be attached. The markers are arranged in a unique pattern on the device so that the BrightMatter Guide can differentiate it from other instruments. The Pointer portion of the device is provided non sterile and requires steam sterilization before use. The passive reflective markers are single-use.

The BrightMatter Pointer is made of either titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) or 17-4 stainless steel conforming to ASTM A564 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "BrightMatter Guide with BrightMatter Pointer." This document focuses on demonstrating the substantial equivalence of the new titanium version of the "Pointer tool" to previously cleared predicate devices. It outlines non-clinical testing performed to show this equivalence, rather than a clinical study establishing the device's efficacy against specific performance criteria for AI-assisted human reading.

Therefore, many of the requested details, such as those related to AI effectiveness studies, multi-reader multi-case studies, ground truth establishment for training and test sets, and sample sizes for training/test sets as they pertain to clinical performance, are not explicitly present in the provided document. The "acceptance criteria" discussed are primarily related to non-clinical performance and biocompatibility to prove substantial equivalence, not clinical efficacy or an improvement in human reader performance with AI.

Here's an attempt to extract and infer information based on the document, focusing on what is available regarding acceptance criteria and the non-clinical study:

Acceptance Criteria and Device Performance (Non-Clinical)

The document does not present clinical acceptance criteria for demonstrating improved diagnostic performance (e.g., sensitivity, specificity for a particular disease) or human reader performance. Instead, the acceptance criteria are focused on non-clinical performance and biocompatibility to prove substantial equivalence of a new material (titanium) for an existing device component (Pointer tool).

1. Table of Acceptance Criteria (Non-Clinical) and Reported Device Performance:

Test	Purpose (Acceptance Criteria Implicit in Purpose)	Reported Performance / Results (Meets Acceptance)
Dimensional analysis	Comparison of measured dimensions to ensure tolerances are within acceptable limits.	Measurements found within acceptable tolerances. If outside tolerance, navigational accuracy testing was performed (implies acceptable accuracy maintained).
Navigational accuracy	Accuracy of navigational components evaluated to ensure performance of the system.	Accuracy testing demonstrated the subject device was as accurate as the predicate device.
Cytotoxicity	Cytotoxicity of the device evaluated to demonstrate biocompatibility.	Testing demonstrated the device is not cytotoxic.
Sensitization	Sensitization of the device evaluated to demonstrate biocompatibility.	Testing demonstrated the device is not sensitizing.
Irritation	Irritation of the device evaluated to demonstrate biocompatibility.	Testing demonstrated the device is not an irritant.
Pyrogenicity	Material mediated pyrogenicity evaluated to demonstrate the absence of a febrile response in an in vivo model.	Testing demonstrated the device is non-pyrogenic.
Endotoxin (LAL test)	Amount of gram negative bacteria evaluated to demonstrate endotoxin units are within acceptable limits.	Endotoxin units were found to be <0.333, lower than the acceptable limit.

2. Sample size used for the test set and the data provenance:

The document describes non-clinical testing. It does not mention "test sets" in the context of patient data or clinical images.
For dimensional analysis, navigational accuracy, and biocompatibility tests, the sample sizes are not specified within this document. These would typically involve a certain number of manufactured units or material samples.
Data provenance (country of origin, retrospective/prospective) is not applicable in the context of these non-clinical, in-vitro/bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. The "ground truth" for these non-clinical tests would be defined by engineering specifications (for dimensional/navigational accuracy) and established ISO/ASTM standards (for biocompatibility tests). There's no mention of human expert adjudication for these tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as there is no human adjudication described for these non-clinical tests.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not described or performed according to this FDA 510(k) summary. This device is a surgical navigation system component, not an AI-assisted diagnostic tool for image interpretation by human readers. The purpose of this submission was to introduce a titanium version of the Pointer tool and demonstrate its substantial equivalence through non-clinical testing.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical instrument (Pointer tool) used with a surgical navigation system, enabling human-in-the-loop guidance. It is not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the non-clinical tests:
- Dimensional analysis: Engineering specifications (tolerances).
- Navigational accuracy: Referencing known physical standards/measurements, aiming for accuracy "as accurate as the predicate device."
- Biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Endotoxin): Established biological testing standards and acceptable limits defined by regulatory guidelines (e.g., ISO 10993 series).

8. The sample size for the training set:

Not applicable. This document describes non-clinical testing of a physical device component, not the development or validation of an AI algorithm with training data.

9. How the ground truth for the training set was established:

Not applicable, for the same reason as above.

Summary of what the document focuses on:

The document describes a 510(k) submission for a minor change (new material for a component) to an existing "Stereotaxic Instrument." The primary "study" is a set of non-clinical, bench and biocompatibility tests designed to demonstrate that the new titanium Pointer tool is substantially equivalent to previously cleared devices. This equivalence is based on similar design, dimensions, tracking mechanisms, reprocessing procedures, and importantly, acceptable performance in direct measurements (dimensional, navigational accuracy) and biocompatibility for the new material. The device itself is a surgical navigation tool, not an AI-based diagnostic or interpretative system intended to assist or enhance human reader performance in areas like image analysis.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three figures intertwined to represent people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 24, 2016

Synaptive Medical Inc. % Allison Komiyama, PhD, RAC Principal Consultant AcKnowledge Regulatory Strategies 2834 Hawthorn Street San Diego. California 92104

Re: K160523

Trade/Device Name: BrightMatter Guide with BrightMatter Pointer Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: May 26, 2016 Received: May 27, 2016

Dear Dr. Allison Komiyama:

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. Isting 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

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 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,

Carlos L. Pena -$ D/A

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160523

Device Name BrightMatter Guide with BrightMatter Pointer

Indications for Use (Describe)

The BrightMatter Pointer is intended to be used for anatomy palpation and as a pointing tool to enable spatial localization and identification by BrightMatter Guide navigational systems.

The system should be operated only by trained personnel such as surgeons and other clinic staff.

Type of Use (Select one or both, as applicable)

2 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)

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510(k) Summary K160523

DATE PREPARED

June 23, 2016

MANUFACTURER AND 510(k) OWNER

Synaptive Medical, Inc. 101 College Street, Suite 200, Toronto, Ontario M5G 1L7, Canada Telephone: (416) 673-6679 Fax: (888) 650-5230 Official Contact: Cameron Piron, President

REPRESENTATIVE/CONSULTANT

Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies Telephone: akomiyama@acknowledge-rs.com Email:

PROPRIETARY NAME OF SUBJECT DEVICE

BrightMatter Guide with BrightMatter Pointer

COMMON NAME

Neurological stereotaxic instrument

DEVICE CLASSIFICATION

Stereotaxic instrument (21 CFR 882.4560, Product Code HAW, Class II)

PREMARKET REVIEW

ODE/DNPMD/NNDB Neurology Panel

PURPOSE OF SUBMISSION

The purpose of this submission is to introduce a titanium version of the Pointer tool.

INDICATIONS FOR USE

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"Accuracy Characterization" section of the User Manual to assess if the accuracy of the system is suitable for their needs.

The BrightMatter Pointer is intended to be used for anatomy palpation and as a pointing tool to enable spatial localization and identification by BrightMatter Guide navigational systems.

The system should be operated only by trained personnel such as surgeons and other clinic staff.

DEVICE DESCRIPTION

The BrightMatter Pointer is substantially equivalent to the following predicates:
510(k)Number	Predicate Device Name / Manufacturer	PrimaryPredicate
K142024	BrightMatter Navigation System v1.0 / Synaptive, Inc.	✓
K153281	BrightMatter Guide with Surface Trace Registration /Synaptive, Inc.
K142344	Disposable Passive Accessory for Medtronic StealthStationSystem / IZI Medical Products LLC
K080450	Stryker Power Tool Navigator / Stryker Instruments

PREDICATE DEVICE IDENTIFICATION

The BrightMatter Pointer is substantially equivalent to the following predicates:

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SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the BrightMatter Guide with BrightMatter Pointer. The following tests were performed to demonstrate substantial equivalence between the subject and predicate devices.

Test	Purpose	Results
Dimensionalanalysis	Comparison of measured dimensions toensure tolerances are within acceptablelimits.	Measurements found withinacceptable tolerances. If outsidetolerance, navigational accuracytesting was performed.
Navigationalaccuracy	Accuracy of navigational componentsevaluated to ensure performance of thesystem.	Accuracy testing demonstratedthe subject device was as accurateas the predicate device.
Cytotoxicity	Cytotoxicity of the device evaluated todemonstrate biocompatibility.	Testing demonstrated the deviceis not cytotoxic.
Sensitization	Sensitization of the device evaluated todemonstrate biocompatibility.	Testing demonstrated the deviceis not sensitizing.
Irritation	Irritation of the device evaluated todemonstrate biocompatibility.	Testing demonstrated the deviceis not an irritant.
Pyrogenicity	Material mediated pyrogenicityevaluated to demonstrate the absenceof a febrile response in an in vivo model.	Testing demonstrated the deviceis non-pyrogenic.
Endotoxin(LAL test)	Amount of gram negative bacteriaevaluated to demonstrate endotoxinunits are within acceptable limits.	Endotoxin units were found to be<0.333, lower than the acceptablelimit.

EQUIVALENCE TO PREDICATE DEVICES

The subject device has a similar design and dimensions as the device originally cleared in K142024 and similar tracking mechanisms (i.e. passive spheres) as the devices cleared in K142024, K153281, and K142344. The position of the passive spheres for the subject device are identical to the device cleared in K142024. The subject device has similar indications to the devices cleared in K142024, K153281, K142344, and K080450. The subject device is reusable and has similar reprocessing procedures as those cleared in K142024 and K080450.

This submission does not include any changes to the previously cleared components of the BrightMatter navigational systems except the Pointer tool.

Synaptive is currently unaware of another Pointer tool on the market that is made of titanium alloy. Therefore, complete biocompatibility testing has been performed to demonstrate substantial equivalence of the new material.

Synaptive Medical, Inc. believes that the BrightMatter Pointer is substantially equivalent to the predicate devices based on the information summarized in the table below.

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CONCLUSION

The proposed BrightMatter Guide with BrightMatter Pointer is considered substantially equivalent to the predicate devices based on the testing performed, the similar indications for use, and similar technological characteristics.

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	Subject Device	Predicate Device
	Synaptive Medical, Inc.	Synaptive Medical, Inc.	IZI Medical ProductsLLC	StrykerInstruments
	BrightMatter Guide with BrightMatterPointer	BrightMatter Navigation System v1.0 /BrightMatter Guide with SurfaceTrace Registration	Disposable PassiveAccessory forMedtronicStealthStation System	Stryker PowerTool Navigator
	K160523	K142024 / K153281	K142344	K080450
Indications forUse	BrightMatter Guide is intended as aplanning and intraoperative guidancesystem to enable open and percutaneouscomputer assisted surgery. The system isindicated for medical conditions requiringneurosurgical cranial procedures wherethe use of computer assisted planningand surgery may be appropriate. Thesystem can be used for intraoperativeguidance where a reference to a rigidanatomical structure can be identified.The user should consult the "AccuracyCharacterization" section of the UserManual to assess if the accuracy of thesystem is suitable for their needs.The BrightMatter Pointer is intended tobe used for anatomy palpation and as apointing tool to enable spatial localizationand identification by BrightMatter Guidenavigational systems.The system should be operated only bytrained personnel such as surgeons andother clinic staff.	K142024: BrightMatter Navigation System is intended as aplanning and intraoperative guidance system to enableopen and percutaneous computer assisted surgery. Thesystem is indicated for medical conditions requiringneurosurgical cranial procedures where the use ofcomputer assisted planning and surgery may beappropriate. The system can be used for intra-operativeguidance where a reference to a rigid anatomical structurecan be identified.The system should be operated only by trained personnelsuch as surgeons and other clinic staff.K153281: BrightMatter Guide with SurfaceTraceRegistration is intended as a planning and intraoperativeguidance system to enable open and percutaneouscomputer assisted surgery. The system is indicated formedical conditions requiring neurosurgical cranialprocedures where the use of computer assisted planningand surgery may be appropriate. The system can be usedfor intraoperative guidance where a reference to a rigidanatomical structure can be identified. The user shouldconsult the "Accuracy Characterization" section of the UserManual to assess if the accuracy of the system is suitablefor their needs.The system should be operated only by trained personnelsuch as surgeons and other clinic staff.	The DisposablePassive Accessory isintended to be usedfor anatomy palpationand registration inimage guidedsurgeries withMedtronicStealthStation®System. The device issterile and designedfor single use.	The Stryker®Power ToolNavigatorattachment isintended toenable spatiallocalization andidentification ofStryker PowerTools by theStryker®NavigationSystem.
ProCodes / Reg #	HAW /21 CFR 882.4560	HAW /21 CFR 882.4560	HAW /21 CFR 882.4560	HAW /21 CFR 882.4560
	Subject Device	Predicate Device
	Synaptive Medical, Inc.	Synaptive Medical, Inc.	IZI Medical Products LLC	Stryker Instruments
	BrightMatter Guide withBrightMatter Pointer	BrightMatter Navigation System v1.0 /BrightMatter Guide with SurfaceTrace Registration	Disposable Passive Accessoryfor Medtronic StealthStationSystem	Stryker Power Tool Navigator
	K160523	K142024 / K153281	K142344	K080450
Technological characteristics
Design	Pointer tool that featuresfour passive reflectivemarkers to enable spatiallocalization andidentification by SynaptiveBrightMatter systems	Pointer tool that features four passive reflectivemarkers to enable spatial localization andidentification by Synaptive BrightMatter systems	Disposable passive probewhere five passive reflectivemarkers are mounted to allowthe probe to be recognizedand registered by theStealthStation system	Tracking device designed anoptical surgical navigationtracker that attaches to apower tool, allowing thattool to be tracked by theStryker Navigation System
Pointer Material	Titanium alloy	Stainless steel 17-4	Stainless steel 303	Unknown
Trackingmechanism	Passive spheres	Passive spheres	Passive spheres	Optical IR LEDs
Passive or Activetracking	Passive	Passive	Passive	Active
Single use orReusable	Reusable	Reusable	Single use	Reusable
Provided Sterileor Non sterile	Non sterile	Non sterile	Sterile	Unknown
Customizedsterilizable tray	Yes	Yes	Unknown	Unknown
Customizedsterilizable traymaterial	Anodized aluminum	Anodized aluminum	Unknown	Unknown
Calibration block	Yes	Yes	Unknown	Unknown
Calibration blockmaterial	Stainless steel 17-4	Stainless steel 17-4	Unknown	Unknown

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Regulation Number and Section

§ 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).