Synaptive ImageDrive Pro is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA.

Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

Device Description

Synaptive ImageDrive Pro is a medical imaging informatics system that allows the storage, management, display and analysis of imaging and non-imaging data. The Synaptive ImageDrive Pro data repository can be populated either by manually uploading data through the user interface (UI) or in an unattended fashion by automatically receiving DICOM objects or HL7 messages from other information systems such as PACS and EMRs. Automatic data processing rules can be configured to process data when it arrives in the system. An example of this is when pre-operative MR scans are done and sent to ImageDrive to ensure that they were acquired using appropriate scan protocol before they are consumed downstream by other Synaptive applications, such as BrightMatter Plan (cleared as a Class-II device, K140337). Once in the system, the data is indexed so that it can be easily searched in the future. Imaging data can also be de-identified and securely shared with authorized persons. Further, the system provides an extensible architecture to enable local or distributed processing of the data. As data accumulates in the system, analytics can be generated to summarize, for example, intra- and inter-patient statistics and trends in surgical treatment planning based on surgical plan data that is output from external software that can generate data in compatible formats. An example of such external system is the surgical planning software manufactured by this applicant - - BrightMatter Plan. The subject device is composed of the following key features: A hierarchical folder system Three data storage areas Data processing functionality Analytics capability Image viewing capability

AI/ML Overview

The provided text does not contain specific acceptance criteria or an explicit study describing the device's performance against those criteria in a quantitative manner. The document is a 510(k) summary for the Synaptive ImageDrive Pro, focusing on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance metrics from a dedicated clinical or non-clinical study to meet specific acceptance criteria.

However, based on the non-clinical testing and design validation sections, we can infer the intent of the acceptance criteria was to ensure the device performs as intended and is safe and effective.

Here's an attempt to answer your request based on the available information, with many points marked as "N/A" or "Not specified" due to the nature of the document:

1. Table of acceptance criteria and the reported device performance

Since specific quantitative acceptance criteria are not provided, I will infer general categories of performance based on the non-clinical testing performed.

Acceptance Criteria Category (Inferred)	Reported Device Performance
Software Functionality (All requirements met)	"Software verification testing for each requirement specification" was conducted, implying that the software met its specified requirements.
System Reliability/Usability (System operates as intended by users)	"System validation testing using intended users" was performed, indicating the system's usability and functionality were validated in a simulated use setting.
Safety and Effectiveness (Equivalent to predicate device, no new questions of safety/effectiveness)	"The results support substantial equivalence to the predicate device and demonstrate that Synaptive ImageDrive Pro is safe for its intended use." The conclusion states that "the differences between the subject device and the predicate device do not raise any new questions regarding safety and effectiveness."
Quality Assurance Adherence (Software developed under quality management system)	Various quality assurance measures were applied: Software development life cycle, Software risk assessment, Risk assessment of OTS software, Risk assessment from Cyber and Information security perspective, Software configuration management and version control, Software issue tracking and resolution. (Performance implicitly means adherence to these processes).

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

Sample size for the test set: Not specified. The document mentions "System validation testing using intended users" but does not provide details on the number of users or the test cases/data used.
Data provenance: Not specified. It's a medical imaging informatics system that displays images from "various imaging sources," but the origin of data used for testing is not detailed. The product description indicates it receives DICOM objects or HL7 messages from PACS and EMRs, implying it handles clinical data.

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

Not specified. The document mentions "System validation testing using intended users," which implies clinical professionals, but does not detail how ground truth was established for the validation tests or how many experts were involved.

4. Adjudication method for the test set

Not specified.

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. The document explicitly states: "This technology is not new, therefore a clinical study was not considered necessary prior to release." The device is a Picture Archiving and Communication System (PACS) and generally, these systems are cleared based on substantial equivalence to existing technology, and not typically through MRMC studies that assess reader performance with and without AI. The device described does not appear to have an "AI" component that assists readers in interpretation in the way that would necessitate such a study.

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

The device itself is a PACS for viewing, communicating, processing, and displaying medical images. It's not an algorithm that performs a diagnostic task independently. Its "performance" is tied to its functional capabilities (storage, management, display, processing, communication). Software verification and system validation were done, which tests the algorithm/system's internal functionality.

7. The type of ground truth used

Not explicitly stated for the "test set" in the context of diagnostic performance. For general software verification and system validation, the "ground truth" would be the expected behavior of the system as defined by its requirements and design specifications. For the "intended users" validation, it would be the successful execution of tasks by users in a simulated environment.

8. The sample size for the training set

Not applicable. This device is a PACS, not a machine learning algorithm that requires a "training set" in the conventional sense. Its "training" is in its development and programming, rather than learning from data.

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

Not applicable, as there is no "training set."

Summary

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

March 29, 2016

Synaptive Medical Inc. % Mr. Cameron Piron President MaRS Centre, South Tower, 101 College Street, Suite 200 TORONTO, ON M5G 1L7 Canada

Re: K153284

Trade/Device Name: Synaptive ImageDrive Pro Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 1, 2016 Received: February 3, 2016

Dear Mr. Piron:

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

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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" (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.

Michael D.'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) K153284

Device Name Synaptive ImageDrive Pro

Indications for Use (Describe)

Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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:	November 10, 2015
Trade Name:	Synaptive ImageDrive Pro
Common/Usual Name:	PACS
Classification:	21 CFR 892.2050System, Image Processing, Radiological
Product Code:	LLZ
Manufacturer:	Synaptive Medical Inc.MaRS Centre, South Tower101 College Street, Suite 200Toronto, ON M5G 1L7 Canada
Establishment Registration:	3010439744
Predicate Device:	Manufacturer: GE HealthcareTrade name: Centricity PACS-IW with Universal Viewer510(k) Number: K123174Date Cleared: November 16, 2012
Device Description	Synaptive ImageDrive Pro is a medical imaging informatics system that allows the storage, management, display and analysis of imaging and non-imaging data. The Synaptive ImageDrive Pro
Table 5.1 510(k) Summary (As required by section 21 CFR 807.92(c))
data repository can be populated either by manually uploadingdata through the user interface (UI) or in an unattended fashionby automatically receiving DICOM objects or HL7 messages fromother information systems such as PACS and EMRs.Automatic data processing rules can be configured to processdata when it arrives in the system. An example of this is whenpre-operative MR scans are done and sent to ImageDrive toensure that they were acquired using appropriate scan protocolbefore they are consumed downstream by other Synaptiveapplications, such as BrightMatter Plan (cleared as a Class-IIdevice, K140337).Once in the system, the data is indexed so that it can be easilysearched in the future. Imaging data can also be de-identifiedand securely shared with authorized persons. Further, thesystem provides an extensible architecture to enable local ordistributed processing of the data.As data accumulates in the system, analytics can be generated tosummarize, for example, intra- and inter-patient statistics andtrends in surgical treatment planning based on surgical plan datathat is output from external software that can generate data incompatible formats. An example of such external system is thesurgical planning software manufactured by this applicant - -BrightMatter Plan.The subject device is composed of the following key features:A hierarchical folder system Three data storage areas Data processing functionality Analytics capability Image viewing capability
Indications for Use	Synaptive ImageDrive Pro is a device that displays medical images(including mammograms) and data from various imaging sources.Images and data can be viewed, communicated, processed anddisplayed within the system or across computer networks atdistributed locations.
Table 5.1 510(k) Summary (As required by section 21 CFR 807.92(c))
	Lossy compressed mammographic images and digitized filmscreen images must not be reviewed for primary imageinterpretations. Mammographic images may only be interpretedusing an FDA approved monitor that offers at least 5 Megapixelresolution and meet other technical specifications reviewed andaccepted by the FDA.Typical users of this system are trained professionals, includingbut not limited to radiologists, physicians, nurses, medicaltechnicians, and assistants.
Summary ofTechnologicalComparisons	Design comparison: Both the subject device and the predicate areinternet based software-only medical devices that allow storage,management, display and analysis of imaging and non-imagingdata. Both systems support communication of data to and fromthe system using DICOM and HL7 data communication standards.Both systems are capable of communicating with EMR and PACS.Technology comparison: Both systems are designed to bedeployed over conventional TCP/IP networking infrastructureavailable in most healthcare organizations and utilize commercialcomputer hardware platforms and operating systems. Neither ofthe systems produce any original medical images and receivemedical images and information various data sources. Theinformation can be stored, communicated, processed anddisplayed across computer networks at distributed locations.
Non-Clinical Testing	Following testing was conducted on Synaptive ImageDrive Prodevice:Software verification testing for each requirementspecification. System validation testing using intended users. The following quality assurance measures were applied duringdevelopment of the software system: Software development life cycle Software risk assessment Risk assessment of OTS software Risk assessment from Cyber and Information securityperspective
Table 5.1 510(k) Summary (As required by section 21 CFR 807.92(c))
	Software configuration management and version control Software issue tracking and resolution.
Design Validation	Design validation was performed using Synaptive ImageDrive Pro in simulated use settings by intended users. The results support substantial equivalence to the predicate device and demonstrate that Synaptive ImageDrive Pro is safe for its intended use.
Clinical Testing	This technology is not new, therefore a clinical study was not considered necessary prior to release. Additionally, the substantial equivalence of the device is supported by the non-clinical testing.
Conclusion:	Synaptive ImageDrive Pro system is a medical system that allows the storage, management, display and analysis of imaging and non-imaging data. It has been shown in this 510(k) submission that the differences between the subject device and the predicate device do not raise any new questions regarding safety and effectiveness. Synaptive ImageDrive Pro as designed and manufactured, is substantially equivalent to, and as safe and effective as, the referenced predicate device.

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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).