LifeSys™ PACS is a Picture Archive and Communications software product used to receive pertinent radiology patient information and DICOM images and allow easy generation of a Radiology Report for distribution over a network.

LifeSys™ PACS software is intended for use as a primary diagnostic and analysis tool for diagnostic images. LifeSys™ PACS is for hospitals, imaging centers, radiologists, radiology professional services providers and any user who requires and is granted access to patient image, demographic and report information.

The LifeSys™ PACS viewer displays images from CT, computed radiography, MRI, nuclear medicine. PET. ultrasound. x-rav angiography. and x-ray fluoroscopy.

Device Description

LifeSys™ PACS is a PACS software product that provides medical imaging departments of all types (Hospitals, Imaging Centers, and Clinics) with the capability to archive patient imaging studies and generate reports on said studies. LifeSys™ PACS is a single piece of software which includes the following functional modules: LifePACS™, which includes a Worklist, Tech Page, Image acquisition, receipt and archive, Report Editor, and tools for integration; and LifeView™, which includes a DICOM image viewer, rapid loading for fast and efficient reading and reporting and multiple monitor support.

AI/ML Overview

The provided document describes the FDA 510(k) premarket notification for the LifeSys™ PACS device. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and studies proving the device meets those criteria.

Specifically, the document focuses on establishing substantial equivalence to a predicate device (eRAD PACS and eRAD RIS/PACS) based on technical characteristics, general function, application, and intended use. It mentions "Thorough non-clinical system verification and validation testing" and that the "LifeSys™ PACS software passed all in-house testing criteria," but it does not provide any specific acceptance criteria, reported device performance metrics, study details (like sample sizes, ground truth establishment, expert qualifications, or multi-reader studies), or effect sizes for human reader improvement.

The document states:

"The two devices are substantially equivalent in the areas of design, architecture, general function, application, and intended use."
"The new device does not raise any new potential safety risks and is equivalent in performance to the predicate device."
"Thorough non-clinical system verification and validation testing was conducted in accordance with applicable international standards and internal design requirement to verify that LifeSys™ PACS software product meets user needs and indications for use."

These statements suggest that performance was evaluated, but the specifics of how that performance was measured against what criteria are not detailed in this 510(k) summary. Given that the device is a Picture Archiving and Communications System (PACS) intended as a "primary diagnostic and analysis tool," its performance in displaying images would be crucial, but the document does not elaborate on this.

Therefore, many of your questions cannot be answered from the provided text.

Here's a breakdown of what can and cannot be inferred/extracted from the document:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document states that the software "passed all in-house testing criteria" and confirms "equivalence in performance to the predicate device," but it does not specify what those criteria were or detail any quantitative performance metrics.

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

Cannot be provided. No information on sample sizes (e.g., number of images, cases, or studies) or data provenance (country of origin, retrospective/prospective) is given for any testing.

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

Cannot be provided. The document does not describe any test set for which ground truth would be established by experts. The focus is on the software's functional equivalence and technical characteristics rather than diagnostic accuracy studies involving human readers.

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

Cannot be provided. As no details on a test set or expert evaluation are given, no adjudication method is mentioned.

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

Cannot be provided. The document makes no mention of AI assistance, nor does it describe any MRMC studies or human reader performance comparisons. The device is a PACS, which is a viewing and archiving system, not an AI-powered diagnostic aid.

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

Cannot be provided. While "non-clinical system verification and validation testing" was done, the document doesn't provide details on what constitutes "standalone performance" for a PACS (as it's primarily a display and management system for human interpretation). It explicitly states, "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed." indicative of human-in-the-loop operation.

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

Cannot be provided. No specific ground truth methodology is mentioned as no independent diagnostic performance study is detailed.

8. The sample size for the training set

Cannot be provided. The document refers to "in-house testing criteria" and verification/validation, but it does not describe a "training set" in the context of an algorithm that learns from data. This device is a PACS software, not an AI/ML algorithm that would typically have a "training set."

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

Cannot be provided. (See point 8).

In conclusion, the provided FDA 510(k) summary for LifeSys™ PACS focuses on demonstrating substantial equivalence primarily through comparing technical specifications and intended use with a predicate device, rather than providing detailed clinical performance studies or specific acceptance metrics for image viewing and diagnostic interpretation capabilities.

Summary

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

April 5, 2017

Lifetrack Medical Systems, Inc. % Mr. Keith Barritt Attorney Fish & Richardson 1425 K Street NW WASHINGTON DC 20005

Re: K161341

Trade/Device Name: Lifesys™ PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 21, 2017 Received: March 22, 2017

Dear Mr. Barritt:

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) K161341

Device Name LifeSys™ PACS

Indications for Use (Describe)

LifeSys™ PACS software is intended for use as a primary diagnostic and analysis tool for diagnostic images. LifeSys™ PACS is for hospitals, imaging centers, radiology professional services providers and any user who requires and is granted access to patient image, demographic and report information.

The LifeSys™ PACS viewer displays images from CT, computed radiography, MRI, nuclear medicine, PET, ultrasound, x-ray angiography, and x-ray fluoroscopy.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 5: 510(k) Summary

Date Prepared: February 21, 2017

Submitter: Lifetrack Medical Systems, Inc. 1007 One World Place, 32nd Street, BGC Taguig City, Metro Manila, 1634, Philippines

Contact Person: Eric Schulze, MD, PhD Chief Executive Officer O: +632 802 9980 F: +632 802 9980

Official Correspondent: Eric Schulze, MD, PhD Chief Executive Officer

O: +632 802 9980 F: +632 802 9980 eric.schulze@lifetrackmed.com

Trade Name: LifeSys™ PACS Classification Name: System, Image Processing, Radiological Picture, archive and communications system (PACS) Common Name: Product Code: LLZ

Predicate Device:

Device Classification Name: System, Image Processing, Radiological 510(k) Number: K120995 Device Name: eRAD PACS and eRAD RIS/PACS Original Applicant: eRAD, Inc., 9 Pilgrim Road, Greenville, SC 29607 Product Code: LLZ Decision Date:December 3, 2012 Decision: Substantial equivalent (SE) Type: Traditional

Device Description:

Indications for Use:

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The LifeSys™ PACS viewer displays images from CT, computed radiography, MRI, nuclear medicine. PET. ultrasound. x-rav angiography. and x-ray fluoroscopy.

Technological Characteristics:

LifeSys™ PACS is a device that does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed.

The LifeSys™ PACS device labeling contains instructions for use and any warnings or cautions to provide for the safe and effective use of the device. Users of the device are responsible to imonsure that display quality, environmental lighting and other possible distractions are consistent with a clinical environment. The hardware components specified are all "off the shelf" computer components.

It is our conclusion that there is no software or hardware component in the LifeSys™ PACS device whose failure or latent design flaw would be expected to result in death or injury to a patient. The "level of concern" on the LifeSys™ PACS device is "moderate".

Substantial Equivalence:

The new device (LifeSys™ PACS) and predicate device (eRAD PACS and eRAD RIS/PACS) are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not raise any new potential safety risks and is equivalent in performance to the predicate device. The two devices are substantially equivalent in the areas of design, architecture, general function, application, and intended use.

Non-Clinical Testing:

Thorough non-clinical system verification and validation testing was conducted in accordance with applicable international standards and internal design requirement to verify that LifeSys™ PACS software product meets user needs and indications for use. The Verification & Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed in each operational mode. LifeSys™ PACS software passed all in-house testing criteria.

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Conclusion

The 510(k) Pre-Market Notification for LifeSys™ PACS contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject device and predicate device are substantially equivalent in the areas of technical characteristics, general function, application, intended use, and does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices. LifeSys™ PACS is substantially equivalent with respect to safety and effectiveness to the 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).