The MedicVOD System is a picture archival and communications systems (PACS) that is intended for image capturing, archiving, displaying and recording of audio/video sequences and patient data during a procedure. The system allows for capture and annotation of the surgical procedure for documentation purposes and for viewing at a later time either locally or on a secure distributed network. The captured audio/video sequences can be broadcasted in real-time with videoconferencing capability during the broadcast. Information captured and stored by the system are for viewing and reference purposes only and are not intended for primary diagnosis.

Device Description

Orpheus Medical MedicVOD System is a picture archiving and communication system intended for image capturing, archiving, displaying and recording of audio/video sequences and patient data during a procedure. The MediVOD System contains the following modules/components: mediCast (ie mediCast Live) - a video stream / image capture device which is connected to a medical scope camera. mediCast App - real-time compression and archiving application displaying session from mediCast Box or from any USB attached camera and broadcast it in real time. mediCast Mobile App - a smart phone application for uploading medical images and videos. mediCast Box - a video stream / image capture device which receives a video signal from various video sources. Connected to a computer via a USB adaptor and uses the mediCast App to display video. mediShow a viewer for real-time broadcasting from a mediCast System. mediSearch – a search utility application which allows the user to search for and view videos and still images previously captured by mediCast. mediWeb - a web based application that provides access to the mediSearch and mediShow applications. The MedicVOD System key features include: Digital recording of medical procedures streamed directly to on-site server for storage and retrieval, Live broadcast of a medical procedure to an unlimited number of viewers, Archiving of video assets to a controlled storage resource, Data fetching with dynamic categories for statistical analysis and multiple report production, and Ability to view/review videos. The mediCAST box is capable of capturing and broadcasting a video stream in real time. MediCAST box captures and stores video and still images, and in parallel, uploads the captured images and video streams to the MedicVOD server. The mediCAST box uploads the videos and images when there is communication with the MedicVOD server. The mediSearch application provides the ability to search within the MedicVOD archive. The mediSearch application allows users to perform searches for video recordings within a captured mediCAST session. Each session could be a combination of several recordings of various kinds. For example, a session could be a combination of several video recordings, several still images (snapshot taken) and several DICOM images that have been stored. MediSearch provides the ability to view the assets which were found, and provides certain editing capabilities. The mediShow application automatically connects into the MedicVOD server and displays currently active sessions or procedures captured by any mediCAST station on the local network.

AI/ML Overview

The provided document is a 510(k) premarket notification for the MedicVOD System, asserting its substantial equivalence to a previously cleared predicate device (K123426). As such, it focuses on demonstrating that the modified device is as safe and effective as the original device, rather than proving the device meets acceptance criteria through a traditional clinical study with performance metrics like sensitivity, specificity, or accuracy.

The document states: "No clinical testing was required to support the substantial equivalence to the predicate device." This immediately tells us that the standard study design elements for evaluating diagnostic performance (like sample size, ground truth, expert adjudication, MRMC studies, or standalone performance) are not present in this submission.

Instead, the "acceptance criteria" here are framed as demonstrating substantial equivalence to a predicate device, and the "study" is a series of non-clinical performance tests proving the new components or modifications do not raise new questions of safety or effectiveness.

Here's an analysis based on the document, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied by Substantial Equivalence and Testing)	Reported Device Performance (Summary from Document)
Substantial Equivalence	Demonstrate that the modified MedicVOD System is as safe and effective as the predicate (K123426) and shares the same indications for use and similar technological characteristics.	Indications for Use: Identical to predicate.Technological Characteristics: Similar to predicate, with new modules (mediCast App, mediCast Mobile App, mediCast Box) and expanded OS compatibility (iOS, Android). The changes were considered "Substantially Equivalent" for hardware configuration and operating system, and "Identical" for other key specifications (Device Name, System Configuration, Clinical Application, Data Storage, Image Sources, Signal Encryption, Resolution, Audio Compression, DICOM Support).
Software Validation Testing	Software testing at the unit level to ensure functionality and safety of new/modified components.	Performed at the unit level for mediCast Box (subject device). Identified as "Identical" in scope to the software testing done for the predicate device. Results demonstrated that the MedicVOD System design met all specifications.
Electrical Safety Testing	Compliance with IEC 60601-1 3rd Edition.	Testing performed to ensure compliance for both the mediCast Box (subject device) and the mediCast Station (predicate device). Results determined to be "Identical."
Electromagnetic Compatibility Testing	Compliance with IEC 60601-1-2:2007.	Testing performed to ensure compliance for both the mediCast Box (subject device) and the mediCast Station (predicate device). Results determined to be "Identical."
Emissions Testing	Compliance with FCC Part 15, Subpart B, Class B.	Tested for both the mediCast Box (subject device) and the mediCast Station (predicate device). Results determined to be "Identical."

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

Sample Size: Not applicable. No clinical test set of patient data was used. The testing described is non-clinical (software, electrical, EMC, emissions).
Data Provenance: Not applicable.

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

Not applicable. No ground truth based on expert review was established for a test set, as no clinical testing was performed or required.

4. Adjudication method for the test set

Not applicable.

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

Not applicable. No MRMC study was done, and the device (a PACS system for archiving and displaying, not for primary diagnosis) does not involve AI or human-in-the-loop performance augmentation for diagnostic tasks.

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

Not applicable. This device is not an algorithm making standalone diagnostic assessments. Its purpose is for capturing, archiving, displaying, and recording, with information "for viewing and reference purposes only and are not intended for primary diagnosis."

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

Not applicable. The equivalence determination relied on non-clinical testing against engineering and regulatory standards and a feature comparison to a predicate device.

8. The sample size for the training set

Not applicable. This document describes a PACS system, not a machine learning or AI model that requires a training set.

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

Not applicable.

In summary: The submission for the MedicVOD System is a 510(k) demonstrating substantial equivalence to an existing cleared device. The "acceptance criteria" are the successful completion of non-clinical tests (software validation, electrical safety, EMC, emissions) to show that the modified device retains the same safety and effectiveness profile as the predicate. No clinical studies were conducted or required, meaning all the elements related to clinical performance evaluation (sample size, ground truth, expert review, MRMC, standalone performance) are not applicable to this particular FDA submission.

Summary

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

February 25, 2016

Orpheus Medical Ltd. % Mr. Ian Marsden Assistant Director Regulatory Affairs Dohmen Life Sciences Services, LLC 11925 W I-70 Frontage Road North, Suite 900 Wheat Ridge, Colorado 80033

Re: K151737

Trade/Device Name: MedicVOD System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: February 1, 2016 Received: February 2, 2016

Dear Mr. Marsden:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

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,

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151737

Device Name MedicVOD System

Indications for Use (Describe)

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)

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Section 07: 510(k) Summary

1. Introduction

1.1 This document contains the 510(k) summary for the modified Orpheus Medical Ltd. MedicVOD System (K151737). The content of this summary is based on the requirements of 21 CFR Section 807.92(c).

2. Applicant Name and Address

Applicant Name:	Orpheus Medical Ltd.
Address:	PO Box 15140Haifa, 31905, Israel
Phone:	Tel: +972-04-6968800
Fax:	Fax: +972-77-4371228
Official Contact:	Ian MarsdenAssistant Director of Regulatory AffairsDohmen Life Science Services, LLC
Address:	11925 W. I-70 Frontage Rd. NorthSuite 900Wheat Ridge, CO 80033
Phone:	303-832-8200
Fax:	303-832-6700
E-mail:	ian.marsden@dlss.com

Summary Preparation Date: February 24, 2016 3.

4. Device Name and Classification

Trade Name	MedicVOD System
Common Name	Picture Archiving and Communication System
Classification Name	Picture Archiving and Communication System
Classification Regulation	21 CFR 892.2050
Product Code	LLZ

5. Predicate Devices

The modified Orpheus Medical Ltd. MedicVOD System is claimed to be substantially 5.1 equivalent to the following legally marketed predicate device:
- 5.1.1 Orpheus Medical Ltd. MedicVOD System (K123426)

6. Performance Standards

6.1 There are no mandatory performance standards for this device.

7. Device Description

7.1 Orpheus Medical MedicVOD System is a picture archiving and communication system intended for image capturing, archiving, displaying and recording of audio/video sequences and patient data during a procedure. The MediVOD System contains the following modules/components:
- 7.1.1 mediCast (ie mediCast Live) - a video stream / image capture device which is connected to a medical scope camera.

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7.1.2 mediCast App - real-time compression and archiving application displaying session from mediCast Box or from any USB attached camera and broadcast it in real time.
7.1.3 mediCast Mobile App - a smart phone application for uploading medical images and videos.
7.1.4 mediCast Box - a video stream / image capture device which receives a video signal from various video sources. Connected to a computer via a USB adaptor and uses the mediCast App to display video.
mediShow a viewer for real-time broadcasting from a mediCast System. 7.1.5
7.1.6 mediSearch – a search utility application which allows the user to search for and view videos and still images previously captured by mediCast.
7.1.7 mediWeb - a web based application that provides access to the mediSearch and mediShow applications.
7.2 The MedicVOD System key features include:
- 7.2.1 Digital recording of medical procedures streamed directly to on-site server for storage and retrieval,
- 7.2.2 Live broadcast of a medical procedure to an unlimited number of viewers,
- 7.2.3 Archiving of video assets to a controlled storage resource,
- 7.2.4 Data fetching with dynamic categories for statistical analysis and multiple report production, and
- 7.2.5 Ability to view/review videos
The mediCAST box is capable of capturing and broadcasting a video stream in real 7.3 time. MediCAST box captures and stores video and still images, and in parallel, uploads the captured images and video streams to the MedicVOD server. The mediCAST box uploads the videos and images when there is communication with the MedicVOD server.
7.4 The mediSearch application provides the ability to search within the Medic/OD archive. The mediSearch application allows users to perform searches for video recordings within a captured mediCAST session. Each session could be a combination of several recordings of various kinds. For example, a session could be a combination of several video recordings, several still images (snapshot taken) and several DICOM images that have been stored. MediSearch provides the ability to view the assets which were found, and provides certain editing capabilities.
The mediShow application automatically connects into the MedicVOD server and 7.5 displays currently active sessions or procedures captured by any mediCAST station on the local network.

8. Comparison of Indications for Use to the Predicate Device

8.1 The modified MedicVOD System which is the subject of this submission has identical indications for use as identified in the original MedicVOD System cleared under K123426. The indications for use for the MedicVOD System are as follows:
- 8.1.1 The MedicVOD System is a picture archival and communications systems (PACS) that is intended for image capturing, archiving, displaying and recording of audio/video sequences and patient data during a procedure. The system allows for capture and annotation of the surgical procedure for documentation purposes and for viewing at a later time either locally or on a secure distributed network. The captured audio/video sequences can be broadcasted in real-time with video-conferencing capability during the

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broadcast. Information captured and stored by the system are for viewing and reference purposes only and are not intended for primary diagnosis.

9. Comparison of Technological Characteristics to the Predicate Device

9.1 The modified MedicVOD System is substantially equivalent to the original MedicVOD System cleared under K123426 with the addition to the following modules/components to the System:
- mediCast App real-time compression and archiving application displaying 9.1.1 session from mediCast Box or from any USB attached camera and broadcast it in real time.
- 9.1.2 mediCast Mobile App - a smart phone application for uploading medical images and videos.
- 9.1.3 mediCast Box - a video stream / image capture device which receives a video signal from various video sources. Connected to a computer via a USB adaptor and uses the mediCast App to display video.
9.2 The table below provides a comparison of the modified MedicVOD System which is the subject of this 510(k), to the original MedicVOD System cleared under K123426.

Specification	Modified Device	Unmodified MedicVODSystem K123426	Comparisonto Predicate
Device Name	MedicVOD System	MedicVOD System	Identical
SystemConfiguration	Video, still Image and audiocapturing workstation,central archiving server andview terminal/s	Video, still Image and audiocapturing workstation,central archiving server andview terminal/s	Identical
ClinicalApplication	During and after surgicalprocedures	During and after surgicalprocedures	Identical
HardwareConfiguration	Touch panel PC, externalkeyboard & mouse,footswitch, mediCast Box,Apple and Android basedtablets and phones	Touch panel PC, externalkeyboard & mouse,footswitch	SubstantiallyEquivalent
Data Storage	Internal storage andtransmission to externalcentral storage server	Internal storage andtransmission to externalcentral storage server	Identical
OperatingSystem	Windows, iOS, Androidbased	Windows based	SubstantiallyEquivalent
ImageSources	Laparoscopic images as wellother audio/image/videooutputs modalities	Laparoscopic images as wellother audio/image/videooutputs modalities	Identical
SignalEncryption	Encrypted digitaltransmission on session andtier base + Variousauthentication levels andexternal LDAP integration	Encrypted digitaltransmission on session andtier base + Variousauthentication levels andexternal LDAP integration	Identical
Resolution	Supports up to high definition:1920x1080	Supports up to high definition:1920x1080	Identical
AudioCompression	Mpeg2 Layer1 or AAC HELC	Mpeg2 Layer1 or AAC HELC	Identical
DICOMSupport	System Supports	System Supports	Identical

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10. Summary of Nonclinical Performance Testing

10.1 The following table summarizes the testing performed on the MedicVOD System to support this 510(k);

	mediCast Box(subject device)	mediCast Station(predicate device –K123426)	Comparison ofsubject deviceto predicate
SoftwareValidationTesting	Software testing at the unitlevel	Software testing at the unitlevel. Additionalnonclinical performancetesting used to supportK123426	Identical
Electrical SafetyTesting	Testing performed toensure compliance to IEC60601-1 3rd Edition	Testing performed toensure compliance to IEC60601-1 3rd Edition	Identical
ElectromagneticCompatibilityTesting	Testing performed toensure compliance to IEC60601-1-2:2007	Testing performed toensure compliance to IEC60601-1-2:2007	Identical
EmissionsTesting	Tested to comply withFCC Part 15, Subpart B,Class B	Tested to comply withFCC Part 15, Subpart B,Class B	Identical

11. Summary of Clinical Performance Testing

11.1 No clinical testing was required to support the substantial equivalence to the predicate device.

12. Conclusion

12.1 Non-clinical verification and validation of the Orpheus Medical Ltd. MedicVOD System was performed through extensive bench testing. Results of the testing demonstrated that the Orpheus Medical Ltd. MedicVOD System design met all specifications and is adequate for its intended use. Additionally, the test results demonstrated substantial equivalence of the Orpheus Medical Ltd. MedicVOD System to its predicate device.
12.2 In conclusion, the Orpheus Medical Ltd. MedicVOD System is substantially equivalent in intended use, technological characteristics, safety, and performance characteristics to the following legally marketed predicate device:

12.2.1 Orpheus Medical Ltd. MedicVOD System (K123426)

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).