Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.

Device Description

The Seno Advantage Workstation is a multi-modality review workstation. It includes a color flat panel for the multi-modality image review and two specific B&W high resolution monitors for the mammographic images review. Moreover, a dedicated keypad is provided to increase productivity. The Seno Advantage is positioned to be the system of choice for all users of Modality: CT, MR, XR, RF, XA, CR, DX, MG, NM, PET, US, SC. The Hardware configuration of Seno Advantage is the following: HP XW8000 Workstation, Monitors specifications (NEC Flat Panel 18.1" LCD, 2 Grayscale 5 Mpixels CRT), Seno Advantage supports the following image networking: Standard 10/100/1000 Base-T Ethernet Protocols supported: DICOM 3.0 Storage SCU/SCP and Query/Retrieve SCU/SCP, InSite, TCP/IP network layer, SdCNet supported to query/retrieve from AW 3.1 and AW 4.0.

AI/ML Overview

This document is a 510(k) summary for the Seno Advantage, a medical image review workstation. The document primarily focuses on demonstrating substantial equivalence to a predicate device (Advantage Workstation 4.1, K020483). It describes the device's hardware, software, indications for use, and comparison with the predicate.

Here's an analysis of the provided text in relation to your questions regarding acceptance criteria and study information:

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

The document does not explicitly state specific acceptance criteria or report device performance in a quantitative manner comparable to what might be expected for a diagnostic or AI device study. Instead, the "Conclusion" section states: "Seno Advantage provides images comparable to the predicate device." This implies an acceptance criterion of image comparability.

The submission is for a medical image review workstation, which is a viewing and processing device, not a diagnostic algorithm that generates a specific output that can be measured against ground truth in terms of sensitivity, specificity, etc. Therefore, performance a device that displays images is typically evaluated by demonstrating that the displayed images meet certain technical specifications (e.g., resolution, brightness, contrast) and are diagnostically acceptable for a trained physician. The document refers to the use of "high-resolution monitors" for mammographic images.

Reported Device Performance (Implicit):

Image Comparability: "Seno Advantage provides images comparable to the predicate device." (This is the primary performance claim).
Workflow Integration: "Seno Advantage brings additional features in order to integrate seamlessly into the Radiology Department Workflow."
Risk Management: "The entire potential new hazards has been studied and controlled by a Risk Management Plan: A hazard analysis/ Risk Management Summary A software development and validation process A software verification plan." (This relates to safety and quality, not clinical performance metrics).

Table (Reconstructed based on implied criteria):

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Images are diagnostically acceptable.	Provides images "comparable to the predicate device."
Image quality meets technical specifications.	Uses "high-resolution monitors" for mammographic images (2560x2048 pixels via 5 Mpixels CRT).
Device functions as a multi-modality review station.	Supports review of CT, MR, XR, RF, XA, CR, DX, MG, NM, PET, US, SC images.
Device integrates into workflow.	"brings additional features in order to integrate seamlessly into the Radiology Department Workflow."
Device is safe and effective.	Risk Management Plan, software development, and validation processes were followed.

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

The document does not mention a specific test set, sample size of images, or data provenance (country of origin, retrospective/prospective) for evaluating image comparability or clinical performance. This type of detail is typical for devices that include diagnostic algorithms, which this workstation does not appear to be. The evaluation seems to be based on technical specifications and functional equivalence to the predicate.

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

Not applicable. As no specific test set or clinical performance evaluation is described, there's no mention of experts or their qualifications for establishing ground truth. The device is a viewing workstation, and its primary claim is image comparability to a legally marketed predicate. The "indications for use" state that images are to be "interpreted by a trained physician," which implies that the human expert is the ultimate interpreter, not the device itself providing automated diagnoses.

4. Adjudication method for the test set

Not applicable. Without a test set and ground truth establishment process, there is no mention of an adjudication method.

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. This device is a viewing workstation, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed and is not mentioned.

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

Not applicable. This device does not feature a standalone diagnostic algorithm. It is a workstation for human review of images.

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

Not applicable. As this device is a workstation for viewing images and demonstrates substantial equivalence based on technical specifications and functionality, there is no discussion of ground truth derived from expert consensus, pathology, or outcomes data. The "ground truth" related to its function would be whether the images are displayed correctly and are diagnostically interpretable by a trained physician, which is implicitly covered by the claim of image comparability to the predicate.

8. The sample size for the training set

Not applicable. The document does not describe a training set as it is not a machine learning or AI-driven diagnostic device.

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

Not applicable. As there is no described training set, there is no mention of how ground truth for such a set would be established.

Summary

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General Electric Medical Systems

K033400 Seno Advantage 510 (k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87 (h)

1. Identification of submitter:
  Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager Telephone: (262) 544-3894 Fax: (262) 548-4768 GE Medical Systems W-400 3000 North Grandview Blvd. Waukesha, WI 53188 USA Date Prepared: August 4, 2003

2. Identification of Product:

Device name	Seno Advantage
ClassificationPanel:	Radiology PACS per 21CFR Section 820 2050

Manufacturer/Distributor	General Electric Medical System283, Rue de la Minière78533 BUC Cedex France
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3. Marketed Devices

Seno Advantage is substantially equivalent to the devices listed below:

Model:	Advantage Windows Review Workstation
Manufacturer:	General Electric Medical Systems
510 (k):	K020483

4. Device Description :

The Seno Advantage Workstation is a multi-modality review workstation. It includes a color flat panel for the multi-modality image review and two specific B&W high resolution

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General Electric Medical Systems

Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular shape. The circle has three small, curved extensions or flourishes emanating from it, spaced evenly around the perimeter.

033400

monitors for the mammographic images review. Moreover, a dedicated keypad is provided to increase productivity.

The Seno Advantage is positioned to be the system of choice for all users of Modality: CT, MR, XR, RF, XA, CR, DX, MG, NM, PET, US, SC.

The Hardware configuration of Seno Advantage is the following:

HP XW8000 Workstation: .
- Dual Intel® Xeon™ Processor .
- 2 x 3.06GHz CPU Clock Speed with 512KB Cache per CPU ●
- 2GB RAM (expandable to 4GB) ●
- 2 x 73 GB: Ultra160 SCSI 15,000rpm Hard Disks .
- 130 GB can be used for image storage as follows: .
  - . 991,821 2562 images OR
  - 247,995 5122 images OR .
  - . 61,989 10244 images OR
  - 12,398 2048 x 2560 images .
- Internal CD-ROM drive (48x read/write) for read/write of DICOM media, . read/write of Data Export data and service use.
- 1 internal 3½" Floppy Drive .
- 1 US QWERTY Keyboard.
- 1 mechanical 3-buttons mouse ●
- 1 Mammography dedicated keypad. .
- 1 B&W Video board 5Mpixels Dual Head .
Monitors specifications : Two types of monitors are used. Specifications for each of these monitors is given here:
- · 1 NEC* Flat Panel 18.1" LCD
- · NEC MultiSync* LCD1880SX
- · 18.1 inch diagonal width
- · 1280x1024 Landscape display
- · 60 Hz refresh rate
- · Height: 44.5cm (17.5in.)
- · Width: 39.8cm (15.7in.)
- · Depth: 21.8cm (8.6in.)
- Weight: 8.5kg (18.7lb.) .
- 110-240VAC, 47-63Hz, 0.35-0.8Amps. .
- 2 Graysacale 5 Mpixels CRT ●
- 21 inch diagonal width .
- 2560x2048 portrait display .

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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The letters are stylized and have a flowing, cursive appearance. The logo is in black and white.

K033400

76 Hz refresh rate ●
Height: 52cm (20.4in.) ●
Width: 40.5cm (16in.) ●
Depth: 50.5cm (19.8in.) �
Weight: 35kg (78.7lb.) .
. 110-240VAC, 47-65Hz

Seno Advantage supports the following image networking:

. Standard Standard 10/100/1000 Base-T Ethernet Protocols supported:
DICOM 3.0 Storage SCU/SCP and Query/Retrieve SCU/SCP .
. InSite
TCP/IP network layer .
SdCNet supported to query/retrieve from AW 3.1 and AW 4.0 .

5. Indications for Use

6. Comparison with Predicate Device

The Seno Advantage is substantially equivalent to the following workstation: Advantage Workstation 4.1 Manufacturer: GE Medical Systems 510(k): K020483 Both of these workstations allow easy selection, review, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems.

7. Conclusions

Seno Advantage brings additional features in order to integrate seamlessly into the Radiology Department Workflow. The entire potential new hazards has been studied and controlled by a Risk Management Plan:

A hazard analysis/ Risk Management Summary .
A software development and validation process .

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Image /page/3/Picture/0 description: The image shows the text "General Electric Medical Systems". The text is in a serif font and is black. The background is white.

Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters and the border are in black, set against a white background. The logo is a well-known symbol associated with the multinational conglomerate.

A software verification plan .
Seno Advantage provides images comparable to the predicate device.

K032400

8. Other – table of acronyms

In the whole submission, the DICOM acronyms are used to describe the various imaging modalities supported by the Seno Advantage workstation. The following table defines these acronyms:

Term	Definition
CR (modality)	Computerized Radiology or Computed Radiography
CRT	Cathode Ray Tube
CT (modality)	Computerized Tomography
DICOM (standard)	Digital Imaging and Communications in Medicine
DX (modality)	Digital X-ray
MG (modality)	Digital Mammography
MR (modality)	Magnetic Resonance
MX (modality)	Mixed modality (i.e. the exam contains series of different modalities)
NM (modality)	Nuclear Medicine
OT (modality)	Other modality
PET or PT (modality)	Positron Emission Tomography
RF or XRF (modality)	Xray Radio &Fluoro
RT (modality)	Radiation Therapy
SC or SCPT (modality)	Secondary Capture
SR (modality)	Structured Report
US (modality)	Ultra Sound
XA (modality)	Xray Angio (vascular and cardio exams)
XR (modality)	X-ray

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing segments, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 4 2003

GE Medical Systems W-400 % Mr. Juergen Welte Acting Program Manager 510(k) TUV Rheinland of North America 12 Commerce Road NEWTON CT 06470

Re: K033400

Trade/Device Name: Seno Advantage Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: November 18, 2003 Received: November 19, 2003

Dear Mr. Welte:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can he 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); 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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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATION FOR USE

KU33400

Device name: Seno Advantage

Indication for use:

Seno Advantage is a medical image review station that allows easy selection, processing, filming Scho revelings is a modical minger ality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution which interpreted by a named for diagnosis. Furthermore filmed images from all modalities may also be used as an clement for diagnosis.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
-OR-
Over-The-Counter Use

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033400

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).