The Digital Lightbox is a system intended for the retrieval and display of medical images from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, 3D reconstruction, basic measurements, and multi-modality image fusion. It is not intended for primary image diagnosis or the review of mammographic images.

Device Description

Digital Lightbox is a medical image viewing device consisting of two high-resolution monitors controlled through touch panels with an integrated PC. It features an Ethernet connection for retrieving medical images through a computer network. Further, the device can read images from CD, DVD or USB drives through external interfaces. The device software is compatible with the DICOM standard and allows basic image manipulation, 3D reconstruction, basic measurements and multi-modality image fusion. The device software integrates a web browser and remote access software.

AI/ML Overview

The provided text is a 510(k) summary for the Digital Lightbox. This document typically focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed clinical study results and acceptance criteria in the format requested for a medical AI device.

Given that the Digital Lightbox is described as a "medical image viewing device" and "not intended for primary image diagnosis," it is highly unlikely to involve acceptance criteria related to diagnostic accuracy (sensitivity, specificity, etc.) or comparative effectiveness studies with human readers assisted by AI. Its validation would primarily address functional performance, safety, and effectiveness as an image display and manipulation tool.

Therefore, the specific information requested in points 1-9 regarding diagnostic performance, sample sizes for test/training sets, expert ground truth, and MRMC studies is not available or applicable in the provided 510(k) summary for the Digital Lightbox.

However, I can extract information related to the device's validation and substantial equivalence claims:

Acceptance Criteria and Study for Digital Lightbox (Based on 510(k) Summary K080608)

While specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) and detailed study designs (e.g., sample sizes, expert qualifications for ground truth) are not provided in this 510(k) summary, the document does state the general validation approach. The Digital Lightbox is a medical image viewing device, not an AI diagnostic algorithm, so its validation focuses on functional performance, safety, and equivalence to existing display systems.

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, or image quality scores) related to diagnostic accuracy are provided or expected for this type of device.
The document implies that the device met functional and safety criteria as part of BrainLAB's internal validation processes and demonstrated substantial equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable/Not provided. This device is for image display and manipulation, not for diagnostic interpretation requiring a "test set" of patient data in the typical sense for AI diagnostic algorithms. Its validation would involve functional testing with various image types and formats, but not a "test set" with ground truth in the way a diagnostic algorithm would.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable/Not provided. As stated above, this is not a diagnostic AI device requiring expert-established ground truth for a diagnostic test set.

4. Adjudication Method for the Test Set

Not applicable/Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improving with AI vs. without AI assistance

No. This device is a display and manipulation tool, not an AI assistance system for human readers. Therefore, an MRMC study comparing human readers with and without "AI assistance" (from this device) is not relevant or reported.

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

Not applicable. The Digital Lightbox is an interactive viewing device; its function inherently involves a human user. There is no "algorithm only" diagnostic performance to evaluate.

7. The type of ground truth used

Not applicable. For a medical image viewing device, "ground truth" as pathology or outcome data is not relevant to its primary function. Its performance would be assessed against expected display fidelity, measurement accuracy, and functionality.

8. The Sample Size for the Training Set

Not applicable/Not provided. As this is not an AI algorithm trained on patient data for diagnostic purposes, there is no "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not provided.

Summary of Device Validation from the 510(k) Document:

The provided text states:

"Digital Lightbox has been verified and validated according to BrainLAB procedures for product design and development. The validation proves the safety and effectiveness of the system." (Page 1, {1})
"The information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate devices iPlan (K 053127), iPlan Hip Templating (K 042543) and DGSCOPE, RELEASE 1.0 (K 070397)." (Page 1, {1})

This indicates that BrainLAB conducted internal verification and validation activities to ensure the device met its design specifications and performed safely and effectively as an image viewing and manipulation system. The primary "study" for regulatory approval here is the demonstration of substantial equivalence to already legally marketed predicate devices, which implies that the Digital Lightbox meets similar performance and safety standards as those devices.

Summary

{0}------------------------------------------------

K080608.

APR 1 7 2008

510 (k) Summary of Safety and Effectiveness for Digital Lightbox

Manufacturer:

Address:	BrainLAB AGKapellenstrasse 1285622 FeldkirchenGermany
	Phone:	+49 89 99 15 68 0
	Fax:	+49 89 99 15 68 33
Contact Person:	Mr. Per Persson
Summary Date:	November 13, 2007

Device Name:

Trade name:

Digital Lightbox

Common/Classification Name:

Digital Lightbox, BrainLAB system, image processing, radiological

Predicate Devices:

iPlan (K 053127) iPlan Hip Templating (K 042543) DGSCOPE, RELEASE 1.0 (K 070397)

Device Classification Name: System, image processing, radiological Requlatory Class: Class II

Intended Use:

Device Description:

{1}------------------------------------------------

Substantial equivalence:

Digital Lightbox has been verified and validated according to BrainLAB procedures for product design and development. The validation proves the safety and effectiveness of the system. The information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate devices iPlan (K 053127), iPlan Hip Templating (K 042543) and DGSCOPE, RELEASE 1.0 (K 070397).

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2008

Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Kapellenstraße 12 85622 Feldkirchen GERMANY

Re: K080608

Trade/Device Name: Digital Lightbox Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 22, 2008 Received: March 4, 2008

Dear Mr. Birkenbach:

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 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.

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Page 2

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 aftthe 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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance pt one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Deporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You max obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html

Sincerely vours.

Nancy C. Brogdon

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

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510(k) Number (if known):

Device Name: Digital Lightbox

Indications For Use:

Prescription Use (Per 21 CFR 801 Subpart D) AND/OR -

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ami M. Whay

(Division Sign Division of Reproductive, Abdomina Radiological Devi 510(k) Number

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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).