The Digital Lightbox is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. 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 visualization (reconstructions and volume rendering), basic measurements, multi-modality image fusion and object and trajectory creation. Basic treatment plans can be exported to BrainLAB navigation systems. The device software integrates a web browser and remote access software.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Digital Lightbox, structured as requested.

It's important to note that the provided text is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than detailing comprehensive performance studies with acceptance criteria. Therefore, some of the requested information (like specific acceptance criteria values, a detailed description of the study design including sample sizes for a test set, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, or standalone performance metrics) is not explicitly present in this type of document. The document primarily attests to verification and validation activities performed according to the manufacturer's procedures.

Acceptance Criteria and Device Performance for Digital Lightbox (K093117)

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) and corresponding quantitative performance metrics for the Digital Lightbox are not detailed in this 510(k) summary. The document states that the device was verified and validated according to BrainLAB procedures for product design and development, and that the validation proves the safety and effectiveness of the system.

The primary "performance" reported is that the device is substantially equivalent to its predicate devices for its intended use, particularly for the new functionalities of 3D visualization and basic surgical planning.

Acceptance Criterion (Implied)	Reported Device Performance
Safety and Effectiveness	Verified and validated according to BrainLAB procedures.
Compliance with Intended Use	System is intended for display of medical images, image manipulation, basic measurements, 3D visualization, and navigation planning features (multi-modality image fusion, object/trajectory creation). Its features for navigation planning and 3D visualization are equivalent to predicate device iPlan (K053127).
DICOM Standard Conformance	Conforms to the DICOM standard.
Substantial Equivalence to Predicate Devices	Found to be substantially equivalent to iPlan (K053127) and Digital Lightbox (K080608) for its stated indications for use (including new functionalities).

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

The 510(k) summary does not specify a sample size for a "test set" in the context of comparative performance metrics (e.g., for accuracy or error rates). The validation mentioned is more likely related to internal testing against functional specifications and equivalence to predicate devices rather than a ground-truth-driven performance study with a defined test set.

Sample Size (Test Set): Not specified.
Data Provenance: Not specified. It's internal validation data, likely from BrainLAB's own testing procedures, but no details on country of origin or retrospective/prospective nature are provided.

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

This information is not provided in the 510(k) summary. The document does not describe a study involving expert-established ground truth for performance evaluation in the typical sense of diagnostic accuracy studies.

4. Adjudication Method for the Test Set

This information is not provided. As no expert-established ground truth study is detailed, an adjudication method is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not described or indicated in the provided 510(k) summary. The focus is on demonstrating substantial equivalence based on technical characteristics and intended use, not on quantifying the improvement of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The Digital Lightbox is described as a medical image viewing device with image manipulation and visualization features, including "navigation planning." It is not directly analogous to a standalone AI algorithm providing a diagnostic output. While the software processes images and creates 3D models/trajectories, its performance isn't typically measured in terms of standalone diagnostic accuracy. The term "standalone performance" as commonly applied to AI algorithms in diagnostic imaging is not applicable or addressed in this document for the described device.

7. The Type of Ground Truth Used

The concept of "ground truth" (e.g., pathology, outcomes data) in the context of diagnostic accuracy is not explicitly mentioned or used in this 510(k) summary for evaluating the Digital Lightbox's performance. The validation relies on functional testing and demonstrating equivalence of features to predicate devices.

8. The Sample Size for the Training Set

The document does not refer to a "training set" as the Digital Lightbox is a software device for image viewing and manipulation, not an AI or machine learning model that would typically undergo a training phase.

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

Since the device is not described as an AI/ML model with a training phase, the concept of "ground truth for the training set" is not applicable to the information provided.

Summary

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K093117

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

Manufacturer:

Address:

DEC 1 1 2009

BrainLAB AG Kapellenstrasse 12 85622 Feldkirchen Germany +49 89 99 15 68 0 Phone: Fax: +49 89 99 15 68 33

Contact Person:

November 19, 2009

Mr. Alexander Schwiersch

Summary Date:

DEC 0 3-2009

FDA CDRH DMC

Received

Device Name:

Tradè name:

Digital Lightbox

Common/Classification Digital Lightbox, BrainLAB system, image processing, radiological Name: LLZ Product Code: Regulation Number 21 CRF §892.2050

Predicate Devices:

iPlan (K053127)

HAW Product Code: -Requlation Number: 21 CFR 882.4560 -
Digital Lightbox (K080608)
Product Code: - LLZ -21 CRF §892.2050 -Regulation Number:
Device Classification Name: System, image processing, radiological Regulatory Class: Class II

Intended Use:

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Device Description:

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 (K053127) and Digital Lightbox (K080608).

Technical Characteristics:

The technical characteristics are equivalent to the predicate device Digital Lightbox (K080608), except for the new functionality 3D visualization and basic surgical planning including object and trajectory creation and plan export to navigation systems. This new functionality is equivalent to the corresponding features in the predicate device iPlan (K053127).

The Digital Lightbox conforms to the DICOM standard.

Documentation:

The reason for this submission is a change in intended use of the previously submitted Digital Lightbox (K080608). This 510(k) submission contains documentation only for features in the product Digital Lightbox that were not included in the previously submitted Digital Lightbox (K080608).

The risk analysis contains only risks identified due to the changes in software and intended use. Further, as all changes apply to software only, this submission contains documentation of the software only. The Digital Lightbox hardware is unchanged and is not affected by the changes in intended use.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

DEC 1 1 2009

Mr. Alexander Schwiersch Regulatory Affairs Manager BrainLAB AG Kapellenstrasse 12 Feldkirchen. 85622 GERMANY

Re: K093117

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: November 27, 2009 Received: December 3, 2009

Dear Mr. Schwiersch:

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 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

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Page 2 -

Enclosure

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Singerely yours

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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: K093117

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)

Colin R. Pollard

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

Page 1 : of

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).