PatXfer RT provides capabilities for the acceptance, transfer, display, storage, and digital processing of medical images and objects according to the DICOM RT standard and according to the BrainLAB proprietary data format.

This includes functions for performing operations related to image manipulation, enhancement, compression, and quantification. The integrity of the original data is maintained.

Device Description

PatXfer RT interfaces between medical devices and provides the patient data for treatment planning or verification.

The application transfers, displays, stores, and processes data received according to the ACR-NEMA standard (DICOM 3.0) or according to the BrainLAB proprietary data format. DICOM RT data are converted into the BrainLAB proprietary data format and vice-versa for further data processing.

PatXfer RT supports Dicom RT data and BrainLAB's proprietary data formats from digital storage media, such as network archive, optical disk or CD-ROM.

To keep the application as user-friendly as possible only the necessary information for the intended procedures are displayed. The patient, image series, and images will be displayed and can be selected and processed.

PatXfer RT creates a history log-file including all the software actions to import the data and can be controlled with the mouse or by touchscreen monitor.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study proving that the device meets specific performance metrics. Instead, it is a 510(k) summary for a medical device (PatXfer RT) that focuses on demonstrating substantial equivalence to a predicate device.

Here's a breakdown of what is and isn't available in the provided document, based on your requested information:

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

Not available. The document states: "A risk analysis was conducted for PatXfer RT and all hazards were mitigated to as low as reasonable possible (ALARP) and found to be acceptable. The Verification showed that PatXfer RT is safe and effective for its intended use." This is a general statement about verification but does not provide specific performance metrics or acceptance criteria in a table format.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not available. There is no mention of a specific test set, its sample size, or data provenance. The document refers to "Verification and Validation" being performed according to BrainLAB's procedures.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not available. Ground truth establishment is not discussed, as there's no specific test set described with human expert evaluation.

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

Not available. No information on adjudication is provided.

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 available. This device (PatXfer RT) is a medical image processing and transfer system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be applicable or relevant to its intended use as described.

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

Not available. The device performs functions like transfer, display, storage, and processing, which are inherently "standalone" in their execution. However, the performance is in terms of data handling and integrity, not diagnostic accuracy that would typically be evaluated in a standalone study for an AI algorithm.

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

Not available. Since specific performance metrics for diagnostic or analytical tasks are not mentioned, the concept of "ground truth" as it applies to such tasks is not discussed. The "ground truth" for this device would likely refer to the accuracy of data transfer, transformation, and integrity, which is assessed through technical verification methods rather than clinical ground truth types.

8. The sample size for the training set

Not available. As this is not an AI/ML algorithm requiring a training set, this information is not applicable.

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

Not available. Not applicable, as there's no mention of a training set.

Summary of Information Present in the Text:

The provided document describes a 510(k) submission for PatXfer RT, focusing on its intended use as a system for the acceptance, transfer, display, storage, and digital processing of medical images and objects according to DICOM RT and BrainLAB's proprietary format. The core of the submission revolves around demonstrating substantial equivalence to a predicate device (PatXfer 5.0, K021583).

The "study that proves the device meets the acceptance criteria" is broadly referred to as:

"A risk analysis was conducted for PatXfer RT and all hazards were mitigated to as low as reasonable possible (ALARP) and found to be acceptable."
"The Verification showed that PatXfer RT is safe and effective for its intended use."
"PatXfer RT has been verified and validated according to BrainLAB's procedures for product design and development and found to be substantially equivalent with BrainLAB medical devices such as PatXfer 5.0 (K021583). The validation proves the safety and effectiveness of the system."

This indicates a process-based validation rather than a detailed performance study with specific acceptance criteria and outcome metrics typical for diagnostic or AI devices. The acceptance criteria would likely relate to functional requirements, DICOM compliance, data integrity, and system reliability established during the design and development verification/validation process, rather than clinical efficacy metrics.

Summary

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

K040961

510 (k) Summary of Safety and Effectiveness for PatXfer RT

Manufacturer:

Address:	BrainLAB AGAmmerthalstrasse 885551 HeimstettenGermanyPhone: +49 89 99 15 68 0Fax: +49 89 99 15 68 33
Contact Person:	Mr. Rainer Birkenbach
Summary Date:	April 5, 2004

Device Name:

Trade name: Common/Classification Name: PatXfer RT System, Image Processing, Radiological

Predicate Device:

PatXfer 5.0 (K021583)

Device Classification Name: Picture archiving and Communication System Requiatory Class: Class II

Intended Use:

This includes functions for performing operations related to image manipulation, enhancement, compression, and quantification. The integrity of the original data is maintained.

Device Description:

PatXfer RT interfaces between medical devices and provides the patient data for treatment planning or verification.

PatXfer RT supports Dicom RT data and BrainLAB's proprietary data formats from digital storage media, such as network archive, optical disk or CD-ROM.

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

PatXfer RT creates a history log-file including all the software actions to import the data and can be controlled with the mouse or by touchscreen monitor.

Typical users of the system are trained professionals, including but not limited to physicians, nurses, and technicians.

Substantial equivalence

A risk analysis was conducted for PatXfer RT and all hazards were mitigated to as low as reasonable possible (ALARP) and found to be acceptable. The Verification showed that PatXfer RT is safe and effective for its intended use.

PatXfer RT has been verified and validated according to BrainLAB's procedures for product design and development and found to be substantially equivalent with BrainLAB medical devices such as PatXfer 5.0 (K021583). The validation proves the safety and effectiveness of the system.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 22 2004

Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Ammerthalstraße 8 85551 Heimstetten GERMANY

Re: K040931 Trade/Device Name: PatXfer RT Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: July 6, 2004 Received: July 8, 2004

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.

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.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) I rab letter 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. Bugden

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

Enclosure

{4}------------------------------------------------

Page

510(k) Number (if known):	K040931
---------------------------	---------

Device Name:

PatXfer RT

Indications For Use:

This includes functions for performing operations related to image manipulation, enhancement, compression, and quantification. The integrity of the original data is maintained.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Pcr 21 CFR 801.109)

ાર

Over-The-Counter Use

Nancy Broadron

(Division Sign-Off) Division of Reproductive. A and Radiological Devices 510(k) Number _

(Optional Format 1-2-96)

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).