ExacTrac 4.0 is a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The ExacTrac 4.0 system uses optical tracking of infrared reflecting markers and x-ray registration as the method of locating the position of the patient.

Device Description

ExacTrac 4.0 is a Patient Positioning System. It is based on an imported isocenter from a planning system or on an isocenter imported from a simulator. It allows verification and, if necessary correction of the patient's position.

Correction of patient's position is based on a comparison of digital reconstructed images (DRR) calculated from a corresponding CT set (reference image) and x-ray images) . Structures on the images to be compared can be either anatomical landmarks or implanted internal markers.

For some applications (e.g. prostate tumors) the correction can alternatively be performed by using the ultrasound module. Here the correction of patient's position is based on a comparison of an outlined structure in the CT set (reference image) and perpendicular ultrasound images) .

AI/ML Overview

This 510(k) summary does not contain a detailed study with acceptance criteria and reported device performance in the format requested. It primarily focuses on demonstrating substantial equivalence to a predicate device based on BrainLAB's internal verification and validation procedures, rather than presenting a specific, independently conducted study with metrics like sensitivity, specificity, or accuracy against a pre-defined ground truth and acceptance criteria.

The document states: "ExacTrac 4.0 has been verified and validated according to BrainLAB's 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 device ExacTrac 2.0 (K003285)."

Therefore, most of the requested information (points 1-9) cannot be extracted from the provided text.

Here's a breakdown of what can and cannot be answered:

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

Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., accuracy thresholds, precision targets) or reported performance metrics from a specific study. It only states that the device was "verified and validated" according to internal procedures.

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

Cannot be provided. The document does not mention any specific test set, its size, or data provenance.

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)

Cannot be provided. No information on ground truth establishment or experts is present for a test set.

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

Cannot be provided. No test set or an adjudication method is mentioned.

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

Cannot be provided. The device is a patient positioning system, not an AI-assisted diagnostic tool for human readers. No MRMC study is described.

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

Cannot be provided definitively for formal study results. The device description implies standalone operation for positioning correction based on image comparison, but no specific performance study in a "standalone" context with metrics is detailed in this summary.

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

Cannot be provided. No specific ground truth type for performance evaluation is mentioned in the summary. The system works by comparing DRRs/CT set outlines with real-time X-ray/ultrasound images, implying an internal consistency check rather than external ground truth for a study.

8. The sample size for the training set

Cannot be provided. No training set or its size is mentioned.

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

Cannot be provided. No training set or ground truth establishment method for it is mentioned.

Summary of what is available from the text:

The provided 510(k) summary focuses on establishing substantial equivalence to a predicate device (ExacTrac 2.0, K003285) rather than detailing a specific clinical performance study with explicit acceptance criteria and results. The validation of the device (ExacTrac 4.0) relies on BrainLAB's internal product design and development procedures, which are stated to prove safety and effectiveness. The core function involves comparing digital reconstructed images (DRR) from a CT set and X-ray images, or in some cases, outlined structures in a CT set with perpendicular ultrasound images, to ensure accurate patient positioning to the isocenter of a linear accelerator.

Summary

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MAY 11 2004

510 (k) Summary of Safety and Effectiveness K84058 for ExacTrac 4.0®

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:	March 03, 2004
Device Name:
Trade name:	ExacTrac4.0, will also be marketed under the name
	ExacTrac X-ray 6D
Common/Classification Name:	Patient Positioning System / System, Radiation Therapy, Charged-Particle, Medical

Predicate Device: ExacTrac (K003285)

Device Classification Name: System, Radiation Therapy, Charged-Particle, Medical Regulatory Class: Class II

X-ray Generator Device Classification Name: Generator, High Voltage X-Ray, Diagnostic Regulatory Class: Class I Exempt Accession Number: 0110172-00

X-ray Tubes Device Classification Name: Assembly, Tube Housing, X-Ray, Diagnostic Regulatory Class: Class I Exempt Accession Number: 7410266-15

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Intended Use:

Device Description:

Substantial equivalence:

ExacTrac 4.0 has been verified and validated according to BrainLAB's 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 device ExacTrac 2.0 (K003285)

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, depicted with stylized lines. The overall design is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 11 2004

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

Re: K040585 Trade/Device Name: ExacTrac 4.0 Patient Positioning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: March 4, 2004 Received: March 5, 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

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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. Brygdon

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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K040585

510(k) Number (if known):

ExacTrac 4.0

Device Name: (BrainLAB's Patient Positioning System)

Indications For Use:

ExacTrac 4.0

ExacTrac 4.0 is a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The Exact on 4.0 system uses optical tracking of infrared reflecting markers and x-ray registration as that nethod of locating the position of the patient.

(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)

Over-The-Counter Use

(Optional Format 1-2-96)

Division Sign Division of Reprodu and Radiological D 510(k) Number

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.