The Frameless Radiosurgery Components only include mechanical devices, which can be repeatedly attached to the patient to keep his/her head and neck (head, neck and shoulders) in the same position for radiotherapy/radiosurgery. All components are intended to be non-invasive. The Frameless Radiosurgery Components are indicated for any medical condition in which the use of stereotactic radiotherapy may be considered to be safe and effective. They may be used also for repeated diagnostic tomographic scanning, The Frameless Radiosurgery Components can be used with other devices, which have already been cleared by the FDA (e.g. BrainLAB Robotics, BrainLAB Brainscan).

AI/ML Overview

The provided document describes a 510(k) submission for "Frameless Radiosurgery Components." It is a premarket notification to demonstrate substantial equivalence to legally marketed predicate devices, not a study performing clinical validation with acceptance criteria and device performance metrics in the way a de novo or PMA would require.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, device performance, study design (sample size for test/training sets, data provenance, expert ground truth details, adjudication methods, or MRMC studies), or standalone performance.

The document states:

"The Frameless Radiosurgery Components have been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system."

This indicates that some internal verification and validation activities were performed, but the specifics of these activities, including acceptance criteria and how they directly relate to quantifiable device performance metrics (accuracy, sensitivity, specificity, etc.), are not provided in this 510(k) summary. The FDA's letter confirms substantial equivalence based on the provided information, but it does not detail a clinical study with performance metrics in this summary.

Therefore, I cannot populate the requested table or answer most of the questions based solely on the provided text.

Here's what can be inferred or directly stated from the document, along with what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not provided in the document. The document states "The validation proves the safety and effectiveness of the system" but does not quantify performance metrics or the specific criteria used to define "safe and effective."	Not provided in the document. No quantifiable performance metrics (e.g., accuracy, precision of positioning, repositioning error) are reported.

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

Sample Size (Test Set): Not provided.
Data Provenance: Not provided. The verification and validation were done "according to BrainLAB's procedures for product design and development," implying internal testing, but no details on the origin of data (e.g., country, retrospective/prospective) are given for any test data.

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

Not applicable/Not provided. The device is a mechanical fixation and repositioning system. Its "ground truth" would likely relate to mechanical precision measurements rather than expert interpretations of medical images or conditions.

4. Adjudication method for the test set:

Not applicable/Not 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:

No. This device is a mechanical component for patient fixation and repositioning during radiosurgery, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant or mentioned.

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

The concept of "standalone performance" as typically applied to algorithms for diagnostic tasks is not directly applicable here. The device is a physical, mechanical system. Its performance would be measured in terms of mechanical precision and accuracy. The document does not provide specifics on such measurements.

7. The type of ground truth used:

Not explicitly stated, but for a mechanical device, the ground truth would typically be based on highly accurate physical measurements of precision, accuracy, and repeatability of fixation and repositioning. This would likely involve metrology tools or highly precise imaging techniques to assess mechanical performance against design specifications.

8. The sample size for the training set:

Not applicable/Not provided. This is a mechanical device, not an algorithm that requires a training set in the machine learning sense.

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

Not applicable/Not provided. (See point 8).

In summary: The provided 510(k) summary is for a mechanical device and focuses on demonstrating substantial equivalence to predicate devices through design validation, rather than presenting a clinical study with detailed performance metrics and ground truth establishment in the context of an AI/software device.

Summary

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053500

FEB 3 2006

510(k) Summary of Safety and Effectiveness for Frameless Radiosurgery Components

Manufacturer:	BrainLAB AG
Address:	Ammerthalstrasse 885551 HeimstettenGermanyPhone: +49 89 99 15 68 0Fax: +49 89 99 15 68 33
Contact Person:	Mr. Rainer Birkenbach
Summary Date:	January 12, 2006
Device Name:Trade name:	Frameless Radiosurgery System
Common/Classification Name:	Frameless Radiosurgery Components
Predicate Device:	BrainLAB Mask System (K945903)BrainLAB CT/X-Ray Localizer (K954861)
Device Classification Name:	Medical charged-particle radiation therapy system (892.5050)
Regulatory Class:	Class II

Intended Use:

The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's

head and neck ເ
ﺳ head, neck, and shoulders

in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures,

Device Description:

Substantial equivalence:

The Frameless Radiosurgery Components have 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 BrainLAB Mask System (K945903) and BrainLAB CT/X-Ray Localizer (K954861).

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 3 2006

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

Re: K053500 Trade/Device Name: Frameless Radiosurgery Components Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: December 7, 2005 Received: December 16, 2005

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 (Premarket Approval), 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 clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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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 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" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Nancy C. Bugdon

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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Indications for Use

510(k) Number (if known):

KOS3500

Device Name:

Frameless Radiosurgery Components

Indications For Use:

The Frameless Radiosurgery Components are a device used for fixation and reposition and repositioning of the patient´s

head and neck
head, neck, and shoulders -

in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures.

Mansel C. Bringdon

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

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)

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.