The Table Tilt Device is an additional device for treatment tables used for radiation treatment. It enables a motorized table tilt around the lateral and longitudinal axis to compensate for patient rotation. In this fashion misalignments and shift of the patient can be precisely compensated.

The Table Tilt Device is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures.

Device Description

The Table Tilt Device is a powered patient support assembly for use in radiotherapy and radiosurgery treatments. It allows the user to undertake motorized tilt adjustment of a patient misalignment to eliminate the need to manually move the patient on the table.

AI/ML Overview

The provided text is a 510(k) summary for a "Table Tilt Device." This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a detailed study proving performance against specific acceptance criteria. Therefore, most of the requested information regarding detailed study design, sample sizes, ground truth establishment, expert qualifications, and specific performance metrics is not available in the provided text.

Here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance (Limited Information)

The document primarily focuses on demonstrating "substantial equivalence" rather than specific numerical acceptance criteria. The "Intended Use" and "Device Description" sections implicitly define the functional requirements.

Acceptance Criteria (Implicit)	Reported Device Performance (Implied)
Compensation for patient rotation (roll and pitch) in a linear accelerator environment.	The device enables motorized table tilt around the lateral and longitudinal axis to compensate for patient rotation, precisely compensating for misalignments and shifts.
Safety and Effectiveness	The validation proves the safety and effectiveness of the system, supporting its substantial equivalence to the predicate.

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

As mentioned above, the provided text does not present explicit, quantifiable acceptance criteria with corresponding reported performance metrics. The core statement is: "The validation proves the safety and effectiveness of the system."

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

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. The document states "The Table Tilt Device will be verified and validated according to BrainLAB's procedures for product design and development." This implies internal testing.

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

Not applicable/Not specified. The validation described is for a mechanical device; "ground truth" in the context of expert consensus on medical images or diagnoses is not relevant here. The validation would likely involve engineering tests against specifications.

4. Adjudication method for the test set

Not applicable/Not specified. As it's a mechanical device, adjudication in the sense of resolving discrepancies in expert interpretations is not relevant.

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 applicable. This is not an AI/imaging device, and no MRMC study is mentioned.

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

A standalone performance evaluation would be inherent in the "verification and validation" mentioned, but details of how this was done (e.g., specific test protocols, performance metrics) are not provided. The device itself is a standalone mechanical component that assists in patient positioning.

7. The type of ground truth used

For a mechanical device like a table tilt mechanism, "ground truth" would typically refer to engineering specifications and measurements (e.g., accuracy of tilt, range of motion, load bearing capacity, stability). This would likely involve:

Engineering drawings and design specifications.
Physical measurements using calibrated instruments.
Stress tests and durability tests.

However, the specific methods are not detailed in this summary.

8. The sample size for the training set

Not applicable. This device is not described as involving machine learning or AI, so there is no "training set."

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

Not applicable. There is no training set for this device.

Summary

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MAY 1 4 2004

510 (k) Summary of Safety and Effectiveness for Table Tilt Device

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Manufacturer:

Address:	BrainLAB AGAmmerthalstrasse 885551 Heimstetten
	GermanyPhone: +49 89 99 15 68 0Fax: +49 89 99 15 68 33
Contact Person:	Mr. Rainer Birkenbach
Summary Date:	January 8, 2004

Device Name:
Trade name:	Robotic Tilt Module
Common/Classification Name:	Table Tilt Device

Predicate Device:	Med-Tec 6 degree axis couch, model MT-6DAC (K031866)
Device Classification Name:	Powered radiation therapy patient support assembly
Regulatory Class:	Class II

Intended Use:

Device Description:

Substantial equivalence:

The Table Tilt Device will be 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 of Med-Tec: Med-Tec 6 degree axis couch, model MT-6DAC (K031866).

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three curved lines representing its body and wings, conveying a sense of motion and flight. The overall design is simple and recognizable, representing the HHS's role in protecting the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 2004

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

Re: K033316 Trade/Device Name: Table Tilt Device Regulation Number: 21 CFR 892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: II Product Code: 90 JAI Dated: February 25, 2004 Received: March 9, 2004

Dear Mr. Birkenbach:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section > re(t) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to regally including the Medical Device American be lo commerce private to May 20, 1770, the claculance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosment Act (Act) that do not reques of the general controls provisions of the Act. The Y ou may, therefore, market the detros, books of the courements for annual registration, listing of general controls provisions of the rice 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 If your device is classince (soo avoro) its . Existing major regulations affecting your device can may be subject to such additional controller. Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Poderal Cleg.
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 mall FUA has made a decemmance. Inc. Jour stered by other Federal agencies. You must comply of any Pederal Statures and regalations and but not limited to: registration and listing (21 CFR Part with an the Act s requirements, menumacturing practice requirements as set forth in the 807), laoching (21 CFR Part 820); and if applicable, the electronic product quality Systems (QB) regions (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) I has lotter will and work your 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. Brogden

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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K033316

510(k) Number (if known):

Table Tilt Device Device Name:

Indications For Usc:

The Table Tilt Device is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures.

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

Concurrence of CDRII, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033316

Regulation Number and Section

§ 892.5770 Powered radiation therapy patient support assembly.

(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.