The AUTIMO 2-D model is a computer-controlled cutting tool to produce customized shielding blocks for use in radiotherapy. The computer accepts files from existing treatment-planning system operating on a LAN. The GE-Target, Siemens Helax, and Theratronics Theraplan systems are examples of such treatment-planning software. The computer interprets the files from the planning system and communicates with the AUTIMO device through a serial port. The 2-D model allows automatic hot-wire-cutting of styrofoam molds such as lung blocks and irregular sections.

AI/ML Overview

The provided text describes the HEK AUTIMO 2-D system, a radiation therapy beam-shaping device. However, it does not include detailed acceptance criteria or a comprehensive study demonstrating that the device meets specific performance criteria in the way typically found in modern regulatory submissions for AI/ML devices.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device, which was the regulatory pathway at the time. This means the testing performed primarily confirmed the safety and basic functionality of the new model in comparison to the existing one, rather than establishing quantifiable performance metrics against pre-defined acceptance criteria for a novel technology.

Here's an analysis based on the provided text, addressing your points where possible, and highlighting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, a formal table of explicit acceptance criteria and corresponding reported device performance metrics (e.g., accuracy, precision, sensitivity, specificity) is not available. The document states:

Acceptance Criteria (Implicit): The primary acceptance criterion was demonstrating "substantial equivalence" to the predicate device (MCP-70-SE). This implicitly means the device should perform at least as safely and effectively as the predicate.
Reported Device Performance: The document only states that "The results from these tests supported the safety and effectiveness of the 2.0-D AUTIMO System and demonstrates that it is substantially equivalent to the predicate device." It does not provide specific performance numbers for cutting accuracy, speed, or other operational parameters.

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

This information is not provided in the document. The text mentions "testing" was carried out, but it doesn't specify the sample size of any test sets (e.g., how many styrofoam molds were cut, or what range of block shapes were tested). It also does not mention data provenance (country of origin, retrospective/prospective).

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

This information is not applicable and not provided. The device is a cutting tool for radiation therapy, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth on medical images or patient data. The "ground truth" for this device would likely be the design specifications for the shielding blocks.

4. Adjudication Method for the Test Set

This information is not applicable and not provided for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable and not provided. The HEK AUTIMO 2-D is a hardware device for fabricating shielding blocks, not an AI system designed to assist human readers (e.g., radiologists) in interpretation. Therefore, an MRMC study is outside the scope of its functionality.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable and not provided. The AUTIMO 2-D is a machine that performs a physical action (cutting), driven by a computer-controlled system. While it operates "standalone" in the sense that a human isn't manually guiding the cutter, it's not an AI algorithm being evaluated for diagnostic performance. Its performance would be evaluated against the accuracy of the cuts it produces compared to the input designs.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI/ML (e.g., pathology, outcomes data, expert consensus on images) is not applicable here. For a device like the AUTIMO 2-D, the "ground truth" against which it would be evaluated would be the engineering specifications and design parameters for the customized shielding blocks it is instructed to produce. The testing mentioned (electrical safety, electromagnetic compatibility) are about fundamental device safety and functionality rather than output accuracy against a clinical ground truth.

8. Sample Size for the Training Set

This information is not provided. As this is not an AI/ML device in the modern sense (it's a computer-controlled cutting tool), it's highly unlikely it had a "training set" in the context of machine learning. Its operation is likely based on pre-programmed algorithms and mechanical precision.

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

This information is not applicable and not provided for the same reasons as point 8.

Summary of the Study Mentioned in the Document:

The document describes "testing" carried out by HEK Medizintechnik to address:

Electrical safety
Electromagnetic compatibility

The conclusion was that "The results from these tests supported the safety and effectiveness of the 2.0-D AUTIMO System and demonstrates that it is substantially equivalent to the predicate device."

In essence, this submission focuses on demonstrating substantial equivalence primarily through safety tests and asserting technological similarity to a predicate device, as was common for 510(k) submissions in 1997 for such a device. It does not provide the detailed performance studies, acceptance criteria, or ground truth methodologies that would be expected for a modern AI/ML medical device submission.

Summary

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

510(k) Summary

K971061

HEK

Radiation Therapy Beam-Shaping Device, 21 Common/Classification Name: CFR 892.5710

HEK Medizintechnik GmgH Sponsor: Kaninchenborn 24-28 Postfach 1832 D-23560 Lübeck : *-GERMANY

Tel: (+49) 451 5300444 FAX: (+49) 451 5300450

Contact:

ﻣﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴ

Reinhard Schröder

Prepared:

March 13, 1997

LEGALLY MARKETED PREDICATE DEVICES · A.

The AUTIMO 2-D System is substantially equivalent to its predecessor device currently marketed by HEK Medizintechnik, the MCP-70-SE (K844180).

B. DEVICE DESCRIPTION

The AUTIMO 2-D model is a computer-controlled cutting tool to produce customized shielding blocks for use in radiotherapy. The computer accepts files from existing treatment-planning system operating on a The GE-Target, Siemens Helax, and Theratronics Theraplan LAN. systems are examples of such treatment-planning software. The computer interprets the files from the planning system and communicates with the AUTIMO device through a serial port.

The 2-D model allows automatic hot-wire-cutting of styrofoam molds such as lung blocks and irregular sections.

C. INTENDED USE

The 2.0-D AUTIMO System is intended for the fabrication and positioning in radiotherapy of irregular shielding blocks.

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

TECHNOLOGICAL CHARACTERISTICS D.

The 2.0-D AUTIMO System has the same technological characteristics as the predicate device. The AUTIMO is simply a modification with updated hardware and cosmetic changes from the predicate device.

E. TESTING

HEK Medizintechnik carried out testing to address the following issues:

(1) electrical safety
ﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤ (2) eletromagnetic compatibility

The results from these tests supported the safety and effectiveness of the 2.0-D AUTIMO System and demonstrates that it is substantially equivalent to the predicate device.

F. CONCLUSIONS

The HEK AUTIMO device has the same intended use and target population as the predicate device. HEK has demonstrated through its performance tests on the 2.0-D AUTIMO systems and its comparison of AUTIMO characteristics with those of the predicate device that the 2.0-D AUTIMO system is substantially equivalent to the predicate device.

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

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a person with outstretched arms. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

HEK Medizintechnik. GmbH c/o T. Whit Athey, Ph.D. S INN 13 Senior Consultant C. L. McIntosh & Associates. Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, MD 20852

Re: K971001 GmbH AUTIMO 2-D Dose Modification System Dated: March 19, 1997 Received: March 19, 1997 Regulatory Class: II ... . . ... .. 21 CFR 892.5710/Procode: 90 IXI

Dear Dr. Athey:

给

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 51 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations,

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

William Yx

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _ _ AUTIMO_2-D

Indications For Use:

- The 2-D AUTIMO system is intended for the fabrication and positioning in radiotherapy of indivdualized (irregular) shielding blocks.
  (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Repreductive, Abdominal, ENT, and Radiological Devices

Radiological Devices
510(k) Number K971001

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

000000

Regulation Number and Section

§ 892.5710 Radiation therapy beam-shaping block.

(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.