Helax-IMCON is an image workstation that replaces the fluoroscopic monitor at a radiotherapy simulator. It is connected to the video signal from the image intensifier of the simulator and the X-ray images are captured by a frame grabber and converted to digital images.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Helax-IMCON Simulator Workstation (IMCON), dated 1998-08-11. It's a regulatory submission affirming the device's substantial equivalence to a predicate device. It is not a scientific publication detailing a study with specific acceptance criteria and performance metrics in the way a clinical trial or performance study report would.

Therefore, most of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, and MRMC study details cannot be found in this document.

The document states that "Performance tests were conducted and the results indicated that the system consistently performed within the design parameters and equivalently to the predicate device." However, it does not provide the specifics of these tests.

Below is a breakdown of what can be extracted or inferred from the provided text, and what information is missing.

Acceptance Criteria and Device Performance

Acceptance Criteria (Stated/Inferred)	Reported Device Performance (Stated/Inferred)
Functional Equivalence: The device should perform the same intended use as the predicate device (Varis Images, including Ximatron Digital Imaging). The intended use is: "a tool for supporting the process of Radiotherapy treatment planning utilising simulator images... used to define the field size and shape... for verification of an established treatment plan."	The document states: "The Helax-IMCON has the same technological characteristics and is similar in design, function, and application to the predicate device." And "The intended use is the same as the predicate devices." This implies functional equivalence was met, though no specific performance metrics (e.g., accuracy of field definition) are provided.
Technological Equivalence: The device should have the same technological characteristics as the predicate device.	"The Helax-IMCON has the same technological characteristics..." and "There are no differences between the technology of the predicate device and the Helax-IMCON and only minor differences in configuration and specifications as noted in the predicate device comparison chart. These differences do not alter the intended use or affect the safety and effectiveness of the Helax-IMCON system when used as labelled." The device was deemed substantially equivalent by the FDA, indicating this criterion was accepted.
Safety and Effectiveness: Minor differences in configuration and specifications compared to the predicate device should not alter the intended use or affect the safety and effectiveness of the system.	"These differences do not alter the intended use or affect the safety and effectiveness of the Helax-IMCON system when used as labelled." The FDA's finding of "substantial equivalence" implies they accepted this claim of continued safety and effectiveness relative to the predicate device.
Compliance with Standards: The device should meet specified electrical medical equipment and radiotherapy equipment standards, and relevant quality system certifications. Standards include IEC 601-1, IEC 601-1-4, IEC 1217, IEC 878. Quality systems include European EG Medical Device Directive, ISO 9001, EN 46001, and FDA's Reviewer Guidance for Computer Controlled Medical Devices.	"The Helax-IMCON is designed, and manufactured to meet, the following standards: [lists IEC standards]." "Helax AB is certified according to European EG Medical Device Directive... ISO 9001 and EN 46001." "The device and its development process also comply with the FDA, CDRH, ODE, August 23, 1991. Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review." These are statements of compliance/certification, indicating these criteria were met.
Performance within Design Parameters: The system should consistently perform within its design parameters.	"Performance tests were conducted and the results indicated that the system consistently performed within the design parameters..." This statement confirms performance within design parameters, but no quantitative results or specific parameters are provided.
Equivalence to Predicate Device (Overall): The system's performance should be equivalent to the predicate device.	"...and equivalently to the predicate device." This is a direct statement, but without specific metrics from either device, the nature of this equivalence cannot be quantified from this document.

Missing Information (and why it's missing from this type of document):

The provided text is a 510(k) Premarket Notification, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. It typically focuses on comparing the new device's intended use, technological characteristics, and safety/effectiveness to an existing one, rather than presenting a detailed performance study with explicit acceptance criteria and quantitative results from a new clinical or technical trial.

Therefore, the following information is not available in the provided text:

Sample size used for the test set and the data provenance: Not mentioned. The "performance tests" are only vaguely referenced.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. No explicit "ground truth" establishment in the context of a performance study is described.
Adjudication method for the test set: Not mentioned.
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 done/mentioned. This device is an imaging workstation, not an AI diagnostic tool in the modern sense.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/mentioned. This device is explicitly an "imageworkstation" intended to be operated by humans (radiographers, physicists, physicians).
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned.
The sample size for the training set: Not mentioned. This is not an AI/ML device in the contemporary sense that would have a "training set" for model development. It's a workstation connected to a simulator.
How the ground truth for the training set was established: Not applicable/mentioned.

In summary: The document serves its purpose as a 510(k) submission by asserting substantial equivalence and compliance with relevant standards. However, it does not contain the detailed performance study data, acceptance criteria, or methodological specifics that would be found in a research paper or a detailed performance validation report. The "study" mentioned is referred to as "Performance tests were conducted and the results indicated that the system consistently performed within the design parameters and equivalently to the predicate device," which is a high-level summary suitable for a 510(k) submission to demonstrate equivalence, but lacks the granular detail requested.

Summary

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1. Submitter's information

Helax AB PO Box 1704 S-751 47 Uppsala Sweden

Contact person Jan Törnqvist, Vice President Regulatory Affairs int 46 18 565017 Phone: Fax: int 46 18 565017 E-mail jan.tornqvist@helax.com

Submission dated: 1998-08-11

2. Device Name

Common or Usual name:

Helax-IMCON Simulator Workstation (IMCON)

Proprietary Name: Helax-IMCON

• Standard Product Nomenclature:	System, Image Processing
• Regulation number:	21 CFR § 892.
• Class:	II
• Product Code:	90LLZ

3. Predicate Device

Varis Images, Including Ximatron Digital Imaging (K952313).

Product is owned by Varian Associated Inc., 3045 Hanover Street, Palo Alto CA 94304-1129, USA.

4. Description of the Device

5. Statement of Intended Use

Helax-IMCON is designed to be a tool for supporting the process of Radiotherapy treatment planning utilising simulator images. Helax - IMCON supports both the

11 helax

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planning of a radiotherapy treatment and the verification of an established treatment plan.

Helax- IMCON is used to define the field size and shape for the radiotherapy treatment of a patient, based on an image or series of merged images taken at the simulator. If the simulator has been equipped with the Helax-IMCON LCD panel these shapes can be projected onto the patient. Defined parameters can be exported to the clinics verification system or to the accelerator.

Helax-IMCON is also used for verification of a treatment plan prepared with a treatment planning system as Helax-TMS. The treatment plan will be imported at the Helax-IMCON workstation. Helax-IMCON will then overlay the planned field size and shape on the image for verification purposes.

Helax - IMCON is intended to be operated by radiographers ,physicists and physicians skilled in radiation therapy and trained in using the system.

The intended use is the same as the predicate devices.

Statement of Technological Characteristics 6.

The predicate device is presently in commercial distribution in the United States. The Helax-IMCON has the same technological characteristics and is similar in design, function, and application to the predicate device.

The Technological Characteristics are the same as the predicate device.

Differences 7.

There are no differences between the technology of the predicate device and the Helax-IMCON and only minor differences in configuration and specifications as noted in the predicate device comparison chart. These differences do not alter the intended use or affect the safety and effectiveness of the Helax-IMCON system when used as labelled.

Special controls 8.

Although there are no performance standard established by the FDA for these devices the Helax-IMCON is designed, and manufactured to meet, the following standards:

Electrical medical equipment General requirements for safety · IEC 601-1
Electrical medical equipment -Part 1 : General requirements for · IEC 601-1-4 safety
1. Collateral Standard: Programmable clectrical medical systems.
· IEC 1217 Radiotherapy equipment - Coordinates, movements and scales
IEC 878 Graphical symbols for electrical equipment in medical practice

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Image /page/2/Picture/0 description: The image shows a black square with a white check mark in the top left corner. Below the square, the word "helax" is written in white, sans-serif font. The check mark is partially cut off by the edge of the square.

Helax AB is certified according to European EG Medical Device Directive. Annex II Section 3.2 - Full Quality Assurance System, per 1997-01-08. The scope of the certification is: Design, development, production, installation and servicing of based systems in oncology in class IIb. Helax AB Quality System is also certified according to the requirements in ISO 9001 and EN 46001.

The Helax-IMCON product was developed by Helax AB. Part of the development work was done by Image Connectivity Sweden AB (ICS), under the control by Helax AB.

The Helax-IMCON product will be released, marketed, produced. serviced and maintained by Helax. A complete Device Master Record will be prepared, maintained and approved by Helax according to Helax procedures. The Helax-IMCON product will be a part of the Product Area VIS within Helax.

The device and its development process also comply with the FDA, CDRH, ODE, August 23, 1991. Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review

Performance tests were conducted and the results indicated that the system consistently performed within the design parameters and equivalently to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV

Vice President, Regulatory Affairs

Re:

K982857 Helax-IMCON Version 1.0 Dated: August 11, 1998 Received: August 13, 1998 Regulatory class: II 21 CFR 892.5840/Procode: 90 KPQ

Dear Ms. Tornqvist:

Jan Tornqvist

Klostergatan 12

Uppsala, Sweden

Helax AB

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 Device Amendments, or to 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 submission does not affect any obligation you might have under sections 531 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 vitin diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, piense 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/cdri/dsmadsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

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

Enclosure

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510(k) NUMBER (IF KNOWN): K982857

DEVICE NAME: Helax-IMCON version 1.0

INDICATIONS FOR USE:

Patients planned for radiation treatment, either to verify a prescribed plan, or to help at the planning at the simulator.

(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)

Daniel A. Seymour
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Dey

510(k) Number K982857

Regulation Number and Section

§ 892.5840 Radiation therapy simulation system.

(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. 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.