The ARTP (Anti-Tumor Radiation Treatment Planning System) is a radiation dose planning and simulation of patients undergoing external beam treatment in the oncology clinic. ARTP is used to plan and simulate radiation treatments with linear accelerators and other similar teletherapy devices with x-ray energies from 1 to 25MV, as well as Cobalt-60, and electron energies from 1 to 25 MeV.

Device Description

The TOPSLANE ATES is a Radiotherapy Treatment Planning System (RTPS) for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. ATES is using modem photon beam convolution dose calculation algorithm and electron pencil beam dose calculation algorithm. The system software is designed to be convenient and low cost to the user.

AI/ML Overview

The provided text describes a Radiation Treatment Planning System (RTPS) called TOPSLANE ATES, which is a medical device subject to FDA 510(k) review. The acceptance criteria and supporting studies for such devices typically focus on demonstrating substantial equivalence to a previously cleared predicate device, rather than explicit numerical performance targets like sensitivity or specificity.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implicit for 510(k))	Reported Device Performance
Intended Use Equivalence: Same indications for use as predicate.	The intended use is the same as the predicate device (Theraplan V05B). The ATES is used for radiation dose planning of patients undergoing external beam treatment in oncology clinics, with linear accelerators, cobalt-60, and electron energies from 1 to 25 MeV.
Technological Characteristics Equivalence: No significant differences in design, materials, energy source, etc. compared to predicate.	No significant change in design, materials, energy source, or other technological characteristics compared to the predicate device. Minor configuration differences do not alter intended use or affect safety/effectiveness.
Safety and Effectiveness: Does not raise new questions of safety and effectiveness.	Performance tests indicated that the system consistently performed within the design parameters and equivalently to the predicate device. The device was designed and manufactured to meet IEC 601-1, IEC 601-1.1, and IEC 878 standards.
Compliance with Standards/Guidance: Adherence to relevant medical device standards and FDA guidance documents.	Complies with IEC 601-1, IEC 601-1.1, IEC 878 standards, and the FDA, CDRH, ODE, August 29, 1991, Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review.

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

The document does not specify a separate "test set" in the context of clinical data or patient outcomes. The performance evaluation appears to be based on:

Engineering/System Performance Tests: "Performance tests were conducted and the results indicated that the system consistently performed within the design parameters and equivalently to the predicate device."
Comparison to Predicate: The core of a 510(k) is demonstrating equivalence. This often involves comparing technical specifications, functionalities, and calculation results of the new device against the predicate.

Therefore, there's no explicitly mentioned sample size for a test set comprising patient data, nor is there information on data provenance (e.g., country of origin, retrospective/prospective). The "test set" here refers to the device itself and its internal performance metrics.

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

Not applicable in this context. The "ground truth" for a RTPS in a 510(k) submission generally involves established physics principles, dose calculation algorithms, and comparisons to recognized "gold standard" methods or the predicate device's output, rather than expert consensus on patient images or diagnoses.

4. Adjudication Method for the Test Set:

Not applicable. There's no mention of an adjudication process for a test set in the clinical sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC study was not done. The document does not describe human readers or AI assistance in the context of improving diagnostic accuracy. This device is a treatment planning system, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The performance evaluation described seems to be a standalone assessment of the system's dose calculation and planning capabilities. The statement "Performance tests were conducted and the results indicated that the system consistently performed within the design parameters and equivalently to the predicate device" implies testing the algorithm and its output directly, without a human-in-the-loop component being the primary focus of the equivalence demonstration.

7. The Type of Ground Truth Used:

The "ground truth" for demonstrating equivalence would likely be:

Predicated Device Performance/Output: The results obtained from the predicate device (Theraplan V05B) for specific treatment planning scenarios.
Physics Principles/Established Models: The accuracy of the "modern photon beam convolution dose calculation algorithm and electron pencil beam dose calculation algorithm" would be evaluated against established physics models for radiation dose distribution.
Engineering Specifications: The device's output meeting its own design parameters for dose calculation, planning geometry, etc.

8. The Sample Size for the Training Set:

Not applicable. This device is a rule-based/algorithmic system for radiation treatment planning, not a machine learning or AI system that requires a separate "training set" in the conventional sense. Its "training" is embodied in its programmed algorithms and adherence to established physics.

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

Not applicable, as there is no "training set" for this type of device mentioned in the document.

Summary

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K963451

1 of 2

SUMMARY OF SAFETY AND EFFECTIVENESS

AUG - 5 1997

1. Submitter's Information:	Dated: August 28, 1996TOPSLANE824 Ruth Dr., Pleasant Hill, CA 94523
Contact Person:	Ann ZengVP of Quality Assurance And Regulatory Affairs
2. Common or Usual Name:Proprietary Name:	RADIATION TREATMENT PLANNING SYSTEMATES
Classification Name:	System, Simulation, Radiation TherapyRA (90) KPQ Class 221 CFR 892.5050
Version Number:	2.0
3. Predicate Device:	Theraplan V05BRadiation Therapy Treatment Planning SystemK940237Theratronies

4. Description of Device:

5. Statement of intended use:

The TOPSLANE product ATES is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. ATES is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray energies from 1 to 25MV, as well as Cobalt-60, and electron energies from 1 to 25 MeV.

The intended use is the same as the predicate device.

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Image /page/1/Picture/0 description: The image shows the word "TOPSLANE" in a bold, outlined font. Each letter is clearly defined with a double outline, giving the word a distinct and somewhat retro appearance. The letters are uniformly sized and spaced, creating a balanced and legible design.

6. Statement of technological characteristics:

The ATES has no significant change in design, materials, energy source or other technological characteristics compared to the predicate device.

The intended use and the technological characteristics are the same as the predicate device and therefore we believe it is substantially equivalent to it.

7. Differences:

The minor configuration differences between the ATES and the predicate device do not alter the intended use or affect the safety and effectiveness of the ATES when used as labeled.

8. Special Controls:

Although there are no performance standards established by the FDA for these devices. ATES has been designed, and manufactured to meet the following standards:

Medical electrical equipment - General requirements for safety IEC 601-1 IEC 601-1.1 Safety requirements for medical electrical systems Graphical symbols for electrical equipment in medical practice IEC 878

The device and its development process also comply with the FDA, CDRH, ODE, August 29, 1991, Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review.

9. Performance Evaluations:

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

THE END

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" around the perimeter. Inside the circle is a stylized image of a human figure embracing a globe. The figure is composed of three curved lines, and the globe is represented by a simple circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ann Zeng VP of Quality Assurance and Regulatory Affairs TOPSLANE 824 Ruth Drive Pleasant Hill, CA ... 94523 ...

AUG - 5 1997

Re: K963451 Anti-Tumor Radiation Treatment Planning System (ARTP) Dated: June 19, 1997 Received: June 23, 1997 Regulatory Class: II ....................... 21 CFR 892.5050/Procode: 90 IYE

Dear Ms. Zeng:

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, subject to the general controls provisions of 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 (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 requirement, as set forth in the Quality System Regulation (QS) 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 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) 594-4613. 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 vours.

h.Liau Yu

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

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510(k) Number (if known): K963451

Device Name: __ Anti-Tumor Radiation Treatment Planning System (ARTP).

Indications For Use:

The ARTP (Anti-Tumor Radiation Treatment Planning System) is a radiation of The AKTF (Allu-Tumor Kammon a radiation dose planning and simulation of patients undergoing external beam treatment in the oncology climic. ARTIF is used pattents midergoning external beath meating with linear accelerators and other similar to plan and summale (amanon treating from 1 to 25MV, as well as Cobalt-60, and electron energies from I to 25 MeV.

CDHOJ CN

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801 109) OR

Over_The_Counter Use

(Optional Format 1-2-96)

L. Mccarthy

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K963451

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.