ROCS TPS (Radiation Therapy Treatment Planning System) is intended to be used for the computation, display, evaluation and output documentation of radiation dose estimations to be submitted for independent clinical review and judgment prior to use. The device provides output data in the form of displays, hardcopy prints and/or plots to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist

Device Description

ROCS treatment planning system is a collection of software modules that execute well known and documented algorithms to produce radiation dose estimations. All data is user controlled and is in a table look-up format. Information is presented graphically on CRT screens and in hardcopy reports. Various models are available based upon the specific features desired by the customer (e.g., asymmetric jaws, electron pencil beam calculations, etc.) to best meet their clinical needs. The software is designed to run on a PC platform utilizing the Microsoft® Windows NT® operating system. ROCS treatment planning system has been designed to be upgradable in both software features and hardware. All dates are four digit numbers so the system is able to handle the year 2000.

AI/ML Overview

The provided text is a 510(k) summary for the ROCS TPS (Radiation Oncology Computer Systems Treatment Planning System). It primarily focuses on describing the device, its intended use, and its substantial equivalence to a predicate device.

Unfortunately, the provided document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Here's a breakdown of why this information is missing and what is available:

No Acceptance Criteria or Performance Study: The document is a 510(k) summary, which is typically a premarket submission to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. For devices like a Radiation Therapy Treatment Planning System (TPS), substantial equivalence is often established through detailed comparisons of technological characteristics, safety, and effectiveness. This usually involves:
- Comparison to a Predicate Device: The document explicitly names Radiation Oncology Computer Systems Treatment Planning System (K862643) as the predicate device and states that ROCS TPS uses "well known and documented algorithms."
- Verification and Validation (V&V): While not explicitly detailed in this summary, a full 510(k) submission would include V&V documentation demonstrating that the software performs as intended. This might involve testing against known physics models, phantom data, or clinical cases, but the results and acceptance criteria are not summarized here.
- Clinical Performance Studies: For a TPS, clinical performance is often assessed through accuracy of dose calculations against established benchmarks or phantom measurements, not necessarily through human reader studies in the same way an imaging AI algorithm would be. The document focuses on the tool's ability to consistently compute and display dose estimations for independent clinical review.

Therefore, I cannot populate the requested table or answer most of the questions about a performance study using the provided text.

Here's an overview of what I can extract and what remains unanswered based on your query:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in the document.	Not specified in the document.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not specified. The document does not describe a performance study or test set.

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

Not applicable. No test set or ground truth establishment process is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No test set is described.

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. The document does not describe an MRMC study. This device is a treatment planning system, not an AI for image interpretation that would typically involve human readers improving with or without AI assistance in the context of disease detection or diagnosis.

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

Not explicitly described as a formal "standalone study" in this summary. However, the device's function is inherently "standalone" in calculating dose estimations. Its output is then subject to "independent clinical review and judgment prior to use." The document emphasizes the system "does not provide direct control over any treatment delivery device" and "only provides output data...to guide a physician." This suggests the algorithm's output is the primary function, but the validation of its accuracy (which would be the standalone performance) is not detailed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not specified. The document does not describe the specific ground truth used for validating the accuracy of its dose estimations. For a TPS, ground truth would typically come from physical measurements (dosimetry, phantom studies) or established theoretical models.

8. The sample size for the training set:

Not applicable. The document describes a system with "well known and documented algorithms" and "table look-up format." This indicates a deterministic system based on physics models and pre-defined data, rather than a machine learning model that requires a "training set" in the conventional sense.

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

Not applicable. As above, this is not a machine learning system with a training set. The "ground truth" for the algorithms would be derived from fundamental principles of radiation physics and validated experimental data.

Summary

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DEC 30 1998

K982291/

510(k) SUMMARY

Submitter:	Radiation Oncology Computer Systems, Inc.6190 Corte Del CedroCarlsbad, CA 92009(760) 929-1811
Contact:	Charlene Neblett, Manager, Quality Assurance
Date Prepared:	July 31, 1998
Device Name:	ROCS TPS
Common Name:	Radiation Therapy Treatment Planning System
Classification Name:Number:	Accelerator, Linear, Medical, Accessory90 IYE (892.5050)
Predicate Device:	Radiation Oncology Computer Systems TreatmentPlanning System510(k) notification K862643

Device Description:

Intended Use:

ROCS TPS (Radiation Therapy Treatment Planning System) is intended to be used for the computation, display, evaluation and output documentation of radiation dose estimations to be submitted for independent clinical review and judgment prior to use. The goal of this system is to provide a tool that will provide consistent results using well documented algorithms. This system does not provide direct control over any treatment delivery device or system in any form. The device only provides output data in the form of displays, hardcopy prints and/or plots to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.

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Technological Characteristics:

The ROCS Treatment Planning System is designed to run on the Microsoft® Windows The House Tradition Panning Offech 18 ablighter to for the Microsoft Windows graphical user interface providing ease of use for anyone familiar with windows products. This differs from the predicate device in that the operating system is now Microsoft® Windows NT®; whereas, the predicate device utilized the DOS operating system.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 30 1998

Charlene Neblett Manager Quality Assurance Radiation Oncology Computer System, Inc. 6190 Corte Del Cedro Carsbad, CA 92009

Re:

K982791 ROCS TPS Dated: November 2, 1998 Received: November 3, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 MUJ

Dear Ms. Neblett:

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 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). 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 (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 (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 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) 594-4613. 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/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird with its wings spread.

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INDICATIONS FOR USE

ROCS TPS

Divi

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

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.