RAPTOR TREATMENT PLANNING SYSTEM by NOMOS CORP.

The RAPTOR® Radiation Treatment Planning System is intended to be used by radiation oncology professionals for clinical review and judgement of radiation treatment plans and dose estimates based on computation, output and displays. The goal of the system is to produce consistent results using well-documented algorithms. It will provide outputs for radiation delivery equipment including documented and released multileaf collimators [MLCs] for planning, optimization, delivery and reporting of treatments. The device provides output data in the form of displays, hardcopy prints and / or plots, set-up instructions and other control information to guide the physician and / or other competent health care professional in selecting the optimum patient treatment plan.

The RAPTOR® Treatment Planning System is used to generate computation, display, evaluation and output radiation dose estimates for clinical review and judgement prior to treating the patient. It uses well-documented algorithms to provide output data in the form of displays, hardcopy prints, plots and treatment instructions to guide the radiation oncology professional and / or physician to select the optimum treatment plan. The MLC module is used to generate plans and instructions for documented and released multileaf collimators.

Device Description

The RAPTOR Treatment Planning System is a collection of software modules that execute known and documented algorithms to produce radiation dose estimations. All data is user controlled and is a table look-up formation is presented graphically on CRT screens and hardcopy reports. Various models are available based on the specific features desired by the customer (e.q., 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. The RAPTOR Treatment Planning System includes modules for the development of instructions and controls for multileaf collimators. It is designed to upgradable in both hardware and software features. All dates are four digit numbers so the system is year 2000 compliant.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device called the RAPTOR® Treatment Planning System. Unfortunately, the provided document does not contain the detailed information required to answer your request about acceptance criteria and the comprehensive study that proves the device meets those criteria.

Here's why and what information is missing:

No specific acceptance criteria table: The document states that the system "has a product specification, which was used as the basis for the development of verification and validation plans, tests and acceptance criteria." However, it does not explicitly list these acceptance criteria.
No detailed study results or performance metrics: While it mentions "Validation and verification testing... demonstrate that the software is safe and effective" and that it "performs and is equivalent to the predicate systems," it does not provide any quantitative performance data (e.g., accuracy percentages, precision values, specific metrics like sensitivity, specificity, AUC) or a comparison against predefined acceptance thresholds.
Missing information on sample size, data provenance, ground truth, experts, MRMC studies, or standalone performance.

Based on the provided text, I cannot complete the table or answer the specific questions about the study design and results. The document focuses on the regulatory submission process, the device's intended use, and its general technological characteristics, rather than the detailed validation study methodology and outcomes.

However, I can extract the following relevant information:

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

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the provided document. The document mentions "product specification, which was used as the basis for the development of verification and validation plans, tests and acceptance criteria."	"Validation and verification testing of the RAPTOR® Treatment Planning System demonstrate that the software is safe and effective. Test completion shows that the device performs and is equivalent to the predicate systems for those features for which this submission is being made as well as overall performance."

Missing Information:

Specific quantitative acceptance criteria (e.g., accuracy within X%, dose calculation deviation within Y%).
Quantitative results from the verification and validation tests (e.g., actual measured accuracies, deviations, etc.) that demonstrate the device met these criteria.

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

Missing Information:

Sample size (number of cases/patients used) for the test set.
Data provenance (e.g., country of origin, retrospective/prospective nature of the data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing Information:

Number of experts.
Qualifications of experts. This document is about a treatment planning system, so "ground truth" would likely relate to the accuracy of dose calculations or treatment plan parameters, which might be compared against established physics models, phantom measurements, or potentially consensus among medical physicists/radiation oncologists.

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

Missing Information:

Adjudication method for establishing ground truth or resolving discrepancies.

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

Missing Information:

There is no indication of an MRMC comparative effectiveness study being performed. This device is a treatment planning system, not an AI-assisted diagnostic tool, so such a study might not be directly applicable in the typical sense of "human readers."

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

Missing Information:

While the validation and verification tests would inherently be "standalone" in evaluating the software's calculations, the specific results and metrics of this standalone performance are not provided. The device focuses on "producing radiation dose estimations" and "output and displays," which implies an algorithm-only component.

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

Missing Information:

The document does not specify the method for establishing "ground truth," which for a radiation therapy planning system would likely involve physical measurements in phantoms, comparison to established analytical models, or potentially simulations.

8. The sample size for the training set

Missing Information:

The document does not mention a training set, as it describes a system involving "known and documented algorithms" and "table look-up." This suggests a more deterministic, physics-based approach rather than a machine learning model that requires a separate training set.

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

Missing Information:

As there's no mention of a training set, this information is not applicable.

Summary

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K993359

Section 2 510(k) Summary of Safety and Effectiveness RAPTOR® Treatment Planning System

Pursuant to Section 513(I) of the Federal food. Drug, and Cosmetic Act and 21 CFR 807.92:

(a) (1) Submitter's name:	NOMOS Corporation
(a) (1) Submitter's address:	2591 Wexford Bayne RoadSewickley, PA 15143
(a) (1) Submitter's telephone number:	(724) 934-8200
(a) (1) Contact person:	William O. ChishkoDirector, Quality and Regulatory Affairs
(a) (1) Date summary was prepared:	October 4, 1999
(a) (2) Trade or proprietary name:	RAPTOR® Treatment Planning System
(a) (2) Common or usual name:	Radiation Therapy Treatment Planning System
(a) (2) Classification name:	Accelerator, Linear, Medical, Accessory90 IYE [21 CFR 892.5050]
(a) (3) Predicate device:	Radiation Oncology Computer Systems, TreatmentPlanning System K982791Theratronics, TheraPlan Plus K970236NOMOS Corporation, PEACOCK® System K963258

(a) (4) Device description:

(a) (5) Intended use:

The RAPTOR® Radiation Treatment Planning System is intended to be used by radiation oncology professionals for clinical review and judgement of radiation treatment plans and dose

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estimates based on computation, output and displays. The goal of the system is to produce consistent results using well-documented algorithms. It will provide outputs for radiation delivery equipment including documented and released multileaf collimators [MLCs] for planning, optimization, delivery and reporting of treatments. The device provides output data in the form of displays, hardcopy prints and / or plots, set-up instructions and other control information to guide the physician and / or other competent health care professional in selecting the optimum patient treatment plan.

(a) (6) Technological characteristics:

The RAPTOR® Treatment Planning System is designed to run on the Microsoft Windows NT operating system the same as the ROCS Treatment Planning System [K982791]. The RAPTOR® Treatment Planning System uses the same software architecture and hardware platform as the ROCS Treatment Planning System. It was developed and tested using Quality system design control and product release procedures.

It differs in that a module for calculating the effects of multileaf collimators and providing instructions for their control like those found in PEACOCK® System is added.

(b) (1) Non-clinical tests submitted:

The RAPTOR® Treatment Planning System was developed and tested using the design controls set forth in the NOMOS Corporation Quality System. It has a product specification, which was used as the basis for the development of verification and validation plans, tests and acceptance criteria. A rigorous hazard analysis also was performed, which includes mitigation for each identified hazard. Design reviews were conducted at appropriate stages of development.

(b) (3) Test Conclusions:

Validation and verification testing of the RAPTOR® Treatment Planning System demonstrate that the software is safe and effective. Test completion shows that the device performs and is equivalent to the predicate systems for those features for which this submission is being made as well as overall performance. Product release also is made in accordance with established NOMOS Corporation Quality System Procedures after all tests are completed, reviewed and meet acceptance criteria and regulatory requirements.

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Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 1999

William O. Chishko Director, Quality Affairs and Regulatory Assurance NOMOS Corporation 2591 Wexford Bayne Road Sewickley, PA 15143

Re:

K993359 RAPTOR Treatment Planning System Dated: October 4, 1999 Received: October 6, 1999 Regulatory Class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Mr. Chishko:

We have reviewed your premarket notification submission and have found this device to be exempt from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (Act). Therefore, you may immediately begin marketing this device as described in your premarket notification.

The Federal Register notice exempting your device type was published on January 21, 1998, Vol. 63, No. 13, page 3142, and was effective immediately. Therefore, manufacturers of devices falling within the above classification regulation are now exempt from the premarket notification requirements of the Act if they comply with the classification criteria. Your device's product code, classification regulation and regulatory class are shown above. When listing your device with the Food and Drug Administration, please use this product code. We suggest that you review this above referenced regulation since it may grant other exemptions from certain general controls of the Act.

In the future, new but substantially equivalent devices which fall within the above classification regulation name and meet the classification criteria may be marketed without sending a premarket notification submission to the Food and Drug Administration. We suggest, however, that you review the section entitled "Limitations on Exemptions" in the above referenced Federal Register notice to determine whether or not your new device(s) meets the exemption criteria. This Federal Register notice may be accessed on the World Wide Web at "www.fda.gov/cdrh/modact/frclass2.html" or obtained by facsimile from the Division of Small Manufacturers Assistance's Facts On Demand at (800) 899-0381 or (301) 827-0111. The order number for this notice is #394.

If you have any questions reqarding this letter, please contact Notification Staff at (301) 594-1190 or the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

CAPT Daniel L.C. Schultz, MD

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

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510(k) Number [if known]: 《993359 Device Name: RAPTOR® Treatment Planning System Indication for Use:

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Concurrence of the CDRH Office of Device Evaluation [ODE]

Prescription Use V (Per 21 CFR 801.109)

Over the Counter Use (Optional Format , 2 January 1996

Urint h. Segers

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

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.