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

Device Description

AI/ML Overview

The provided text describes a 510(k) submission for a Radiation Treatment Planning System called TiGRT TPS. This submission focuses on demonstrating substantial equivalence to a predicate device (WiMRT, K041971) rather than presenting a detailed performance study with specific acceptance criteria and outcome metrics for standalone or human-in-the-loop performance.

Here's an analysis of the requested information based on the provided document:

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

The document does not explicitly state quantitative acceptance criteria for device performance (e.g., accuracy of dose calculation, speed of optimization) or present specific reported device performance metrics against such criteria. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device. The "performance documentation" listed is about the process of development and risk management, not a direct measurement of the device's functional output against numerical benchmarks.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Intended Use is the same as the predicate.	TiGRT TPS has the same intended use as WiMRT.
Technological Characteristics are similar to the predicate.	TiGRT TPS has similar design, function, application, operating system, networking, application use (Conformal, IMRT, SRS/SRT), dose calculation algorithm (Super-position Convolution), and IMRT optimization algorithm (Genetic Algorithm) as WiMRT. It uses DICOM 3/RT.
No new issues of safety or effectiveness are introduced.	"No new issues of safety or effectiveness are introduced by using this device." Also, "No new issues of biocompatibility are raised."
Compliance with design and development controls.	Provided documentation including: Level of Concern of TPS (Major), TiGRT TPS Description, Risk Management, Hazard Analysis Report, Product Requirement Specification, Architecture Design Chart, Software Design Description, PRS/SDD Traceability Matrix, PRS/STT Traceability Matrix, Development Environment Description, Verification and Validation Documents, Revision Level History, and Unresolved Anomalies.

2. Sample size used for the test set and the data provenance

The document does not describe a traditional "test set" in the context of clinical or performance validation data (e.g., patient cases, imaging data) for evaluating the device's diagnostic or treatment accuracy. The submission focuses on comparing the new device's specifications and design to a predicate, and the provided "Performance Documentation" relates to software development and risk management. Therefore, no specific sample size or data provenance for a performance test set is mentioned.

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

Since no specific test set involving medical data (e.g., images for diagnosis, treatment plans for review) is described, this information is not applicable and not provided in the document. The "ground truth" for this submission revolves around the technical specifications and safety profile being equivalent to an already approved device.

4. Adjudication method for the test set

As there is no described test set requiring expert review or ground truth establishment, no adjudication method is mentioned.

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

The TiGRT TPS is a Radiation Treatment Planning System, not a diagnostic AI tool that assists human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not described and not relevant to this type of device. The document does not mention any AI capabilities that would directly assist human interpretation in a diagnostic sense.

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

The document does not provide details of a standalone performance study in terms of metrics like dose calculation accuracy against physical measurements or clinical outcomes for a specific patient cohort. The "performance documentation" relates to the software development process and risk analysis rather than direct performance measurement of the algorithm itself against ground truth. The acceptance is based on design and functional similarity to the predicate, implying that if the design is substantially equivalent, the performance is also considered equivalent.

7. The type of ground truth used

The concept of "ground truth" in this 510(k) submission is primarily established by:

Predicate Device Specifications: The technical characteristics and intended use of the legally marketed predicate device (WiMRT) serve as the "ground truth" or benchmark against which TiGRT TPS is compared for substantial equivalence.
Industry Standards and Best Practices: Implied "ground truth" for software development and risk management practices (e.g., "Hazard Analysis Report," "Verification and Validation Documents," "Software Design Description") ensure the device is developed safely and effectively, analogous to how the predicate was developed.

8. The sample size for the training set

The document does not describe any machine learning or AI components that would require a "training set" of data. The device relies on established dose calculation algorithms (Super-position Convolution) and optimization algorithms (Genetic Algorithm) which typically do not involve statistical machine learning training on a large dataset in the same way modern AI systems do. Therefore, this information is not applicable and not provided.

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

As there is no described training set for a machine learning model, this information is not applicable and not provided.

Summary

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1090893

JUL 1 5 2009

510(k) Executive Summary

July 8, 2009

1. Submitter's Information

Company Name: Company Address: LinaTech, LLC 1294 Kifer Road, #705 Sunnyvale, CA 94086

Trade Name: TiGRT TPS

Common Name: Radiation Treatment Planning System Classification Name: System, Planning, Radiation Therapy Treatment

2. Predicate Device Identification

21 CFR 892.5050 Radiation Treatment Planning System Product Code: MUJ Device Class: II

3. Legally Marketed Equivalent Device

WIMRT (K041971)

4. Intended Use and Device Description

The intended use is the same as the predicate device.

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5. Technological Characteristics of the Device as to Compared to Predicate Device

Characteristic	Current Modified DeviceTiGRT TPS	Predicate DeviceWiMRT (K041971)
Operating System	Windows XP ProfessionalWindows Vista	Windows XP Professional
Networking	TCP/IP	TCP/IP
Intended Use	TiGRT TPS is a RadiationTherapy Treatment PlanningSystem for radiation doseplanning of patientsundergoing external beamtreatment in the oncologyclinic. TiGRT TPS is used toplan radiation treatmentswith linear accelerators andother similar teletherapydevices with x-ray, electronand/or photon energies from1 to 25MV, as well asCobalt-60.	The product WiMRT is aRadiation Therapy TreatmentPlanning System for radiationdose planning of patientsundergoing external beamtreatment in the oncology clinic.WiMRT is used to plan radiationtreatments with linearaccelerators and other similarteletherapy devices with x-rayenergies from 1 to 25MV, aswell as Cobalt-60, and electronenergies from 1 to 25 MeV.
Application(Use)	Conformal Planning;Step & Shoot Inverse IMRTPlanningDynamic Sliding WindowInverse IMRT PlanningSRS and SRT.	Conformal Planning;Step & Shoot Inverse IMRTPlanningDynamic Sliding WindowInverse IMRT PlanningSRS and SRT
Dose CalculationAlgorithm	Super-position Convolution	Super-position Convolution
IMRTOptimizationAlgorithm	Genetic Algorithm for IMRTsegmentation, Auto-beamangle selection	Genetic Algorithm for IMRTsegmentation, Auto-beam angleselection
DICOM	DICOM 3/RT	DICOM 3/RT

Predicate Product Comparison Table:

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Comparisons Summary

A. Intended Use

The intended use is the same as the predicate device.

B. Technological Characteristics

The predicate device is presently in commercial distribution globally including the United States of America. The TiGRT TPS has the similar technological characteristics and is similar in design, function, and application to the predicate device.

The Technological Characteristics are the same as the predicate devices.

C. Differences

This device is similar in design and construction, and has the same intended use and performance characteristics to the predicate device. It utilizes materials that are already in use in other medical devices. No new issues of safety or effectiveness are introduced by using this device.

D. Argument for Substantial Equivalence to Predicate Devices

The intended use and the technological characteristics of TiGRT TPS are the same as the predicate device and therefore we believe it is Substantially Equivalent to it.

6. Biocompatibility

No new issues of biocompatibility are raised with regard to this device.

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7. Summary for Performance Testing

Performance Documentation	Concern
Level of Concern of TPS	Major
TiGRT TPS Description	Provided
TiGRT TPS Risk Management	Provided
TiGRT TPS Hazard Analysis Report	Provided
TiGRT TPS Product Requirement Specification	Provided
TiGRT TPS Architecture Design Chart	Provided
TiGRT TPS Software Design Description	Provided
TiGRT TPS PRS/SDD Traceability Matrix	Provided
TiGRT TPS PRS/STT Traceability Matrix	Provided
TiGRT TPS Development Environment Description	Provided
TiGRT TPS Verification and Validation Documents	Provided
TiGRT TPS Revision Level History	Provided
TiGRT TPS Unresolved Anomalies (Bugs or Defects)	Provided

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with three lines representing the body and wings. The eagle is facing to the right.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 5 2009

Mr. Jonathan Yao President : LinaTech, LLC 1294 Kifer Road, Suite 705 SUNNYVALE CA 94086

Re: K090893

Trade/Device Name: TiGRT TPS Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: June 18, 2009 Received: June 22, 2009

Dear Mr. Yao:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_1 of_1

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: _ TiGRT TPS

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Prescription Use ﺳﮯ

OR Over-The-Counter Use

(Per 21 CFR 801.109)

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