TIGRT MLC is a dynamic multileaf collimator designed to be mounted on the linear accelerator. It is intended to shape the specific fields, either in static or dynamic mode, to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

Device Description

AI/ML Overview

The provided document, KO90802 from July 7, 2009, is a 510(k) summary for the TiGRT MLC (Dynamic Multileaf Collimator). This document establishes substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of analytical or clinical performance metrics.

Instead, this submission focuses on demonstrating substantial equivalence to the DMLC (K060187) based on similarity in design, construction, intended use, and performance characteristics. The comparison table (Table 1) highlights minor differences in operating system, number of COM ports, and selectable leaf pairs, which are not presented as acceptance criteria or performance metrics derived from a study.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: This information is not present in the provided document. The table in the document is for comparing characteristics with a predicate device, not for reporting performance against acceptance criteria.
Sample sized used for the test set and the data provenance: No test set or data provenance is mentioned as part of a performance study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment for a test set is not discussed.
Adjudication method for the test set: No test set adjudication is 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: No MRMC study is described. This device is a mechanical component for radiation delivery, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance is discussed.
The type of ground truth used: No ground truth is mentioned in the context of a performance study.
The sample size for the training set: No training set is mentioned.
How the ground truth for the training set was established: No training set ground truth establishment is mentioned.

The document primarily states:

"This device is similar in design and construction, and has the same intended use and performance characteristics to the predicate device."
"No new issues of safety or effectiveness are introduced by using this device."

This type of submission relies on demonstrating that the new device functions similarly to an already approved device, rather than providing novel clinical or analytical performance data against specific, quantifiable acceptance criteria.

Summary

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KO90802

JUL - 7 2009

Summary of Safety and Effectiveness

March 20, 2009

1. Submitter's Information

DYNAMIC MULTILEAF COLLIMATOR Common/Usual Name:

Proprietary Name:

TiGRT MLC, TiGRT DMLC

Applicant Name and Address:

LinaTech, LLC 1294 Kifer Road, #705 Sunnyvale, CA 94086 Telephone: 408-733-2051 Fax: 408-733-2045

2. Predicate Devices

DMLC (K060187)

3. Classification

This device is classified as a Class II device according to 21 CFR 892:5050

4. Performance Standards

No applicable standards have been established by FDA under section 514 of the Food, Drug and Cosmetic Act.

Image /page/0/Picture/16 description: The image is a black and white picture that appears to be a scan of a document or a textured surface. The image is mostly white with a scattering of black spots and marks across the surface. The distribution of the black marks is somewhat uneven, with some areas having a higher concentration than others. There are also some vertical lines or streaks present, particularly along the edges of the image.

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5. Device Description and Intended Use

The intended use is the same as the predicate device.

6. Biocompatibility

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

7. Summary of Substantial Equivalence

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.

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Characteristic	Current Modified Device	Predicate Device
	TiGRT MLC	DMLC (K061087)
OperatingSystem	MS Windows XP and Vista	MS Windows XP
Intended Use	TIGRT MLC is a dynamicmultileaf collimator designed to bemounted on the linear accelerator.It is intended to shape the specificfields, either in static or dynamicmode, to assist the radiationoncologist in the delivery ofradiation to well-defined targetvolumes while sparingsurrounding normal tissue andcritical organs from excessradiation.	DMLC is a dynamic multileafcollimator designed to bemounted on the linearaccelerator. It is intended toshape the specific fields, either instatic or dynamic mode, to assistthe radiation oncologist in thedelivery of radiation towell-defined target volumeswhile sparing surroundingnormal tissue and critical organsfrom excess radiation.
Application(Use)	Static Field Shaping;Step and Shoot IMRT FieldShaping;Sliding Window IMRT FieldShaping;SRS and SRT Field Shaping;Dynamic (Arc) field shaping.	Static Field Shaping;Step and Shoot IMRT FieldShaping;Sliding Window IMRT FieldShaping;SRS and SRT Field Shaping;Dynamic (Arc) field shaping.
Beam Shaping	Linac with Photon and Electronbeam, and C60 beam	Linac with Photon and Electronbeam, and C60 beam
Communication	DICOM RT	DICOM RT
COM portssupport	8 COM ports, reserved for Arc RT,R/V, IGRT, Breathing Signal Input	6 COM ports, reserved for ArcRT, R/V, IGRT Signal Input
Leaf Pairs	27 pairs- 53 pairs (selectable)	27 pairs
Networking	TCP/IP	TCP/IP

: .

Table 1: Comparison of Modified Device TiGRT MLC with Predicate Device

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with three wing-like shapes. The image is in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 2009

Mr. Jonathan Yao President and CEO LinaTech, LLC 1294 Kifer Road, #705 SUNNYVALE CA 94086

Re: K090802

Trade/Device Name: TIGRT MLC Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 10, 2009 Received: June 11, 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. Ilsting 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 (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 (QS) 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/cdrl/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

K090802 510(k) Number (if known):_

Device Name: ___ TIGRT MLC

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

OR Over-The-Counter Use

. (Per 21 CFR 801.109)

Hulda Russo

(Division Sign (Division Sign-On)
Division of Reproductive, Abdominal, Division ological 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.