The 120 Leaf MLC is indicated for use with the Mitsubishi EXL series linear accelerators to provide the ability to adjust the field shape to conform to tumor shapes. It can be a substitute for conventional customer blocks.

Device Description

This submission is intended to be applicable to the 120 Leaf multileaf collimator system (MLC) which can be used on Mitsubishi linear accelerators for external beam radiotherapy. The MLC system is design to provide the ability to adjust the field shape to conform to tumor shapes. It can be a substitute for conventional customer provided blocks. The MLC system consists of the collimator, the Local Control Equipment (LCE) located in the treatment room, and Multi Leaf Controller Unit (MLCU).

The collimator consists of three sets of jaws which determines the field size and shape. The top (Y-direction) jaws consist of a pair of monoblocks just like conventional accelerator therapy collimators. The middle (X-direction) jaws also consist of a pair of monoblocks. These jaws move in tandem and determine the field length.

The lower set of jaws consist of 60 pairs of leaves (120 leaves). Each pair of leaves is independently driven by a stepping motor. Each pair of leaves can be independently set to provide irregular-shaped field settings.

AI/ML Overview

This 510(k) summary for the Mitsubishi 120 Leaf MLC (K973963) does not contain specific acceptance criteria or a detailed study proving the device meets those criteria in the way a typical diagnostic or AI-driven medical device submission would.

The document describes a medical device, a Multileaf Collimator (MLC), which is an accessory for linear accelerators used in radiation therapy. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily by highlighting the increased number of leaves (from a previous Mitsubishi MLC) and its intended use to conform to tumor shapes, substituting for conventional blocks.

Therefore, many of the requested sections regarding acceptance criteria and performance study details cannot be extracted from the provided text because such information is not present.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the document. For a device like an MLC, typical acceptance criteria would relate to leaf positional accuracy, speed of movement, repeatability, leakage radiation, and field shaping capabilities. However, these are not quantified or presented as acceptance criteria in this submission.
Reported Device Performance: Not explicitly stated or quantified in terms of specific performance metrics against acceptance criteria. The document only describes the device's function and intended use.

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

Test Set Sample Size: Not applicable/not reported. This submission does not describe a clinical performance study with a test set of patient data. The device is hardware for radiation therapy delivery, not an imaging or diagnostic algorithm.
Data Provenance: Not applicable/not reported.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Number of Experts: Not applicable. No ground truth establishment related to clinical outcomes or diagnoses is described or required for this type of device submission.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Was an MRMC study done? No. This type of study is relevant for diagnostic or AI-assisted interpretation devices, not for a hardware accessory like an MLC.
Effect Size: Not applicable.

6. Standalone (Algorithm Only) Performance Study:

Was a standalone study done? No. This device is a mechanical accessory, not a standalone algorithm.

7. Type of Ground Truth Used:

Type of Ground Truth: Not applicable. The purpose of this device is to shape radiation beams, not to make diagnoses or predictions that would require a "ground truth" in the clinical sense (e.g., pathology for a lesion, patient outcome for a prognosis). Its performance would be evaluated against engineering specifications and physics parameters rather than clinical ground truth derived from patient data.

8. Sample Size for the Training Set:

Training Set Sample Size: Not applicable. This device is a hardware component and does not involve machine learning or AI that would require a "training set" of data.

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

Ground Truth Establishment: Not applicable.

Summary based on the provided text:

The provided 510(k) summary for the Mitsubishi 120 Leaf MLC (K973963) is a premarket notification for a radiation therapy accessory. It focuses on demonstrating substantial equivalence to previously marketed devices (Mitsubishi multileaf collimator and a Varian multileaf collimator) by highlighting its technological characteristics (increased number of leaves) and intended use.

The document does not contain information about specific acceptance criteria or a detailed clinical performance study as would be expected for a diagnostic device or a device incorporating artificial intelligence. The regulatory review process for such a device would likely have focused on engineering specifications, safety, and performance data from bench testing or preclinical studies, rather than human-reader studies or clinical ground truth establishment, which are not detailed in this public summary.

Summary

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K973963

510 (k) SUMMARY

JAN | 4 1998

MITSUBISHI LINEAR ACCELERATORS EXL SERIES

1. Submitter:

The 510 (k) is submitted by Hideyuki Kawakami, Product Manager, Medical Systems Division, Mitsubishi Electronics America, Inc., 800 Cottontail Lane, Somerset, NJ 08873. This 510 (k) summary was prepared on October 9, 1997.

2. Device Name:

The 510 (k) submission is for Mitsubishi 120 Leaf MLC, an accessory for Mitsubishi EXL series of linear accelerators with computerized control consoles.

3. Predicate device:

The devices described in this submission are considered to be substantially equivalent to the Mitsubishi multileaf collimator.

The device is also equivalent to a multileaf collimator manufactured and distributed by Varian Associates Inc.

The predicate device are legally marketed, having been found to be substantially equivalent through the 510 (k) premarket notification process.

4. Device description:

5. Intended use:

The 120 Leaf MLC is indicated for use with the Mitsubishi EXL series linear accelerators to provide the ability to adjust the field shape to conform to tumor shapes. It can be a

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substitute for conventional customer blocks.

6. Comparison of technological characteristics:

This submission describes the modification of existing MLC by increasing the number of leaves. Positions of leaves in both types of MLC are adjusted by motor drive mechanisms using computerized controllers.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Cornorate Boulevard Rockville MD 20850

Mitsubishi Electronics America, Inc. c/o C. L. McIntosh & Associates 12300 Twinbrook Parkway. Suite 625 Rockville, MD 20852

T. Whit Athey

Re:

K973963 Mitsubishi 120 Leaf Multileaf Collimator (MLC) for EXL Accelerator Series Dated: October 14, 1997 Received: October 16, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

JAN 1 4 1998

Dear Mr. Athey:

Attn:

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, 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 (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 OS 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 marked 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 question 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/cdrb/dsmamain.html"..............................................................................................

Sincerely yours.

W.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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STATEMENT OF INDICATIONS FOR USE

X973963 510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

120 Leaf Multileaf Collimator for EXL Linear Accelerator Series

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ONANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Elvid A. bejerm

n of Reproductive. Abdominal. 510(k) Number

Prescription Use

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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.