TOPSLANE DMLC 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

TOPSLANE DMLC is a dynamic multileaf collimator designed to be mounted on the various linear accelerator. It comprises multiple motorized tungsten leafs and By controlling each leaf to the designed position according to the software. treatment planning system (TPS), TOPSLANE DMLC is intended to shape the specific field, either in static or dynamic mode. TOPSLANE DMLC can perform different field shaping methods, such as Static Field Shaping, or Step and Shoot IMRT Field Shaping or Sliding Window IMRT Field Shaping.

AI/ML Overview

This document is a 510(k) premarket notification for the TOPSLANE DMLC, a dynamic multileaf collimator. It is a regulatory submission to the FDA, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics in the way a clinical trial might.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in this type of regulatory document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or detailed performance metrics in a tabular format as one would find in a clinical study report. Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device (m3 micro-Multileaf Collimator, K004022, K020860).

The primary "acceptance criterion" for this type of submission is that the FDA determines the device is "substantially equivalent" to legally marketed predicate devices. This is based on comparisons of design, construction, intended use, and performance characteristics.

The document states:

"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."

Therefore, a table of acceptance criteria and reported performance cannot be created from the provided text. The document asserts that its performance characteristics are comparable to the predicate, implying it meets the performance standards already established for such devices.

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

Not applicable / Not provided.
This 510(k) submission does not describe a test set or associated data provenance from a new clinical study. Instead, it relies on the known performance and substantial equivalence to existing predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable / Not provided.
No new test set requiring expert ground truth establishment is described in this submission.

4. Adjudication Method for the Test Set

Not applicable / Not provided.
No test set and adjudication are described.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done

No.
An MRMC comparative effectiveness study was not done, as this is a 510(k) submission seeking substantial equivalence for a physical medical device (a dynamic multileaf collimator), not an AI algorithm.

6. If a Standalone Performance (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable.
This document is for a physical device (TOPSLANE DMLC), not an AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant. The device's function is to shape radiation fields, which integrates into the larger radiation therapy workflow managed by radiation oncologists.

7. The Type of Ground Truth Used

Not applicable / Not provided for new data.
The "ground truth" here is effectively the established performance and safety profile of the predicate devices. The submission asserts that the TOPSLANE DMLC operates similarly, thereby inheriting the "ground truth" of safe and effective operation within the scope of its intended design.

8. The Sample Size for the Training Set

Not applicable.
This document is for a physical device, not a machine learning algorithm, so there is no concept of a "training set" in the context of AI.

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

Not applicable.
As this is not an AI algorithm, the concept of a training set and its ground truth establishment is not relevant.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

Compliance with 513(i) of the Federal Food, Drug and Cosmetic Act

660187

January 18, 2006

JUL 27 2006

1. Submitter's Information

Common/Usual Name:	DYNAMIC MULTILEAF COLLIMATOR
Proprietary Name:	TOPSLANE DMLC
Applicant Address:	Topslane International, LLC15375 Roosevelt Blvd. Suite #300,Clearwater, FL 33760
Contact Person:	Jim Marsh, President
Telephone:	727-507-8500
Fax:	727-507-9192

2. Predicate Devices

m3 (micro-Multileaf Collimator) (K004022, K020860)

Therapeutic X-Ray Collimator Device Classification Name: Regulatory Class: Class II (according to 21 CFR 892.5050)

3. Performance Standards

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

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4. Device Description

K60187

5. Intended Use

The intended use is the same as the predicate device.

6. 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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Image /page/2/Picture/1 description: The image is a circular seal with the logo of the Department of Health & Human Services (HHS). The seal features the HHS emblem, which consists of a stylized caduceus-like symbol with three wavy lines representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 27 2006

Mr. James N. Marsh President TOPSLANE International. LLC 15375 Roosevelt Blvd.. Suite #300 CLEARWATER FL 33760

Re: K060187

Trade/Device Name: TOPSLANE DMLC Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE. IXI Dated: June 16. 2006 Received: June 20, 2006

Dear Mr. Marsh:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. The letters "PA" are in the center of the logo in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial". The logo is surrounded by a dotted border.

Protecting and Promoting Public Health

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Page 2 -

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Nancy C.Bogdon

Nancy C. Brogdon 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): K[60187]

Device Name:

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 Over-The-Counter Use OR (Per 21 CFR 801.109) (Division Sign-Off), Division of Reproductive, Ab

and Padiological Devices 510(k) Number _

Regulation Number and Section

§ 892.5710 Radiation therapy beam-shaping block.

(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.