The MLCi2 Multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.

Device Description

This Special 510(k) describes modifications to the MLCi multileaf collimator for use as an accessory for the Elekta range of medical digital linear accelerators. These modifications provide the following improvements;

. Improved x-ray performance (peak and average leakage).
Improved repeatability of leaf edge position.
. The ability for leaves to interdigitate.

AI/ML Overview

The provided document is a 510(k) summary for the Elekta MLCi2, a multileaf collimator, and the FDA's clearance letter. This document does not describe a clinical study with acceptance criteria and reported device performance in the manner typically associated with studies assessing diagnostic accuracy or clinical outcomes for AI devices.

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (MLCi) for a hardware modification, which is a different type of regulatory submission.

Here's an analysis based on the information provided, highlighting why many of your requested points are not applicable or cannot be answered from this specific document:

1. Table of acceptance criteria and the reported device performance

The document does not present acceptance criteria and reported performance in a table format for clinical efficacy. The "performance" described is in terms of technical improvements over its predecessor, not clinical outcomes.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Technical Improvements)
Technical characteristics are substantially equivalent to the predicate device, MLCi (K963624).	- Improved x-ray performance (peak and average leakage).
Safety and effectiveness are comparable to the predicate device.	- Improved repeatability of leaf edge position.
Functionality is equivalent to the predicate device.	- Ability for leaves to interdigitate.
	- Leaf height increased by 6.5%.
	- Leaf profile and attitude changed to reduce leakage.
	- Leaf guidance improved to allow interdigitation.

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

Not Applicable. This submission is for a hardware modification of a medical device (multileaf collimator) and does not involve a "test set" of patient data in the context of evaluating a diagnostic or AI device's performance. The "test" performed would likely be engineering verification and validation testing to confirm the stated technical improvements and safety.

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

Not Applicable. As above, there is no "test set" requiring ground truth established by experts in this type of submission. Performance is measured against engineering specifications and comparison to the predicate device's technical capabilities.

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

Not Applicable. No test set or expert adjudication is described.

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

Not Applicable. This is not an AI device, and no MRMC study was performed or described. The MLCi2 is a hardware component for radiation therapy.

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

Not Applicable. The MLCi2 is a mechanical accessory, not an algorithm.

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

Not Applicable. No explicit "ground truth" for clinical performance is mentioned. The "truth" in this context refers to engineering specifications met and performance comparable to the predicate device.

8. The sample size for the training set

Not Applicable. This is not an AI device, and therefore, no training set data is relevant to this submission.

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

Not Applicable. As above, no training set is relevant.

Study that proves the device meets the acceptance criteria:

The document describes this as a Special 510(k) submission for modifications to an existing device (MLCi to MLCi2). The "study" (or rather, the basis for approval) is the demonstration of substantial equivalence to the predicate device (MLCi, K963624).

The core of the "proof" is that:

The MLCi2 has fundamental technical characteristics that are the same as the predicate device.
The modifications (improved x-ray performance/leakage, improved leaf edge position repeatability, ability for leaves to interdigitate, increased leaf height, changed leaf profile/attitude, improved leaf guidance) are described and are considered improvements that do not raise new questions of safety or effectiveness.
The functionality of the MLCi2 is equivalent to its predicate device. This is typically presented through comparison charts and engineering data (though not detailed in this public summary).

In essence, the study is a technical comparison and verification process, rather than a clinical trial or AI performance study. The FDA's clearance letter confirms their agreement that substantial equivalence has been demonstrated, allowing the device to be marketed.

Summary

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Kös2122

AUG 2 9 2008

510(k) SUMMARY

Date of preparation of summary: 18th July 2008

Submitted by:

Elekta Limited Linac House, Fleming Way, Crawley, West Sussex RH20 9RR, United Kingdom Telephone: +44 (0) 1293 544422 Fax: +44 (0) 1293 654260

Contact name: Mr. Patrick Hull

Trade Name:	MLCi2
Common Name:	Multileaf Collimator
Classification Name:	Medical Linear Accelerator Accessory, IYE
Predicate Device:	MLCi (K963624)

Product Description:

. Improved x-ray performance (peak and average leakage).
Improved repeatability of leaf edge position.
. The ability for leaves to interdigitate.

Intended Use Statement:

The MLCi2 Multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.

Summary of Technological Characteristics:

The MLCi multileaf collimator has been modified to improve leaf design. The changes made result in the following characteristics;

Leaf height increased by 6.5%. .
◆ Leaf profile and attitude changed to reduce leakage.
Leaf guidance improved to allow interdigitation. ●

Substantial Equivalence

The functionality for the MLCi2 is equivalent to its predicate device the MLCi (K963624) in safety and effectiveness. The fundamental technical characteristics are the same as those of the predicate device and differences in operation are described in the comparison chart and discussion provided elsewhere in this 510(k) submission.

2008/07/18	MLCi2	Document 05 - 01
© 2008 Elekta Limited, Crawley, UK. All rights reserved.		Page 1 of 1

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG 2 9 2008

Mr. Patrick T. M. Hull Regulatory Affairs Engineer Elekta Limited Linac House, Fleming Way Crawley, West Sussex RH10 9RR UNITED KINGDOM

Re: K082122

Trade/Device Name: MLCi2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 23, 2008 Received: July 28, 2008

Dear Mr. Hull:

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/1/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" in cursive font in the middle. The letters "FDA" are prominently displayed in a bold, stylized font. The logo is surrounded by text that appears to be part of a circular border, but the text is not fully legible. The logo seems to commemorate a centennial, likely related to the FDA.

Promoting Public -

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.

Sincerely yours,

Nancy Brogdon

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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Indications for Use

510(k) Number (if known):

K082122

Device Name ...................... MLCi2

The MLCi2 Multileaf collimator is indicated for use when additional Indication for Use: flexibility is required in conforming the radiation beam to the anatomy to be exposed.

Prescription Use - YES AND/OR Over-The-Counter Use - NO (Per 21 CFR 801.109 Subpart D) (21 CFR 801 Subpart C)

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _______________________________________________________________________________________________________________________________________________________________

2008/07/18	MLCi2	Document- 0104
	Elekta Limited.Crawlev. UK.	I------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- adeOf

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.