Apex is an add-on microMLC system. It is an accessory to the linear accelerator used for radiation therapy and it is intended to shape the X-ray field both in static (fixed) or dynamic mode with rotating gantry as a function of the gantry angle. It is provided to assist the radiation oncologist to deliver radiation to the target tissue while sparing the surrounding normal tissues.

Device Description

This Traditional 510(k) describes modifications made to the add-on DMLC accessory for the Elekta range of digital linear accelerators. The primary reason for these enhancements is to improve the leaf resolution - Apex 11 has a reduced leaf width of 2.5mm and increased field size. The add-on MLC Apel M consist of a 112 leaves individually controlled and monitored having a 2.5mm thickness at the isocenter and a field size of 120 mm x 140 mm.

AI/ML Overview

The provided document {0} is a 510(k) summary for the Elekta Apex microMLC, an add-on accessory for linear accelerators used in radiation therapy. This submission focuses on modifications to improve leaf resolution (2.5mm leaf width and increased field size) compared to its predicate device, the DMLC IV (K001163). The core of the submission revolves around demonstrating substantial equivalence to the predicate device.

Based on the information provided, the document describes the device, its intended use, and its technological characteristics but does not contain information about specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or comparative effectiveness studies (MRMC or standalone) in the manner typically associated with clinical performance evaluation of medical devices where diagnostic accuracy or similar metrics are assessed.

The document is a regulatory submission for a device that shapes radiation beams. The evaluation of such devices primarily focuses on their technical performance in shaping the beam accurately and safely, rather than a clinical study evaluating diagnostic accuracy or treatment efficacy as might be seen with an AI-powered diagnostic tool.

Therefore, for most of the requested points, the answer derived from the provided text will indicate that the information is "Not provided in the document."

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Functional Equivalence to Predicate Device: The functionality for the Apex™ is equivalent to its predicate device DMLC IV (K001163) in safety and effectiveness. The fundamental technical characteristics are the same as those of the predicate device.	The primary reason for enhancements is to improve leaf resolution – Apex has a reduced leaf width of 2.5mm and increased field size. The add-on MLC Apex™ consists of 112 individually controlled and monitored leaves, having a 2.5mm thickness at the isocenter and a field size of 120 mm x 140 mm.

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided in the document. The 510(k) summary provided here is a technical and regulatory declaration of substantial equivalence, not a report of a clinical performance study with a test set of data. The "study" mentioned mainly refers to the comparison against the predicate device based on technical specifications and functional equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided in the document. There is no indication of a "test set" with a ground truth established by experts. The device's function is to shape radiation beams, and its performance is typically evaluated through engineering tests and phantom studies rather than expert-labeled clinical data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided in the document. No test set or expert adjudication is described.
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 was done, or at least, it is not mentioned in this document. This device is a radiation therapy accessory (a microMLC), not an AI-powered diagnostic tool that assists human readers. Its function is mechanical beam shaping.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided in the document. The device is a physical component (microMLC) that operates as an accessory to a linear accelerator, not a standalone algorithm. Its performance is inherent to its mechanical and control accuracy.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided in the document. No such "ground truth" as typically understood for diagnostic or prognostic AI devices is relevant or described for this device in this submission. The "ground truth" for a microMLC would relate to its physical accuracy in beam shaping, measured through dosimetry and mechanical verification, not clinical outcomes or expert consensus on clinical images/data.
The sample size for the training set:
- Not applicable / Not provided in the document. This document describes a physical medical device, not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable / Not provided in the document. As above, no training set or its associated ground truth is relevant or described for this device submission.

Summary

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510(k) SUMMARY

SEP 3 0 2011

Date of preparation of summary: May 10th 2011

Submitted by:

Trade Name:

Elekta Limited Linac House, Fleming Way, Crawley, West Sussex RH10 9RR, United Kingdom Fax: +44 (0) 1293 654260 Telephone: +44 (0) 1293 654201

Contact name:

Mr Patrick Hull Apex TM

Common Name: Add-on microMLC

Classification Name:

5710, Product Code IXI)

Predicate Device: DMLC IV (K001163)

Product Description:

BLOCK, BEAM-SHAPING, RADIATION THERAPY (21CFR 892

Intended Use Statement:

Apex™ is an add-on microMLC system. It is an accessory to the linear accelerator used for radiation therapy and it is intended to shape the X-ray field both in static (fixed) or dynamic mode with rotating gantry as a function of the gantry angle. It is provided to assist the radiation oncologist to deliver radiation to the target tissue while sparing the surrounding normal tissues.

Indication for Use Statement:

Apex ™ is an add-on microMLC system. It is an accessory to the linear accelerator used for radiation therapy and it is intended to shape the X-ray field both in static (fixed) or dynamic mode with rotating gantry as a function of the gantry angle. It is provided to assist the radiation oncologist to deliver radiation to the target tissue while sparing the surrounding normal tissues.

Summary of Technological Characteristics:
The add-on MLC Apel M consist of a 112 leaves individually controlled and monitored having a 2.5mm thickness at the isocenter and a field size of 120 mm x 140 mm.

There has been no substantial change made to the underlying technological characteristics of the product.

Substantial Equivalence

The functionality for the Apex™ is equivalent to its predicate device DMLC IV (K001163) 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 as and discussion provided elsewhere in this 510(k) submission.

2011/05/10	Apex	Document 05-01
© 2011 Elekta Limited, Crawley, UK. All rights reserved.		Page 1 of 1

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's name in blue text. To the left of the text is an emblem featuring a stylized human figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

JUL 2 4 2012

Mr. Patrick Hull Regulatory Affairs Engineer Elekta Limited Linac House, Fleming Way CRAWLEY, WEST SUSSEX RH10 9RR UNITED KINGDOM

Re: K111676

Trade/Device Name: Apex Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation Therapy beam-shaping block Regulatory Class: II Product Code: IXI Dated: May 10, 2011 Received: June 15, 2011

Dear Mr. Hull:

This letter corrects our substantially equivalent letter of September 30. 2011. 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Section 4 - Indications for Use Statement and Technical Description of Apex

Apex

510(k) Number (if known): _ KII I676

Device Name:

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

PAGE OF NEEDED)
Mary S Potts

Concurrence of CDRH, Office of Device Evaluation of

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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.