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

The associated Integrity R3.0 software is the interface and control software for the Elekta medical digital linear accelerator and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumors), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.

Device Description

This Traditional 510(k) describes the addition of the new Agility multileaf collimator beam limiting device and its associated control software to the Elekta medical linear accelerator. The new device has 160 leaves of 5mm width at isocenter, a fast leaf speed of up to 65 mm/s, low leakage (<0.5%) and is capable of interdigitation within a maximum field size of 40 x 40 cm. Control is by extension to the existing Elekta linear accelerator control system software. Synchronization of the movement of the dynamic leaf guides with individual leaf movements achieves enhanced leaf speed and removes the need for a split field.

The Agility includes dynamic leaf guides, fluorescing ruby leaf markers ('Rubicon') for improved leaf tracking by the optics system, the elimination of backup diaphragms by providing low interleaf leakage, sculpted field defining diaphragms, separate lighting systems for patient plane illumination and movement control using LEDs, and a new control cabinet on which the Integrity user interface and machine control software is executed including a hardware firewall to provide safe network connection.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Agility™," a multileaf collimator, and its associated control software, Integrity R3.0. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than a detailed comparative effectiveness study of AI versus human readers or standalone AI performance.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI performance are not applicable or cannot be extracted from this specific document.

However, I can provide information based on the engineering and performance specifications detailed in the 510(k) summary.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the reported performance of the device and its predicate, primarily focusing on mechanical and physics performance characteristics to demonstrate substantial equivalence. The "study" proving the device meets these criteria is described as "module, integration and system level verification," "regression testing," and "validation... under clinically representative conditions."

Table of Acceptance Criteria and Reported Device Performance:

Attribute	Acceptance Criterion (Predicate Device Performance - K082122)	Reported Device Performance (Agility™ - This Submission)
Mechanical
Interdigitation capable	yes	yes
Number of leaves	80	160
Nominal leaf width at isocenter	10 mm	5 mm
Maximum field size	40 x 40 cm	40 x 40 cm
Max distance between leaves	32.5 cm	20 cm
Leaf travel over central axis	12.5 cm	15 cm
Leaf nominal height	82 mm	90 mm
Leaf positioning resolution	0.1 mm	0.1 mm
Leaf positioning verification	Optical and machine vision system	Optical and machine vision system (Rubicon)
Diaphragm over-travel	0	12 cm
Dimensions / Weight / Speeds
Head rotation	365 degrees	365 degrees
Head weight	380 kg	420 kg
Radiation head diameter	620 mm	815 mm at widest, 694 mm at narrowest
Head to isocenter clearance	45 cm	45 cm
Head rotation speed (set-up)	12°/s	12°/s
Head rotation speed (dynamic)	6°/s	6°/s
Leaf speed (combined w/ guide)	2.0 cm/sec	up to 6.5 cm/s
Leaf speed	2.0 cm/sec	up to 3.5 cm/s
Diaphragm speed	1.5 cm/s	up to 9 cm/s
Wedge
Integrated wedge size	Automatic 0-60°	Automatic 0-60°
Wedge field size	30 x 40 cm	30 x 40 cm
Physics Performance
Leaf position accuracy	± 1 mm	1 mm at isocenter, 0.5 mm RMS*
Leaf position repeatability	0.5 mm	0.5 mm
Avg transmission through leaf bank	1.5%	<0.375%
Peak transmission through leaf bank	2.1%	<0.5%
X-radiation leakage (patient plane)	<0.2% max; <0.1% avg.	<0.2% max, <0.1% avg.
X-radiation leakage (outside patient plane)	<0.5%	<0.5% (at 1 m)
Delivery techniques
Dynamic Delivery Capability	yes (sliding window, dynamic arc, VMAT, multiple island shielding, offset field shaping)	yes (sliding window, dynamic arc, VMAT, multiple island shielding, offset field shaping)

Note: The "Acceptance Criterion" column reflects the performance of the predicate device (MLCi2), as the submission aims to demonstrate substantial equivalence and often improved performance. The acceptance for the new device is typically meeting or exceeding these established benchmarks.

Study Details (as inferable from the document):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify a "test set" in the context of patient data or clinical images for performance testing like an AI algorithm would.
- Performance testing was conducted on "production equivalent systems both at Elekta and at hospital sites." No specific sample size (e.g., number of machines, number of tests) is provided, nor is the country of origin of the data explicitly stated other than Elekta Limited being based in the UK.
- The testing described is engineering verification and validation, not a clinical trial with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable. The device is a hardware component (multileaf collimator) and its control software. "Ground truth" in the clinical sense (e.g., definitive diagnosis from experts) is not relevant to its performance testing.
- Validation was performed by "competent and professionally qualified personnel," but their specific number or detailed qualifications (e.g., radiologist with X years of experience) are not provided as it's not a diagnostic AI device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are used to establish ground truth in clinical studies, particularly for diagnostic devices or AI algorithms. This device's testing involves engineering and physics measurements.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a component of a linear accelerator used for radiation therapy, not a diagnostic AI system that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable in the context of an AI algorithm's standalone performance. The device is hardware with control software. Its "standalone" performance refers to its mechanical and physics capabilities as documented in the table, without direct human intervention in the moment-to-moment leaf movement (which is automated by the software). However, it is explicitly designed to assist a "licensed practitioner" in delivering radiation, meaning it is ultimately human-in-the-loop for treatment planning and oversight.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The concept of "ground truth" as pathology or outcomes data is not applicable here. The "ground truth" for the device's performance is typically established by:
  - Technical specifications: Design requirements for leaf width, speed, accuracy, leakage, etc.
  - Physics measurements: Using dosimeters, films, or other calibrated instruments to verify radiation beam shaping, dose delivery accuracy, leakage, etc.
  - Mechanical measurements: Calibrated tools to verify physical dimensions, movements, and resolutions.
The sample size for the training set:
- This is not applicable. This device is not an AI algorithm trained on a dataset in the conventional sense. The "control software" is developed through traditional software engineering processes, not machine learning model training.
How the ground truth for the training set was established:
- This is not applicable, as there is no "training set" in the context of machine learning. The "ground truth" for the software's functionality would be its design requirements and specifications, validated through formal verification and validation protocols.

Summary

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K121328

JUN 1 2 2012

510(k) SUMMARY

Date of preparation of summary: 27th April 2012

Submitted by:

Elekta Limited Linac House, Fleming Way, Crawley, West Sussex RH10 9RR, United Kingdom Telephone: +44 (0)1293 654422 Fax: +44 (0)1293 654260

ontact name: Patrick Hull

Trade Name:	Agility ™
Common Name:	Multileaf Collimator
Classification Name:	Medical Linear Accelerator Accessory, 21CFR 892.5050
Product Code:	IYE
Predicate Device:	MLCi2 (K082122)

Product Description:

Indications For Use and Intended Use Statement:

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

The associated Integrity R3.0 software is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumors), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.

Summary of Technological Characteristics:

Agility TM is a new multileaf collimator with a dedicated linac control system.

There are no novel forms of technology introduced by this device.

Substantial Equivalence

The functionality of the Elekta medical linear accelerator with Agility™ is substantially equivalent to that of its predicate device, MLCi2 (K082122), in safety and effectiveness. The intended use, principles of operation, technological characteristics and labelling are substantially equivalent.

The primary differences between the predicate device and the new device are the improved resolution across the 40cm x 40cm field size provided by the 5mm leaf width at isocenter, faster leaf and diaphragm speeds, and longer diaphragm over-travel. It does not directly infroduce additional clinical functionality.

Elekta Limited, Linac House, Fleming Way, Crawley, West Sussex RH10 9RR UK . Tel: +44 (0)1293 54422 Fax: +44 (0)1293 654321 www.elekta.com Registered.in England No. 3244454

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Attributes	Elekta linac with Agility &Integrity R3.0 (this submission)	Elekta linac with MLCi2 &Integrity R1.1 (K802122)
Mechanical
Interdigitation capable	yes	yes
Number of leaves	160	80
Nominal leaf width projection atisocenter	5 mm	10 mm
Maximum field size	40 x 40 cm	40 x 40 cm
Maximum distance between leaves onthe same leaf guide	20 cm	32.5 cm
Leaf travel over central axis	15 cm	12.5 cm
Leaf nominal height	90 mm	82 mm
Leaf positioning resolution	0.1 mm	0.1 mm
Leaf positioning verification method	Optical and machine visionsystem (Rubicon)	Optical and machine visionsystem
Diaphragm over-travel	12 cm	0
Dimensions / Weight / Speeds
Head rotation	365 degrees	365 degrees
Head weight	420 kg	380 kg
Radiation head diameter	815 mm at the widest,694 mm at the narrowest	620 mm
Head to isocenter clearance	45 cm	45 cm
Head rotation speed for set-up	12°/s	12°/s
Head rotation speed for dynamicdelivery techniques	6°/s	6°/s
Leaf speed combined with the dynamicleaf guide	up to 6.5 cm/s	2.0 cm/sec
Leaf speed	up to 3.5 cm/s	2.0 cm/sec
Diaphragm speed	up to 9 cm/s	1.5 cm/s
Wedge
Integrated wedge size	Automatic 0-60°	Automatic 0-60°
Wedge field size	30 x 40 cm	30 x 40 cm
Physics Performance
Leaf position accuracy	1 mm at isocenter0.5 mm RMS*	± 1 mm
Leaf position repeatability	0.5 mm	0.5 mm
Average transmission through leaf bank	<0.375%	1.5%
Peak transmission through leaf bank	<0.5%	2.1%
X-radiation leakage in patient planeoutside collimator cone	<0.2% max, <0.1% avg.	<0.2% max; <0.1% avg.
X-radiation leakage outside patientplane	<0.5% (at 1 m)	<0.5%
Delivery techniques
Dynamic Delivery Capability, slidingwindow	yes	yes
Dynamic Delivery Capability, dynamicarc	yes	yes
Dynamic Delivery Capability, VMAT	yes	yes
Multiple island shielding	yes	yes
Offset field shaping	yes	yes

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measured using stripe test

information from official product data - the test method may not be equivalent

Information from official product data - the test standard not specified

Summary of non clinical performance testing

Testing in the form of module, integration and system level verification was performed to evaluate the performance and functionality of the new and existing features against the requirement specification.

Regression testing has been performed successfully to verify the integrity of any changes.

Validation of the system under clinically representative conditions has been performed by competent and professionally qualified personnel. Results from verification and validation testing demonstrate that conformance to applicable technical design specifications have been met and assured safety & effectiveness as been achieved.

Testing has been undertaken on production equivalent systems both at Elekta and at hospital sites.

The system is subject to compliance testing to voluntary consensus safety standards. Details of the standards employed in the design are specified in the Standard Data Report in section 9 which includes but not limited to IEC 60601-1, IEC 60601-2-1, IEC 60601-1-2, IEC 62304, IEC 62366 and ISO 14971.

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Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three overlapping, curved shapes resembling bird wings or stylized waves. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the perimeter of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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

Re: K121328

Trade/Device Name: Agility Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 30, 2012 Received: May 3, 2012

Trade/Device

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 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

JUN 1 2 2012

{4}------------------------------------------------

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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Indications for Use

510(k) Number (if known):

Device Name:

Agility

Indications for Use

Indications for Use: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.

The associated Integrity R3.0 software is the interface and control software for the Elekta medical digital linear accelerator and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumors), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions. delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)

Division of Radiologic Office of In Vitro Diagnostic Device Evaluati 510K

2012/04/14	Agility ™	Document 04 - 01
© 2012 Elekta Limited, Crawley, UK. All rights reserved.		Page 1 of 1

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.