MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) by ELEKTA ONCOLOGY SYSTEMS, LTD.

The EOS iViewGT™ Electronic Portal Imaging Device (EPID), as with the predicate iView, is intended to be used with radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

Device Description

The iViewGT™ EPID is an enhancement to the existing iView Electronic Portal Imaging Device which has previously been cleared for commercial distribution under D.C. K981790. These devices have an established and proven track record for safety. The primary reason for this modification to support solid state detectors for image acquisition. The iViewGTTM EPID does not raise additional types of safety or effectiveness considerations.

AI/ML Overview

The provided text is a K012289 Summary of Safety & Effectiveness for the Elekta Oncology Systems iViewGT™ Electronic Portal Imaging Device (EPID). This document primarily focuses on demonstrating that the iViewGT™ EPID is substantially equivalent to a previously cleared device (iView K981790) and meets relevant safety and quality standards.

Crucially, the provided text does NOT contain information about specific acceptance criteria or a study that rigorously proves the device meets such criteria in terms of analytical or clinical performance (e.g., accuracy, sensitivity, specificity).

The document highlights the device's adherence to quality management systems, safety standards, and its intended use as an enhancement to an existing, cleared device. It asserts that the iViewGT™ EPID "does not raise additional types of safety or effectiveness considerations" compared to its predicate. This implies that the 'acceptance criteria' in this context are primarily related to regulatory compliance, manufacturing quality, and substantial equivalence, rather than a clinical performance study with specific metrics.

Therefore, many of the requested sections about acceptance criteria and study details cannot be answered based solely on the provided text.

Here's an attempt to answer the questions based on the available information, noting where information is absent:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Device is an enhancement to a previously cleared device.	The iViewGT™ EPID is an enhancement to the existing iView Electronic Portal Imaging Device, which was previously cleared for commercial distribution under D.C. K981790.
Does not raise new types of safety or effectiveness concerns.	Elekta Oncology Systems has conducted hazard analysis and concluded that the iViewGT™ EPID does not introduce hazards that raise new types of safety or effectiveness considerations. "The iViewGT™ EPID does not raise additional types of safety or effectiveness considerations."
Compliance with international safety standards.	The iViewGT™ EPID is subject to compliance testing as defined in IEC 60601-1 and IEC 60601-2-1. Proprietary IT equipment is procured to IEC 60950 and/or UL 1950.
Compliance with European Directives (CE mark).	The iViewGT™ EPID is designed to bear the CE mark affirming compliance with all relevant European Directives in force, particularly the European Medical Device Directive and the European Electromagnetic Compatibility Directive.
Developed under an established Quality Management System.	The Elekta Oncology Systems Software Quality System has been established to satisfy ISO 9001, EN 46001, ISO 13485, Medical Device Directive 93/42/EEC Annex II, and US 21 CFR 820 GMP. The iViewGT™ EPID was developed using an established and documented Quality Management System. The Quality System is subject to periodic internal Quality Audits and regular, planned, and documented GMP audits by external auditors (SGS Yarsley and FDA).
Intended use aligns with predicate device.	"The EOS iViewGT™ Electronic Portal Imaging Device (EPID), as with the predicate iView, is intended to be used with radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner."
Documents provided for the user ensure safe and effective use.	"The accompanying documents provided for the user contain comprehensive information to ensure safe and effective use."
Substantial equivalence to predicate device.	The FDA determined the device is "substantially equivalent" to devices marketed in interstate commerce prior to May 28, 1976, or reclassified in accordance with the Act.

Regarding a "study that proves the device meets the acceptance criteria," the provided document does not describe a performance study with specific metrics for the iViewGT™ EPID's effectiveness. Instead, it relies on:

Substantial Equivalence: The primary assertion is that the iViewGT™ EPID is an "enhancement" to the already cleared iView (K981790) and "does not raise additional types of safety or effectiveness considerations."
Compliance with Standards: Adherence to established safety standards (IEC 60601-1, IEC 60601-2-1, IEC 60950, UL 1950) and quality management systems (ISO 9001, EN 46001, ISO 13485, Medical Device Directive 93/42/EEC Annex II, 21 CFR 820 GMP).
Hazard Analysis: A hazard analysis was conducted, concluding no new hazards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No information provided. The document does not describe a test set or data related to clinical or analytical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

No information provided. No test set or ground truth establishment is described.

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

No information provided. No test set or adjudication method 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

No information provided. The document does not describe an MRMC study, nor does it mention AI assistance. The device is an EPID, primarily for image acquisition, not an AI diagnostic tool.

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

Not applicable / No information provided. The iViewGT™ EPID is an image acquisition device for radiation therapy. Its "performance" would likely be in terms of image quality, detector sensitivity, and integration with the treatment system, rather than an algorithm performing a standalone diagnostic task. The document does not mention any standalone algorithmic performance evaluation.

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

Not applicable / No information provided. Since no performance study is described, there's no mention of a "ground truth" for clinical or analytical performance.

8. The sample size for the training set

No information provided. The document does not describe a training set. The device is not an AI/ML algorithm in the context of typical training/test sets.

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

Not applicable / No information provided. No training set or ground truth for it is mentioned.

Summary

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KO12289 SUMMARY OF SAFETY & EFFECTIVENESS

1. Elekta Oncology Systems is a registered medical device manufacturer of assessed capability against the requirements of ISO 9001. EN 46001. ISO 13485 and the Medical Device Directive 93/42/EEC Annex II.
1. In accordance with the above requirements all parts of the Quality System are subject to periodic and systematic internal Quality Audits. These audits are performed by trained personnel not having direct responsibilities in the functions being audited.
1. The quality system is subject to regular, planned and documented GMP audits conducted by external auditors from SGS Yarsley (UK Notified Body) and the FDA.
Elekta Oncology Systems has conducted hazard analysis on the 10) iViewGT™ EPID and has concluded that it does not introduce hazards that raise new types of safety or effectiveness considerations. After considering the Guidance for the Content of Pre-Market Nøtification Submissions of Medical Devices Containing Software EOS has concluded the level of concern appropriate to the device is "Higher".

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Vice President Research & Development

Signature ...

Director Product Management

Signature ..

Vice President Quality and Regulatory Affairs Manager

REF.: MO1RA011	N.C. 4513 341 2200Attachment No: 6
	Page 2 of 2	17/07/01
© 2001 Elekta Oncology Systems Ltd. All rights reserved
ELEKTA ONCOLOGY SYSTEMS LTD. CRAWLEY, UK

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SUMMARY OF SAFETY & EFFECTIVENESS

Elekta Oncology Systems Ltd hereby provide the following material summarising safety and effectiveness information for the Elekta Oncology Systems iViewGT™ Electronic Portal Imaging Device(EPID). This information is summarised as follows :-

The iViewGT™ EPID is an enhancement to the existing iView Electronic 1) Portal Imaging Device which has previously been cleared for commercial distribution under D.C. K981790. These devices have an established and proven track record for safety. The primary reason for this modification to support solid state detectors for image acquisition. The iViewGTTM EPID does not raise additional types of safety or effectiveness considerations.
It is our opinion that the iViewGT™ EPID does not have technological 2) characteristics that raise additional types of safety or effectiveness questions, and that we consider them an enhancement to the existing iView Electronic Portal Imaging Device.
The accompanying documents provided for the user contain 3) comprehensive information to ensure safe and effective use. Past experience with substantially equivalent predicate devices has shown our device to be safe and effective when used as directed by the accompanying documents provided for the user.
The iViewGT™ EPID is subject to compliance testing as defined in the 4) internationally recognised safety standards IEC 60601-1 and IEC 60601-2-1. As appropriate, proprietary information technology equipment is procured to the internationally recognised standards IEC 60950 and/or UL 1950.
The iViewGT™ EPID is designed to bear the CE mark affirming 5) compliance with all relevant European Directives in force, in particular the European Medical Device Directive and the European Electromagnetic Compatibility Directive. As a result of this products may be sold freely without restriction throughout the entire European Union.
Elekta Oncology Systems Software Quality System has been established to 6) satisfy the requirements of ISO 9001, EN 46001, ISO 13485, the Medical Device Directive 93/42/EEC Annex II and the US 21 CFR 820 GMP. Elekta Oncology Systems has developed the iViewGT™ EPID using an established and documented Quality Management System.

REF.: MO1RA011	Summary of Safety & Effectiveness Informationfor the Elekta Oncology Systems iViewGTTMElectronic Portal Imaging Device (EPID)	N.C. 4513 341 2200Attachment No: 6Page 1 of 217/07/01
© 2001 Elekta Oncology Systems Ltd. All rights reserved

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three birds in flight, arranged in a stacked formation. The birds are depicted with curved lines, giving them a sense of movement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Elekta Oncology Systems (EOS), Ltd. % Mr. Peter Stegagno Director, Regulatory Affairs & Quality Assurance Elekta Instruments, Inc. 3155 Northwoods Parkway NORCROSS GA 30071

Re: K012289

iView GT Electronic Portal Imaging Device Dated: July 19, 2001 Received: July 20, 2001 Regulatory Class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Mr. Stegagno:

We have reviewed your Section 510(k) notification of intent to market to the marketed above and we bave decemined the interstant We have reviewed your Section 310(K) notification of the connects on the devices maketed in interstate device is substantially equivalent (to the use success to receive) to to devices that have been been been commerce prior to May 28, 1976, in eliacinent uac or the Federal Food, Drug, and Cosmetic Act (Act.). You may, therefore, narke reclassified in acordance with the provisions of the Act. The general provisions of the Act indude requirements the device, subject to the general colludis provisions of the river seating and prohibitions against misbranding and adulteration.

AUG 1 4 2001

If your device is classified (see above) into either class II (grecial Controls) or class III (provaries Approval), it may be subjicon If your device is classified (see above) into entrely of the Coast on to for the Code of Feed in the Code of Feed Meeplations, to such additional controls. Existing major regulations areculiance with the Current Good Manufacturing
Title 21, Parts 800 to 895. A substantialiy equivalent determination Title 21, Parts 800 to 895. A substanted minutes and on included by incerc Central regulation (21 CFR Partice Practice requirements, as Set lotti in the Quality of the Manistration (FDA) will verify such assumptions. Failure 820) and that, through periodic QS inspection. In e rood and Drug Tournal publish further announcements.
to comply with the GMP regulation may result in regulatory action. I to comply with the GMP regulation may result inis response to your prematic notification submission does not
concerning your device in the Federal Register. Please not of th concerning your device in the Federal Register. Prease note for your possible of the Electronic Product affect any outgation , as other Federal laws or regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarker notification for your device ond This letter will allow you to begily marketed predicated in your 3 to (pressure 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 809.00 for in vitte If you desire specific advice for your device of (301) 502-4639. Additionally, for questions on the promotions on the promotion diagnosite devices), please contact the Office of Compliance at (301) 592-4639. Also, please not the regulation and advertising of your device, please contribution on Complance at (197) - noor personalistical integral discussion in the pumber entitled, "Misfranding by reterence notification" (216) in and Consumer Assistance at its toll-free number Act may be obtained from the DVVsloll of Sthan Mandrass http://www.da.gov/odrh/dsmaldsmamain.html.

Sincerely Yours

Percy Brogdon

Nancy C. rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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N.C. 4513 341 2200

K0/2289

510(k) Number (if known):

EOS iViewGT™ EPID

Device Name:

Indication for Use:

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

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Nancy Skogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012289

(Optional Format 1-2-96)

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.