RT DESKTOP by ELEKTA ONCOLOGY SYSTEMS, LTD.

The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

Device Description

The RT Desktop is an enhancement to the SL/SLi Interface (Javelin) which has previously been cleared for commercial distribution. This device has an established and proven track record for safety. The enhancement contains industry standard computer components to address the issue of component obsolescence currently associated with SL/SLi interface (Javelin). The RT Desktop does not raise additional types of safety or effectiveness considerations.

AI/ML Overview

The provided text is a premarket notification for the Elekta Oncology Systems RT Desktop, which is an enhancement to an existing device (SL/SLi Interface). The document focuses on demonstrating that the RT Desktop does not raise new safety or effectiveness concerns compared to its predicate device and complies with various quality and safety standards.

However, the document does NOT contain information regarding a specific study to prove the device's performance against acceptance criteria in the context of clinical efficacy or diagnostic accuracy, which would typically involve metrics like sensitivity, specificity, accuracy, or effect size for AI-assisted workflows.

The "Summary of Safety & Effectiveness" primarily asserts the device's safety and effectiveness through:

Comparison to a predicate device: Stating the RT Desktop is an enhancement to an already cleared device with a "proven track record for safety."
Compliance with industry standards: IEC 60601-1, IEC 60601-2-1, IEC 950, UL 1950, CE mark, ISO 9001, EN 46001, Medical Device Directive 93/42/EEC Annex II, and 21 CFR 820.
Hazard analysis: Concluding it "does not introduce hazards that raise new types of safety or effectiveness considerations."
Comprehensive user information: Ensuring safe and effective use.

Therefore, I cannot populate the requested table and answer the majority of the questions because the document does not describe a study involving performance metrics for a device that involves clinical outcomes or diagnostic tasks. It's a regulatory submission demonstrating substantial equivalence and safety compliance for a system enhancement, rather than a clinical performance study.

Here's what I can extract based on the provided text, highlighting the absence of the requested performance study details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from a performance study)	Reported Device Performance
Not specified by a performance study	Not specified by a performance study
Instead, the document focuses on:
- Substantial equivalence to predicate device	- Stated as an "enhancement" to a previously cleared and proven device (SL/SLi Interface/Javelin)
- Compliance with safety standards	- IEC 60601-1, IEC 60601-2-1, IEC 950, UL 1950, CE Mark, ISO 9001, EN 46001, 93/42/EEC Annex II, 21 CFR 820
- Hazard analysis	- Concluded "does not introduce hazards that raise new types of safety or effectiveness considerations."

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

Not applicable. The document does not describe a performance study with a test set.

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)

Not applicable. No ground truth establishment for a test set is described.

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

Not applicable. 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. The document does not describe an MRMC study or any AI component. The device is a user interface for linear accelerators.

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

Not applicable. The device described is a user interface, not a standalone algorithm.

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

Not applicable. No ground truth is mentioned in the context of a performance study.

8. The sample size for the training set

Not applicable. The document does not describe an AI/ML algorithm requiring a training set.

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

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

Conclusion:

The provided document is a regulatory submission for a device enhancement. It demonstrates safety and effectiveness through compliance with standards, comparison to a predicate device, and hazard analysis, rather than through a clinical performance study involving specific acceptance criteria, test sets, or ground truth. The questions posed are highly relevant for AI/ML-driven medical devices or devices where clinical performance metrics (like diagnostic accuracy) are directly being evaluated, which is not the case in this particular submission.

Summary

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NOV 2 1998

K982713

SUMMARY OF SAFETY & EFFECTIVENESS

Elekta Oncology Systems Ltd hereby provides the following material summarising safety and effectiveness information for the Elekta Oncology Systems RT Desktop. This information is summarised as follows:

1. The RT Desktop is an enhancement to the SL/SLi Interface (Javelin) which has previously been cleared for commercial distribution. This device has an established and proven track record for safety. The enhancement contains industry standard computer components to address the issue of component obsolescence currently associated with SL/SLi interface (Javelin). The RT Desktop does not raise additional types of safety or effectiveness considerations.
1. accompanying documents provided for the user contain The 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.
1. It is our opinion that the RT Desktop does not have technological characteristics that raise additional types of safety or effectiveness questions, and that we consider them an enhancement to the existing SL/SLi device.
1. The RT Desktop is subject to compliance testing as defined in the 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 950 and/or UL 1950.
The RT Desktop is designed to bear the CE mark affirming compliance ર) with all relevant European Directives in force, in particular the European Device Directive and the European Electromagnetic Medical Compatibility Directive. As a result of this, products may be sold freely without restriction throughout the entire European Union.
Elekta Oncology Systems is a registered medical device manufacturer of () assessed capability against the requirements of ISO 9001, EN 46001, and the Medical Device Directive 93/42/EEC Annex II.

REF: 804/PC52MAO8452
MO8QA039
Summary of Safety & Effectiveness Informationfor the Elekta Oncology Systems RT Desktop
N.C. 4513 364 5769Attachment No: 13
Page 1 of 2	28/07/98

ELEKTA ONCOLOGY SYSTEMS LTD, CRAWLEY. UK.

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Elekta Oncology Systems Quality System has been established to satisfy 7) the requirements of ISO 9001, EN 46001, the Medical Device Directive 93/42/EEC Annex II, and 21 CFR 820. Elekta Oncology Systems has developed the RT Desktop using an established and documented Quality Management System.
In accordance with the above requirements, all parts of the Quality 8) 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.
The Quality System is subject to regular, planned and documented ਰੇ ) quality system audits conducted by external auditors from SGS Yarsley (UK Notified Body) and the FDA.
Elekta Oncology Systems has conducted hazard analysis on the RT 10) Desktop 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 Notification Submissions of Medical Devices Containing Software EOS has concluded the level of concern appropriate to the device is "Higher".

Signature

P.A. Hart

Vice President Research & Development

Signature........................................

P.J. Gaccione

Vice President Field Support

Signature

C.R. Everett

Quality and Regulatory Affairs Manager

REF: 804/PC52MAO8452MO8QA039	N.C. 4513 364 5769Attachment No: 13
	Page 2 of 2	28/07/98
© 1998 Elekta Oncology Systems Ltd. All rights reserved
ELEKTA ONCOLOGY SYSTEMS LTD, CRAWLEY. UK.

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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings forming a human profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 1998 NOV

Paul L. Sumner Director, Regulatory Affairs & Quality Assurance Elekta Instruments, Inc. 8 Executive Park West Atlanta, GA 30329

Re:

K982713

EOS RT Desktop (RTD) System Dated: August 3, 1998 Received: August 4, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Mr. Sumner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitn diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdr/dsmardsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):	K982713
---------------------------	---------

EOS RT Desktop

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 _________________________________________________________________________________________________________________________________________________________

Skirid le. Sypor

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dey 510(k) Number

(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.