quality assurance of patient specific treatment delivery during and before external radiotherapy treatment, including IMRT, VMAT and 4DRT (respiratory gating and tumour tracking)
quality assurance of the radiation delivery system.

Device Description

The device is an instrument specifically designed to check delivered treatment plans by medical accelerator systems used for radiation therapy applications for quality assurance (QA) purposes.

The device consists of a 2-dimensional matrix of semiconductors and associated acquisition, display and analysis computer programs. It is a quality assurance (QA) device enabling detailed mapping of therapeutic radiation dose distributions. This dose information is used in both quantitative and subjective assessments of the performance of radiation therapy treatment planning systems and therapeutic radiation delivery systems.

The detector matrix is inserted into the radiation field of a medical linear accelerator. If radiation (from a radiotherapy treatment field) hits the detectors a signal is created and transferred to a computer where it is evaluated (e.g. by comparing planned with measured dose distributions).

AI/ML Overview

The provided text does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, expert involvement, or sample sizes related to algorithms. The document is a 510(k) premarket notification summary for the "Delta4 Discover" and "Delta4 Discover+" devices, which are quality assurance (QA) tools for radiation therapy.

Here's an analysis of what is available in the text, and where specific requested information is missing:

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

Acceptance Criteria: Not explicitly stated in the document. The document mentions that "The new device is designed in full accordance with the applicable sections of the following standards: IEC 60601-1, IEC 60601-1-2", which are general safety and essential performance standards, not specific clinical performance acceptance criteria for its QA function.
Reported Device Performance: Not detailed in terms of specific metrics like accuracy, sensitivity, or specificity. The document broadly states, "The new device is superior or at least equivalent with the predicate devices regarding safety, design and performance." It does not provide any quantitative comparison or performance data to support this claim.

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

This information is not present in the provided text. No test set or data provenance is mentioned.

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)

This information is not present in the provided text. Given the device is a QA tool for radiation dose distributions, ground truth would likely refer to highly accurate dose measurements or calculations, not necessarily expert image interpretation. However, the exact methodology is not described.

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

This information is not present in the provided text.

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

This information is not present in the provided text. The device is described as a QA instrument for measuring radiation dose, not an AI-assisted diagnostic or interpretation tool for human readers. Therefore, an MRMC study related to human reading improvement with AI assistance would not be applicable or expected for this type of device.

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

The document implies standalone performance for the device in its role as a QA instrument, as it "enabling detailed mapping of therapeutic radiation dose distributions" and "evaluates (e.g. by comparing planned with measured dose distributions)." However, no specific study methodology for standalone performance is described, and no quantitative results are given.

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

The document does not explicitly state the type of ground truth used for any studies. For a radiation dose QA device, the "ground truth" for dose distributions would typically be based on highly accurate measurements from a reference dosimetry system or physics-based calculations.

8. The sample size for the training set

This information is not present in the provided text. The document does not mention a training set, as it describes a measurement device, not an AI/machine learning algorithm that would typically require a training set.

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

This information is not present in the provided text, as no training set is mentioned.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black.

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

January 29, 2016

ScandiDos AB % Mr. Thomas Matzen Product Manager Dag Hammarskjolds vag 52A Uppsala, SE-75237 Uppsala Lan SWEDEN

Re: K151426

Trade/Device Name: "Delta Discover, and "Delta" Discover+" Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: December 28, 2015 Received: December 28, 2015

Dear Mr. Matzen:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K151426

Device Name "Delta4 Discover" and "Delta4 Discover+"

Indications for Use (Describe)

The intended use of the device is

· quality assurance of patient specific treatment delivery during and before external radiotherapy treatment, including IMRT, VMAT and 4DRT (respiratory gating and tumour tracking)

· quality assurance of the radiation delivery system.

Type of Use (Select one or both, as applicable)	☒Prescription Use (Part 21 CFR 801 Subpart D) ☐Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

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ScandiDos

This document may not be copied without the written consent of ScandiDos AB.

Confidential

Document Title:	FDA 510(k) - Summary - Delta4 Discover	Document ID:	Page
Subject:	Delta4 Discover	D012 04 016 01	002_06_1 (002_06_2)
Author:	Signature	Date	Thomas Matzen

D012 04 016 01 FDA 510(k) - Summary - Delta4 Discover.docx

Version	Comment	Author	Description
01	Released	Thomas Matzen	First release

1 APPLICANT

510(k) owner's Name	ScandiDos AB
Street address	Dag Hammarskjölds väg 52A
Postal Code, City	SE-75237 Uppsala
Country	Sweden
Phone Number	+46-18-472 30 30
Fax Number	+46-18-10 74 02
Name of official correspondent	Thomas Matzen
Date the summarywas prepared (yyyy-mm-dd)	2015-05-20

2 DEVICE

Trade Name	"Delta4 Discover" and "Delta4 Discover+"
Common/Usual Name	QA device for verification of radiotherapy treatments andtreatment plans
Device Classification Name	Medical charged-particle radiation therapy system(§892.5050)
Product code	IYE

3 PREDICATE DEVICES

Predicate Devices	RegisteredEstablishment Number	510(k) Premarket submissionnumber
PTW DAVID IMRT QCverification system	9681124	K062817
IBA Compass	9614952	K072374

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	ScandiDos	© ScandiDos AB
Document Title:	FDA 510(k) - Summary - Delta4 Discover	Document ID:	Page
		D012 04 016 01	002_06_2(002 06 2)

4 DESCRIPTION OF THE DEVICE

The device is an instrument specifically designed to check delivered treatment plans by medical accelerator systems used for radiation therapy applications for quality assurance (QA) purposes.

5 INTENDED USE OF THE DEVICE

The intended use of the device is

o quality assurance of patient specific treatment delivery during and before external radiotherapy treatment, including IMRT, VMAT and 4DRT (respiratory gating and tumour tracking)
quality assurance of the radiation delivery system. .

6

SAFETY AND ESSENTIAL PERFORMANCE

The new device is designed in full accordance with the applicable sections of the following standards:

IEC 60601-1
. IEC 60601-1-2

7

TECHNOLOGICAL COMPARISON WITH THE PREDICATE DEVICES

All devices are intended for quality assurance of patient specific treatment delivery and quality assurance of the radiation delivery system.

Based on the technological characteristics, the intended use, safety and effectiveness, essential performance, performance the new device is substantially equivalent to the predicate devices.

The documentation submitted for review supports this claim.

8 SUMMARY

The new device is superior or at least equivalent with the predicate devices regarding safety, design and performance.

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.