· quality assurance of patient specific treatment delivery prior to the treatment in IMRT (including VMAT) and 4DRT (e.g. respiratory gating and tumour tracking).

· quality assurance of the radiation delivery system.

Device Description

The device consists out of matrices of semiconductors embedded in a phantom. These matrices are inserted into the radiation field of a medical linear accelerator. If radiation (from a radiotherapy treatment field) hits the semiconductors a signal is created and transferred to a computer where it is analysed and among others compared with the intended dose distribution.

AI/ML Overview

This document is a 510(k) premarket notification for the Delta4 Phantom+ device, which is an improved version of the predicate device, Delta4. The submission focuses on demonstrating substantial equivalence to the predicate, rather than an independent clinical study to establish acceptance criteria and performance against those criteria as would be typical for a device with a new clinical function or significant safety/performance changes.

Therefore, the information you're requesting regarding acceptance criteria and performance studies in the context of an AI device is not fully available or directly applicable from this specific document. This document describes a medical device used for Quality Assurance of patient-specific radiation treatment delivery in radiotherapy. It is not an AI/ML powered device in the context of diagnostic or predictive tasks.

However, I can extract the closest analogous information available from the document regarding performance comparison against its predicate device.

Here's a breakdown of what can be extracted based on your request, with caveats where the information isn't directly present or relevant to AI device assessment:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly define specific numerical acceptance criteria for performance beyond stating that the measurements "had very good correlation" with the predicate device. This is typical for a 510(k) submission where substantial equivalence to a legally marketed predicate is being demonstrated for a physical quality assurance device, rather than a novel diagnostic AI algorithm.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Equivalence or superiority to predicate device (Delta4) in safety, effectiveness, design, and performance for Quality Assurance of patient-specific radiation treatment delivery in IMRT (including VMAT) and 4DRT.	"The results [from pre-treatment verification measurements] were compared with each other and it was determined that the results had very good correlation." "The new device is superior or at least equivalent, in many cases identical with the predicate devices regarding safety, effectiveness, design and performance."
Wireless operation (battery-powered, Wi-Fi communication)	Achieved, improving convenience, setup speed, and safety (due to elimination of cable entangling risk).
Main Analysis Parameters (Dose Difference, Distance to agreement, Gamma index)	Same as predicate device.
Compliance with existing medical device standards (IEC 61010-1, IEC 60601-1-2)	Met.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated in terms of a specific number of cases or measurements. The document mentions "numerous treatment plans."
Data Provenance: Not specified (e.g., country of origin). The study involved "pre-treatment verification measurements." Given the manufacturer is Swedish, data may originate from European or other regions where the predicate device is used.
Retrospective or Prospective: Not explicitly stated, but "pre-treatment verification measurements" suggest they were likely conducted as part of internal testing or possibly in a clinical setting but not necessarily as a formal prospective clinical trial for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. For this type of physical quality assurance device, the "ground truth" and performance evaluation are typically based on physical measurement comparisons, not expert human interpretation for diagnostic tasks. The device itself is designed to measure physical radiation dose distributions. Performance is assessed against the expected dose distribution from the treatment plan and comparison with a known, validated device (the predicate).

4. Adjudication Method for the Test Set

Not Applicable. As the "ground truth" is not established by human experts in a diagnostic context, there is no expert adjudication method like 2+1 or 3+1. The comparison is between the new device's measurements and those of the predicate device, against expected dose distributions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document describes a physical measurement device for quality assurance in radiotherapy, not an AI diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or reported here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, analogous to standalone performance. The "performance" assessment described for the Delta4 Phantom+ is inherently standalone. The device measures dose distributions and compares them to intended distributions via its integrated software. The validation involved comparing these measurements against the predicate device. Human involvement would be in operating the device and interpreting its outputs, but the measurement and comparison itself is an algorithmic function of the device. The "very good correlation" indicates its standalone performance similarity to the predicate.

7. Type of Ground Truth Used

The "ground truth" for evaluating this device's performance is multi-faceted:
- Intended Dose Distribution: The theoretical dose distribution prescribed by the treatment planning system.
- Predicate Device Measurements: Measurements obtained from the legally marketed predicate device (Delta4), which is assumed to be accurate and provide a valid reference.

8. Sample Size for the Training Set

Not Applicable. This is a physical hardware and software device for measurements, not an AI/ML model that is "trained" on a dataset in the conventional sense. The device's algorithms are based on physics and signal processing principles.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. See point 8. No "training set" or "ground truth for training set" in the context of an AI/ML model is relevant to this device. Its operational principles are founded on established physics and engineering.

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

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

August 19, 2015

ScandiDos AB % Mr. Thomas Matzen Product Manager Dag Hammarskjölds väg 52A SE-75237 Uppsala SWEDEN

Re: K151180

Trade/Device Name: Delta" Phantom+ Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 22, 2015 Received: July 22, 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. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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D017 04 008 07

-001061

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K151180

Device Name Delta4 Phantom+

Indications for Use (Describe)

The intended use of the device is:

· quality assurance of patient specific treatment delivery prior to the treatment in IMRT (including VMAT) and 4DRT (e.g. 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		© ScandiDos AB
		This document may not be copied without the written consent of ScandiDos AB.
Document Title:			Confidential
FDA 510(k) - Summary - Delta4			Document ID:D017 04 010 02
Phantom+
Subject:	Delta4 Phantom+		Pagea-007_01_1(a-007_01_6)
Author:	Signature	Date
Thomas Matzen

D017 04 010 02 FDA 510(k) - Summary - Delta4 Phantom+.docx

Version	Comment	Author	Description
01.01	2015-04-27	Thomas Matzen	First Draft
01	Released	Thomas Matzen	No changes
02	Released	Thomas Matzen	Corrected Spelling mistake in IEC standardAdded non-clinical test comparison

APPLICANT 1

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 summary	2015-07-17
was prepared (yyyy-mm-dd)

2 DEVICE

Trade Name	Delta4 Phantom+
Common Name	Pre-treatment Verification System (for Quality Assurance)
Classification Name	Medical charged-particle radiation therapy system,§892.5050, Product code: IYE

3 PREDICATE DEVICE

Predicate Device	Delta4
Listing Number	D002954
510(k) Premarket submissionnumber	K052920

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Document Title:	Document ID:	Page
FDA 510(k) - Summary - Delta4 Phantom+	D017 04 010 02	a- 007_01_2(a-007_01_6)

DESCRIPTION 4

5 COMPARISON

5.1 General

The Delta Phantom+ dosimetry system is an improved version of its predicate device Delta4.

The most obvious improvement is that the Delta4 Phantom+ dosimetry system is wireless: no power cables, no trig cable and no data cables.

Otherwise the principal design is left unchanged.

Area	Delta4 (predicatedevice)	Delta4 Phantom+	Comment
IntendedUse	The intended use ofDelta4 isquality assurance ofpatient specific treatmentdelivery prior to thetreatment in IMRT and4DRT (respiratory gatingand tumor tracking).	The intended use ofthe device isquality assurance ofpatient specifictreatment deliveryprior to thetreatment in IMRT(including VMAT)and 4DRT (e.g.respiratory gatingand tumourtracking). quality assurance ofthe radiationdelivery system.	The intended usedefinitions are almostidentical. However, thetext had been changedslightly to easeunderstanding.VMAT is just a specialform of intensitymodulated treatmentand is by definitionincluded in "IMRT".However, sometimes"VMAT" is used as if itwas somethingdifferent. Forclarification VMAT isnamed in the intendeduse of Phantom+explicitly. pre treatment deliveryquality assuranceincludes qualityassurance of machineparameters. Forclarification QA of theradiation delivery systemis named explicitly in theintended use of.

5.2 Use context

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ScandiDos

Document Title:
FDA 510(k) - Summary - Delta4 Phantom+

Document ID:D017 04 010 02	Pagea- 007_01_3(a-007_01_6)
--------------------------------	-------------------------------------

Area	Delta4 (predicate device)	Delta4 Phantom+	Comment
Intended User	The intended user is a health care professional in the field of radiotherapy like a medical physicist or a dosimetrist who have been educated in the safe use of the device.	Same as predicate device	N/A

5.3 Energy

Area	Delta4 (predicatedevice)	Delta4 Phantom+	Comment
Powersupply	AC power socket	Battery powered.(Rechargeable) Batteryis embedded in device.	While the predicate devicemust be connected to the asocket-outlet is the Delta4Phantom+ dosimetrysystem battery powered.This makes it much moreconvenient to set up thedevice.
Energydelivered	No energy is delivered touser or patient	Same as predicatedevice	N/A

5.4 Performance, technology, materials

Area	Delta4 (predicate device)	Delta4 Phantom+	Comment
Operating principal	The device consists out of matrixes of semiconductors embedded in a phantom. These matrixes are inserted into the radiation field of a medical linear accelerator. If radiation (from a radiotherapy treatment field) hits the semiconductors a signal is created and transferred to a computer where it is analysed and among others compared with the intended dose distribution.	Same as predicate device	N/A
Detector technology	Semiconductors	Same as predicate device	N/A
Area	Delta4 (predicate device)	Delta4 Phantom+	Comment
Detector placement	Two 2D arrays; the arrays are mounted in a 3D phantom	Same as predicate device	N/A
Shape:DimensionsPhantom	Cylinder, 22x40cm	Same as predicate device	N/A
Dimension phantomincluding electronicshousings	Length: About 72cm Total height when in lowest position: about 36cm Center height when in lowest position: about 18cm	Length: About 71cm Total height when in lowest position: about 28cm Center height when in lowest position: about 15.5cm	Practically and from the safety and effectiveness point of view there is no difference between the devices regarding overall length. The new device has lower phantom supports. The new phantom supports do not block the longitudinal alignment laser at all. Therefore the set up and the alignment of the new device is more convenient, safer and more effective compared to the predicate device. The center height has been lowered by some centimeters in the new device. This increases the clearance between the linac and the treatment couch for beams from beneath the couch with reduced risk for collision between linac and couch - the set up of the new device is therefore safer, more convenient and more effective compared to the predicate device.
Weight	About 27kg	Same as predicate device	N/A
MainAnalysisparameters	Dose Difference Distance to agreement Gamma index	Same as predicate device	N/A

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Document Title:

FDA 510(k) - Summary - Delta4 Phantom+

Document ID:	D017 04 010 02
Page	a- 007_01_4 (a-007 01 6)

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Document Title:
FDA 510(k) - Summary - Delta4 Phantom+

Document ID:	Page
D017 04 010 02	a- 007_01_5
	(a-007_01_6)

5.5 Communication

Area	Delta4 (predicatedevice)	Delta4 Phantom+	Comment
Communicationsoftware ←→access point/router	Via an ethernet cableconnected the PC isconnected directly withthe access point/router.	Same as predicate device	N/A
CommunicationAccess point/router ←→measuringhardware	Via Ethernet cables.	Wi-Fi 802.11n	By eliminating theethernet cable to thehardware the risk forentangling (rotatinggantry) has beeneliminated. This makesthe usage both safer andalso more convenientand effective (set up ismuch faster).The communicationprotocol used is a widelyspread standard protocol(used in hospitals,homes, offices)guaranteeing a safe andeffective use of the newdevice.

5.6 (Safety) Standards met

Area	Delta4 (predicate device)	Delta4 Phantom+	Comment
Standards met	• IEC 61010-1• IEC 60601-1-2	Same as predicate device	N/A

5.7 Biocompatibility

Area	Delta4 (predicate device)	Delta4 Phantom+	Comment
General	Device is never in contact with patients	Same as predicate device	N/A
Compatibility of Phantom material	Good, see21CFR886.1385(PMMA)	Same as predicate device	N/A

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	© ScandiDos AB
Document Title:FDA 510(k) - Summary - Delta4 Phantom+		Document ID:D017 04 010 02	Pagea- 007_01_6(a-007_01_6)

5.8 Compatibility with the environment and other devices, safety (mechanical, chemical, physical, thermal, radiation)

Area	Delta4 (predicate device)	Delta4 Phantom+	Comment
General	Device fulfils the essential requirements as defined in the “Council Directive 93/42/EEC of 14 June 1993 concerning medical devices” (MDD)	Same as predicate device	N/A

5.9 Sterility

Area	Delta4 (predicate device)	Delta4 Phantom+	Comment
General	Device is not intended to be sterile	Same as predicate device	N/A

5.10 Comparison with predicate

Comparison tests have been performed with the predicate device in clinical and non-clinical situations.

Among others pre-treatment verification measurements of numerous treatment plans have been performed with both the new device and the predicate device. The results were compared with each other and it was determined that the results had very good correlation.

6 SUMMARY

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

Regulation Number and Section

N/A