Adaptivo is a stand-alone software product that provides comparative dose information about the daily and cumulative dose received by a radiotherapy patient relative to their treatment plan. It is to be used by a radiation oncology licensed medical professional as a guide to provide pre-treatment plan delivery verification; to monitor daily treatments and indicate potential clinically relevant deviations from the intended plan delivery: to provide estimates of daily and cumulative dose delivered to the patient, accounting for patient position and anatomy changes; and to aid in determining whether a patient plan should be altered partway through the course of treatment in order to meet the treatment planning goals. Adaptivo is not a primary treatment planning software, and cannot be used to generate radiotherapy treatment plans.

Device Description

Aurora Technology Development (ATD) Adaptivo is a stand-alone software product that provides comparative dose information about the daily and cumulative dose received by a radiotherapy patient relative to their treatment plan. It provides:
• pre-treatment plan delivery verification;
• the ability to monitor daily treatments and indicate potential clinically relevant deviations from the intended plan delivery;
• estimates of daily and cumulative dose delivered to the patient, accounting for patient position and anatomy changes; and
• an aid in determining whether a patient plan should be altered partway through the course of treatment in order to meet the treatment planning goals.
ATD Adaptivo is not a primary treatment planning software, and cannot be used to generate radiotherapy treatment plans.
ATD Adaptivo has two (2) primary software modules: (1) the Adaptive Dose Recalculation (ADR) module; and (2) the In-vivo Dosimetry (IVD) module. These two (2) modules integrate seamlessly to provide the user full benefit of ATD Adaptivo.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Adaptivo device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list acceptance criteria in a table format with corresponding reported performance values. Instead, it states that "Test results indicated that ATD Adaptivo complies with predetermined specifications and the applicable standard" and that "Verification and validation activities were conducted to establish the performance and safety characteristics of ATD Adaptivo. The results of these activities demonstrate that ATD Adaptivo is as safe, as effective, and performs as well as or better than the predicate device."

Therefore, I cannot populate a table with specific numerical acceptance criteria and reported performance metrics based on the given information. The document focuses on demonstrating substantial equivalence to predicate devices and adherence to general software development and medical device guidelines.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It broadly mentions "Test results indicated that ATD Adaptivo complies with predetermined specifications."

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

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No, the document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done.
Therefore, there is no effect size given for how much human readers improve with AI vs without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The document describes Adaptivo as a "stand-alone software product." The performance testing described (Bench testing and V&V activities) appears to evaluate the algorithm's performance based on internal specifications. While not explicitly using the term "standalone study," the nature of the software and testing suggests its performance was assessed independently. However, specific metrics of this standalone performance are not provided.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for testing. It refers to "predetermined specifications" and "internal specifications," implying that the device's output was compared against established baselines or expected results, but the nature of these ground truths (e.g., expert consensus, pathology, phantom measurements, etc.) is not detailed.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set.

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

The document does not explain how the ground truth for the training set was established, nor does it explicitly mention a training set, though it implies software development and validation, which often involve such stages.

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 features the department's name encircling a stylized emblem. The emblem consists of a caduceus-like symbol with three figures intertwined, representing health and human services. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

February 3, 2016

Aurora Technology Development, LLC % Mr. Thomas Kroenke Principal Consultant Speed To Market, Inc. Po Box 3018 NEDERLAND CO 80466

Re: K152994

Trade/Device Name: Adaptivo Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: December 29, 2015 Received: December 30, 2015

Dear Mr. Kroenke:

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/ResourcesforYou/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. O'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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4 Indications for Use

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Indications for Use

510(k) Number (if known): K152994

Device Name: Aurora Technology Development, LLC Adaptivo

Indications For Use: Adaptivo is a stand-alone software product that provides comparative dose information about the daily and cumulative dose received by a radiotherapy patient relative to their treatment plan. It is to be used by a radiation oncology licensed medical professional as a guide to provide pre-treatment plan delivery verification; to monitor daily treatments and indicate potential clinically relevant deviations from the intended plan delivery: to provide estimates of daily and cumulative dose delivered to the patient, accounting for patient position and anatomy changes; and to aid in determining whether a patient plan should be altered partway through the course of treatment in order to meet the treatment planning goals. Adaptivo is not a primary treatment planning software, and cannot be used to generate radiotherapy treatment plans.

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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 Center for Devices and Radiological Health (CDRH)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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5 510(k) Summary

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Submission Date:	12 October 2015
Submitter:	Aurora Technology Development, LLC555 D'Onofrio Drive, Suite 104Madison, WI 53719
Submitter Contact:	Mr. Gustavo H. OliveraAurora Technology Development, LLCPhone: +1 (608) 831-5419Fax: +1 (239) 768-5281Email: Gustavo.Olivera@21co.com
ApplicationCorrespondent:	Thomas KroenkeSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net303 956 4232
Manufacturing Site:	Aurora Technology Development, LLC555 D'Onofrio Drive, Suite 104Madison, WI 53719
Trade Name:	Aurora Technology Development, LLC Adaptivo
Common Name:	Quality Assurance Software for Patient Radiation Treatment
Classification Name:	Accelerator, Linear, Medical
ClassificationRegulation:	21 CFR §892.5050
Product Code:	IYE
SubstantiallyEquivalent Devices:	New ATD Model	Predicate510(k) Number	PredicateManufacturer / Model
	ATD Adaptivo	K141800	Sun Nuclear Corporation Model1215 PerFRACTION
		K132605	Math Resolutions DosimetryCheck v4.1

K140660 Mobius Medical Systems Mobius3D

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Device Description:	Aurora Technology Development (ATD) Adaptivo is a stand-alonesoftware product that provides comparative dose information about thedaily and cumulative dose received by a radiotherapy patient relative totheir treatment plan. It provides:
	• pre-treatment plan delivery verification;
	• the ability to monitor daily treatments and indicate potentialclinically relevant deviations from the intended plan delivery;
	• estimates of daily and cumulative dose delivered to the patient,accounting for patient position and anatomy changes; and
	• an aid in determining whether a patient plan should be alteredpartway through the course of treatment in order to meet thetreatment planning goals.
	ATD Adaptivo is not a primary treatment planning software, andcannot be used to generate radiotherapy treatment plans.
	ATD Adaptivo has two (2) primary software modules: (1) the AdaptiveDose Recalculation (ADR) module; and (2) the In-vivo Dosimetry(IVD) module. These two (2) modules integrate seamlessly to providethe user full benefit of ATD Adaptivo.
Intended Use:	Adaptivo is a stand-alone software product that provides comparativedose information about the daily and cumulative dose received by aradiotherapy patient relative to their treatment plan. It is to be used by aradiation oncology licensed medical professional as a guide to providepre-treatment plan delivery verification; to monitor daily treatmentsand indicate potential clinically relevant deviations from the intendedplan delivery; to provide estimates of daily and cumulative dosedelivered to the patient, accounting for patient position and anatomychanges; and to aid in determining whether a patient plan should bealtered partway through the course of treatment in order to meet thetreatment planning goals. Adaptivo is not a primary treatment planningsoftware and cannot be used to generate radiotherapy treatment plans

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Technology Comparison:

ATD Adaptivo employs the same technological characteristics as the predicate device.

Characteristic	Sun NuclearPerFraction(K141800)	MathResolutionDosimetryCheck(K132605)	Mobius MedicalSystemsMobius3D plusFX(K140660)	ATD Adaptivo
Patient datainput	Automatic	Manual	Manual	Manual orautomaticretrieval fromARIA system
Workflow oncepatient dataare received	Automatic	Manual	Automatic	Automatic
Pre-treatmentpatient specificQA	Yes	Yes	Yes	Yes
During-treatmentdeliverymonitoring	Yes	No	Yes	Yes
Patient setuperror detection	Yes	Yes	No	Yes
Interactiveview of dosedistribution oncomplete CTimage set	No	Yes	Yes	Yes
Comparisonbetween planand daily dose	Partial (plan CTonly)	No	Partial (plan CTonly)	Yes
Comparisonbetween planand cumulativedose	No	No	No	Yes

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Summary of Performance Testing:

Software	ATD Adaptivo contains MODERATE level of concern software.Software was designed and developed according to a robust softwaredevelopment process, and was rigorously verified and validated.Software information is provided in accordance with
	• FDA guidance: The content of premarket submissions for softwarecontained in medical devices, 11 May 05;
	• FDA guidance: Off-the-shelf software use in medical devices, 09 Sep99;
	• FDA guidance: General principles of software validation; Finalguidance for industry and FDA staff, 11 Jan 02;
	• FDA guidance: Content of Premarket Submissions for Management ofCybersecurity in Medical Devices, 02 Oct 14; and
	• IEC 62304: 2006, Medical device software – Software life cycleprocesses.
	Test results indicated that ATD Adaptivo complies with predeterminedspecifications and the applicable standard.
Performance Testing– Bench	ATD Adaptivo was tested in accordance with internal specifications.
	Test results indicated that ATD Adaptivo complies with predeterminedspecifications.
Conclusion	Verification and validation activities were conducted to establish theperformance and safety characteristics of ATD Adaptivo. The results ofthese activities demonstrate that ATD Adaptivo is as safe, as effective,and performs as well as or better than the predicate device.
	Therefore, ATD Adaptivo is considered substantially equivalent to thepredicate device.

Regulation Number and Section

N/A