The QuickPlan Treatment Planning System is indicated for use in planning radiotherapy treatments for patients with malignant or benign diseases. After image acquisition, QuickPlan supports the treatment planning process for external beam irradiation with photon, electron, and proton beams by predicting a plan.

The QuickPlan software does not provide full plan generation; it does not include final dose calculation, final beam geometry, nor does it enable plan approval. QuickPlan is not connected to any radiation emitting equipment. The QuickPlan software is intended for use by trained medical professionals to use in clinical settings. The QuickPlan software is compatible with Treatment Planning Systems that use the DICOM-RT format.

Device Description

The new QUICKPLAN Software manufactured by Siris Medical is an independent software solution to plan radiotherapy treatments for patients with malignant or benign diseases. It is used to plan external beam irradiation with photon, electron, and proton beams. The new QUICKPLAN Software is intended for trained medical professionals to use in clinical settings. The new QUICKPLAN software application includes three modules:

QuickMatch Matches a critical structure-set to the closest match within a database. It is a rapid file locator.
QuickPredict Predicts the dose to critical structures based upon models extracted from historical data looking through previous patient data.
QuickCompare - Provides dose estimates to critical structures with one or more alternative energy modalities, i.e. Photon vs. Proton.
The new QuickPlan software does not provide full plan generation; it does not include final dose calculation, final beam geometry, nor does it enable plan approval.

AI/ML Overview

The provided text does not contain the acceptance criteria or the details of a study demonstrating the device meets such criteria.

The document is a 510(k) premarket notification summary for the QuickPlan device, focusing on demonstrating substantial equivalence to a predicate device. It highlights the device's indications for use, technological features, and compliance with software standards, but does not present acceptance criteria or a study with performance metrics against those criteria.

Here's an breakdown of what information is missing based on your request:

A table of acceptance criteria and the reported device performance: This is entirely absent. The document mentions "performance bench testing" but does not provide any specific criteria or quantitative results.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set details are provided.
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 ground truth establishment details are provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: No adjudication method is mentioned.
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 MRMC study or human reader improvement data is presented.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states "No clinical testing has been performed in support of this QUICKPLAN software 510(k) submission," implying no standalone clinical performance evaluation was done. The bench testing performed would likely be considered standalone in a technical sense, but no performance metrics are given.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not specified.
The sample size for the training set: Not specified. The document mentions "models extracted from historical data looking through previous patient data" but does not provide the size of this historical dataset.
How the ground truth for the training set was established: Not specified.

In summary: The provided document is a regulatory submission focused on substantial equivalence based on design, intended use, technology, and compliance with general software and medical device standards, rather than a detailed performance study with quantifiable acceptance criteria. It explicitly states, "No clinical testing has been performed in support of this QUICKPLAN software 510(k) submission." Therefore, it does not contain the information required to answer your specific questions about acceptance criteria and a study proving those criteria are met.

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 representation of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in black and have a flowing, ribbon-like appearance. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

September 11, 2015

Siris Medical % Ms. Cynthia Pillar Consultant CJP Consulting, Inc. 5831 N Kostner Avenue CHICAGO IL 60646

Re: K151560

Trade/Device Name: QuickPlan Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: June 29, 2015 Received: July 1, 2015

Dear Ms. Pillar:

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

510(k) Number (if known) K151560

Device Name OuickPlan

Indications for Use (Describe)

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.

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

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Image /page/3/Picture/1 description: The image shows the logo for Siris Medical. The logo is blue and consists of the word "siris" in a sans-serif font, with the word "MEDICAL" in smaller letters underneath. To the right of the word "siris" is a cluster of blue dots arranged in a cross shape. The logo is simple and modern, and the blue color gives it a professional and trustworthy feel.

SECTION 5: TRADITIONAL 510(k) SUMMARY AS REQUIRED BY 21 CFR 807.92

Traditional 510(k) Summary

Date Prepared:	June 29, 2015
Submitter:	SIRIS MEDICAL257 Castro Street, Suite 224Mountain View, CA 94041Telephone: 1 (650) 394-5161
Contact:	Cynthia J. Pillar, RACPhone: 1 (773) 677-8886
Trade/ProprietaryName of Device:	QUICKPLAN (K151560)
Common Nameof Device:	Medical charged-particle radiation therapy system
Classification:	Class II per 21 CFR 892.5050, System, Planning, RadiationTherapy Treatment, Product Code MUJ
Legally MarketedPredicateDevice:	Eclipse Treatment Planning System manufactured by VarianMedical Systems Inc., K141283, Class II per 21 CFR892.5050, Medical charged-particle radiation therapysystem, Product Code MUJ

Description of New QUICKPLAN Device:

QuickMatch Matches a critical structure-set to the closest match within a ● database. It is a rapid file locator.
QuickPredict Predicts the dose to critical structures based upon models ● extracted from historical data looking through previous patient data.

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Image /page/4/Picture/1 description: The image shows the logo for Siris Medical. The logo is blue and consists of the word "siris" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font below it. To the right of the word "siris" is a plus sign made up of small circles.

. QuickCompare - Provides dose estimates to critical structures with one or more alternative energy modalities, i.e. Photon vs. Proton.
The new QuickPlan software does not provide full plan generation; it does not include final dose calculation, final beam geometry, nor does it enable plan approval.

As with the RapidPlan module of the predicate Eclipse Treatment Planning System by Varian Medical Systems, Inc. (K141283), the new QUICKPLAN software uses GHz microprocessor technology along with clinician guided learning and standardized structured data sets to vield knowledge-based planning. Specifically, knowledge-based planning is the result of using dose and anatomical information from previously treated patients to realize models that can accurately estimate deliverable treatment plans based on the type of external radiation source being utilized.

Historically, radiation treatment planning required a team of specialists working with planning software to deliver a prescribed dose of treatment to the tumor while minimizing the dose to surrounding organs referred to as 'organs at risk', or OARs. Coordination of the team of specialists resulted in a treatment planning process that typically spanned several hours over several days.

The treatment planning process typically involves the following steps:

1. Import of patient images
1. Creation of critical structures and tumor volumes
1. Definition of the 3D volume of the tumor
1. Definition of the 3D volume of the Organs at Risk
1. Establishment an estimate of the dose that is desired to the tumor
1. Establishment of a maximum threshold for the dose to each of the OARs
1. Generation of a plan beam geometry
1. Dose calculation
1. Plan approval
1. Quality Assurance activities

As with the predicate software, the new QuickPlan software involves the following steps:

1. Definition of the 3D volume of the tumor
1. Definition of the 3D volume of the OARs
1. Establishment an estimate of the dose that is desired to the tumor
1. Establishment of a maximum threshold for the dose to each of the OARs

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Image /page/5/Picture/1 description: The image shows the logo for Siris Medical. The word "siris" is written in large, bold, blue letters. Below that, the word "MEDICAL" is written in smaller, thinner, blue letters. To the right of the word "siris" is a blue plus sign made up of small circles.

Once these steps have been completed, a software program solves for the 4D positioning of the radiation beam for these constraints. This process can take anywhere from 20 - 40 minutes each iteration. If the specialists decide to change the target delivery volume by a few millimeters to determine the effect on the dose to the tumor and OARs, the treatment planning process must begin again.

The new QUICKPLAN software will enable the physician to see the implications of changing these treatment parameters without needing to involve the whole team. In addition, the new QUICKPLAN software eliminates the need to run the treatment planning optimizer again until the clinician is satisfied with the dose distribution. The new QUICKPLAN includes a manual contour editor that allows the clinician to augment or redact margins as they see fit, and provides nearinstantaneous insight as to how changes affect dose to critical structures, saving valuable time to treatment.

lt is important to note that the new QUICKPLAN software is intended as a tool for the clinician to use in planning radiotherapy treatments for patients. It is not connected to, nor does it control, any other devices. The new QUICKPLAN software does not deliver any energy or treatment to the patient. The new QuickPlan software also does not provide full plan generation; it does not include final dose calculation, final beam geometry, nor does it enable plan approval.

Indications for Use of the New QUICKPLAN Device:

The QuickPlan software does not provide full plan generation: it does not include final dose calculation, final beam geometry, nor does it enable plan approval. QuickPlan is not connected to any radiation emitting equipment. The QuickPlan Software is intended for use by trained medical professionals to use in clinical settings. The QuickPlan software is compatible with Treatment Planning Systems that use the DICOM-RT format.

Intended Use of the New QUICKPLAN Device

The QuickPlan Treatment Planning System is intended for use in planning radiotherapy treatments for patients with malignant or benign diseases.

After image acquisition, QuickPlan supports the treatment planning process for

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Image /page/6/Picture/1 description: The image shows the logo for Siris Medical. The word "Siris" is in a bold, sans-serif font, with a blue color. To the right of the word "Siris" is a cluster of blue circles arranged in a cross shape. Below the word "Siris" is the word "Medical" in a smaller, sans-serif font, also in blue.

external beam irradiation with photon, electron, and proton beams by predicting a plan.

The intended use of the new QUICKPLAN device and the predicate Eclipse RapidPlan module device are the same. Both devices are intended to plan radiotherapy treatments for patients with malignant or benign diseases. The new QUICKPLAN does not claim to include the additional indications of internal irradiation (brachytherapy) or treatment of neoplasms of the eye that are specifically stated in the predicate Varian Medical Systems - Eclipse (K141283) indications for use statement. This difference is not critical to the intended use of the new QUICKPLAN device for its indications, nor does it affect the safety and effectiveness of the device when used as labeled. In addition, the new QUICKPLAN software device performs only a subset of what a full Treatment Planning System (TPS) does. It functions outside of the full TPS by allowing the user to predict plans using DICOM-RT files imported from the full TPS. The risk to the user or patient is extremely low since the QUICKPLAN software does not control any external treatment delivery equipment. Once the QUICKPLAN treatment plan is predicted, the plan is uploaded into the full TPS for dose calculation, plan approval and quality assurance activities, which is identical to what the TPS-produced plans must go through when used without the new QUICKPLAN software.

Comparison of the Technological Features of the New Device and Predicate Device:

We believe that the new QUICKPLAN device has been shown to be substantially equivalent to the predicate Varian Medical Systems Eclipse Treatment Planning System RapidPlan module (K141283). The new and predicate devices are very similar in overall design and technology, principles of operation, and intended use. Main differences are as follows:

1. The new QUICKPLAN device is not a full treatment planning system (fTPS) and includes only treatment planning prediction, a subset of an fTPS process.
1. The new QUICKPLAN device limits its indications to patients with malignant and benign diseases. It does not include internal irradiation (brachytherapy) or treatment of neoplasms of the eye. It specifically excludes functions that the new QUICKPLAN does not provide to distinguish itself from an fTPS.

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Image /page/7/Picture/1 description: The image shows the logo for Siris Medical. The word "siris" is written in a bold, sans-serif font in blue. Below the word "siris" is the word "MEDICAL" in a smaller, sans-serif font, also in blue. To the right of the word "siris" is a blue symbol that resembles a plus sign made up of small circles.

1. The new QUICKPLAN device performs simultaneous dose prediction and contouring. The predicate Eclipse performs these steps of the process separately.
1. The new QUICKPLAN device uses Dose Indices to display predicted doses and the predicate device uses Dose Volume Histograms. .

The differences between the new QUICKPLAN device and the predicate Varian Eclipse Treatment Planning System RapidPlan module device do not raise any new questions of safety or effectiveness. Shown in TABLE 5.1 below are selected properties and characteristics of the new Siris Medical QUICKPLAN software and the predicate Varian Medical Systems Eclipse Treatment Planning System RapidPlan device (K141283) compared side-by-side.

DESCRIPTIVEINFORMATION	NEW QUICKPLANSOFTWARE	PREDICATE DEVICE:Varian EclipseTreatment PlanningSystem RapidPlanmodule (K141283)
Indications forUse	The QuickPlanTreatment PlanningSystem is indicated foruse in planningradiotherapy treatmentsfor patients withmalignant or benigndiseases. After imageacquisition, QuickPlansupports the treatmentplanning process forexternal beam irradiationwith photon, electron,and proton beams bypredicting a plan.The QuickPlan softwaredoes not provide fullplan generation; it doesnot include final dosecalculation, final beamgeometry, nor does itenable plan approval.	The Eclipse TreatmentPlanning System(Eclipse TPS) is used toplan radiotherapytreatments for patientswith malignant or benigndiseases. Eclipse TPSis used to plan externalbeam irradiation withphoton, electron, andproton beams, as well asfor internal irradiation(brachytherapy)treatments. In addition,the Eclipse Proton Eyealgorithm is specificallyindicated for planningproton treatment ofneoplasms of the eye.
	QuickPlan is notconnected to anyradiation emittingequipment. TheQuickPlan Software isintended for use bytrained medicalprofessionals to use inclinical settings. TheQuickPlan software iscompatible withTreatment PlanningSystems that use theDICOM-RT format.
Intended Use	The QuickPlanTreatment PlanningSystem is intended foruse in planningradiotherapy treatmentsfor patients withmalignant or benigndiseases.	Used to planradiotherapy treatmentsfor patients withmalignant or benigndiseases.
Product Code	MUJ	MUJ
Regulation
Number	892.5050	892.5050
Regulation Name	Medical charged-particle	Medical charged-particle
	radiation therapy system	radiation therapy system
Intended Users	Medical Professionals	Medical Professionals
Environment of
Use	Clinical Setting	Clinical Setting
Display	Computer, Web Browser	Computer, Web Browser
FEATURES	NEW QUICKPLANSOFTWAREAPPLICATION	PREDICATE DEVICE:Varian EclipseTreatment PlanningSystem RapidPlanmodule (K141283)
Full TreatmentPlanning System	No	Yes
Ability to importDICOM-RT	Yes	Yes
Structure	Yes	Yes
Identification
Dose Prediction	Yes	Yes
Contouring	Yes	Yes
SimultaneousDose Prediction& Contouring	Yes	No
Axial view	Yes	Yes
Zoomfunctionality	Yes	Yes
Panningfunctionality	Yes	Yes
Error in patientloadingdisplayed touser	Yes	Yes
Contour displayerrors displayedto the user	Yes	Yes
Display of dose	Dose Indices	Dose VolumeHistograms

Device Comparison Table 5.1

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Image /page/8/Picture/1 description: The image shows the logo for Siris Medical. The logo is blue and features the word "siris" in a bold, sans-serif font. To the right of the word "siris" is a cluster of blue dots arranged in a circular pattern. Below the word "siris" is the word "MEDICAL" in a smaller, sans-serif font.

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Image /page/9/Picture/1 description: The image shows the logo for Siris Medical. The logo is blue and features the word "siris" in a bold, sans-serif font. To the right of the word "siris" is a plus sign made up of small circles. Below the word "siris" is the word "MEDICAL" in a smaller, sans-serif font.

Device Comparison Table

Testing:

Non-Clinical Performance Data Testing:

Performance bench testing was conducted to verify that the new QUICKPLAN software device meets all design specifications and demonstrates substantial equivalence to its predicate, the Eclipse Treatment Planning System Rapid Plan module by Varian Medical Systems, Inc. (K141283). In addition, the new QUICKPLAN software device complies with the following standards:

IEC 62083 - Edition 2.0 - 2009-09 - Medical electrical equipment -Requirements for the safety of radiotherapy treatment planning systems
IEC 62366 Medical devices Application of usability engineering to ● medical devices

Biocompatibility:

Since the new QUICKPLAN software device is stand alone software, there are no patient contacting parts and therefore no biocompatibility testing has been performed.

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Image /page/10/Picture/1 description: The image shows the logo for Siris Medical. The word "Siris" is in a bold, sans-serif font, with the letters in blue. To the right of the word "Siris" is a graphic of a plus sign made up of blue circles. Below the word "Siris" is the word "Medical" in a smaller, sans-serif font, also in blue.

Software:

The new QUICKPLAN software has been validated and complies with the FDA Guidance for the content of Premarket Submission for Software Contained in Medical Devices as well as IEC 62304: 2006, Medical device software -Software life cycle processes.

Risk Analysis:

Risk management activities were performed throughout development of the new QUICKPLAN software device. Potential individual risks were identified, evaluated, and mitigated to the extent possible. Remaining overall residual risk was assessed and determined that any remaining risk is as low as possible and is outweighed by the benefits of the new QUICKPLAN software.

Clinical Performance Testing:

No clinical testing has been performed in support of this QUICKPLAN software 510(k) submission.

Conclusion:

The conclusions drawn from the specifications and performance testing of the new QUICKPLAN software device demonstrate that the new QUICKPLAN software device is at least as safe and as effective and performs as well as or better than the predicate the Eclipse Treatment Planning System Rapid Plan module by Varian Medical Systems, Inc. (K141283). For these reasons, we believe the new QUICKPLAN software device is substantially equivalent to the predicate device.

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.