Mobius3D software is used for quality assurance, treatment plan verification, and patient alignment and anatomy analysis in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Patient alignment and anatomy analysis is based on read-in treatment planning images (such as computed tomography) and read-in daily treatment images (such as registered cone beam computed tomography).

Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.

Device Description

Mobius3D is a software product used within a radiation therapy clinic for quality assurance and treatment plan verification. It is important to note that while Mobius3D operates in the field of radiation therapy, it is neither a radiation delivery device (e.g. a linear accelerator), nor is it a treatment planning system (TPS). Mobius3D cannot design or transmit instructions to a delivery device, nor does it control any other medical device. Mobius3D is an analysis tool meant solely for quality assurance (QA) purposes when used by trained medical professionals. Being a software-only QA tool, Mobius3D never comes into contact with patients.

Mobius3D performs dose calculation verifications for radiation treatment plans by doing an independent calculation of radiation dose. Radiation dose is initially calculated by a treatment planning system (TPS), which is a software tool that develops a detailed set of instructions (i.e. a plan) for another system (e.g. a linear accelerator) to deliver radiation to a patient. The dose calculation performed by Mobius3D uses a proprietary collapsed cone convolution superposition (CCCS) algorithm.

Mobius3D also performs dose delivery quality assurance for radiation treatment plans by using the measured data recorded in a linear accelerator's delivery log files to calculate a delivered dose. This is presented to the end user in a software component of Mobius3D called MobiusFX. The MobiusFX component is available to users through licensing as an add-on to the core Mobius3D software features.

Compared to the previously cleared Mobius3D v 1.3.2 (K140660), Mobius3D v 2.0.0 contains the additional intended use of performing quality assurance of a patient's alignment and anatomy analysis. This analysis is based on comparison of Cone Beam Computed Tomography (CBCT) images taken immediately before treatment to the images used for treatment planning, which are typically acquired using standard Computed Tomography (CT). This analysis is presented to the end user in an add-on software module within Mobius3D called CBCT Checks.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in a quantitative, measurable format (e.g., "sensitivity must be > X%", "accuracy must be > Y%"). Instead, it describes a functional evaluation.

Acceptance Criteria (Implied)	Reported Device Performance
Software Functionality	"Software development, verification, and validation have been carried out in accordance with FDA guidelines. The software was tested against the established Software Design Specifications and passed all required tests." (This indicates the software functions as designed according to internal specifications.)
Risk Mitigation	"A Risk Management Report was completed which identified and verified the mitigation of all required hazards." (Suggests potential risks identified during development were addressed.)
Patient Positioning/Anatomy Analysis (CBCT Module)	"The report demonstrates the Mobius3D CBCT module’s ability to notify users to a potential patient positioning or anatomical difference." (This is the primary functional performance claim for the new feature, indicating its ability to detect the specified differences.)

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

Sample Size: "anonymized data from 22 different patients over 163 different fractions"
Data Provenance: The document does not specify the country of origin. It states the data was "anonymized," implying it was real patient data, but it does not clarify if it was retrospective or prospective. Given it was "bench testing" and "anonymized data from 22 different patients over 163 different fractions," it is highly likely to be retrospective real-world patient data.

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

The document does not explicitly state how many experts were used or their qualifications for establishing ground truth in the "Mobius3D CBCT Module Evaluation" study. The study focuses on the module's ability to notify users of differences, not necessarily on the module's accuracy compared to expert consensus. Ground truth, in this context, might implicitly refer to the actual patient positioning/anatomical differences that the module was designed to detect, which would typically be evaluated by a medical physicist or radiation oncologist in a clinical setting, but this is not detailed.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method (e.g., 2+1, 3+1). The study's focus, as described, is on the module's ability to notify users of differences, rather than a comparison against an adjudicated "correct" answer for each case.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported in the provided text. The study described focuses on the standalone performance of the CBCT module ("ability to notify users") rather than comparing human readers with and without AI assistance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone study was done for the Mobius3D CBCT module. The "bench testing" described in "Mobius3D CBCT Module Evaluation - Patient Positioning / Anatomical Changes Bench Testing" evaluated the algorithm's performance in identifying potential patient positioning or anatomical differences without human interaction being part of the module's core evaluation. The report demonstrates the module's "ability to notify users," which indicates the algorithm itself is performing the detection and flagging.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for the CBCT module evaluation. However, based on the description ("ability to notify users to a potential patient positioning or anatomical difference"), the implied ground truth would be the actual presence of patient positioning shifts or anatomical changes between the planning CT and daily CBCTs. How this actual presence was definitively established is not detailed (e.g., an expert review of the images themselves, comparison to log files, etc.). It's likely an existing clinical assessment that the software is designed to emulate or flag.

8. Sample Size for the Training Set:

The document does not provide any information regarding the sample size used for the training set for Mobius3D or its CBCT module. It mentions the "proprietary collapsed cone convolution superposition (CCCS) algorithm" for dose calculation, which is a physics-based model, not typically "trained" on a dataset in the same way a machine learning algorithm is. For the CBCT module features, if any machine learning was used, the training data is not disclosed.

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

Since no information about a training set is provided, there is no information on how ground truth for a training set was established.

Summary

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

April 29, 2016

Mobius Medical Systems, LP % Mr. Stan Eshelman COO 5012 Tamarisk Street BELLAIRE TX 77401

Re: K153014 Trade/Device Name: Mobius3D Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 7, 2016 Received: April 8, 2016

Dear Mr. Eshelman:

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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Indications for Use

510(k) Number (if known)

K153014

Device Name Mobius3D

Indications for Use (Describe)

Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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5 510(K) Summary

5.1 510(K) Owner

Mobius Medical Systems, LP 5012 Tamarisk St Bellaire, TX 77401 Tel: (888) 263-8541 Fax: (888) 263-8541

5.2 Contact Person

Stan Eshelman

5.3 Preparation Date

April 7, 2016 (revised from original October 14, 2015 submission)

5.4 Trade Name

Mobius3D

5.5 Common Name

Secondary Check QA Software

5.6 CLASSIFICATION NAME

Accelerator, Linear, Medical 21 CFR 892.5050 Product Code - IYE

5.7 PREDICATE DEVICES

Primary Predicate:

o K140660 Mobius3D (Mobius Medical Systems, LP)
Secondary Predicates:
K090531 RadCalc Software (Lifeline Software, Inc.) o
K081076 VelocityAIS (Velocity Medical Solutions, LLC) o

5.8 Device Description

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when used by trained medical professionals. Being a software-only QA tool, Mobius3D never comes into contact with patients.

5.9 Intended Use

Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.

5.10 TECHNOLOGICAL CHARACTERISTICS SUMMARY

The principle technological characteristic of Mobius3D is to perform quality assurance evaluations on the radiation treatment planning system (TPS) and radiation delivery systems (e.g. linear accelerators). Mobius3D (v 2.0.0) adds the technical characteristic of performing comparative analysis between patient images acquired at different times using different image modalities.

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Detailed technological characteristics and indications for use presented within the full set of submitted documentation for this 510(k) application support the claim that Mobius3D is substantially equivalent to the predicate devices.

5.11 Testing Summary

Software development, verification, and validation have been carried out in accordance with FDA quidelines. The software was tested against the established Software Design Specifications and passed all required tests. A Risk Management Report was completed which identified and verified the mitigation of all required hazards.

In addition, bench testing was performed and is presented in a report titled: Mobius3D CBCT Module Evaluation - Patient Positioning / Anatomical Changes Bench Testing. The report was generated by performing a full suite of tests utilizing anonymized data from 22 different patients over 163 different fractions with varying treatment sites to validate each portion of the analysis. The report demonstrates the Mobius3D CBCT module's ability to notify users to a potential patient positioning or anatomical difference.

5.12Conclusions

Based on the evidence presented in this 510k submission, Mobius Medical Systems believes that Mobius3D is substantially equivalent to its predicate devices both in terms of its indications for use and its technical characteristics, and that Mobius3D is a safe and effective medical device for its intended users.

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.