The .decimal astroid Dosimetry App device is used for planning and analysis of proton radiation therapy treatments. The Dosimetry App serves as a tool which provides tested and validated calculation and design functions for use in other enduser applications. The Dosimetry App provides access to the functions that make up what is considered much of the core components of a typical proton treatment planning system. Through the use of these functions in user generated scripts or programs, users will be able to design and/or analyze proton treatment plans for regular fields using custom designed blocks and range compensators. Additionally, the functions provided by this device can also allow users to generate programs and scripts capable of performing treatment preparation and plan analysis tasks, such as structure/contour modification, image data analysis, and secondary dose calculation checks. Users should be experienced computer programmers, researchers, and physicists that contain a strong working knowledge of proton radiation therapy and general treatment planning processes.

Device Description

The .decimal Astroid Dosimetry App device is used for planning and analysis of proton radiation therapy treatments. The Dosimetry App device is not an interactive end user application. Users of the system will write scripts or fully interactive software programs that make calls to the functions provided by the Astroid Dosimetry App. In essence, this device serves a foundational proton dosimetry calculation library that greatly reduces the burden and time required to develop treatment planning and plan analysis software by making readily available much of the core functionality common to these types of applications. This core functionality includes various CT image processing tools, structure and contour modification operators, proton dose calculations, proton aperture and range compensator device design algorithms, and other low-level radiotherapy specific calculation functions.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the .decimal Astroid Dosimetry App:

Important Note: The provided document is a 510(k) premarket notification summary. This type of FDA filing focuses on demonstrating substantial equivalence to a predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials. Therefore, the information provided will reflect this focus on non-clinical testing and comparison.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative "acceptance criteria" in a typical pass/fail format with specific thresholds. Instead, it describes a validation approach aimed at demonstrating the device performs "as well as" predicate devices and is "safe and effective for clinical use" based on comparisons to experimental and analytical datasets.

Acceptance Criteria (Implied)	Reported Device Performance
Accuracy of Proton Dose Calculations:	Comparisons of proton dose calculations (including treatment delivery devices) to experimental and analytical datasets were performed. The device performed "as well as the predicate devices."
Accuracy of Patient-Specific Treatment Device Design:	Verification and validation tests were performed for all functions. This implies accuracy in designing patient-specific treatment devices (apertures, range compensators).
Accuracy of Proton Energy Range Estimation:	The device provides tools to calculate, analyze, and compare potential treatment plans, which would inherently include estimation of proton energy ranges. Performance was deemed "as well as" predicate devices.
Overall Functionality Performance:	"Additional verification and validation tests were also performed for all other functions available for external use through the system." The device was deemed "safe and effective for clinical use."

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

Sample Size for Test Set: Not explicitly stated as a number of patient cases or specific datasets. The testing involved "experimental and analytical datasets" and "clinically oriented validation test cases."
Data Provenance: Not explicitly stated. The document mentions "hospital-based testing partners" and "experimental and analytical datasets," suggesting a mix of simulated/laboratory data and potentially real-world clinical scenarios represented by the test cases. It does not provide country of origin or whether the data was retrospective or prospective.

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

Number of Experts: Not explicitly stated. The testing involved ".decimal personnel and hospital-based testing partners." While it doesn't specify a number, the involvement of "hospital-based testing partners" implies the use of clinical experts in the validation process.
Qualifications of Experts: Not explicitly stated. However, the target users of the app are described as "experienced computer programmers, researchers, and physicists that contain a strong working knowledge of proton radiation therapy and general treatment planning processes." It is reasonable to infer that the "hospital-based testing partners" would possess similar qualifications.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "clinically oriented validation test cases" were "written and executed by .decimal personnel and hospital-based testing partners," suggesting a collaborative or independent validation approach rather than a formal adjudication process for establishing ground truth from multiple expert readings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not performed as part of the development of this product." The focus was on non-clinical testing to demonstrate substantial equivalence. Therefore, there is no effect size reported for human readers improving with or without AI assistance. The device acts as a calculation library, not a direct AI assistant for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence, a standalone evaluation was performed. The device is described as a "foundational proton dosimetry calculation library" that provides "tested and validated calculation and design functions." The "Summary of Non-Clinical Testing" focuses on the performance of these functions against "experimental and analytical datasets" and "clinically oriented validation test cases." The device itself is not an interactive end-user application but rather a tool for developers to build upon, meaning its core functions are evaluated independently of human interaction in the context of the 510(k) submission.

7. The Type of Ground Truth Used

The ground truth used for testing appears to be based on:

Experimental data: Comparisons to "experimental... datasets." This would typically involve physical measurements in a laboratory or clinical setting.
Analytical data: Comparisons to "analytical datasets." This implies data derived from established physics models or theoretical calculations.
Clinically oriented validation test cases: These would likely represent scenarios with known outcomes or established correct calculations, potentially based on expert consensus or established treatment planning principles.

8. The Sample Size for the Training Set

The document is a 510(k) summary for a software library, not a machine learning model. It does not mention a training set because it's not describing a system that learns from data in a typical machine learning sense. It's a set of pre-defined calculation and design functions.

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

As stated above, this is not applicable as the device is not described as involving a machine learning component requiring a training set. The functions within the Astroid Dosimetry App are based on established scientific and clinical principles of proton radiation therapy, rather than being "trained" on data.

Summary

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

May 15, 2015

.decimal. Inc. % Kevin Erhart, Ph.D. Senior Engineer 121 Central Park Place SANFORD FL 32771

Re: K150547

Trade/Device Name: .decimal Astroid Dosimetry App Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: March 9, 2015 Received: March 11, 2015

Dear Dr. Erhart:

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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Indications for Use

510(k) Number (if known) K150547

Device Name Astroid Dosimetry App

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for ".decimal", a company that provides custom radiation therapy. The logo is in two colors, blue and gray. The text below the logo reads "The benchmark for custom radiation therapy."

Section 5 510(k) Summary

Section 807.87 (h) A 510(k) Summary as described in Section 807.92

Premarket Notification [510(k)] Summary as required by 21 CFR 807.92

Date summary was prepared:

February 25, 2015

Submitter's Name:

.decimal, Inc. 121 Central Park PL Sanford, Florida32771

Contact Person:

Kevin Erhart Senior Engineer Phone: 407-330-3300 407-322-7546 Fax: Email:kerhart@dotdecimal.com

Device Name:

Astroid Dosimetry App

Classification Name:

MUJ 21 CFR 892.5050 Medical charged-particle radiation therapy systems Class II

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Image /page/4/Picture/0 description: The image shows the logo for '.decimal', a company that provides custom radiation therapy. The logo is in a sans-serif font, with the 'd' in '.decimal' in blue and the rest of the word in gray. Below the logo is the tagline 'The benchmark for custom radiation therapy' in a smaller font.

Device Description:

Predicate Device(s):

Proton Vision 7.0 K002312 RayStation 3.5 K130617

Intended Use:

The intended use for the Astroid Dosimetry application is to aid software developers in accessing calculation functions necessary in developing, analyzing, and testing proton radiation therapy software programs and algorithms. This device serves a foundational proton dosimetry calculation library that greatly reduces the burden and time required to develop treatment planning and plan analysis software by making readily available much of the core functionality common to these types of applications. These core functions will allow users to perform image processing, proton dose calculation, proton device design, and other plan review and analysis tasks.

Indications for Use:

The .decimal Astroid Dosimetry App device is used for planning and analysis of proton radiation therapy treatments. The Dosimetry App serves as a tool which provides tested and validated calculation and design functions for use in other end-user applications. The Dosimetry App provides access to the functions that make up what is considered much of the core components of a typical proton treatment planning system. Through the use of these functions in user generated scripts or programs, users will be able to design and/or analyze proton treatment plans for regular and irregular fields using custom designed blocks and range compensators. Additionally, the functions provided by this device can also allow users to generate programs and scripts capable of performing treatment preparation and plan analysis tasks, such as structure/contour modification, image data analysis, and secondary dose calculation checks. Users should be experienced computer programmers, researchers, and physicists that contain a strong working knowledge of proton radiation therapy and general treatment planning processes.

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Image /page/5/Picture/0 description: The image shows the logo for "decimal", a company that provides custom radiation therapy. The word "decimal" is written in a sans-serif font, with the ".d" in blue and the rest of the word in gray. Below the logo is the tagline "The benchmark for custom radiation therapy".

Summary of Technological Characteristics:

The astroid Dosimetry App technology is substantially equivalent to both the listed predicate devices. The astroid Dosimetry App, ProtonVision 7.0, and RayStation 3.5 all provide tools to calculate, analyze, and otherwise compare potential treatment plans for proton radiation therapy courses. All three systems allow for estimation of proton energy ranges, design of patient-specific treatment devices, and provide proton dose calculations that rely on machine specific proton beam models. While the predicate devices do also include functionality for direct display of results, this does not detract from the point that the underlying functions contained within all three systems are substantially equivalent.

Summary of Non-Clinical Testing:

Clinical testing was not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Clinically oriented validation test cases were written and executed by .decimal personnel and hospital-based testing partners. Validation tests comparing results of proton dose calculations, with the inclusion of all applicable treatment delivery devices, to experimental and analytical datasets were performed. Additional verification and validation tests were also performed for all other functions available for external use through the system. These tests show that the astroid Dosimetry App performed as well as the predicate devices and that the astroid Dosimetry App is deemed safe and effective for clinical use.

Image /page/5/Picture/5 description: The image shows a stylized lowercase letter 'd' in a light gray or white color against a white background. The letter is composed of a small circle on the lower left and a larger, rounded shape with a vertical line extending upwards on the right. The overall effect is minimalist and clean, with the letter appearing almost translucent or faded into the background.

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.