(73 days)
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.
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.
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.
§ 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.