(84 days)
The DiversiLabs Dose Volume Histogram (DVH) Evaluator is intended to aid with comparing radiation therapy treatment plans to applicable dose tolerance limits, and for recording followup patient response and symptoms.
The Dose Volume Histogram (DVH) Evaluator is a stand alone software application product for use on a personal computer.(PC) intended to aid with comparing radiation therapy treatment plans to applicable dose tolerance limits, and for recording followup patient response and symptoms.
The DVH Evaluator is intended for use by trained medical physicists, physicians, or dosimetrists. The results must be evaluated by qualified personnel before a patient treatment. It is the responsibility of the medical physicist, physician or dosimetrist to determine whether the displayed limits and dose is adequate for a particular patient.
The DVH Evaluator imports a file produced by a radiation TPS in the format of an industry standard Dicom-RT™ or vendor specific file. which contains information about a treatment. The file contains information related to the radiation dose volume for patient anatomical structures.
After importing the TPS information, DVH Evaluator allows the user to select dose tolerance limits and overlay them on the dose volume information. If the dose to any contoured critical anatomical structures exceeds any of the tolerance limits, warnings are displayed on the plots. This enables clinical users to conveniently and comprehensively compare treatment plans to the user- selected dose tolerance limits. The DVH Evaluator does not control any radiation delivery devices and does not allow the export of dose limit information.
The Followup Evaluator is an optional module of the DVH Evaluator which conveniently enables the user to record any response or symptoms that the patient experiences, either prior to or following treatment. This information is stored in the same database along with the DVH data for each patient for subsequent analysis. This enables convenient offline feedback to assess whether the dose tolerance limits are optimal for each clinic.
The DVH Evaluator is provided to the customer on a CD or downloaded from www.DiversiLabs.com. A PC is not provided with the product. The PC requires Microsoft Windows XP or Windows Server 2003 Operating System, a minimum of 500 MHz microprocessor speed, a minimum of 256 MB RAM and 1 GB available hard drive space. Display requirements include 1024 x 768 minimum resolution with 1280 x 1024 preferred.
Here's an analysis of the provided text regarding the acceptance criteria and study for the DiversiLabs Dose Volume Histogram (DVH) Evaluator:
Summary of Acceptance Criteria and Device Performance Study for the DiversiLabs Dose Volume Histogram (DVH) Evaluator
The provided 510(k) summary for the DiversiLabs Dose Volume Histogram (DVH) Evaluator focuses on establishing substantial equivalence to predicate devices through a design and development process that included software verification and validation. However, it does not contain explicit performance acceptance criteria or a detailed clinical study demonstrating the device's ability to meet them in the traditional sense of diagnostic accuracy metrics (e.g., sensitivity, specificity).
The device, being a software accessory for radiation therapy treatment planning systems, aims to aid in comparing treatment plans to dose tolerance limits and recording patient response. Its performance is evaluated primarily through software testing to ensure it functions as intended and accurately displays information.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Accuracy: Correctly import Dicom-RT or vendor-specific files containing dose volume information. | The DVH Evaluator "imports a file produced by a radiation TPS in the format of an industry standard Dicom-RT™ or vendor specific file." |
| Functional Accuracy: Accurately display user-selected dose tolerance limits overlaid on dose volume information. | "DVH Evaluator allows the user to select dose tolerance limits and overlay them on the dose volume information." |
| Functional Accuracy: Correctly identify and display warnings if dose to critical anatomical structures exceeds tolerance limits. | "If the dose to any contoured critical anatomical structures exceeds any of the tolerance limits, warnings are displayed on the plots. Simple numerical interpolation is used to determine if any of the specified limits are violated." |
| Functional Accuracy: Enable recording of patient response and symptoms in the optional Followup Evaluator module. | The "Followup Evaluator... enables the user to record any response or symptoms that the patient experiences... This information is stored in the same database along with the DVH data for each patient for subsequent analysis." |
| Software Reliability & Robustness: Compliance with predetermined specifications. | "Software for the DVH Evaluator was designed and developed according to a robust software development process, and was rigorously verified and validated. Test results indicated that the DVH Evaluator complies with its predetermined specification." (Specific metrics not provided) |
| System Compatibility: Operate on specified PC environment. | "The PC requires Microsoft Windows XP or Windows Server 2003 Operating System, a minimum of 500 MHz microprocessor speed, a minimum of 256 MB RAM and 1 GB available hard drive space. Display requirements include 1024 x 768 minimum resolution with 1280 x 1024 preferred." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data for evaluating diagnostic accuracy. The performance testing section mentions "Software Testing" but does not detail the nature or size of data used for verification and validation. It's implied that various radiation treatment plans (potentially synthetic or real, but not specified in terms of quantity or origin) were used to test the software's functionality.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. Since the device is a software tool for displaying and comparing data rather than making a diagnosis or independent clinical decision, the "ground truth" for its testing would primarily be the correct output given a specific input, verifying the algorithms and display. This would typically be established by software engineers and medical physicists ensuring the calculations and warnings are accurate according to established tolerance limits.
4. Adjudication Method for the Test Set
Not applicable. The document describes software verification and validation, not a study requiring adjudication of clinical outcomes or expert readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document does not describe any study involving human readers or comparing human performance with and without AI assistance. The device is an "aid" and its primary function is to present data, not to interpret it in a way that would replace human judgment or directly improve human reader performance in a controlled study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
Yes, implicitly. The "Software Testing" described is essentially a standalone evaluation of the algorithm's functionality and accuracy in generating plots and warnings based on input data and defined dose tolerance limits. The description states, "Test results indicated that the DVH Evaluator complies with its predetermined specification," implying evaluation of the software's outputs independent of human interpretation efficacy.
7. The Type of Ground Truth Used
For the software testing, the ground truth would be:
- Algorithmic Correctness: Verification that the software correctly imports DICOM-RT data, accurately applies user-selected dose tolerance limits, performs numerical interpolation correctly, and generates warnings when limits are violated, according to its design specifications.
- Display Accuracy: Verification that the graphical representations (DVH plots) and warnings are displayed accurately and as intended.
This is a technical ground truth based on the software's specifications and medical physics principles, rather than a clinical ground truth like pathology, expert consensus on images, or patient outcomes.
8. The Sample Size for the Training Set
Not applicable. This device is not described as a machine learning or AI-driven system that requires a "training set" in the conventional sense. It's an analytical software tool that applies predefined rules and calculations to input data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set (for machine learning) is mentioned. The "ground truth" for the software's development (its design specifications and correctness criteria) would have been established by the software development team, likely in consultation with medical physicists and clinicians, based on established medical physics principles and industry standards for dose evaluation.
§ 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.