(262 days)
MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MR, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications:
- Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects.
- Create, display, and print reports from medical images.
- Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning.
- Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction.
- Localization and definition of objects such as tumors and normal tissues in medical images.
- Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
- Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans.
- Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres).
- Calculating absorbed radiation dose as a result of administering a radionuclide.
- Assist with the planning and evaluation of ablation procedures by providing visualization and analysis, including energy zone visualization through the placement of virtual ablation devices validated for inclusion in MIM-Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success.
When using the device clinically, within the United States, the user should only use FDA approved radiopharmaceuticals. If used with unapproved ones, this device should only be used for research purposes.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using an FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.
MIM – Dose Analysis extends features of MIM – Ablation (K220256). It is designed for use in medical imaging and operates on both Windows and Mac computer systems. MIM - Dose Analysis is a standalone software application that provides:
- Calculation of Biologically Effective Dose (BED) and Equieffective Dose in specified fractions (e.g., EQD2)
- Evaluation of radiation dose on different image sets through the use of rigid and deformable registration objects
- Accumulation of doses
The provided text describes the regulatory clearance of "MIM - Dose Analysis" software. While it outlines the device's functionality and states that testing was performed, it does not provide explicit acceptance criteria in a quantitative table or the detailed study results needed to prove those criteria were met. Instead, it offers broad statements about the testing methodology and validation.
However, based on the provided text, we can infer the acceptance criteria and reconstruct what the study aimed to prove, along with the limited information available regarding the study itself.
Inferred Acceptance Criteria and Reported Device Performance
Given the nature of the device (calculating radiation dose and accumulating doses) and the statements in the "Testing and Performance Data" section, the acceptance criteria would revolve around the accuracy and consistency of these calculations.
Table 1: Inferred Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from text) | Reported Device Performance (as stated in text) |
|---|---|
| BED, EQD, and TCP Calculations: | |
| The calculated Biologically Effective Dose (BED), Equieffective Dose (EQD2), and Tumor Control Probability (TCP) by the MIM software must be accurate and fall within acceptable clinical limits when compared to manual calculations using standard equations referenced in literature. | |
| (Implicitly, this implies numerical agreement within a defined tolerance, though no specific tolerance is provided.) | "All test results yielded dose and TCP results within acceptable clinical limits when compared to manual calculations." (No specific numerical deviation or clinical limits are defined in the text.) |
| Dose Accumulation: | |
| The accumulated radiation dose calculated by the MIM software, especially when involving rigid and deformable registration objects across separate treatment timepoints and within physician-contoured anatomical structures, must be consistent and accurate when compared to manual dose accumulation calculations. | |
| (Implicitly, this implies numerical agreement within a defined tolerance for accumulated dose values within ROIs.) | "These test results showed consistent and accurate dose accumulation methods applied in MIM." (No specific numerical deviation or criteria for "consistent and accurate" are defined in the text.) |
| Overall Clinical Adequacy & Alignment: The software's performance must validate its adequacy for clinical use and demonstrate alignment with standardized equations found in literature and behavior of previously FDA-cleared software that performs similar functions (RaySearch RayStation 12A and Radformation ClearCheck). | "Altogether, the testing performed validates the adequacy of MIM - Dose Analysis for clinical use and verifies alignment between MIM software, standardized equations referenced in literature, and previously FDA-cleared softwares." (This is a high-level conclusion rather than specific performance metrics.) |
Study Details from the Provided Text:
Unfortunately, the provided document is a 510(k) summary for regulatory clearance and does not contain the extensive detail of a full clinical study report. Therefore, many of the requested details are not explicitly stated.
1. Sample sized used for the test set and the data provenance:
* Sample Size: Not specified. The text mentions "Several different applications of the standard Linear-Quadratic (LQ) BED Model were tested" and "radiation doses delivered at separate timepoints for each patient dataset." This implies a case-based testing approach, but the number of cases is not provided.
* Data Provenance: Not specified regarding country of origin or whether it was retrospective or prospective data. The use of "patient datasets" could imply retrospective patient data, but this is not explicitly stated.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not specified. The ground truth for BED, EQD, and TCP calculations was established by "manual calculations using the same equations referenced in literature." For dose accumulation, it was compared against "manual dose accumulation calculations" and involved "physician-contoured anatomical structures." This suggests expert involvement in contouring, but the number or qualifications of these physicians are not detailed.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable/Not specified. The testing described primarily compares algorithmic output against manual calculations or established formulas, not against a human reader's interpretation that would require adjudication.
4. 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 or comparative effectiveness study involving human readers is mentioned or described. The study focuses on the software's calculation accuracy in a standalone manner.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Yes, implicitly. The testing described ("BED, EQD, and TCP calculations implemented in MIM were compared against manual calculations" and "Accumulated dose was calculated in MIM... and these dose results were compared against manual dose accumulation calculations") is a standalone performance assessment of the algorithm against a defined ground truth (manual calculations/literature equations).
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Calculated Ground Truth / Standardized Equations: For BED, EQD, and TCP, the ground truth was derived from "manual calculations using the same equations referenced in literature."
* Manual Calculation/Physician Contours: For dose accumulation, the ground truth was derived from "manual dose accumulation calculations" applied to "physician-contoured anatomical structures of interest."
7. The sample size for the training set:
* Not specified. This document only describes verification and validation testing, not the training of a potential machine learning model. If this software does not contain machine learning components, then "training set" is not applicable. The text does not indicate the presence of AI/ML components beyond standard imaging processing and calculation functionalities.
8. How the ground truth for the training set was established:
* Not applicable, as a training set or its ground truth establishment are not mentioned for this device in the provided text.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).