(120 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, MRI, 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).
- Post-treatment dose calculation of permanent Yttrium-90 (Y90) microsphere implants.
MIM - Y90 Dosimetry is a feature of MIM SurePlan. It is designed for use in diagnostic imaging and oncology and operates on both Windows and Mac computer systems. MIM - Y90 Dosimetry extends the functionality of MIM 5.2 (BRACHY) (K103576) and MIM – Thin client (mobile) (K151913) software. The following functions have been added to allow dose calculations for patients undergoing a course of brachytherapy using permanent Yttrium-90 (Y90) microsphere implants:
- · Allows dose calculation on PET or SPECT images after administration of permanent Y90 microsphere implants with three available methods for dose calculation: Local Deposition Model. Local Deposition Model with scaling for known injected activity, and the Voxel S Value approach based on the schema in MIRD Pamphlet 17(1). All three methods are available for PET while only the Local Deposition Model with scaling for known injected activity is available for SPECT images that are not in Becquerel per milliliter (Bq/ml).
- · Allows user to decay correct imaqe back to the time of injection if needed,
- Allows correction of branching fraction and decay parameters to reflect the values for Y90 for cases where a PET scanner does not provide Y90 as a possible radioisotope and a substitute radioisotope was used for acquisition.
- · Should not be used to change a treatment plan after treatment has been delivered with Yttrium-90 (Y90) microsphere implants.
Here is an analysis of the provided FDA 510(k) summary for MIM - Y90 Dosimetry, focusing on the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria in a table format. However, it states the overall performance:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Functional Requirements | "In all cases, the software passed its performance requirements and met specifications." |
| "Furthermore, MIM Software Inc. has conducted performance and functional testing on the MIM - Y90 Dosimetry software. In all cases, the software passed its performance requirements and met specifications." | |
| Clinical Validation | "Validation testing with MIM - Y90 Dosimetry was performed by board certified clinicians." |
| "clinicians using MIM - Y90 Dosimetry performed validation in comparison to independently implemented, industry-standard solutions. It was demonstrated that MIM software, when used according to operating instructions, can be used safely and effectively." | |
| Substantial Equivalence | "MIM - Y90 Dosimetry is substantially equivalent to a combination of the predicate devices MM - Thin Client (mobile) (K151913), which was substantially equivalent to MIM 5.2 (BRACHY) (K103576), and OLINDA EXM (K033960)." |
| "MIM - Y90 Dosimetry extends the indications for use of MIM -Thin Client (mobile) (K151913) to include the post-treatment dose calculation and evaluation of permanent Yttrium-90 (Y90) microsphere implants. This functionality is also provided in the OLINDA software (see reference K033960)." |
2. Sample Size for Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "Validation testing with MIM - Y90 Dosimetry was performed by board certified clinicians."
3. Number of Experts and Qualifications for Ground Truth
The document mentions that "Validation testing with MIM - Y90 Dosimetry was performed by board certified clinicians." However, it does not specify the exact number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience").
4. Adjudication Method
The document does not mention any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that an MRMC comparative effectiveness study was done, nor does it report any effect size for human reader improvement with AI assistance. The validation focused on the software's performance and clinical comparison to existing solutions, not a direct human reader effectiveness study.
6. Standalone Performance (Algorithm Only)
Yes, a standalone performance evaluation (algorithm only) was implicitly done. The document states: "MIM Software Inc. has conducted performance and functional testing on the MIM - Y90 Dosimetry software. In all cases, the software passed its performance requirements and met specifications." This indicates testing of the software's inherent capabilities, which would include the algorithm's performance. The comparison to "independently implemented, industry-standard solutions" also points to standalone evaluation of the device's output.
7. Type of Ground Truth Used
The documentation primarily refers to the device's ability to perform "post-treatment dose calculation of permanent Yttrium-90 (Y90) microsphere implants" and its validation "in comparison to independently implemented, industry-standard solutions." This suggests the ground truth was based on:
- Calculated values from established, industry-standard dosimetry models/software (e.g., OLINDA EXM).
- Expert clinical assessment/validation performed by board-certified clinicians.
It does not specifically mention pathology, or outcomes data as direct ground truth for the dose calculation aspect, unlike some other medical device approvals.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size for the training set. Given that this device is for dose calculation based on established physical models and image processing, it's possible that a traditional "training set" in the machine learning sense might not be as directly applicable as for image interpretation AI, or if machine learning was used, that information is not disclosed here.
9. How Ground Truth for the Training Set Was Established
Since no training set information is provided, the method for establishing ground truth for a training set is also not described in this document.
§ 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).