(28 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).
· Calculating absorbed radiation dose as a result of administering a radionuclide.
When using device clinically, the user should only use FDA approved radiopharmaceuticals. If using 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 interretations. Images that are printed to film must be printed using a FDA-approved printer for the diagital 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 on Linux is a standalone medical device software application that provides the same functionality of previous MIM predicates. MIM software was originally designed for use on both Windows and Mac computer systems. For this Special 510(k) submission, MIM has the capability to run on Linux-based operating systems. The rationale to allow MIM to run on Linux based workstations is to provide more flexibility and workstation options for end users.
Indications for use have not been modified. The intended use is the same as last 510(k) clearance for MIM software (K182624).
MIM on Linux utilizes the same technological characteristics that are included in past predicates, therefore, no engineering drawings, schematics, etc. are not applicable to the device.
The provided document is a 510(k) premarket notification for "MIM on Linux," a medical imaging software. It primarily focuses on demonstrating substantial equivalence to previously cleared MIM software versions. However, it does not contain the detailed performance study information typically found when a novel device or a device with new functionality requires rigorous validation against acceptance criteria.
Specifically, the document states: "MIM on Linux utilizes the same technological characteristics that are included in past predicates, therefore, no engineering drawings, schematics, etc. are not applicable to the device." and "MIM Software Inc. conducted functional testing as a means of verification and validation on MIM software running on a Linux-based operating system workstation. The Linux distribution used was specifically Ubuntu 18.04. Functional testing was identical to that which is done with all major releases of MIM software running on Windows and Mac operating systems workstations. In all cases, MIM on Linux passed its performance requirements and met specifications."
This indicates that the submission relies on the established performance of the predicate devices and functional testing to confirm that the software operates correctly on a new operating system (Linux) without altering its core functionality or indications for use. Therefore, the requested information regarding specific acceptance criteria, test set sizes, ground truth establishment, expert adjudication, or MRMC studies is not present in this document because such detailed clinical performance studies were likely not required for this type of 510(k) submission (a Special 510(k) for a platform change).
Based on the provided text, I cannot extract the level of detail requested for a comprehensive performance study description. The document focuses on showing that the port of the existing software to Linux does not introduce new safety or effectiveness concerns, rather than new clinical performance validation.
Here's a breakdown of what can be inferred or what is explicitly stated, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for clinical tasks (e.g., sensitivity, specificity, accuracy). The acceptance criterion appears to be "passed its performance requirements and met specifications" in functional testing.
- Reported Device Performance: "In all cases, MIM on Linux passed its performance requirements and met specifications."
- This is a general statement about functional integrity on the new OS, not detailed clinical performance data (e.g., no AUC, sensitivity, specificity, or clinically relevant error rates are provided).
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document mentions "functional testing" but does not quantify the number of images, cases, or specific tests performed.
- Data Provenance: Not specified. It only states that functional testing was "identical to that which is done with all major releases of MIM software running on Windows and Mac operating systems workstations." This implies a set of internal test data, but details are absent. The images used for functional testing are not described (e.g., real patient data, synthetic data, specific modalities).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable/Not Specified: Given the nature of the submission (porting to a new OS), the focus was on functional equivalency, not new clinical performance validation requiring expert-derived ground truth.
4. Adjudication Method for the Test Set:
- Not Applicable/Not Specified: No mention of expert adjudication as this was functional, not clinical performance testing.
5. MRMC Comparative Effectiveness Study:
- No: The document does not describe any MRMC study. It focuses on the software's functional performance on a new operating system, not its impact on human reader performance.
6. Standalone (Algorithm Only) Performance:
- Not explicitly detailed as a separate study: The software itself is a standalone application, but the "performance data" section describes functional testing (i.e., software functions correctly) rather than a standalone clinical performance study with specific metrics (e.g., sensitivity/specificity of an automated detection algorithm). The device's primary function is as a PACS/post-processing tool aiding human users.
7. Type of Ground Truth Used:
- Not Applicable/Not Specified: No clinical ground truth (e.g., expert consensus, pathology, outcome data) is mentioned for the "functional testing."
8. Sample Size for the Training Set:
- Not Applicable/Not Specified: This document describes a software port and its validation (functional testing), not an AI/ML model development. Therefore, there's no "training set" in the machine learning sense.
9. How Ground Truth for Training Set was Established:
- Not Applicable/Not Specified: As there's no mention of a traditional training set for an AI/ML model, this information is not relevant to the provided text.
In summary: The provided FDA 510(k) clearance letter and summary concern a regulatory submission for moving existing, cleared medical imaging software (MIM) to a new operating system (Linux). This type of submission relies on demonstrating that the core functionality and safety/effectiveness are preserved, not on conducting new clinical performance studies with detailed acceptance criteria, gold standards, or expert reviews as would be typical for a novel AI/driven diagnostic device.
§ 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).