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MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital 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 MM-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 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 interpretations. Images that are printed to film must be printed using a FDAapproved 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 - Symphony HDR Fusion extends the existing features and capabilities of MIM -Monte Carlo Dosimetry (K232862) by offering enhanced capabilities to better support the High Dose Rate (HDR) brachytherapy workflow. It is designed for use in medical imaging and operates on Windows, Mac, and Linux computer systems. The intended use and indications for use in MIM - Symphony HDR Fusion are unchanged from the predicate device MIM – Monte Carlo Dosimetry.

MIM – Symphony HDR Fusion is a standalone software application within the MIM software suite that uses the existing functionality of the predicate device, applied now in the context of a High Dose Rate (HDR) brachytherapy clinical workflow.

MIM – Symphony HDR Fusion leverages the foundational functionalities that were introduced in the predicate device to support Low Dose Rate (LDR) brachytherapy clinical workflows. These features are extended with necessary enhancements and optimizations to optimally support the HDR workflow. Specifically, the subject device MIM - Symphony HDR Fusion provides the following core processes:

• Reslicing and Predictive Fusion presents data to inform the user's placement of medical devices (in this case, brachytherapy applicators). MIM receives and displays 2D images from a Trans-rectal Ultrasound (TRUS) probe and overlays contours from the registered pre-op image volume. The user is able to modify the position of the TRUS probe in the patient in order to match the visible pre-op contours. The user may also manually adjust the registration using software tools.
• . Ultrasound Capture: MIM receives an image feed from an US machine and position information from a stepper that holds the TRUS probe. The 2D TRUS images are processed into 3D image volumes-enabling their registration, fusion display, and storage as DICOM objects.
• Catheter Digitization provides tools for the user to localize and define HDR . brachytherapy applicators (catheters) in medical images.
• Registration Chaining allows the user to transfer information (contours) from the pre-op image (typically MR) through to the final planning image (US or CT). This is achieved using existing rigid registration tools from the predicate device to sequentially register each new image to its immediate predecessor in the clinical workflow.
• Export Data: The end of the MIM Symphony HDR Fusion workflow is to export the final planning image and user-defined structures-including organs and brachytherapy applicator models—into DICOM files for use in third-party radiation therapy treatment planning systems. Structured reports may also be created.

Here's a breakdown of the acceptance criteria and study information for MIM - Symphony HDR Fusion, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify an exact numerical sample size for the test set. It mentions "each of the five core features" underwent testing.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Unspecified, but referred to as "trained medical professionals with extensive experience in HDR brachytherapy."
• Qualifications of Experts: "trained medical professionals with extensive experience in HDR brachytherapy."

4. Adjudication Method for the Test Set

• The document does not describe a specific adjudication method (e.g., 2+1, 3+1). It states that "external validation by trained medical professionals" was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study explicitly measuring the effect size of human readers improving with AI vs. without AI assistance was not reported. The validation involved external medical professionals, but it was to validate the software's functionality, not a comparative study on reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, the performance of the device's features was evaluated. The validation included "internal verification by MIM's own qualified testers" and "external validation by trained medical professionals." While the "external validation" implies human interaction for the final assessment of the software's utility in a workflow, the "internal verification" likely involved standalone testing of the algorithms comprising each feature. The description focuses on the software as a "tool to aid in evaluation," implying a human-in-the-loop context for clinical use, but the individual feature testing suggests standalone performance evaluation.

7. The Type of Ground Truth Used

• The document implies an expert consensus/determination based on the involvement of "trained medical professionals with extensive experience in HDR brachytherapy" for external validation. For internal verification, "MIM's own qualified testers" would have established the ground truth based on predefined specifications and expected outputs for each feature.

8. The Sample Size for the Training Set

• The document does not specify a sample size for a training set. This suggests that MIM - Symphony HDR Fusion is an extension of existing features from a predicate device (MIM - Monte Carlo Dosimetry) and leverages "foundational functionalities." The description focuses on verification and validation of the new and extended functionalities rather than the development of entirely new machine learning algorithms requiring a distinct training set.

9. How the Ground Truth for the Training Set Was Established

• As a training set is not explicitly mentioned, the method for establishing its ground truth is also not described.

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