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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 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, 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 PE7/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 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 device clinically, within the United States, the user should only use FDA approved radionly, 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 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 - Ablation is a standalone software application that allows for the planning and evaluation of ablation procedures. This is achieved by utilizing the following functionality:

• . Manual and automatic tools for normal structure, target region, and ablation zone segmentation
• lmage re-slicing and reorientation orthogonally to a user-defined angle to give a . "probe's-eye view" image for planning
• Manual and constraint-driven placement of virtual ablation devices on medical . imaging in order to visualize the ablation energy zones.
• . The calculation of the percentage of designated structures that are covered by each energy zone during planning, as well as a calculation of the final ablation zone coverage after the ablation has been performed
• Multimodality image registration, including rigid and deformable fusion, for the . comparison of images taken at different times during the ablation planning and treatment administration
  MIM - Ablation is run on a dedicated workstation in the hospital healthcare environment and can be used with an 3D DICOM image. The software can be used on image data for any patient demographic that is undergoing ablation treatment with devices validated for inclusion in MIM - Ablation.

The acceptance criteria and study proving MIM-Ablation meets these criteria are detailed below, based on the provided FDA 510(k) summary.

MIM-Ablation Acceptance Criteria and Performance Study

The MIM-Ablation software, as described in the 510(k) summary, demonstrates its efficacy and safety through specific performance testing. The core functionality validated is the accurate representation and calculation of "energy zones" (simulated ablation zones) based on manufacturer specifications of validated ablation devices within the software.

1. Table of Acceptance Criteria and Reported Device Performance

• Percent difference ranged from -3.75% to 1.53%, falling within the manufacturer tolerance. |
  | Image Resolution Independence | Volume of imported 3D energy zone objects in MIM is independent of image resolution (0.5mm, 1.0mm, 1.5mm). | Percent Difference in Volume:
• At 0.5 mm: -1.65% to 0.29%
• At 1.0 mm: -0.87% to -0.6%
• At 1.5 mm: -0.70% to 0.00%.
  This demonstrates consistency across various resolutions. |
  | Contour Resolution Independence | Dimensions of imported 3D energy zone objects in MIM match manufacturer specifications, independent of contour resolution. | Percent Difference in Dimensions:
• At 0.25 mm: -1.43% to -0.43%
• At 0.5 mm: -1.16% to 0.00%
• At 1.0 mm: -2.15% to -0.38%.
  This indicates independence from contour resolution. |
  | Image Modality Independence | Dimensions of 3D energy zone objects in MIM match manufacturer specifications across four image modalities. | Percent Difference in Dimensions:
• Ranged from 0.64% to 0.89%.
  This highlights the minimal effect of image modality on contour dimensions. |
  | Percent Coverage Calculation | Accuracy of "Percent Coverage" statistic (volume of structure covered by energy zone) with one or multiple ablation probes. | Percent Difference in Calculation:
• With one ablation probe: 0.00% to 1.57%
• With two ablation probes: 0.00% to 0.19%.
  This validates the accuracy of the coverage calculation feature. |
  | HIFU Energy Zone Dimensions | Dimensions of the unique HIFU energy zone (3cm and 4cm transducer treatment heights, overlap) match manufacturer specifications. | Percent Error in Measurements (MIM vs. SonoBlate):
• Ranged from 0.00% to 6.00%.
  These measurements fell within the manufacturer tolerance, verifying consistency in HIFU dimensions. |
  | Constraint-Driven Planning | Constraint-driven planning functionality places energy zones that adhere to user-set constraints, and indicates when planning is not possible. | Verified Functionality:
• The work verified that energy zones adhere to constraints and that an "unattainable plan" is indicated when a scenario is not possible, ensuring appropriate targeting and preventing impossible planning. |

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

The provided document does not specify the exact sample size for the test set in terms of an overall number of cases or images. Instead, the testing appears to be highly controlled and synthetic or semi-synthetic, focusing on the accuracy of internal calculations and representations based on input parameters (manufacturer specifications, different resolutions, different contour resolutions, multiple modalities, and various probe configurations).

• Data Provenance: The data provenance is primarily "internal" verification data, based on manufacturer specifications (user guides, marketing material) of the Varian V-Probes and SonaBlate HIFU system. This suggests a controlled environment, likely using simulated or canonical data derived from these specifications. The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective clinical data. Given the "verification and validation testing" language and the precise percentage differences, it points towards rigorous technical and performance testing rather than a clinical study on patient data.

3. Number of Experts and Qualifications for Ground Truth

The document does not describe the establishment of ground truth through expert consensus for the performance testing. The ground truth for the device's calculations and representations of ablation zones is explicitly stated as the manufacturer specifications of the validated ablation devices (Varian V-Probes and SonaBlate HIFU system). This is a technical ground truth rather than a clinical one from human experts evaluating medical images.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the ground truth is derived from manufacturer specifications rather than subjective expert interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The study described focuses on the device's technical performance in accurately representing and calculating energy zones, not on its impact on human reader performance or the improvement of human readers with AI assistance.

6. Standalone Performance (Algorithm Only)

The testing described is primarily focused on the standalone performance of the algorithm in generating and calculating energy zones based on defined inputs (manufacturer specifications, different image/contour resolutions, etc.). It verifies the internal consistency and accuracy of the software's representations independent of a human operator, beyond the initial input parameters.

7. Type of Ground Truth Used

The ground truth used for this study is manufacturer specifications (from user guides and marketing material) of the validated ablation devices. This serves as the engineering/technical ground truth against which the software's generated energy zone dimensions and volumes are compared.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of a machine learning model that learns from data. MIM-Ablation's functionality, as described, appears to be based on predefined models and algorithms derived from the physical specifications of ablation devices, rather than a data-driven machine learning approach requiring a training set. The descriptions point to a rule-based or model-based system.

9. How Ground Truth for the Training Set Was Established

As no training set (for machine learning) is implied, there is no mention of how ground truth for a training set was established. The "ground truth" for the device's functionality is the engineering specifications of the ablation devices, which were used to "generate models and import into MIM-Ablation."

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