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MIM 5.2 software is intended for trained medical professionals including, but not limited to, radiologists, oncologists, physicians, medical technologists, dosimetrists and physicists.

MIM 5.2 is a medical image and information management system that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, as well as create, display and print reports from those images. The medical modalities of these medical imaging systems 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 5.2 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 5.2 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.

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 5.2 is a software package designed for use in diagnostic imaging and oncology. It is a stand-alone package which operates on both Windows and Mac computer systems. MIM 5.2 aids the efficiency of medical professionals by providing various tools for display, registration and fusion of medical images from multiple modalities, to quickly create, transform, and modify 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.

MIM 5.2 functions as a medical image and information management system intended to receive, transmit, store, retrieve, display, print and process digital medical images, as well as create, display and print reports from those images. MIM 5.2 is an expansion of MIM 4.1 (SEASTAR) software, which was granted marketing clearance to MIM Software Inc. (formerly MIMvista Corp.) on September 26, 2007 under 510(k) Accession Number 071964 with the following additional features and capabilities allowing it to become a general purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy using permanent implants of various radioisotopes:

• allows for structure contouring on a patient scan and specifying any implant vector for seed implant. MIM 5.2 will re-slice and display the scan orthogonal to the specified vector.
• allows for automatic generation of 3D display of patient data and contours.
• allows user to select an implant template from a template database. The template grid will be displayed upon patient scan. The user is able to align the template to the desired location.
• allows user to specify the type of seed from a seed database. The user is able to manually place seeds either at locations specified by a template grid or at arbitrary locations within the scan. Based on the type and location of the seeds, MIM 5.2 will update the dose volume in real time to reflect current dose coverage. MIM 5.2 allows the user to change isodose line settings.
• allows saving the treatment plan. The saved plan can be loaded for evaluation and modification.
• allows generation of seed planning report which contains information of template type, seed type, seed locations, needle configuration, screen captures, 3D displays, and re-slicing vector. The report can be exported as an electronic file (e.g. PDF or DICOM SR) and easily transferred to seed vendor.

The MIM Software Inc. 510(k) summary for MIM 5.2 (Brachy) states, "MIM Software Inc. has conducted performance and functional testing on the MIM 5.2 software. In all cases, the software passed its performance requirements and met specifications." However, the document does not explicitly present a table of acceptance criteria with reported device performance, nor does it describe a specific study that proves the device meets those criteria.

Instead, the submission relies on the concept of substantial equivalence to predicate devices (MIM 4.1 (SEASTAR), Brachyvision 6.0, and VariSeed 7.1). This means the manufacturer is asserting that their new device is as safe and effective as existing legally marketed devices, primarily by demonstrating that the new features and capabilities are similar to or extensions of those found in the predicate devices.

Given the information provided in the document, here's what can be inferred or explicitly stated regarding your questions, with the caveat that detailed study methodologies and results are absent:

1. A table of acceptance criteria and the reported device performance

   • Not provided within the document. The document generally states that "the software passed its performance requirements and met specifications," but it does not enumerate these specifications or present a comparative table.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not provided within the document. The document does not describe a "test set" in terms of patient data or image datasets used for a performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

   • Not provided within the document. There is no mention of experts or ground truth establishment for a specific test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not provided within the document. No information on adjudication is present.

5. 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

   • Not provided within the document. This type of study is not mentioned, nor is any AI component clearly highlighted in the sense of directly assisting human readers for a measured improvement. The software provides tools to aid medical professionals, but not necessarily in an "AI vs. without AI assistance" comparative effectiveness study format in this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not provided within the document. The device is described as a tool for medical professionals, implying human-in-the-loop use. No standalone algorithm-only performance is detailed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not provided within the document. Given the lack of a described performance study or test set, the type of ground truth is not specified.

8. The sample size for the training set

   • Not provided within the document. Information regarding a "training set" is not included because the submission does not detail the development or validation of a machine learning or AI model in the way implied by this question. The product is an "expansion" of existing software with added functionality.

9. How the ground truth for the training set was established

   • Not provided within the document. Similar to point 8, this information is not applicable given the content of this 510(k) summary.

Summary of available information regarding acceptance criteria and study:

The document states: "MIM Software Inc. has conducted performance and functional testing on the MIM 5.2 software. In all cases, the software passed its performance requirements and met specifications."

This statement indicates that internal testing was performed, and the software met unstated internal requirements. However, the 510(k) summary does not include the details of these tests, such as the specific acceptance criteria, methodology, datasets used, or the results of these tests beyond the general statement of compliance. The primary argument for clearance rests on its substantial equivalence to previously cleared predicate devices, rather than a detailed presentation of a specific clinical or performance study with quantified acceptance criteria.

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