(89 days)
The Image Fusion and Review System is intended to register images geometrically in 3D and display sets of different types of medical images, such as, MCD, SPECT, PET, CT, and MRI, as composite images. It allows the operator to rotate, translate, and align images anatomically, and match the geometric position of the images relative to each other.
The Image Fusion and Review System is an image registration software that is applicable to planar or volumetric images acquired using MCD, SPECT, PET, CT, and MRI modalities. Different image modalities provide complementary information. For example, anatomical imaging modalities like CT and MRI show anatomical features with little regard to function, while functional imaging modalities, such as, MCD, SPECT, etc., show the physiology, blood flow or metabolism. As a result, functional information is difficult to derive from anatomical modalities and anatomical information is hard to identify in functional modalities. Thus, image registration provides a tool to combine information from different modalities to produce a new and more comprehensive image.
The provided text describes the ADAC Laboratories Image Fusion and Review System, a device for registering and displaying medical images from various modalities.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to combine information from different modalities. | Demonstrated that "information from different modalities could be combined to produce a new and more comprehensive image." |
| Quality of combined images similar to the predicate device. | "The quality of the images produced was similar to the quality of images produced by the predicate device." |
| Ability to register images geometrically in 3D. | Intended to "register images geometrically in 3D." (Implied successful demonstration by 510k clearance) |
| Ability to display composite images from multiple modalities. | Intended to "display sets of different types of medical images...as composite images." (Implied successful demonstration by 510k clearance) |
| Ability for operator to rotate, translate, and align images. | "It allows the operator to rotate, translate, and align images anatomically, and match the geometric position of the images relative to each other." (Implied successful demonstration by 510k clearance) |
| Display functions (checkerboard, dithered, splash) similar to predicate. | Utilizes "the same display algorithms, types of display and operating principle" as the predicate's display portion. |
| Operator interface consistent with Pegasys interface. | "The display systems differ only in the operator interface, which has been modified for Image Fusion and Review to be consistent with the Pegasys interface." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the test set. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). It simply states "A study was conducted."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set.
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. It focuses on the technical capability of image fusion and qualitative similarity to a predicate device.
6. Standalone Performance:
The study described is focused on the device's ability to combine and display images, which inherently describes its standalone functionality (algorithm only). The comparison to the predicate device also refers to the display systems and their operating principles, implying standalone performance evaluation for the fusion and display capabilities.
7. Type of Ground Truth Used:
The document implies a qualitative assessment of the "quality of the images produced" in comparison to a predicate device. This suggests that the ground truth was likely based on expert assessment or comparison to established clinical standards/predicate device performance, rather than pathology or outcomes data. However, the exact nature of this "quality" assessment is not detailed.
8. Sample Size for the Training Set:
The document does not provide information on a training set or its sample size. This device appears to be an image processing and display tool, not a machine learning model that typically requires a distinct training phase.
9. How Ground Truth for the Training Set Was Established:
As there is no mention of a training set, there is no information on how its ground truth might have been established.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.