(47 days)
The aycan mobile software program is used to display medical images for diagnosis from CT and MRI modalities only.
aycan mobile provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
This device is not to be used for mammography.
aycan mobile is an App for the Apple iPad. It can be used for receiving and visualization of medical images.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, where available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for the clinical studies. Instead, it generally states that the device "passed all testing criteria" and that radiologists "confirmed" its capability for diagnostic reading.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Nonclinical Testing | |
| Verification & Validation | All verification and validation activities performed by designated individuals demonstrated that the predetermined acceptance criteria were met. The system passed all testing criteria. |
| Display and Technical Aspects Tests | Extensive performance tests conducted regarding display and other technical aspects. Display tests leveraged capabilities regarding IEC 62563-1 and TG18 guideline. All tests had been passed successfully. |
| Clinical Testing | |
| Diagnostic Reading Capability | Series of studies performed by qualified radiologists reading different CT and MRI studies under different environmental lighting conditions. The capability of aycan mobile as a device for diagnostic reading – when used within the indications for use – was confirmed by the results of these studies. |
| Safety and Effectiveness | All radiologists came to the conclusion that the devices is safe and effective when used within its defined Intended Use, leading to the conclusion that aycan mobile is safe and effective when used as labeled. |
| Substantial Equivalence | The device was determined to be substantially equivalent to the predicate device (MOBILE MIM, K103785) based on the comparison of technological characteristics, intended use, and performance data. The reduction of functionality and modalities compared to the predicate device did not negatively affect safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "different CT and MRI studies," but does not specify the exact number of cases or images used in the clinical studies.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: "Qualified radiologists" performed the studies, but the exact number is not specified.
- Qualifications of Experts: They were "qualified radiologists." No further details on their experience (e.g., years of experience) are provided.
4. Adjudication Method for the Test Set
- The document implies that radiologists individually confirmed the diagnostic capability. There is no mention of a specific adjudication method like 2+1 or 3+1 consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- The document describes a clinical study where "qualified radiologists" read "different CT and MRI studies" using
aycan mobile. However, it does not describe an MRMC comparative effectiveness study that assesses human readers' improvement with AI vs. without AI assistance. The study described focuses on confirming the diagnostic capability and safety/effectiveness of theaycan mobiledevice itself.
6. Standalone (Algorithm Only) Performance
- The
aycan mobiledevice is described as an application for displaying medical images for diagnosis. It does not appear to be an AI algorithm in the traditional sense that performs automated detection or analysis. Therefore, a standalone (algorithm only) performance metric would not be applicable, as it's a viewing device used by a human for diagnosis.
7. Type of Ground Truth Used
- The ground truth for the clinical studies was based on the "conclusion" of "qualified radiologists" regarding the diagnostic capability, safety, and effectiveness of the device when reading CT and MRI studies. This suggests expert consensus/opinion as the basis for ground truth. There's no mention of pathology or outcomes data.
8. Sample Size for the Training Set
- Since
aycan mobileis a viewing and communication system and not an AI algorithm that requires training, there is no mention of a training set sample size.
9. How the Ground Truth for the Training Set Was Established
- As
aycan mobileis not an AI algorithm requiring a training set, this information is not applicable and therefore not provided in the document.
§ 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).