(77 days)
iTR2000 is a software communications tool intended to be used in the transportation, storage and retrieval of digital medical images for the purpose of off-site review.
iTR2000™ is a stand-alone software product which may be marketed as a software-only product, as well as for use in conjunction with standard PC hardware, off-the-shelf software or third-party teleradiology/PACS software. iTR2000™ provides short-term remote access to medical images by radiologists, referring physicians and other licensed professionals, utilizing a personal computer or workstation with internet access. Images are securely stored on a internet website for on-demand remote retrieval via the iTR2000™ software, or via a standard web browser without the use of propriety software. The iTR2000™ system employs the latest internet security techniques and meets all current federal medical communications standards including recent proposals from HCFA and HHS. iTR2000™ is primarily intended to allow the transmission, retrieval and review of images produced by imaging equipment otherwise not part of a digital Picture Archive and Communication System (PACS) network or legacy equipment not compatible with ACR/NEMA DICOM 3.0. Conventional film-based images can be optically digitized and stored in a standard image format, such as JPEG. iTR2000™ can also be configured to web-enable third-party DICOM-capable teleradiology/PACS systems in low-volume environments for remote or on-call activities. iTR2000™ is designed for use primarily with small-matrix imaging modalities, such as images produced by Computed Tomography (CT), Ultrasound (US), Magnetic Resonance Imaging (MRI), Nuclear Medicine (NM), digital flourography and digital angiography. The use of images produced by large-matrix imaging systems, such as digitized radiographic films and computed radiography or mammography. requires the use of digitization and viewing equipment which exceed the stated minimum requirements for the standard iTR2000™ system. iTR2000™ does not control the actual image-taking system (i.e. x-ray, MRI, ultrasound or scintography machines).
This document describes the iTR2000™ teleradiology software, its intended use, and its substantial equivalence to predicate devices, rather than a study proving the device meets specific performance acceptance criteria. The document is a 510(k) Summary, which is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly provided in this type of document.
Here's an analysis based on the provided text, addressing the points where information is available or noting its absence:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Safety: | |
| No patient contacting components | Device has no patient contacting components. |
| Does not impact quality of original acquired image data | Device does not impact the quality of the original acquired image data. |
| Utilizes standard data communications controls for error detection and correction | Standard data communications controls for error detection and correction are utilized. |
| Employs latest internet security techniques | Employs the latest internet security techniques and meets all current federal medical communications standards. |
| Substantial equivalence to predicate devices regarding safety | Concluded to be as safe as legally marketed predicate devices. |
| Effectiveness: | |
| Ability to transfer digital image files between personal computers | Primarily an image communications software program used to transfer digital image files between personal computers. |
| Functional for off-site review of medical images | Intended to be used for the transportation, storage and retrieval of digital medical images for the purpose of off-site review. |
| Compatibility with small-matrix imaging modalities (CT, US, MRI, NM, digital fluorography, angiography) | Designed for use primarily with small-matrix imaging modalities. |
| Image compression equivalent to predicate devices | Recommended JPEG image compression libraries and default compression settings are believed to be substantially equivalent to those in previously cleared products. |
| Substantial equivalence to predicate devices regarding efficacy | Concluded to be as effective as legally marketed predicate devices. |
| Functional testing of image transfer | Functional testing included the transfer of diagnostic imaging studies for over 1200 complete studies. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: "Functional testing including the transfer of diagnostic imaging studies for over 1200 complete studies." The document does not specify if these "studies" were used as a "test set" in a formal performance evaluation against predefined criteria or if this refers to internal development testing. It's likely the latter given the context of a 510(k) summary focused on substantial equivalence.
- Data Provenance: Not specified. It's almost certainly retrospective given the time period and nature of the product (software for image transfer). Country of origin is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable / Not Provided: The document does not describe a study involving expert-established ground truth for a test set to measure diagnostic accuracy or similar performance. The device is a communication tool, not a diagnostic algorithm. The "ground truth" for its function would be successful and accurate transfer of image data, which was likely evaluated through technical means rather than expert adjudication of clinical findings.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided: As no expert-established ground truth or clinical performance study is described for a test set, there is no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No: No MRMC study is described. The device is a teleradiology software for image transfer, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes (for its function as a communication tool): The "functional testing" involving the transfer of over 1200 studies represents a standalone evaluation of the software's core function: to transfer images. The criteria for this testing would have related to successful transmission, integrity of the data, and speed, not clinical diagnostic performance.
7. The Type of Ground Truth Used
- Technical Verification: For the described functional testing, the "ground truth" would have been the integrity and successful transmission of the digital image files. This would be verified through technical checks (e.g., checksums, visual comparison to original files, successful display) rather than clinical ground truth like pathology or outcomes data.
8. The Sample Size for the Training Set
- Not Applicable / Not Provided: This device is software for image communication and transfer, not a machine learning or AI algorithm that requires a training set in the typical sense. Functional testing (described above) would be more analogous to system validation.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Provided: As explained in point 8, there's no "training set" in the context of an AI/ML algorithm.
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.