(69 days)
The Remotelmage™ System is indicated to be used for remote viewing of medical image data.
Remotelmage is a client-server software system designed to allow access to medical images by licensed medical professionals. This product is intended to allow the review of images from a modality of digital imaging systems (including the Vidar (K933632) film digitizer, a digital camera, a radiography system (PACS) or other modality) using a personal computer for standard Internet access. Remotelmage software is installed on a computer configured with connections to a mode of digital imaging and the internet. Once images are obtained, the Remotelmage™ software converts the images from their original format to JPEG format and transmits them over 128 bit SSL encryption to an Internet server where they are stored for a specified period of time. Authorized medical personnel, upon password authentication, may download the images over 128 bit SSL encryption for viewing. The software program is written in C and is approximately 1 megabyte in size.
Here's a breakdown of the acceptance criteria and study information for the Remotelmage™ System, based on the provided 510(k) Premarket Notification:
Acceptance Criteria and Device Performance Study for Remotelmage™ System
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Image Delivery Success Rate: All transmitted images must be delivered successfully in a complete and usable format. | 100% Final Delivery Ratio: All 2,016 images were delivered successfully in complete and usable format with a loss of zero percent. (Initially 5% retransmission rate due to modem connectivity, but successfully retransmitted within 120 seconds). |
| Image Loss/Corruption: Zero percent image loss. | Zero percent loss. |
| Retransmission Success: If retransmission is needed, it must be successful within a specified timeframe. | Retransmitted within 120 seconds via Remotelmage software reconnection functionality. |
| Data Integrity (Implied): Images are transmitted and stored securely without alteration. | 128 bit SSL encryption used for transmission and download, indicating a measure for data integrity. (No direct test for alteration, but encryption is a control). |
Note: The provided document is a 510(k) summary, which often focuses on establishing substantial equivalence to a predicate device rather than detailed clinical trial results for efficacy or accuracy. The "acceptance criteria" here are derived from the performance testing described.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 2,016 images.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It describes "transmitting 2,016 images in an aggregate for a seven day period." This implies the images were test data generated or selected for testing the system's transmission capabilities rather than a dataset of clinical cases with established diagnoses.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. The "ground truth" in this context is simply the successful delivery and usability of the images, not a medical diagnosis or interpretation. The testing focused on technical performance of image transmission.
- Qualifications of Experts: Not applicable, as no experts were mentioned for establishing ground truth related to medical interpretation.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. The testing described is a technical performance test of image transmission and delivery, not a diagnostic study requiring adjudication of expert interpretations. The device's "acceptance" was based on whether the images were successfully sent and received in a usable format.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is an image communication system, not a diagnostic aid that would typically undergo an MRMC study to compare human readers' performance with and without AI assistance. The study focused on the technical delivery of images.
- Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no MRMC study or AI assistance comparison was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Standalone Performance: The testing described is essentially a standalone technical performance test of the system's ability to transmit images. The "algorithm" here is the software system for image conversion, encryption, transmission, and retrieval. The testing verifies its functionality without direct human intervention in the transmission process itself (though a human initiated the transmission and verified receipt).
7. The Type of Ground Truth Used:
- Type of Ground Truth: The ground truth used was successful image delivery and usability. This means confirming that the transmitted images arrived at the destination in their complete, original (or correctly converted JPEG), and viewable format, without loss or corruption. It essentially validates the technical function of the transfer process.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: The document does not describe a "training set" in the context of machine learning. The Remotelmage™ System is a software for image communication, not an AI or machine learning algorithm that requires training data for its core function. "Testing procedures adhered to during development and testing stages of the device software prior to release" are mentioned, but these refer to general software development quality assurance, not AI model training.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set Establishment: Not applicable, as there is no mention of a training set for an AI/ML model for this device.
§ 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).