(67 days)
The Olicon 02-Workstation and/or PACSView™ Software is a device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images/data can be stored, communicated, processed, and displayed within the workstation and or across computer networks at distributed locations.
The Olicon 02-Workstation and/or PACSView™ software is a general purpose computer system consisting of a computer (console, display, keyboard, and mouse) and software which is used to store, communicate, and view radiological images and data in a digital format. Images are stored and displayed utilizing Intel Pentium processing unit with high resolution monitors.
The provided text is a 510(k) Summary for the Olicon 02-Workstation and/or PACSView™ software, dated September 23, 1997. It describes a digital imaging workstation and software designed to store, communicate, process, and display radiological images and data.
Here's an analysis of the provided information regarding acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or report specific numerical device performance metrics in the way modern AI/CAD device submissions would.
Instead, the performance data section focuses on general compliance and functionality:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Data Communication Error Handling | "The subject and predicate devices both use standard data communications controls to detect and correct errors." |
| Electrical Safety Standard Compliance | "The subject device complies with UL-1950 Standard for Safety of Business Equipment. Including Electrical Information Technology Equipment." |
| Operating System Compatibility | "The Olicon 02-Workstation and/or PACSView™ software uses the Microsoft Windows NT or 95 operating systems, (as a minimum & depending upon system configuration)..." |
| DICOM Standard Compliance | "...and is DICOM 3.0 compliant." |
| Functionality as a Digital Imaging Workstation (Substantial Equivalence) | "Similar to the predicate device, the Olicon 02-Workstation and/or PACSView™ software does not contact the patient, nor does it control any life sustaining devices. Images and information being reviewed, processed, relayed, and or transmitted are interpreted by a physician or trained medical personnel, providing ample opportunity for competent human intervention. The subject device and the predicate share the same certification of conformance to UL-1950 and both function as Digital Imaging Workstations." |
| Data Recovery/System Reliability (Implied) | "Device failures which might result in partial or failed transmissions, images, and or data may be recovered by re-transmission after correcting the problems." |
| Security (Implied) | "Passwords are required for operation and to protect against unauthorized use of the system." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The submission pre-dates the era where detailed clinical performance studies, especially for AI/CAD devices, were commonly required for imaging workstations. This device is primarily for viewing, storage, and communication, not for diagnostic interpretation automation or assistance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. As the device is not an AI/CAD system performing diagnostic tasks, there was no requirement for establishing ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not provided. Not applicable as there was no diagnostic accuracy test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported. The document does not describe any study measuring the impact of the workstation on human reader performance. This is consistent with the device's function as a general-purpose imaging workstation rather than a diagnostic aid.
6. Standalone (Algorithm Only) Performance Study
No, a standalone performance study was not done or reported. The device is a workstation and software for image handling, not an algorithm that performs standalone diagnostic tasks separate from human review.
7. Type of Ground Truth Used
This information is not provided and is not applicable in the context of this device. The device's performance evaluation was based on its operational characteristics, standard compliance, and functionality in image management, not on diagnostic accuracy against a "ground truth" of disease presence or absence.
8. Sample Size for the Training Set
This information is not provided. The device is not an AI/ML product developed using training datasets in the modern sense. It's software developed using traditional programming paradigms.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. Not applicable for this type of device.
§ 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.