(90 days)
The Pacs Unit ARRI OSCAR NET/CD will be used to acquire, display, process, archive, retricve, and transmit diagnostic medical images and information about these images in a single user or network enviroment. The typical users are trained medical professionals.
The device is intendet to be used to convert an medical film/S-VHS Tape -Image into a digital format(DICOM), electronic storage for an medical image and electronic tranfer of medical image data.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ARRI-Oscar Net/CD device.
Key Observation: The provided 510(k) submission document does not contain specific acceptance criteria or performance study data in the way one typically expects for a device performance study (e.g., sensitivity, specificity, accuracy metrics). Instead, it lists harmonized standards that the device adheres to, and briefly describes its intended use. This document is primarily concerned with establishing substantial equivalence to a predicate device and ensuring compliance with regulatory standards.
Therefore, the answers to many of the questions will be "Not Applicable" or "Not Provided" in the given document.
Description of Acceptance Criteria and Study
The provided document describes the ARRI OSCAR NET/CD, a Picture Archiving and Communication System (PACS), intended to convert medical film/S-VHS tape images into a digital format (DICOM) for electronic storage and transfer. The acceptance criteria, as presented in this document, are primarily based on adherence to recognized technical and safety standards, rather than specific performance metrics like diagnostic accuracy. The "study" alluded to is the 510(k) submission process itself, where the manufacturer demonstrates substantial equivalence to a legally marketed predicate device (MEDIMAGE) and compliance with these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (as per DIN/EN/IEC/VDE/CISPR Standards) | Reported Device Performance (as per document) |
|---|---|
| DIN 6856, Part 1: Demands for the manufacture and operation of viewing apparatus for evaluation of transparent images in medical diagnostics. | The device is an "Image Work Station" (PACS) intended to acquire, display, process, archive, retrieve, and transmit diagnostic medical images. |
| DIN 6856, Part 2: Quality-guaranteeing measures in medical diagnostics, -testing procedures, measuring instruments. | Implied compliance by meeting the standard. No specific test results are provided. |
| EN 60601-1 (IEC 601-1, VDE 0750 T1): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. | Implied compliance by meeting the standard. No specific test results are provided. |
| EN 50082-1 (VDE 839 T82-1): Electromagnetic compatibility - Generic immunity standard - Part 1: Residential, commercial and light industry. | Implied compliance by meeting the standard. No specific test results are provided. |
| EN 60601-1-1 (IEC 601-1-1, VDE 0750 T1-1): Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems. | Implied compliance by meeting the standard. No specific test results are provided. |
| EN 60601-1-2 (IEC 601-1-2, VDE 0750 T1-2): Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests. | Implied compliance by meeting the standard. No specific test results are provided. |
| EN 60601-1-4 (IEC 601-1-4, VDE 0750 T1-4): Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems. | Implied compliance by meeting the standard. No specific test results are provided. |
| EN 55022 (VDE 878 T22/A1, CISPR 22): Information technology equipment - Radio disturbance characteristics - Limits and methods of measurement. | Implied compliance by meeting the standard. No specific test results are provided. |
| Intended Use Goal: Convert medical film/S-VHS Tape -Image into a digital format (DICOM), electronic storage, and electronic transfer. | The PACS Unit ARRI OSCAR NET/CD will be used to acquire, display, process, archive, retrieve, and transmit diagnostic medical images and information. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable / Not provided. The document focuses on regulatory compliance and substantial equivalence to a predicate device, not on a clinical performance study with a test set of medical images.
- Data Provenance: Not applicable / Not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable / Not provided.
- Qualifications of Experts: Not applicable / Not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable / Not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not mentioned or performed according to this document. The device is a PACS system for digitizing and managing images, not an AI diagnostic tool that assists human readers.
- Effect Size: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This device is a PACS system designed for image management, not a diagnostic algorithm. Its performance is related to its ability to accurately digitize, store, and transmit images, and comply with technical standards.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the context of this device (a PACS system), the "ground truth" would be related to the accuracy and integrity of the digitized images, successful data transfer, adherence to DICOM standards, and compliance with the listed safety and performance standards. No specific ground truth type (e.g., pathology, outcomes data) is mentioned for evaluating diagnostic performance, as that is not the device's primary function.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable / Not provided. This document does not describe a machine learning algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable / Not provided.
§ 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).