(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.
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Image /page/0/Picture/0 description: The image shows the ARRI logo in black and white. The logo consists of the word "ARRI" in bold, sans-serif font. To the right of the word "ARRI" is a circular design with the letters "ARD" inside. The logo is simple and modern.
Summary of Safety and Effectiveness Information For 510(k) Submission Medical Image Digitizer
| General Information: | |
|---|---|
| Proprietary Name: | OSCAR NET/CD |
| Common Name: | Picture archiving and communications system |
| Classification Name: | Picture archiving and communications system, § 892.2050 |
| Classification: | Class II |
| Classificatin Number: | |
| Intendet use: | 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. |
| Legally marketed device: | MEDIMAGE |
| Proprietary Name: | MEDIMAGE and Cardio Viewing Station |
| Common Name: | |
| Classification Name: | |
| Classification: | Class II |
| Classificatin Number: | |
| Date of Submission: | Nov.19.1997 |
| 510(k) Number: | K 912275 |
Standards for OSCAR NET/CD:
| 1. DIN 6856,Part1 | 5. EN 60601-1-1 |
|---|---|
| Demands for the manufacture and the operation Of viewing apparatus for the evaluation of tansparent images in medical diagnostics. | -IEC 601-1-1 |
| -VDE 0750 T1-1 | |
| 2. DIN 6856,Part2 | 6. EN 60601-1-2 |
| Quality-guaranteeing meaures in medical Diagnostics, -testing procedures, measuring instruments | -IEC 601-1-2 |
| -VDE 0750 T1-2 | |
| 3. EN 60601-1 | 7. EN 60601-1-4 |
| -IEC 601-1 | -IEC 601-1-4 |
| -VDE 0750 T1 | -VDE 0750 T1-4 |
| 4. EN 50082-1 | 8. EN 55022 |
| -VDE 839 T82-1 | -VDE 878 T22/A1 |
| -CISPR 22 |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird with three curved lines representing its body and wings. The bird is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 19 2000
i.V. Thomas Popp Product Group Manager Arnold & Richter Cine Technik GMBH & Co. Turkenstrasse 89 Munich 80799, By GERMANY
K993283 Re: ARRI-Oscar Net/CD (Image Work Station) Dated: September 29, 1999 Received: September 30, 1999 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Popp:
This letter corrects our substantially equivalent letter of December 29, 1999, regarding the 510(k) I his letter correct. Van buostantial) equal r the error and hope it has not caused any inconvenience.
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we The nave revealy our Desires is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the to regally indificited production of to devices that have been reclassified in enal ment date of the Medical Device Inneral Food, Drug, and Cosmetic Act (Act ). Your may, therefore, accordance with the provisions of the Act. The general controls provisions of the Act. The general controls provisions of market the device, babyer to the annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classified (see acove) and controls. Existing major regulations affecting your devices ripptorul) it inaly be babyer Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent career in the in and see compliance with the Good Manufacturing Practice requirements, as set forth in acterimmuner abounter couplement (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and the Quanty of seen regarines ( < ) = ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = and and regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this may publish farther announces on the submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to continue marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page -2 - Mr. Popp
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Elinor b. Wycom
CAPT Daniel Schul z. M.D Acting Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: PICTURE ARCHIVING AND COMMUNICATION SYSTEM
Indications For Usc:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K993283
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Form 1-7
§ 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).