(42 days)
Amber DU provides the Radiologist the ability to acquire chest images on film, to digitize these images real time for analysis on the Operator Workstation and retain the ability to analyze the films on a conventional lightbox, and to export the digital images Dicom 3 conformant to the hospital's network server for storage and eventual retrieval if desired.
The Oldelft Amber DU is comprised of the currently marketed Oldelft Amber AU, the Lumisys Lumiscan 75 LASER Film Digitizer which is commercially available, and a digital workstation based on a commercially available workstation from Rogan Imaging Corporation using software written by Rogan to Oldelft's specifications. The workstation displays screens to the operator for data input and for data and image display. The Oldelft Amber DU display is configured as a shell about the Rogan software which operates in the background to perform essential functions and to provide miniPACS features to Amber DU and allow the importation of patient demographic information and to allow the exportation of digital image data into which patient demographics have been incorporated.
The provided document is a 510(k) submission for the Oldelft Amber DU, primarily focusing on its regulatory approval as a Class II medical device. While it describes the device's components and intended use, it does not contain detailed information about acceptance criteria and a study proving the device meets those criteria, as typically found in clinical performance studies.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be extracted based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, F1 score). Its focus is on demonstrating substantial equivalence to a predicate device and adherence to general controls and performance standards for stationary X-ray systems (21 CFR 1020.30 and 21 CFR 1020.31). The "Indications for Use" section describes the functionality of the device rather than quantitative performance.
2. Sample size used for the test set and the data provenance:
Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not provided in the document. The document mentions "Radiologist" in the indications for use, implying the device is for use by such professionals, but it doesn't describe expert involvement in a test set ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not provided in the document. The Amber DU combines existing technologies like an X-ray system, a film digitizer, and a workstation with software. The submission does not describe it as an "AI" device as we understand it today, nor does it detail MRMC studies or human reader improvement data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not provided in the document. The device is described as an "Operator Workstation" that displays screens for "data input and for data and image display," implying a human-in-the-loop operation, not a standalone algorithmic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not provided in the document.
8. The sample size for the training set:
Not applicable or not provided. Given the device's description as a combination of existing hardware and software for image acquisition, digitization, and display, it's unlikely to have a "training set" in the context of a machine learning algorithm.
9. How the ground truth for the training set was established:
Not applicable or not provided.
In summary: The provided document is a regulatory submission for premarket notification (510(k)) that focuses on demonstrating "substantial equivalence" of the Amber DU to a legally marketed predicate device. It addresses regulatory classification, standards, and intended use, but it does not include the detailed performance study results, acceptance criteria, or ground truth establishment methodologies that would be expected for a device making claims about performance benchmarks or AI capabilities. This type of information is typically found in clinical study reports, which are not part of this 510(k) summary.
{0}------------------------------------------------
Summary of Safety and Effectiveness
| Device proprietary name: | AMBER DU |
|---|---|
| Classification name: | Stationary X-ray System (90-KPR) |
| OCT - 8 1997 | |
| Establishment Registration Number: | 1180516 |
| Oldelft Corporation of America | |
| 9108 Guilford Road | |
| Columbia, MD 21046 | |
| Owner/Operator and Manufacturer: | Oldelft BV |
| Roentgenweg 1, 2624 BD Delft | |
| P. O. Box 5082, 2600 GB Delft | |
| The Netherlands | |
| Establishment Registration No: | 9611894 |
| Owner/Operator Number: | 8030474 |
| Classification: | Class II |
| Product code: | 90-KPR (Stationary X-ray System) |
| CFR Citation: | 21 CFR 892.1680 |
| Tier I submission | |
| Panel: | Radiology |
| Performance standard: | 21 CFR 1020.30 and 21 CFR 1020.31 |
| Accession number: | 8811863 |
The Oldelft Amber DU is comprised of the currently marketed Oldelft Amber AU, the Lumisys Lumiscan 75 LASER Film Digitizer which is commercially available, and a digital workstation based on a commercially available workstation from Rogan Imaging Corporation using software written by Rogan to Oldelft's specifications. The workstation displays screens to the operator for data input and for data and image display. The Oldelft Amber DU display is configured as a shell about the Rogan software which operates in the background to perform essential functions and to provide miniPACS features to Amber DU and allow the importation of patient demographic information and to allow the exportation of digital image data into which patient demographics have been incorporated.
{1}------------------------------------------------
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol of three abstract human figures, possibly representing health, help, and services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
- 8 1997
L Don Phillips Oldelft Corporation of America 9108 Guilford Rd. Columbia, MD 21046
Re: K973219
Amber DU (Chest Unit) Dated: August 25, 1997 Received: August 27, 1997 Regulatory class: II 21 CFR 892.1680/Procode: 90 KPR
Dear Mr. Phillips:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranion.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin 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.
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 question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours
W.Liau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
{2}------------------------------------------------
Statement of indications for use
| 510(k) Number (if known): | (k97) 3219 |
|---|---|
| --------------------------- | ------------ |
Device Name: Amber DU
Indications for Use:
Amber DU provides the Radiologist the ability to acquire chest images on film, to digitize these images real time for analysis on the Operator Workstation and retain the ability to analyze the films on a conventional lightbox, and to export the digital images Dicom 3 conformant to the hospital's network server for storage and eventual retrieval if desired.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use
Ulimil A. Segerson
(Optional Formal 1-2-96)
r
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.