K Number
K973219
Device Name
AMBER DU
Date Cleared
1997-10-08

(42 days)

Product Code
Regulation Number
892.1680
Panel
RA
Reference & Predicate Devices
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

Device Description

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.

AI/ML Overview

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.

§ 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.