OLDELFT DIGIDELCA by OLDELFT CORP. OF AMERICA

Digidelca provides the radiologists or pneumologists the ability to acquire chest xray images by filmless radiography (digital radiography), based on CCD technology. The x-ray transmission profile of the chest is converted into an electronic, digital image in real-time. Chest images become available for preview by the x-ray technician on the operators workstation only seconds after the x-ray exposure. After acceptance by the tech, digital (DICOM) images can be stored on electronic media, as e.g. CD-ROM, magnetic disk, or be exported to a (DICOM/PACS) network, c.q. clinical review station or to a film printer.

Device Description

Digidelca is a product which was developed around hardware and software components which are already market within the United States and therefore substantial equivalence is claimed to Electrodelca for the electrical, mechanical and optical system layout and to AMBER-DU and HyperPACS for the software configuration:

The Oldelft Electrodelca (tm) mass chest x-ray system (K892659) for the camera . housing basic design, the image intensifier tube, the elevator stand basic design and the compatible x-ray tube and high voltage generator selection. The image capturing device in Digidelca is a TDI CCD sensor, instead of radiographic film.
The Rogan HyperPACS (tm) software package (K950343) for the principal software ● tasks for the Operators Workstation: image acquisition and storage, image export, network interfacing.
The Oldelft Amber-DU (K973219) software package (reconfigured) for user interfacing . at the Operators Workstation.

The Operators Workstation displays screens to the operator for data input and for data and image display. The Digidelca software is configured as a dedicated shell around the Rogan software which operates in the background to perform essential functions for data acquisition, image storage and image export. The OWS allows for importing patient demographic information and exportation of digital images into which patient demographics have been incorporated (DICOM compatible data structures).

The Date Entry System is an additional pc platform which is used to copy patient demographics to a card formation carrier by a thermal printing process. The card is handed out to the examinee who will submit it to the Digidelca(-M) operator prior to making his/het x-rays. Patient demographics are scanned from the card by a two dimensional barcode reader and thereby entered into the Digidelca(-M) operators workstation.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Digidelca device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the Digidelca device in terms of performance metrics (e.g., sensitivity, specificity, resolution targets with numerical thresholds). Instead, the performance is described qualitatively and comparatively to the predicate device, Electrodelca.

Therefore, the table below reflects the implied acceptance criteria based on the claims of substantial equivalence and the qualitative performance descriptions.

Acceptance Criteria (Implied)	Reported Device Performance
Equivalence to Predicate Device (Electrodelca) for basic system layout and components	"Electrodelca for the electrical, mechanical and optical system layout and to AMBER-DU and HyperPACS for the software configuration."
Image Resolution and Contrast Comparable to Electrodelca	"In-house prototype tests include a.o. resolution and contrast measurements... which show comparable results as for Electrodelca."
Functionality as a Filmless Radiography System	"Digidelca provides the radiologists or pneumologists the ability to acquire chest x-ray images by filmless radiography (digital radiography), based on CCD technology." "Chest images become available for preview by the x-ray technician on the operators workstation only seconds after the x-ray exposure."
Enhanced Imaging Performance Compared to Electrodelca	"Digidelca is successfully operational at a beta test site in The Netherlands... and images are generally appreciated by radiologists as 'better' then those from Electrodelca." "Digidelca is a reliable system for chest screening with enhanced imaging performance when compared to Electrodelca. Digital augmentations have proved to be very useful."
Clinical Utility for Chest Radiography	"Clinically used for both in-patients and out-patients." "Digidelca provides the radiologists or pneumologists the ability to acquire chest x-ray images..."
Reliability for Chest Screening	"Digidelca is a reliable system for chest screening..."
Compatibility with DICOM andPACS/Network Export	"After acceptance by the tech, digital (DICOM) images can be stored on electronic media... or be exported to a (DICOM/PACS) network, c.q. clinical review station or to a film printer." "The OWS allows for importing patient demographic information and exportation of digital images into which patient demographics have been incorporated (DICOM compatible data structures)."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a numerical sample size for the clinical test set. It only mentions that the device is "clinically used for both in-patients and out-patients" at a beta test site.
Data Provenance: The clinical testing was conducted at a "beta test site in The Netherlands (Twenteborg Hospital, Almelo)." The data is prospective as it describes ongoing clinical use since mid-1997.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: The document does not explicitly state the number of experts. It refers to "radiologists" (plural), implying more than one.
Qualifications of Experts: The experts are described as "radiologists." No further details on their experience level (e.g., years of experience) are provided.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1). It states that "images are generally appreciated by radiologists as 'better' then those from Electrodelca," which suggests a qualitative assessment by multiple radiologists, but not a formal adjudication process to establish a definitive ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done? The document does not describe a formal MRMC comparative effectiveness study in the sense of a controlled study comparing human readers with and without AI assistance.
Effect Size: Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The Digidelca device, as described, is an x-ray system for acquiring digital images. While it mentions "Digital augmentations," these are enhancements to the imaging process, not a standalone AI algorithm for interpretation or diagnosis. Therefore, a standalone (algorithm only) performance study as typically understood for AI diagnostic tools was not performed or described in this document. The focus is on the imaging system itself, with human radiologists performing the interpretation.

7. Type of Ground Truth Used

The ground truth used for assessing image quality was expert consensus/opinion from radiologists. They appreciated the images as "better" than those from the predicate device. This is a subjective assessment of image quality and clinical utility, rather than an objective "ground truth" derived from pathology, outcomes data, or a strict consensus protocol.

8. Sample Size for the Training Set

The document does not mention a training set in the context of an AI algorithm learning from data. The device's "software configuration" is based on existing market software packages (Rogan HyperPACS and Oldelft Amber-DU), which would have had their own development and testing, but not a specific training set for an AI component of Digidelca itself.

9. How the Ground Truth for the Training Set Was Established

Since no training set for an AI algorithm is mentioned, this information is not applicable to the provided text. The device primarily concerns hardware and software integration for image acquisition and display, not a learned diagnostic model.

Summary

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FDA/CDRH/ODE/DMC

I I MAR 90 15 0 / APR 17 1:158

21 january 1998

Oider!! B V

Röntgenweg 1, 2624 BD Delft P.O. Box 5082, 2600 GB Delft The Netherlands Tel.: +31 (0) 15 269 89 00 Fax: +31 (0) 15 269 84 88 Trade Register No .: 260.30.374 Vat No.: NL 008897852 B 06 Bankers: ABN AMRO Account no .: 47.95.05.683

K980296

Summary of Safety and Effectiveness

Device proprietary (trade) name:

Classification name:

Establishment Registration Number:

Owner/operator:

ﺮ ﺩ

Digidelca-DES)

Digidelca (Digidelca-M, Digidelca-C,

Stationary X-ray System (90-KPR)

1180516 Oldelft Corporation of America 9108 Guilford Road Columbia, MD-21046

Oldelft BV Röntgenweg 1 Postbus 5082 NL-2600 GB Delft The Netherlands

Establishement Registration Number:

Owner/operator Number:

Classification:

Product Code:

CFR Citation:

Panel:

Intended use:

Performance standard:

9611894

8030474

Class II

90-KPR (Stationary X-Ray System)

21 CFR 892.1680 Tier 1 submission

Radiology

Clinical or mass chest radiography

21 CFR 1020.30 and 21 CFR 1020.31

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page no 11 1

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Description:

ﺘﺮﺍ

The Oldelft Electrodelca (tm) mass chest x-ray system (K892659) for the camera . housing basic design, the image intensifier tube, the elevator stand basic design and the compatible x-ray tube and high voltage generator selection. The image capturing device in Digidelca is a TDI CCD sensor, instead of radiographic film.
The Rogan HyperPACS (tm) software package (K950343) for the principal software ● tasks for the Operators Workstation: image acquisition and storage, image export, network interfacing.
The Oldelft Amber-DU (K973219) software package (reconfigured) for user interfacing . at the Operators Workstation.

Non-clincial tests:	In-house prototype tests include a.o.resolution and contrast measurements whichare reported in Tab N of this application andwhich show comparable results as forElectrodelca.
Clinical tests:	Digidelca is successfully operational at a betatest site in The Netherlands (TwenteborgHospital, Almelo) since mid 1997 and isclinically used for both in-patients and out-patients. It replaced the Electrodelcaavailable there before, and images aregenerally appreciated by radiologists as"better" then those from Electrodelca.
Conclusion	Digidelca is a reliable system for chest

Dividel. I

01 DI 1 1 1 1

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screening with enhanced imaging performance when compard to Electrodelca. Digital augmentations have proved to be very useful.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 17 1998

Ernest King Service Manager Oldelft Corporation of America 9108 Guilford Road Columbia, MD 21046

Re:

K980296 Digidelca, Stationary X-Ray System Dated: Janauary 21, 1998 Received: January 27, 1998 Regulatory class: II 21 CFR 892.1680/Procode: 90 KPR

Dear Mr. King:

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 misbranding and adulteration.

If your device is classified (see above) into either class III (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 requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (2) 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 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 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 questions on the promotion 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/cdr/dsmaln.html".

Sincerely yours,

Kilian Yi

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

510(k) Number (if known):

Device Name:

Digidelca

K980296

Indications for Use:

Note: PACS, networks, clinical review stations and (laser-) film printers are not considered part of the Digidelca system for which this application is filed. only external interfacs to this type of equipment are defined.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thomas J. Celabie

Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological De 5100k) Number

Prescription Use
(Per 21 CFR 801.109) ✓

Over-The-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.