ThoraScan provides the radiologists or pneumologists the ability to acquire chest x-ray images by filmless radiography (digital radiography), based on a Csl/CCD slot scan detector produced by Thomson TE.

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 operator's workstation only seconds after the x-ray exposure.

operator o wonecation one 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.

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 interfaces tot this type of equipment are defined.

The Nucletron Oldelft ThoraScan is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and certified medical professional.

Device Description

ThoraScan is a digital X-ray chest camera based on slot-scan technology and is designed to perform radiographic chest examinations. The detector is comprised of CCD's directly coupled to a cesium iodide scintillator. The digital image is sent through a DICOM network. The ThoraScan consists of a camera stand with detector, tube stand, control unit, x-ray tube, collimator, generator and the OWS (Operators workstation).

AI/ML Overview

The provided 510(k) summary for the Nucletron Oldelft ThoraScan describes non-clinical and clinical tests, but it does not provide specific, quantifiable acceptance criteria or detailed results in the format requested. The document primarily focuses on demonstrating substantial equivalence to a predicate device (Digidelca) and highlighting improvements.

Here's an analysis based on the information provided and what is missing:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The Nucletron Oldelft ThoraScan is a digital X-ray chest camera based on slot-scan technology, designed for radiographic chest examinations. The study presented is a comparison to a predicate device, the Nucletron Digidelca, aiming to demonstrate substantial equivalence and improved performance. However, there are no explicitly stated, quantifiable acceptance criteria for either non-clinical or clinical performance, nor is there a detailed study report with metrics to prove these criteria were met.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Quantitative)	Reported Device Performance (Quantitative)
Not explicitly stated in the document. The document generally states "superior results" and "better image quality" compared to the predicate device.	Not explicitly stated in the document.
Example of what might be expected: Modulation Transfer Function (MTF) at certain spatial frequencies > X	Reported for ThoraScan: Superior results compared to Digidelca-C (for resolution and contrast)
Example of what might be expected: Signal-to-Noise Ratio (SNR) > Y	Reported for ThoraScan: Superior results compared to Digidelca-C (for resolution and contrast)
Example of what might be expected: Radiologist agreement on diagnostic quality improvement > Z%	Reported for ThoraScan: Digital images had "better image quality than the Digidelca-C" as judged by radiologists.

Missing Information: The document states "resolution and contrast measurements which are reported in Tab 10 of this application," but "Tab 10" is not included in the provided text. Without this table, specific numerical acceptance criteria and performance data are unavailable.

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

Test Set Sample Size: Not specified. The document only mentions "PA and lateral radiograms were judged."
Data Provenance: Not specified. The country of origin for the clinical data is not mentioned, nor is it stated whether the study was retrospective or prospective.

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

Number of Experts: "several radiologist" - the exact number is not specified.
Qualifications of Experts: Not specified (e.g., years of experience, subspecialty).

4. Adjudication Method

Adjudication Method: Not specified. The document only states that radiograms "were judged by several radiologist." It does not detail how disagreements were resolved or if a consensus method (e.g., 2+1, 3+1) was used.

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

The document describes a comparative evaluation where "PA and lateral radiograms were judged by several radiologist and found the digital images had better image quality than the Digidelca-C." This suggests a comparative reading, but it's not explicitly framed as a formal MRMC comparative effectiveness study in the way modern AI clearance studies are.
Effect Size of Human Readers Improve with AI vs without AI: Not applicable, as this device itself is an imaging system, not an AI algorithm assisting human readers. The comparison is between two imaging systems (ThoraScan vs. Digidelca-C) with human readers evaluating image quality. The "better image quality" implies a positive effect, but no quantifiable effect size is provided.

6. Standalone (Algorithm Only) Performance

This question is not applicable in the context of the Oldelft ThoraScan. The device is a digital X-ray system, not an AI algorithm. Its performance is inherent in the image acquisition and output, which is then interpreted by human readers. The non-clinical tests (resolution, contrast) could be considered standalone performance metrics of the imaging system.

7. Type of Ground Truth Used

Ground Truth Type: Expert consensus on "image quality." This is subjective judgment by radiologists, rather than objective pathology or outcomes data.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. As an imaging device (hardware/firmware), the ThoraScan does not utilize a "training set" in the machine learning sense. Its design and calibration are based on engineering principles and prototype testing.

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

Ground Truth Establishment for Training Set: Not applicable, as a training set is not relevant to this type of device.

Summary of Limitations in the Provided Text for a Modern AI/Medical Device Study Perspective:

The provided 510(k) summary is typical for medical device submissions from 2001, focusing on establishing substantial equivalence to a predicate device. It lacks the quantitative detail, rigorous study design, and specific metrics that would be expected for a modern AI-powered diagnostic device, particularly regarding acceptance criteria, sample sizes, and detailed expert adjudication methods. The "clinical tests" described are more akin to a usability or preference study regarding image quality than a definitive diagnostic accuracy trial.

Summary

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510(K) Nucletron [Oldelft ThoraScan] [June 27th, 2001]

SEP 1 9 2001

Image /page/0/Picture/2 description: The image is a black and white graphic. It features a square border, inside of which is a black oval shape. Two white circles are positioned on opposite sides of the oval, partially overlapping it. The overall design is simple and geometric.

K012165/S1

NUCLETRON B.V.

Waardgelder 1 3905 TH Veenendaal 3900 AX Veenendaal P.O.Box 930 The Netherlands Phone +31 318 557133 Fax +31 318 550485

Department of Health and Human Services Center of Device and Radiological Health Office of Device Evaluation Special 510(k) section

ucletron

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 807.92(c)

Submitter of 510(k): a.

Company name:	Nucletron Corporation
Registration number:	1121753
Address:	7080 Columbia Gateway Drive
	Columbia, MD 21046-2133
Phone:	410-312-4100
Fax:	410-312-4197
Correspondent:	Lisa Dimmick

Device Name: b.

Trade/Proprietary Name:	Oldelft ThoraScan (internally also known as
Name:	ThoraScan and Digidelca-T)
Common/Usual Name:	Digital Chest X-ray System
Classification Name:	Stationary X-ray System (90-KPR)
Classification	Class II
CFR Citation	21 CRF 892.1680 Tier 1 submission
Panel	Radiology

Legally Marketed Device(s) C.

Our device is substantially equivalent to the legally marketed predicate device cited in the table below:

Manufacturer	Device	510(k) #
Nucletron BV	Digidelca	K980296

Description: ರ.

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510(K) Nucletron [Oldelft ThoraScan] [June 27th, 2001]

Intended use e.

Clinical or mass-chest radiography

Summary of technological considerations f.

The ThoraScan is substantially equivalent to the predicate device (Digidelca). Compared to the Digidelca the slot-scan detector and the control unit have been improved.

The ThoraScan presents no new safety concerns. It will comply with the x-ray requirements of 21CFR 1020.30/31 as well as safety requirements of UL -187, IEC601-1 rood collateral standards, as well as the requirements of the Medical Device Directive (93/42/EEC) and the EMC Directive (89/336/EEC).

Non-clinical tests ்.

Prototype tests of the detector include a.o. resolution and contrast measurements which are reported in Tab 10 of this application and which show superior results compared to the Digidelca-C.

Clinical tests h.

PA and lateral radiograms were judged by several radiologist and found the digital images had better image quality than the Digidelca-C

Conclusions i.

Nucletron considers the ThoraScan to be equivalent with the predicate device. The ThoraScan provides radiograms that result in better imaging performance than Digidelca.

Jtc

Name: Rudolf Scholte Title: Business Manager Nucletron B.V. Veenendaal, The Netherlands

28/06/01

Date

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

SEP 1 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa Cole Dimmick Director of Regulatory Affairs Nucletron Corporation 7080 Columbia Gateway Drive COLUMBIA MD 21046-2133

Re: K012165

Trade/Device Name: Oldelft Thorascan Number 180T Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: II Product Code: 90 KPR Dated: August 24, 2001 Received: August 27, 2001

Dear Ms. Dimmick

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device 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 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) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

proceed to the market.

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510(K) Nucletron [Oldelft ThoraScan] [June 27, 2001]

Image /page/4/Picture/1 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square logo. The logo contains a black circle with two white circles inside of it.

K012165

NUCLETRON B.V. Waardgelder 1 3905 TH Veenendaal 3900 AX Veenendaal P.O.Box 930 The Netherlands Phone +31 318 557133 Fax +31 318 550485

Department of Health and Human Services Center of Device and Radiological Health Office of Device Evaluation Special 510(k) section

Statement of intended use

Device Name:

Oldelft ThoraScan

Intended Use:

Prescription use:

The Nucletron Oldelft ThoraScan is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and certified medical professional.

Name: Title: Business Manager Nucletron B.V. Veenendaal, The Netherlands

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012165

28/6/01.

Date

Prescription Use ✓

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.