The SIEMENS Flat Panel Detector, in both the THORAX FD and the MULTIX FD systems, allows acquisition of x-ray exposures without the use of conventional film/screen systems. The THORAX FD system is a stand alone automated chest unit, while the MULTIX FD is a universal radiographic x-ray system. The MULTIX FD and THORAX FD both allow radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions.

Device Description

The SIEMENS Flat Panel Detector is a scintillator-photodetector device. The Flat Panel Detector is used in two different configurations which allow acquisition of radiographic exposures. The two configurations in which the detector is used are the vertical position, marketed as the THORAX FD, and the horizontal position, marketed as the MULTIX FD. Both x-ray system configurations utilize the digital capabilities of the detector, in conjunction with other system components, to produce radiographic images of various anatomical regions of the body. The SIEMENS Flat Panel Detector, in the THORAX FD and the MULTIX FD configurations, allows acquisition of exposures without the use of conventional film/screen systems. This process is done via semiconductor sensors which facilitate direct conversion of x-ray quanta into digital image data.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Radiographic images comparable to standard film images	"The results from the studies showed that the digital images were comparable to film."
Diagnostic imaging quality equal to or better than film/screen	"This clinical outcome supported the diagnostic imaging quality of the digital system as being equal to or better than film/screen."
Substantial equivalence to predicate devices (DIGISCAN 2, THORAMAT, Multix TOP/PRO)	The FDA granted clearance based on substantial equivalence to the listed predicate devices.

Note: The document doesn't explicitly state numerical acceptance criteria (e.g., a specific AUC or sensitivity threshold). Instead, the acceptance criteria are implicitly defined by the goal of demonstrating 'comparability' and 'equal or better diagnostic imaging quality' relative to standard film/screen systems and substantial equivalence to established predicate devices.

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

Sample Size: Not specified in the provided text.
Data Provenance: The clinical study was carried out in Regensburg, Germany. The text does not specify if the data was retrospective or prospective.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. The document only mentions "The results from the studies showed that the digital images were comparable to film." without detailing how this comparison was adjudicated by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: The document does not explicitly state that a multi-reader multi-case (MRMC) comparative effectiveness study was performed in the described clinical study. It mentions a "clinical study" where "digital images were comparable to film," but the methodology isn't detailed enough to confirm an MRMC design.
Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as the device described is a direct-conversion digital X-ray detector, not an AI assistance tool for human readers. The comparison is between the output of the digital detector and traditional film/screen, not between human readers with and without AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Yes, in essence, the "clinical study" described focuses on the direct output of the digital system ("digital images") compared to standard film, without explicitly detailing human interpretation in the loop of that comparison. The diagnostic quality of the system's images was assessed.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth used appears to be the diagnostic quality of standard film images. The study aimed to determine if the digital images were "substantially equivalent to standard film images" and if their "diagnostic imaging quality... [was] equal to or better than film/screen." This implies that the standard clinical diagnostic interpretation of film images served as the reference.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable/not specified. The device is hardware (a flat panel detector) for image acquisition. The description does not indicate the use of machine learning or an "algorithm" requiring a training set in the modern sense. The "clinical study" mentioned here is for performance validation, not for training an AI model.

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

Ground Truth for Training Set: Not applicable, as there is no mention of a training set for an AI algorithm.

Summary

{0}------------------------------------------------

4/21/99

ATTACHMENT 12

K983732

510(K) SUMMARY

Flat Panel Detector Submitted by:

SIEMENS Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830

October 21, 1998

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Contact Person: 1.

Ms. Malgorzata Stanek Fax: (732) 321-4841 Phone: (732) 321-3950

2. Device Name and Classification:

THORAX FD Trade Name: Solid State X-ray Imager (SSXI) Classification Name: Classification Panel: Radiology CFR Section: 21 CFR §892.1680 Stationary X-ray System Class II Device Class: Product Code: 90MQB

Trade Name: Classification Name: Classification Panel: CFR Section:

Device Class: Product Code:

MULTIX FD Solid State X-ray Imager (SSXI) Radiology 21 CFR §892.1680 Stationary X-ray System Class II 90MQB

{1}------------------------------------------------

3. Substantial Equivalence:

The Flat Panel Detector is designed for use in the MULTIX FD and the THORAX FD stationary x-ray systems. These configurations allow acquisition of radiographic exposures of various anatomical regions of the body. They are substantially equivalent to the following SIEMENS Medical Systems devices:

SIEMENSDevice Name	System Type	FDA ClearanceNumber	FDA ClearanceDate
DIGISCAN 2	Phosphor Plate System	K924459	12/17/92
THORAMAT	Vertical Chest X-ray System	Pre-Ammendment	Pre-Ammendment
Multix TOP/PRO	Stationary X-ray System	K971452	5/14/97

4. Device Description:

The SIEMENS Flat Panel Detector, in the THORAX FD and the MULTIX FD configurations, allows acquisition of exposures without the use of conventional film/screen systems. This process is done via semiconductor sensors which facilitate direct conversion of x-ray quanta into digital image data.

ડ. Intended Use of the Device:

The SIEMENS Flat Panel Detector, in both the THORAX FD and the MULTIX FD systems, allows acquisition of exposures without the use of conventional film/screen systems. The THORAX FD system is a stand alone automated chest unit, while the MULTIX FD is a universal radiographic x-ray system. The MULTIX FD and the THORAX FD both allow radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or prone positions.

{2}------------------------------------------------

6. Summary of Technological Characteristics of the Devices Compared to the Predicate:

Both configurations, THORAX FD and MULTIX FD, are capable of acquiring radiographic images in a manner similar to that of the in the DIGISCAN 2, the THOROMAT, and the Multix TOP/PRO. The difference is that the THORAX FD and the MULTIX FD systems use SSXI digital technology, as opposed to the predicates which use standard film or phosphor plate technology.

7. Clinical Study and Conclusion:

A clinical study were carried out in Regensburg, Germany to determine whether radiographic images taken using the digital technology of the THORAX FD and the MULTIX FD systems were substantially equivalent to standard film images. The results from the studies showed that the digital images were comparable to film. Laboratory test results also support the equivalence to standard film images shown in the clinical studies. This clinical outcome supported the diagnostic imaging quality of the digital system as being equal to or better than film/screen.

Kathleen Rutherford

Kathleen Rutherford Manager, Regulatory Submissions SIEMENS Medical Systems, Inc.

{3}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 1999

Malgorzata Stanek Technical Specialist, RAC Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin. New Jersev 08830

RE:

K983732 Thorax FD & Multix FD Solid State X-Ray Imaging Systems Dated: January 27, 1999 Received: January 28, 1999 Regulatory Class: II 21 CFR 892.1630/Procode: 90 MQB

Dear Ms. Stanek:

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 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). 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 (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 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 requlatory 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 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel C. Schultz, M.D.

CAPT Daniel G. Schultz, 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

{4}------------------------------------------------

ATTACHMENT 13

INDICATIONS FOR USE

510(k) Number (if known): __ K98 3732 Flat Panel Detector in the THORAX FD and MULTIX FD Device Name: --

Indications For Use:

(Please do not write below this line - continue on another page if needed)

Concurrence of the CDRH, Office of Device Evaluation (ODE)

Yhmid h. Segson
Sign-Off)

==============================================================================================================================================================================

ion of Reproductive, Abdominal, ENT,
Kadiological Devices
(k) Number K983732

Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)

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.