The Fluorospot Compact digital imaging system, is an optional integral component of a radiographic/fluoroscopic x-ray system, as such it is not considered a stand alone device. The Fluorospot Compact is intended for use with x-ray systems to digitally acquire, record and display radiographic images. The Fluorospot Compact enables the trained healthcare professional to consistently acquire high quality images for fluoroscopic examinations with contrast medium, urological examinations as well as vascular and non-vascular procedures.

Device Description

The Fluorospot Compact is a PC-based, 10 bit acquisition digital imaging system where images are acquired in 10242 format. It can be configured with conventional overtable/under-table x-ray systems (e.g. commercially available Sireskop SX and Siregraph CX). Configuring the conventional systems with Fluorospot Compact provides the systems with multi-functional use capability, thus allowing trained healthcare professionals to perform x-ray imaging using conventional film or digital imaging. Upon acquiring digital images, the user can display them on the live monitor in the exam room, as well as the control room for review. Multiple digital image acquisition and storage is possible without interrupting the procedure to change film.

AI/ML Overview

This submission is a 510(k) premarket notification for the Siemens Fluorospot Compact, an optional integral component of a radiographic/fluoroscopic x-ray system. The document focuses on establishing substantial equivalence to previously cleared devices rather than presenting data from a new clinical study with specific acceptance criteria and performance metrics. Therefore, many of the requested details about acceptance criteria and study design are not present in the provided text.

Here is an analysis based on the information provided:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria or report specific device performance metrics in the format of a clinical study. The submission focuses on substantial equivalence to predicate devices rather than proving performance against predefined clinical thresholds.

The key claim regarding performance is:
"The Fluorospot Compact enables the trained healthcare professional to consistently acquire high quality images for fluoroscopic examinations with contrast medium, urological examinations as well as vascular and non-vascular procedures."

This is a statement of intended performance rather than a measurable acceptance criterion with a corresponding reported result.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. The provided document does not describe a new clinical study with a test set of patient data. The basis for clearance is substantial equivalence to predicate devices, not performance on a new dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No new test set requiring expert ground truth establishment for a clinical study is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No new test set requiring adjudication is described.

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 applicable. There is no mention of an MRMC study or AI assistance in this submission. The device described is a digital imaging acquisition and display system for X-rays, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is explicitly stated not to be a standalone device: "The Fluorospot Compact digital imaging system, is an optional integral component of a radiographic/fluoroscopic x-ray system, and as such it is not considered a stand alone device." Therefore, a standalone performance study as typically understood for an AI algorithm was not performed or claimed. Its function is to acquire, record, and display images for a trained healthcare professional.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No new ground truth for a clinical study is described. The device's "ground truth" for substantial equivalence would relate to its technical specifications and image quality characteristics matching those of the predicate devices.

8. The sample size for the training set

Not applicable. The document does not describe a machine learning model or an AI algorithm that would require a training set. This is a digital imaging system.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for a machine learning model, ground truth establishment for it is not relevant.

Summary of Device and Basis for Clearance:

The Siemens Fluorospot Compact is a PC-based, 10-bit acquisition digital imaging system for fluoroscopic X-ray systems. It acquires images in 1024x1024 format. Its primary function is to digitally acquire, record, and display radiographic images, enabling trained healthcare professionals to perform various X-ray examinations.

The device received 510(k) clearance based on substantial equivalence to two previously cleared Siemens devices:

Fluorospot T.O.P (K961871, cleared July 31, 1996)
Fluorospot H (Version 2) (K914525, cleared November 19, 1991) and Fluorospot H (Version 1) (K911082, cleared May 1, 1991)

The submission states that the Fluorospot Compact has the "same technological characteristics" as these predicates, utilizing PC-based technology to acquire, store, and post-process images from an image intensifier/TV chain output of a fluoroscopic system. The FDA's letter confirms findings of substantial equivalence to these legally marketed predicates.

Summary

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SIEMENS

K982028

APPENDIX 1

JUL 1 4 1998

510(k) Summary Fluorospot Compact

Submitted by:

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

June 8, 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.

1. Contact Person:

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

Device Name and Classification: 2.

Trade Name: Classification Name: CFR Section: Device Code:

Fluorospot Compact Image Intensified Fluoroscopic X-ray System 21 CFR 8892.1650. Class II 90JAA

" "

3. Substantial Equivalence:

The Fluorospot Compact is substantially equivalent to the following Siemens Medical Systems' devices:

1. Fluorospot T.O.P K961871, cleared by FDA on July 31, 1996
1. Fluorospot H (Version 2) K914525, cleared by FDA on November 19, 1991

Fluorospot H (Version 1) K911082, cleared by FDA on May 1, 1991

4. Device Description:

Siemens Medical Systems, Inc.

Sales and Service

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SIEMENS

systems with multi-functional use capability, thus allowing trained healthcare professionals to perform x-ray imaging using conventional film or digital imaging. Upon acquiring digital images, the user can display them on the live monitor in the exam room, as well as the control room for review. Multiple digital image acquisition and storage is possible without interrupting the procedure to change film.

న. Intended Use of the Device:

The Fluorospot Compact digital imaging system, is an optional integral component of a radiographic/fluoroscopic x-ray system, and as such it is not considered a stand alone device. The Fluorospot Compact is intended for use with x-ray systems to digitally acquire, record and display radiographic images. The Fluorospot Compact enables the trained healthcare professional to consistently acquire high quality images for fluoroscopic examinations with contrast medium, urological examinations as well as vascular and non-vascular procedures.

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

The Fluorospot Compact has the same technological characteristics as the predicates Fluorospot T.O.P. and Fluorospot H. They utilize PC based technology to acquire, store and post process images from the image intensifier/TV chain output of an image intensified fluoroscopic system.

Kathleen Rutherford

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

Siemens Medical Systems, Inc.

Sales and Service

186 Wood Avenue South Iselin, NJ 08830

Tel: (732) 321-4500 Fax: (732) 494-2250

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three lines representing its head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 1998

Malgorzata Stanek Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830

Re:

K982028

Fluorospot Compact Dated: June 8, 1998 Received: June 9, 1998 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA

Dear Mr. 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 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, 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 Resulations, 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 (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 predication 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/cdrb/dsmaldsmamain.html".

Sincerely yours,

Kilian Yih

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

Enclosure

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APPENDIX 2 INDICATIONS FOR USE

510(k) Number (if known): Fluorospot Compact Device Name:

Indications For Use:

( please do no write below this line- continue on another page if needed )

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

・・・・

David A. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic

510(k) Number K982028

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

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.