The ACCENT systems are mobile image-intensified fluoroscopic x-ray systems, intended for use in general surgical procedures such as orthopedics, traumatology, visceral surgery, pacemaker implants, urology, etc. or other interventional procedures.

Device Description

The ACCENT system is composed of: a mobile C-Arm that includes: an image intensifier with CCD video camera, an x-ray generator and controller, an x-ray tube mounted in the same housing as the x-ray generator, a beam-limiting device, optional: a Laser beam alignment device, optional: a dose area product meter and display. and a monitor cart that includes: TV monitors, an image digital processing and storage system, may be of different models, optional: VCR and video printers.

AI/ML Overview

The provided text is a 510(k) summary for the ACCENT Mobile X-ray System, which is a premarket notification to demonstrate substantial equivalence to legally marketed predicate devices. It does not describe a study to prove the device meets specific acceptance criteria in terms of performance metrics like sensitivity or specificity for a particular clinical task. Instead, it focuses on demonstrating that the device is safe and effective by complying with established standards and being substantially equivalent to existing devices.

Therefore, many of the requested sections about acceptance criteria, study design, and ground truth establishment are not applicable to the information contained in this 510(k) summary.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for a new algorithm or diagnostic aid. Instead, it refers to compliance with safety and performance standards relevant to X-ray systems.

Acceptance Criteria (Compliance/Safety Standards)	Reported Device Performance/Compliance
All construction and materials compliant with UL 2601-1, and IEC 601-1 equipment standards.	Compliant: "All construction and materials are compliant with UL 2601-1, and IEC 601-1 equipment standards."
Design meets or exceeds standards set forth in UL 2601-1 and IEC 601-1.	Meets/Exceeds Standards: "The design meets or exceeds standards set forth in UL 2601-1 and IEC 601-1." Additionally, includes "hardware redundancies to prevent single point failures (such as x-ray emission and C-Arm motion)".
Exposure levels comply with 21CFR 1020.30 - 31 - 32.	Compliant: "Systems comply with the requirements of 21CFR 1020.30 - 31 - 32." Specifics include: Maximum rated peak tube potential: 110 kV, Fluoroscopic Entrance Exposure Rate (EER): less than 10 R/min., Radiography: 160 mAs maximum, manual setting.
Controls for potential hazards (x-ray, mechanical, electrical).	Controlled: "The potential hazards (x-ray, mechanical and electrical) are controlled by compliance with the federal x-ray standard, adherence to industry standards (UL 2601-1) and with the recommendations of other industry experts as described in the labeling."
Substantial Equivalence to Predicate Devices (STENOSCOP 2, Model 6000 and 9000).	Substantially Equivalent: "The ACCENT systems are substantially equivalent to the above listed devices. The energy source, exposure levels and principles of operation are very similar." The device performs the same functions and replaces the listed units. (This is the primary "acceptance criterion" for a 510(k) pathway, rather than a clinical performance study).

2. Sample size used for the test set and the data provenance:

Not Applicable: This document does not describe a performance study with a test set of patient data. The evaluation is based on engineering compliance and substantial equivalence to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable: No ground truth was established from clinical experts for this type of submission.

4. Adjudication method for the test set:

Not Applicable: No test set or adjudication process for clinical outcomes 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: This device is a mobile X-ray system, not an AI-powered diagnostic aid. No MRMC study was performed.

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

Not Applicable: This device is hardware (X-ray system), not an algorithm for standalone performance evaluation.

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

Not Applicable (in the context of clinical ground truth): The "ground truth" for this submission would be regulatory standards and the specifications of predicate devices, against which the ACCENT system's design and operating parameters were compared.

8. The sample size for the training set:

Not Applicable: There is no mention of a training set as this is not an AI/machine learning device.

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

Not Applicable: No training set was used.

In summary: The provided text is a regulatory submission demonstrating the safety and effectiveness of a mobile X-ray system through compliance with established engineering and radiation safety standards, and by demonstrating substantial equivalence to legally marketed predicate devices. It does not contain information about a clinical performance study with defined acceptance criteria, test sets, or ground truth as would be associated with a new diagnostic algorithm or AI-enabled device.

Summary

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K980 322

APR 2 4 1998

510(k) SUMMARIES OF SAFETY AND EFFECTIVENESS

IDENTIFICATION OF THE PRODUCT

ACCENT, MODELS 16 and 22 NAME: MOBILE X-RAY SYSTEM

GE MEDICAL SYSTEMS - EUROPE MANUFACTURER: Loncin, Belgium

GE MEDICAL SYSTEMS DISTRIBUTOR: Milwaukee, Wi

INDICATIONS FOR USE:

The ACCENT systems are mobile image-intensified fluoroscopic x-ray systems, intended for use in The ACCENT systems are noble intension instruction instructions of the orgery, pacemaker
general surgical procedures such as orthopedics, traumatology, visceral surgery, pace general surgiour procedures or other interventional procedures.

DEVICE DESCRIPTION

The ACCENT system is composed of:

a mobile C-Arm that includes:

an image intensifier with CCD video camera .
an x-ray generator and controller ●
an x-ray generator and comfolio.
an x-ray tube mounted in the same housing as the x-ray generator ●
a beam-limiting device ●
optional: a Laser beam alignment device .
optional: a dose area product meter and display .

and a monitor cart that includes:

TV monitors ●
r v Thonkols
an image digital processing and storage system, may be of different models .
optional: VCR and video printers ●

Materials:	All construction and materials are compliant with UL 2601-1, and IEC 601-1
	equipment standards.

Design:	The design meets or exceeds standards set forth in UL 2601-1 and IEC 601-1. There are hardware redundancies to prevent single point failures (such asx-ray emission and C-Arm motion)
Energy Source:	Single phase, plus ground, 100-108-120-200-208-220-228-240 V, 50/60Hz.The supply voltage is set at the installation.
Exposure levels:	Maximum rated peak tube potential: 110 kVFluoroscopic Entrance Exposure Rate (EER): less than 10 R/min.Radiography: 160 mAs maximum, manual settingSystems comply with the requirements of 21CFR 1020.30 - 31 - 32
Mechanical features:	- mobile: forth and back, interlocked lateral travel- C-Arm: forth and back, tilting (wig-wag), rotations

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MARKETING HISTORY:

The ACCENT systems perform the same functions and replace the units listed below:

STENOSCOP 2, Model 6000 ACCENT 16: STENOSCOP 2, Model 9000 ACCENT 22:

ADVERSE EFFECTS ON HEALTH:

The potential hazards (x-ray, mechanical and electrical) are controlled by compliance with the label The potential hazards (X-ray, mechanical and electived) are ochinations of other in the labeling.
federal x-ray standard, adherence to industry standards (UL 2601-1) and wari

CONCLUSIONS

The ACCENT systems are substantially equivalent to the above listed devices. The ACCENT systems are substantians of operation are very similar.
The energy source, exposure levels and principles of operation are very similar. The energy source, exposure levels and pinciples of operation in the courte.

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Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a central emblem. The emblem depicts a stylized image of three human profiles facing right, with flowing lines extending from their heads, resembling a bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Mr. Mike Chilbert Quality, Safety, & Regulatory Engineer Technology & Product Assurance Group GE Medical Systems P.O. Box 414, W-709 MILWAUKEE WI 53201

NOV 1 7 2011

Re: K980322

Trade/Device Name: Accent 16 and 22 (Mobile X-ray System) Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system, mobile Regulatory Class: II Product Code: OXO Dated: January 22, 1998 Received: January 27, 1998

Dear Mr. Chilbert:

This letter corrects our substantially equivalent letter of April 24, 1998.

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 (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. Please Note: CDRH does not evaluate information related to contact liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely Yours,

Michael D. O'Hannon for

Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

avice Name: __ Accent Mobile X-RAY System_

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Slavid C. Segnor
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devi

510(k) Number K980322

Prescription Use_ (Per 21 CFR 801.109)

ﺎ.

Over-The-Counter Use_

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.