The B-400 Ceiling Mounted C-Positioner is a device intended to hold an X-Ray tube and an image intensifier 180° apart in a "C" configuration for the purpose of verforming general purpose diagnostic fluoroscopic procedures. The C-Positioner allows variable positioning of the X-Ray tube/Image Intensifier from +145 degrees Left Anterior Oblique (LAO) to 55 degrees Left Posterior Oblique (LPO). The device will maintain isocenter throughout its full range of motorized movement. The entire assembly is mounted to a set of ceiling rails.

AI/ML Overview

The provided text is a 510(k) summary for the OMEGA MEDICAL IMAGING, INC. B-400 Isocentric Ceiling Mounted C-Positioner, a device intended to hold an X-Ray tube and an image intensifier for general purpose diagnostic fluoroscopic procedures. The document establishes substantial equivalence to predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) cannot be answered because the document details a regulatory submission based on substantial equivalence, not a performance study as would be typical for an AI/ML device.

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

The provided document does not explicitly state acceptance criteria in the typical sense of a performance study with numerical targets for metrics like accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" are based on demonstrating substantial equivalence to existing legally marketed predicate devices. The "reported device performance" is essentially a comparison of its technological characteristics and intended use to these predicate devices.

Here's a table based on the substantial equivalence comparison:

Characteristic/Criteria Category	Predicate Devices (Representative Range/Values)	B-400 Performance (Claimed)	Assessment against "Criteria" (Substantial Equivalence)
Intended Use	To support X-Ray Diagnostic Source Assembly & Image Receptor for Fluoroscopy (Common to all listed predicates)	To support X-Ray Diagnostic Source Assembly & Image Receptor for Fluoroscopy	Meets: Identical intended use, which is a primary criterion for substantial equivalence. The document explicitly states: "All of the devices listed above have the same intended use."
Device Description/Type	Ceiling Mounted 'C' Positioner / Cardiac Positioner / Fluoroscopy C-Arm (All predicates are ceiling-mounted C-arms)	Ceiling Mounted 'C' Positioner	Meets: Categorized as a ceiling-mounted C-Arm, consistent with predicates. The summary states: "The above devices are essentially all ceiling suspended C-Arms with some variations."
Technological Characteristics			Meets: The document repeatedly asserts: "The B-400 and the predicate devices all have the same intended use: to support the X-Ray tube (Diagnostic Source Assembly) and the Image Intensifier (Image Receptor) directly opposite each other with some variation in the distance from the X-Ray tube to the Image Receptor (SID), for diagnostic fluoroscopic procedures." The differences are described as "market driven variables."
Source to Image Distance (SID)	Variable (e.g., 32"-42" for B350, 34"-50" for Pegasus, 86.5-116.6 cm for Philips, Not available for Ariel)	Variable 46" to 56"	Meets: Range is within the variability seen across predicate devices and considered a "market driven variable", not a fundamental difference in safety or effectiveness.
Rotation about Vertical Axis	Fixed at lateral center (B350), +45°/-90° (Pegasus), +90°/-90° (Ariel, Integras)	+/- 180°	Meets: While the range is different, it's presented as a variation in capability (a "market driven variable") rather than a fundamental difference in technology or safety/effectiveness that would preclude substantial equivalence for the core function of a fluoroscopic C-arm.
Arc Rotation	+60°/-30° (B350), +30°/-90° (Pegasus), +45°/-45° (Ariel), +70°/-90° LAO/RAO (Integras)	+145°/-55°	Meets: Again, a different range, but considered a "market driven variable" or user preference.
C-Arm Radius (Throat)	43" (B350), 46½" (Pegasus), 36" (Integras), Not available (Ariel)	36"	Meets: Falls within the range or is comparable to predicate devices.
C-Arm Width O.D. Dimension	89" (B350), 91" (Pegasus), Not available (Ariel, Integras)	78"	Meets: Falls within the range or is comparable to predicate devices. Smaller width may even be seen as advantageous in some contexts.
Safety and Effectiveness	Implied to be safe and effective due to prior marketing and regulatory clearance of predicate devices when used for general diagnostic fluoroscopic procedures.	Implied to be safe and effective based on substantial equivalence to predicate devices for its intended use and technological characteristics.	Met implicitly: The fundamental 'acceptance criterion' is that the device is as safe and effective as the predicate devices. The discussion explicitly states: "The Omega B-400 Ceiling Mounted C-Positioner (C-Arm) has the same intended use & technological characteristics as the above listed devices as well as any number of other Ceiling Mounted C-Arms that have been legally marketed in the U.S. for many years."

Summary

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

ﻪ ..

1990053 OMEGA MEDICAL IMAGING, INC. -B-400

January 6, 1999

510 (k) Summary

Submitter: Omega Medical Imaging, Inc., 675 Hickman Circle, Sanford, FL 32771 Douglas M. Coon, President.

Device Name: B-400 Isocentric Ceiling Mounted C-Positioner.

Classification Name: System, Fluoroscopic, Image Intensified, All Types,

Common/Usual Name: C-Arm

Substantially Equivalent Devices: Fisher's PEGASUS Ceiling Mounted Cardiac Positioner. Fisher's ARIEL Ceiling Mounted C-Arm, Fisher's CPS Ceiling Mounted Imaging System, Philip's INTEGRIS HM 3000 and Omega B-350 Ceiling Mounted Positioner.

Description: The B-400 Ceiling Mounted C-Positioner is a device intended to hold an X-Ray tube and an image intensifier 180° apart in a "C" configuration for the purpose of verforming general purpose diagnostic fluoroscopic procedures.

The C-Positioner allows variable positioning of the X-Ray tube/Image Intensifier from +145 degrees Left Anterior Oblique (LAO) to 55 degrees Left Posterior Oblique (LPO). The device will maintain isocenter throughout its full range of motorized movement. The entire assembly is mounted to a set of ceiling rails.

Intended Use: To support the Diagnostic Source Assembly & Image Receptor used in performing general-purpose diagnostic fluoroscopic procedures.

Summary of Technological Characteristics: The B-400 Ceiling Mounted C-Positioner has the same technological characteristics as the predicate devices. The B-400 and the predicate devices all have the same intended use: to support the X-Ray tube (Diagnostic Source Assembly) and the Image Intensifier (Image Receptor) directly opposite each other with some variation in the distance from the X-Ray tube to the Image Receptor (SID), for diagnostic fluoroscopic procedures. The only differences in the devices are market driven variables such as the SID, arc rotation for different procedures, and the ability to rotate about the ceiling axis. The above devices are essentially all ceiling suspended C-Arms with some variations, depending on user preference. The Omega B-400 Ceiling Mounted C-Positioner (C-Arm) is substantially equivalent to the predicate devices as well as any number of other Cciling Mountcd C-Arms that have been legally marketed in the U.S. for many years.

Page 86

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

OMEGA MEDICAL IMAGING, INC. _ _ B-400

SUBSTANTIAL EQUIVALENCE COMPARISON

Device Model:	Omega B400	Omega B350	Fisher Pegasus	Fisher Ariel	Philips IntegrasHM 3000
510(k):Classification:	Submitted Herein90JAA	K97094790JAA	K91559290JAA	K88052790JAA	K92381390JAA
Description:	Ceiling Mounted'C' Positioner	Ceiling Mounted'C' Positioner	Ceiling MountedCardiac Positioner	Ceiling MountedFluoroscopy C-Arm	Ceiling MountedC-Arm Portion
Intended Use:	'C'-Arm to supportX-Ray DiagnosticSource Assembly& Image Receptorfor Fluoroscopy	'C'-Arm to supportX-Ray DiagnosticSource Assembly& Image Receptorfor Fluoroscopy	'C'-Arm to supportX-Ray DiagnosticSource Assembly& Image Receptorfor Fluoroscopy	'C'-Arm to supportX-Ray DiagnosticSource Assembly& Image Receptorfor Fluoroscopy	'C'-Arm to supportX-Ray DiagnosticSource Assembly& Image Receptorfor Fluoroscopy
Source to ImageDistance (SID):	Variable46" to 56"	Variable32"to 42"	Variable34" to 50"	Not available	Variable86.5 to 116.6 cm
Rotation aboutVertical Axis:	+/- 180°	Fixed atlateral center	+45°/-90°	+90°/-90°	+90°/-90°
Arc Rotation:	+145°/-55°	+60°/-30°(30° LAO to 120° LPO)	+30°/-90°	+45°/-45°	+70°/ 90°LAO/RAO
C-Arm Radius(Throat):	36"	43"	46½"	Not available	36"
C-Arm WidthO.D. Dimension:	78"	89"	91"	Not available	Not available

DISCUSSION: All of the devices listed above have the same intended use: to support the X-Ray tube (Diagnostic Source Assembly) and the Image Intensifier (Image Receptor) directly opposite each other with some variation in the distance from the X-Ray tube to the Image Receptor (SIP), for diagnostic fluoroscopic procedures. The only differences in the above devices are market driven variables such as the SID, arc rotation for different procedures, and the ability to rotate about the ceiling axis. The above devices are essentially all ceiling suspended C-Arms with some variations depending on user preference. The Omega B-400 Ceiling Mounted C-Positioner (C-Arm) has the same intended use & technological characteristics as the above listed devices as well as any number of other Ceiling Mounted C-Arms that have been legally marketed in the U.S. for many years.

Page 87

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

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1999

Douglas Coon President & CEO Omega Medical Imaging Incorporated 675 Hickman Circle Sanford, FL 32771

Re:

K990055 B-400 Ceiling Mounted Positioner Dated: January 6, 1999 Received: January 7, 1999 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA

Dear Mr. Coon:

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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic 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 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 micht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation 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 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

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Model B-400 C-Arm ( C-Positioner)

Indications For Use:

Device Intended Use

This device is intended to support the X-Ray Diagnostic Source Assembly and the Image Receptor. It is not designed nor intended to be used in any General Purpose X-Ray System.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Segner

(Division Sign-Off)

Division of Reproductive, Abdominal, EN and Radiological I 510(k) Number

Prescription Use(Per 21 CFR 801.109)	X
------------------------------------------	---

Over-The-Counter Use

(Optional Format 1-2-96) Page 9

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.