The Fluoroscan InSight is a Mini C-Arm Fluoroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including, but not limited to surgical orthopedic and podiatry use, critical and emergency care procedures, and light anatomy imaging situations.

Device Description

The Fluoroscan InSight is a Mini C-Arm Fluoroscopic Imaging System. It has dimensions of 65" (165.1cm) x 35" (88.9cm) x 35" (88.9cm) and a maximum weight of 650 lbs (295.46 kg). It uses a grounded anode x-ray tube with a 0.005" (0.127 mm) Beryllium window and Stainless Steel with Al equivalence > 2.5mm beam filtration. The focal spot is 0.0018" (0.045mm) @ 7.5 watts. The field of view is operator selectable, 4" or 6" collimation (10.16 cm or 15.24 cm) at the plane of the Image Intensifier. The rated peak tube potential is 75kVp with a tube kVp range of 40 to 75kVp. The system includes a digital video camera, a 2.4 GHz processor with 512 MB RAM, Serial 80 GB HDD, DVD RAM drive, and a 3.5" Floppy drive. It runs on Windows XP and has a medical grade 2 Mega Pixel 19.8" Monochrome Flat LCD display. Input devices include a Keyboard, Footswitch, and Touch Screen.

AI/ML Overview

The provided text is a 510(k) summary for the "Fluoroscan InSight Mini C-Arm Fluoroscopic Imaging System." This document aims to demonstrate substantial equivalence to a predicate device, not to present a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for an AI/CAD system would.

Therefore, the requested information elements related to acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are largely not applicable or cannot be directly extracted from this type of regulatory submission.

The 510(k) summary focuses on comparing the new device's technical specifications and intended use against a legally marketed predicate device (Fluoroscan Premier - FS-IV) to assert that it is substantially equivalent and thus safe and effective. It does not contain a study explicitly designed to prove performance against pre-defined acceptance criteria in terms of accuracy, sensitivity, specificity, or reader performance improvement.

Here's a breakdown of why some questions are not directly answerable by the provided text, along with what can be inferred:

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

Acceptance Criteria: Not explicitly stated in the document as performance metrics (e.g., specific accuracy thresholds, sensitivity, or specificity). The "acceptance criteria" in this context would implicitly be that the new device's technical specifications and intended use are substantially equivalent to the predicate device, and that it meets relevant regulatory standards for fluoroscopic imaging systems (e.g., radiation safety, image quality for diagnostic purposes).
Reported Device Performance: The document provides a comparison of technical specifications between the new device (Fluoroscan InSight) and its predicate (Fluoroscan Premier FS-IV) in the "Substantial Equivalence" table. This comparison is the "performance" data relevant to this submission, demonstrating that the new device performs similarly or better in key technical aspects.

Feature / Criterion (Implicit)	Predicate Device (Fluoroscan Premier - FS-IV)	Fluoroscan InSight (New Device)
Intended Use	Mini C-Arm Fluoroscopic Imaging System for general visualization in orthopedic, podiatry, critical, emergency, and light anatomy situations	Same (Substantially Equivalent)
Device Type	Mini C-Arm Fluoroscopic Imaging System	Same
510(k) Number	K974058	Same (implies substantial equivalence due to prior clearance)
Dimensions (HxWxD)	60" x 36" x 32" (152cm x 91cm x 81cm)	65" x 35" x 35" (165.1cm x 88.9cm x 88.9cm) (Slightly larger)
Weight (maximum)	500 lbs (227 kg)	650 lbs (295.46 kg) (Heavier)
Voltage (nominal)	100/120/220/240 Single Phase	Same
Frequency	50/60 Hz	Same
Source-Image receptor distance	17.5" (44cm)	Same
X-Ray Source	Grounded anode x-ray tube 0.005" (0.127mm) Beryllium	Same
Beam Filtration	Stainless Steel with Al equivalence > 2.5mm	Same
Focal Spot	0.0018" (0.045mm) @ 7.5 watts	Same
Field of View	Operator selectable, 4" or 6" collimation	Same
Rated peak tube potential	75kVp	Same
Tube kVp range	40 to 75kVp	Same
Tolerances (kVp, mA)	kVp ± 5%; mA ± 8% ≤ 0.035mA; mA ± 5% ≥ 0.035mA	Same
Maximum duty cycle at 75 kVp/0.100mA	50%	Same
Video Camera	Analog	Digital (Improved)
System computer processor	850 MHz	2.4 GHz (Improved)
System computer RAM (minimum)	128 MB	512 MB (Improved)
System computer storage	CD-ROM, 20 GB HDD, 3.5" Floppy	Serial 80 GB HDD, DVD RAM drive, 3.5" Floppy drive (Improved)
Operating System	Windows NT Embedded	Windows XP (Improved/Updated)
Display	Dual 15" Hi-Res CRT	Medical grade 2 Mega Pixel 19.8" Monochrome Flat LCD (Improved)
Input Devices	Keyboard, Footswitch, Touch Screen	Same

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

Not Applicable. This is a 510(k) submission for a fluoroscopic imaging system, not an AI/CAD device. There is no "test set" in the sense of a dataset of patient images used to evaluate algorithmic performance. The evaluation is based on technical specifications and engineering tests.

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. See point 2. There's no test set requiring expert ground truth for image interpretation.

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

Not Applicable. See point 2.

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 is not an AI/CAD device. It's a fluoroscopic imaging system. No MRMC studies are described.

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

Not Applicable. This is not an AI/CAD device.

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

Not Applicable. For a fluoroscopic imaging system, "ground truth" relates to physical measurements and engineering standards (e.g., kVp accuracy, dose measurements, image resolution tests) rather than diagnostic patient outcomes. The document doesn't detail these underlying engineering tests.

8. The sample size for the training set

Not Applicable. This is not an AI/CAD device that requires a "training set."

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

Not Applicable. See point 8.

Summary

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F. 510(k) Summary

F.1 Manufacturing Establishment and Contact Information

F.1.1 Manufacturer Name and Address:

Hologic, Inc. 35 Crosby Drive Bedford, MA 01730

F.1.2 Establishment Registration Number:

1221300

F.1.3 Name, Title, and Telephone Number of Contact:

Daniel F. Phelan Senior Regulatory Affairs Specialist (781) 999-7300

F.2 Device Identification

F.2.1 Device Trade Name:
Fluoroscan InSight Mini C-Arm Fluoroscopic Imaging System
F.2.2 Common / Usual Name:
Fluoroscopic Imaging System
F.2.3 Proposed Intended Use:
The Fluoroscan InSight is a Mini C-Arm Fluoroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including, but not limited to surgical orthopedic and podiatry use, critical and emergency care procedures, and light anatomy imaging situations.

F.3 Device Classification

F.3.1 Classification:
Class II
F.3.2 Classification Name and Rule:
Image-Intensified Fluoroscopic X-Ray System, 21 CFR 892.1650
F.3.3 Classification Panel:
Radiology
F.3.4 Product Code:
90 JAA
F.3.5 Predicate Device
510(k) No.: K974058

Trade Name: FS IV Mini C- Arm System

January 12, 1998. SE Date:

Manufacturer: Hologic, Inc.

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F.4 Substantial Equivalence

	Fluoroscan Premier(FS-IV)	Fluoroscan InSight
	Image: Fluoroscan Premier(FS-IV)	Image: Fluoroscan InSight
510(k) Number	K974058	Same
Indications for Use	Mini C-Arm Fluoroscopic Imaging Systemdesigned to provide physicians with generalfluoroscopic visualization of a patient,including, but not limited to surgicalorthopedic and podiatry use, critical andemergency care procedures, and lightanatomy imaging situations	Same
Dimensions (HxWxD)	60" (152cm) x 36" (91cm) x 32" (81cm)	65" (165.1cm) x 35" (88.9cm) x 35" (88.9cm)
Weight (maximum)	500 lbs (227 kg)	650 lbs (295.46 kg)
Voltage (nominal)	100/120/220/240 Single Phase	Same
Frequency	50/60 Hz	Same
Source-Image receptordistance	17.5" (44cm)	Same
X-Ray Source	Grounded anode x-ray tube 0.005" (0.127mm) Beryllium	Same
Beam Filtration	Stainless Steel with Al equivalence >2.5mm	Same
Focal Spot	0.0018" (0.045mm) @ 7.5 watts	Same
Field of View	Operator selectable, 4" or 6" collimation(10.16 cm or 15.24 cm) at plane of ImageIntensifier	Same
Rated peak tubepotential	75kVp	Same
Tube kVp range	40 to 75kVp	Same
Tolerances	kVp ± 5%mA ± 8% ≤ 0.035mAmA ± 5% ≥ 0.035mA	Same
Maximum duty cycleat 75 kVp/0.100mA	50%	Same
Video Camera	Analog	Digital
System computer	850 MHz processor	2.4 GHz processor
minimum requirements	128 MB RAM	512 MB RAM
	CD-ROM	Serial 80 GB HDD
	20 GB HDD	DVD RAM drive
	3.5" Floppy	3.5" Floppy drive
Operating System	Windows NT Embedded	Windows XP
Display	Dual 15" Hi-Res CRT	Medical grade 2 Mega Pixel 19.8" MonochromeFlat LCD
Input Devices	Keyboard, Footswitch, Touch Screen	Same

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Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird in the center. The text around the perimeter appears to be the name of a department or organization. The bird is depicted with three curved lines representing its body and wings, giving it a sense of motion. The logo has a simple, clean design, likely intended to represent the organization's values or mission.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 13 2005

Mr. Daniel F. Phelan Senior Regulatory Affairs Specialist HOLOGIC, Inc. 35 Crosby Drive BEDFORD MA 01730

Re: K051025

Trade/Device Name: Fluoroscan InSight Mini C-Arm Fluoroscopic Imaging System Regulation Number: 21 CFR §892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA r K Dated: April 21, 2005 Received: April 25, 2005

Dear Mr. Phelan:

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 (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 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 r carrar states and regarding, 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) (21 CFR Part 801); 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 Section 510(k) I mis letter will anow you to ogin hances of substantial equivalence of your device to a legally premarket notification. The I Dri mailig of oation 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), please If you desire specific advice for your de restled in the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation entersely formation on your responsibilities under the Act from the 007.97). Tou may obtain outer general missance at its toll-free number (800) DIVISION of Stilan Manufactures, Internet address http://www.fda.gov/cdrh/dsmaldsmamain.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

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A.2 Indications for Use Statement

510(k) Number (if known):K0510 25 ____________________________________________________________________________________________________________________________________________

Device Name: _Fluoroscan InSight Mini C-Arm Fluoroscopic Imaging System

Indications for Use:

The Fluoroscan InSight is a Mini C-Arm Fluoroscopic Imaging System designed to provide physicians TTle Fluoroscan frisualization of a patient, including, but not limited to surgical orthopedic and with general hoorosopic visualization of a patient, wis and light anatomy imaging situations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter-Use

(Per 21 CFR 801.109)

(Optional Format 1)

Nancy Beaudoin

(Division Sign Division of Reproductive, Ab and Radiological Device 510(k) Number

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.