ARCO FP-S is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during othopaedic, neuro, abdominal, vascular, thoracic and cardiac procedures. ARCO FP-S device can be used on all patients except paediatric patients within the limit of the device.

Device Description

ARCO FP-S is a mobile C-arm with the solid-state image detector "Flat Panel". It will be realized in 2 models, depending on the size of the detector: Model: ARCO FP-SR21 Dual focus 0.3/0.6 mm, rotating anode X-Ray tube, generator nominal power 5 KW. Detector size 21x21 cm, 1024x1024 pixel. Models: ARCO FP-SR30 Dual focus 0.3/0.6 mm, rotating anode X-Ray tube, generator nominal power 5 KW. Detector size 30x30 cm, 1536 x 1536 pixel. The system consists of: C-arm Stand, X-RAY MONOBLOC, rotating anode, FLAT PANEL DETECTORS: 2121cm or 3030cm, MONITOR LCD 27" QUAD HD format 16:9, CONTROL PANEL, X-RAY COLLIMATOR, SYSTEM CONTROLLER, X-RAY HAND SWITCH, ARTICULATED ARM FOR MONITOR SUPPORT, ANTISCATTERING GRID. Optional components include FOOTSWITCH, two-foot pedal, LASER LOCALISER, Dose Area Meter, DSA Packages, I.R. remote controls, DICOM Classes, EXTERNAL VIDEO OUTPUT-Wireless transmission, DICOM DATA Wi-Fi transmission to Ethernet/PACS, NFC LOGIN, Wireless monitor trolley, model TROTTER W, for duplicating the image of the monitor on board.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called ARCO FP-S, a mobile X-ray device. The submission aims to demonstrate substantial equivalence to a predicate device (ARCO FP K182086). The study is primarily a non-clinical bench test and radiologist's image evaluation to confirm that the changes made to the device (specifically, the digital x-ray receptor panels) do not negatively impact its performance or safety compared to the predicate.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative table format with pass/fail thresholds in the provided document. Instead, the document asserts "substantial equivalence" based on various performance specifications relative to the predicate device and the evaluation of image quality by a radiologist. The implicit acceptance criterion is that the performance of the ARCO FP-S, especially concerning image quality, must be at least equivalent to, or better than, the predicate device.

Performance Characteristic	Acceptance Criteria (Implicit: at least equivalent to predicate)	Reported Device Performance (ARCO FP-S)	Conclusion (Implicit)
Detector (21x21 Model)	- Active detector size: ~207x207 mm (predicate PIXIUM 2121S)	- PaxScan 2121DXV (new)	Met
	- Pixel size: ~154 μm (predicate PIXIUM 2121S)	- Active detector size: 1024x1024 pixel, 205x205 mm	Met
	- Detective Quantum Efficiency (DQE) RQA5:	- Pixel size: 205 μm	Met
	- @1.0 Lp/mm: 56% (predicate PIXIUM 2121S)	- DQE RQA5:	Met
	- @2.0 Lp/mm: 46% (predicate PIXIUM 2121S)	- @1.0 Lp/mm: 65% (improved from predicate)
	- Modulation Transfer Function (MTF) RQA5:	- @2.0 Lp/mm: 40% (slightly lower for 21x21 vs 46% for predicate, but still considered substantially equivalent given overall performance)
	- @1.0 Lp/mm: 59% (predicate PIXIUM 2121S)	- MTF RQA5:	Met
	- @2.0 Lp/mm: 29% (predicate PIXIUM 2121S)	- @1.0 Lp/mm: 50% (slightly lower for 21x21 vs 59% for predicate, but still considered substantially equivalent given overall performance)
	- Nyquist: 11% (predicate PIXIUM 2121S)	- @2.0 Lp/mm: 22% (slightly lower for 21x21 vs 29% for predicate, but still considered substantially equivalent given overall performance)
Detector (30x30 Model)	- Active detector size: ~301x301 mm (predicate PIXIUM 3030S)	- Nyquist: 15% (improved from predicate)
	- Pixel size: ~154 μm (predicate PIXIUM 3030S)	- PaxScan 3030DXV (new)	Met
	- Detective Quantum Efficiency (DQE) RQA5:	- Active detector size: 1516x1516 pixel, 294x294 mm	Met
	- @1.0 Lp/mm: 57% (predicate PIXIUM 3030S)	- Pixel size: 194 μm	Met
	- @2.0 Lp/mm: 48% (predicate PIXIUM 3030S)	- DQE RQA5:	Met
	- Modulation Transfer Function (MTF) RQA5:	- @1.0 Lp/mm: 65% (improved from predicate)
	- @1.0 Lp/mm: 59% (predicate PIXIUM 3030S)	- @2.0 Lp/mm: 44% (slightly lower for 30x30 vs 48% for predicate, but still considered substantially equivalent given overall performance)
	- @2.0 Lp/mm: 29% (predicate PIXIUM 3030S)	- MTF RQA5:	Met
	- Nyquist: 11% (predicate PIXIUM 3030S)	- @1.0 Lp/mm: 55% (slightly lower for 30x30 vs 59% for predicate, but still considered substantially equivalent given overall performance)
Maximum frame per second	25 (predicate)	- @2.0 Lp/mm: 23% (slightly lower for 30x30 vs 29% for predicate, but still considered substantially equivalent given overall performance)	Met
Workstation Monitor Resolution	1920 x 1080 (predicate)	- Nyquist: 15% (improved from predicate)
Diagnostic Image Quality	Acceptable diagnostic quality (predicate)	30 (improved from predicate)	Met
		2560 x 1440 (4K) (Improved from predicate)	Met
		A Board Certified Radiologist reviewed the still and moving images acquired by the newer digital receptor panels and found them to be of good and acceptable diagnostic quality.	Met

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

Sample Size for Test Set: Not explicitly stated in terms of a numerical count of images or cases. The document mentions a "Radiologist's Images evaluation" where the radiologist reviewed "the still and moving images acquired by the newer digital receptor panels." It does not specify how many images or what types of images were reviewed.
Data Provenance: The images were "acquired by the newer digital receptor panels" (PaxScan), implying they are current acquisitions using the modified device. The document does not specify the country of origin or whether the data was retrospective or prospective. Given it's a bench test, the images were likely acquired in a controlled setting for testing purposes.

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

Number of Experts: One ("A Board Certified Radiologist").
Qualifications of Experts: "Board Certified Radiologist." No specific information about years of experience is provided.

4. Adjudication method for the test set

Adjudication Method: Not applicable or "None" in the typical sense of multiple readers and consensus. A single Board Certified Radiologist evaluated the images.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

MRMC Study: No, an MRMC comparative effectiveness study was not explicitly stated or described. The evaluation involved a single radiologist reviewing images to confirm diagnostic quality, not a comparison of human readers with and without AI assistance. The device itself is a C-arm X-ray system, not an AI-assisted diagnostic tool.

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

Standalone Performance: Not applicable for this device as it is an X-ray imaging system, not an AI algorithm performing diagnostic interpretations. The "performance" being evaluated is the quality of the raw images produced by the system.

7. The type of ground truth used

Type of Ground Truth: "Expert consensus" in a limited sense, as it was the subjective assessment of a single Board Certified Radiologist who determined the images were of "good and acceptable diagnostic quality." This is essentially expert opinion on image interpretability for diagnostic purposes. It is not pathology, outcomes data, or an objective gold standard.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. The ARCO FP-S is a hardware device (X-ray system) with upgraded software. There is no mention of a machine learning component requiring a "training set" of images for an AI algorithm. The software upgrade is described as "FUNCTIONALLY IDENTICAL" to the predicate's software.

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

Ground Truth for Training Set: Not applicable, as there is no specified training set for a machine learning algorithm.

Summary

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August 13, 2021.

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

A.T.S. Applicazione Tecnologie Speciali S.R.L % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K211777

Trade/Device Name: ARCO FP-S Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO Dated: June 2, 2021 Received: June 9, 2021

Dear Mr. Kamm:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 contract 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 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211777

Device Name ARCO FP-S

Indications for Use (Describe)

ARCO FP-S is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures.

In particular, the device is to be applied during othopaedic, neuro, abdominal, vascular, thoracic and cardiac procedures. ARCO FP-S device can be used on all patients except paediatric patients within the limit of the device.

Type of Use (Select one or both, as applicable)

	☑ Prescription Use (Part 21 CFR 801 Subpart D)
	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K211777

Image /page/3/Picture/1 description: The image shows a logo with the letters "ATS" in a stylized, bold, sans-serif font. The letters are a dark blue color against a light blue background. The letters are connected to each other, forming a single, unified shape.

A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.. VIA A. VOLTA, 10 -TORRE DE' ROVERI (BG) 24060 ITALY -TEL. +39.035.584311 -FAX +39.035.580220 Date Prepared: July 19, 2021

1. Administrative Information

Submitter:

Submission contact person: Eng. Livia PILLITTERI, QMS & Regulatory Affairs Manager

Identification:

Identification:	ARCO FP-S
Regulation Number:	21 CFR 892.1650
Regulation Name:	Image-intensified fluoroscopic x-ray system
Regulatory Class:	Class II
Product Code:	OWB, OXO

This is a MODIFIED device. The digital x-ray receptor panels have changed.

Substantially equivalent device: K182086

Manufacturer:	A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.
Trade/Device Name:	ARCO FP
Regulation Number:	21 CFR 892.1650
Regulation Name:	Image-intensified fluoroscopic x-ray system
Regulatory Class:	Class II
Product Code:	OWB, OXO

REFERENCE Device: (New digital x-ray receptor panels) K200022 submitted by Livermoretech Trade/Device Name: FLUSION-9001 Fluoroscopic C-arm Mobile X-ray System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA, IZI

1. Indications for Use: ARCO FP-S is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during orthopedic, neuro, abdominal, vascular, thoracic and cardiac procedures. ARCO FP-S device can be used on all patients except pediatric patients within the limit of the device.
1. Device description: ARCO FP-S is a mobile C-arm with the solid-state image detector "Flat Panel" It will be realized in 2 models, depending on the size of the detector: Model: ARCO FP-SR21

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Dual focus 0.3/0.6 mm, rotating anode X-Ray tube, generator nominal power 5 KW. Detector size 21x21 cm, 1024x1024 pixel.

Models: ARCO FP-SR30

Dual focus 0.3/0.6 mm, rotating anode X-Ray tube, generator nominal power 5 KW. Detector size 30x30 cm, 1536 x 1536 pixel.

Image /page/4/Picture/3 description: The image shows two medical devices, a C-arm and a mobile monitor stand. The C-arm is a medical imaging device used in surgical procedures, and it has a large, C-shaped arm that houses an X-ray tube and detector. The image also has labels indicating the stand, footswitch, and remote control. The mobile monitor stand is a device used to display medical images during surgical procedures.

Photo: ARCO FP-S

OPTIONAL STAND: Wireless Monitor

The system consists of:

C-arm Stand:

MECHANICAL STAND
X-RAY MONOBLOC, rotating anode
FLAT PANEL DETECTORS: 2121cm or 3030cm
MONITOR LCD 27" QUAD HD format 16:9
CONTROL PANEL
X-RAY COLLIMATOR
SYSTEM CONTROLLER
X-RAY HAND SWITCH
ARTICULATED ARM FOR MONITOR SUPPORT
ANTISCATTERING GRID

Options:

FOOTSWITCH, two-foot pedal
LASER LOCALISER
Dose Area Meter,
DSA Packages

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I.R. remote controls.
DICOM Classes
EXTERNAL VIDEO OUTPUT-Wireless transmission
DICOM DATA Wi-Fi transmission to Ethernet/PACS
NFC LOGIN
Wireless monitor trolley, model TROTTER W, for duplicating the image of the monitor on board.

Technology Employed

ARCO FP-S is a mobile C-arm unit for fluoroscopy and radiography designed for a wide rangeof surgical applications.

The normal use allows for imaging in the following modes:

Low Dose Fluoroscopy -
-High Quality Fluoroscopy
Digital radiography (Snapshot) l
-Fluoroscopy in Road Mapping mode (optional)
-Fluoroscopy in DSA mode (optional)

The image acquisitions employ X-rays emitted by an X-ray generator which can produce upto 5 kW. The X-rays, attenuated in different ways depending on the tissue they have to pass through, leave an impression on a detector and then they are converted into electrical signal, which forms the image. The main differences from the predicate device are:

The image detectors are new. The Pixium detectors (used in the predicate device) were replaced with Paxscan (used with the subject device, cleared under K200022).

Only the 5 kW power generator is now available.

The software has been upgraded from the predicate software functionality remains the same. The original software (SYSTEMA dRF- software ISIX) and the modified software (SYSTEMA DRF-S software) are FUNCTIONALLY IDENTICAL.

The workstation image display monitor is being upgraded to a higher resolution.

The operating system is upgraded (Windows 7 is no longer supported).

Comparison Chart	PROPOSED DEVICEARCO FP-S	PREDICATE DEVICEARCO FP K182086
INDICATIONS FOR USE	ARCO FP-S is a mobile X-ray device used forradiological guidance and visualizationduring diagnostic, interventional andsurgical procedures. In particular, thedevice is to be applied during orthopedic,neuro, abdominal, vascular,thoracic andcardiac procedures. ARCO FP-S device canbe used on all patients except pediatricpatients, within the limits ofthe device.	ARCO FP is a mobile X-ray device used forradiological guidance and visualizationduring diagnostic, interventional andsurgical procedures. In particular, thedevice is to be applied during orthopedic,neuro, abdominal, vascular,thoracic andcardiac procedures. ARCO FP device can beused on all patients except pediatricpatients, within the limits ofthe device.
CLASS	2	2

4. Technological characteristics: Comparison Table

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Comparison Chart	PROPOSED DEVICEARCO FP-S	PREDICATE DEVICEARCO FP K182086
Product code	OWB; OXO	OWB: OXO
Photo	Image: PROPOSED DEVICE ARCO FP-S	Image: PREDICATE DEVICE ARCO FP K182086
PERFORMANCE SPECIFICATION
A. C-arm
C-Arm Weight	310 kg	280 kg
B. Power Supply
Supply type	Single phase (live/neutral,separateearth)	Single phase (live/neutral,separate earth)
Input Voltage	100, 110, 120, 130, 210, 220, 230, 240 V@50-60Hz	100, 110, 120, 130, 210, 220, 230, 240 V@50-60Hz
X-ray GeneratorMaximum power	5kW	5kW; 20kW
C. X-ray tube
Type	Rotating anode	Rotating anode
Nominal voltage	120 kV	120 kV
Nominal focalspot valuesinputpower	0.3 mm = 6.0kW0.6 mm = 25 kW	0.3 mm = 6.0kW0.6 mm = 25 kW
Maximum heatdissipation	750 W	750 W
Maximumanode heat	225 kJ	225 kJ

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Comparison Chart	PROPOSED DEVICEARCO FP-S	PREDICATE DEVICEARCO FP K182086
content
Anode material	Rhenium-Tungsten-Molybdenum	Rhenium-Tungsten-Molybdenum
Filtration	Possible Filters To Apply:- none- 2mmAl- 1mmAl + 0,1mmCu- 1mmAl + 0,2mmCu	Possible Filters To Apply:- none- 2mmAl- 1mmAl + 0,1mmCu- 1mmAl + 0,2mmCu
D. Detector
	PaxScan2121DXV	PaxScan3030DXV	PIXIUM 2121S	PIXIUM 3030S
Activedetectorsize /Sensitivearea	1024x1024 pixel205x205 mm	1516x1516 pixel294x294 mm	1344 x 1344 pixel207x207 mm	1956 x 1956 pixel301x301 mm
Pixel size	205 μm	194 μm	154 μm	154 μm
Cooling	Passive		Passive
Detective	0 –80%	0 –80%	0 –77%	0 –77%
QuantumEfficiency,RQA5[ Lp/mm@2uGy ]	1.0 - 65%	1.0 - 65%	1.0 - 56%	1.0 – 57%
	2.0 - 40%	2.0 - 44%	2.0 - 46%	2.0 - 48%
ModulationTransferEfficiency(MTF)[ Lp/mm@2uGy ]	1.0 - 50%	1.0 – 55%	1.0 – 59%	1.0 – 59%
	2.0 – 22%	2.0 – 23%	2.0 – 29%	2.0 – 29%
	Nyquist - 15%	Nyquist - 15%	Nyquist-11%	Nyquist-11%
Maximum frame persecond	30		25
	E. Anti-Scattering Grid
Material	Aluminum		Aluminum
Lines/cm	80		80
Grid focus distance	100 cm		100 cm

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Comparison Chart	PROPOSED DEVICEARCO FP-S	PREDICATE DEVICEARCO FP K182086
Ratio	8:1	8:1
F. Workstation monitor
Size / Type	21.7" / LCD	21.5" / LCD
Resolution	2560 x 1440 (4K)	1920 x 1080
Nominal light output	350 cd/m²	1000 cd/m²
G. Control panel monitor
Size / Type	12.5" / LCD touch	12.5" / LCD touch
Resolution	1920 x 1080	1920 x 1080
H. Workstation Operating system
Windows version	Windows 10 (Windows 7 is no longersupported)	Windows 7 or Windows 10

Non clinical testing: In order to demonstrate the EMC and Electrical safety of the proposed device ARCO FP-S, the manufacturer A.T.S. Applicazione Tecnologie Speciali Srl. has performed safety tests incompliance with the standards listed here below:

IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basicsafety and essential performance;
IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests;
IEC 60601-1-3: Medical Electrical Equipment - Part 1-3: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Radiation ProtectionIn Diagnostic X-Ray Equipment;
IEC 60601-1-6: Medical Electrical Equipment - Part 1-6: General Requirements ForBasic Safety And Essential Performance - Collateral Standard: Usability;
IEC 60601-2-43: Medical Electrical Equipment - Part 2-43: Particular RequirementsFor The Safety And Essential Performance Of X-Ray Equipment For Interventional Procedures;
IEC 60601-2-54: Medical Electrical Equipment - Part 2-54: Particular RequirementsFor The Basic Safety And Essential Performance Of X-Ray Equipment For Radiography And Radioscopy.
IEC 60825-1: Safety of laser products - Part 1: Equipment classification andrequirements
IEC 62304: Medical device software - Software life cycle processes
ETSI EN 301 489-17: ElectroMagnetic Compatibility (EMC) standard for radio equipment and services - Part 17: Specific conditions for Broadband Data Transmission Systems; Harmonised Standard for Electro Magnetic Compatibility

In order to demonstrate the performance of the ARCO FP-S, the following quality testing has been performed by A.T.S. Applicazione Tecnologie Speciali Srl:

Radiologist's Images evaluation. A Board Certified Radiologist reviewed the still and moving images ●

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acquired by the newer digital receptor panels and found them to be of good and acceptable diagnostic quality.

The software remains at a MODERATE LEVEL OF CONCERN, and software was validated according to the FDA Software Guidance at that level.

The following FDA guidance was employed in regard to cybersecurity concerns: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff. Our labeling and internal procedures were updated to reflect the recommendations of this guidance.

Clinical testing. Clinical Images are not necessary to establish substantial equivalence to the predicate. Adequate bench testing results should clearly indicate device safety and effectiveness.

7. Substantial Equivalence Discussion.

The ARCO FP-S performs the same functions as the predicate using the same technological methods to produce and store diagnostic x-ray images. In all material aspects, the A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L. devices are substantially equivalent to each other. The detector technological characteristics (resolution, MTF and DQE performance, see comparison table above) all point to substantial equivalence

8. Substantial Equivalence Conclusion:

After analyzing bench test results, risk analysis, and standards compliance, it is the conclusion of A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.. that the ARCO FP-S is as safe and effective as the predicate device, has few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.

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.