The Suinsa Diagnostic X-Ray System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Device Description

This system is a combination of the following Suinsa manufactured components:
The Hercules Generator, with models from 32 to 80 kW. .
The NOVA Ceiling Mounted Tube Stand .
. The NET4000 series X-ray table
The NBS2100 Bucky Wall Stand .

AI/ML Overview

The provided text is a 510(k) summary for the Suinsa Diagnostic X-Ray System (K083104) and a corresponding FDA clearance letter (K083109 - appears to be a typo for K083104 in the letter).

This submission does not describe a study that uses acceptance criteria in the way typically associated with AI/CADe device performance evaluation. Instead, it focuses on demonstrating substantial equivalence to a previously cleared predicate device. Therefore, many of the requested criteria for a study proving device performance (e.g., sample size for test/training sets, ground truth methodology, expert qualifications, MRMC studies, standalone performance) are not applicable or provided in this document.

The "acceptance criteria" here are effectively the demonstration of comparable safety and effectiveness based on bench testing and adherence to standards, rather than clinical performance metrics often seen in AI device submissions.

Here's the information extracted, with explanations for what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k), the "acceptance criteria" relate to demonstrating equivalence to the predicate device in terms of design, function, and adherence to safety standards. The "reported device performance" is essentially that it meets these criteria by being substantially equivalent.

Characteristic	Acceptance Criteria (Predicate)	Reported Device Performance (Suinsa Diagnostic X-Ray System)
Intended Use	Intended for diagnostic radiographic exposures of skull, spinal column, chest, abdomen, extremities, and other body parts, for adult and pediatric subjects, with patient sitting, standing, or lying prone/supine.	SAME as predicate. (Implies the Suinsa device performs these tasks equally well as the predicate).
Configuration	Ceiling Mount (made by Suinsa)	SAME. (Implies similar structural and functional characteristics, leading to comparable performance).
Generator	High Frequency Sedecal	High Frequency Suinsa. (While the manufacturer is different, the "High Frequency" characteristic implies a similar type of performance in X-ray generation, indicating functional equivalence).
Maximum Output	Various models, 32 to 80 kW	SAME, 32 to 80 kW. (Direct matching of a key performance specification for X-ray power, indicating comparable imaging capabilities).
Image Acquisition	Film	Film. (Indicates the same method of image capture, implying similar output quality and handling as the predicate).
Collimator	RALCO	SAME. (Indicates equivalent beam shaping and radiation safety characteristics).
Safety	UL Listed	CSA listed to US Standards. (Demonstrates compliance with recognized safety standards in the US, indicating an equivalent level of safety testing and assurance).
Standards	US Performance Standard + applicable IEC standards	SAME. (Confirms adherence to the same set of regulatory and performance standards, implying equivalent safety and effectiveness based on those standards).
Overall	Bench and standards testing demonstrate safety and effectiveness.	"The results of bench and standards testing indicates that the new device is as safe and effective as the predicate devices." and "After analyzing bench and standards testing data, it is the conclusion of Suinsa that the Suinsa Diagnostic X-Ray Systems is as safe and effective as the predicate devices, have few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate devices."

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

Not Applicable. This submission does not describe a clinical performance study with a "test set" of patient data. The evaluation is based on bench testing and comparison to the predicate device's specifications and compliance.

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 establishment from experts is mentioned for a test set, as no clinical performance study was conducted.

4. Adjudication method for the test set

Not Applicable. No adjudication method is mentioned, as no clinical performance study was conducted.

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

No. This device is a basic X-ray system, not an AI/CADe (Computer-Aided Detection/Diagnosis) device. Therefore, no MRMC study looking at human reader improvement with AI assistance was performed or is relevant.

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

No. This is a hardware X-ray system, not an algorithm. Standalone performance as typically understood for AI/CADe devices is not applicable.

7. The type of ground truth used

Not Applicable. The "ground truth" in this context is the established safety and effectiveness characteristics of the predicate device, against which the new device's specifications and test results (from bench testing) are compared.

8. The sample size for the training set

Not Applicable. There is no mention of an algorithm or AI component requiring a training set.

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

Not Applicable. No training set or ground truth for a training set is mentioned.

Summary

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510(k) Summary

K08 3104

Image /page/0/Picture/3 description: The image contains a logo with the word "Suiinsa" in bold, sans-serif font. Below the word is the phrase "YOUR IMAGING PARTNER" in a smaller font size. There is a black rectangle below the phrase. The image appears to be a company logo or branding element.

SUINSA C/Primavera 39 - Polígono Industrial 'Las Monjas' 28850 Torrejón de Ardoz Madrid / Spain · Tel .: +34 91 6559500 - FAX : +34 91 6755253 Prepared October 8, 2008 Contact: Jose Maria Ortega, CEO

1. Identification of the Device: Proprietary-Trade Name: Suinsa Diagnostic X-Ray System (STATIONARY). Classification Name: Stationary X-ray system, Product Codes Product Code 90 KPR Common/Usual Name: General purpose diagnostic X-ray Unit.
1. Equivalent legally marketed devices: Almana Medical Radvision ET Diagnostic X-Ray Systems K082064
1. Indications for Use (intended use) This X-Ray System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
1. Description of the Device: This system is a combination of the following Suinsa manufactured components:
- The Hercules Generator, with models from 32 to 80 kW. .
- The NOVA Ceiling Mounted Tube Stand .
- . The NET4000 series X-ray table
- The NBS2100 Bucky Wall Stand .
1. Safety and Effectiveness, comparison to predicate device. The results of bench and standards testing indicates that the new device is as safe and effective as the predicate devices.

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6. Substantial Equivalence Chart

Characteristic	Almana Medical Radvision ET	Suinsa Diagnostic X-Ray
	Diagnostic X-Ray Systems K082064	System
Intended Use:	Intended for use by a qualified/trained doctoror technician on both adult and pediatricsubjects for taking diagnostic radiographicexposures of the skull, spinal column, chest,abdomen, extremities, and other body parts.Applications can be performed with thepatient sitting, standing, or lying in the proneor supine position.	SAME
Configuration	Ceiling Mount (made by Suinsa)	SAME
Generator	High Frequency Sedecal	High Frequency Suinsa
Maximum output	Various models, 32 to 80 kW	SAME, 32 to 80 kW
Image Acquisition	Film	Film
Collimator	RALCO	SAME
Safety	UL Listed	CSA listed to US Standards
Standards	US Performance Standard + applicable IECstandards	SAME

7. Conclusion

After analyzing bench and standards testing data, it is the conclusion of Suinsa that the Suinsa Diagnostic X-Ray Systems is as safe and effective as the predicate devices, have few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The words "DEPARTMENT OF HEALTH HUMAN SERVICES - USA" are arranged in a circle around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 4 2008

Suinsa % Mr. Daniel Kamm, P.E. Principal Consultant Kamm & Associates PO Box 7007 DEERFIELD IL 60015

Re: K083109

Trade/Device Name: Suinsa Diagnostic X-Ray System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: October 15, 2008 Received: October 21, 2008

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, Orve 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 (PMA), 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.

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Page 2

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

loque Mr. Whang

Joyce M. Whang, Ph.D. Acting Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):_ K08 3 | OS

Device Name: Suinsa Diagnostic X-Ray System

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dales Lemen

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.