The Digital X-ray Capture Device Saturn 8000 Systems is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).

Device Description

The "Digital X-ray Capture Device (Saturn 8000 System)" (as Saturn 8000 System) is equipped with digital detector. X-ray generator interface, and image acquisition. The digital detector is a flat panel detector. The input X-ray photons are absorbed in scintillator layer that creates a visible light photon, and then the photon is absorbed in TFT-array to create an electrical charge which is representation of the X-ray inout. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. Interfacing with generator can be achieved by Automatic Exposure Detection ("AED") technology which allows detector to automatically detects X-ray exposure. The Saturn 8000 System contains the operation workstation software, which is installed on acquisition workstation ("AWS"), which contains monitor, keyboard and mouse, computer, electronics, and accessory storage. The resultant output signal can be transmitted to remote viewing sites, and/or it can be stored electronically for later viewing. The AWS is used for image acquisition, processing, and display. The AWS can also be used for database management and can send images to archive, review or filming.

AI/ML Overview

Based on the provided text, the Saturn 8000 System is a general-purpose diagnostic X-ray system. The document describes a 510(k) submission to the FDA, indicating that the device aims to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria and clinical study design is not present in these documents.

Here's a breakdown of what can be extracted and what is not available:

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

This information is not provided in the given documents. The submission focuses on demonstrating substantial equivalence to a predicate device (Samsung LTX240AA01-A) through bench testing and electrical safety assessments, rather than presenting a clinical study with specific performance acceptance criteria.

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

This information is not provided. As no clinical study is detailed, there's no mention of a test set, sample size, or data provenance.

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):

This information is not provided. There is no mention of a ground truth established by experts for a test set in these documents.

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

This information is not provided. There is no mention of a test set or adjudication method.

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:

An MRMC comparative effectiveness study was not mentioned or described in the provided text. The device is a digital X-ray capture system, not an AI assistance tool for human readers.

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

This information is not applicable in the context of this device. The Saturn 8000 System is a hardware device (digital X-ray capture system) combined with acquisition workstation software. It generates images for human interpretation, not an algorithm that performs standalone diagnoses.

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

This information is not provided. No ground truth for a clinical evaluation is discussed.

8. The sample size for the training set:

This information is not provided. There is no mention of a training set, as this is a 510(k) submission for a hardware device, not an AI/machine learning algorithm that requires training data.

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

This information is not provided. No training set or ground truth for it is mentioned.

Summary of available information:

The provided documents describe a 510(k) submission for the Saturn 8000 System, a "Digital X-ray Capture Device."

Device Function: Generates digital X-ray images for general radiographic applications, excluding fluoroscopic, angiographic, and mammographic uses. It replaces traditional film-screen based general radiography systems.
Mechanism: Uses a flat panel detector where X-ray photons are absorbed by a scintillator layer, creating visible light photons, which are then absorbed by a TFT-array to create an electrical charge representing the X-ray input. This charge is converted into an electrical signal and processed by acquisition workstation software.
Substantial Equivalence Claim: The device claims substantial equivalence to the Samsung LTX240AA01-A (cleared as 510k K090742).
Proof of Equivalence: Substantiated through "Bench testing and electrical safety."
Safety and Effectiveness Concerns: Electrical, mechanical safety, and performance testing were conducted according to standards EN/IEC 60601-1 (ed.2);am1;am2, and EMC testing according to IEC 60601-1-2: 2007 (ed.3). All test results were reported as "satisfactory," and the device "does not raise any new significant issues of safety, effectiveness or performance" compared to predicate devices.
FDA Clearance: The FDA issued a substantial equivalence determination (K120380) dated March 9, 2012, based on the submitted information.

In essence, the document serves as a regulatory submission demonstrating the safety and effectiveness of a new medical device by comparing it to an already cleared device, rather than providing details of a clinical trial with specific performance metrics and acceptance criteria for a novel technology.

Summary

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MAR - 9 2012

Doc. NO. Rev. NO. 1.0 Issued date Page

15.of 51 2012.01.27

This 510k summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

Saturn 8000

510k Submission

Initial Importer/Distributor Address:

New Medical Co., Ltd. No.32, 3F., Section 2, Zhongyang S. Rd., Beitou District, Taipei City 112, Taiwan, ROC +886-2-2892-2275 +886-2-2892-2172

Contact Person

Phone number:

Fax number:

Email: Phone: Fax:

Manufacturer

WesleyL@newmedical.com.tw +886-2-2892-2275 +886-2-2892-2172

Vieworks Co., Ltd #604 Suntechcity II, 307-2 Sangdaewon-dong, Jungwon-gu, Seongnam-city, Gyeonggi-do, 462-806, South Korea Tel: +82-70-7011-6161 Fax: +82-31-737-4954

Device Name and Classification Trade name/Product Name: Classification name: Common name: Product Code: Regulation Number

Saturn 8000 System Stationary X-ray System General purpose diagnostic X-ray System MQB 892.1650

Date Prepared

2011.01.27

Substantial Equivalence claimed to:

Samsung LTX240AA01-A

New Medical Co., Ltd. Confidential

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Device Description

Indications for Use

The Saturn 8000 system generates digital X-ray images that can be used for general X-ray system except fluoroscopic, angiographic, and mammographic applications. The Saturn 8000 system can interface to any X-ray generator and get digital X-ray image. The Saturn 8000 is intended to be used in same clinical application as traditional film-screen based general radiography system.

Substantial Equivalence

The Saturn 8000 System is substantially equivalent to the commercially available Samsung LTX240AA01-A cleared as 510k K090742. Bench testing and electrical safety further substantiate equivalence to the predicate. The Saturn 8000 System utilizes the Vieworks VIVIX-S panel and LTX240AA01-A is manufactured by Samsung Mobile Display Co., Ltd.

General Safety and Effectiveness Concerns

Electrical, mechanical safety and performance testing according to standard EN/IEC 60601-1(ed.2), EN/IEC 60601-1(ed.2);am1, and EN/IEC 60601-1(ed.2);am2 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2: 2007(ed.3). All test results were satisfactory.

New Medical Co., Ltd. Confidential

16/5,1

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Image /page/2/Picture/0 description: The image shows a stylized logo with the letters 'N' and 'I' intertwined. The 'N' is larger and bolder, appearing in black with a textured, almost distressed look. The 'I' is smaller and positioned to the right of the 'N', also in black but with a similar textured effect. The overall design has a slightly edgy or urban feel due to the distressed texture.

Saturn 8000 510k Submission

Doc. NO.
Rev. NO.	1.0
Issued date2012.01.27	Page17 of 51

Conclusion

The results of all testing demonstrate that the Saturn 8000 does not raise any new significant issues of safety, effectiveness or performance of the device when compare to the existing predicate devices.

New Medical Co., Ltd. Confidential

17/51

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

9 2012 MAR -

New Medical Co., Ltd. % Mr. Jun-Hsiung Lin New Medical Co., Ltd. 1441 Kem Way WALNUT CA 91789

Re: K120380

Trade/Device Name: Saturn 8000 System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: January 27, 2012 Received: February 2, 2012

Dear Mr. Lin:

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, Dray, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic recry that as novice, subject to the general controls provisions of the Act. The r ou may, therefore, manol at 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 class II (Special Controls), it may be subject to such 11 your device is clussified (bee acor regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 I loase of action and I Dr. Direction that your device complies with other requirements of the Act that I Dri has intact a and regulations administered by other Federal agencies. You must of any I oderal statutes and regulaments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as over in in in in in the as described in your Section 510(k) premarket with anow you to begin malinential 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 Parts 801 and 11 you don't be office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 9 150. Those note 1800 1000 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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting 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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Saturn 8000 510k Submission

Doc. NO.
Rev. NO.	1,0
Issued date	2012.01.27
Page	13 of 51

510(K) Number (if known):

Device Name: Saturn 8000 System

Indications For Use:

Prescription Use V (Part 21 CFR 801 Subpart D)

·AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary Pastel
(Division Sign-Off)

Division of Radiological De Office of In Vitro Diagnostic Device Eva

New Medical Co., Ltd. Confidential 510K

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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.