The Saturn 9000-550 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-550 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000-550 is intended to be used in same clinical application as traditional film-screen based general radiography system.

Device Description

The Saturn 9000-550 is equipped with a digital detector, X-ray generator interface, and image acquisition workstation. The digital detector is a-Se deposited plat panel detector. The input X-ray photons are absorbed in a-Se layer that creates an electrical charge which is representation of the Xray input. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. X-ray exposure is controlled by switch box, which also controls the acquisition timing of the detector. Saturn 9000-550 includes acquisition workstation ("AWB") monitor, keyboard and mouse, computer, electronics, and accessory storage. 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

The provided 510(k) summary (K072984) is for a "Special" submission regarding the replacement of a component (the detector) in the Saturn 9000-550 X-ray system. This type of submission, often for modifications to previously cleared devices, typically demonstrates substantial equivalence through technical comparison rather than extensive clinical studies with specific performance acceptance criteria for diagnostic efficacy.

Therefore, the document does not contain the detailed clinical study information and acceptance criteria requested in the prompt. The submission focuses on demonstrating that the modified device (Saturn 9000-550 with a different detector pixel size) maintains the same fundamental technology, indications for use, and safety/effectiveness as its predicate device (Saturn 9000).

Here's why the requested information is absent and what is provided:

A table of acceptance criteria and the reported device performance: This is not present. The document provides a technical comparison table between the predicate and proposed device, highlighting key specifications like detector technology, selenium layer thickness, imaging area, detector pixel size, image bit depth, and data interface. There are no performance metrics (e.g., sensitivity, specificity, accuracy) provided against specific acceptance criteria.
Sample size used for the test set and the data provenance: This information is not provided because a clinical test set demonstrating diagnostic performance against a ground truth is not typically required or presented for a "Special" 510(k) focusing on component replacement that doesn't alter the fundamental scientific technology or indications for use.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic performance study described.
Adjudication method for the test set: Not applicable.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned. The submission is not focused on comparing improvements with AI assistance, as it's an X-ray detector.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for an X-ray imaging system, not an AI algorithm.
The type of ground truth used: Not applicable, as no diagnostic performance study is described.
The sample size for the training set: Not applicable, as this is not an AI/algorithm submission requiring a training set.
How the ground truth for the training set was established: Not applicable.

What the document does provide to demonstrate substantial equivalence:

Device Description: The Saturn 9000-550 is described as using an a-Se deposited flat panel detector, similar to the predicate. The operational principle (X-ray absorption, charge creation, readout) is consistent.
Indications for Use: Explicitly states that the Saturn 9000-550 maintains the same indications for use as the predicate device: "generates digital X-ray images that can be used for general X-ray system not for Mammography" and "is intended to be used in same clinical application as traditional film-screen based general radiography system."
Comparison Table (Predicate vs. Proposed Device):
- Detector Technology: Both use "a-Se, Direct."
- Thickness of Se layer: Both "450μm."
- Imaging Area: Both "14" X 17"."
- Image Bit Depth: Both "14bits."
- Image Data Interface: Both "Camera Link."
- Control Box, Switch Box, Image Acquisition Software, Accessories: All are "Same as Saturn 9000."
- Key Difference: The only highlighted difference in the comparison table is the Detector Pixel size, which changed from "139μm" in the predicate (Saturn 9000) to "168μm" in the proposed device (Saturn 9000-550). For this type of submission, the manufacturer would have demonstrated that this change in pixel size does not adversely affect image quality or diagnostic performance to a degree that would raise new questions of safety or effectiveness, often through non-clinical bench testing or technical rationale, but not typically through a full-scale clinical trial with acceptance criteria for diagnostic accuracy.

In summary, for K072984, the acceptance criteria are implicitly that the new device component (the detector) renders images that are safe and effective for the stated indications, and that its performance is substantially equivalent to the predicate device, despite the change in pixel size. This is established through a technical comparison and the absence of any new or different indications for use or questions of safety/effectiveness arising from the modification. The study mentioned is the comparison itself, showing technical equivalence and that the change in pixel size is not deemed significant enough to require a full clinical performance study with specific diagnostic outcome-based acceptance criteria often reserved for novel devices or major changes in intended use.

Summary

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510(K) Summary

Image /page/0/Picture/1 description: The image shows handwritten text on a white background. The text "K072984" is at the top, followed by "Page 1 of 2" on the next line. The writing appears to be done with a dark ink pen, and the overall impression is that of a document or record marking.

Image /page/0/Picture/2 description: The image shows a large, stylized letter 'N' in black. The letter has a bold, slightly distorted appearance, with a textured or patterned fill. The background is plain and light, providing contrast to the dark letter.

1. Date Prepared: October 19th 2007

2. Submitter:

Company Name:	New Medical Co.,LTD.
Company Address:	4F, No.42, SingZhong Rd., NeiHu DistrictTaipei 114, Taiwan
Contact Person:	Young-Hoon Shin, Diretor of R&D, yhshin@newmedical.com.tw
Phone number:	+886-2-8791-6268
FAX number:	+886-2-8791-6269
NOV 14 2007

3. Proposed Device:

Type of the Submission:	Special
Reason For 510(k):	Replacement of the component
Manufacturer:	New Medical Co.,LTD
Trade Name:	New Medical
Model Name:	Saturn 9000-550
Regulatory Class:	II
Classification Name:	MQB, Solid State X-ray Imager
FDA 510(K) Number:	To be assigned

4. Predicate Device:

Manufacturer:	New Medical Co.,LTD.
Trade Name:	New Medical
Model Name:	Saturn 9000
Regulatory Class:	II
Classification Name:	MQB, Solid State X-ray Imager
FDA 510(K) Number:	K063710

Device Description: The Saturn 9000-550 is equipped with a digital detector, X-ray generator interface, and image acquisition workstation. The digital detector is a-Se deposited plat panel detector. The input X-ray photons are absorbed in a-Se layer that creates an electrical charge which is representation of the Xray input. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. X-ray exposure is controlled by switch box, which also controls the acquisition timing of the detector. Saturn 9000-550 includes acquisition workstation ("AWB") monitor,

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keyboard and mouse, computer, electronics, and accessory storage. 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.

The Saturn 9000-550 is substantially equivalent to the Saturn 9000.

1. Indications for Use: The Saturn 9000-550 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-550 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000-550 is intended to be used in same clinical application as traditional film-screen based general radiography system.

7. Comparison between Predicate Device and Proposed Device

		Predicate DeviceSaturn 9000	Proposed DeviceSaturn 9000-550
Detector	Technology	a-Se, Direct	a-Se, Direct
	Thickness of Se layer	450μm	450μm
	Imaging Area	14" X 17"	47" X 17"
	Detector Pixel size	139μm	168μm
	Image Bit Depth	14bits	14bits
	Image Data Interface	Camera Link	Camera Link
Control Box			Same as Saturn 9000
Switch Box			Same as Saturn 9000
Image Acquisition software		DxWorks	DxWorks(Same as Saturn 9000)
Accessories			Same as Saturn 9000

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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo includes the department's seal on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The seal features a stylized human figure and a globe, surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

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

Mr. Young-Hoon Shin Director of R&D New Medical Company, Ltd. 4F, No. 42, SingZhong Road NEIHU DISTRICT TAIPEI TAIWAN

AUG 2'3 2013

Re: K072984

Trade/Device Name: Saturn 9000-550 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: October 19, 2007 Received: October 23, 2007

Dear Mr. Shin:

This letter corrects our substantially equivalent letter of November 14, 2007.

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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 conninered phorts to May 20, 1978, are occordance with the provisions of the Federal Food, Drug, devices mat have been recuired in assere approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, distore, mances 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 class II (Special Controls), it may be subject to such If your device is clussified (600 acorre) affecting your device can be found in Title 21, additional controls. Blackly indjes regulation, 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 of any 1 coural statures and enginements, 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 medical device-related adverse events) (21 CF regulation (21 CFR Part 820). This letter requirements as set form in the quality systems (20) regardina (20 constitution of legally market will allow you to begin marketing your device of your device to a legally marketed notification. The FDA finding of subsantal equivalise of the many of the spermits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and If you desire specific advice for your device on our into Evaluation and Safety at (301) 796809), please contact the Office of In Vitro Diagnostic Device Frances to premark 5450. Also, please note the regulation entitled, "Misbranding by reference to premating of odverse even 5450. Also, please note the regulation canactions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

under the MDK regulation (21 CFR Pat 803), pices go to
http://www.fda.gov/MedicalDevices/Safety/Reportalers/default.html for the CDRH's Office nttp://www.lda.gov/Nionetrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the You may obtain other geliefal informational and Copymer 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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Indications for Use

K072984

510(k) Number (if Known): To be assigned

Device Name: Saturn 9000-550

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arst M. Whry

etiva. Abdominal a 510(k) Nu

Page 1 of 1

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.