FS-500DDR Medical Radiographic X-Ray System is designed to be used by a qualified/trained doctor or technician on adult and pediatric patients for taking diagnostic images of the skull, spinal column, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Device Description

AI/ML Overview

The provided text describes the FS-500DDR Medical Radiographic X-Ray System. However, it does not include detailed acceptance criteria or a specific study that proves the device meets those criteria in the way typically expected for an AI/ML medical device.

The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, primarily through safety and performance standards compliance, and a "clinical concurrence study." It lacks the granular detail of acceptance criteria, performance metrics, and study methodology often found in AI/ML performance evaluations.

Therefore, I cannot populate the table and answer all questions comprehensively as the requested information is largely absent. I will extract what is available and highlight the missing information.

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

Acceptance Criteria	Reported Device Performance
Specific quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC) are not provided in the document.	The document states: "Clinical concurrence study of images pairs to demonstrate the equivalent diagnostic capability." This implies that the images produced by the FS-500DDR were deemed diagnostically equivalent, but no specific metrics or thresholds are given.
Compliance with various safety and performance standards (e.g., EN 60601-1, IEC 60601-2-7, IEC 60601-2-54, ISO 10993)	"After analyzing both bench and external laboratory testing data, including electrical safety, mechanical safety and EMC compliance, the intended use and supporting data can conclude that the device in the submission is safe and effective as the predicate devices." (Implies compliance was met, but no specific test results are provided.)

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

Sample Size for Test Set: Not specified. The document only mentions a "clinical concurrence study of images pairs."
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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)

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The study involved a "qualified/trained doctor or technician" for operation, implying medical professionals, but their role in establishing ground truth for the "concurrence study" is not detailed.

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

Adjudication Method: Not specified.

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

MRMC Study: No. The device described is a medical radiographic X-ray system, not an AI/ML diagnostic aid designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this submission. The "clinical concurrence study" was likely to assess image quality for diagnostic equivalence, not reader performance improvement with AI.
Effect Size of AI assistance: Not applicable.

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

Standalone Study: Yes, in the sense that the device itself is a standalone imaging system. The performance evaluated was of the X-ray system producing diagnostic images, not an algorithm's interpretation of those images. The "clinical concurrence study" evaluated the diagnostic capability of the images produced by the device without human interpretation being directly compared against an AI algorithm's interpretation.

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

Type of Ground Truth: Implied to be expert diagnostic assessment based on the "clinical concurrence study of images pairs to demonstrate the equivalent diagnostic capability." The specific method of establishing this "ground truth" (e.g., consensus, comparison to a gold standard, pathology) is not detailed.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is an X-ray imaging system, not an AI/ML algorithm that requires a training set in the conventional sense.

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

How Ground Truth for Training Set was Established: Not applicable.

Summary

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

December 2, 2016

ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD. % Mr. Jun Peng Principal Consultant P&L Scientific, Inc. 6840 SW 45th Lane, Unit 5 MIAMI FL 33155

Re: K152813

Trade/Device Name: FS-500DR Medical Radiographic X-Ray System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: September 26, 2016 Received: November 8, 2016

Dear Mr. Peng:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K152813

Device Name

FS-500DDR Medical Radiographic X-Ray System

Indications for Use (Describe)

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

510(k) summary of Safety and Effectiveness as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which Substantial Equivalence is based: The Assigned 510(k) Number is: K152813

1. Submitter Information:

Sponsor/510(k) Owner: . ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD. No. 16 Cuiming Road YAT-SEN Scientific Industrial Park, Tianjin Economic Technological Development Area, Tianjin 301726, China Phone: +86 22 8216 1240 Fax: +86 22 8216 0813

Date: September 26, 2016

510(k) Contact Name: .

Mr. Jun Peng P&L SCIENTIFIC, INC. 6840 SW 45TH LN Unit 5 Miami, FL 33155 Phone: (305) 609 4701 Fax: (305) 397 0289 Email: jpeng@plscientificinc.com

2. Device Name and Classification

Trade Name:	FS-500DDR Medical Radiographic X-Ray System
Common Name:	Direct Digital Radiographic X-Ray System
Classification Name:	Stationary X-Ray System, Product code 90 KPR
Classification:	21 CFR 892.1680, Class II
Product code:	KPR

4. Predicate Devices:

Manufacturer Name	GE Medical Systems, Inc.	Orich Medical Equipment(Tianjin) Co., Ltd.
Regulation Number	K012389	K120034
Trade Name	GE Revolution XR/d Digital Radiographic Imaging System	DF-211H Radiographic X-Ray System
Common Name	System, X-Ray, Stationary	System, X-Ray, Stationary
Classification Name	Stationary X-Ray System	Stationary X-Ray System
Classification Number	21 CFR 892.1680	21 CFR 892.1680
Product Code	KPR	KPR
Date of Clearance	Aug. 10, 2001	Apr. 17, 2012

5. Description of Device

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The FS-500DDR is a Medical Radiographic X-Ray System with digital radiography (DR) technology. It is consisting of a high voltage generator, control console, X-Ray tube assembly, collimator, UC bracket or Rail suspension assembly, solid-state X-Ray flat panel detector, work station and radiographic table. This product is applicable to clinical diagnostic radiography in all hospitals whether large or small. It is applicable to the radiography of various parts of human body. It can also be used in scientific research and education of medical scientific research institutes and medical colleges. Power supply requirements: three phase: 380Vac, 50Hz/60Hz; fluctuation range for voltage: 10%; the power source capacity: 50kVA, the range of tube voltage is 40-150kV, with current 10-630mA. The time range of exposure is 1ms-10s, the range of mAs is 0.1-630mAs.

There are two types of configuration (1001-1002) for FS-500DDR; the difference is for the mounting of the X-ray tube. For X-ray tube mounting the configuration is either the UC arm or Rail suspension assembly.

Component	Model	Manufacturer
Digital imageacquisition andprocessing system	FU-800CCS	Orich Medical Equipment (Tianjin)Co., Ltd.
Medical monitor	RTV-5	Orich Medical Equipment (Tianjin)Co., Ltd.
High-voltage generator	HK801-1(50kW)	Orich Medical Equipment (Tianjin)Co., Ltd.
X-ray tube assembly	DX7254/150	Orich Medical Equipment (Tianjin)Co., Ltd.
X-ray tube	E7843	Toshiba Electron Tubes and Devices Co., Ltd.
Flat panel detector	FDX4343R	Toshiba Electron Tubes and Devices Co., Ltd.
UC arm	FSU-I	Orich Medical Equipment (Tianjin)Co., Ltd.
Mobile radiographicpatient table	YDC-I	Orich Medical Equipment (Tianjin)Co., Ltd.
Beam limiting device	S/DS-2	Orich Medical Equipment (Tianjin)Co., Ltd.

Table 1-1 Components of FS-500DDR (1001)

Table 1-2 Components of FS-500DDR (1002)

Component	Model	Manufacturer
Digital imageacquisition andprocessing system	FU-800CCS	Orich Medical Equipment (Tianjin)Co., Ltd.
Medical monitor	RTV-5	Orich Medical Equipment (Tianjin)Co., Ltd.
High-voltage generator	HK801-1(50KW)	Orich Medical Equipment (Tianjin)Co., Ltd.
X-ray tube assembly	DX7254/150	Orich Medical Equipment (Tianjin)Co., Ltd.
X-ray tube	E7843	Toshiba Electron Tubes and Devices Co., Ltd.
Flat panel detector	FDX4343R	Toshiba Electron Tubes and Devices Co., Ltd.
Rail suspensionassembly	FSU-III	Orich Medical Equipment (Tianjin)Co., Ltd.
Elevating photographytable	DFY-III	Orich Medical Equipment (Tianjin)Co., Ltd.

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Beam limiting device	S/DS-2	Orich Medical Equipment (Tianjin)Co., Ltd.
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6. Intended Use

FS-500DDR Medical Radiographic X-Ray System is designed to be used by a qualified/trained doctor or technician on adult and pediatric for taking diagnostic images 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.

7. Comparison of Technological Characteristics

The FS-500DDR Medical Diagnostic X-Ray system is similar to the predicate devices:

Has the same intended use and indications for use .
. Utilizes the same operating principle
Incorporates the same basic design ●
Incorporates the same technological characteristics .
Tested to the same electrical and electromagnetic safety standards for medical . electrical equipment
. Manufactured under a quality system

The differences between the subject devices and predicate devices:

The subject device utilizes a lower frequency X-ray generator which does not raise . any level of safety concern and affect any effectiveness; the generator frequency does affect the X-ray exposure parameters.
. The subject device utilizes a radiographic table with smaller weight capacity which does not raise any level of safety concern and affect any effectiveness.
. The inherent filtration for the collimator in the subject device is different from the predicate device; this difference does not affect the safety and effectiveness.
. The subject device utilizes a different X-Ray flat panel detector, however, both the bench and clinical test demonstrate that does not raise the level of safety concern and affect any effectiveness.

8. Summary Performance Data

EN 60601-1 Medical electrical equipment Part 1: General requirements for basic ● safety and essential performance 2006 + AC:2010
EN 60601-1-2:2007 (Third Edition, 2007), Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic
IEC 60601-2-7:1998 Medical electrical equipment -Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
. IEC 60601-2-28:2010 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
. IEC 60601-2-54:2009 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
. IEC 60601-1-3:2008 Medical electrical equipment - Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment + AC2010

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. ISO 10993-5:1999: Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity
. ISO 10993-10:2002, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
ISO 10993-1:2009 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
Clinical concurrence study of images pairs to demonstrate the equivalent diagnostic . capability

9. Conclusion

After analyzing both bench and external laboratory testing data, including electrical safety, mechanical safety and EMC compliance, the intended use and supporting data can conclude that the device in the submission is safe and effective as the predicate devices.

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.