The XR5 diagnostic X-ray system is intended for use on adult and pediatric patients for taking diagnostics radiographic exposure of all body parts and operated by a qualified/trained doctor or technician. The XR5 diagnostic X-ray system is designed to be used with conventional film/screen, CR cassettes or digital detectors. NOT intended for Mammography use.

Device Description

The XR5 diagnostic X-ray system is used for image capture by using X-rays on a patient's body. The XR5 is a conventional X-ray machine, with an intuitive operation console to provide the user an easy way to manage optimal conditions for quality images. The high frequency generator is capable of delivering the exposition dose appropriate for general X-ray and diagnostic images of a patient. This system is made to use other detector options including: conventional films, CR, or Digital Flat Panel Detectors. Please note that the quality of the image in any detector depends on the manufacture of the receptor device. The XR5 diagnostic X-ray system doesn't provide an AEC feature.

AI/ML Overview

The provided text describes the OSKO, INC. XR5 Diagnostic X-ray System, which is a conventional X-ray machine. However, the document (a 510(k) summary) focuses on demonstrating substantial equivalence to a predicate device (Multix Fusion by Siemens Medical Solutions USA, Inc.) rather than outlining specific acceptance criteria or a dedicated study proving the device meets those specific acceptance criteria in terms of clinical performance metrics.

Instead, the document emphasizes:

Technical equivalence: Comparing specifications like generator type, image acquisition methods, and the use of FDA-cleared digital detectors.
Compliance with safety and electrical standards: Referencing IEC 60601-1, IEC 60601-2-54, and EN60601-1-2.
Performance of individual components: The digital detectors are evaluated based on DQE, MTF, and line resolution, with these parameters serving as indicators of their performance.

Therefore, many of the requested items (e.g., specific acceptance criteria for diagnostic accuracy, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance) are not detailed in this type of regulatory submission, as it's not a clinical performance study report for diagnostic accuracy of the overall system.

Here's an attempt to answer the questions based only on the provided text, with many fields explicitly stated as "Not Applicable" or "Not Provided" due to the nature of the document:

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

The document does not explicitly define specific "acceptance criteria" for diagnostic performance of the overall XR5 system as a diagnostic device (e.g., sensitivity, specificity, accuracy for a particular condition). Instead, it relies on demonstrating substantial equivalence to a predicate device by comparing technical specifications and performance of key components (digital detectors). The "reported device performance" primarily refers to the technical specifications and the performance metrics of the digital detectors used with the system.

Acceptance Criteria Category (Implied by document)	Specific Criteria (from document)	Reported Device Performance (XR5 / Digital Detectors)
System Functionality	General X-ray and diagnostic imaging of all body parts for adult and pediatric patients.	The XR5 diagnostic X-ray system is intended for use on adult and pediatric patients for taking diagnostics radiographic exposure of all body parts. Operated by a qualified/trained doctor or technician. Designed to be used with conventional film/screen, CR cassettes, or digital detectors.
Safety Standards Compliance	Compliance with IEC 60601-1; 2005 + A1 (2012) and IEC 60601-2-54; Edition 1.0.2009. Applicable EMC requirements (EN60601-1-2:2007 / AC : 2010).	"The XR5 diagnostic X-ray system has been tested in accordance with Safety standard of IEC 60601-1; 2005 + A1 (2012) and IEC 60601-2-54; Edition 1.0.2009. The test reports have shown good performance, substantially equivalent to the predicate device. The XR5 has also met applicable Electro Magnetic Compatibility (EMC) requirements; EN60601-1-2:2007 / AC : 2010 (IEC60601-1-2:2007)."
Digital Detector Performance (Component Level)	Evaluation according to IEC 62220-1:2003 Standard (for DQE, MTF, line resolution).	MTF @ 3.5 lp/mm: 1717SCC (K122173): 13%, 1417WCC (K141566): 12.1%, FLAATZ600 (K132842): 50.02%. DQE @ 0 spatial frequency: 1717SCC: 54%, 1417WCC: 76.7%, FLAATZ600: 50%. Line resolution: Similar between 3.0~3.5 lp/mm for all listed detectors.
Software Validation	Firmware validation testing to verify risk analysis and individual performance results within predetermined acceptance criteria.	"The complete system configuration including the firmware function has been assessed and tested by the manufacturer and passed all in-house testing criteria. The firmware validation test was designed to evaluate for the X-ray system including X-ray exposure control and exposure switch performed by XR5. ... individual performance results were within the predetermined 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)

Sample Size for Test Set: Not provided. The document states that "Bench performance parameters for the digital detectors are sufficient to demonstrate substantial equivalence to a predicate device" and that "Clinical images are not necessary to establish substantial equivalence based on the previously FDA cleared detectors." This implies that a formal clinical test set with a specific sample size for diagnostic performance was either not conducted or not deemed necessary for this 510(k) submission.
Data Provenance: Not provided for any clinical data. Non-clinical performance data for the detectors references the IEC 62220-1:2003 Standard.

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)

Not applicable/Not provided. No clinical test set to establish ground truth for diagnostic accuracy is described.

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

Not applicable/Not provided. No clinical test set for diagnostic accuracy is described.

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

Not applicable/Not provided. This device is a conventional X-ray system, not an AI-powered diagnostic tool, and no MRMC study is mentioned.

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

Not applicable/Not provided. This device is a conventional X-ray system, not an algorithm, and no standalone performance study in this context is mentioned.

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

Not applicable/Not provided for diagnostic accuracy of the overall system. The document does not describe the establishment of clinical ground truth for diagnostic accuracy for the XR5 system itself. For the digital detectors, their performance metrics (DQE, MTF, line resolution) are physics-based measurements rather than clinical ground truth on patient outcomes.

8. The sample size for the training set

Not applicable/Not provided. This device is a hardware X-ray system, not an AI algorithm requiring a training set. The firmware is "programmed with ANSI C language," suggesting traditional software development and testing rather than machine learning training.

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

Not applicable/Not provided. As above, this device is a hardware X-ray system; no training set for an AI algorithm is mentioned.

Summary

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

May 7, 2015

OSKO, INC. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025

Re: K150663

Trade/Device Name: XR5 Diagnostic X-ray System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: March 13, 2015 Received: March 16, 2015

Dear Mr. Kim:

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,

Robert A Ochs

Robert Ochs. Ph.D. Acting 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) K150663

Device Name

XR5 Diagnostic X-ray System

Indications for Use (Describe)

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

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

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Image /page/3/Picture/0 description: The image shows the logo and contact information for OSKO, INC. The logo features the company name in bold blue letters next to a stylized blue graphic. The contact information includes the address 7260 NW 58th Street, Miami, FL, 33166 USA, as well as the phone number +1-305-599-7161, fax number +1-305-599-7144, and website www.oskomedical.com.

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date 510k summary prepared: May 1, 2015

Submitter's Name, address, telephone number, a contact person:

1. Submitter	OSKO, Inc.7260 NW 58th Street, Miami, Florida 33166, USAwww.oskomedical.com
2. Contact Person	Name: Wang ChoiPosition: Vice PresidentE-mail: bioking@medisoneconet.comTelephone: + 1 305-599-7161

Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:

3. Regulation Name	Stationary X-ray System
4. Device Name	XR5
5. Classification	21 CFR 892.1680
6. Product Code	KPR
7. Device Class	2
8. Predicate Device	Multix Fusion by Siemens Medical Solutions USA, IncK121513 (Decision Date – Aug 10, 2012)Stationary X-ray System21CFR892.1680KPR

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Image /page/4/Picture/0 description: The image shows the logo and contact information for OSKO, INC. The logo features the company name in blue, with a stylized blue graphic to the left. The contact information includes the address 7260 NW 58th Street, Miami, FL, 33166 USA, as well as the phone number +1-305-599-7161, fax number +1-305-599-7144, and website www.oskomedical.com.

9. Device Description

10. Indications for Use

11. Specifications of Device

11.1 System Environment Requirement
- a) ENVIRONMENTAL SPECIFICATIONS

OPERATING

Ambient temperature range	10 to 40 °C (50 to 104 °F).
Relative humidity	20 to 80%, non-condensing.
Altitude	-700 to 3000 meters (1100 to 700 hPa, 825 to 525 mmHg).

Electrical Requirement

System Part	Specifications
Generator	220 ~ 240 VAC monophasic, 50/60 Hz @40kW
Mechanical Part	110~220VAC

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Image /page/5/Picture/0 description: The image shows the logo and contact information for OSKO, INC. The logo features the company name in blue, with a stylized graphic of intersecting lines. The contact information includes the address 7260 NW 58th Street, Miami, FL, 33166 USA, as well as the telephone number +1-305-599-7161, fax number +1-305-599-7144, and website www.oskomedical.com.

11.2 Movement Specifications Required power : 24V, 3A Tube stand height : 1,940 mm / 73" SID range : 1,000 ~ 1,800 mm / 39" ~ 70" Vertical movement : 1,480 mm / 58" Longitudinal movement : 2,540 mm / 100" Tube rotation range : - 135° ~ +135° Forward/backward tube head range : ± 120 mm / ± 4.7"
11.3 Patient Table Specifications

Type : 4-Way floating table Dimensions : 220 X 806 X 728 X 655 mm / 9" x 32" x 26" (Rounded to nearest inch) Backward/forward movement : ± 105 mm / ± 4.1" Left/right Movement: ± 450 mm / ± 18" Patient Weight Limit: Patient Weight(215 kg) + Accessory Weight(15kg) / Patient Weight(473lb) + Accessory Weight (33lb)

11.4Collimator Specifications
Type : Manual Power Output : DC 24V Projecting lamp : 150W Halogen lamp Lighting type : Automatic illumination Lighting time: press button, 30 sec APR memory : No Laser guide : No Max. window : 48 x 48 cm (SID 100 cm) / 19"x 19" ( SID 39")
Min. window : 5 X 5 cm (SID 100 cm) / 2"x 2" ( SID 39")
11.5X-ray Tube Specifications

Model : E7239x Focal Spot : 1.0 / 2.0 mm Operation Voltage : 40 ~ 125 kVp Target angle : 16° Composition of the target : Rhenium - Tungsten faced molybdenum Permanent filtration : 0.9mmAl/75kV Anode Heat capacity : 140 KHU Additional Filter : 1.5mmAl Target : rhenium-tungsten-faced molybdenum Permanent filtration : 0.9mm Al at 75 kV Cooling method : Natural / Forced air Operation Temp. : 10 ~ 40°C / 50 ~ 104°F Operation Hum. : 30 ~ 85%

11.6Grid Specifications

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Image /page/6/Picture/0 description: The image shows the logo and contact information for OSKO, INC. The logo features the company name in blue, with a stylized graphic to the left. The contact information includes the address 7260 NW 58th Street, Miami, FL, 33166 USA, as well as the phone number +1-305-599-7161, fax number +1-305-599-7144, and website www.oskomedical.com.

Composition : interspaced carbon with carbon fiber cover Dimensions : 46 x 46,8 cm / 18"x 18"x 3" Density : 103 lp/cm Ratio : 10:1 FID : 100 and 180 cm / 39" and 71" 12.HF Generator Specifications

OUTPUT PARAMETER	GENERATOR SERIES	LOADING FACTOR
Maximum X-ray tube voltageand highest X-ray tubecurrent at that voltage	40 kW	125 kV, 320 mA / 150 kV, 250 mA
Maximum X-ray tube currentand highest X-ray tubevoltage at that current	40 kW	500 mA, 80 kV
Combination of X-ray tubecurrent and X-ray tubevoltage resulting in highestoutput power	40 kW	400 mA, 100 kV
Highest constant outputpower at 100 kV, 0.1 sec	40 kW	40 kW (400 mA,100 kV, 0.1 s)

Summary of the Technological Characteristics of the device compared to the Predicate Device

The XR5 diagnostic X-ray system described in this 501K has the similar indications for use and technical characteristics as the predicate device, Multix Fusion of Siemens Medical Solution USA, Inc. (K121513)

Feature	New Device: XR5Product Code: KPR	Predicate: Multix Fusion (K121513)Product Code: KPR
Manufacturer	OSKO, Inc	Siemens Medical Solution USA, Inc
Indicationsfor Use	The XR5 diagnostic X-ray system is intendedfor use on adult and pediatric patients fortaking diagnostics radiographic exposure ofall body parts and operated by aqualified/trained doctor or technician. The XR5diagnostic X-ray system is designed to be usedwith conventional	The Multix Fusion system is a radiographicsystem used in hospitals, clinics, andmedical practices. Multix Fusion enablesradiographic exposures of the whole bodyincluding: skull, chest, abdomen, andextremities and may be used on pediatric,adult and bariatric patients. It can also beused for intravenous, small interventions(like biopsy, punctures, etc.) andemergency (trauma, critical ill)applications.Exposures may be taken with the patientsitting, standing, or in the prone position.

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	film/screen, CRcassettes or digitaldetectors. NOT intendedfor Mammography use.	The Multix Fusion system is not meant formammography.The Multix Fusion uses a mobile (wired) orportable (wireless) digital detectorfor generating diagnostic images byconverting x-rays into electronic signals.The Multix Fusion is also designed to beused with conventional film/screenor Computed Radiography (CR) cassettes.
Configuration	Patient sitting, standing,in the prone position	Patient sitting, standing, in the proneposition
PerformanceStandard	21 CFR 1020.30	21 CFR 1020.30
Generator	High frequency	High frequency
Collimator	Manual (K062788)	ACSS collimator (Automatic Cassette SizeSensing)
Imageacquisition	Film/Screen, CRCassettes, or digital flatpanel detectors	Film/Screen, CR Cassettes, or digital flatpanel detector
Flat PanelDetector	1717SCC(K122173):43cm x 43 cm1417WCC (K141566):43 cm x 36cmFLAATZ600 (K132842):43cm x 36cm	43cm X 36cm (4336X)
ImagingSoftware	By default, XR5 does not provide the imaging software with imageprocessing features. Separate imaging software with a FDAclearance is available for the user provided by the manufacturer of thedetector of choice; FEEL-DRCS (K110033) for FLAATZ 600(K132842) and XmaruView V1(K102078) for 1417 WCC (K141566)and 1717SCC (K122173).

Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:

The XR5 diagnostic X-ray system does not have significant changes in energy source, or technological characteristics when compared to the predicate device. It uses the components similar to the predicate device (tube, generator, floor anchored tube support, table, bucky wall stand). The indications for use and fundamental scientific technology are similar to the predicate device, with the exception of bariatric patients and tomography application.

The main differences are the digital detectors used for XR5 X-ray system. However, the fundamental imaging technology is the same. The safety and effectiveness of the

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Image /page/8/Picture/0 description: The image contains the logo for OSKO. The logo consists of the word "OSKO" in a bold, sans-serif font, with the letters in a dark blue color. To the right of the word is a stylized graphic element, also in shades of blue, that resembles a waveform or a stylized butterfly. The graphic element is composed of two curved shapes that intersect in the middle.

digital detectors for XR5 have been reviewed and cleared by FDA as indicated by the 510K number of each detector.

1717SCC (K122173) 1417WCC (K141566) FLAATZ600 (K132842)

By default, XR5 does not provide the imaging software with image processing features. Separate imaging software with a FDA clearance is available for the user provided by the manufacturer of the detector of choice; FEEL-DRCS (K110033) for FLAATZ 600 (K132842) and XmaruView V1(K102078) for 1417 WCC (K141566) and 1717SCC (K122173).

15. Summary of Software Validation

XR5 firmware is a software embedded device programmed with ANSI C language. It controls the hardware operating module to run the equipment and synchronize the positions of the X-ray tube and buck according to the patient's position. It also displays information necessary for taking an X-ray image including SID.

The complete system configuration including the firmware function has been assessed and tested by the manufacturer and passed all in-house testing criteria. The firmware validation test was designed to evaluate for the X-ray system including X-ray exposure control and exposure switch performed by XR5.

The level of concern is moderate and the firmware is not based on any predicate device. The validation testing verified and validated the risk analysis and individual performance results were within the predetermined acceptance criteria. Both subject device and predicate device are categorized in product code KPR ; equivalence between these models is evident.

In conclusion, the XR5 is substantially equivalent to predicate devices.

16. Summary of Non-Clinical Testing

The detectors listed have been cleared by FDA's 510(k) process. The detector performance parameters including DQE and MTF are evaluated according to IEC 62220-1:2003 Standard to demonstrate the safety and effectiveness performance. MTF of 1717SCC (K122173) and 1417 WCC (K141566) and FLAATZ600 (K132842) are 13%, 12.1% and 50.02%, respectively at 3.5 lp/mm. DQE of 1717SCC (K122173) and 1417 WCC (K141566) and FLAATZ600 (K132842) are 54%, 76.7% and 50%, respectively at 0 spatial frequency,. The line resolution of 1717SCC (K122173) and 1417 WCC (K141566) and FLAATZ600 (K132842) are similar between 3.0~3.5 lp/mm.

The risk analysis is performed to identify additional hazards, conduct risk mitigation measures and evaluate the acceptance criteria for residual risks.

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Image /page/9/Picture/0 description: The image shows the logo and contact information for OSKO, INC. The logo features the company name in blue, along with a blue abstract graphic. The contact information includes the address 7260 NW 58th Street, Miami, FL, 33166 USA, as well as the telephone number +1-305-599-7161, fax number +1-305-599-7144, and website address www.oskomedical.com.

17. Summary of Clinical Testing

Bench performance parameters for the digital detectors are sufficient to demonstrate substantial equivalence to a predicate device. While the sample clinical images may be helpful for demonstrating the clinical use of your device and that it performs adequately in the general use radiographic imaging for which your device is indicated, bench performance data should be sufficient for determining substantial equivalence. Clinical images are not necessary to establish substantial equivalence based on the previously FDA cleared detectors.

18. Functional and Safety Testing

The XR5 diagnostic X-ray system has been tested in accordance with Safety standard of IEC 60601-1; 2005 + A1 (2012) and IEC 60601-2-54; Edition 1.0.2009. The test reports have shown good performance, substantially equivalent to the predicate device.

The XR5 has also met applicable Electro Magnetic Compatibility (EMC) requirements; EN60601-1-2:2007 / AC : 2010 (IEC60601-1-2:2007).

19. Conclusion

The XR5 diagnostic X-ray system is intended for the similar use as Multix Fusion (with the exception of bariatric patients and tomography application). It uses similar components cleared for the Multix Fusion (e.g. tube, generator, ceiling-mounted tube support, table, bucky wall stand). The XR5 is substantially equivalent to the already cleared predicate device.

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.