Xmaru1210P Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy including head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.

Device Description

Xmaru1210P is a portable digital X-ray flat panel detector which consists of a scintillator directly coupled to an a-SI TFT sensor. It makes high-resolution, high-sensitive digital images. Xmaru1210P is designed specifically to be integrated with an operating PC and a Xray generator to digitalize x-ray images into DICOM compatible image files for the purpose of diagnostic analysis.

AI/ML Overview

The provided text describes the Xmaru1210P Digital Flat Panel X-ray Detector and its substantial equivalence to a predicate device. However, it does not contain the level of detail requested for a comprehensive description of acceptance criteria and the study proving adherence to them, especially regarding clinical study specifics like sample sizes, ground truth establishment, or expert involvement.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

The document describes the device performance primarily in comparison to its predicate device, the Canon CXDI-50G, rather than against explicit, pre-defined acceptance criteria with specific thresholds. The "acceptance criteria" appear to be implicit in demonstrating performance superior or equivalent to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance (Xmaru1210P)
Image Quality (MTF)	Better performance than Canon CXDI-50G
Image Quality (DQE)	Better performance than Canon CXDI-50G
Resolution	Better than Canon CXDI-50G
Exposure Sensitivity	Higher than Canon CXDI-50G
Image Quality (Overall)	Better than Canon CXDI-50G
Safety (Electrical)	Satisfactory (according to IEC 60601-1, IEC 60601-1-1)
Safety (Mechanical)	Satisfactory (according to IEC 60601-1, IEC 60601-1-1)
Safety (Environmental)	Satisfactory (according to IEC 60601-1, IEC 60601-1-1)
EMC	Satisfactory (according to IEC 60601-1-2)

Study Details

The document mentions "SSXI non-clinical report" and "SSXI Non-clinical and clinical report" as evidence of performance. However, it lacks most of the specific details requested for a clinical study.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The manufacturer is based in Korea (Vatech Co., Ltd.).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not mention the involvement of experts for establishing ground truth in a clinical study.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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 specified. The device is a digital X-ray detector, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable in this context. The study focuses on evaluating the imaging capabilities of the detector itself.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The "non-clinical" and "clinical" reports mentioned would inherently evaluate the device's imaging performance in a standalone capacity (i.e., how well it produces images) without human interpretation as part of the primary performance metric, though human evaluation of the image quality would be implicit. No "algorithm only" performance is mentioned as this is a hardware device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. Given the nature of a digital X-ray detector (producing images for diagnostic analysis rather than an automated diagnosis), the "ground truth" in a clinical evaluation would likely relate to the diagnostic utility of the images produced, potentially via radiologist interpretation or comparison to other imaging modalities or clinical outcomes, but this is not detailed.
The sample size for the training set:
- Not applicable as this is a hardware device (digital X-ray detector), not a machine learning algorithm that requires a "training set" in the conventional sense.
How the ground truth for the training set was established:
- Not applicable for the same reason as above.

In summary, the provided text highlights that the Xmaru1210P detector demonstrated better performance in technical specifications (MTF, DQE, resolution, exposure sensitivity) compared to its predicate device, based on non-clinical and clinical reports. However, it significantly lacks the granular details about the clinical study methodology, sample sizes, and expert involvement that would be expected for a detailed description of acceptance criteria proof.

Summary

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NOV 2 9 2010

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

June 1, 2010

Manufacturer

Vatech Co., Ltd.

473-4 Bora-Dong, Giheung-Gu, Yong In-Si, Gyeonggi-Do, 446-904, Korea Republic

Tel: +82-31-679-2266

Fax: +82-31-679-2161

Contact person: Ms. Yang-kyoung Kim / Compliance Officer

Email: anis.kim@vatech.co.kr

United States Sales Representative (U.S. Designated agent)

VATECH America.

333 Meadowlands Parkway, #303, Secaucus, NJ, 07094, USA

Tel: +832-623-2099 Fax: +713-464-8880 Contact person: Mr. Dave Kim Email: davekim@vatechamerica.com

Trade/Proprietary Name:

Xmaru1210P

Common Name:

Digital Flat Panel X-ray Detector

Classification Name:

Solid State X-ray Imager, flat panel/digital imager (21CFR 892.1650, Product code MQB,

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Class2)

Description:

Indication for use:

Predicate Device:

Manufacturer	: Canon Inc.
Device	: CXDI-50G
510(k) Number	: K031447 (Decision Date - May 21. 2003)

Substantial Equivalence:

VATECH Co., Ltd. considers Xmaru1210P is as safe and effective as the predicated device , Canon digital radiography CXDI-50G, cleared under the document number K031447 and the performances for both devices are substantially equivalent as indicated in the SSXI non-clinical report of this submission.

The intended use, application and detector type of Xmaru1210P are the same as those of CXDI-50G. However, the differences in the material for fluorescent screen of Xmaru ! 210P are described below:

Both Xmaru1210P and CXD1-50G use the same amorphous silicon alley as the sensing means, however, Xmaru1210P uses a different material from CXDI-50G for fluorescent screen which is deposited on the amorphous silicon array. Xmaru1210P uses Csl (Cesium lodide> with a high X-ray absorption capacity as fluorescent screen. The SSXI test report

Vatech Oo, Ltd.

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shows that Xmaru1210P.has a better performance than Canon's CXDI-50G in terms of MTF (Modulaion Transfer Function) and DQE (Detective Quantum Efficiency) performance to result a better resolution, higher exposure sensivity and better image quality as demonstrated in the SSXI Non-clinical and clinical report included in this submission.

The differences in the external dimensions and the weight of Xmaru1210P are as follows: The external dimensions of Xmaru1210P (422x403x22mm) is smaller than CXD1-50G (491x477x23mm).

The weight of Xmaru1210P (3.4 kg) is lighter than CXDI-50G (4.8 kg). The physical appearance of Xmaru1210P are different than CXDI-50G.

The indications for use for Xmaru1210P are limited to head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.).

Safety, EMC and Performance Data:

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1(1995), IEC 60601-1-1 (2001) was performed, and EMC testing were conducted in accordance with'standard IEC 60601-1-2 (2001).

Non-clinical & Clinical considerations according to FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed. All test results were satisfactory.

Conclusion:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. Vatech Co., Ltd. concludes that Xmaru1210P is safe and effective and substantially equivalent to the predicate device as described herein.

END

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Image /page/3/Picture/0 description: The image shows the logo for 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 an eagle with its wings spread, and the text is written in a clear, sans-serif font.

Public Health Service

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

VATECH Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Consultant VATECH America 333 Meadowlands Parkway, #303 SECAUCUS NJ 07094

Re: K101590

Trade/Device Name: Digital Flat Panel X-ray Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: October 6, 2010 Received: October 8, 2010

AUG 2 3 2013

Dear Mr. Kim:

This letter corrects our substantially equivalent letter of November 29, 2010.

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major 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 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 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 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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

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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510(K) Number (if known):

K101590 NOV 2 9 2010

Device Name: Digital Flat Panel X-Ray Detector /Xmaru1210P

. 30

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (Part 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)

(Division Sign-Off)
Division of Radiological Devices

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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.