REXTAR LCD is a portable X-ray systems to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is intended for both adult and pediatric subjects.

Device Description

The REXTAR LCD consists of an X-ray tube, X-Ray tube assembly, X-Ray Controller built into a hand held camera-like device. The REXTAR LCD is an extraoral source x-ray system with a DC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source a, X-ray camera, is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

AI/ML Overview

The provided text describes a 510(k) submission (K122016) for the REXTAR LCD, a portable X-ray system. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than an independent study proving the device meets specific acceptance criteria through clinical performance metrics like sensitivity, specificity, or reader agreement.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes for test and training sets, expert qualifications, and adjudication methods for ground truth establishment is not available in the provided document. The document primarily highlights compliance with performance standards and a comparison of technical specifications with predicate devices.

However, based on the information provided, here's what can be inferred and what is explicitly stated:

Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide a table of explicit "acceptance criteria" for clinical performance metrics (e.g., sensitivity, specificity, or diagnostic accuracy) or "reported device performance" against such criteria. Instead, it demonstrates compliance with recognized electrical and safety standards and compares technical specifications to predicate devices to establish substantial equivalence.

Parameter (from Comparison Table)	Acceptance Criteria (Implied by Predicates)	Reported Device Performance (REXTAR LCD)
Intended Use	Similar to predicate devices	Portable X-ray system for diagnostic x-ray imaging using intraoral image receptors, for adult and pediatric subjects.
Indications	Similar to predicate devices	X-ray system for images of patients for dental procedures (Bite wing, periapical, occlusal, panoramic images).
X-ray Generator	High-Frequency	High-Frequency
Tube Power	Approx. 60-70kV / 2mA	70kV / 2mA
Tube Type	Stationary	Stationary
Tube Focal Spot	0.4mm - 0.8mm	0.4mm
Target Angle	12° - 20°	12°
Exposure Time	Within a range (e.g., 0.01 - 2.00 sec)	0.01 ~ 1.3 (sec) (43 Steps)
Power Requirement	DC 11.1V - 24V	DC 11.1 V
Weight	Around 1.80 kg - 2.95 kg	1.88 kg
Picture Quality	"Normal"	"Good"
Battery Type	Rechargeable	Rechargeable
Digital Sensor Compatibility	Yes (implied by "X" for predicates)	Compatible with all Digital Sensors
LCD	Present ("X" for predicates mean not present)	LCD Panel Display (4 Digits, 0.5 Inch Character Height)

Study and Data Information:

Sample size used for the test set and the data provenance:
- Not provided. The document does not describe a clinical study with a test set of images or patients for performance evaluation. The submission relies on technical comparisons and compliance with standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No clinical test set or ground truth establishment by experts is described for performance evaluation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No clinical test set involving expert adjudication is described.
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:
- No. This device is an X-ray system, not an AI-assisted diagnostic tool. No MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware device for image acquisition, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided. The substantial equivalence claim is based on comparison of technical specifications and compliance with safety and electrical standards, not on clinical ground truth.
The sample size for the training set:
- Not applicable/Not provided. This is not an AI/algorithm-based device requiring a training set.
How the ground truth for the training set was established:
- Not applicable/Not provided.

Summary of what the document explicitly states regarding compliance/testing:

Compliance with performance standards: "All components to which the standard applies are certified to conform to diagnostic equipment standards, 21 CFR 1020.30 and 1020.31." (Section 8)
The device "will comply with applicable requirements of the Underwriters Laboratories Standard for Safety-UL/IEC 60601-1, IEC 60601-2-7, IEC 60601-2-28 and IEC 60601-2-32." (Section 11)
"EMC testing was conducted by (EMC Compliance Co., Ltd. in accordance with Standard EN/IEC 60601-1-2). All test results were satisfactory." (Section 11)

The "study" in this context is the comparison to predicate devices and the demonstration of compliance with various electrical, safety, and diagnostic equipment standards, rather than a clinical performance study. The "acceptance criteria" are implied by the requirements of these standards and the characteristics of the predicate devices.

Summary

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K122016

MAR 0 1 2013

Attachment 3

Section 5: 510(k) Summary

lan Yun

Sales Director

1. 510(k) Owner:
  Metabiomed, Inc. 110 Gibraltar Road, suite 106 Horsham, PA 19044 USA Ph: 267-282-5893 Fax: 267-282-5899 Email: metabiomed@gmail.com
1. Company Contact: Title:
1. 510(k) Preparer:

Blix Winston ACMD Consulting, LLC. 2600 Mullinix Mill Road Mt. Airy, MD 21771 USA Ph: 301-607-9185 Email: fblixwinston@aol.com

Date of Submission
Device Name and Classification:

Trade name - REXTAR LCD Common name - Portable X-Rav System Classification name - Extraoral source x-ray system

1. Predicate Devices:
  Manufacturer : Device : 510(k) Number :

July 7, 2012

Genoray Co. Ltd. PORTX-II K063121 (Decision Date -01/11/2007)

Manufacturer: Device: 510(k) number:

Digimed Corporation DIOX K082167 (Decision Date-04/08/2011)

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7. Classifications Names & Citations:

21CFR 872.1800, EHD - Extraoral source x-ray system, Class 2

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1. Compliance with performance standards
  All components to which the standard applies are certified to conform to diagnostic equipment standards, 21 CFR 1020.30 and 1020.31.

9. Device Description:

a. General:
The REXTAR LCD consists of an X-ray tube, X-Ray tube assembly, X-Ray Controller built into a hand held camera-like device.

b. Outline:

The REXTAR LCD is an extraoral source x-ray system with a DC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source a, X-ray camera, is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

c. Features:
REXTAR LCD is a portable X-ray system that has the following qualities:
· High Frequency X-ray Generator (70kV-2mA Fixed)
· High Quality Toshiba Tube used (Tube Focal Spot (0.4mm))
· Target Angle 12°
· Easy to Move
· Eliminates the need for multiple X-Ray units in doctor's office
· Efficient to use
· Compact Size & Light Weight Design for Ultimate Portability
· Long Battery Life Hundreds of images can be obtained from one time charge
· Diverse Applications (Field Hospital, Emergency, Forensic Science, Operation Room)
· Can use conventional film or digital sensors to obtain images
· Images from digital sensors are displayed on a computer that is not included as a part of the camera for the Rextar LCD

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· REXTAR also has:
- Compatibility with all Digital Sensors All Digital Imaging . Sensor (USB Type) existing in the world can be used for Rextar LCD unlike other products.
- Easy & Simple Installation by USB Memory Stick & ODD, . Memory Cards (SD,MMC)
- Samsung Ultra Q1 (UMPC) Embedded .
- Wireless data transmission has Not been tested with this device . and should not be used
d. Operating principle:

Operating principle is that X-ray generated by high voltage electricity into X-ray tube, which penetrates hand, tooth and jaw, and makes X-ray images on receptor (Chemical Film or Digital Sensor).

Indications for use:

REXTAR LCD is a portable X-ray system to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic xray images using intraoral image receptors. It is intended for both adult and pediatric subjects.

1. Substantial equivalence:
  The REXTAR device had been tested to demonstrate substantial equivalence with the predicate devices. A comparison of features is included below.

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Comparison Table: REXTAR LCD and the Predicate Devices

Parameter	Rextar LCD	PORTX-II	DIOX
510(k)	Submitted formarketingclearance	K063121	K103600
IntendedUse	REXTAR LCD isa portable X-raysystem to beused by traineddentists anddental techniciansas a mobile,extraoral x-raysource forproducingdiagnostic x-rayimages usingintraoral imagereceptors. It isintended for bothadult andpediatric subjects.	To be used bytrained dentistsand dentaltechnicians amobile,extraoral x-raysource forproducingdiagnostic x-rayimages usingintraoral imagereceptors. It isintended forboth adult andpediatricsubjects.	To be used bytrained dentistsand dentaltechnicians as amobile,extraoral x-raysource forproducingdiagnostic x-rayimages usingintraoral imagereceptors. It isintended forboth adult andpediatricsubjects.
Indications	X-ray systemdesigned toprovide imagesof the patientsundergoingdentalprocedures.Clinical usesinclude Bitewing, periapical,occlusal andpanoramicimages.	X-ray systemdesigned toprovide imagesof the patientsundergoingdentalprocedures.Clinical usesinclude Bitewing, periapical,occlusal andpanoramicimages.	X-ray systemdesigned toprovide imagesof the patientsundergoingdentalprocedures.Clinical usesinclude Bitewing, periapical,occlusal andpanoramicimages.
Dentist/dental assistantInvolvement	Supervision	Supervision	Supervision
Labeling	Submitted	Original,Cleared	Original,Cleared
X-rayGenerator	High-Frequency	High-Frequency	High-Frequency
Tube Power	70kV /2mA	60kV /2mA	60kV /2mA
Tube Type	Stationary	Stationary	Stationary
Tube FocalSpot	0.4mm	0.8 mm	0.8 mm
TargetAngle	12°	20 °	20°
ExposureTime	0.01 ~ 1.3 (sec)(43 Steps)	0.02 ~ 2.00 (sec)(24Steps)	0.01~1.60 (sec)(0.01 sec/ step)
ParameterPowerRequirement	Rextar LCDDC 11.1 V	PORTX-IIDC 22.2V	DIOXDC 24 V
Weight (kg)	1.88	2.95	1.80
PictureQuality	Good	Normal	Normal
BatteryType	Rechargeable	Rechargeable	Rechargeable
DigitalSensor	X	X	X
LCD	LCD PanelDisplay (4Digits, 0.5 InchCharacterHeight)	X	X
Chipset &Graphics		X	X
Memory		X	X
Storage		X	X
Communication-tions		X	X

: 上一篇:

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11. Standards:

The portable x-ray system, REXTAR LCD, will comply with applicable requirements of the Underwriters Laboratories Standard for Safety-UL/IEC 60601-1, IEC 60601-2-7, IEC 60601-2-28 and IEC 60601-2-32. EMC testing was conducted by (EMC Compliance Co., Ltd. in accordance with Standard EN/IEC 60601-1-2). All test results were satisfactory.

A complete list of performance standards is listed below.

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No.	OEN	Reference	Title of standard	Year ofratificatio
1	IEC	IEC 60601-1	Medical electrical equipment-Part1:	1990
2	IEC	AmendmentA1 to EN60601-1	Medical electrical equipment-Part 1: General requirementfor safety	1991
3	IEC	Amendment A2	Medical electrical equipment-Part1:	1995
No.	OEN	Reference	Title of standard	Year ofratificatio
4	IEC	IEC 60601-1-2	Medical electrical equipment-Part 1: General requirementfor safety - 2Collateral standard:ElectromagneticCompatibility - Requirements andtest.	2001
5	IEC	IEC 60601-1-3	Medical electrical equipment-Part 1: General requirementfor safety - 3Collateral standard: Generalrequirements for radiationprotection in diagnostic X-rayequipment.	1994
6	IEC	IEC 60601-1-4	Medical electrical equipment-Part 1: General requirementfor safety - 4Collateral standard:Programmable electrical medicalsystems	1996
7	IEC	IEC 60601-2-7	Medical electrical equipment-Part 2: Particular requirementsfor the safety of High-voltagegenerators of diagnostic X-raygenerators	1998

8	IEC	IEC 60601-2-28	Medical electrical equipment-Part 2: Particular requirementsfor the safety of X-ray sourceassemblies and X-ray tubeassemblies for medicaldiagnosis	1993
9	IEC	IEC 60601-2-32	Medical electrical equipment-Part 2: Particular requirementsfor the safety of associatedequipment of X-ray equipment	1995
10	Cenelec	EN 980	Graphical symbols for usein the labeling of medical	2003
11	Cenelec	EN 1041	Information supplied by themanufacturer with medicaldevices	1998
No.	OEN	Reference	Title of standard	Year ofratificatio
12	ISO	ISO 14971	Medical devices - Applicationof risk	2007
13	ISO	ISO 13485	Medical devices. Qualitymanagement systems.Requirements for regulatorypurposes.	2003
14	FDA	21 CFR 1020.30and 1020.31	Diagnostic equipment standards	N/A

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Conclusion: Based on comparison with the predicate devices and the results of testing Metabiomed believes its REXTAR LCD device is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

March 1, 2013

Meta Biomed, Incorporated C/O Mr. Blix Winston ACMD Consulting, Limited Liability Company 2600 Mullinix Mill Road MOUNT AIRY MD 21771

Re: K122016

Trade/Device Name: REXTAR LCD

Regulation Number: 21 CFR 872.1800

Regulation Name: Extraoral Source X-Ray System

Regulatory Class: II

Product Code: EHD

Dated: February 7, 2013

Received: February 12, 2013

Dear Mr. Winston:

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.

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Page 2 - Mr. Winston

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 devicerelated 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Reportal roblem/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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/9/Picture/7 description: The image shows the name "Kwame O. Ulmer" in bold, black font. The letters "FDA" are in the background, with a complex, patterned design. To the right of the name, there is the text "fc" in a smaller, regular font.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 2

Indications for Use Statement

510(k) Number (if known): K122016

Device Name: REXTAR LCD

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:	X
(Per-21MFR S01usubpart D)
Susan Runner, DOSMA	2013.02.22
	11:44:41-0500

AND.OR Over-The-Counter Use: (21 CFR 801 Subpart C)

(Division Sign-On) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division Control Dental Devices Division of Anesules.org
Infection Control, Dental Devices - 11

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Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.