(29 days)
REXTAR X 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 x-ray lmages using intraoral image receptors. It is intended for both adult and pediatric subjects.
The REXTAR X consists of an X-ray tube, X-Ray tube assembly, X-Ray Controller built into a hand held camera-like device. The Rextar model contains additional accessories. The REXTAR X 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.
The provided text does not contain detailed information about specific acceptance criteria, a scientific study with performance metrics, or the methodologies for establishing ground truth, as would be expected for an AI/ML device.
This document describes a conventional X-ray device, the REXTAR X, and its substantial equivalence to a predicate device (REXTAR LCD) for FDA 510(k) clearance. The comparison focuses on technical and operational specifications rather than AI/ML performance.
Therefore, many of the requested sections about acceptance criteria, study details, human reader improvement, and ground truth establishment cannot be answered from the provided input.
However, based on the information available, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for this device appear to be primarily based on demonstrating substantial equivalence to a predicate device (REXTAR LCD) and compliance with relevant safety and performance standards for X-ray systems.
| Parameter (Criterion) | REXTAR X Performance (Reported Device Performance) | REXTAR LCD Performance (Predicate Device Performance) |
|---|---|---|
| Intended Use | Matches predicate device | 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. |
| Indications | Matches predicate device | X-ray system designed to provide images of the patients undergoing dental procedures. Clinical uses include Bite wing, periapical, occlusal and panoramic images. |
| Dentist/dental assistant Involvement | Supervision | Supervision |
| X-ray Generator | High-Frequency | High-Frequency |
| Tube Power | 70kV /2mA | 70kV /2mA |
| Tube Type | Stationary | Stationary |
| Tube Focal Spot | 0.4mm | 0.4mm |
| Target Angle | 12° | 12° |
| Exposure Time | 0.01 ~ 1.30 (sec) (43 steps) | 0.01 ~ 1.3 (sec) (43 Steps) |
| Power Requirement | DC 11.1 V | DC 11.1 V |
| Picture Quality | Good | Good |
| Battery Type | Rechargeable | Rechargeable |
| Display | LCD Panel Display (3.5 Inch, BTN LCD, 1/4Duty, 1/3BIAS) | LCD Panel Display (4 Digits, 0.5 Inch Character Height) |
| Size | 146×155×139mm | 404× 234× 198mm |
| Weight (kg) | 2 | 1.88 |
| Compliance with Standards | UL/IEC 60601-1, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, EN/IEC 60601-1-2 | (Implied compliance for predicate, not explicitly listed as acceptance criteria for REXTAR X in the table) |
The "study" that proves the device meets "acceptance criteria" is essentially the comparison table demonstrating substantial equivalence and the EMC testing results. The conclusion states: "Based on comparison with the predicate devices and the results of testing Metabiomed believes its REXTAR and REXTAR LCD devices are substantially equivalent" (Section 13).
2. Sample size used for the test set and the data provenance
Not applicable for this type of submission. The performance assessment is based on technical specifications and comparison to a predicate device, not a diagnostic accuracy study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable.
4. Adjudication method for the test set
Not applicable.
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. This is a conventional X-ray device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable.
7. The type of ground truth used
Not applicable. The "ground truth" for this submission concerned the technical specifications and safety compliance of the device itself, rather than diagnostic accuracy against a clinical gold standard.
8. The sample size for the training set
Not applicable. No AI/ML component.
9. How the ground truth for the training set was established
Not applicable. No AI/ML component.
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JUL 3 1 2013
Section 9
Attachment 5
510(k) Summary
(Rest left blank)
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| 1. 510(k) Owner: | Metabiomed, Inc.110 Gibraltar Road, suite 106Horsham, PA 19044USA |
|---|---|
| Ph: | 267-282-5893 |
| Fax: | 267-282-5899 |
| Email: | metabiomed@gmail.com |
| 2. Company Contact: | Ian Yun |
| Title: | Sales Director |
| 3. 510(k) Preparer: | Blix WinstonACMD Consulting, LLC.2600 Mullinix Mill RoadMt. Airy, MD 21771USA |
| Ph: | 301-607-9185 |
| Email: | fblixwinston@aol.com |
| 4. Date of Submission | June 25, 2013 |
| 5. Device Name and Classification: | Trade name - REXTAR XCommon name - Portable X-Ray SystemClassification name - Extraoral source x-ray system |
| 6. Predicate Devices: | Manufacturer : Poskom Co. Ltd.Device : Rextar LCD510(k) Number : K122016 (Decision Date - |
- Classifications Names & Citations: 21CFR 872.1800, EHD - Extraoral source x-ray system, Class 2
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- 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.
03/01/2013)
- 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.
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- Device Description:
- a. General:
The REXTAR X consists of an X-ray tube, X-Ray tube assembly, X-Ray Controller built into a hand held camera-like device. The Rextar model contains additional accessories.
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b. Outline:
The REXTAR X 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 X has the following qualities: -
· High Frequency X-ray Generator (70kV-2mA Fixed)
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· High Quality Toshiba Tube used (Tube Focal Spot (0.4mm))
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· Target Angle 12°
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· Easy to Move
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· Eliminates the need for multiple X-Ray units in doctor's office
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· Efficient to use
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· Compact Size & Light Weight Design for Ultimate Portability
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· Long Battery Life Hundreds of images can be obtained from one time charge
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· Diverse Applications (Field Hospital, Emergency, Forensic Science, Operation Room)
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· Can use conventional film or digital sensors to obtain images
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· Images from digital sensors are displayed on a computer that is not included as a part of the camera for the Rextar X
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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).
10. Indications for use:
REXTAR X is 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.
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- Substantial equivalence:
The REXTAR devices have been tested to demonstrate substantial equivalence with the predicate devices. A comparison of features is included below.
- Substantial equivalence:
Comparison Table: REXTAR, REXTAR LCD and the Predicate Devices
| Parameter | Rextar X | Rextar LCD |
|---|---|---|
| 510(k) | Submitted for marketingclearance | K122016 |
| Intended Use | To be used by trained dentistsand dental technicians as amobile, extraoral x-ray sourcefor producing diagnostic x-rayimages using intraoral imagereceptors. It is intended forboth adult and pediatricsubjects. | To be used by trained dentistsand dental technicians as amobile, extraoral x-ray sourcefor producing diagnostic x-rayimages using intraoral imagereceptors. It is intended for bothadult and pediatric subjects. |
| Indications | X-ray system designed toprovide images of the patientsundergoing dental procedures.Clinical uses include Bite wing,periapical, occlusal andpanoramic images. | X-ray system designed toprovide images of the patientsundergoing dental procedures.Clinical uses include Bite wing,periapical, occlusal andpanoramic images. |
| Dentist/dentalassistantInvolvement | Supervision | Supervision |
| Labeling | Submitted | Submitted |
| X-rayGenerator | High-Frequency | High-Frequency |
| Tube Power | 70kV /2mA | 70kV /2mA |
| Tube Type | Stationary | Stationary |
| Tube FocalSpot | 0.4mm | 0.4mm |
| Target Angle | 12° | 12° |
| ExposureTime | 0.01 ~ 1.30 (sec)(43 steps) | 0.01 ~ 1.3 (sec)(43 Steps) |
| PowerRequirement | DC 11.1 V | DC 11.1 V |
| PictureQuality | Good | Good |
| Battery Type | Rechargeable | Rechargeable |
| Parameter | Rextar X | Rextar LCD |
| Display | LCD Panel Display( 3.5 Inch, BTN LCD, 1/4Duty,1/3BIAS ) | LCD Panel Display (4 Digits, 0.5Inch Character Height) |
| Size | 146×155×139mm | 404× 234× 198mm |
| Weight (kg) | 2 | 1.88 |
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- Standards:
The portable x-ray system, REXTAR X 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.
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- Conclusion: Based on comparison with the predicate devices and the results of testing Metabiomed believes its REXTAR and REXTAR LCD devices are substantially equivalent
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 31, 2013
Meta Biomed. Incorporated C/O Mr. Blix Winston ACMD Consulting, Limited Liability Company 2600 Mullinix Mill Road MT AIRY MD 21771
Re: K132041
Trade/Device Name: Rextar X Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: II Product Code: EHD Dated: June 24, 2013 Received: July 2, 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Kwame Ulmer, M.S. Acting Division 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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510(k) Number (if known): )x 1 32 OY |
Device Name: REXTAR X
Indications for Use:
REXTAR X 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 x-ray lmages using intraoral image receptors. It is intended for both adult and pediatric subjects.
Prescription Use Yes AND/OR
(Part 21 CFR 810 Subpart D)
(21 CFR 801 Subpart C)
. . . . . . . . . .
(PLEASE DO NOT WRITE BELOW THUS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Andrew I. Steen -S 2013.07.30 14:51:48 -04'00'
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anast.lessons Bevices
113204 510(k) Number:
A1-03
§ 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.