(110 days)
The PaX-Uni3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
PaX-Uni3D (PHT-7500), a dental radiographic imaging system, consists of dual image acquisition modes; panoramic, cephalometirc and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PaX-Uni3D (PHT-7500) is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental panoramic, cephalometric and cone beam computed tomographic radiography. The dental CBCT system is based on CMOS digital X-ray detector. CMOS CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic and cephalometric dental x-ray system based on CMOS X-ray detector.
The provided text describes a 510(k) submission for a dental X-ray imaging system, PaX-Uni3D (PHT-7500). The submission aims to demonstrate substantial equivalence to a predicate device, PaX-Uni3D (K090467). The document focuses on non-clinical performance and safety data, rather than a clinical study evaluating the device's diagnostic performance compared to a baseline or human readers.
Here's a breakdown of the requested information based on the provided text, noting where specific details are not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, diagnostic performance sense (e.g., sensitivity, specificity, accuracy thresholds). Instead, it primarily focuses on demonstrating equivalence to the predicate device through technical specifications and adherence to international safety and performance standards.
| Characteristic / Standard | Acceptance Criteria (Implicit) | Reported Device Performance (PaX-Uni3D (PHT-7500)) |
|---|---|---|
| Indications for Use | Same as predicate device | Matches predicate device |
| Performance Specification (Modes) | Panoramic, cephalometric, computed tomography | Panoramic, cephalometric, computed tomography |
| Input Voltage | Within acceptable range | AC 100-120 / 200-240 V |
| Tube Voltage | Within acceptable range | 50-90 kV |
| Tube Current | Within acceptable range | 2-10 mA |
| Focal Spot Size | Matches predicate device | 0.5 mm |
| Exposure Time (Pano) | Within acceptable range | Max 20.2s |
| Exposure Time (CT) | Within acceptable range | 15s/24s selectable |
| Exposure Time (Ceph) | Within acceptable range | 0.9-1.2s |
| Total Filtration | Matches predicate device | 2.8 mmAl |
| Software | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible |
| Anatomical Sites | Maxillofacial | Maxillofacial |
| CT Resolution (Xmaru0712CF, Xmaru1215CF Plus) | Equivalent to or better than predicate | 3.5 lp/mm |
| Pano Resolution (Xmaru1501CF) | Equivalent to or better than predicate | 5 lp/mm |
| Ceph Resolution (1210SGA) | Equivalent to or better than predicate | 3.9 lp/mm |
| CT Pixel Size (Xmaru0712CF, Xmaru1215CF Plus) | Equivalent to or better than predicate | 140 x 140 μm |
| Pano Pixel Size (Xmaru1501CF) | Equivalent to or better than predicate | 100 x 100 μm |
| Ceph Pixel Size (1210SGA) | Equivalent to or better than predicate | 127 x 127 μm |
| Safety Standards | Compliance with IEC standards | Met IEC 60601-1, -1-1, -1-3, -2-7, -2-28, -2-32, -2-44, -1-2 (EMC) |
| DICOM Compliance | Compliance with NEMA PS 3.1-3.18 | Met NEMA PS 3.1-3.18 |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "an expert review of image comparisons for both devices" and "Non-clinical & Clinical considerations according to FDA Guidance 'Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices.'" However, it does not specify the sample size (number of images or patients) used for this "expert review" or "clinical consideration." The data provenance (e.g., country of origin, retrospective or prospective) is also not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document refers to "an expert review of image comparisons." It does not specify the number of experts or their precise qualifications (e.g., "radiologist with 10 years of experience").
4. Adjudication Method for the Test Set
The document mentions "an expert review of image comparisons" but does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used to establish ground truth or resolve discrepancies among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study is mentioned in the provided text. The submission focuses on demonstrating substantial equivalence through technical specifications and non-clinical performance, rather than evaluating the diagnostic improvement of human readers with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device itself is an X-ray imaging system, not an AI algorithm performing diagnostic tasks. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" as usually applied to AI models is not relevant in this context. The performance evaluation is related to the image quality and physical specifications of the imaging system.
7. The Type of Ground Truth Used
For the "expert review of image comparisons," the implicit "ground truth" would likely be the expert consensus or judgment on the diagnostic quality and clinical utility of the images produced by the new device compared to the predicate device. The specific criteria for this judgment are not detailed, but it would relate to image resolution, clarity, ability to visualize relevant anatomical structures, and potential for diagnosis. There is no mention of pathology or outcomes data being used as ground truth for this comparison.
8. The Sample Size for the Training Set
This document describes a 510(k) for an X-ray imaging system, not an AI-powered diagnostic algorithm that would typically have a "training set." Therefore, the concept of a training set sample size is not applicable to this submission.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an AI algorithm in this context, this question is not applicable. The device is a hardware system for image acquisition.
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Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The string appears to be "K121400". The characters are written in a simple, slightly messy style, with varying stroke thicknesses. The image is in black and white, with the characters standing out against the white background.
Special 510(k) Summary
AUG 2 8 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 872.1800.
Date
May 2, 2012
Manufacturer
Vatech Co., Ltd.
23-4, Seogu-Dong, Hwaseong-Si, Gyeonggi-Do, 445-170, Korea Republic
Tel: +82-31-379-9585 Fax: +82-31-379-9638
Contact person: Park Sung-Hee
Official Correspondent (U.S. Designated agent)
Mtech Group 12946 Kimberley Ln, Houston, TX 77079 Tel: +713-467-2607 Fax: +713-464-8880 Contact person: Mr. Dave Kim (davekim@mtech-inc.net)
Trade/Proprietary Name:
PaX-Uni3D (PHT-7500)
Common Name: .
Digital X-ray Imaging System
Classification Name:
System, X-ray, Tomography, Computed, Dental (21CFR 892.1750, Product code OAS, Class2)
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Description:
PaX-Uni3D (PHT-7500), a dental radiographic imaging system, consists of dual image acquisition modes; panoramic, cephalometirc and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PaX-Uni3D (PHT-7500) is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental panoramic, cephalometric and cone beam computed tomographic radiography. The dental CBCT system is based on CMOS digital X-ray detector. CMOS CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic and cephalometric dental x-ray system based on CMOS X-ray detector.
Indication for use:
The PaX-Uni3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Predicate Device:
| Manufacturer | : Vatech Co., Ltd |
|---|---|
| Device | : PaX-Uni3D |
| 510(k) Number | : K090467 (Decision Date -- Jan. 8, 2010) |
Substantial Equivalence:
PaX-Uni3D (PHT-7500) described in this 510(k) has the similar intended use and technical characteristics as PaX-Uni3D of Vatech Co., Ltd.
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510(k) Submission – PaX-Uni3D (PHT-7500)
| Characteristic | ProposedVatech Co., Ltd.PaX-Uni3D (PHT-7500) | PredicateVatech Co., Ltd.PaX-Uni3D |
|---|---|---|
| 510(k) number | - | K090467 |
| Indicationsfor use | The PaX-Uni3D is a computedtomography x-ray system whichis a diagnostic x-ray systemintended to produce panoramic,cephalometric and cross-sectionalimages for dental examination anddiagnosis of diseases of the teeth,jaw and oral structure bycomputer reconstruction of x-raytransmission data from the sameaxial plane taken at differentangles. | The PaX-Uni3D is a computedtomography x-ray system whichis a diagnostic x-ray systemintended to produce panoramic,cephalometric and cross-sectionalimages for dental examination anddiagnosis of diseases of the teeth,jaw and oral structure bycomputer reconstruction of x-raytransmission data from the sameaxial plane taken at different angles. |
| PerformanceSpecification | Panoramic, cephalometric and computedtomography | Panoramic, cephalometric and computedtomography |
| Input Voltage | AC 100-120 / 200-240 V | AC 110/230 V |
| Tube Voltage | 50-90 kV | 40-90 kV |
| Tube Current | 2~10 mA | 2~10 mA |
| Focal Spot Size | 0.5 mm | 0.5 mm |
| Exposure Time | Max 20.2s (Pano)15s/24s selectable (CT)0.9-1.2s (Ceph) | 0.5-12.7s |
| Total Filtration | 2.8 mmAl | 2.8 mmAl |
| PerformanceSpecification | Dental Computed tomography | Dental Computed tomography |
| Software | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible |
| AnatomicalSites | Maxillofacial | Maxillofacial |
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| Characteristic of detector | ProposedPaX-Uni3D (PHT-7500) | PredicatePaX-Uni3D | ||
|---|---|---|---|---|
| Image Receptor | ComputedTomography(CMOS photodiodearray) | Xmaru0712CF | ||
| Panoramic(CMOS photodiodearray) | Xmaru1215CF Plus | Xmaru0808CF | ||
| Cephalometric(Flat Panel Detector) | Xmaru1501CF | S7199-01 | ||
| Size of ImagingVolume | 1210SGA | Xmaru1210 | ||
| Xmaru0712CF | 5 x 5 cm / 8 x 5 cm / 8 x 8 cm | |||
| Xmaru1215CF Plus | 5 x 5 cm / 8 x 5 cm /8.5 x 8.5 cm /12 x 8.5 cm | |||
| Xmaru0808CF | - | 5 x 5 cm / 8 x 5 cm | ||
| PixelResolution | CT | Xmaru0712CF | 3.5 lp/mm | - |
| Xmaru1215CF Plus | 3.5 lp/mm | - | ||
| Xmaru0808CF | - | 3.3 lp/mm | ||
| Pano | Xmaru1501CF | 5 lp/mm | - | |
| S7199-01 | - | 10.43 lp/mm | ||
| Ceph | 1210SGA (FDAK113630) | 3.9 lp/mm | - | |
| Xmaru1210 | - | 3.9 lp/mm | ||
| Pixel Size | CT | Xmaru0712CF | 140 x 140 μm | - |
| Xmaru1215CF Plus | 140 x 140 μm | - | ||
| Xmaru0808CF | - | 150 x 150 μm | ||
| Pano | Xmaru1501CF | 100 x 100 μm | - | |
| S7199-01 | - | 48 x 48 μm | ||
| Ceph | 1210SGA (FDAK113630) | 127 x 127 μm | - | |
| Xmaru1210 | - | 127 x 127 μm |
510(k) Submission - PaX-Uni3D (PHT-7500)
The indications for use, material, form factor, performance, and safety characteristics between PaX-Uni3D (PHT-7500) and the predicate device are the same. The primary differences are as follows: PaX-Uni3D (PHT-7500) introduces four new SSXI sensors: Xmaru0712CF and Xmaru1215CF Plus for CT mode, 1210SGA for Cephalometric mode and Xmaru1,501CF for panoramic mode.
:
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The non-clinical performance and clinical consideration report for the new SSXI CBCT sensors are provided separately in this submission. Based on the non-clinical and clinical consideration and the outcome of an expert review of image comparisons for both devices, new PaX-Uni3D (PHT-7500) is substantially equivalent, in terms of safety and effectiveness, with PaX-Uni3D, the predicate device.
Safety, EMC and Performance Data:
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1(A1+A2, 1995), IEC 60601-1-1 (2001), IEC 60601-1-3 (Ed. 1, 1994), IEC 60601-2-7 (1998), IEC 60601-2-28 (Ed. 1, 1993), IEC 60601-2-32 (Ed. 1, 1994) and IEC 60601-2-44 (Ed. 2, 2002) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2.
PaX-Uni3D (PHT-7500) meets the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set.
Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed.
Acceptance test according to IEC 61223-3-4 and IEC 61223-3-5 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 PaX-Uni3D (PHT-7500) is safe and effective and substantially equivalent to predicate device as described herein.
END
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular fashion around the bird image.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903*New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
· AUG 2 8 2012
Vatech Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 12946 Kimberley Lane HOUSTON TX 77079
Re: K121400
Trade/Device Name: PaX-Uni3D (PHT-7500) Regulation Number: · 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: July 30, 2012 Received: August 1, 2012
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.
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 mountal device related ad retor e vality systems (QS) regulation (21 CFR Part 820). This letter requirements as bet form in the quality as described in your Section 510(k) premarket motification. 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 If you ucare specific an 100 for your urro 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 Tou inal 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
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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Indications for Use
510(K) Number (if known):
Device Name: PaX-Uni3D (PHT-7500)
.
Classification: System, X-ray, Tomography, Computed, Dental
Indications for Use:
The PaX-Uni3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Prescription Use_ (Part 21 CFR 801 Subpart D)
. Over-The-Counter Use AND/OR (P art 21 CFR 801 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 Office of In Vitro Division of Naciological Evaluation and Safety
K121460
510K
Page 1 of l
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.