(281 days)
The ClearVision ExamVue Flat Panel detector is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems.
The ClearVision ExamVue Flat Panel detector is not indicated for use in mammography.
The ClearVision ExamVue Flat Panel Detector consists of a line of 3 different models of solid state x-ray detectors, of differing size and characteristics, designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. The ClearVision ExamVue Flat Panel Detector captures digital images of anatomy through the conversion of x-rays to electronic signals, eliminating the need for film or chemical processing to create a hard copy image. The ClearVision ExamVue Flat Panel Detector incorporates the ExamVueDR software, which performs the processing, presentation and storage of the image in DICOM format.
All models of the ClearVision ExamVue Flat Panel Detector use aSi TFTD for the collection of light generated by a CsI scintillator, for the purpose of creating a digital x-ray image. The three available models are:
- a. A 14x17in (35x43cm) tethered cassette sized panel
- b. A 14x17in (35x43cm) wireless cassette sized panel with automatic exposure detection
- c. A 17x17in (43x43cm) tethered panel for fixed installations.
The provided document is a 510(k) premarket notification for a medical device called the "ClearVision ExamVue Flat Panel Detector". This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving a device meets specific clinical acceptance criteria through a dedicated study.
Therefore, many of the requested elements for describing specific acceptance criteria and study details cannot be fully extracted from this document. The document presents laboratory performance data and mentions "clinical images" but does not detail a formal clinical study with specific acceptance criteria as one would find in a clinical trial.
However, based on the information provided, here's what can be inferred and stated:
Acceptance Criteria and Reported Device Performance
The document does not specify formal clinical acceptance criteria (e.g., sensitivity, specificity, accuracy targets that the device must meet for a specific diagnostic task). Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through technical specifications and performance characteristics, as well as indications for use and safety. The primary "study" proving the device meets these (implied) acceptance criteria is the comparison of its technical specifications and general performance to those of the predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (ClearVision ExamVue Flat Panel Detector) |
|---|---|
| Technical Equivalence to Predicate Devices: | |
| Pixel Pitch (similar to 139um-143um of predicates) | 143um (FDX3543RP, FDX4343R), 140um (FDX3543RPW) |
| Limiting Resolution (compared to predicates) | 3.7lp/mm (all models), which is superior to "Over 3lp/mm" and "3lp/mm" of predicates. |
| DQE @ 1 lp/mm (compared to predicates) | 57% (FDX3543RP), 60% (FDX3543RPW), 58% (FDX4343R), which is superior to 33% Gadox / 46% CsI and 45% Gadox / 65% CsI of predicates. (Note: The new device exclusively uses CsI, which is stated to be higher performance than Gadox). |
| MTF @ 1 lp/mm (compared to predicates) | 63% (FDX3543RP), 68% (FDX3543RPW), 65% (FDX4343R), which is comparable to or superior to 63% Gadox / 72% CsI and 57% Gadox / 59% CsI of predicates. (Again, comparing CsI to CsI performance where applicable given the new device's exclusive use of CsI). |
| Scintillator technology (same type as predicate CsI option) | Exclusively CsI |
| Digital Image Conversion (14-16 bit) | 16 bit (FDX3543RP), 14 bit (FDX3543RPW, FDX4343R) - comparable to 14 bit of predicates. |
| DICOM compatibility | Yes |
| Use of aSi TFTD technology | Yes |
| Functional Equivalence: | |
| General radiography and exclusion of mammography in Indications for Use | Indicated for general radiology, specialist radiology (podiatry, orthopedic), and mobile x-ray systems. Not indicated for mammography. (Same as predicates). |
| Integration with ExamVueDR software for image processing, presentation, and storage | Integrated with ExamVueDR software for final processing and presentation, which was previously 510(k) cleared (K142930) and used with the predicate devices. |
| Electrical Safety and EMC Standards (IEC 60601-1, IEC 60601-1-2) | Met. |
| Biocompatibility | Data provided for patient-contacting surfaces showing no known adverse reactions. |
| Image acquisition control interface (hard-wired to x-ray generator or AED, and software) | Tested as part of laboratory and clinical testing; software control interface for exposure settings previously tested with K142930. |
Study Details
-
Sample size used for the test set and the data provenance:
- The document mentions "Clinical images were provided" and "clinical testing of the hardware" but does not specify a separate "test set" in terms of number of cases/patients used to evaluate performance against specific diagnostic endpoints or ground truth.
- Data provenance (country of origin, retrospective/prospective) is not specified for these "clinical images". The application is from JPI Healthcare Co., LTD, based in Seoul, South Korea, so the data may originate from there, but this is not explicitly stated.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The "clinical images" and "clinical testing" are used to show the device "works as intended" in addition to laboratory data, rather than for a formal evaluation against expert-derived ground truth for diagnostic accuracy.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as a formal adjudication process for a diagnostic performance test set is not 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 MRMC comparative effectiveness study is mentioned. This device is an X-ray detector, not an AI diagnostic algorithm, so "human readers improve with AI vs without AI assistance" is not applicable in this context.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The device itself is a hardware component (Flat Panel Detector) and not an "algorithm" in the sense of an AI/CAD system. Its performance is assessed standalone through technical specifications and image quality metrics (DQE, MTF, Limiting Resolution) in a laboratory setting, and "clinical images" are used for qualitative assessment.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "clinical images" mentioned, the type of ground truth is not specified. Given the context, it's likely qualitative assessment by radiologists that the images are of diagnostic quality for their intended use, rather than a comparison to a definitive clinical ground truth for specific pathologies. For the technical specifications (DQE, MTF, Limiting Resolution), these are objective measurements derived from physical phantom or test object images, not clinical ground truth.
-
The sample size for the training set:
- This device is hardware; it does not have a "training set" in the context of machine learning algorithms. The associated software (ExamVueDR) processes and presents images, but details about its own training data (if any for image processing algorithms) are not provided here.
-
How the ground truth for the training set was established:
- Not applicable, as this is hardware and not a machine learning algorithm.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design of three human profiles facing to the right, with a stylized caduceus-like symbol above them. The design is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2016
JPI Healthcare, Inc. % Mr. William Little Senior Product Manager JPI Healthcare Solutions, Inc. 52 Newtown Plaza PLAINVIEW NY 11803
Re: K160143
Trade/Device Name: ClearVision Exam Vue Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: September 12, 2016 Received: September 13, 2016
Dear Mr. Little:
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.
Michael D'Hara For
Robert Ochs, Ph.D. 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) K160143
Device Name
ClearVision ExamVue Flat Panel Detector
Indications for Use (Describe)
The ClearVision ExamVue Flat Panel detector is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems.
The ClearVision ExamVue Flat Panel detector is not indicated for use in mammography.
| 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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510 (k) Summary
August 10, 2016.
-
- Company and Correspondant Making the Submission:
Name: JPI Healthcare Co., LTD Address: Woolim e-BIZ center #608 170-5, Kuro-3-dong, Kuro-gu Seoul, 152-769 Telephone: +82-2-2108 - 2580 (Ext. 500-504) Fax: +82-2-2108-1180 Contact: John Lim Website: http://www.jpi.co.kr/
- Company and Correspondant Making the Submission:
-
- Identification of Device
| Classification Name: | Solid State X-ray Imager (flat panel/digital imager) |
|---|---|
| Common Name: | Solid State X-ray Imager |
| Trade/Proprietary Name: | ClearVision ExamVue Flat Panel Detector |
3. Predicate Device
| Manufacturer: | Atlaim |
|---|---|
| Device: | ATAL-8 |
| 510(k) Number: | K113812 |
| Classification Name: | Solid State X-ray Imager (flat panel/digital imager) |
| Common Name: | Solid State X-ray Imager |
| Regulatory Number: | 21 CFR 892.1680 |
| Regulatory Class: | II |
| Product Code: | 90 MQB |
| Manufacturer: | Samsung Mobile Display |
|---|---|
| Device: | DIGITAL FLAT PANEL X-RAY DETECTOR, MODELLTX240AA01-A |
| 510(k) Number: | K090742 |
| Classification Name: | Solid State X-ray Imaging Device |
| Common Name: | Digital Flat Panel Xray Detector |
| Regulatory Number: | 21 CFR 892.1680 |
| Regulatory Class: | II |
| Product Code: | 90 MQB |
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- Product Classification Names and Citations 4.
Regulatory Number: 21 CFR 892.1680 Regulatory Class: II Product Code: 90 MQB
5. Description:
The ClearVision ExamVue Flat Panel Detector consists of a line of 3 different models of solid state x-ray detectors, of differing size and characteristics, designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. The ClearVision ExamVue Flat Panel Detector captures digital images of anatomy through the conversion of x-rays to electronic signals, eliminating the need for film or chemical processing to create a hard copy image. The ClearVision ExamVue Flat Panel Detector incorporates the ExamVueDR software, which performs the processing, presentation and storage of the image in DICOM format.
All models of the ClearVision ExamVue Flat Panel Detector use aSi TFTD for the collection of light generated by a CsI scintillator, for the purpose of creating a digital x-ray image. The three available models are:
- a. A 14x17in (35x43cm) tethered cassette sized panel
- b. A 14x17in (35x43cm) wireless cassette sized panel with automatic exposure detection
- c. A 17x17in (43x43cm) tethered panel for fixed installations.
6. Indication for use
The ClearVision ExamVue Flat Panel Detector is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems.
The ClearVision ExamVue Flat Panel Detector is not indicated for use in mammography.
7. Comparison with Predicate Device:
JPI Healthcare Co., Ltd, believes that the ClearVision ExamVue Flat Panel Detector is substantially equivalent to the ATAL-8 detector of Atlaim and the LTX240AA01-A of Samsung Mobile Display, Ltd.
The ClearVision ExamVue Flat Panel Detectors have similar or superior characteristics to the predicate devices, including:
- The same aSi TFTD technology, converting visible light from a a. scintillator into a digital image.
- b. Similar pixel pitch (140um-143um for the Clear Vision Exam Vue Flat
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Panels vs 139um-143um for the predicate devices)
- Exclusively CsI scintillators, compared to the option of CsI or the lower C. performance Gadolinium Oxide scintillator in the predicate devices.
- d. Similar indications for use, focused on general radiography and excluding mammography.
- Have been integrated to function with the same image acquisition e. software, ExamVueDR, for final processing and presentation.
Clinical images were provided; these images were not necessary to establish equivlance based on the modifications to the device (x-ray detector technology identical to predicate devices) but they provide further evidence in addition to the laboratory performance data to show that the subject device works as intended.
The image acquisition control interface testing was performed as part of laboratory and clinical testing. This control interface consists of hard wired control signal to the x-rav generator (all models) or AED (FDX3543RPW). The software control interface for exposure settings on selected generators had been previously tested in the notification of the ExamVueDR software as a stand-alone product (K142930).
-
- Safety, EMC and Performance Data
Bench tests reports have been provided, detailing the safety and EMC testing, as well as non-clinical performance data for the ClearVision ExamVue Flat Panel Detector.
- Safety, EMC and Performance Data
Biocompatibility data has been provided for patient-contacting surfaces of the device, demonstrating that there are no known adverse reactions to skin contact with the device.
We have also provided clinical testing of the hardware, showing comparison images using identical software, as recommended by the FDA guidance document "Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices"
-
- Conclusions:
In accordance with the Federal Food. Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification JPI Healthcare Co., Ltd. concludes that The ClearVision ExamVue Flat Panel Detector is safe and effective and substantially equivalent to predicate devices as described herein.
- Conclusions:
A detailed comparison supporting this conclusion can be found in Exhibit 1, Substantial Equivalence Chart.
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EXHIBIT 1
SUBSTANTIAL EQUIVALENCE CHART
| Device Name | ExamVueFPDFDX3543RP | Examvue FPDFDX3543RPW | ExamvueFPDFDX4343R | ATAL-8 | LTX240AA01-A |
|---|---|---|---|---|---|
| Manufacturer | Toshiba | Toshiba | Toshiba | ATLAIM | SamsungMobile Display |
| FDA 510(k)K# | K160143 | K160143 | K160143 | K113812 | K090742 |
| Intended use. | The ClearVision ExamVue Flat Panel detectoris indicated for use in general radiology,specialist radiology including podiatry,orthopedic, and other specialties, and in mobilex-ray systems.The ClearVision ExamVue Flat Panel detectoris not indicated for use in mammography. | The ClearVision ExamVue Flat Panel detectoris indicated for use in general radiology,specialist radiology including podiatry,orthopedic, and other specialties, and in mobilex-ray systems.The ClearVision ExamVue Flat Panel detectoris not indicated for use in mammography. | The ClearVision ExamVue Flat Panel detectoris indicated for use in general radiology,specialist radiology including podiatry,orthopedic, and other specialties, and in mobilex-ray systems.The ClearVision ExamVue Flat Panel detectoris not indicated for use in mammography. | The ATAL 8and ATAL 8Care indicatedfor use ingeneralradiographicimages ofhumananatomy. It isintended toreplaceradiographicfilm/screensystems in allgeneral-purposediagnosticprocedures,excludingfluoroscopic,angiographic,andmammographicapplications. | LTX240AA01-A digital flatpanel X-raydetector isindicated fordigital imagingsolutiondesigned forprovidinggeneralradiographicdiagnosis ofhumananatomytargeting bothadult andchildren. It isintended toreplace filmbasedradiographicdiagnosticsystems andprovide a casediagnosis andtreatmentpalnning forphysicians andother healthcareprofessionals.Not to be usedformammography. |
| Configuration | This submission is for the digital panel and | This | This |
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| software only, no generator or stand provided. | submission isfor the digitalpanel only, nogenerator orstand provided. | submission isfor the digitalpanel only, nogenerator orstand provided. | |||
|---|---|---|---|---|---|
| Detector Type | Amorphous Silicon (a-Si) Photodiode | SAME | SAME | ||
| Pixel Pitch | 143um | 140um | 143um | 139um | 143um |
| LimitingResolution | 3.7lp/mm | 3.7lp/mm | 3.7lp/mm | Over 3lp/mm | 3lp/mm |
| A/DConversion | 16 bit | 14 bit | 14 bit | 14 bit | 14 bit |
| Active Area | 14x17 inch | 14x17 inch | 16.9x17.3 inch | 17x17 inch | 17x17 inch |
| Dimensions(mm) | 384(w) x460(D) x15(H) | 384(w) x460(d) x 15(h) | 512(w) x495(d) x43(h) | 500(w) x500(1) x 25(h) | 500(w) x497(1) x 44mm(H) |
| Weight | 3kg | 3kg | 9kg | 7.8kg | 13.4kg |
| Pixels | 2448x2984(7.3Mpx) | 2466x3040(7.5Mpx) | 3008x3072(9.2Mpx) | 3072x3072(9.4Mpx) | 3072x3072(9.4Mpx) |
| DQE @ 1lp/mm | 57% | 60% | 58% | 33% Gadox /46% CsI | 45% Gadox /65% CsI |
| MTF @ 1lp/mm | 63% | 68% | 65% | 63% Gadox /72% CsI | 57% Gadox /59% CsI |
| DICOM | Yes | Yes | Yes | Yes | Yes |
| Scintillator | CsI | CsI | CsI | CsI/Gadox | CsI/Gadox |
| Interface | GigabitEthernet | GigabitEthernet orWireless | GigabitEthernet | GigabitEthernet | GigabitEthernet |
| AutomaticExposureDetection | No | Yes | No | Yes | No |
| GeneratorExposureTrigger orSensor | Yes | Yes | Yes | Yes | Yes |
| Power Source | AC Line | AC Line | AC Line | AC Line | AC Line |
| Standards | ElectricalSafety perIEC 60601-1and EMC perIEC 60601-1-2. | ElectricalSafety per IEC60601-1 andEMC per IEC60601-1-2. | ElectricalSafety perIEC 60601-1and EMC perIEC 60601-1-2. | ElectricalSafety per IEC60601-1 andEMC per IEC60601-1-2. | ElectricalSafety per IEC60601-1 andEMC per IEC60601-1-2. |
| Acquisitionand ControlSoftware | ExclusivelyExamVueDR(K142930) | ExclusivelyExamVueDR(K142930) | ExclusivelyExamVueDR(K142930) | *Option forExamVueDR(K142930) | *Option forExamVueDR(K142930) |
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*: The ExamVueDR software 510(k) notification (K149230) includes the indicated detector as one of the detectors the software can be integrated with to form a retrofit solution. The ExamVueDR software is not referenced in the 510(k) notification for the detector itself.
The intended use and environment of the device is the same as the predicate devices, with only minor differences in features that are not integral to the function of the device. The image acquisition and user interface software in the device has been previously 510(k) notified for use with the predicate devices. For this reason, we believe it is substantially equivalent to the predicate devices.
§ 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.