(52 days)
"Picasso-Master also known as ECT and Master3D" is a computed tomography 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. It provides diagnostic details of the anatomic structures for surgical planning of oral and maxillofacial area by acquiring 360° rotational image sequences of the head and neck areas, including the ENT and dentomaxillofacial area. The device is operated and used by physicians, dentists, and x-ray techniciana.
"Picasso-Master also known as ECT and Master3D" is equipped with state-of-the-art CMOS-CT sensor to capture 3D x-ray computerized tomography scanned image. It is capable of real time-image acquisition through an advanced digital imaging process which allows considerably efficient diagnosis, information management, and real-time sharing of image information on network.
Here's a breakdown of the acceptance criteria and the study information for the "Picasso-Master also known as ECT and Master3D" device, based on the provided 510(k) summary:
This device is an X-ray tomography system. As such, acceptance criteria generally focus on demonstrating that the new device functions similarly and produces comparable image quality to a legally marketed predicate device, especially considering the lack of an AI component explicitly described in this document.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" for performance metrics in a quantitative manner. Instead, the demonstration of substantial equivalence relies on showing that the new device has similar design, function, and intended use as the predicate devices, and that it has undergone appropriate testing according to internal company procedures. The "acceptance criteria" here are implicitly linked to demonstrating equivalency in technical specifications and image generation capabilities.
| Feature / Acceptance Criteria (Implicit: Equivalence to Predicate) | Predicate: EPX-Impla (K070658) Reported Performance | New Device: "Picasso-Master, ECT, Master3D" Reported Performance |
|---|---|---|
| Intended Use (Produce cross-sectional images for diagnostic details of oral & maxillofacial structures and ENT/dentomaxillofacial area via 360° rotational imaging) | Identified for "three Dimensional imaging for dental Purposes. Provides details of the anatomic structures for oral and maxillofacial surgical procedures." Acquires 360° rotational sequence of head and neck areas for diagnostic support. | Identified for "produce cross-sectional images... for surgical planning of oral and maxillofacial area by acquiring 360° rotational image sequences of the head and neck areas, including the ENT and dentomaxillofacial area." |
| X-ray Beam Type | Cone | Cone |
| Detector | Flat-Panel Detector (CsI + Photo Diode) | Flat-Panel Detector (CsI + Photo Diode) |
| Grayscale | 12 | 12 |
| Voxel size (mm) | 0.2 | 0.2 |
| Rotation angle | 360 degree | 360 degree |
| Scan time (sec) | 15 | 24 |
| Patient Position | Stand | Seated |
| Reconstruction time | Less than 2 min | 3min |
| KVp range | 40~90 (Normal 85kV) | 50~90 (Normal 85kV) |
| mA range | 2~10 (Normal 7) | 2~10 (Normal 7) |
| Focal spot (mm) | 0.4 | 0.4 |
| CT Slice Thickness | 0.1~1.0mm | 0.1~1.0mm |
| Overall Safety and Effectiveness | Satisfactory (as a legally marketed device) | Substantially equivalent to predicate device |
| Software Functionality and Performance | Not detailed, assumed satisfactory | "Software testing and validation were done according to written test protocols... Test results support the conclusion that actual device performance satisfies the design intent." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for a clinical test set in terms of patient cases or images. The testing mentioned refers to "Software testing and validation" and "internal company procedures," which suggests laboratory or engineering testing rather than a clinical trial with a specific test set of patient data.
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified, but given it's an X-ray imaging system, data would typically be derived from phantom studies, cadaver studies, or potentially a limited number of human scans (though not detailed here). The manufacturer is E-Woo Technology Co., Ltd. from Korea, so if any human data was used, it would likely be from Korea.
- Retrospective/Prospective: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since this is a 510(k) for an X-ray medical device (hardware and reconstruction software), and not an AI/CADe/CADx system that interprets images, the concept of "ground truth" established by human experts for a "test set" in the context of diagnostic accuracy is not directly applicable in the same way as it would be for an AI algorithm. The device's performance is assessed on its ability to produce images with certain technical specifications and quality, not on its diagnostic interpretation.
- Number of Experts: Not specified, and likely not applicable in the context of establishing ground truth for diagnostic performance of the device itself. Technical professionals would have reviewed test results.
- Qualifications of Experts: "Designated technical professionals" reviewed test results. Specific qualifications not provided.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication method as would be used for assessing diagnostic interpretations of images by human readers or AI. The testing described is for the device's technical performance and software validation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes a medical imaging device, not an AI or CAD system that assists human readers. Therefore, there is no mention of human reader improvement with or without AI assistance, or an effect size.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone X-ray CT system. Its performance refers to its ability to acquire and reconstruct images, not to an algorithm that provides diagnostic output independent of a human. There is no AI algorithm being described that would have a "standalone performance" in the context of diagnostic decision-making. The device is operated by physicians, dentists, and x-ray technicians.
7. The Type of Ground Truth Used
For a pure imaging device, "ground truth" typically refers to the accuracy of the physical measurements, image quality metrics (e.g., spatial resolution, contrast resolution, noise levels), and geometric accuracy of the reconstructed images against known phantoms or established imaging standards. The document states that "Test results support the conclusion that actual device performance satisfies the design intent," which implies that these types of technical ground truths were used for validation. There is no mention of pathology, outcomes data, or expert consensus on diagnostic findings as ground truth for evaluating the device itself.
8. The Sample Size for the Training Set
Not applicable. This document describes an X-ray CT device, not an AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no AI algorithm training set described.
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Korisy7?
EXHIBIT 2 510(k) Summary
AUG 2 1 2008
E-Woo Technology Co., Ltd. 1F/4F/5F, Yunmin Technotown, 473-4, Bora-Dong, Giheung-Gu, Yongin-Si, Gyeonggi-Do, Korea 446-904 Tel: 82-31-899-7967 Fax: 82-31-286-3007 Taewoo Kim, President & CEO January 15, 2008
- Identification of the Device:
Proprietary-Trade Name: "Picasso-Master also known as ECT and Master3D" Classification Name: System, X-Ray, Tomography, Computed / Product Code JAK Common/Usual Name: Computed Tomography X-ray System
- Equivalent legally marketed device:
This product is similar in design and identical in function to E-Woo's computed tomography X-ray system Model EPX-Impla (K070658, E-Woo Technology Co., Ltd.), Extraoral Source X-ray System, Model i-CAT Scanner (K061284, Imaging Science International (nc.)
- Indications for Use (intended use):
"Picasso-Master also known as ECT and Master3D" is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission from the same axial plane taken at different angles. It provides diagnostic details of the anatomics structures for surgical planning of oral and maxillofacial area by acquiring of the matomal image sequences lot the head and neck areas, including the ENT and dentomaxillofacial area. The device is operated and used by physicians, dentists, and x-ray technicians.
4. Description of the device:
"Picasso-Master also known as ECT and Master3D" is equipped with state-of-the-art CMOS-CT sensor to capture 3D x-ray computerized tomography scanned image. It is capable of real time-image acquisition through an advanced digital imaging process which allows considerably efficient diagnosis, information management, and real-time sharing of image information on network.
| Feature | Predicate:(I-CAT Scanner, K061284) | Predicate: Dental ImagingSystem(EPX-Impla, K070658) | New Device"Picasso-Master, ECT,Master3D" |
|---|---|---|---|
| Manufacturer | Imaging Sciences International Inc.USA | E-Woo Technology Co., Ltd.Korea | E-Woo Technology Co., Ltd.Korea |
| Intended Use | The Imaging Sciences International Inc. i-CAT Scanner constructs a threedimensional model from images takenduring a rotational X-ray sequence. TheImaging Sciences i-CAT Scanner isintended to be used whenever a dentist,oral surgeon, or other physician needs 3Dinformation of high contrast objects.The system is designed for imaging of | EPX-Impla is intendedto be used for threeDimensional imaging for dentalPurposes. Provides details ofthe anatomic structures for oraland maxillofacial surgicalprocedures. | "Picasso-Master, ECT,Master3D" is a computedtomography x-ray systemintended to producecross-sectional images ofthe body by computerreconstruction of x-raytransmission data from |
| TM Joint studies, mandible & maxilla forimplant planning, sinuses, and other areasof the maxillofacial complex. | the same axial planetaken at different angles.It provides diagnosticdetails of the anatomicstructures for oral andmaxillofacial surgicaltreatment. | ||
| Indication forUse | The i-CAT Scanner is a dedicated X-Rayimaging device that acquires a 360orotational X-ray sequence, reconstructs athree-dimensional matrix of the examinedvolume and produces two dimensionalviews of this volume. The i-CAT Scannercan measure distances and thickness ontwo dimensional images.Images produced by the i-CAT Scannercan be printed or exported on magneticand optical media. | EPX-impla is a computedtomography x-ray system thatacquires a 360° rotationalsequence of the head and neckareas, including the ENT anddentomaxillofacial area for usein diagnostic support. Thedevice is operated and used byphysicians, dentists, and x-raytechnologists. | "Picasso-Master, AKA ECT,Master3D"acquires a 360°rotational sequence of the headand neck areas, including theENT and dentomaxillofacialarea for use in diagnosticsupport. The device is operatedand used by physicians,dentists, and x-ray technicians. |
| X-ray Beam | Cone | Cone | Cone |
| Detector | Flat-Panel Detector(Amorphous Silicon) | Flat-Panel Detector(CsI + Photo Diode) | Flat-Panel Detector(CsI + Photo Diode) |
| Grayscale | 14 | 12 | 12 |
| Voxel size (mm) | 0.2-0.4 | 0.2 | 0.2 |
| Number ofVoxel | 275 x 425 | 416 x 416 | 224 × 224 × 160 (20X15)352 × 352 × 256 (20X15)608 × 608 × 448 (20X15) |
| Rotation angle | 360 degree | 360 degree | 360 degree |
| Scan time (sec) | 10, 20 (standard), 40 | 15 | 24 |
| Pateintposition | Seated | Stand | Seated |
| FOV(3)(cm x cm) | 17 x 1316 x 22 (Optimal Extended FOV) | 12 x 78 x 5 | 20 x 1520 x 19 |
| Reconstructiontime | 1.5min (20 sec scan) | Less than 2 min | 3min |
| KVp range | 120 | 40~90(Normal 85kV) | 50~90(Normal 85kV) |
| mA range | 3-8 (Pulse mode) | 2~10(Normal 7) | 2~10(Normal 7) |
| Focal spot(mm) | 0.5 | 0.4 | 0.4 |
| CT SliceThickness | 0.800~0.200 mm | 0.1~1.0mm | 0.1~1.0mm |
5. Safety and Effectiveness, comparison to predicate device
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6. Testing information and Conclusion
In all material respects, the "Picasso-Master also known as ECT and Master3D" is substantially equivalent to Dental Imaging System EPX-Impla,(K070658, E-Woo Technology Co., Ltd.). Testing was performed according to internal company procedures. Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2008
E-Woo Technology Company, Ltd. % Mr. Tamas Borsai Responsible Third Party Official TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K081847
Trade/Device Name: Picasso-Master also known as ECT and Master 3D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: August 13, 2008 Received: August 14, 2008
Dear Mr. Borsai:
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 either class II (Special Controls) or class III (PMA), it may be subject to such 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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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); 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.
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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | () | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure .
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Indications for Use
510(k) Number (if known) :
Device Name : "Picasso-Master, also known as ECT and Master3D"
Indications For Use : "Picasso-Master also known as ECT and Master3D" is a computed tomography 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. It provides diagnostic details of the anatomic structures for surgical planning of oral and maxillofacial area by acquiring 360° rotational image sequences of the head and neck areas, including the ENT and dentomaxillofacial area. The device is operated and used by physicians, dentists, and x-ray techniciana.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Page 1 of 1
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(Division Sign-Off)_
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K081847
§ 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.