The Picasso-Duo is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce cross-sectional images(optionally with panoramic) 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.

Device Description

E-WOO Dental Imaging system Picasso-Duo is a Computed Tomography X-ray System. Computed Tomography (CT) provides valuable 3-D imaging of the dental and maxillofacial structures for diagnosis and treatment planning. Uses of CT imaging include for assessment of impacted teeth, root configurations and mandibular condyle evaluation. This technology allow for 3-D imaging but at lower equipment cost, simpler image acquisition and lower patient radiation dose.

Model Picasso-Duo is diagnostic equipment which consists of panoramic dental x-ray system and computed tomography x-ray system. The panoramic dental x-ray is a system based on digital and computed tomography (CMOS CT Sensor to Capture 3D x-ray Computerized tomogram scanned image)

AI/ML Overview

The provided text is a 510(k) summary for the Picasso-Duo Computed Tomography X-ray System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or performance metrics from such a study.

The summary focuses on regulatory compliance, electrical, mechanical, and environmental safety, and performance testing according to established IEC standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, IEC 60601-2-44, and IEC 60601-1-2 for EMC). It states that all test results were satisfactory, implying the device meets the safety and performance requirements of these standards.

Without a dedicated study section, specific details regarding acceptance criteria for diagnostic accuracy, sample sizes for test or training sets, ground truth establishment methods, or expert qualifications are not present in this document.

Therefore, I cannot populate the requested table or answer most of the questions as the information is not provided in the input text.

However, based on the information provided, here are the answers I can deduce or explicitly state:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated as specific diagnostic performance metrics (e.g., sensitivity, specificity, accuracy for a particular condition). The implied acceptance criteria are compliance with the referenced IEC safety and performance standards.
Reported Device Performance: "All test results were satisfactory" for electrical, mechanical, environmental safety, and performance testing according to the specified IEC standards. The device is also stated to provide "high quality digital image" and "A clear Tomography image upto minimum 0.1mm at any directions."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: Not specified.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not specified.

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:

No mention of an MRMC study or AI assistance. This device is a Computed Tomography X-ray system, not an AI-powered diagnostic tool in this context.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable, as this is a medical imaging device, not a standalone algorithm in the context of diagnostic performance evaluation mentioned in the request.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not specified. (Likely relies on physical measurements and image quality metrics rather than clinical ground truth for a diagnostic accuracy study, as none is described).

8. The sample size for the training set:

Not specified. (Not applicable for this type of device submission which doesn't describe an AI training process).

9. How the ground truth for the training set was established:

Not specified. (Not applicable).

Summary of what the document DOES state regarding performance/testing:

The device's safety and performance are affirmed by compliance with a series of IEC standards:

IEC 60601-1 (General requirements for basic safety and essential performance)
IEC 60601-1-1 (Safety requirements for medical electrical systems)
IEC 60601-1-3 (General requirements for radiation protection in diagnostic X-ray equipment)
IEC 60601-2-7 (Particular requirements for the safety of high-voltage generators for diagnostic X-ray equipment)
IEC 60601-2-28 (Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies)
IEC 60601-2-32 (Particular requirements for the safety of associated equipment for X-ray equipment)
IEC 60601-2-44 (Particular requirements for the safety of X-ray equipment for computed tomography)
IEC 60601-1-2 (Electromagnetic compatibility - Requirements and tests)

The document asserts that "All test results were satisfactory" for these standards tests. It also mentions features like "high quality digital image" and "A clear Tomography image upto minimum 0.1mm at any directions."

Summary

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K070991

510(k) Summary

OCT - 9 2009

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: _Mar. 25, 2009

Company and Correspondent making the submission:

Name - E-WOO Technology Co., Ltd.

Address - 1F, 4F, Yunmin Technotown, 473-4, Bora-dong, Giheung-gu, Yongin-si,

Gyeonggi-do, 446-904, Korea

Telephone -- +82-31-285-6950

Fax -- +82-31-286-3007

Contact - Mr. DongTaek, Oh

Internet - http://www.e-wootech.com

1. Device :

Trade/proprietary name	: Picasso-Duo
Common Name	: Computed tomography x-ray system
Classification Name	: Computed tomography x-ray system

1. Predicate Device

Predicate Device A:
Manufacturer	: VATECH Co., Ltd.
Device	: PaX-500
510(k) Number	: K082350 (Decision Date - Oct. 10. 2008)
Predicate Device B:
Manufacturer	: E-WOO Technology Co., Ltd.
Device	: EPX-Impla: Picasso-Trio
510(k) Number	: K070658 (Decision Date - Apr. 5. 2007)

E-WOO Technology Co., Ltd.

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4. Classifications Names & Citations :

21CFR 892.1750, OAS, Computed tomography x-ray system, Class2

5. Description :

5.1 General

5.2 Product features

· Picasso-Duo, the dental CT system with digital panoramic unit, provides the high quality digital image.
It is not necessary to attach / detach the panoramic sensor when you capture CT images by Auto-Switching system.
· It is possible to capture Maxillary, mandible and whole arch by wider FOV (15 * 15).
With Picasso-Trio it is not required to purchase a CT and a panoramic system each separately.
· It is helpful for treatments by viewing the invisible part with a 3-D CT images.
The disk space for installation is no bigger than that of a general panoramic system.
· A clear Tomography image upto minimum 0.1mm at any directions
· You can set and control the Examination Program Mode with a console PC
· Support more accurate diagnosis imaging than LCD as well as voice announcement function for patients and staffs
· Picasso-Duo supports the DICOM Format

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510(k) Submission - Picasso-Duo

ട Indication for use :

Comparison with predicate device : ಲ

E-WOO Technology Co., Ltd., believes that the Picasso-Duo is substantially equivalent to the EPX-Impla of E-WOO Technology Co., Ltd. and PaX-500 of VATECH Co., Ltd.

7 Safety, EMC and Performance Data :

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32 and IEC 60601-2-44 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. All test results were satisfactory.

9. 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 E-WOO Technology Co., Ltd. concludes that The Picasso-Duo is safe and effective and substantially equivalent to predicate devices as described herein.

1. E-WOO Technology Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
  END

E-WOO Technology Co., Ltd.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a caduceus, with three curved lines emanating from a central point.

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

OCT - 9 2009

E-Woo Technology c/o Mr. Vincent Lee E-Woo Technology USA, Inc. 256 North Sam Houston Pkwy. E, Suite 115 HOUSTON TX 77060

Re: K090991

Trade/Device Name: Computed tomography x-ray system /Picasso-Duo Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 22, 2009 Received: September 24, 2009

Dear Mr. Lee:

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 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

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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.

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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting 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):

K090991

Device Name: Computed tomography x-ray system /Picasso-Duo

Indications for Use:

Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (Part 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)

Division of

Page 1 of 1

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Device 510(k) Number

Regulation Number and Section

§ 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.