The Duet DRF is a digital image acquisition system to be used in conjunction with a solid state detector during radiography or fluoroscopy x-ray examination to capture, digitalize, review images and format images according to DICOM protocol to be sent through network connection. This device is not intended for mammography use

Device Description

The Duet DRF is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) same as in K080859 DRF 4343, Villa sistemi medicali S.p.A. (this is the 510(k) for the system that incorporate the same flat panel detector and state of the art object-oriented software and connectivity.

AI/ML Overview

The provided text describes the 510(k) submission for the Duet DRF device, a Digital Radiography system. However, it does not contain the detailed information requested regarding the acceptance criteria, specific performance study results, sample sizes for test sets or training sets, expert qualifications, or ground truth establishment methods.

The document states:
"The device has been designed verified and validated complying with 21CFR 820.30 regulations. Tests data demonstrate that the Duet DRF meets the required specifications. No adverse affects have been detected."

This is a general statement indicating that testing was performed to verify and validate the device, and that it met specifications. It does not provide the specifics needed for the requested information.

Therefore, for your current input, much of the requested information cannot be extracted. I will outline what can be gleaned and state where information is missing.

Here's a breakdown of the requested information based on the provided text, highlighting what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in the document. The document generally states that "Tests data demonstrate that the Duet DRF meets the required specifications." However, what those specific specifications or acceptance criteria were (e.g., image resolution, signal-to-noise ratio, image acquisition speed, diagnostic accuracy) and the quantitative results are not provided.	Not specified in the document. No specific metrics or performance values are reported.

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

Sample Size for Test Set: 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.
Ground Truth Establishment Method for Test Set: Not specified. The document does not describe how ground truth was established for "tests data."

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

Adjudication Method: 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

MRMC Comparative Effectiveness Study: Not mentioned. The device is described as a "digital image acquisition system," not an AI-assisted diagnostic tool. Therefore, a study on human reader improvement with AI assistance would not be applicable based on the device description.

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

Standalone Performance Study: Not explicitly mentioned in terms of diagnostic accuracy or a specific algorithm study. The "tests data" mentioned suggests performance tests were done for the system (hardware and software), but not specifically for a standalone algorithm's diagnostic capability. The device's primary function described is image acquisition, digitalization, review, and formatting, not automated diagnosis.

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

Type of Ground Truth: Not specified.

8. The sample size for the training set

Sample Size for Training Set: Not applicable/Not specified. The document primarily describes a hardware system for image acquisition. There's no indication of a machine learning model that would require a "training set" in the context of diagnostic AI.

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

Ground Truth for Training Set Establishment: Not applicable/Not specified, as there is no mention of a training set.

Summary of Device and Safety/Effectiveness Claims from the Document:

Device Name: Duet DRF
Device Type: Digital Radiography system with an integrated flat panel digital detector.
Purpose: To capture, digitalize, review, and format X-ray images during radiography or fluoroscopy examinations, sending them via DICOM protocol.
Predicate Device: K080859 DRF 4343
Intended Use: Not for mammography.
Safety & Effectiveness Claim: The device has been designed, verified, and validated complying with 21CFR 820.30 regulations. "Tests data demonstrate that the Duet DRF meets the required specifications. No adverse affects have been detected." The manufacturer believes it is substantially equivalent in safety and effectiveness to the predicate device.

Conclusion:

The provided text serves as a 510(k) summary, which often focuses on substantial equivalence to a predicate device and general declarations of meeting regulatory requirements. It does not delve into the detailed technical specifications, specific acceptance criteria, or performance study methodologies and results that would typically be found in a detailed validation report. Therefore, most of the specific questions about acceptance criteria, test set details, expert involvement, and ground truth establishment cannot be answered from this document.

Summary

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510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(m))

Kl.03038

, I

Device Name Proprietary Device Name: Duet DRF

Establishment Name and Registration Number of Submitter

MAR 2 9 2011

Name: CMT Medical Technologies Ltd. Registration: 8030112 Submission contact: Shlomi Dines Hacarmel St. Bld 7/2, POB. 111, Industrial Park, Yoqneam Ilit 20692, ISRAEL, Tel:+972-4-8566220 +972-52-4854411, Fax:+972-3-5212202,

Device Classification

Product Code: Regulation Number: Common Name: Classification Name: Regulatory class:

MOB 892.1650 Solid state X-Ray imager Image intensified fluoroscopic x-ray system Class II

Reason for 510(k) Submission Abbreviated 510(k) Submission

Identification of Legally Marketed Equivalent Devices K080859 DRF 4343

Device Description

Indications for use

· This device is not intended for mammography use

Safety & Effectiveness

The device has been designed verified and validated complying with 21CFR 820.30 regulations. Tests data demonstrate that the Duet DRF meets the required specifications. No adverse affects have been detected.

Substantial Equivalency

It is CMT opinion that the Duet DRF is substantially equivalent in terms of safety and effectiveness to the predicate device.

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's emblem on the left, which features a stylized human figure. To the right of the emblem, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is displayed in a clear, sans-serif font.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Shlomi Dines Director of Quality and Regulatory Affairs CMT Medical Technologies, Ltd. Hacarmel St. Bld 7/2, PO Box 111, Industrial Park YOQNEAM ILIT 20692 ISRAEL

AUG 2 0 2013

0 2013

Re: K103038 Trade/Device Name: Duet DRF Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA and MOB Dated: December 14, 2011 Received: February 22, 2011

Dear Mr. Dines:

This letter corrects our substantially equivalent letter of March 29, 2011.

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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro 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 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/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

1103038 510(k) Number (if known):

Duet DRF Device Name:

Indications For Use: The Duet DRF is a digital image acquisition system to be used in conjunction with a solid state detector during radiography or fluoroscopy x-ray examination to capture, digitalize, review images and format images according to DICOM protocol to be sent through network connection.

This device is not intended for mammography use

Prescription Use: YES (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use: NO (Part 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)

Mary S Pastls
(Division Sign-On

Office of In

'510K K103038

Page 1 of

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.