The PrestoDR Portable ™, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR Portable ™ allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.

Device Description

The PrestoDR Portable is a Digital Radiography system, featuring an integrated portable flat panel digital detector (FPD) K090625 WIRELESS PORTABLE DETECTOR FD-W17, Philips Medical Systems North America CO (this is the 510(k) for the wireless portable flat panel detector) and CMT's proprietary technology, which incorporates state of the art object-oriented software and connectivity. The legally marketed SMARTRAD K003438 has been modified: To integrate the portable flat panel digital detector (FPD) K090625, improve its cost effectiveness, aging technologies and components (hardware and software) have been redesigned. The device major functions and principle of operation were not changed.

AI/ML Overview

The provided text is a 510(k) Summary and related FDA correspondence for the PrestoDR Portable, a Digital Radiography system. It focuses on establishing substantial equivalence to predicate devices rather than presenting a detailed study proving performance against specific acceptance criteria for AI or diagnostic accuracy.

The document indicates that the PrestoDR Portable is primarily a hardware and software system for general radiography, replacing conventional screen-film systems. The "Reason for 510(k) Submission" states it's a "Special 510(k) Submission" due to integration of a portable flat panel digital detector and redesign of "aging technologies and components (hardware and software)." It explicitly says, "The device major functions and principle of operation were not changed."

Therefore, the submission does not contain the detailed study results, acceptance criteria for device performance (especially in a diagnostic context), or specific data regarding AI-driven diagnostic improvements as requested in the prompt. The text focuses on regulatory compliance and substantial equivalence to a predicate device, as opposed to a clinical performance study with specific diagnostic accuracy metrics.

Here's a breakdown of why most of the requested information cannot be found in the provided text:

1. Table of acceptance criteria and the reported device performance

Not found. The document states, "Tests data demonstrate that the PrestoDR Portable meets the required specifications." However, it does not specify what those specifications or acceptance criteria are, nor does it provide a table of reported device performance against them. The focus is on safety and effectiveness through substantial equivalence and compliance with 21CFR 820.30 regulations for design, verification, and validation, rather than specific clinical performance metrics.

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

Not found. No information is provided about any specific test set, its sample size, or data provenance. The submission describes a device modification and asserts substantial equivalence, which typically relies on demonstrating that the modified device performs similarly to the predicate, rather than new clinical trials measuring diagnostic accuracy.

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)

Not found. Since no specific test set or clinical performance study is described, there is no mention of experts establishing ground truth.

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

Not found. No adjudication method is described because no specific test set or study requiring such a method is presented.

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

Not found. The document does not describe an MRMC study or any AI assistance. The device is a digital radiography system; while it uses "state of the art object-oriented software," this doesn't imply an AI-driven diagnostic aid that would require an MRMC study to show human reader improvement with AI.

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

Not found. There is no mention of a standalone algorithm performance study.

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

Not found. No ground truth type is specified, as no clinical performance study involving diagnostic accuracy is detailed.

8. The sample size for the training set

Not found. There is no mention of a training set, as the document doesn't describe the development or validation of a diagnostic algorithm based on machine learning.

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

Not found. Consequently, no information is provided on how ground truth for a training set was established.

Summary

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510(k) Summary of Safety and Effectivencss (in accordance to 21 CFR 807.87(h))

Device Name

Proprietary Device Name: PrestoDR Portable

Establishment Name and Registration Number of Submitter

APR 2 2 2010

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:+972-4-9590888,

Device Classification

Product Code: MOB Regulation Number: 892.1650 Common Name: Solid state X-Ray imager Classification Name: Image intensified fluoroscopic x-ray system Regulatory class: Class II

Reason for 510(k) Submission Special 510(k) Submission

Identification of Legally Marketed Equivalent Devices K003438 SMARTRAD K090625 WIRELESS PORTABLE DETECTOR FD-W17

Device Description

Indications for use

The PrestoDR Portable, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR Portable allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.

Safety & Effectiveness

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

Substantial Equivalency

It is CMT opinion that the PrestoDR Portable 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 U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

Mr. Shlomi Dines Director of Quality & Regulatory Affairs CMT Medical Technologies, Ltd. Hacarmel St., Bld. 7/2. POB. 111 Industrial Park, Yoqneam Ilit 20692 ISRAEL

AUG 2 3 2013

Re: K100400 Trade/Device Name: PrestoIDR Portable Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL and MQB Dated: April 9, 2010 Received: April 13, 2010

Dear Mr. Dines:

This letter corrects our substantially equivalent letter of April 22, 2010.

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

510(k) Number (if known):

Device Name: PrestoDR: Portable

Indications For Use: The PrestoDR Portable ™, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR Portable ™ allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.

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

БЮК.

AND/OR

. . .

Over-the-Counter Use: NO (Part 21 CFR B01 Subpart C)

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Concurrence of CDRH; Office of Device Evaluation (ODE)

Robert Bookerf
(Division Sign-Off)

Division of Rediological Dev Office of In Vitro Diagnostic Device Evalu tion and Safety

Regulation Number and Section

§ 892.1720 Mobile x-ray system.

(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.