The Models SimonDR DRP Digital X-Ray Imager is a digital x-ray Imager intended for physicians or technologists operating under the guidance of the physician, to use for diagnostic x-ray imaging in podiatric practices instead of using a film based system.

Device Description

The SimonDR Inc. model DRP is used to directly capture and convert conventional projection X-Ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for podiatric radiographic examinations.

AI/ML Overview

The provided text describes a 510(k) summary for the SimonDR DRP digital X-ray imager, comparing it to two predicate devices: a Kodak/Carestream film-screen system and a Canon CXDI-55G digital X-ray imager. The document focuses on demonstrating substantial equivalence based on technical characteristics rather than clinical performance or AI integration. Therefore, much of the requested information regarding AI-specific studies, training sets, and expert adjudication methods is not present in this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the substantial equivalence to the predicate devices, particularly in technical specifications like MTF and Dynamic Range.

Characteristic	Acceptance Criteria (Predicate 1: Lanex Detail Screen/Film System)	Acceptance Criteria (Predicate 2: Canon CXDI-55G)	Reported Device Performance (SimonDR Inc. Model DRP)
MTF	4-5 lp/mm 35%	MTF@2 lp/mm 40%	4.0 lp/mm 35%
Dynamic Range	Approximately 20 (about 5 bits)	(linear A/D: 14 bit), (output data: 12 bit)	Up to 16 bit capture, display ranging from 8 to 12 bits

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The comparison is based on technical specifications (MTF, Dynamic Range) rather than a clinical study with a test set of images.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided as there is no mention of a human-read test set or ground truth establishment by experts in this technical comparison.

4. Adjudication Method for the Test Set

This information is not provided as there is no mention of a human-read test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned in the provided document. The document describes a digital X-ray imager, which is a hardware device, not an AI algorithm assisting human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

A standalone performance study for an AI algorithm was not mentioned in the provided document. The device is a digital X-ray imager.

7. The Type of Ground Truth Used

The ground truth or comparison for the device's performance relies on technical specifications (MTF and Dynamic Range) of legally marketed predicate devices, not clinical ground truth (like expert consensus, pathology, or outcomes data).

8. The Sample Size for the Training Set

This information is not provided. The document describes a hardware device, implying no AI model with a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not provided as there's no mention of a training set or AI model.

Summary

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Section 5 - Revised 3/10/2010:

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APR - 5 2010

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510(K) Summary (K093790)

Prepared:	February 24, 2010
Submitter:
Company Name:	SimonDR Inc.
Company Address:	3515 Marmenco Court
	Baltimore, Maryland 21230
Contact Person:	Jason Simon, President
Official Correspondent:	Valerie Lohr, General Manager
Phone Number:	410-636-5555
Fax Number:	410-636-4415
Proposed Device:
Reason For 510(K):	New Device
Manufacturer:	SimonDR Inc.
Trade Name:	SimonDR
Model Number:	DRP
Classification Name:	90 MQB SSXI- Solid State X-Ray Imager
FDA 510(k)#:	Submission in progress
Predicate Device(s) 1:
Manufacturer:	Kodak (Carestream) Lanex Screen/AGFA 1/2 Speed Film
Trade Name:	Kodak/Carestream
Model Number:	Lanex
Classification Name:	Radiographic film/screen system
FDA 510(k)#:	N/A
Manufacturer:	Canon Inc.
Trade Name:	Canon
Model Number:	CXDI-55G
Classification Name:	MQB, Solid State X-Ray Imager
FDA 510(k)#:	K091345

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Predicate Device(s) 2:

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Description of Device :

The full Device Comparison Table is found in section 12 of this application; however, in terms of . Resolution (MTF) and Dynamic Range the comparison with the digital and analog predicate device is found below.

Characteristic	SimonDR IncModel DRP	Lanex DetailScreen/FilmSystemDevice 1
MTF	4.0 lp/mm 35%	4 -5 lp/mm 35% (seealso Section 18)
Dynamic Range	Up to 16 bit capture,display ranging from8 to 12 bits	Approximately20(about 5 bits),depending on filmprocessing

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Characteristic	SimonDR Inc.Model DRP	CanonDevice 2
MTF	4.0 lp/mm 35%	MTF@2 lp/mm 40%
Dynamic Range	Up to 16 bit capture,display ranging from8 to 12 bits	(linear A/D: 14 bit)(output data: 12 bit)

Intended Use:

The SimonDR DRP is a digital x-ray Imager intended for physicians, or technologists operating under the supervision of a physician, to use for podiatric x-ray instead of using a film based system.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal

and Radiological Devices

510(k) Number _______________________

Prescription Use_XX__

OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

510(k) Summary Statement

I certify that in my capacity as President of Simon DR, Inc, I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent, The information I agree to make available will be a duplicate of the premarket notification including any adverse safety and effectiveness information, but excluding

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all patient identification, and trade secret and confidential commercial information, as defined in 21 CFR 20.61.

・

Signed:

Torn Son

Jason Simon

President

Date: 2/24/2010

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of two parts: a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is written 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

Ms. Valerie Lohr General Manager SimonDR, Inc. 3515 Marmenco Court BALTIMORE MD 21230

Re: K093790

Trade/Device Name: SimonDR DRP Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: March 11, 2010 Received: March 15. 2010

AUG 2 3 2013

Dear Ms. Lohr:

This letter corrects our substantially equivalent letter of April 5, 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 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

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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Section 4 Indications for Use Statement

510K number:

Submission in progress

Device Name:

SimonDR DRP

Indications For Use:

11093790

(Division Sign-Off)

Office of In Vit

510K. K093700

Regulation Number and Section

§ 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.