The GMR40 Digital X-ray Imaging System is intended for use with portable radiographic applications wherever conventional screen-film systems or computed radiography (CR) may be used. This device is not intended for mammographic applications.

Device Description

GMR40 DR Upgrade System (GMR40) integrates a traditional analog portable X-ray system with the speed and image quality benefits of digital capture technology to produce high quality images. The GMR40 can transition a portable system like GE AMX 4 / 4+ into a portable DR solution, improving the workflow of any cassette-based exam. This is a retrofit system consisting of Detector, Power supply box, Battery pack, Battery charger, Access point, CIB (Control Interface Box), Workstation and Main cable. This retrofit system is designed to generate a digital image while using the current analogue Xray system by upgrading only the part of an analogue cassette film to the digital panel (detector), and does not get involved in controlling X-ray radiation related parameters, which is still controlled by the existing X-ray system.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the GMR40 device:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It is not a detailed study report. Therefore, much of the information typically found in an independent study (like specific sample sizes for test sets, number of experts for ground truth, adjudication methods, or MRMC studies) is either not present or is inferred based on the comparison to the predicate device. The document explicitly states that the image quality of the GMR40 is considered the same as the predicate (GR40CW) because the key image acquisition components and software are identical.

Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in the traditional sense of numerical thresholds for a new clinical study. Instead, the "acceptance criteria" for this 510(k) revolve around demonstrating that the GMR40 system, despite modifications as a retrofit kit, maintains the same performance as its predicate device (GR40CW) while meeting relevant safety and regulatory standards.

The primary performance metric is the assertion of identical image quality and functional equivalence for its intended use.

Here's a table based on the provided comparison:

Acceptance Criteria (Inferred from Equivalence Claim)	Reported Device Performance (GMR40)
Image Quality: Identical to predicate device (GR40CW)	"Image quality of the GMR40 is the same in comparison to the predicate device GR40CW (K153401) since the major image acquisition components such as the detector panel and the imaging software are identical to GR40CW."
Detector Type: Csl	Csl
Detector Area: 14" x 17" (345mm x 425mm)	14" x 17" (345mm x 425mm)
Pixel Pitch: 140 µm	140 µm
High Contrast Limiting Resolution: 3.5 lp/mm	3.5 lp/mm
CIB Max. Signal Input Voltage: 400V DC/AC	400V DC/AC
Software Functionality: As designed, no new safety concerns	"The performance of the S-Station (Operational Software) and the power management system software have been validated as well and do not raise any new safety or effectiveness concerns."
Power Management System: Intelligent charging, reconditioning, state of charge monitoring, DC power control, EN 60601 certified.	The hybrid controller is a medical grade system with these features, designed, manufactured, and certified to EN 60601.
Battery Functionality: Withstand overcharge, overdischarge, vibration, shock.	Sealed lead acid batteries, UL recognized, designed to withstand these conditions.
Wireless Functionality: Tested and verified	"Wireless function was tested and verified following the FDA Guidance for Radio frequency Wireless Technology in Medical Devices."
Compliance with Standards: ES 60601-1, IEC 60601-1-2, ISO 14971, ISO 13485, 21 CFR Subchapter J 1020.30 and 1020.31.	All test results were compliant with the standards.

Study Information

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Size: Not explicitly stated as a separate "test set" for a clinical study. The device was "installed and tested on GE AMX 4 & 4+ models." This suggests testing on physical units. No information on the number of images or patients.
- Data Provenance: Not specified. The verification and validation activities were internal to NeuroLogica Corporation. It's implied to be laboratory/engineering testing rather than clinical data from a specific country or patient population.
- Retrospective or Prospective: Primarily engineering verification and validation. Not a clinical retrospective or prospective study as typically understood for clinical efficacy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
- Given the nature of the submission (substantial equivalence based on physical and software component identity), expert evaluation of ground truth for a clinical dataset would not be the primary focus.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not mentioned. This type of clinical adjudication is not relevant to the engineering and comparative performance testing described.
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 Study: No, an MRMC comparative effectiveness study was not done. The device is an X-ray imaging system retrofit kit, not an AI-powered diagnostic tool for interpretation assistance. The focus is on the hardware's image acquisition and processing capabilities.
- Effect Size: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The core components (detector panel and imaging software) are stated to be "identical to the predicate device GR40CW." Nonclinical testing data for these components (MTF, DQE) was provided in conformance to FDA guidance. While not a "standalone algorithm" in the AI sense, the imaging performance itself (what the device produces) is evaluated independently of human interpretation in terms of technical metrics.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: For the technical performance aspects (MTF, DQE), the "ground truth" would be the physical measurements and established scientific standards for X-ray imaging device performance. For functional aspects (battery life, connectivity), the ground truth is the expected operational specifications. There is no mention of clinical ground truth (like pathology or outcomes) for a test set, as this is a device modification submission, not a demonstration of a new diagnostic capability.
The sample size for the training set:
- Training Set Size: Not applicable. This is a hardware/software system retrofit, not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" for the software would be its development and testing against specifications, not data-driven machine learning.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no "training set" in the context of machine learning. The software (S-Station and power management) was "validated" against its design specifications and intended functionality.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 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 image of three human profiles facing to the right, with flowing lines suggesting movement or connection.

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

May 11, 2017

NeuroLogica Corporation, a Subsidiary of Samsung Electronics Co., Ltd % Dr. Ninad Gujar Director, Regulatory Affairs and Quality Assurance 14 Electronics Avenue DANVERS MA 01923

Re: K171085

Trade/Device Name: GMR40 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: March 24, 2017 Received: April 12, 2017

Dear Dr. Gujar:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael D'Hara

For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171085

Device Name GMR40

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for NeuroLogica. The logo consists of the word "NeuroLogica" in a bold, sans-serif font. The "O" in "NeuroLogica" is replaced with a blue circle. Below the logo is the text "A Subsidiary of Samsung Electronics Co., Ltd" in a smaller font.

Section 5: 510(k) Summary

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510(k) SUMMARY

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92

Date: March 24, 2017

Submitter:

NeuroLogica Corporation, a subsidiary of Samsung Electronics Co., Ltd 14 Electronics Avenue, Danvers, MA 01923

Contact:

Dr. Ninad Gujar Director, Regulatory Affairs & Quality Assurance Telephone: 978-564-8503 Fax: 978-564-8677 E-mail: ngujar@neurologica.com

Proposed Device:

Trade Name:	GMR40
Device Model:	GMR40
Common Name:	Mobile Retrofit Kit
Classification Name:	Stationary x-ray system
Product Code:	MQB
Device Classification:	Class II (per 21 CFR § 892.1680)

Predicate Device:

Trade Name:	GR40CW
Device Model:	GR40CW
Common Name:	Retrofit Kit
Classification Name:	Stationary x-ray system
Product Code:	MQB
Device Classification:	Class II (per 21 CFR § 892.1680)

Device Description:

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Integration Information:

This is a retrofit system consisting of Detector, Power supply box, Battery pack, Battery charger, Access point, CIB (Control Interface Box), Workstation and Main cable. This retrofit system is designed to generate a digital image while using the current analogue Xray system by upgrading only the part of an analogue cassette film to the digital panel (detector), and does not get involved in controlling X-ray radiation related parameters, which is still controlled by the existing X-ray system.

The GMR40 retrofit system can be applied to the existing analogue X-ray system in CIB mode. CIB is connected to a signal line of a hand switch for passively detecting the signal, as On or Off, coming out from the hand switch to the X-ray Generator Console, to make the digital detector ready to active or inactive to receive X-ray radiation.

The GMR40 retrofit system has been installed and tested on GE AMX 4 & 4+ models and can be integrated with existing X-ray equipment which has certified generator with minimum 12.5kW capacity using CIB. The detector can be used in bucket with 43cm x 35cm cassette size in wall stand or patient. The EI and DI are guidance values used to emit an acceptable amount of X-rays on the detector.

Integration Diagram:

Image /page/5/Figure/5 description: This image shows a diagram of the GMR40 Retrofit Kit and the Existing X-ray System. The GMR40 Retrofit Kit includes a detector, workstation, CIB, and hand switch. The Existing X-ray System includes an X-ray generator console. The diagram shows the flow of signals between the different components of the two systems.

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Indications for Use:

Comparison of Technological Characteristics with the Predicate Device:

All parameters associated with image quality are the same between the device subject in this application (GMR40) and the predicate device referenced (GR40CW). The proposed GMR40 device has same imaging workstation software, detector, wireless access point and CIB with the GR40CW predicate device. There are no significant differences in materials, energy source or technological characteristics compared to the predicate device other than the ones noted below in the table.

Model # Name	GMR40(proposed device)	GR40CW(predicate deviceK153401)	Discussion
Indications forUse	The GMR40 DigitalX-ray ImagingSystem is intendedfor use with portableradiographicapplications whereverconventional screen-film systems orcomputedradiography (CR)may be used. Thisdevice is not intendedfor mammographicapplications.	The GMR40 DigitalX-ray ImagingSystem is intendedfor use in generalprojectionradiographicapplications whereverconventional screen-film systems or CRsystems may be used.This device is notintended formammographicapplications.	Different (1)
Detector type	Csl	Csl	Same as predicatedevice
Detector area	14" x 17"(345mmX425mm)	14" x 17"(345mmX425mm)	Same as predicatedevice
Pixel Pitch (µm)	140	140	Same as predicatedevice
Model # Name	GMR40(proposed device)	GR40CW(predicate deviceK153401)	Discussion
High ContrastLimitingResolution(lp/mm)	3.5	3.5	Same as predicatedevice
CIB	Max. signal inputvoltage 400V DC/AC	Max. signal inputvoltage 400V DC/AC	Same as predicatedevice
Monitor	23 inches(1,920 X 1,080)	21.5 inches(1,920 X 1,080)	Different (2)
Access Point	2.4 GHz and 5 GHz802.11n radios	2.4 GHz and 5 GHz802.11n radios	Same as predicatedevice
PowerManagementSystem	AC/DC HybridController	-	Different (3)
Lead AcidBatteries	12 V , 17 Amp Hr	-	Different (4)
Imaging workstation
CPU	Intel Core i7-6700T2.8G 4C	Intel® Xeon®E5-1620	Different (5)
Memory (RAM)	8GB	8GB	Same as predicatedevice
Storage (HDD)	1TB	1TB	Same as predicatedevice

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Differences:

The differences identified in the above table are described in further detail.

1. Indications for Use

The indications for use has been modified to make the retrofit unit compatible to portable analog x-ray systems instead of the fixed systems predicate device GR40CW

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(K153401) is intended for. The Detector, Power supply box, Battery pack, Battery charger, Access point, Control Interface Box (CIB) from the predicate device GR40CW (K153401) remain the same for the proposed device GMR40.

2. Monitor

The GMR40 monitor has the same resolution as the predicate device GR40CW (K153401) however the screen size is slightly bigger and provides touchscreen functionality.

3. Power Management System

The hybrid controller is a medical grade power management system designed for use with sealed lead acid batteries in mobile / point of care products for hospitals and long term healthcare facilities. The unit uses microprocessor based technology for intelligent charging, reconditioning, state of charge monitoring and DC power control. It is designed, manufactured and certified to the EN 60601 medical equipment standard.

4. Lead Acid Batteries

The retrofit kit is self-powered through its own internal batteries which are valve regulated lead acid batteries. These sealed lead acid batteries are UL recognized and are designed to withstand overcharge, overdischarge and resisting vibration and shock.

5. Workstation CPU

This is an off the shelf equipment that has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. The performance of the S-Station (Operational Software) and the power management system software have been validated as well and do not raise any new safety or effectiveness concerns.

The differences noted above were tested both internally through our verification and validation. These activities tested that the retrofit kit can be operated on battery power or when plugged into a wall outlet for charging besides confirming the operation of the device and wireless connectivity of the detector panel. Usage time, battery functionality, power voltages, PC performance and control interface were verified during the testing. In addition, all modifications were evaluated as part of the system that was tested for product safety (IEC 60601-1) and EMC / EMI (IEC 60601-1-2). The integrated GMR40 retrofit system was installed and tested on GE AMX 4 & 4+ models. The testing ensured that the modifications were successfully integrated and that GMR40 performs as designed.

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As these modifications do not raise any new safety or effectiveness concerns, the results demonstrate the GMR40 system is of comparable type and substantially equivalent to the currently marketed GR40CW system (K153401).

Safety, EMC and Performance Data:

Electrical, mechanical, environmental safety and performance testing were conducted according to standard ES 60601-1 (2012), and EMC testing was conducted according to IEC 60601-1-2 (2007). Wireless function was tested and verified following the FDA Guidance for Radio frequency Wireless Technology in Medical Devices. All test results were compliant with the standards.

In addition to conformance to the above harmonized standards, GMR40 quality assurance activities include the following:

Risk analysis and mitigation
. System verification and validation testing
트 Testing at unit level

The software contained in the proposed device has been developed based on the FDA Guidance for Content of Premarket Submissions for Software Contained in Medical Devices and the in addressing cybersecurity issues considered the FDA guidance document Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.

The performed verification and validation testing activity confirmed that GMR40 was successfully integrated into radiographic systems where conventional screen-film systems or CR is used and that it performs as designed.

Non-clinical Data:

The digital detector is identical to the predicate device GR40CW (K153401). Nonclinical testing data was provided in conformance to the FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices", which includes MTF and DQE measurements as tested by IEC 6220-1. The proposed device non-clinical testing data such as MTF and DQE measurements is identical to the predicate device. It conforms to the followings: ISO 14971, ISO 13485, 21 CFR Subchapter J 1020.30 and 1020.31.

Clinical Data:

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Image quality of the GMR40 is the same in comparison to the predicate device GR40CW (K153401) since the major image acquisition components such as the detector panel and the imaging software are identical to GR40CW.

Conclusion:

Based upon the above considerations, NeuroLogica Corporation, subsidiary of Samsung Electronics, believes that the GMR40 (proposed device) is as safe, as effective, and performs as well as the legally marketed devices.

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.