The RSM 1824C detector panel is an indirect conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive scintillator layer. The energy of the incoming photons generates light distribution in the scintillator laver. Light is converted to a modulated electrical signal through PIN diode within the pixel of the thin film transistor. The amplified signal is converted to a voltage signal and is then converted from an analog to digital signal which can be transmitted to a viewed image print out, transmitted to remote viewing or stored as an electronic data file for later viewing.

The RSM 1824C consists of main components such as SSU (System Synchronization Unit: RSM-SSU01, RSM-SSU02 (Code# B12160000)), LAN Cable (Code# C20050502) and POE Cable (Code# C16050700), Power Cord (Code# E00050023), Ethernet Adaptor and software CD.

The System Synchronization Units, RSM-SSU01 and RSM-SSU02, only differ in their sizes. Only one System Synchronization Unit will be provided to the customer based on their choice. Also, only one System Synchronization Unit can be connected to the one detector.

The RConsole1 is digital radiography operating console software specialized for the RSM series, a digital X-rav detector developed by DRECH Inc.

RConsloe1 provides an integrated solution for X-ray projection. It integrates with the X-ray generator and the digital detector and acquires and processes images. In addition, it complies with DICOM standards and is able to transmit and receive data with the PACS system, and print images through the DICOM printer.

AI/ML Overview

The provided text describes a 510(k) summary for the DRTECH RSM 1824C with RConsole1, indicating its substantial equivalence to predicate devices. The information primarily focuses on the device's technical specifications and a clinical study conducted for the detector (RSM 1824C).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Understanding the Acceptance Criteria and Device Performance from the Text:

The document states that substantial equivalence for the detector (RSM 1824C) was demonstrated through "non-clinical performance in compliance with the requirements specified in the international and FDA recognized consensus standards" and "a clinical test, which was conducted in compliance with the requirements specified in the 'CDRH's Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System'". The "results of these tests demonstrate that the RSM 1824C meets the acceptance criteria".

However, the specific quantitative acceptance criteria are not explicitly listed in a table format with corresponding reported performance values in the provided document. Instead, the document compares technical characteristics of the subject device to the predicate devices, indirectly suggesting that meeting or being comparable to the predicate's performance serves as an acceptance criterion.

The document mentions several parameters and their values for the subject and predicate devices. While not explicitly termed "acceptance criteria," we can infer them from the comparison.

1. Table of Acceptance Criteria (Inferred from Predicate Comparison) and Reported Device Performance:

Parameter	Inferred Acceptance Criterion (via Predicate)	Reported Device Performance (RSM 1824C)	Remark (from text)
For Detector (RSM 1824C)
Pixel Pitch	~40 μm (Predicate: Lorad Digital Breast Imager)	76 μm	Different
Image Size	186 x 248 mm (Predicate: Lorad Digital Breast Imager)	233.4 x 175.1 mm	Similar
Scintillator Material	CsI:Tl (Predicate: Lorad Digital Breast Imager)	CsI	Same
DQE @ 1 lp/mm	~45% (Predicate: Lorad Digital Breast Imager)	50%	Similar
DQE @ 2 lp/mm	~35% (Predicate: Lorad Digital Breast Imager)	43%	Similar
MTF @ 2 lp/mm	~70% (Predicate: Lorad Digital Breast Imager)	70%	Similar
MTF @ 5 lp/mm	~30% (Predicate: Lorad Digital Breast Imager)	20%	Similar
Resolution	4,800 x 6,400 (Predicate: Lorad Digital Breast Imager)	3,072 x 2,304	Different
Detector Type	CCD CsI:Tl (Predicate: Lorad Digital Breast Imager)	TFT a-Si	Different
For Software (RConsole1)
Software Function	Image viewing, search, storage, annotation, measurement, processing, stitch (Predicate: Econsole1)	Image viewing, search, storage, annotation, measurement, processing, stitch	Same
DICOM 3.0 Compatibility	Yes (Predicate: Econsole1)	Yes	Same

Note: The document explicitly states: "Even though the predicate device and the subject device differ in the pixel pitch, resolution and types of the detector, the differences are not critical in terms of the diagnostic purposes because the clinical image evaluation demonstrate that the subject devices are substantially equivalent to the predicate device." This indicates that the clinical study served to bridge the gap for these specific differences in technical parameters, demonstrating that despite the differences, the diagnostic capability is equivalent.

2. Sample size used for the test set and the data provenance:

The document states "The single-blinded concurrence study conducted in compliance with CDRH's Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System)".
Sample Size: The exact sample size (number of images or cases) used in the clinical study is not specified in this document.
Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state if the study was retrospective or prospective, though "concurrence study" often implies a retrospective comparison of images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document mentions a "single-blinded concurrence study" but does not specify the number of experts used or their qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication method for the test set:

The document mentions a "single-blinded concurrence study" but does not specify the adjudication method used (e.g., 2+1, 3+1, none).

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:

The document describes a "single-blinded concurrence study" to confirm that the new x-ray detectors "provide images of equivalent diagnostic capability to the predicate device."
It does not mention a multi-reader, multi-case (MRMC) comparative effectiveness study that involved AI assistance or human reader improvement with AI. The study appears to be focused on the equivalence of the detector's image quality for diagnostic capability, not on AI's impact on human readers.

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

The document focuses on the performance of the detector (RSM 1824C) in terms of image quality and diagnostic capability for mammography, and the console software (RConsole1) as an integrated solution.
There is no mention of a standalone algorithm or AI performance test in this document. The device primarily consists of a digital X-ray detector and its operating software, which facilitate imaging, not an AI for image analysis.

7. The type of ground truth used:

The document states the study confirmed that the images "provide images of equivalent diagnostic capability to the predicate device." This implies that the ground truth was established by clinical assessment of the diagnostic content of the images, likely based on expert consensus or comparison to established diagnoses from the predicate device's images (given it's a "concurrence study").
However, the specific nature of the ground truth (e.g., pathology, outcomes data) is not explicitly stated.

8. The sample size for the training set:

The document describes a 510(k) submission for a digital X-ray detector and its console software. It primarily focuses on demonstrating substantial equivalence to predicate devices, which involves comparing technical characteristics and clinical image quality.
There is no mention of a "training set" or "training data" as this device does not appear to be an AI/ML algorithm that requires a distinct training phase.

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

As there's no mention of a training set for an AI/ML algorithm, this question is not applicable based on the provided text.

Summary

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

February 23, 2017

DRTECH Corporation % Mr. Choul-Woo Shin Vice President Suite No. 2. 3 Floor, 29, Dunchon-daero541 beon-gil, Jungwon-gu Seongnam-si, Gyeonggi-do 13230 REPUBLIC OF KOREA

Re: K162670 Trade/Device Name: RSM 1824C with RConsole1 Regulation Number: 21 CFR 892.1715 and 21 CFR 892.2050 Regulation Name: Full-field digital mammography system and Picture archiving and communications system Regulatory Class: II Product Code: MUE, LLZ Dated: January 20, 2017 Received: January 23, 2017

Dear Mr. Shin:

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 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.

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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/Resourcesfor You/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 yours.

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) K162670

Device Name RSM 1824C with RConsole1

Indications for Use (Describe)

The RSM 1824C is a detector indicated for use in screening and diagnostic mammography.

The RConsole1 is an integrated software solution indicated for use with the RSM Series detectors.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

[As required by 21 CFR 807.92]

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92

1. Date Prepared [21 CFR 807.92(a) (1)]

10/25/2016

2. Submitter's Information [21 CFR 807.92(a) (1)]

•	Name of Sponsor:	DRTECH Corporation
•	Address:	Suit No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil,Jungwon-gu, Seongnam-si, Gyeonggi-do 13230Republic of Korea
•	Contact Name:	Choul-Woo Shin
•	Telephone No.:	+ 82-31-779-7783
•	Fax No.:	+ 82-31-779-7790
•	Email Address :	cwshin@drtech.co.kr
•	Registration Number:	3005172103
•	Name of Manufacturer:	Same as Sponsor

3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]

	Detector (RSM 1824C)	Software (Rconsole1)
• Trade Name	RSM 1824C with RConsloel
• Common Name	Digital Flat Panel X-ray Detector	Radiological Image Processing System
• Classification Name	Full Field Digital, System, X-ray,Mammographic	Picture archiving and communicationssystem
• Classification Panel	Radiology
• ClassificationRegulation	21 CFR 892.1715	21 CFR 892.2050
• Product Code	MUE	LLZ
• Device Class	II

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	For Detector	For Software
• 510(k) Number	P010025	K152172
• Applicant	HOLOGIC, INC.	DRTECH CORPORATION
• Trade Name	Lorad Digital Breast Imager (LDBI)	Econsole1
• Classification Name	Full Field Digital, System, X-ray, Mammographic	Picture archiving and communications system
• Classification Panel	Radiology
• Classification Regulation	21 CFR 892.1715	21 CFR 892.2050
• Product Code	MUE	LLZ
• Device Class	II
• Remark	The predicate device that has been reclassified from Class III to II

4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]

5. Description of the Device [21 CFR 807.92(a) (4)]

The RConsole1 is digital radiography operating console software specialized for the RSM series, a digital X-rav detector developed by DRECH Inc.

6. Intended Use [21 CFR 807.92(a)(5)]

The RSM 1824C is a detector indicated for use in screening and diagnostic mammography.

The RConsole1 is an integrated software solution indicated for use with the RSM Series detectors.

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7. Technological Characteristics [21 CFR 807.92(a)(6)]

The RSM 1824C detector panel is an indirect conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive scintillator layer. The energy of the incoming photons generates light distribution in the scintillator layer. Light is converted to a modulated electrical signal through PIN diode within the pixel of the thin film transistor. The amplified signal is converted to a voltage signal, and then it is converted from an analog to digital signal which can be transmitted to a print-out image viewer, transmitted to remote viewing, or stored as an electronic data file for later viewing.

Based on a technical feature comparison, the subject device was found to be similar to the predicate device in regards of detector technology (CsI).

Rconsole1 is medical software. It digitalizes the signal sent from the detector and displays the x-ray image. Also, it can enter patient information, shot information, and other necessary references for convenience.

Compared with the predicate device, the technological characteristics of the proposed device, Rconsole1, are substantially equivalent to those of the predicate device. The proposed device is functionally similar to the predicate device.

Parameter	Subject Device	Predicate Device		Remark
		For Detector	For Software
510(K) Number	Unknown	P010025	K152172	-
Manufacturer	DRTECH Corporation	HOLOGIC, INC.	DRTECH Corporation	-
Model Name	RSM 1824C withRconsole1	Lorad Digital Breast Imager(LDBI)	Econsole1	-
Classification Name	Full Field Digital, System,X-ray, Mammographic	Full Field Digital, System, X-ray, Mammographic	Picture archiving andcommunications system	same
Classification Panel	Radiology			same
Classification Regulation	21 CFR 892.1715,21 CFR 892.2050	21 CFR 892.1715	21 CFR 892.2050	same
Product Code	MUE, LLZ	MUE	LLZ	same
Device Class	Class II			same
Intended Use	The RSM 1824C is adetector indicated for use inscreening and diagnosticmammography.The RConsole1 is anintegrated software solutionindicated for use with theRSM Series detectors.	The Lorad Digital BreastImager generates digitalmammographic images thatcan be used for screening anddiagnosis of breast cancer.The Lorad Digital BreastImager is intended to be usedin the same clinicalapplications as traditionalscreen-film mammographicsystems.	The Econsole1 software isindicated for use ingeneral radiographicimages of human anatomy(excluding fluoroscopic,angiographic, andmammographicapplications).	same
Pixel Pitch	76 μm	40 μm	N/A	different
Image Size	233.4 x 175.1mm	186 x 248 mm	N/A	similar
MaterialsScintillator	CsI	CsI:Tl	N/A	same
DQE	50% at 1 lp/mm43% at 2 lp/mm	45% at 1 lp/mm35% at 2 lp/mm30% at 3 lp/mm24% at 4 lp/mm	N/A	similar
MTF	70% at 2 lp/mm20% at 5 lp/mm	70% at 2 lp/mm30% at 5 lp/mm6% at 10 lp/mm	N/A	similar

8. Substantial Equivalence [21 CFR 807.92(b)]

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Resolution	3,072 x 2,304	4,800 x 6,400	N/A	different
Detector Type	TFT a-Si	CCD CsI:Tl	N/A	different
Acquisitiondevices	Digital X-ray Detector	Digital X-ray Detector	Digital X-ray Detector	same
	SoftwareFunction	Image viewingImage searchImage storageImage annotationImage measurementImage processingImage stitch	Not Known	Image viewingImage searchImage storageImage annotationImage measurementImage processingImage stitch	same
DICOM 3.0Compatibility		Yes	Yes	Yes	same

The predicate devices (P010025, K152172) and the subject device, RSM 1824C/Rconsole1 are equivalent in terms of the following matters:

Intended Use
· Technological characteristics
· Operating principle
· Design features
· Image Size
· Performance (DQE, MTF)
· Software function

A few differences are as follows

· Performance (Pixel Pitch, Resolution)
Detector Type

There is no significant difference between the RSM 1824C/Rconsole1 and the predicate device that would adversely affect the use of the product. The subject device is substantially equivalent to the predicate device in design, function, materials, operational principles, intended use software function.

Even though the predicate device and the subject device differ in the pixel pitch, resolution and types of the detector, the differences are not critical in terms of the diagnostic purposes because the clinical image evaluation demonstrate that the subject devices are substantially equivalent to the predicate device.

9. Summary of Non-Clinical Data [21 CFR 807.92(b)(1)]

The non-clinical performance tests were performed to evaluate the Sensitometric Response(=Pixel Response), Spatial resolution - Modulation Transfer Function (MTF), Noise analysis - Noise Power Spectrum (NPS), Signal-to-noise ratio transfer - Detective Quantum Efficiency (DQE), Dynamic range, Phantom testing, Image erasure and fading, Repeated exposure testing (Ghosting), Patient radiation dose and Automatic exposure control performance.

The RSM 1824C complies with the following international and FDA-recognized consensus standards:

AAMI ANSI ES60601-1: Medical Electrical Equipment -- Part 1: General Requirements for Basic Safety And Essential Performance (IEC 60601- 1:2005, Mod)

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IEC 60601-1-2:	Medical Electrical Equipment - Part 1-2: General Requirements For BasicSafety And Essential Performance - Collateral Standard: ElectromagneticCompatibility - Requirements And Tests (Edition 3)
ISO 14971:	Medical Devices - Application of Risk Management to Medical Devices.(General I (QS/RM))
IEC 62220-1:	Medical electrical equipment - Characteristics of digital X-ray imagingdevices - Part 1: Determination of the detective quantum efficiency
IEC 61267:	Medical Diagnostic X-ray Equipment – Radiation Conditions for Use inthe Determination of Characteristics
NEMA PS 3.1 - 3.20:	Digital Imaging and Communications in Medicine (DICOM) Set

Rconsole1 complies with the FDA guidance document entitled 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, ' May 11, 2005

10. Summary of Clinical Data [21 CFR 807.92(b)(2)]

The single-blinded concurrence study conducted in compliance with CDRH's Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System) confirmed that the new x-ray detectors (RSM 1824C) provide images of equivalent diagnostic capability to the predicate device. The results of the study demonstrate substantial equivalence.

This section is not applicable to Rconsole1.

11. Conclusion [21 CFR 807.92(b)(3)]

The RSM 1824C/Rconsole1 is substantially equivalent to the currently marketed predicate device (Lorad Digital Breast Imager (P010025) and Econsole1 (K152172)) in terms of design, fundamental scientific technology, indications for use, safety, and effectiveness.

Substantial equivalence for detector (RSM 1824C) was demonstrated through the non-clinical performance in compliance with the requirements specified in the international and FDA recognized consensus standards, AAMI ANSI ES60601-1, IEC 60601-1-2, ISO 14971, IEC 6220-1 and NEMA PS 3.1 - 3.20. Also, substantial equivalence was demonstrated through a clinical test, which was conducted in compliance with the requirements specified in the "CDRH's Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System".

The results of these tests demonstrate that the RSM 1824C meets the acceptance criteria, and the device is adequate for its intended use. The comparison of technological characteristics, non-clinical performance data, safety testing, and clinical image concurrence data demonstrate that the RSM 1824C is substantially equivalent to the predicate devices (Lorad Digital Breast Imager).

Additionally, when compared to the predicate the device (K152172), The Rconsole1 presented in this submission has the same of the intended use, technological characteristics, performance properties and software function. Therefore, Rconsole1 is substantially equivalent to the predicate device (Econsole1).

Regulation Number and Section

§ 892.1715 Full-field digital mammography system.

(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.