Intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the KrystalRad "New Series" is intended to acquire digital radiographic images. It is suitable for all routine radiography exams, including specialist areas like intensive care or trauma work, excluding fluoroscopy, angiography and mammography.

Device Description

This device represents the combination of already cleared software and already cleared digital receptor panels. This device is a functional replacement for radiographic film. It serves as an upgrade to film based or older digital panel diagnostic x-ray systems. Digital radiography uses digital X-ray sensors instead of traditional photographic film. Advantages include time efficiency through bypassing chemical processing and the ability to digitally transfer and enhance images. Also less radiation can be used to produce an image of similar contrast to conventional radiography. This gives advantages of immediate image preview and availability; elimination of costly film processing steps; a wider dynamic range, which makes it more forgiving for over- and under-exposure; as well as the ability to apply special image processing techniques that enhance overall display of the image.

AI/ML Overview

This document describes the premarket notification (510(k)) for the KrystalRad "New Series" Digital Radiographic Portable Retrofit System. The device is intended as an upgrade for radiographic film-based or older digital panel diagnostic x-ray systems.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly define "acceptance criteria" in a quantitative manner for performance metrics like sensitivity, specificity, or image quality scores. Instead, the demonstration of safety and effectiveness relies on establishing substantial equivalence to a predicate device (KrystalRad 660, K112132). The "acceptance criteria" in this context are primarily the absence of significant differences in technical characteristics and diagnostic quality, and compliance with relevant safety and performance standards.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (KrystalRad "New Series")
Intended Use: Acquire digital radiographic images for routine exams, intensive care, trauma (excluding fluoroscopy, angiography, mammography).	SAME as KrystalRad 660, unchanged. (i.e., meets this criterion)
Technological Characteristics: Functionality, image acquisition panel specifications (resolution, bit depth), communication, DICOM compliance, electrical safety.	* Functionality: Functionally identical to predicate.
	* Image Acquisition Panel: Wired panels: 2,560 x 3,072 pixels / 3,072 x 3,072 pixels; Wireless panel: 2,560 x 3,072 pixels; Pitch: 140 µm; Bit depth 14 bit. (Comparable to predicate's 2,400 x 3,000 pixels, 144 µm pitch, 14 bit, with minor improvements in resolution and pitch).
	* Communication Standard: IEEE 802.11n (2.4 GHz) or hardwire Ethernet. (SAME as predicate).
	* DICOM: DICOM 3. (SAME as predicate).
	* Electrical Safety: Electrical Safety per IEC-60601, UL listed. (SAME as predicate).
Image Quality: Diagnostic quality comparable to predicate.	Clinical images were found to be of excellent diagnostic quality and had no significant differences when compared to predicate images.
Safety and Effectiveness: No new questions of safety or effectiveness.	Integration testing, bench testing, safety testing, and software validation indicate the new device is as safe and effective as the predicate device. Conforms to US Performance Standards.

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

Sample Size for Test Set: The document states that "Clinical images were acquired and compared to our predicate images by a board certified radiologist." However, it does not specify the number of clinical images or cases used in this comparison.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given the context of a 510(k) submission to the FDA, it is highly likely that the images would have been collected in a manner compliant with US regulations, potentially from a US healthcare setting. The term "acquired" suggests prospective collection for the purpose of the comparison, but this is not definitively stated.

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

Number of Experts: One (1) board certified radiologist.
Qualifications of Experts: Board certified radiologist. No further details on years of experience or specific sub-specialty are provided.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. Only one radiologist was used for comparison, so there was no need for an adjudication method. The radiologist directly compared the images from the new device to those from the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improvement with AI vs Without AI Assistance:

MRMC Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not performed, nor was it applicable. This device is a digital X-ray panel and software system, not an AI-assisted diagnostic tool. Its purpose is to acquire and display images, not to interpret them or provide AI assistance to readers. Therefore, there is no AI component for human readers to improve with, and no effect size on human reader performance is reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Standalone Performance Study: No, a standalone performance study in the context of an "algorithm only" or AI performance was not done, nor was it applicable. The device is a hardware and software system for image acquisition and display, not an AI algorithm. Its performance is assessed through its ability to produce diagnostically acceptable images, not through an independent algorithm's diagnostic accuracy.

7. The Type of Ground Truth Used:

Type of Ground Truth: The "ground truth" for the clinical image comparison was established by the expert opinion (board certified radiologist), who assessed the "diagnostic quality" and "significant differences" of the images from the new device compared to the predicate device. This is a form of expert consensus, although with only one expert, it's essentially a single expert's opinion. There is no mention of pathology, outcomes data, or other objective measures for ground truth.

8. The Sample Size for the Training Set:

Sample Size for Training Set: The document does not mention a training set in the context of machine learning or AI development. This device is a digital X-ray system, and its development process, as described, involves engineering and integration of already cleared components. No AI model training is indicated.

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

Ground Truth for Training Set: Not applicable, as there is no mention of a training set or AI model development.

Summary

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MAY 1 7 2013

510(K) Summary, 510(k) K130377 Submitter: MedicaTech USA 50 Maxwell Irvine . CA . 92618 Toll Free : +1 800 817 5030 Phone : +1 949 679 2881 . FAX : +1 949 679 2882 Registration Number 3004989804 Contact: George Makar, Predsident Date Prepared: March 27, 2013

1. Identification of the Device:
  Proprietary-Trade Name: KrystalRad "New Series" Radiographic Portable Retrofit System Classification Name: Solid state x-ray imager (flat panel/digital imager). MQB Common/Usual Name: Digital X-Ray Panel
Equivalent legally marketed devices: K112132. KrystalRad 660. MedicaTech USA. The 2. modified device represents the combination of already cleared devices.
1. Description of the Device: This device represents the combination of already cleared software and already cleared digitan receptor panels.

a) How the device functions. This device is a functional replacement for radiographic film. It serves as an upgrade to film based or older digital panel diagnostic x-ray systems. Digital radiography uses digital X-ray sensors instead of traditional photographic film. Advantages include time efficiency through bypassing chemical processing and the ability to digitally transfer and enhance images. Also less radiation can be used to produce an image of similar contrast to conventional radiography. This gives advantages of immediate image preview and availability; climination of costly film processing steps; a wider dynamic range, which makes it more forgiving for over- and under-exposure; as well as the ability to apply special image processing techniques that enhance overall display of the image. b) Scientific concept forming the basis of the device.

Image /page/0/Figure/7 description: The image shows a schematic of an X-ray detector. The detector consists of a layer of Cesium Iodide (CsI) or Gadolinium oxysulfide (Gadox) that converts X-ray radiation into light. The light is then detected by an array of pixels, each containing a photodiode and a thin-film transistor (TFT). The signal from each pixel is read out by a detector circuit, which includes a readout integrated circuit (IC) and an analog-to-digital converter (ADC), and then transmitted via Gigabit Ethernet to a computer.

The Thin Film Transistor (TFT) Panel accumulates the visible ray (rendered visible by the scintillator, which is transformed from X-ray by the scintillator, at the photodiodes. The accumulated photic signal in the photodiode is output by readout Integrated Circuit (ROIC) anddisplayed after an Analog to Digital Convertor (ADC) transforms photic signal to digital signal. When the detector receives a signal from X-ray high voltage generator, it converts cumulated

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signal to 14-bit digital images at detector circuit and transmits those images to the workstation using the Gigabit Ethernet. The workstation receives images them with software to display on the monitor and to save data in the hard disk.

c) Significant physical and performance characteristics: This device is functionally identical to our recent submission K112132, a wireless digital upgrade to existing film systems. A wired panel is also available. We have changed the wireless panel to another model of a nearly identical size and resolution (already cleared). We have changed the software to the 510(k) cleared package from K 103554, now sold under the trade name Voyance-M. The upgrade should be installed by a qualified trained field engineer. Alternately we still offer the original software package, the Modern Module Omnivision.

1. Indications for Use (intended for use by a qualified/trained doctor or technologist. As part of a radiographic system. the KrystalRad "New Series" is intended to acquire digital radiographic images. It is suitable for all routine radiography exams, including specialist areas like intensive care or trauma work, excluding fluoroscopy, angiography and mammography..
1. Safety and Effectiveness, comparison to predicate device. This combination device has the same indications for use and technological characteristics as the predicate devices, in fact employing already cleared devices in the end product.

Comparison Chart, KrystalRad "New Series," MedicaTech USA
Characteristic	K112132, KrystalRad 660,MedicaTech USA	KrystalRad "New Series,"MedicaTech USA
Explanation	This is the device we have MODIFIEDwith new panels and software	This device represents thecombination of already cleareddevices, PACS software anddigital x-ray panels.
Intended Use:	Intended to acquire digitalradiographic images. It is suitable forall routine radiography exams,including specialist areas like intensivecare or trauma work, excludingfluoroscopy, angiography andmammography	SAME as KrystalRad 660,unchanged.
Configuration	Battery operated wireless or WiredEthernet	Battery operated wireless orWired Ethernet
Image acquisition panelspecifications	Wireless panel2400 by 3000 pixelsPitch: 144 $\mu$mBit depth 14 bit	Wired panels:2,560 x 3.072 pixels3,072 x 3.072 pixelsor Wireless panel2560 x 3072 pixelsPitch: 140 $\mu$mBit depth 14 bit.
Identification of the Panels	PIXIUM 3543 pR	Vieworks Vivix-S K122866 orVivix-S Wireless K122865
Communication Standard	IEEE 802.11n (2.4 GHz) or hardwireEthernet	IEEE 802.11n (2.4 GHz) orhardwire Ethernet
DICOM	DICOM 3	DICOM 3
Image acquisition software	Same as: K080582 DDR MAK SeriesMedicatech USA (E-Com) - OR-K110040 OmniVision. ModernModule Inc	Same as: K103554 Metron MD,EponaTech LLC, rebrandedVoyance-M OR OmniVision.K110040 made by ModernModule Inc

6. Substantial Equivalence Chart

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K130377

Characteristic	K112132, KrystalRad 660,MedicaTech USA	KrystalRad "New Series,"MedicaTech USA
Communication	WiFi or hardwire	SAME
Image Dimensions	14 x 17 in. (35 x 43 cm) / 17 x 17 in.(43 x 43 cm)	14 x 17 in. (35 x 43 cm) / 17 x 17in. (43 x 43 cm)
Weight	4.7 kg	6.3 lbs (2.9 kg / GOS) & 6.8lbs.(3.1 kg / Csl)Wireless: 6.8 lbs (3.1 kg / GOS)& 7.2 lbs.(3.3 kg / Csl)17 x 17 in. Fixed: 24.2 lbs (11 kg /GOS) & 24.2 lbs.(11 kg / Csl)
Electrical safety	Electrical Safety per IEC-60601. ULlisted	Electrical Safety per IEC-60601.UL listed

1. Summary of non-clinical testing: We performed integration testing. The results of a review of bench. safety test, and software validation documentation indicates that the new device is as safe and effective as our predicate device. The modified device conforms to US Performance Standards and the hardware is UL Listed to US Standards for safety for medical devices. Standards testing performed included:
- a. IEC 60601-1 (1988) +IEC 60601-1 Amendment 1 (1991); +IEC 60601-1 Amendment 2 (1995) Safety of Medical Electrical Equipment, Part 1. General Requirements for Safety
- b. IEC 60601-1-2 Collateral standard: Electromagnetic compatibility -Requirements and tests
- c. NEMA PS 3.1 3.18 (2009), Digital Imaging and Communications in Medicine (DICOM) Set.
1. Summary of clinical testing: Clinical images were acquired and compared to our predicate images by a board certified radiologist. There were no significant differences between them. Images were found to be of excellent diagnostic quality.
1. Conclusion: After analyzing software integration validation, safety testing data, and clinical images, it is the conclusion of Medicatech USA that the KrystalRad "New Series" is as safe and effective as the predicate devices. have almost no technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

May 17, 2013

Medicatech USA C/O Daniel Kamm. P.E. Kamm & Associates 8870 Ravello Ct. NAPLES FL 34114

Re: K130377

Trade/Device Name: KrystalRad "New Series" Digital Radiographic Portable Retrofit

System Regulation Number: 21 CFR 892,1680 Regulation Name: Stationary X-ray System Regulatory Class: II Product Code: MQB Dated: April 1, 2013 Received: April 5, 2013

Dear Mr. Kamm:

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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Page 2-Mr. Kamm

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Smh)

for

Janine M. Morris 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): K130377

Device Name: KrystalRad "New Series" Digital Radiographic Portable Retrofit System

Indications For Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Sm.h.7)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) 510(k): K130377

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.