The MasterX 800 Series is intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the MasterX 800 Series is intended to acquire digital radiographic images on adult and pediatric patients. 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 a new combination of already cleared solid state digital x-ray acquisition panels and already cleared software. It is suitable for use with adult and pediatric populations. This is an upgrade kit for existing or new systems.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the MasterX 800 Series, structured according to your request:

Based on the provided FDA 510(k) Summary, the MasterX 800 Series device is primarily an upgrade kit consisting of a new combination of already cleared digital X-ray acquisition panels and existing software. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with strict acceptance criteria for novel performance claims.

Therefore, the "acceptance criteria" here are implicitly tied to demonstrating safety and effectiveness compared to the predicate, and the "study" is primarily non-clinical validation and integration testing.

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission for an existing technology combination, explicit quantitative acceptance criteria for new clinical performance aren't stated as they would be for a novel AI device with specific performance metrics. Instead, the "performance" shown is its equivalence to the predicate device and the compliance of its components with relevant standards.

Acceptance Criteria (Implicit from Substantial Equivalence Goal)	Reported Device Performance	Comments
Indications for Use:	The MasterX 800 Series has the same Indications for Use as the predicate, with an added mention of "adult and pediatric patients" for clarity.	"Patient population added" is the only comment, implying functional equivalence.
Technological Characteristics:
- Configuration of Digital Panels	Exactly the same as predicate.
- Power Source	Same as predicate, with some models now "AC Line only."
- Digital Panel Models	8 new models from InnoCare are used, which are "Newer models" but are individually 510(k) cleared.	This is the primary technological difference, but panels are pre-cleared.
- Panel Performance (DQE @ 1lp/mm, MTF @ 1lp/mm)	DQE @ 1lp/mm: 50% (same as predicate) MTF @ 1lp/mm: 63% (predicate was 60%)	"Similar" performance. The new device shows slightly better MTF, which is not a concern for equivalence.
- Interface	Same as predicate.
- Panel Sizes	Same sizes available as predicate.
- X-ray Conversion Layer	Csl or GOS (predicate was Csl only).	GOS is described as "lower cost but has nearly comparable performance", indicating acceptable equivalence.
- Active Areas (pixels)	"Nearly identical" to predicate.	Minor variations in pixel counts are presented as substantially equivalent.
- Pixel Pitch	140 μm (same as predicate).
- A/D Conversion	16 bits (predicate was 14 bits).	"Better" implies an improvement that does not raise new questions of safety or effectiveness.
- Image Acquisition Software	"Voyance" (same as predicate).
- DICOM Compliance	DICOM 3 (same as predicate).
Safety and Effectiveness:	Summarized through software validation, risk management, integration testing, and compliance with FDA guidances and standards.	The conclusion states the device is "as safe and effective as the predicate device" and has "insignificant technological differences." No new safety/effectiveness issues were identified.

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

The document states: "Summary of clinical testing: Not required."
Therefore, there is no clinical test set, sample size, or data provenance from a clinical study. The evaluation relies on non-clinical testing.

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 applicable as no clinical test set or ground truth established by experts was used for performance evaluation in a clinical context. The evaluation was primarily engineering and regulatory in nature, comparing an assembled system to a predicate device.

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

Not applicable as no clinical test set requiring adjudication was used.

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

No MRMC comparative effectiveness study was done. This device is an X-ray acquisition system, not an AI-powered diagnostic or assistive tool.

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

Not applicable as this is an X-ray acquisition system, not an algorithm being evaluated for standalone performance. The "software" referred to is image acquisition software, which is part of the system operation, not an AI for interpretation.

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

No clinical ground truth (expert consensus, pathology, outcomes data) was used, as no clinical study was performed. The "ground truth" for the non-clinical testing was defined by engineering specifications, regulatory standards compliance, and comparison to the predicate device's established performance parameters (e.g., DQE, MTF).

8. The sample size for the training set

No training set is mentioned or applicable, as this device is an X-ray acquisition system and not an AI/machine learning algorithm that requires training data.

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

Not applicable, as there is no training set mentioned or used.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.

September 1, 2023

Medicatech USA % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K230918

Trade/Device Name: MasterX 800 Series Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: August 7, 2023 Received: August 7, 2023

Dear Daniel 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K230918

Device Name MasterX 800 Series

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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510(K) Summary, 510(k) 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: August 25, 2023

1. Identification of the Device:

Trade/Device Names: MasterX 800 Series Regulation Number: 21CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: II Product Code: MQB Common/Usual Name: Digital Diagnostic X-Ray System Upgrade

1. Equivalent legally marketed device: K130377 Trade/Device Name: KrystalRad "New Series" Radiographic Portable Retrofit Manufacturer: MedicaTech USA Regulation Number: 21CFR892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: II Product Code: MQB Common/Usual Name: Digital Diagnostic X-Ray System Upgrade
1. Reference Devices: Uses software cleared in our 510(k) number K190601, but updated. Uses one of the following previously cleared digital receptor panels, supplied unmodified:

InnoCare Model Name Yushan Series	510(K)numbers	Product code/regulation
Yushan V14C/ Yushan V14G/ Yushan V17C/ Yushan V17G/ Yushan V17Ge	K201528	MQB/21CFR892.1680
Yushan F14C/ Yushan F14G	K210988	MQB/21CFR892.1680
Yushan V17Ce	K220510	MQB/21CFR892.1680

1. Indications for Use The MasterX 800 Series is intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the MasterX 800 Series is intended to acquire digital radiographic images on adult and pediatric patients. It is suitable for all routine radiography exams, including specialist areas like intensive care or trauma work, excluding fluoroscopy, angiography and mammography.
1. Description of the Device: This device represents a new combination of already cleared solid state digital x-ray acquisition panels and already cleared software. It is suitable for use with adult and pediatric populations. This is an upgrade kit for existing or new systems.

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The purchaser may select their digital panel from this list:

InnoCare ModelName YushanSeries	MedicatechUSAModel NameMasterx80XX	510(K)number	Size and Description
Yushan V14C	MasterX80IC	K201528	14X17 Csi Wireless Panel (Can work as Tethered)
Yushan V14G	MasterX801G	K201528	14X17 GOS Wireless Panel (Can work as Tethered)
Yushan F14C	MasterX802C	K210988	17X17 Csi Wireless Panel (can work as Tethered)
Yushan F14G	MasterX802G	K210988	17X17 GOS Wireless Panel (can work as Tethered )
Yushan V17C	MasterX803C	K201528	Glassless 14X17 Csi Wireless Panel (Can work as Tethered)
Yushan V17G	MasterX803G	K201528	Glassless 14X17 GOS Wireless Panel (Can work as Tethered)
Yushan V17Ce	MasterX804Ce	K220510	17X17 Csi Fixed Tethered Panel
Yushan V17Ge	MasterX804Ge	K201528	17X17 GOS Fixed Tethered Panel

As compared to our predicate system, the digital panels are more recently cleared by FDA. The image acquisition software is our Voyance software most recently cleared in K190601. The digital panels all comply with the voluntary IEC 60601-1 and IEC 60601-1-2.

1. Safety and Effectiveness, comparison to predicate device. This combination device has the same indications for use and very similar technological characteristics as the predicate device, and employs already 510(k) cleared digital panels (except for the Toshiba unit) and software.

7. Substantial Equivalence Chart:

Item	K130377 KystalRad "New Series"Radiographic Portable Retrofit	MasterX 800 Series	Comment
Indicationsfor Use:	Intended for use by a qualified/traineddoctor or technologist. As part of aradiographic system, the KrystalRad"New Series" is intended td acquiredigital radiographic images. It issuitable for all routine radiographyexams, including specialist areas likeintensive care or trauma work,excluding fluoroscopy, angiography andmammography.	The MasterX 800 Series is intended for useby a qualified/trained doctor ortechnologist. As part of a radiographicsystem, the MasterX 800 Series is intendedto acquire digital radiographic images onadult and pediatric patients. It is suitable forall routine radiography exams, includingspecialist areas like intensive care or traumawork, excluding fluoroscopy, angiographyand mammography.	Patientpopulationadded.
Configur-ation ofDigital Panels	Battery or AC operated wireless IEEEac/a/g/n or Wired Ethernet (dependingon the model chosen)	Battery or AC operated wireless IEEE ac /a/g/n or Wired Ethernet (depending on themodel chosen)	Exactly thesame.
PowerSource	AC Line or Rechargeable BatteryBattery life up to 8 hours	AC Line or Rechargeable BatteryBattery life up to 8 hoursSome models use AC Line only. See chartabove.	SAME
Item	K130377 KystalRad "New Series"Radiographic Portable Retrofit	MasterX 800 Series	Comment
Digital PanelModels	Vieworks Vivix-S K122866 orVivix-S Wireless K122865	8 new models from InnoCare, see list inparagraph 5, above.	Newermodels
PanelPerformance	DQE @ 1lp/mm : 50 %MTF @ 1lp/mm : 60 %	DQE at 1 lp/mm, 50%MTF @ 1 lp/mm, 63%	Similar
Interface	Tethered or Wireless	Tethered or Wireless (See table above)	SAME
Photo(example)	Image: Two radiographic panels, one with a cable attached.	Image: Two radiographic panels.	Similarappear-ance.
Panel sizes	14" x 17" or 17" x 17"	SAME sizes are available.	SAME
X-rayConversionLayer	Cesium lodide (Csl) with AmorphousSilicon (a-Si) Photodiode	Csi OR GOS (GOS is lower cost but has nearlycomparable peformance)	SAME
Active Areas	Wired panel pixels:2,560 x 3,072, or 3,072 x 3,072or Wireless panel pixels2560 x 3072	MasterX80IC/G: 2500 x 3052MasterX802C/G: 2500 x 3052MasterX803C/G: 3072 x 3072MasterX804Ce/Ge: 3072 x 3072 (wiredonly)	Nearlyidentical
Pixel pitch	140 μm	140 μm	SAME
A/DConversion	14 Bits	All the new panels have 16 bit conversion	Better
Imageacquisitionsoftware	Voyance	Voyance	SAME
DICOM	DICOM 3	DICOM 3	SAME

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Summary of non-clinical testing: We performed software validation and risk management for the 8. updated software version. The following FDA guidances were employed in those activities: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The software comlies with NEMA PS 3.1 - 3.18 (2009) Digital Imaging and Communications in Medicine (DICOM) Set. Our labeling reflects the FDA guidance: Pediatric Information for X-ray Imaging Device Premarket Notifications. We performed integration testing to show that each panel performed correctly in the full system. The software comlies with NEMA PS 3.1 - 3.18 (2009) Digital Imaging and Communications in Medicine (DICOM) Set. The results of a review of bench, safety test, and software validation documentation indicates that the new device is as safe and effective as the predicate device

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Summary of clinical testing: Not required. 9.
1. Conclusion: After analyzing software integration validation, safety testing data, and test MasterX 800 Series images, it is the conclusion of Medicatech USA that the MasterX 800 Series system is as safe and effective as the predicate device, has insignificant technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate device.

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.