The DIGIVIEW 395, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.

Device Description

The DIGIVIEW 395 is a flat panel X-ray detector consisting of an amorphous silicon panel with a directly deposited CsI:TI scintillator. The DIGIVIEW 395 detector has an active area of 43.2 cm x 35.5 cm at a pixel pitch of 100μm. Data and control communication is accomplished via a Gigabit Ethernet interface or 802.11n WiFi. The detector can be integrated into a fixed room X-ray system to enable digital radiography.

AI/ML Overview

The provided document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or a detailed breakdown of test set/training set sizes, ground truth establishment, or expert involvement in the way requested.

This document is a 510(k) summary for a medical device (Kubtec DIGIVIEW 395), which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance metrics against specific acceptance criteria.

Here's what can be extracted and what is missing based on your request:

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

Not available in the document. The document states "Kubtec's DIGIVIEW 395 successfully completed internal safety testing requirements to recognized consensus standards listed below." However, it does not provide specific performance metrics (e.g., sensitivity, specificity, accuracy) or the quantitative acceptance criteria for those metrics. The comparison chart (page 6) shows physical and technical specifications of the device and its predicate, not performance against clinical or technical acceptance criteria.

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

Not available in the document. The document explicitly states: "No clinical studies were conducted in support of the DIGIVIEW 395 as agreed upon during Pre-Submission discussions with the Agency for the predicate device (K140551). The conduct of a clinical concurrence study was deemed unnecessary to demonstrate substantial equivalence." This means there was no test set of patient data for evaluating performance.

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 studies were conducted, there was no test set and therefore no ground truth established by experts in this context.

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

Not applicable. As no clinical studies were conducted, there was no test set requiring adjudication.

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, an MRMC study was not done. The device is a stationary X-ray system (hardware), not an AI-powered diagnostic tool intended to assist human readers. The document states "No clinical studies were conducted."

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

Not applicable. The device is a flat panel X-ray detector, which is hardware for image generation, not an algorithm being evaluated for standalone diagnostic performance.

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

Not applicable. As no clinical studies were conducted, there was no ground truth for diagnostic performance evaluation. The device's "performance" was assessed against recognized consensus standards for physical and technical characteristics of X-ray imaging devices.

8. The sample size for the training set

Not applicable. The device is a hardware component (a flat panel X-ray detector). While it uses "DIGICOM software to manage operation of detector," there is no mention of machine learning or AI that would require a "training set" in the context of diagnostic performance evaluation. The software mentioned is for detector operation, not for diagnostic interpretation.

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

Not applicable. (See point 8).

Summary of what the document does state regarding validation:

Basis for Equivalence: The primary method for demonstrating the safety and effectiveness of the Kubtec DIGIVIEW 395 was by proving its "substantial equivalence" to a legally marketed predicate device (PerkinElmer, XRpad 4336 MED, K140551). This means showing that it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
No Clinical Studies: Explicitly states "No clinical studies were conducted in support of the DIGIVIEW 395 as agreed upon during Pre-Submission discussions with the Agency for the predicate device (K140551). The conduct of a clinical concurrence study was deemed unnecessary to demonstrate substantial equivalence."
Technical Standards: Safety testing was completed to recognized consensus standards, including:
- IEC 62220-1 (Determination of the detective quantum efficiency)
- IEC 62220-1-3 (DQE for dynamic imaging)
- IEC 62494-1 (Exposure index for general radiography)
- IEC PAS 61910-1 (Radiation dose documentation)
- NEMA PS 3.1 - 3.20 (DICOM Set)
- IEC 60601-2-43 (Safety and essential performance of X-ray equipment)
- NEMA XR 24-2008 (Primary user controls for interventional angiography x-ray equipment)
Comparison Chart (Similarities to Predicate): The document provides a detailed comparison chart (pages 6-7) highlighting that the proposed device and the predicate device share identical intended use/indications for use, panel type, scintillator, pixel matrix, pixel pitch, active area, external dimensions, weight, housing material, communication interface, and power. The only difference noted is the utilization of Kubtec's DIGICOM software for detector operation, which itself was previously cleared in other 510(k) submissions.

In conclusion, for this specific 510(k) document, the device approval was based on substantial equivalence and compliance with engineering standards, not on clinical performance metrics or studies involving patient data or human readers.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of unity and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the emblem.

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

June 23, 2015

KUB Technologies, Inc. % Vikram Butani President 270 Rowe Avenue, Unit E MILFORD CT 06461

Re: K151221

Trade/Device Name: Kubtec DIGIVIEW 395 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: May 5, 2015 Received: May 7, 2015

Dear Vikram Butani:

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.

For

Robert Ochs. Ph.D. Acting 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)

K151221

Device Name Kubtec DIGIVIEW 395

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image is a logo for Kubtec. The logo features a stack of three squares in different shades of gray and blue on the left side. To the right of the squares is the word "kubtec" in red, with the tagline "GOING BEYOND THE SURFACE" in gray underneath.

DIGIVIEW 395 510(K) Summary

Identification of Device:

Proprietary/Trade Name:	DIGIVIEW 395 (DV395)
Classification name:	SYSTEM, STATIONARY X-RAY
Classification:	Class II
CFR Section:	21 CFR 892.1680
Product Codes:	MQB
Common Name:	Stationary X-ray system

Predicate Device:

Device Name:	Perkinelmer, XRpad 4336 MED Flat Panel Detector
510(k) Number:	K140551
Classification	Class: II
Regulation Number:	21 CFR 892.1680
Product Code:	MQB
Regulation Name:	Stationary x-ray system

I. INDICATIONS FOR USE

The DIGIVIEW 395, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic Xray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.

II. DEVICE DESCRIPTION

The DIGIVIEW 395 is a flat panel X-ray detector consisting of an amorphous silicon panel with a directly deposited CsI:TI scintillator.

The DIGIVIEW 395 detector has an active area of 43.2 cm x 35.5 cm at a pixel pitch of 100μm. Data and control communication is accomplished via a Gigabit Ethernet interface or 802.11n WiFi.

The detector can be integrated into a fixed room X-ray system to enable digital radiography. The following accessories are available for the DIGIVIEW 395

DV395 LBP (Lithium Battery Pack) ●
DV395 LBC (Lithium Battery Charger) ●
DV395 IPU (Interface Power Unit) ●
DV395 LPT Detector Cable, 3m/100ft ●
DV395 Protective Insert ●

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Image /page/4/Picture/0 description: The image contains the logo for Kubtec. To the left of the logo are three overlapping squares in different shades of gray and blue. To the right of the squares is the word "kubtec" in red font, with the words "GOING BEYOND THE SURFACE" in gray font underneath.

. DV395 Connector Cover Set
Trigger cable (5m or 20m) ●
. GigE interface cable (7.6m, 15.25m, or 30.5m)

The DIGIVIEW 395 is designed to work with X-ray systems (consisting of an Xray source, generator, collimator, and positioner) intended for use in generating radiographic images of human anatomy for diagnostic X-ray procedures that the following parameters may fulfil. Applicable detector parameters, such as dynamic range, exposure time range, energy range, image size, resolution, detective quantum efficiency, etc. are designed to support the necessary compatibility.

Energy range for compatibility is 20-150kVp.

The DIGIVIEW 395's auto exposure detection (AED) mode allows integration with OEM systems that there is no access to intercept the Prep/Expose signal.

Any modifications for hard wire integration to a previously installed OEM x-ray system that was utilized for analog or Computed Radiography are limited to integration between the hand-switch and it's connector to the x-ray console.

All integration work must be conducted by qualified service personnel and proper operation verified before releasing system for use on patients.

SUMMARY OF STUDIES AND SAFETY III.

Kubtec's DIGIVIEW 395 successfully completed internal safety testing requirements to recognized consensus standards listed below. No clinical studies were conducted in support of the DIGIVIEW 395 as agreed upon during Pre-Submission discussions with the Agency for the predicate device (K140551). The conduct of a clinical concurrence study was deemed unnecessary to demonstrate substantial equivalence.

Recognized Consensus Standards

IEC 62220-1 Edition 1.0 (2003-10) Medical electrical equipment -. Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency

IEC 62220-1-3 Edition 1.0 (2008-06) Medical electrical equipment -● Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging

IEC 62494-1 Edition 1.0 (2008-08) Medical electrical equipment -. Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography

IEC PAS 61910-1 First Edition 2007-07 Medical electrical equipment -. Radiation dose documentation - Part 1: Equipment for radiography and radioscopy

. NEMA PS 3.1 - 3.20 (2011) Digital Imaging and Communications in Medicine (DICOM) Set

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Image /page/5/Picture/0 description: The image contains the logo for Kubtec. The logo features a series of overlapping squares in shades of gray and blue on the left. To the right of the squares is the word "kubtec" in red, with the tagline "GOING BEYOND THE SURFACE" in smaller, dark blue letters underneath.

. IEC 60601-2-43 - Ed. 2.0 2010-03 Medical electrical equipment - Part 2 43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures

NEMA XR 24-2008 (R2014) Primary user controls for interventional . angiography x-ray equipment

IV. BASIS FOR THE SUBMISSION

This summary of 510(k) safety and effectiveness information is supplied in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 to show Substantial Equivalence of the proposed device and the predicate device.

PerkinElmer XRpad 4336 MED (K140551)
There is no change for the indication for use from the predicate 510(k) approved device.

Design and Use of the Device
Question	YES	NO
Is the device intended for prescription use (21 CFR 801 Subpart D) ?	X
Is the device intended for over-the-counter use (21 CFR807 Subpart C)?		X
Is the device provided sterile?		X
Is the device intended for single use?		X
Is the device a reprocessed single use device?		X
If yes, does this device type require reprocessed validation data?
Does the device contain a drug?		X
Does the device contain a biologic?		X
Does the device use software?	X
Does the submission include clinical information?		X
Is the device implanted?		X

V. COMPARISON CHART

Characteristics	Proposed device KubtecDIGIVIEW 395	Predicate device(K140551)PerkinElmer XRpad4336 MED
-----------------	------------------------------------------	----------------------------------------------------------------

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Image /page/6/Picture/0 description: The image shows the Kubtec logo. On the left side of the logo are three overlapping squares that are different shades of gray and blue. To the right of the squares is the word "kubtec" in red font. Below the word "kubtec" is the phrase "GOING BEYOND THE SURFACE" in a smaller, gray font.

Intended Use/ Indicationsfor Use	The DIGIVIEW 395, when used with aradiographic imaging system, is indicatedfor use in generating radiographic imagesof human anatomy for diagnostic X-rayprocedures, wherever conventionalscreen-film (SF), digital radiography (DR),or computed radiography (CR) systemsmay be used. It is not intended formammographic use.	The XRPad 4336 MED,when used with aradiographic imagingsystem, is indicated foruse in generatingradiographic images ofhuman anatomy fordiagnostic X-rayprocedures, whereverconventional screen-film (SF), digitalradiography (DR), orcomputed radiography(CR) systems may beused. It is not intendedfor mammographicuse.
Panel	Single substrate amorphous silicon activeTFT/diode array	Same
Scintillator	Direct deposition Csi:TI	Same
Pixel matrix	3556 x 4320 pixels	Same
Pixel Pitch	100 μm	Same
Active area	355 mm x 432 mm	Same
External dimensions(w x l x h)	384 mm x 460 mm x 15 mm	Same
Weight	Approximately 4 kg	Same
Housing material	Aluminum with carbon-fiber	Same
Communication interface	Gb Ethernet or 802.11n WiFi	Same
Power	External power supply or battery	Same

SUBSTANTIAL EQUIVALENCE VI.

The proposed device and predicate device DIGIVIEW 395 is substantially equivalent to the following currently cleared predicate device:

PerkinElmer XRpad 4336 MED (K140551) a.
The proposed and predicate devices utilize the same technology and materials, comparable safety and effectiveness features, and is similar in design and construction. The Indications for Use and labeling are the same and our labeling contain the required Cautions, Warnings and Contraindications consistent to those required for similar cleared devices. Both systems produce digital images which can be sent to hardcopy printers, softcopy diagnostic workstations and/or stored in archive. The only difference is utilization of Kubtec's DIGICOM

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Image /page/7/Picture/0 description: The image contains the logo for Kubtec. The logo consists of a series of overlapping squares in shades of gray and blue, followed by the word "kubtec" in red, and the tagline "GOING BEYOND THE SURFACE" in a smaller, sans-serif font. The logo is clean and modern, with a focus on the company name and tagline.

software to manage operation of detector which had previously received 510(K with the Kubtec KUB250 (K141539) and the Kubtec Digiview 250 (K103348)

VII. CONCLUSION

The DIGIVIEW 395 is as safe and effective as the predicate device, has no technological differences in the hardware, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices and conforms to applicable medical device safety standards. The only difference is utilization of Kubtec's DIGICOM software to manage operation of detector which had previously received 510(K) with the Kubtec KUB250 (K141539) and the Kubtec Digiview 250 (K103348)

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.