The Televere Digital Dental Imaging System is intended for radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures. Not for mammography. Not for fluorosopy.

Device Description

The Televere Digital Dental Imaging System is an extraoral digital x-ray system comprised of two previously cleared individual components: (1) an intraoral detector component (K162619) which connects to a PC via a USB port and (2) and image management software package (i.e., Tigerview Professional, K061035). The device detector comes in two sizes: 600mm² (Hamamatsu CMOS area image sensor, S11684-12) and 884mm² (Hamamatsu CMOS area image sensor, S116845-12). X-ray generators that can integrate with the Televere Digital Dental Imaging System are wall-mounted x-ray generators (both AC and DC) with a tube current between 1 and 15mA inclusive, and with a tube voltage between 50 and 100kV inclusive, with built in controls to set exposure parameters. Generators allow variable mA/kV to be selected, all will control the exposure time. The device and software cannot act as an x-ray generator controller. All control of xray generation is done by controls built into the generator itself. There is no connection between the device and the x-ray generator. The device is an x-ray receiver and does not control the generator.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Televere Digital Dental Imaging System." The application aims to demonstrate substantial equivalence to a legally marketed predicate device rather than undergoing a de novo classification or a PMA. As such, the information provided focuses on the device's technical specifications and how they compare to the predicate, rather than detailed acceptance criteria and a "study" in the traditional clinical trial sense with statistical performance metrics against a defined ground truth.

Here's an analysis of the provided text in the context of your request:

Key Takeaway: This submission is a 510(k) for a digital dental imaging system (hardware + software), where the primary demonstration of safety and effectiveness relies on showing substantial equivalence to existing cleared components (an intraoral detector and image management software). It's not a diagnostic AI/CAD device that interprets images or provides a diagnosis, and therefore, the testing described is not a performance study against a clinical ground truth for diagnostic accuracy.

Based on the provided document, here's what can be inferred/extracted regarding acceptance criteria and "study" that proves the device meets them:

The "acceptance criteria" in this context are implicitly that the new device is as safe and effective as the predicate device and raises no new technical issues of safety or effectiveness. The "study" isn't a complex MRMC or standalone performance study measuring diagnostic accuracy of an AI, but rather a demonstration of technical equivalence and image quality to show non-inferiority.

1. Table of Acceptance Criteria and Reported Device Performance

Strictly speaking, the document does not present acceptance criteria in a quantitative, pre-defined table with numerical targets for diagnostic performance (e.g., sensitivity, specificity, AUC) because it's a 510(k) for an imaging system, not a diagnostic AI.

Instead, the "acceptance criteria" are qualitative and comparative:

Safety and Effectiveness: "new device is as safe and effective as the predicate device."
Image Quality: "Clinical images highlight equal or better image quality as compared to the predicate."
No New Technical Issues: "no new technical issues of safety or effectiveness raised by substitution of the imaging software component."
Clinical Acceptability: "Professional evaluation of imaging samples were of excellent quality, high resolution, clinically acceptable and substantially equivalent to the predicate device."

Reported Device Performance (Comparative):

Criterion/Metric	Predicate Device (I-View and Imagen Sensor K162619)	Proposed Device (Televere Digital Dental Imaging System)	Statement of Equivalence/Performance
CMOS Sensor	Hamamatsu, S11684/5-12	SAME	Functionally identical sensor.
Intended Use	"The Televere Digital Dental Imaging System is used for a radiographic examination by a dental professional to assist in the diagnosing of disease of the teeth, jaw and oral structures. Not for mammography. Not for fluoroscopy."	SAME	Identical intended use.
Configuration	CMOS sensor and imaging software only. No generator or stand provided.	SAME	Identical configuration.
Digital Panel Pixels	1000 x 1056 (S11684-12) / 1300 x 1700 (S11685-12)	SAME	Identical resolution specifications.
Software	Deep-View™	TIgerview Professional™, K061035	Difference in software, but "unchanged from the Predicate software (i.e., K061035)" and demonstrated to raise no new issues.
Scintillator	Cesium Iodide (CsI)	SAME	Identical scintillator material.
Interface	USB 2.0	SAME	Identical interface type.
Power Source	External Power Supply 100-240 VAC	SAME	Identical power requirements.
Standards Compliance	IEC 60601-1, IEC 60601-1-2, IEC 62220-1-1:2015, ANSI 60529-2004, IEC 60601-2-65:2012	SAME	Compliance with same relevant standards.
Overall Image Quality	Implied to be clinically acceptable.	"excellent quality, high resolution, clinically acceptable" (of evaluation samples). "Clinical images highlight equal or better image quality as compared to the predicate."	Positive comparison: "equal or better image quality."
Safety Testing	Demonstrated by compliance with standards.	Bench testing per IEC Standards (Electrical Safety, EMC), UL Listed power supply, performance testing per FDA guidance, Risk Analysis, System operation verification. Confirmation testing performed as no software modifications.	Demonstrated through standard compliance and specific bench testing.

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

Test Set Sample Size: The document mentions "Sample clinical images from the new device were also provided" but does not specify the exact number of images/cases. It states they "were not necessary to demonstrate substantial equivalence," implying a limited set or perhaps general examples rather than a statistically powered test set for diagnostic accuracy.
Data Provenance: Not specified (country of origin). The document does not indicate if the data was retrospective or prospective. Given the nature of a 510(k) for an imaging system, it's likely pre-existing generic clinical images or images taken during testing.

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

Number of Experts: Not explicitly stated. The document refers to "Professional evaluation of imaging samples," which implies at least one, but no specific number is given.
Qualifications of Experts: Not specified beyond "Professional evaluation." It's assumed to be dental professionals as per the device's indications for use.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not described. This level of detail in adjudication (e.g., 2+1, 3+1) is typically associated with studies establishing ground truth for diagnostic AI, which is not the primary purpose of this 510(k). The evaluation appears to be a qualitative assessment of image quality for substantial equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done or described. The submission is focused on demonstrating substantial equivalence of an imaging system, not the diagnostic performance improvement of human readers using an AI algorithm.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not applicable. This device is an imaging system (hardware and software), not an AI algorithm designed to generate a diagnosis or detection result on its own. The "software" component (Tigerview Professional) is a PACS-like image management software with basic adjustment features, not a diagnostic AI.

7. The Type of Ground Truth Used

Type of Ground Truth: The concept of "ground truth" as a clinical diagnosis confirmed by pathology or outcomes data is not applicable here. The "ground truth" (or basis for comparison) was the clinical acceptability and image quality of the predicate device. The new device's images were evaluated against the expectation of quality for dental X-ray images and in comparison to what the predicate device produces. This is a qualitative assessment of imaging system performance, not diagnostic accuracy.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is not a machine learning/AI device where a training set is used to develop an algorithm. The software component, Tigerview Professional, is a previously cleared PACS software (K061035) and is "unchanged" for this new device.

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

Ground Truth for Training Set: Not applicable, for the same reasons as #8. There is no mention of an algorithm being trained, hence no training set ground truth established.

Summary

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Image /page/0/Picture/0 description: The image contains 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 20, 2018

Televere Systems, LLC % Robert Bakin Regulatory Consultant Technology and Business Law Advisors, LLC 1244 Capuchino Ave. BURLINGAME CA 94010

Re: K181358

Trade/Device Name: Televere Digital Dental Imaging System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: May 20, 2018 Received: May 22, 2018

Dear Robert Bakin:

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 of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set 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.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Hole 2. Nils

Robert A. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K181358

Device Name

Televere Digital Dental Imaging System

Indications for Use (Doscribo)

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 shows the logo for TELEVERE SYSTEMS. The word "TELEVERE" is in orange, with a stylized font. Below that, in smaller, gray letters, is the word "SYSTEMS". The logo is simple and modern.

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510(k) Summary:

Televere Systems, LLC 1160 Cavalier Road Arnold, MD 21012 Email: rquaal@tigerview.com Establishment Registration Number: 2954358

CONTACT: Robert E. Bakin Email: rbakin@tblawadvisors.com Technology & Business Law Advisors, LLC 1244 Capuchino Avenue, Burlingame, CA 94010 Phone: 571-215-3507 Prepared May 20, 2018

Identification of the Device: Proprietary-Trade Name: Televere Digital Dental Imaging System Classification Name: Extraoral Source X-ray System Product Code: MUH Common/Usual Name: Intraoral Digital X-Ray Sensor Device Class/Regulation Number: Class II per regulation 21 C.F.R. §872.1800
Equivalent legally marketed device: I View and Imagen Sensor (K162619). Classification Name: Extraoral Source X-ray System Product Code: MUH Common/Usual Name: Intraoral Digital X-Ray Sensor Device Class/Regulation Number: Class II per regulation 21 C.F.R. §872.1800
Associated legally marketed devices: TigerView Professional (PACS Software) K061035. This is the software used with this device.

Classification Name: System, Image Processing, Radiological, Code LLZ Common/Usual Name: Picture Archiving and Communications System Device Class/Regulation Number: Class II per regulation 21 C.F.R. §892.2050

Indications for Use: The Televere Digital Dental Imaging System is used for a radiographic examination by a dental professional to assist in the diagnosing of disease of the teeth, jaw and oral structures. Not for mammography. Not for fluoroscopy.
Device Description: The Televere Digital Dental Imaging System is an extraoral digital x-ray system comprised of two previously cleared individual components: (1) an intraoral detector component (K162619) which connects to a PC via a USB port and (2) and image management software package (i.e., Tigerview Professional, K061035). The device detector comes in two sizes: 600mm² (Hamamatsu CMOS area image sensor, S11684-12) and 884mm² (Hamamatsu CMOS area image sensor, S116845-12). X-ray generators that can integrate with the Televere Digital Dental Imaging System are wall-mounted x-ray generators (both AC and DC) with a tube current between 1 and 15mA inclusive, and with a tube voltage between 50 and 100kV inclusive, with built in controls to set exposure parameters. Generators allow variable mA/kV to be selected, all will control the exposure time. The device and software cannot act as an x-ray generator controller. All control of xray generation is done by controls built into the generator itself. There is no connection between the device and the x-ray generator. The device is an x-ray receiver and does not control the generator.

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Image /page/4/Picture/0 description: The image contains the logo for TELEVERE SYSTEMS. The word "TELEVERE" is in orange, and the word "SYSTEMS" is in gray and is located below the word "TELEVERE". The font is sans-serif.

SQUARE STORE SQUARE

The previously cleared Tigerview™ Professional software (K061035) provides basic image adjustment features. An image adjustment system allows the physician to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. Tigerview™ Professional runs on standard PC-compatible computers and is compatible with capture devices which attach to the computer using a Network Adaptor, USB port, PCI slot, parallel port, memory card, S-video port on a video capture card, or SCSI card. NOTE: The Tigerview ™ Professional software incorporated into the Televere Digital Dental Imaging system is unchanged from the Predicate software (i.e., K061035)

Safety and Effectiveness, Comparison to predicate device. The results of clinical image inspection, bench, and laboratory test results demonstrate that the new device is as safe and effective as the predicate device. Clinical images highlight equal or better image quality as compared to the predicate.

	Predicate Device	Proposed Device
Device Name	I-View and Imagen Sensor K162619	Televere Digital Dental Imaging System
CMOS Sensor	Hamamatsu, S11684/5-12	SAME
Intended Use	The Televere Digital Dental ImagingSystem is used for a radiographicexamination by a dental professionalto assist in the diagnosing of disease ofthe teeth, jaw and oral structures. Notfor mammography. Not forfluoroscopy.	SAME
Configuration	CMOS sensor and imaging softwareonly. No generator or stand provided.	SAME
Digital Panel Pixels	1000 x 1056 (S11684-12)1300 x 1700 (S11685-12)	SAME
Software	Deep-View™	TIgerview Professional™, K061035
Scintillator	Cesium Iodide (CsI)	SAME
Interface	USB 2.0	SAME
Power Source	External Power Supply 100-240 VAC	SAME
Standards	IEC 60601-1IEC 60601-1-2IEC 62220-1-1:2015ANSI 60529-2004IEC 60601-2-65:2012	SAME

7. Substantial Equivalence Chart

Substantial Equivalence Conclusion: The comparison table reveals there are no new technical issues of safety or effectiveness raised by substitution of the imaging software component. Professional evaluation of imaging samples were of excellent quality, high resolution, clinically acceptable and substantially equivalent to the predicate device.

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Image /page/5/Picture/0 description: The image shows the logo for TELEVERE SYSTEMS. The word "TELEVERE" is in a large, orange, sans-serif font. Below it, in a smaller, gray, sans-serif font, is the word "SYSTEMS". The logo is simple and modern.

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Summary of Bench Testing Conducted: IEC Standards have been employed for: Electrical Safety and Electromagnetic Compatibility. The panel power supply is UL Listed. The CMOS area image sensor manufacturerconductedperformancetestingaccordingtotheFDAguidancedocumentforsolidstate digital x-ray panels. Risk Analysis and System operation verification tests were conducted in accordance with FDAguidancedocuments. Sincenosoftwaremodificationswererequired,confirmationtestingwas performed. Labeling was developed to comply with the FDA solid state panel guidance document.
Summary of Clinical Testing: Sample clinical images from the new device were also provided however they were not necessary to demonstrate substantial equivalence.

Conclusion: After analyzing bench, clinical image, and external laboratory testing to applicable 10. standards, it is the conclusion of Televere that the Televere Digital Dental Imaging System is as safe and effective as the predicate device K162619, has few technological differences, and has no new indication(s) for use, thus rendering it substantially equivalent to the predicate device.

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.