The Dentsply/Gendex 765DC Intraoral Dental X-Ray System is an extraoral source of x-rays for intraoral images in dental radiography. The system is comprised of the following main components: X-ray tubehead, Yoke with user interface capabilities, Articulation arm, Horizontal arm, Electronic control unit (which my be mounted remotely), Wall mount, 8" or 20cm cone. Optional components include: 8 ft. coil cord with exposure switch, 55" and 65" reach option, Optional cone lengths and shapes. The power supply is regulated to provide a fixed 65kVp, and the x-ray target current is fixed at 7ma. Predefined exposure times may be selected directly through the control or yoke switchpads. The range of exposure time is 0.02 through 2.00 seconds.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Gendex 765DC Intraoral Dental X-Ray System, focusing on its substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving performance against those criteria. As such, the information required for a comprehensive answer to your request is largely absent in the document.

However, I can extract and infer some information based on the typical requirements for such submissions and what is explicitly stated.

Acceptance Criteria and Device Performance Study (Based on Submitted Document)

The document does not explicitly state numerical acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or AUC that are typical for AI/ML device evaluations. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.

The "study" described is a regulatory submission process rather than a standalone clinical trial with quantifiable acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from regulatory context)	Reported Device Performance (From K992610)
Safety:	Device is safe when used as labeled.
- Meets product specifications	Performance testing to meet product specifications was conducted.
- Software validated	Software testing validated software design/performance.
- Hazard analysis completed	Hazard analysis including risk level and solution completed.
Effectiveness:	Device is effective when used as labeled.
- Produces effective clinical images	Effective clinical image exposures were demonstrated.
- Similar indications for use as predicates	Shares the same indications for use as predicate devices.
- Similar materials, design, operational, and functional features as predicates	Shares similar materials, design, operational, and functional features as predicate devices.

2. Sample Size for the Test Set and Data Provenance

Test Set Sample Size: Not specified. The document refers to "Performance testing to meet product specifications" and "Effective clinical image exposures" but does not detail the size of any test sets used in these evaluations.
Data Provenance: Not specified. It's likely that any performance testing or clinical image evaluations would have been conducted internally by the manufacturer (Gendex Dental X-Ray Division of Dentsply International, Inc.) or contracted labs. The document does not indicate country of origin for data or if it was retrospective/prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document mentions "Effective clinical image exposures," implying evaluation by dental or radiology professionals, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given the nature of a 510(k) for an X-ray system (which focuses on device safety and performance characteristics rather than diagnostic interpretation by an AI), a formal adjudication method for a test set of interpretations is unlikely to be discussed in this document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No, the document does not mention an MRMC study. This type of study is typically done for diagnostic AI devices where human performance changes with AI assistance. The Gendex 765DC is an X-ray imaging system, not an AI diagnostic tool.
Effect Size of Human Readers with/without AI: Not applicable, as no MRMC study was reported and the device is not an AI diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

Was a standalone study done? Not explicitly in the sense of an "algorithm only" performance. The device is a hardware system (X-ray machine). The "Software testing to validate software design / performance" would be similar to a standalone evaluation of the device's internal software functions, but not an independent diagnostic algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: The document refers to "Effective clinical image exposures." For an X-ray system, the ground truth would typically relate to:
- Image Quality Metrics: Resolution, contrast, signal-to-noise ratio, dose-to-image quality relationship, absence of artifacts.
- Compliance with Standards: Meeting electrical, radiation safety, and performance standards.
- Clinical Efficacy (Inferential): The ability to produce images suitable for diagnostic tasks, as judged by experts (though not explicitly detailed here).
  No specific "pathology" or "outcomes data" ground truth is mentioned in relation to proving the device's utility, as it is a foundational imaging tool.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is an X-ray system, not an AI model that undergoes a "training" phase with a dataset. Any internal software development would not use a "training set" in the AI sense.

9. How Ground Truth for Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no training set for an AI model.

Summary

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SEP 7 1999

K992610

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GENDEX Dental X-Ray Division Dentsply International Inc. 901 West Oakton Street Des Plaines, IL 60018-1884 Phone (847) 640-4800 (847) 640-4970 FAX

510(k) Summary Statement for the Gendex 765DC Intraoral Dental X-Ray System

I General Information

Submitter:	Gendex Dental X-Ray Division of Dentsply International, Inc.901 West Oakton St.Des Plaines, IL 60018
------------	--------------------------------------------------------------------------------------------------------------

(847) 640-4800 – Company Number Telephone: (847) 640-4908 - Contact Person

Fax: (847) 640-4970

Daniel P. Murphy Contact Person: Director of Operations

Summary Preparation Date: August 4, 1999

II Names

Gendex 765DC Device Name: Intraoral Dental X-Ray System

Primary Classification Name: 76EHD - Unit, X-Ray, Extraoral with Timer

III Predicate Devices

Sirona Heliodent DS .
Planmeca Prostyle Intra .
. Gendex GX-DC
. Gendex GX-770

00196 00197

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IV Product Description

The Dentsply/Gendex 765DC Intraoral Dental X-Ray System is an extraoral source of x-rays for intraoral images in dental radiography.

The Dentsply/Gendex 765DC Intraoral Dental X-Ray System is comprised of the following main components:

X-ray tubehead .
. Yoke with user interface capabilities
Articulation arm .
Horizontal arm .
Electronic control unit (which my be mounted remotely) .
. Wall mount
. 8" or 20cm cone

Optional components:

8 ft. coil cord with exposure switch .
55" and 65" reach option .
· Optional cone lengths and shapes

The power supply is regulated to provide a fixed 65kVp, and the x-ray target current is fixed at 7ma. Predefined exposure times may be selected directly through the control or yoke switchpads. The range of exposure time is 0.02 through 2.00 seconds.

V Indications for Use / Rationale for Substantial Equivalence

The 765DC Intraoral Dental X-Ray System is to be used and an extraoral source of x-rays in Dental Radiography.

It shares the same indications for use, similar materials, design, operational, and functional features and therefore is substantially equivalent to the predicate devices listed in section III of this summary.

00197 00198

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VI Safety and Effectiveness Information

Safety and Effectiveness is demonstrated by:

Performance testing to meet product specifications
Software testing to validate software design / performance ﺍ
Effective clinical image exposures ו
Hazard analysis including risk level and solution ।
Same indications for use as predicate devices. ।

All the above steps and evaluations combine to demonstrate that the 765CD Intraoral Dental X-Ray System is safe and effective when the device is used as labeled.

VII Conclusion

The Gendex 765DC Intraoral Dental X-Ray System was found to be is Substantially Equivalent to the predicate devices; the Sirona Heliodent DS, the Planmeca Prostyle Intra, the Gendex OX-770, and the Gendex GX-DC. The Gendex 765DC Intraoral Dental X-Ray System shares the same indications for use, similar materials, design, operational, and functional features as the current marketed predicate devices. It has been shown to be safe and effective when used as labeled.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services.

7 1999 SEP

Mr. Daniel P. Murphy Director of Operations GENDEX Dental X-Ray Division Dentsply International Inc. 901 West Oakton Street Des Plaines, IL 60018-1884

Dear Mr. Murphy:

Re:

K992610 Gendex 765DC ™ Intraoral Dental X-Rav System Dated: August 4, 1999 Received: August 4, 1999 Requiatory Class: II (two) Product Code: 90 EHD 21 CFR 872.1800

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,
OART Daniel O. Schultz, M.D.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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510(k) Number (if known): Not Assigned

Device Name:

Gendex 765DC Intraoral Dental X-Ray System

Indications for Use:

The Gendex 765DC Intraoral Dental X-Ray System is to be used as an extraoral source of x-rays in Dental Radiography.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Daniel A. Synn
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices

and Radiological Devic 510(k) Number

Prescription Use (Per 21CFR 801.109) OR

Over-The-Counter Use _

(Optional Format 1-2-96)

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.