The AcuCam Concept IVF"T Digital Dental Intraoral Camera System is a dental imaging system intended for use by health professionals in taking intraoral and extraoral images of dental anatomy.

Device Description

The DENTSPLY International, Gendex Division AcuCam Concept IVf"" Digital Dental Intraoral Camera System is an imaging device that is intended for use in taking intraoral and extraoral images. The DENTSPLY International, Gendex Division AcuCam Concept IVF™™ Digital Dental Intraoral Camera System is comprised of the following main components: Docking station (wall mounted, or counter top), Handpiece assembly with monocoil cable. Optional components: Video monitor, Printer.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a specific study that proves the device meets those criteria in a quantitative manner as typically expected for modern medical device submissions. Instead, it describes a 510(k) summary for the AcuCam Concept IVF™T Digital Dental Intraoral Camera System, focusing on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics against pre-defined acceptance criteria through a standalone study.

However, based on the information provided, we can infer some aspects and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria or device performance metrics are explicitly stated in the provided document. The document primarily focuses on demonstrating "Safety and Effectiveness" through a list of general testing and analysis types, and then concludes substantial equivalence to predicate devices.

Acceptance Criterion	Reported Device Performance
(No specific quantitative criteria provided)	Performance testing to meet product specifications
	Software testing to validate software design/performance
	Effective clinical image exposures
	Hazard analysis including risk level and solution
	Same indications for use as predicate devices

Detailed Explanation of What is Missing:
A typical acceptance criteria table would include quantifiable targets (e.g., image resolution, magnification accuracy, color fidelity, illumination uniformity, signal-to-noise ratio, software error rates, cybersecurity penetration test results, etc.) and specific test outcomes directly demonstrating that these targets were met. The document only lists general categories of testing performed.

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

The document does not specify a "test set" in the context of an algorithm or AI model, nor does it provide a sample size or data provenance (country of origin, retrospective/prospective).

Sample Size for Test Set: Not applicable or not specified.
Data Provenance: Not applicable or not specified.

Explanation: The device is an intraoral camera system, not an AI/algorithm-based diagnostic device. Therefore, the concept of a "test set" for algorithm evaluation isn't relevant in the context of this 510(k) submission. "Effective clinical image exposures" are mentioned, but no details on the number of images or patients are given.

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

This information is not applicable as the device is an imaging system and not an AI/algorithm that requires expert consensus for ground truth establishment.

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

4. Adjudication Method

This information is not applicable as the device is not an AI/algorithm that would typically involve an adjudication process for its output.

Adjudication Method: Not applicable.

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

No MRMC study was conducted or reported. The device is a direct imaging tool, not an AI-assisted diagnostic aid that would improve human reader performance.

MRMC Study Conducted: No.
Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone Performance Study

A standalone performance study was conducted, but the results are not quantitatively detailed. The "performance testing to meet product specifications" and "software testing to validate software design / performance" are forms of standalone testing. However, no specific metrics or results are provided in the summary.

Standalone Study Conducted: Yes, implied by "Performance testing to meet product/specifications" and "Software testing to validate software design / performance."
Results: Not quantitatively specified in the provided summary.

7. Type of Ground Truth Used

The concept of "ground truth" (e.g., pathology, outcomes data) as it pertains to evaluating diagnostic algorithm accuracy is not directly applicable here. For an imaging device, the "ground truth" implicitly refers to the accuracy and fidelity of the captured image in representing the actual dental anatomy. This is assessed through physical performance tests and user observation ("effective clinical image exposures").

Type of Ground Truth: Not explicitly stated in the AI/diagnostic algorithm sense. For an imaging system, it would be the accurate visual representation of the actual dental anatomy, assessed through engineering and clinical performance evaluations.

8. Sample Size for the Training Set

This information is not applicable as the device is not an AI/algorithm that uses a "training set."

Sample Size for Training Set: Not applicable.

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

This information is not applicable.

How Ground Truth for Training Set was Established: Not applicable.

Summary of the Study (as described in the document):

The document describes the submission of a 510(k) Premarket Notification for the AcuCam Concept IVF™T Digital Dental Intraoral Camera System. The "study" described is essentially the process of demonstrating substantial equivalence to legally marketed predicate devices.

Key components of this demonstration include:

Performance testing: To ensure the device meets its own product specifications. Specific metrics or results are not provided.
Software testing: To validate the design and performance of the software. Specific details are not provided.
Effective clinical image exposures: Implies some form of clinical evaluation of the images produced, but no case numbers or outcomes are detailed.
Hazard analysis: To identify and mitigate risks.
Comparison to predicate devices: The core argument for substantial equivalence is based on the device sharing "the same indications for use, similar materials, design, operational, and functional features" as the established predicate devices (Gendex AcuCam Concept IV, Vistacam Omni and Vistacam Omni (IC), and Ultracam).

The conclusion from these activities is that the device is "safe and effective when used as labeled" and "Substantially Equivalent" to the predicate devices. This type of submission does not typically include a detailed, quantitative clinical study report with specific acceptance criteria and performance metrics for novel AI algorithms, but rather focuses on demonstrating that the new device operates similarly and safely to existing, legally marketed devices.

Summary

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OCT 1 4 2003

Image /page/0/Picture/1 description: The image shows the logos for Dentsply and Gendex. The Dentsply logo is in a bold, sans-serif font, with a stylized "P" that has a triangular cutout. Below Dentsply, the Gendex logo is displayed in a simpler, sans-serif font. Both logos are in black and are positioned one above the other.

K032904

DENTSPLY International Gendex Division 901 West Oakton Street Des Plaines, IL 60018-1884 Phone (847) 640-4800 Fax (847) 640-4970

510(k) Summary Statement for the Gendex AcuCam Concept IVFMT Digital Dental Intraoral Camera System

I.	General Information
	Submitter:	DENTSPLY InternationalGendex Division901 West Oakton St.Des Plaines, IL 60018
	Telephone:	(847) 640-4800 – Company Number(847) 640-4924 - Contact Person
	Fax:	(847) 640-4970
	Contact Person:	John R. MillerDirector, Quality Assurance and Regulatory Affairs
	Summary Preparation Date:	September 16, 2003
II.	Names
	Device Name:	AcuCam Concept IV FWT Digital Dental IntraoralCamera System
	Primary Classification Name:	EIA - Dental Operative Unit

III. Predicate Devices

Gendex AcuCam Concept IV Intraoral Camera System .
. Vistacam Omni and Vistacam Omni (IC)
. Ultracam

IV. Product Description

The DENTSPLY International, Gendex Division AcuCam Concept IVf"" Digital Dental Intraoral Camera System is an imaging device that is intended for use in taking intraoral and extraoral images.

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The DENTSPLY International, Gendex Division AcuCam Concept IVF™™ Digital Dental Intraoral Camera System is comprised of the following main components:

Docking station (wall mounted, or counter top) .
Handpiece assembly with monocoil cable .

Optional components:

Video monitor .
Printer .

V. Indications for Use / Rationale for Substantial Equivalence

The AcuCam Concept IVFWT Digital Dental Intraoral Camera System is an imaging device, which is intended for use by health professionals in taking intraoral and extraoral images of dental anatomy in order to:

1. To assist the dental practitioner in the assessment of the overall dental health of the patient by providing high quality, magnified images of regions of the oral cavity which otherwise are difficult or impossible to view.
1. Allow the dental practitioner to provide educational information to the patient and to more effectively communicate a treatment plan.
1. Provide documented images for patient records, insurance companies, and health professionals.
1. To allow the practitioner to provide before and after color images showing the results of the dental procedures performed.

The end user must insure that any peripheral equipment (i.e., monitor, printer, computer, etc.) used with the AcuCam Concept IV Digital Dental Intraoral Camera System is approved for medical applications under the respective national regulations.

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.

VI. Safety and Effectiveness Information

Safety and Effectiveness is demonstrated by:

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

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All the aforementioned steps and evaluations combine to demonstrate that the AcuCam Concept IVEWT Digital Dental Intraoral Camera System is safe and effective when the device is used as labeled.

VII. Conclusion

The AcuCam Concept IVF™T Digital Dental Intraoral Camera System was found to be Substantially Equivalent to the predicate devices; the Gendex AcuCam Concept IV, the Air Techniques Vistacam Omni and Vistacam Omni (IC), and Mr. W. Edward Johansen's Ultracam. The AcuCam Concept IVF"" Digital Dental Intraoral Camera 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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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 2003

Mr. John R. Miller Director Quality Assurance and Regulatory Affairs Dentsply International 901 West Oakton Street Des Plaines, Illinois 60018-1884

Re: K032904

Trade/Device Name: AcuCam Concept IV™ Digital Intraoral Camera System Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: September 16, 2003 Received: September 25, 2003

Dear Mr. Miller:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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.

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Page 2 -Mr. Miller

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); good 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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Cluiz

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

AcuCam Concept IVFWT Digital Dental Intraoral Camera System Device Name:

Indications for Use:

The AcuCam Concept IVF"T Digital Dental Intraoral Camera System is a dental imaging system intended for use by health professionals in taking intraoral and extraoral images of dental anatomy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suser Runser

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental De

510(k) Number: K032904

Prescription Use (Per 21CFR 801.109)

Over-The-Counter Use __

(Optional Format 1-2-96)

000036

Regulation Number and Section

§ 872.6640 Dental operative unit and accessories.

(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.