Claris i310D intra oral camera system and accessories is indicated for use to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as showing the results.

Device Description

Claris i310D comprises of a light (0.1 Ibs), small (8.3" x 0.85"), and ergonomic handpiece. The handpiece consists of a focusing mechanism and a capture button to assist the doctor in taking intraoral or full face images of the patient. The handpiece connects to the computer via USB 2.0 port. A cradle is provided to allow for on-off functions. Claris i310D has a digital resolution (720x480 pixels) to capture images at 60 degrees field of view. Images may be stored using third party software vendors.

AI/ML Overview

The provided text describes a 510(k) summary for the Claris i310D Intra Oral Camera System and Accessories. The submission claims substantial equivalence to a predicate device (Claris i310, 510k# K032341) rather than presenting a performance study with specific acceptance criteria as would be typical for new, non-substantially equivalent devices or AI/ML-based devices.

Therefore, many of the requested details are not applicable as the submission relies on demonstrating similarity to an already approved device.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" and "reported device performance" in the context of a de novo clinical study with quantitative metrics is not explicitly present. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device. The "performance" aspect is framed as a comparison of technological characteristics.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Comparison Result)
Indications for use are identical or very similar	Identical
Target population is identical or very similar	Identical
Design is similar	Similar
Materials are identical or similar	Identical
Performance is similar	Similar
Sterility is identical or similar	Identical (being not applicable as well)
Biocompatibility is identical or similar	Identical
Mechanical safety is similar	Similar
Chemical safety is identical or similar	Identical (being not applicable as well)
Anatomical sites are identical or similar	Identical
Human factors are similar	Similar
Energy used and/or delivered is similar	Similar
Compatibility with environment and other devices is similar	Similar
Standards met are identical or similar	Identical
Electrical safety is identical or similar	Identical
Thermal safety is similar	Similar
Radiation safety is similar	Similar

Study Details:

Sample size used for the test set and the data provenance: Not applicable. This is a 510(k) submission seeking substantial equivalence based on technological characteristics, not a clinical performance study with a test set of data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established by experts for a test set in this type of submission.
Adjudication method for the test set: Not applicable.
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: Not applicable. This device is an intraoral camera, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical camera device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the technological characteristics and safety profile of the predicate device.
The sample size for the training set: Not applicable. This is a hardware device, not a machine learning algorithm.
How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) summary for a medical device (intraoral camera) seeking market clearance through the substantial equivalence pathway. It does not present a de novo performance study with acceptance criteria, test sets, or ground truth establishment in the way typically associated with AI/ML or novel diagnostic devices. Instead, the "study" is a comparison of the device's technical specifications and intended use against a legally marketed predicate device to demonstrate that it is "as safe and effective."

Summary

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K061175.
p. 1 of 2

510(k) Summary

As Required by 21 section 807.92 ( c )

SOTA PRECISION OPTICS, INC. 1-Submitter Name:

1073 NORTH BATAVIA STREET, ORANGE, CA 92867 2-Address:

(714) 532-6100 3-Phone:

(714) 532-6107 4-Fax:

5-Contact Person:

6-Date summary prepared: April 14th, 2006

7 Official Correspondent for this 510k submission: Jay Mansour, Mansour Consulting LLC
8- Address: 845 Aronson Lake Court, Roswell, GA 30075
9- Phone: 678-908-8180

10- Fax: 678-623-3765

11- Contact Person: Jay Mansour, President
12-Device Trade or Proprietary Name: Claris i310D

13-Device Common or usual name: Intraoral camera system and accessories

14-Device Classification Name: Unit, Operative, Dental
15-Substantial Equivalency is claimed against the following device:
Claris i310 from SOTA PRECISION OPTICS, INC. . 510k# K032341
16-Description of the Device: (For technical specifications, refer to the user manual) (Full listing and photos of accessories is available within this submission- refer to user manual)

Claris i310D comprises of a light (0.1 Ibs), small (8.3" x 0.85"), and ergonomic handpiece.

The handpiece consists of a focusing mechanism and a capture button to assist the doctor in taking intraoral or full face images of the patient.

The handpiece connects to the computer via USB 2.0 port.

A cradle is provided to allow for on-off functions.

Claris i310D has a digital resolution (720x480 pixels) to capture images at 60 degrees field of view. Images may be stored using third party software vendors.

17-Intended use of the device: (refer to FDA form attached)

18-Safety and Effectiveness of the device:

This device is safe and effective as the predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 19 below)

PAGE II

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19-Summary comparing technological characteristics with predicate device:

Please find below a tabulated comparison supporting that this device is substantially r lease lind bother medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Indeed, this device is SUBSTANTIALLY EQUIVALENT to the predicate device. Refer to the explanations/details within the main submission.

FDA file reference number	510k # K032341
TECHNOLOGICAL CHARACTERISTICS	Comparison result
Indications for use	Identical
Target population	Identical
Design	Similar
Materials	Identical
Performance	Similar
Sterility	Identical (being not applicable as well)
Biocompatibility	Identical
Mechanical safety	Similar
Chemical safety	Identical (being not applicable as well)
Anatomical sites	Identical
Human factors	Similar
Energy used and/or delivered	Similar
Compatibility with environment and other devices	Similar
Where used	Identical
Standards met	Identical
Electrical safety	Identical
Thermal safety	Similar
Radiation safety	Similar

Refer to the submission for more details.

PAGE 12

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2006

Sota Precision Optics, Incorporated C/O Jay Mansour Mansour Consulting, LLC 845 Aronson Lake Court Roswell, Georgia 30075

Re: K061175

Trade/Device Name: Claris i310D Intra Oral Camera System and Accessories Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: April 14, 2006 Received: April 27, 2006

Dear Mr. Mansour:

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. Mansour

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 (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.

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 (240) 276-0115. 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/industry/support/index.html.

Sincerely yours,

Sujite Y. Mchair Omd.

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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Indications for Use

K061175 510(k) Number (if known):

Device Name: Claris i310D Intra Oral Camera System and accessories

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Raaser

.. Sa-Citi) -n of Anesthesiology, General Hospital, Jon Control, Dental Devices

inter K061175

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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.