Claris i310 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 i310 comprises of a light (0.1 lbs), small (8"x0.86"), and ergonomic handpiece along with a docking station.

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 a docking station via a cable. The docking station in turn can connect directly to a monitor. PC, or a printer via a S-Video or a standard composite connection.

Claris i310 is also available in a wireless option.

It uses high definition imaging (494 lines/inch) to capture images at 60 degrees field of view.

Images may be stored using third party software vendors.

Claris i310 includes also an optional footswitch.

AI/ML Overview

The provided text describes a 510(k) summary for the Claris i310 Intra Oral Camera System and Accessories. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a rigorous study on the device's performance.

Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, ground truth establishment, and MRMC studies are not available in the provided document.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Specific functional or performance metrics (e.g., image resolution, accuracy in detecting conditions, error rates)	Not Available. The document states "Performance: Similar" to the predicate device. It mentions "high definition imaging (494 lines/inch)" but doesn't provide specific performance criteria or tests against them.

2. Sample size used for the test set and data provenance:

Sample Size: Not available. No specific test set or study validating performance is described.
Data Provenance: Not available.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

Number of Experts: Not applicable, as no specific performance test set with ground truth is described.
Qualifications of Experts: Not applicable.

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

Adjudication Method: Not applicable, as no specific performance test set is described.

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:

MRMC Study: No, an MRMC study was not done or described. This device is an intra-oral camera, not an AI-powered diagnostic tool, so such a study would not be relevant in this context.

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

Standalone Performance: No, a standalone algorithm performance study was not done or described. The device is purely an imaging tool, not a diagnostic algorithm.

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

Type of Ground Truth: Not applicable, as no specific performance test with ground truth is described.

8. The sample size for the training set:

Sample Size: Not applicable. This device is a hardware imaging system, not an AI model requiring a training set.

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

Ground Truth Establishment: Not applicable.

Summary of Device and 510(k) Claims:

The Claris i310 Intra Oral Camera System and Accessories is an imaging device intended to provide dentists and patients with a view of the mouth before and after dental procedures to assist in describing procedures and showing results.

The 510(k) submission (K032341) claims substantial equivalence to the predicate device "DIGITAL DOC from Digital Doc. Inc." (510k # K981663). The basis for this claim is a comparison of technological characteristics, finding them "Identical" or "Similar" across various categories, including:

Indications for use: Identical
Target population: Identical
Design: Similar
Materials: Similar
Performance: Similar (stated as "high definition imaging (494 lines/inch)")
Biocompatibility: Similar
Mechanical safety: Similar
Chemical safety: Similar
Anatomical sites: Identical
Human factors: Similar
Energy used and/or delivered: Similar
Compatibility with environment and other devices: Similar
Where used: Identical
Standards met: Similar
Electrical safety: Similar
Thermal safety: Similar
Radiation safety: Similar

The document does not provide a detailed "study that proves the device meets the acceptance criteria" in terms of specific performance metrics because the 510(k) pathway for this type of device relies on demonstrating equivalence to a legally marketed predicate, rather than novel performance claims requiring extensive new clinical or performance studies. The "study" here is essentially the comparison of technological characteristics to the predicate device, showing that it performs similarly and is thus safe and effective for its stated intended use.

Summary

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AUG 2 5 2003

510(k) Summary As Required by 21 section 807.92 ( c )

1-Submitter Name:	Sota Precision optics, Inc
2-Address:	1073 North Batavia StreetOrange, CA 92867
3-Phone:	714-532-6100
4-Fax:	714-532-6107
5-Contact Person:	Jay Mansour of Mansour Consulting LLC, on behalf of submitter1308 Morningside Park Dr. Alpharetta, GA 30022. 770-777-4146
6-Date summary prepared:	July 22nd, 2003
7-Device Trade or Proprietary Name:	Claris i310

8-Device Common or usual name: Intra Oral Camera system and accessories

9-Device Classification Name: Unit, Operative, Dental
10-Substantial Equivalency is claimed against the following device:
DIGITAL DOC from Digital Doc. Inc. . 510k # K981663
11-Description of the Device: (For tochnical specifications, refer to the user manual) (Full listing and photos of accessories is available within this submission- refer to User Manual pages 22 and 23)

Claris i310 comprises of a light (0.1 lbs), small (8"x0.86"), and ergonomic handpiece along with a docking station.

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 a docking station via a cable. The docking station in turn can connect directly to a monitor. PC, or a printer via a S-Video or a standard composite connection.

Claris i310 is also available in a wireless option.

It uses high definition imaging (494 lines/inch) to capture images at 60 degrees field of view.

Images may be stored using third party software vendors.

Claris i310 includes also an optional footswitch.

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

13-Safety and Effectiveness of the device:

This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)

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14-Summary comparing technological characteristics with other predicate device:

Please find below a tabulated comparison supporting that this device is substantially r loase find b other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Refer to the detailed explanations within the main submission.

FDA file reference number	510k # K981663
Attachments inside notification submission file	510k FDA website print out
TECHNOLOGICAL CHARACTERISTICS	Comparison result
Indications for use	Identical
Target population	Identical
Design	Similar
Materials	Similar
Performance	Similar
Sterility	Not Applicable
Biocompatibility	Similar
Mechanical safety	Similar
Chemical safety	Similar
Anatomical sites	Identical
Human factors	Similar
Energy used and/or delivered	Similar
Compatibility with environment and other devices	Similar
Where used	Identical
Standards met	Similar
Electrical safety	Similar
Thermal safety	Similar
Radiation safety	Similar

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Image /page/2/Picture/1 description: The image is a black and white logo. The logo is circular and contains an image of a bird with three lines above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2003

Sota Precision Optics. Incorporated C/O Mr. Donald J Sherratt Responsible Third Party Official Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01779

Re: K032341

Trade/Device Name: Claris i310 Intra Oral Camera System and Accessories Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: August 15, 2003 Received: August 18, 2003

Dear Mr. Sherratt:

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 vour 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. Sherratt

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 (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,

SusaRuroer

Susan Runner, DDS, MA Interim 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 statement

510(k) Number (if known): K032341 Claris i310 Intra Oral Camera System and Accessories Device Name:

Indications For Use:

Kein Mulvey for MSN

nesthesiology, General Hospital, Control. Dental D

510(k) Number: K032341

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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.