Axial rotation x-ray source (PC-1000). The PC-1000 panoramic X-ray machine portion of the Sunipan Imaging System generates the required ionizing radiation (x-rays) This unit is identical to the PC-1000 model supplied directly by Panoramic Corporation for use with standard x-ray film. The Sunipan Imaging System combines this base x-ray unit with an available aftermarket digital imaging sensor, creating a filmless digital imaging system.

Digital Image Sensor (Scan300fp/Retropan) is a high speed x-ray camera tailored for dental panographic applications. Originally designed and cleared for retro-conversion of existing standard panographic x-ray units. The sensor system utilizes direct conversion technology which offers a number of benefits over CCD technology. The images obtained may be reviewed and adjusted after exposure to focus on different layers or areas of clinical it rest.

AI/ML Overview

The provided document is a 510(k) premarket notification for the SuniPan Imaging System. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo clinical study data with detailed acceptance criteria and performance metrics typically seen for novel devices or AI/ML-based systems.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific device performance against those criteria, ground truth establishment, sample sizes for training/test sets, expert qualifications, or MRMC studies.

Here's a breakdown of why the requested information isn't available in the provided text:

Premarket Notification (510(k)) Context: A 510(k) submission aims to prove that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, indications for use, and performance claims to the predicate. It usually doesn't require new clinical efficacy studies of the same rigor or depth as a PMA (Premarket Approval) submission, especially for established technologies like X-ray imaging.
Device Type: The SuniPan is a digital imaging device that combines an existing X-ray unit (PC-1000, identical to a film-based unit) with an aftermarket digital sensor (Scan300fp/Retropan). The digital sensor itself was previously cleared. The focus here is on the combination being equivalent to other digital panoramic systems.
Absence of Clinical Study Section: The document is primarily administrative and descriptive, listing device details, classification, equivalency claims, and the FDA's clearance letter. It lacks a dedicated "Clinical Study" or "Performance Data" section with detailed methodologies.

Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and study details. The document indicates the device meets the regulatory requirements for "substantial equivalence" based on comparison to predicate devices, but it does not describe a study with explicit acceptance criteria for performance as would be expected for a novel diagnostic instrument.

However, I can extract what is available regarding "equivalency" which serves as the basis for marketing clearance:

1. Table of "Acceptance Criteria" (Implied by Substantial Equivalence) and Reported Device Performance

Feature/Criterion (Implied by 510(k) Equivalency)	Reported Device Performance (Summary from Document)
Premarket Notification Goal	Substantial Equivalence: Suni Medical Imaging, Inc. believes the SuniPan Imaging System is substantially equivalent to legally marketed predicate devices (K051664 Scan300fp/Retropan and K043557 PC 1000). The FDA concurred with this determination, allowing the device to be marketed.
Place of Manufacture	Equivalent to predicate devices.
Physical Appearance	Equivalent to predicate devices.
Functional Testing	Equivalent to predicate devices. (Details of this testing are not provided in the excerpt.) The PC-1000 panoramic X-ray machine portion is identical to a unit supplied by Panoramic Corporation for use with standard x-ray film. The digital image sensor (Scan300fp/Retropan) is a high-speed x-ray camera tailored for dental panographic applications, originally designed and cleared for retro-conversion. It uses direct conversion technology. Images can be reviewed and adjusted after exposure to focus on different layers or areas of clinical interest.
Material Certification	Equivalent to predicate devices.
Instructions for Use	Equivalent to predicate devices.
Indications for Use	Substantially equivalent to predicate devices: "For diagnostic radiographic use in dental, oral surgery, and orthodontic practices." (This indication was formally cleared by the FDA). The system generates required ionizing radiation (x-rays) and combines a base x-ray unit with an aftermarket digital imaging sensor to create a filmless digital imaging system.
Patient Safety (Radiation Control)	The device meets general controls provisions of the Act, including, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. (Implied compliance rather than specific performance metrics against acceptance criteria for radiation dose, etc.).

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

Not explicitly stated in the document. The 510(k) process typically relies on bench testing, comparison to predicate device specifications, and sometimes limited clinical data, but the specifics are not detailed here.

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

Not explicitly stated. Given it's a 510(k) for an established imaging technology, expert review for image quality or substantial equivalence might have been performed, but the document does not detail this.

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

Not explicitly stated.

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:

No. This is not an AI/ML device, nor is it a multi-reader multi-case study as described in the document. The device is a standard digital X-ray imaging system.

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

No. This is not an AI/ML diagnostic algorithm. It is a digital imaging acquisition system.

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

Not explicitly stated. For an imaging system, "ground truth" (if established for performance testing) would typically relate to the accuracy of imaging features against known physical standards or clinical outcomes. However, the document relies on its substantial equivalence to previously cleared devices.

8. The sample size for the training set:

Not applicable as this is not a machine learning/AI device requiring a "training set."

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

Not applicable.

Summary

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Kobo 149

FEB 3 2006

Appendix V

Summary Information

DIGITAL.DOC

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Summary of Safety Information
Premarket Notification, Section 510(k)

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

Device Name: Sunipan

Common Name(s): Digital imaging device

Classification Name(s): Digital imaging device

Manufacturer: Suni Medical Imaging, Inc. 6840 Via Del Oro, Suite 160 San Jose, CA 95119 408.227.6698 408.227.9949

Registration Number: 3003952803

Classification(s):

Sec. 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 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.

Device Class:	Class II for the requested indications
Classification Panel:	Dental Devices Panel
Product Code(s):	90-EHD

Equivalent Predicate Device:

Suni Medical Imaging, Inc. believes that the Sunipan Imaging System is substantially equivalent to the following legally marketed Digital imaging device(s):

1. K051664 Scan300fp/Retropan
1. K043557 PC 1000

Equivalency can be seen with respect to place of manufacture, physical appearance, functional testing, material certification, instructions for use and indications for use. A feature comparison chart follows this section.

Device Description:

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The sensor utilizes Ajat software .

Accessories:

Disposable Mouth Pieces. 2. Positioning Aids.

Indications for Use:

For diagnostic radiographic use in dental, oral surgery, and orthodontic practices

Company Contact: Mr. F. A. Bettencourt Suni Medical Imaging, Inc. 6840 Via Del Oro, Suite 160 San Jose, CA 95119 408.227.6698

408.227.9949

Submission Correspondent: Mr. F. A. Bettencourt Suni Medical Imaging, Inc. 6840 Via Del Oro, Suite 160 San Jose, CA 95119 408.227.6698 408.227.9949

DIGITAL.DOC

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is depicted in a simple, abstract style.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Suni Medical Imaging, Inc. % Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Medical Device Services Underwriters Laboratories, Inc. 455 E. Trimble Road SAN JOSE CA 95131

Re: K060149 Trade/Device Name: SuniPan Imaging Systems & Accessories Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: January 19, 2005 Received: January 20, 2005

Dear Mr. Christensen:

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.

FEB 3

2006

If your device is classified (see above) into either class II (Special Controls) or 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow yours ough finding of substantial equivalence of your device to a legally prematice notification: "Thesalts 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 n you desire speome at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, product not regaration on your responsibilities under the Act from the 807.77). " Ou may oount ourers, 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.litml.

Sincerely yours,

Nancy C. Bigdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number : // 06 0149

SuniPan Imaging System & Accessories Device Name(s):

Indications for Use Statement(s):

For diagnostic radiographic use in dental, oral surgery, and orthodontic practices.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR Over-The-Counter Usc PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segerson

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K060149

(Per 21 CFR 801.109)

(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.