ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY by PANORAMIC CORP.

The ENCOMPASS HF100- Eagle Panoramic X-Ray Machine is a complete system for dental imaging capable of: Film Panoramic Profiles Film Cephalometric Profiles Digital Panoramic Profiles Digital Cephalometric Profiles The digital machines use a sensor with CdTe/CMOS technology for imaging that allows for direct conversion between x-ray photons into voltage levels making it less noisy than traditional scintillator technologies. The equipment has three movement axes (two in orthogonal directions and one rotational) making it possible to execute elaborate imaging profiles. It features a complex profile movement around the dental arch and radiographic emission compensation in the spinal region, when necessary reconstructing the dental arch into a plane image. Each individual profile prioritizes a set of characteristics improving diagnostic capabilities. For example, the standard panoramic prioritizes image layer width, constant vertical magnification and homogeneous exposure along the whole image. Likewise, the low dosage profile prioritizes the reduction of dosage (time and anodic current).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ENCOMPASS HF100- Eagle Panoramic/Cephalometric X-Ray device. This document focuses on demonstrating substantial equivalence to a predicate device and safety and performance testing for overall device functionality, rather than presenting a study to prove a specific algorithm's performance against defined acceptance criteria for diagnostic accuracy.

Therefore, the requested information regarding acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies for AI algorithm performance is not available in the provided text.

The document primarily addresses:

Device Description: It's an X-ray machine for dental, oral surgery, and orthodontic practices.
Safety and Performance: Electrical, mechanical, environmental safety, and X-ray specific compliance testing are mentioned. It states "Accuracy testing and software validation was performed. All test results were satisfactory." However, it does not detail what accuracy was tested or what the acceptance criteria were for this 'accuracy testing'.

Summary of available information:

A table of acceptance criteria and the reported device performance: Not explicitly stated for diagnostic accuracy criteria of an algorithm. The document mentions "Accuracy testing and software validation was performed. All test results were satisfactory." but does not provide specific metrics or criteria.
Sample size used for the test set and the data provenance: Not applicable/not provided for an algorithm performance study. The document refers to general device testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided.
Adjudication method for the test set: Not applicable/not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not for an AI algorithm.
If a standalone was done: The "Accuracy testing and software validation" mentioned is for the overall device functionality, but not presented as a standalone clinical performance study for an AI algorithm.
The type of ground truth used: Not applicable/not provided for an AI algorithm performance study.
The sample size for the training set: Not applicable/not provided. This device is not described as having a machine learning component requiring a training set.
How the ground truth for the training set was established: Not applicable/not provided.

Conclusion:

This 510(k) summary focuses on the safety and effectiveness of the physical X-ray device and its equivalence to a predicate, not on the performance of a specific AI algorithm intended for diagnostic interpretation. The "accuracy testing" mentioned is likely related to the physical output and image quality of the X-ray machine itself, not a diagnostic algorithm's performance.

Summary

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MAR 1 7 2011

510(k) Summary K : 110371

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date prepared: _November 15, 2010

Company and Correspondent making the submission: Name - Panoramic Corp. Address – 4321 Goshen rd. , Fort Wayne, IN 46818 Telephone - 800-654-2027 Contact - Doug Pack
Device :

Trade/proprietary name : ENCOMPASS HF100- Eagle Panoramic/Cephalometric X-Ray Common Name : Dental X-rav Classification Name : Extraoral source x-ray system

3. Predicate Device:

K043307, Cranex D made by Soredex.

1. Classifications Names & Citations :
  21 CFR § 872.1800, Class 2 Product code EHD
1. Description : The ENCOMPASS HF100- Eagle Panoramic X-Ray Machine is a complete system for dental imaging capable of: Film Panoramic Profiles Film Cephalometric Profiles Digital Panoramic Profiles Digital Cephalometric Profiles The digital machines use a sensor with CdTe/CMOS technology for imaging that allows for direct conversion between x-ray photons into voltage levels making it less noisy than traditional scintillator technologies. The equipment has three movement axes (two in orthogonal directions and one rotational) making it possible to execute elaborate imaging profiles. It features a complex profile movement around the dental arch and radiographic emission compensation in the spinal region, when necessary reconstructing the dental arch into a plane image. Each individual profile prioritizes a set of characteristics improving diagnostic capabilities. For example, the standard panoramic prioritizes image layer width, constant vertical magnification and homogeneous exposure along the whole image. Likewise, the low dosage profile prioritizes the reduction of dosage (time and anodic current).
1. Indication for use: For Panoramic or Cephalometric diagnostic radiographic use in dental, oral surgery, and orthodontic practices.
1. Comparison with predicate devices: . The Cranex D made by Soredex is a Pan/Ceph device digital image capture system. The new device ENCOMPASS HF100 Eagle is a digital capture type Pan/Ceph system. Technologies employed by the predicates and our new device are nearly identical.

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8. Safety, EMC, Biocompatibility (N/A) and Performance Data :

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2(2001). Compliance testing was performed for the applicable portions of the following X-Ray standards: IEC 60601-1-3/2001; IEC 60601-2-7/2001; 60601-2-28/2001; IEC 60601-2-32/2001. Performance testing: Accuracy testing and software validation was performed. All test results were satisfactory.

9. Conclusions :

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Panoramic Corp. concludes that the ENCOMPASS HF100- Eagle Panoramic/Cephalometric X-Ray is safe and effective and substantially equivalent to predicate devices as described herein.

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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is an abstract symbol of a human figure. To the right of the seal is the word "DEPART" in a bold, sans-serif font.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Panoramic Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1 394 25" Street NW BUFFALO MN 55313

MAR 1 7 201

Re: K110371

Trade/Device Name: ENCOMPASS HF100-Eagle Panoramic/Cephalometric X-Ray Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: February 7, 2011 Received: February 8, 2011

Dear Mr. Job:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 500(). This stet notification. The FDA finding of substantial equivalence of your device to a logal y renable 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (01) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollying mo (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Statel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number(if known): K1003 7 /

Device Name: ENCOMPASS HF100- Eagle Panoramic/Cephalometric X-Ray

Indications for Use:

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

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (Part 21 CFR 807 Subpart C)

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

Mary S. Pastel

Concurrence of/CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K110321

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.