The ENCOMPASS HF100-Eagle Panoramic X-Ray Machine with CCD sensor is a complete system for dental imaging capable of Digital Panoramic Profiles and Digital Cephalometric Profiles. The machines use a sensor CCD sensor technology with the traditional scintillator technologies and auto image processing that allow a speed up the diagnostic and improve the clinic workflow. 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). ONLY THE SENSOR HAS CHANGED.

AI/ML Overview

The provided text describes the ENCOMPASS HF100-Eagle Panoramic/Cephalometric X-Ray with CCD sensor. Based on the information, here's a description of the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance

The device sought substantial equivalence to its predicate device (K110371, Encompass made for Panoramic Corp.). The acceptance criteria appear to be focused on achieving comparable diagnostic quality, sharpness, and overall image quality to the predicate device, as well as meeting relevant safety and performance standards.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Substantial Equivalence	Diagnostic quality comparable to predicate	"He found them to have comparable diagnostic quality"
	Sharpness comparable to predicate	"He found them to have comparable...sharpness"
	Overall quality comparable to predicate	"He found them to have comparable...overall quality"
Technical Performance	Resolution figures	"The resolution figures are as good as or better than our former sensors used in our predicate K110371."
Safety	Electrical, mechanical, environmental safety	"Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 was performed"
EMC	Electromagnetic Compatibility	"EMC testing was conducted in accordance with standard IEC 60601-1-2(2001)."
X-Ray Standards Compliance	Compliance with applicable X-Ray standards	"Compliance testing was performed for the applicable portions of the following X-Ray standards: IEC 60601-1-3/2001: 60601-2-28/2001; IEC 60601-2-32/2001."
Software Validation	Software functionality and reliability	"Software validation was performed."
Accuracy	Accuracy of testing	"Accuracy testing...was performed."

Overall Result: "All test results were satisfactory." and the clinical summary states the images were found to have comparable diagnostic quality, sharpness, and overall quality.

Study Details:

Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text only mentions "the predicate and new device pan and ceph images."
- Data Provenance: Not specified. It does not mention the country of origin of the data, nor whether the data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "a licensed dentist" (singular).
- Qualifications of Experts: A "licensed dentist." No further details on experience level (e.g., years of experience, specialization) are provided.
Adjudication method for the test set:
- Adjudication Method: Not specified. With only one expert reviewing, there was no adjudication process (like 2+1 or 3+1 consensus). The assessment was based on a single licensed dentist's review.
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. The evaluation involved a single licensed dentist comparing images from the new device and the predicate device, not assessing human reader performance with or without AI assistance. This device is an X-ray machine with a new sensor, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable in the context of an X-ray imaging device itself. The device produces images for human interpretation. The "resolution figures" and technical performance tests (safety, EMC, X-ray standards) could be considered standalone performance metrics for the device's technical capabilities, but not a standalone diagnostic "algorithm" performance.
The type of ground truth used:
- Ground Truth Type: Expert opinion/consensus. In this case, it was the opinion of a single "licensed dentist" who evaluated the diagnostic quality, sharpness, and overall quality of the images. There is no mention of pathology or outcomes data being used as ground truth.
The sample size for the training set:
- Sample Size: Not applicable. The device is an X-ray machine with a new sensor, not a machine learning model that requires a "training set" in the conventional sense. The "auto image processing" mentioned is likely built-in firmware/software rather than a continually learning AI.
How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable, as there is no mention of a training set for a machine learning model.

Summary

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JUL 3 0 2014

510(k) Summary Page 1 of 2.

ENCOMPASS HF100-Eagle Panoramic/Cephalometric X-Ray with CCD ser K141130

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

Date prepared: July 28, 2014

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 with CCD sensor

Common Name: Dental Panoramic/Cephalometric X-ray Classification Name: Extraoral source x-ray system

Predicate Device: K110371, Encompass made for Panoramic Corp.
Classifications Names & Citations: 21 CFR § 872.1800, Class 2 Product codes MUH (Primary) and EHD (Secondary)
Description : The ENCOMPASS HF100-Eagle Panoramic X-Ray Machine with CCD sensor is a complete system for dental imaging capable of Digital Panoramic Profiles and Digital Cephalometric Profiles. The machines use a sensor CCD sensor technology with the traditional scintillator technologies and auto image processing that allow a speed up the diagnostic and improve the clinic workflow. 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). ONLY THE SENSOR HAS CHANGED.

Indication for use: For Panoramic or Cephalometric diagnostic radiographic use in dental, oral surgery, and orthodontic practices.
Comparison with predicate devices: The ENCOMPASS HF100 Eagle with CdTe sensor made for Panoramic is a Pan/Ceph device digital image capture system. The new device ENCOMPASS HF100 Eagle with CCD sensor is a digital capture type Pan/Ceph system. Technologies employed by the predicates and our new device are nearly identical. The resolution figures are as good as or better than our former sensors used in our predicate K110371 .

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K141130
Page 2 of 2

510(k) Summary Page 2 of 2. ENCOMPASS HF100-Eagle Panoramic/Cephalometric X-Ray with CCD sensor K141130

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: 60601-2-28/2001; IEC 60601-2-32/2001. Performance testing: Accuracy testing and software validation was performed. All test results were satisfactory.
Clinical Summary: We had a licensed dentist review the predicate and new device pan and ceph images. He found them to have comparable diagnostic quality, sharpness, and overall quality.
Conclusion: 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 with CCD sensor is safe and effective and substantially equivalent to predicate devices as described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 a stylized symbol featuring three horizontal lines that curve upwards, resembling a human figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, M1) 20993-0002

July 30, 2014

Panoramic Corporation % Daniel Kamm, P.E. Principal Consultant Kamm and Associates 8870 Ravello Court NAPLES FL 34114

K141130 રિભ: Trade/Device Name: Encompass Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source X-Ray system Regulatory Class: II Product Code: MUH. EHD Dated: April 22, 2014 Received: May 1, 2014

Dear Mr. Kamm:

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 upproval 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not mislcading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2-Mr. Kamm

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (2) 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K141130

Device Name

ENCOMPASS HF100- Eagle Panoramic/Cephalometric X-Ray

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

8 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

Sm.h.7)

FORM FDA 3881 (1/14)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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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.