The indications for use of the Progeny Vantage Extra-Oral Panoramic X-Ray System is to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Device Description

The Progeny Vantage Panoramic X-ray System is an extraoral radiographic imaging system for producing digital radiographs in a panoramic view of the teeth, jaw, and oral structure. The Progeny Vantage Panoramic Extraoral Radiographic Imaging System consists of the following main components: X-ray tubehead with integrated collimation. Digital Image Receptor Rotating C-Arm for tubehead and image receptor mounting Overhead arm Elevating Column Patient Positioning Table Electronic Control Unit Computer Display Workstation 8 ft. coil cord with exposure switch

AI/ML Overview

The provided 510(k) summary for the Progeny Vantage Panoramic X-Ray System primarily focuses on demonstrating substantial equivalence to predicate devices through comparison of technical specifications and indications for use. It does not contain information about specific acceptance criteria related to device performance in terms of diagnostic effectiveness that would typically be evaluated in a study with a ground truth, human readers, or quantitative performance metrics like sensitivity and specificity.

Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment cannot be extracted from this document, as they are not present.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating substantial equivalence to predicate devices by matching their characteristics. The "reported device performance" in this context refers to the device's technical specifications.

Characteristic	Acceptance Criteria (Implied by Predicate Devices)	Reported Device Performance (Progeny Vantage)
kVp	60-84 kVp (within range of predicates)	60-84 kVp
mA	1-16 mA (within range of predicates)	4-10 mA
Digital Sensor	Yes	Yes
Image Pixel size	66 µm - 96 µm (within range of predicates)	96 µm
Exposure Time	2-17s (within range of predicates)	8-10s
Image Profiles	Pan, TMJ, Ortho (matching predicates)	Pan, TMJ, Ortho
Operator Exposure Control	Deadman Switch	Deadman Switch
User Interface	Color Touch Screen / Keypad & LED Display	Color Touch Screen
X-Ray tube focal spot	0.4mm² - 0.5mm² (within range of predicates)	0.5mm²
Magnification	1.2 - 1.3 (within range of predicates)	1.2
Column	Telescoping / Fixed	Telescoping
Construction	Aluminum castings/extrusions with plastic/metal	Aluminum castings with plastic/metal covers
Indications For Use	To provide dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures (matching predicates)	To provide dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures
Safety & Effectiveness (General)	Performance testing, software testing, hazard analysis, same indications as predicates	Performance testing and verification to meet product specifications, Software testing to validate software design and performance, Hazard analysis and risk level assessment, Same indications for use as predicate devices

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not explicitly provided in the document. The filing mentions "Performance testing and verification to meet product specifications" and "Software testing to validate software design and performance" but does not detail the size or nature of the test sets used for these evaluations, nor their provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The application focuses on technical equivalence rather than a clinical study requiring expert assessment of ground truth.

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

This information is not provided.

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

This type of study was not done, nor is it applicable, as the device is a panoramic x-ray system, not an AI-powered diagnostic tool for interpretation. Its function is to produce images, not to analyze them with AI assistance.

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

This information is not provided, and it is not applicable given the nature of the device as an imaging system rather than an algorithm for standalone diagnosis.

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

This information is not provided. For an imaging device like this, ground truth for image quality assessments would typically involve objective measurements (e.g., spatial resolution, contrast-to-noise ratio) and potentially subjective evaluation by clinicians to confirm diagnostic utility. However, the document does not elaborate on how these were established.

8. The sample size for the training set

This information is not provided. There is no mention of a "training set" as the device is an imaging system, not a machine learning model requiring a training phase for its core function.

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

This information is not provided and is not applicable for the reasons mentioned above.

Summary

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K091866

Progeny

SECTION 7

Proprietary and Confidential

510(k) Summary

as required by CFR section 807.92(c)

JUL 2.0 2009

I. General Information

June 4, 2009 Date: Midmark Applicant: 675 Heathrow Dr. Lincolnshire, Ill. ୧୦୦୧୨ Contact Person: Alan Krema
847-415-9800 x785 Telephone:
847-415-9801 Fax:

II. Names

Device Name:

Trade Name:	Progeny Vantage Panoramic X-Ray System
Common Name:	Panoramic X-Ray System
Classification Name:	MUH - Unit, X-Ray, Extra oral with Timer

III. Predicate Devices

#K011619	Planmeca Promax
#K992385	Instrumentarium Orthopantomograph OP100D
#K050255	Gendex Orthoralix 8500

Product Description

The Progeny Vantage Panoramic X-ray System is an extraoral radiographic imaging system for producing digital radiographs in a panoramic view of the teeth, jaw, and oral structure.

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The Progeny Vantage Panoramic Extraoral Radiographic Imaging System consists of the following main components:

X-ray tubehead with integrated collimation. Digital Image Receptor Rotating C-Arm for tubehead and image receptor mounting Overhead arm Elevating Column Patient Positioning Table Electronic Control Unit Computer Display Workstation 8 ft. coil cord with exposure switch

Optional Components: None

V. Indications for Use / Rationale for Substantial Equivalence

Indications For Use of the Progeny Vantage Panoramic X-Ray System:

The indications for use of the Progeny Vantage Panoramic Extra Oral X-Ray System is to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. As a digital device, the images are displayed on a monitor. The Image management software, including any image manipulation, archiving, and communication are not a part of this device.

The Vantage shares the same indications for use, materials, design, operational and functional features and is therefore substantially equivalent to the predicate devices listed in section III of this summary.

The Progeny Panoramic Radiographic Imaging System is similar in design, composition, and function to the following devices introduced into commercial distribution after May 28, 1976:

#K011619	Planmeca Promax
#K992385	Instrumentarium Orthopantomograph OP100D
#K050255	Gendex Orthoralix 8500

Labeling for the currently marketed devices is included as Appendix B.

Comparison Table

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Characteristic	PlanMecaPromax	Gendex8500	InstrumentariumOP200D	ProgenyVantage
kVp	60-84 kVp	60-80 kVp	57-85 kVp	60-84 kVp
mA	1-16 mA	4-10 mA	2-16 mA	4-10mA
Digital Sensor	Y	Y	Y	Y
Image Pixel size	66µm	96 µm	96 µm	96 µm
Exposure Time	2-17s	11-12s	12s	8-10s
Image Profiles	Pan, TMJ,Ortho	Pan	Pan, TMJ,Ortho	Pan, TMJ,Ortho
Operator ExposureControl	DeadmanSwitch	DeadmanSwitch	DeadmanSwitch	DeadmanSwitch
User Interface	ColorTouch Screen	Keypad andLED Display	ColorTouch Screen	ColorTouch Screen
X-Ray tube focal spot	$0.5mm^2$	$0.4mm^2$	$0.5mm^2$	$0.5mm^2$
Magnification	1.2	1.25	1.3	1.2
Column	Telescoping	Telescoping	Fixed	Telescoping
Construction	Aluminumcastings withplastic andmetal covers	Aluminumextrusions withplastic covers	Aluminumcastings withplastic andmetal covers	Aluminumcastings withplastic andmetal covers

The predicate devices show a range of specifications. The Progeny Vantage is equivalent to at least one of the predicate devices for each of the specifications excepting exposure time. The shaded areas in the table above show the areas of congruence. Exposure time, by itself, is not a critical specification for comparison, as the equivalence in sensors across two of the predicate devices indicates a similar dose to achieve the same level of image detail.

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VI. Safety and Effectiveness Information

Safety and effectiveness is demonstrated by:

Performance testing and verification to meet product specifications. Software testing to validate software design and performance. Hazard analysis and risk level assessment. Same indications for use as predicate devices.

All of the above steps and evaluations combine to demonstrate that the Panoramic Extraoral Radiographic Imaging System is safe and effective when the device is used as labeled.

VII. Conclusion

The Progeny Vantage Panoramic Extraoral Radiographic Imaging System is determined to be substantially equivalent to the predicate devices, the Planmeca Promax, the Instrumentarium Orthopantomograph OP100D, and the Gendex. The Panoramic Extraoral Radiographic Imaging System shares the same indications for use, materials, design, operational and functional features to the currently marketed predicate devices listed in section III of this summary. The Panoramic Extraoral Radiographic Imaging System is safe and effective when the device is used as labeled.

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Image /page/4/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized design featuring three curved shapes that resemble a person with outstretched arms.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2009

Midmark

% Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K091866

Trade/Device Name: Progeny Vantage Panoramic X-Ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: July 8, 2009 Received: July 9, 2009

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 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 of medical

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrl/mdr/ 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 toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Iveline M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Ko91866

Progeny Vantage Panoramic X-Ray System Device Name:

Indications For Use:

The indications for use of the Progeny Vantage Extra-Oral Panoramic X-Ray System is to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K091866
Page 1 of 1

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.