(17 days)
For diagnostic radiographic use in dental, oral surgery, and orthodontic practices.
The PC-1000 panoramic X-ray machine provides a panoramic picture, showing 70-80% more anatomy than a standard series of full-mouth X-rays. Inscribed lines and an angled mirror aid in accurately establishing the Frankfort plane and the midsagittal plane. In addition, the numbered temple supports allow accurate measurement of skull density for proper kVp settings, eliminating the guess work typical in panoramic radiography.
The provided text describes a 510(k) premarket notification for the Model PC-1000 Panoramic / Cephalometric X-ray Systems. This document is a predicate device comparison for substantial equivalence rather than a study demonstrating an AI device's performance against acceptance criteria.
Therefore, many of the requested categories for AI device performance are not applicable to this submission. The document focuses on showing the new device is as safe and effective as a previously marketed device (K882436) through benchmarking its characteristics against the predicate and compliance with relevant standards.
Here's an attempt to address the request based on the available information, noting the significant gaps due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Device K882436) | Reported Device Performance (Modified Model PC-1000) | Meets Criteria? |
|---|---|---|---|
| Intended Use | Diagnostic Dental X-Rays (Panoramic and Cephalometric) | SAME (Diagnostic Dental X-Rays) | Yes |
| Energy Source | 120 V Ac 20 A | SAME (120 V Ac 20 A) | Yes |
| User Interface | Dedicated Controls | Touch Controls | N/A (Technological Difference, deemed not to affect safety/effectiveness) |
| Maximum output | 90 kVp | SAME (90 kVp) | Yes |
| Focal spot | 0.5 mm x 0.5 mm | SAME (0.5 mm x 0.5 mm) | Yes |
| Tube Current | 6 ma | SAME (6 ma) | Yes |
| Exposure time | 12 seconds | SAME (12 seconds) | Yes |
| Method of Control | Analog Hardware | (3) Microprocessors | N/A (Technological Difference, deemed not to affect safety/effectiveness) |
| Performance Standard | Complies with 21 CFR Part 1020 | SAME (Complies with 21 CFR Part 1020) | Yes |
| International Standards | IEC 60601-1 (1988-12) & amend., IEC 60601-2-7, IEC 60601-2-28, IEC 60601-1-2 | SAME (IEC 60601-1 (1988-12) & amend., IEC 60601-2-7, IEC 60601-2-28, IEC 60601-1-2) | Yes |
| Safety | UL Listing | SAME (UL Listing) | Yes |
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is detailed in the "Summary of Safety and Effectiveness" (referred to as Exhibit 2, although content from the exhibit is spread across the provided text) which broadly states: "The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices."
The "Substantial Equivalence Chart" (likely part of Exhibit J) explicitly compares the characteristics of the new Model PC-1000 (Modified) against the predicate Model PC-1000 (K882436). The conclusion states: "After analyzing bench, user, and standards testing data, it is the conclusion of Panoramic Corporation that the Model PC-1000 Panoramic / Cephalometric X-ray Systems are as safe and effective as the predicate device, have few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate device."
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document references "bench, user, and standards testing data" without providing specific numbers of tests conducted or units observed.
- Data Provenance: Not specified. This type of submission would typically involve internal testing by the manufacturer (Panoramic Corp.) and potentially accredited lab testing for standards compliance. The document does not mention country of origin for data or if it was retrospective/prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a comparison of hardware technical specifications and compliance with safety standards, not a diagnostic accuracy study requiring expert ground truth for image interpretation.
4. Adjudication method for the test set:
- Not Applicable. As above, this is not an diagnostic accuracy or image interpretation study. Adjudication methods are common for clinical studies involving disagreement among readers/experts.
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:
- Not Applicable. This is not an AI device or a diagnostic aid. It's a conventional panoramic/cephalometric X-ray system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device does not have an "algorithm only" component in the way an AI diagnostic or analytical tool would.
7. The type of ground truth used:
- For technical specifications (e.g., kVp, focal spot, exposure time, current), the "ground truth" would be established by physical measurements and calibration according to industry standards and engineering principles.
- For compliance with standards (e.g., 21 CFR Part 1020, IEC standards, UL Listing), the "ground truth" is verified through audits and specific tests mandated by those standards, conducted by the manufacturer or accredited testing bodies.
8. The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an AI/ML algorithm is involved.
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K043557
Page 1 of 2
JAN 1 3 2005
EXHIBIT 2 510(k) Summary PANORAMIC CORP. 4321 Goshen Rd. Fort Wayne, IN 46818 800.654.2027 260.489.2291 Fax 260.489.5683 www.pancorp.com December 14, 2004 Contact: Doug Pack, Director of Operations.
-
- Identification of the Device: Proprietary-Trade Name: Model PC-1000 Panoramic / Cephalometric X-ray Systems Classification Name: Unit, x-ray, extraoral with timer Product Code: EHD Common/Usual Name: Panoramic Dental X-Ray System
-
- Equivalent legally marketed devices: Model PC-1000 Panoramic / Cephalometric X-ray System K882436
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- Indications for Use (intended use) For diagnostic radiographic use in dental, oral surgery, and orthodontic practices.
-
- Description of the Device: The PC-1000 panoramic X-ray machine provides a panoramic picture, showing 70-80% more anatomy than a standard series of full-mouth X-rays. Inscribed lines and an angled mirror aid in accurately establishing the Frankfort plane and the midsagittal plane. In addition, the numbered temple supports allow accurate measurement of skull density for proper kVp settings, eliminating the guess work typical in panoramic radiography. Panoramic's quick and easy installation allows more time to be spent on demonstration. As your new Panoramic X-ray is installed, our service representative will test and calibrate the equipment, as well as teach your personnel how to use it. Panoramic provides you with a professional operator's manual in both print and on video tape so you can teach new personnel the operation of the PC-1000 as well as refresh the memory of your current staff. Each free-standing PC-1000 is shipped and delivered almost completely assembled, avoiding the noise and hours of disruption that is common with unassembled models. Also, the PC-1000 plugs into a standard 115-volt outlet eliminating the need for expensive rewiring or modifications to one's office.
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- Safety and Effectiveness, comparison to predicate device. The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices.
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K043551
Paylerz
| J. Substantial Equivalence Chart, Model PC-1000 Panoramic / Cephalometric X-ray Systems------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ||
|---|---|---|
| -- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
| Characteristic | Model PC-1000 Panoramic /Cephalometric X-ray SystemsK882436 | Modified ModelPC-1000 Panoramic/ Cephalometric X-ray Systems |
|---|---|---|
| Intended Use: | Diagnostic DentalX-Rays (Panoramicand Cephalometric) | SAME |
| Energy Source: | 120 V Ac 20 A | SAME |
| User Interface | Dedicated Controls | Touch Controls |
| Maximum output | 90 kVp | SAME |
| Focal spot | 0.5 mm x 0.5 mm | SAME |
| Tube Current | 6 ma | SAME |
| Exposure time | 12 seconds | SAME |
| Method of Control | Analog Hardware | (3) Microprocessors |
| PerformanceStandard | Complies with 21CFR Part 1020. | SAME |
| InternationalStandards | IEC 60601-1 (1988-12) & amend.IEC 60601-2-7 IEC60601-2-28,IEC 60601-1-2 | SAME |
| Safety | UL Listing | SAME |
7. Conclusion
After analyzing bench, user, and standards testing data, it is the conclusion of Panoramic Corporation that the Model PC-1000 Panoramic / Cephalometric X-ray Systems are as safe and effective as the predicate device, have few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate device.
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
JAN 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Panoramic Corp. % Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015
Re: K043557 Trade/Device Name: Model PC-1000 Panoramic/ Cephalometric X-ray Systems Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD
Dated: December 24, 2004 Received: December 27, 2004
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 strect 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 provisions of the Al and prohibitions against misbranding and adulteration.
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 deternination that your device complies with other requirements of the Act any Federal statutes and regulations administered by other Federal agencies. You must comply with the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807) vilan and (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.
{3}------------------------------------------------
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 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 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,
Nancy C. brogdon
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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Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Model PC-1000 Panoramic / Cephalometric X-ray Systems . (Modification to K882436)
Indications For Use: For diagnostic radiographic use in dental, oral surgery, and orthodontic practices.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Nancy C. Brydon
(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
§ 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.