(71 days)
Portadur P 2 is a gold casting alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Inlays/ Onlays . - Crowns . - Short span bridges . - Long span bridges . - Removable partials . and can be used for - Telescopic and milling work .
Portadur P 2 is an extra-hard gold casting alloy with high contents of noble metals (75.1%), intended for dental technicians to fabricate dental restorations. lt has an indication which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics and to removable partials. In addition, it is suitable for telescopic and milling work. Portadur P 2 is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
The provided 510(k) summary for the Portadur P 2 device does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI/medical device performance evaluation. The summary is for a dental casting alloy and focuses on its material properties, biocompatibility, and intended use as a medical device, rather than an AI or image-based diagnostic tool.
Therefore, many of the requested categories in your prompt are not applicable to the provided document. I can, however, extract relevant information about the device itself from the text.
Here's an analysis based on the provided text, indicating where information is present or absent for your specific questions:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the 510(k) summary. The document states that the device "fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." However, it does not specify the numerical acceptance criteria for various physical or chemical properties defined by ISO 1562, nor does it present a table of the device's performance against such criteria. It generally describes the device as being "extra-hard" and "highly corrosion resistant."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not an AI/diagnostic device, and no test set in that context is discussed.
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)
Not applicable. This is not an AI/diagnostic device, and no ground truth establishment by experts is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a dental alloy would relate to its physical and chemical properties as measured by standardized tests, not diagnostic accuracy. The text refers to compliance with ISO 1562.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device Information from the Provided Text:
- Trade Name: Portadur P 2
- Manufacturer: Wieland Edelmetalle GmbH & Co. (Germany)
- Device Type: Extra-hard gold casting alloy
- Composition: High noble metal content (75.1%)
- Intended Use: For dental technicians to fabricate dental restorations.
- Specific Indications: Inlays/Onlays, Crowns, Short span bridges, Long span bridges, Removable partials, Telescopic and milling work.
- Key Properties: Highly corrosion resistant, excellent biocompatibility.
- Standards Met: ISO 1562, European directive 93/42/ECC concerning medical devices.
- Predicate Device: Aurofluid 3 (K911539)
- Regulatory Class: II (under 21 CFR 872.3060, Alloy, Gold Based, For Clinical Use)
The document is a 510(k) summary demonstrating substantial equivalence to a predicate device, which primarily involves comparing material specifications, intended use, and general performance claims (like biocompatibility and corrosion resistance) to established standards and the predicate device. It does not involve a clinical study or performance evaluation as would be typical for an AI-based diagnostic device.
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NOV 0 2 2001
Premarket Notification 510(k)
Portadur P 2
5. 510 (k) Summary
Wieland Edelmetalle GmbH & Co. Submitter of 510(k): Schwenninger Str. 13 D-75179 Pforzheim Germany Phone: +49-7231-3705-0
2001-07-21
Contact person: Phone: Fax: : e-mail:
Dr. Gerhard Polzer +49-7231-3705-219 +49-7231-357959 gerhard.polzer@wieland-dental.de
Date of Summary:
Portadur P 2 Trade name:
Classification name: Product code: C.D.R section: Classification:
Alloy, gold based, for clinical use EJT 872.3060 Class II
Legally marketed Aurofluid 3 equivalent device:
K911539 510(k) number:
Device description
Portadur P 2 is an extra-hard gold casting alloy with high contents of noble metals (75.1%), intended for dental technicians to fabricate dental restorations.
lt has an indication which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics and to removable partials. In addition, it is suitable for telescopic and milling work.
Portadur P 2 is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
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Image /page/1/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is a stylized symbol that resembles an abstract representation of a human form or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 02 2001
Dr. Gerhard Polzer Director of Regulatory Affairs Wieland Edelmetalle GmbH & Company Schwenninger Strabe 13 D-75179 Pforzheim, GERMANY
Re: K012843
Trade/Device Name: Portadur P 2, Model #2031 Regulation Number: 872.3060 Regulation Name:Alloy, Gold Based, For Clinical Use Regulatory Class: II Product Code: EJT Dated: October 18, 2001 Received: October 22, 2001
Dear Dr. Polzer:
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 such additional controls. Existing major regulations affecting vour 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
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Page 2 - Dr. Polzer
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 as electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 11th lection will and w Jean 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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NOV 0222001
Premarket Notification 510(k)
Portadur P 2
4. Statement of indication for use
Portadur P 2 is a gold casting alloy that can be used by dental technicians to fabricate dental appliances for patients.
It is intended for manufacturing
- Inlays/ Onlays .
- Crowns .
- Short span bridges .
- Long span bridges .
- Removable partials .
and can be used for
- Telescopic and milling work .
Susan Runns
Chrision Sign-Off) Sien of Dental, Infection Control, · Ceneral Hospital D ் (வ Number _
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.