(56 days)
AP-052-5 is a high-noble, gold based alloy suitable for use with the porcelainfused-to-metal technique of fabricating dental restorations. The mechanical and rated to moter veemmake AP-052-5 suitable for use as a substrate for single unit restorations in the anterior region (Bicuspids, cuspids, and incisors)
AP-052-5 is a high-noble, gold based alloy suitable for use with the porcelain-fusedto-metal technique of fabricating dental restorations.
The provided text describes a 510(k) submission for a dental alloy, AP-052-5. The submission focuses on demonstrating substantial equivalence to a predicate device (Helioform - K990670) based on mechanical, physical, and biocompatibility properties.
Unfortunately, the text does not contain any information about acceptance criteria or a study proving that a device (in the sense of a medical imaging or diagnostic AI device) meets those criteria.
Instead, the document is concerned with the regulatory clearance of a material (a dental alloy). Therefore, most of the requested points are not applicable to the provided context.
Here's a breakdown of why and what information is available:
- No "device performance" in the AI/diagnostic sense is reported. The "performance" described is the material properties of the alloy.
- No "study" in the sense of a clinical or image-based diagnostic study is mentioned. The "data" presented focuses on mechanical, physical, and biocompatibility properties.
- No ground truth, experts, adjudication, MRMC, or standalone performance studies are relevant or discussed. These concepts are specific to diagnostic or AI device evaluations.
Based on the provided text, the dental alloy AP-052-5:
-
Acceptance Criteria for Approval (Implicit, inferred from the text):
- Mechanical properties demonstrating suitability for porcelain-fused-to-metal technique.
- Physical properties demonstrating suitability for porcelain-fused-to-metal technique.
- Biocompatibility according to International Standard ISO 10993-1.
- Substantial equivalence to the predicate device (Helioform - K990670) for these properties.
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How the "Device" (Alloy) Meets Criteria:
- "Data has been presented to demonstrate that the mechanical and physical properties of AP-052-5 make it substantially equivalent to the predicate device listed, and therefore it is suitible for use as a substrate for single unit restorations in the anterior region."
- "Biocompatibility of AP-052-5 has been assesed according to International Standard ISO 10993-1."
- "The safety and effectiveness of AP-052-5 is therefore determined to be equivalent to the predicate device."
Summary of Requested Information vs. Available Information:
| Section of Request | Information from Text (AP-052-5 Dental Alloy) |
|---|---|
| 1. A table of acceptance criteria and the reported device performance | Acceptance Criteria (Implicit from 510(k) process): Substantial equivalence to predicate device in mechanical, physical, and biocompatibility properties for use in porcelain-fused-to-metal dental restorations.Reported Performance: "Data has been presented to demonstrate that the mechanical and physical properties of AP-052-5 make it substantially equivalent to the predicate device listed," and "Biocompatibility of AP-052-5 has been assesed according to International Standard ISO 10993-1." |
| 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 pertains to clinical studies for performance evaluation, not material characterization. The text does not provide details on sample sizes for mechanical, physical, or biocompatibility testing, nor their provenance. |
| 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts | Not applicable. No ground truth in the sense of clinical diagnosis is established. Performance is based on material properties testing. |
| 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set | Not applicable. This pertains to expert review for clinical ground truth. |
| 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 a material (dental alloy) submission, not an AI or diagnostic imaging device. No human readers or AI assistance are involved. |
| 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done | Not applicable. This is a material (dental alloy) submission, not an AI or diagnostic imaging device. |
| 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc) | Not applicable in the clinical sense. Ground truth for a material is typically established by standardized laboratory testing (e.g., tensile strength, hardness, cytotoxicity tests) that yield measurable values, which are then compared to established standards or predicate device properties. The text mentions ISO 10993-1 for biocompatibility. |
| 8. The sample size for the training set | Not applicable. There is no "training set" as this is not an AI or machine learning device. |
| 9. How the ground truth for the training set was established | Not applicable. There is no "training set" as this is not an AI or machine learning device. |
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Section E
510(k) SUMMARY
| Submitted by: | Jensen Industries50 Stillman RoadNorth Haven CT 06473(203) 239-2090 phone(203) 239-1015 faxContact: John Slanski |
|---|---|
| Date Prepared: | July 18, 2003 |
| Device Name:Common Name:Classification:Product Code: | R&D designation AP-052-5Dental alloy, precious metal for porcelain-fused-to-metalClass IIEJT |
| Predicate Device(s): | Helioform - K990670 |
Device Description:
AP-052-5 is a high-noble, gold based alloy suitable for use with the porcelain-fusedto-metal technique of fabricating dental restorations. .
Data has been presented to demonstrate that the mechanical and physical properties of AP-052-5 make it substantially equivalent to the predicate device listed, and therefore it is suitible for use as a substrate for single unit restorations in the anterior region.
Biocompatability of AP-052-5 has been assesed according to International Standard ISO 10993-1.
The safety and effectiveness of AP-052-5 is therefore determined to be equivalent to the predicate device.
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Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
SEP 1 7 2003
Mr. John Slanski Manager, Research & Development Jensen Industries. Incorporated 50 Stillman Road North Haven, Connecticut 06473
Re: K032267
Trade/Device Name: R&D Designation AP-052-5 Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical use Regulatory Class: II Product Code: EJT Dated: July 21, 2003 Received: August 5; 2003
Dear Mr. Slanski:
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 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.
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Page 2 - Mr. Slanski
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); 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.
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 (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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,
Susan Runne
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Ver/ 3 - 4/24/96 Jensen Industries Incorporated Applicant: 510(k) Number (if known): Device Name: R&D designation AP-052-5 Indications For Use: AP-052-5 is a high-noble, gold based alloy suitable for use with the porcelainfused-to-metal technique of fabricating dental restorations. The mechanical and rated to moter veemmake AP-052-5 suitable for use as a substrate for single unit restorations in the anterior region (Bicuspids, cuspids, and incisors) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sian-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental De 510(k) 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.