(10 days)
Precious alloy for use in Crown and Bridge dental restorations.
Apollo is a yellow Crown and Bridge Alloy.
The provided FDA submission for Sterngold's "Apollo" device is an Abbreviated 510(k) and does not contain detailed information about specific acceptance criteria or a study with performance data in the typical sense of a diagnostic or AI-driven device.
Instead, an Abbreviated 510(k) relies on demonstrating conformity with FDA guidance documents and recognized standards. The "study" here is the demonstration of conformity.
Therefore, many of the requested fields will be marked as "Not Applicable" (N/A) or "Not Provided" (NP) as they are not relevant to this type of submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance (as demonstrated) |
|---|---|
| Conformity with FDA guidance document "Guidance Document for the Preparation of Premarket Notifications [510(k) 3] for Dental Alloys)" | Sterngold "has provided information to demonstrate conformity with FDA's guidance document entitled Guidance Document for the Preparation of Premarket Notifications [510(k) 3] for Dental Alloys)." |
| Substantial Equivalence to legally marketed predicate devices (Minigold (k)905326, Suncast (k)923720, Select 40 (k)895069) based on indications for use and technological characteristics. | "Based on the indications for use, technological characteristics, and comparison to predicate devices, Apollo has been shown to be safe and effective for its intended use." (Conclusion statement) FDA determined the device is "substantially equivalent." |
| Safety and Performance for intended use (Precious alloy for use in Crown and Bridge dental restorations). | "Apollo has been shown to be safe and effective for its intended use." (Conclusion statement) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not Applicable (N/A). This submission did not involve a test set of clinical samples or a comparison of performance on data. It's a material and manufacturing process conformity demonstration.
- Data Provenance: Not Applicable (N/A). The "data" here refers to the technical specifications, material properties, and manufacturing processes of the Apollo alloy, and its comparison to the predicate devices and relevant standards. This is likely derived from internal testing, material science data, and possibly historical data on the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not Applicable (N/A). Ground truth as typically understood for diagnostic or AI devices (e.g., disease presence/absence in images) is not relevant here. The "ground truth" for this submission is adherence to material science standards and established safety/efficacy requirements for dental alloys.
- Qualifications of Experts: N/A.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not Applicable (N/A). No test set requiring expert adjudication was used.
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
- MRMC Study: No. This is a dental alloy, not an AI or imaging device with human readers.
- Effect Size: Not Applicable (N/A).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: No. This is a dental alloy, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" implicitly refers to the established scientific and regulatory requirements for dental alloys. This includes:
- Material Science Standards: Conformance to recognized industry standards for composition, physical properties (e.g., strength, corrosion resistance, biocompatibility) for dental alloys. While not explicitly stated, the FDA guidance document referenced likely points to such standards.
- Predicate Device Performance: The safety and effectiveness of the predicate devices are implicitly the "ground truth" against which the new device is compared for substantial equivalence.
8. The sample size for the training set
- Sample Size: Not Applicable (N/A). This device is not developed using a training set in the AI sense. Its development is based on material science, engineering principles, and manufacturing processes.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not Applicable (N/A). No training set as typically understood for machine learning was used.
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Sterngold Special 510(k) Premarket Notification: Abbreviated 510(k)
APR = 4 2002
March 15, 2002 Apollo
510(k) Summary
Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Sterngold is required to submit with this Premarket Notification either an " ... adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." Sterngold chooses to submit a summary of the safety and effectiveness information. The summary is as follows:
| Trade Name: | Apollo |
|---|---|
| Sponsor: | Sterngold23 Frank Mossberg DriveP.O. Box 2967Attleboro, MA 02703-0967Registration #2921595 |
| Device Generic Name: | Dental Alloy |
| Classification: | According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II. |
Predicate Devices:
| Alloy Name | 510(k) | Manufactured By |
|---|---|---|
| Minigold | (k)905326 | Ivoclar North America |
| Suncast | (k)923720 | Jelenko |
| Select 40 | (k)895069 | Leach & Dillon Co. |
Product Description:
Apollo is a yellow Crown and Bridge Alloy.
Indications for Use:
Precious alloy for use in Crown and Bridge dental restorations.
Safety and Performance:
This submission is an Special 510(k): Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Sterngold has provided information to demonstrate conformity with FDA's guidance document entitled Guidance Document for the Preparation of Premarket Notifications [510(k) 3] for Dental Alloys).
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, Apollo has been shown to be safe and effective for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration. 9200 Corporate Boulevard Rockville MD 20850
Ms. Maria Rao Quality Manager Sterngold 23 Frank Mossberg Drive Attleboro, Massachusetts 02703-0967
APR = 4 2002
Re: K020949
Trade/Device Name: Apollo Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: Class II Product Code: EJT Dated: March 15, 2002 Received: March 25, 2002
Dear Ms. Rao:
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 - Ms. Rao
Please be advised that FDA's issuance of a substantial equivalence determination does not r least 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. or the recor any 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 and insting (2) see t 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 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,
Timoth A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Sterngold Special 510(k) Premarket Notification: Abbreviated 510(k)
Page 1 of
510(k) Number (if known):
Device Name: Apollo
Indications for Use:
Precious Alloy for use in Crown and Bridge Dental Restorations.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-the -Counter Use __
OR
(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices 510(k) Number J
§ 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.