(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.
§ 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.