Search Results
Found 1 results
510(k) Data Aggregation
(202 days)
Filling material as a treatment for dental caries
The subject devices are a mixture (alloy) of silver and several other metals, used by dentists to make fillings for tooth cavities. Amalgam alloys have been the most commonly used direct restorative filling material for over a 100 years.
The provided text describes a 510(k) summary for several dental amalgam devices, asserting their substantial equivalence to a predicate device. This submission focuses on comparing the physical and chemical properties of the devices to establish this equivalence, rather than on the performance of an AI-powered diagnostic device.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, ground truth for training set) are not applicable to this document as it does not describe a study involving an AI-powered diagnostic device that requires such metrics for validation.
Here's the information that can be extracted relevant to acceptance criteria and performance:
1. A table of acceptance criteria and the reported device performance:
| Product Characteristic | Acceptance Criteria (from ISO 24234) | Subject Devices Performance (Reported as complying) | Predicate Device Performance | Difference & Remarks |
|---|---|---|---|---|
| Chemical Composition | ||||
| Silver (Ag) (CAS 7440-22-4) | ≥ 40% | a) 44.5%; b) 70% | 56% | Compositions meet the requirements of ISO 24234. |
| Tin (Sn) (CAS 7440-31-5) | ≤ 32% | a) 30%; b) 18% | 27.9% | Compositions meet the requirements of ISO 24234. |
| Copper (Cu) (CAS 7440-50-8) | ≤ 30% | a) 25.5%; b) 12% | 15.4% | Compositions meet the requirements of ISO 24234. |
| Zinc (Zn) | ≤ 2% | Not explicitly stated, but implied to meet criteria | 0.2% | Compositions meet the requirements of ISO 24234. |
| Alloy-mercury Ratio | Not explicitly stated as a single criterion, but values provided | 1:1 (Mercury 50%) | Varies between 1/0.86 and 1/0.96 (46.2% to 49.5% by weight mercury) | Compositions meet the requirements of ISO 24234. |
| Physical Properties | ||||
| Particle shape & size | Not specified by a standard | Admix - spherical and lathe cut 15 μm - 35 μm | Admix - spherical and lathe cut 15 μm - 35 μm | This parameter is not specified by a technical standard; depends on product characteristics. Amalgams made from lathe-cut powders or admixed powders tend to resist condensation better. |
| Compressive strength @ 1hr | > 100 MPa | 171 MPa | 260 MPa | Data received is similar and products tested per ISO 24234. All results are within specifications and provide good performance of restoration. |
| Compressive strength @ 24hr | > 350 MPa | 443 MPa | 500 MPa | Data received is similar and products tested per ISO 24234. All results are within specifications and provide good performance of restoration. |
| Working times (minutes) - Condense | Not explicitly a criterion | 2.5 - 5 | 2.5 - 5 | No significant difference. |
| Working times (minutes) - Carving | Not explicitly a criterion | 4.5 - 7 | 5.5 - 7 | No significant difference. |
| Corrosion products (μg/cm²) | Not explicitly a criterion | 2 | 2.5 | No significant difference. |
| Ions leached and mercury vapor released during corrosion (ng/cm² in 4 hrs) | Not explicitly a criterion | < 65 | < 65 | No significant difference. |
| Creep | Max. 2% | 0.5% | 0.2% | All values are well within the maximum 2% criterion. |
| Dimensional change | -0.10 to +0.15 | 0.1 | -0.04% | All values are within the specified range. |
| Trituration time (seconds) High speed Amalgamator for capsule form | Not explicitly a criterion | 4-8 | 6 - 8 | Trituration time depends on spill size, variations in amalgamator. Does not affect safety and effectiveness. |
| Presentation forms | Not explicitly a criterion | Capsules: 1, 2 and 3 spill | Capsules: 1, 2, 3 & 5 spill | Difference in available spill sizes, but does not impact safety or effectiveness of the material itself. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in terms of distinct numerical values (e.g., number of amalgam samples tested for each property). The testing was completed in accordance with ISO 24234, which would specify sample size requirements for each test.
- Data Provenance: Not explicitly stated. The submitter is World Work Srl from Italy, so the testing was likely conducted in Europe or by contractors for the Italian company. The document does not indicate if it was retrospective or prospective.
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 a material science characterization, not a diagnostic study requiring expert ground truth establishment in the clinical sense. The "ground truth" here is the adherence to established international standards (ISO 24234) and their specified test methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. The evaluation is based on compliance with a standard (ISO 24234), not on human interpretation or adjudication of diagnostic findings.
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-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI-powered diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the device's performance is adherence to the physical and chemical property specifications set forth by ISO 24234. This standard provides the benchmark against which the device's characteristics are measured.
8. The sample size for the training set
- Not applicable. This is not an AI-powered device that undergoes a training phase.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI-powered device that undergoes a training phase.
Study Description (Summary of the "study" conducted):
The "study" conducted for these dental amalgam devices was non-clinical performance testing according to ISO 24234. The purpose was to demonstrate that the physical and mechanical properties of the subject devices meet the requirements of this international standard.
The tests carried out included:
- Package & Capsule contamination
- Chemical composition and purity of the dental amalgam alloy
- Large particles in the dental amalgam alloy powder
- Loss of mass from the capsule during mixing
- Yield of amalgam from the capsule
- Consistency of the dental amalgam from capsule to capsule
- Physical properties (Creep, dimensional change, compressive strength, corrosion)
Based on the data from these tests, the manufacturer concluded that the subject devices are substantially equivalent to the predicate device (Permite Dental Amalgam Alloy K801639) by demonstrating compliance with the ISO 24234 standard.
Ask a specific question about this device
Page 1 of 1