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510(k) Data Aggregation
(202 days)
, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy Regulation Number: 21 CFR 872.3070
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 |
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(103 days)
|
| Regulation | 21 CFR 872.3070
Amalgam Alloy (NU Alloy DP 40, NU Alloy DP, NU Alloy DP Active and Micronic) Regulation Number: 21 CFR 872.3070
New Stetic NU Alloy DP 40, NU Alloy DP, NU Alloy DP Active and Micronic Dental Amalgam Alloys are commonly used as a filling material for restoring the morphology and function of posterior teeth (cavities class I and II in molars and premolars), when these have lost their structure due to injuries such as cavities or fractures.
New Stetic Dental Amalgam Alloys for dental amalgam used as a filling material for oral cavities. They are made of silver, tin and copper and free of zinc. The products are packaged in different forms: pre-dosed capsules, tablets and powder.
The provided 510(k) summary for K140125 describes the New Stetic Dental Amalgam Alloys and compares them to predicate devices to establish substantial equivalence. The "study" here refers to the performance testing conducted to meet regulatory standards and demonstrate equivalence rather than a clinical trial on human subjects improved with the AI.
Here's an analysis based on the provided document:
Acceptance Criteria and Study Details for K140125: New Stetic Dental Amalgam Alloys
1. Table of Acceptance Criteria and Reported Device Performance:
The device's performance is assessed against the specifications outlined in ISO 24234:2004 for dental amalgam. The tables below compile the acceptance criteria from this ISO standard and the reported performance of the New Stetic Dental Amalgam Alloys (NU ALLOY DP 40, NU ALLOY DP, NU ALLOY DP ACTIVE, and MICRONIC).
Acceptance Criteria and Device Performance (NU ALLOY DP 40)
| Property | Acceptance Criteria (ISO 24234:2004) | Reported Device Performance (NU ALLOY DP 40, Lot N°: 020713B) |
|---|---|---|
| Compressive strength (1h) | 80 MPa min | 87 MPa (12618 PSI) |
| Compressive strength (24h) | 300 MPa min | 364 MPa (52794 PSI) |
| Maximum Creep (%) | 2.0% max | 0.23% |
| Dimensional Change (%) | -0.10 to +0.20 % | -0.05% |
Acceptance Criteria and Device Performance (NU ALLOY DP)
| Property | Acceptance Criteria (ISO 24234:2004) | Reported Device Performance (NU ALLOY DP, Lot N°: 010913) |
|---|---|---|
| Compressive strength (1h) | 80 MPa min | 182 MPa (26397 PSI) |
| Compressive strength (24h) | 300 MPa min | 526 MPa (76290 PSI) |
| Maximum Creep (%) | 2.0% max | 0.30% |
| Dimensional Change (%) | -0.10 to +0.20 % | -0.05% |
Acceptance Criteria and Device Performance (NU ALLOY DP ACTIVE)
| Property | Acceptance Criteria (ISO 24234:2004) | Reported Device Performance (NU ALLOY DP ACTIVE, Lot N°: 010713) |
|---|---|---|
| Compressive strength (1h) | 80 MPa min | 159 MPa (23061 PSI) |
| Compressive strength (24h) | 300 MPa min | 500 MPa (72519 PSI) |
| Maximum Creep (%) | 2.0% max | 0.18% |
| Dimensional Change (%) | -0.10 to +0.20 % | -0.06% |
Acceptance Criteria and Device Performance (MICRONIC)
| Property | Acceptance Criteria (ISO 24234:2004) | Reported Device Performance (MICRONIC, Lot N°: 010913M) |
|---|---|---|
| Compressive strength (1h) | 80 MPa min | 183 MPa (26542 PSI) |
| Compressive strength (24h) | 300 MPa min | 398 MPa (57725 PSI) |
| Maximum Creep (%) | 2.0% max | 0.20% |
| Dimensional Change (%) | -0.10 to +0.20 % | -0.03% |
For all products, the report states: "Although the results are not exactly the same, our tests are carried out according to ISO 24234-2004 and all products are within specifications, which ensure the suitable performance of restoration."
2. Sample Size Used for the Test Set and Data Provenance:
The document refers to "Performance /Non-Clinical Testing" which was "completed in accordance to ISO 24234:2004". The results for each alloy type are provided with "Lot N°", indicating that samples from specific production lots were tested. However, the exact sample size (number of specimens per test) used for each physical property measurement is not explicitly stated in this document. The provenance of the data is from New Stetic S.A., located in Guarne - Antioquia, Colombia, who are the submitters of the 510(k). The testing is retrospective, as it was performed on finished product lots.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This document does not describe the establishment of a "ground truth" by experts in the context of diagnostic interpretation. Instead, the "ground truth" refers to objective physical and chemical properties measured against an international standard (ISO 24234:2004). There is no mention of human experts being involved in establishing the ground truth for these physical and chemical performance tests.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study involving human interpretation or subjective assessment that would require an adjudication method. The performance is based on objective measurements against a standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a submission for a dental material (amalgam alloy), not an AI-assisted diagnostic device. Therefore, a study comparing human reader performance with and without AI assistance is not relevant and was not conducted.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This device is a physical material, not an algorithm or software. Its performance is evaluated through material science testing.
7. Type of Ground Truth Used:
The ground truth used is the objective physical and chemical specifications defined by the international standard ISO 24234:2004. This standard sets the minimum or maximum acceptable values for properties like compressive strength, creep, and dimensional change.
8. Sample Size for the Training Set:
Not applicable. This is a physical dental material, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this device.
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