Search Results
Found 1 results
510(k) Data Aggregation
(90 days)
System Plus is a vinyl polysiloxane dental impression material. It is ideal for one-step impressions to reproduce the structure of a patient's teeth and gums to produce crowns, bridges, inlays, partial and complete dentures, denture repairs, implants and other dental restorations prescribed by a dentist.
System Plus is an addition-reaction silicone impression material. This vinyl polysiloxane (VPS) impression material comes in two different viscosities intended to help reproduce the structure of a patient's teeth and gums in order to produce, crowns, bridges, implants, and other dental restorations.
The provided text describes the "System Plus Impression Material," a dental impression material. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than a comprehensive clinical study. Therefore, some of the requested information, particularly regarding studies with human participants, AI performance, and expert consensus for ground truth, is not applicable or present in this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria are established by comparing the physical properties of the System Plus Impression Material to a predicate device (Splash! - Discus Dental, Inc.) and relevant ISO standards (ISO 4823). The table below summarizes the key properties and their values for the System Plus material. The "acceptance criteria" are implied by demonstrating comparable performance to the predicate and meeting standard ranges.
| Property | Acceptance Criteria (Implied by Predicate/ISO) | Reported Device Performance (System Plus) |
|---|---|---|
| Consistency, ISO 4823 | Type 0-3 (Splash! range) | Medium Body: Type 2 |
| Light Body: Type 3 | ||
| Strain in Compression % | <5% (Splash! <5%) | 4.7% |
| Shrinkage after 24hr | <0.1% (Splash! <0.1%) | <0.1% |
| Shore A Hardness | Comparable to predicate (Splash! 62-67) | 45 |
| Working Time (Including Mixing) | Comparable to predicate (Splash! 55-65 sec) | 30-60 seconds |
| Time in Mouth | Comparable to predicate (Splash! 1 min 15 sec) | 3 minutes |
| Total Setting Time (Including Mixing) | Comparable to predicate (Splash! 2 min 15 sec) | < 4 minutes |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a test set with a specific sample size in the context of a clinical study with human subjects. The data provenance for the physical properties (e.g., Strain in Compression, Shrinkage, Shore A Hardness) is based on laboratory testing of the material itself, not human subjects. The origin of this data is from Continental Dental Laboratory's internal testing as part of their 510(k) submission. This is not a retrospective or prospective study in the typical clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as there is no mention of a test set that required expert ground truth in the context of human outcomes or diagnoses. The "ground truth" for the material's physical properties is established through standardized laboratory testing methods.
4. Adjudication Method for the Test Set:
This information is not applicable as there is no mention of a test set that required adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not conducted. This type of study typically involves multiple human readers evaluating medical images or patient cases, often comparing performance with and without an AI assist. The System Plus Impression Material is a physical dental material, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
A standalone study, as defined for an algorithm without human involvement, was not conducted. The "performance" assessment for this device is based on its physical properties.
7. Type of Ground Truth Used:
The "ground truth" for the device's performance is based on standardized laboratory measurements and physical property testing (e.g., ISO 4823 for consistency). This is not expert consensus, pathology, or outcomes data in the clinical sense.
8. Sample Size for the Training Set:
This information is not applicable. The System Plus Impression Material is a physical product and does not involve an "algorithm" or a "training set" in the context of machine learning or AI. The product's formulation and manufacturing processes are developed through R&D, not trained on data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable. As stated above, there is no training set for an algorithm. The "truth" for the material's characteristics is based on established scientific principles and material science testing.
Ask a specific question about this device
Page 1 of 1