(94 days)
- Impression material in a dual phase impression technique
- Precise duplication of models
- Capturing multiple unit impressions
i-Sil is impression material. It has 5 types: Heavy, Medium, Light, Putty and Bite.
The i-Sil dental impression material has been determined to be substantially equivalent to the predicate device K152766 (Dentkist, Inc.'s CharmFlex products) based on performance data gathered through bench testing, outlined in the 510(k) Summary.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents performance data for the i-Sil device and compares it to the predicate device across various types (Heavy body, Medium body, Light body, Putty, Bite). The acceptance criteria are implicitly defined by the properties and values reported for both the subject and predicate devices, largely referencing ISO 4823 standards for elastomeric impression materials where applicable.
Heavy Body, Medium Body, Light Body Types:
| Test Item | Standard/Predicate Performance (Acceptance Criteria) | i-Sil Performance (Reported Device Performance) |
|---|---|---|
| Appearance | ISO 4823 Dentistry-Elastomeric impression materials | (implicitly meets standard) |
| Weight | ISO 4823 Dentistry-Elastomeric impression materials | (implicitly meets standard) |
| Component | ISO 4823 Dentistry-Elastomeric impression materials | (implicitly meets standard) |
| Working time (Predicate) | 1'30" (cartridge), 2' (tube), 2'~2'30" (others) | Heavy: 1'36", Medium: 1'59", Light: 1'21" |
| Minimum strength | ISO 4823 Dentistry-Elastomeric impression materials | (implicitly meets standard) |
| Hardness | ISO 4823 Dentistry-Elastomeric impression materials | (implicitly meets standard) |
| Linear dimensional change (Predicate) | -0.063 % (for Heavy/Medium/Light) | Heavy: 0.18 %, Medium: 0.20 %, Light: 0.15 % |
| Consistency (Predicate) | 34.25 mm | Heavy: 33.83 mm, Medium: 34.83 mm, Light: 45.33 mm |
| Detail reproduction (Predicate) | 20 µm | Heavy: Pass, Medium: Pass, Light: Pass |
| Compatibility with gypsum (Predicate) | 20 µm | Heavy: Pass, Medium: Pass, Light: Pass |
| Elastic recovery (Predicate) | 99.67 % | Heavy: 99.64 %, Medium: 99.6 %, Light: 99.58 % |
| Strain-in-compression (Predicate) | 4.12 % | Heavy: 2.34 %, Medium: 3.29 %, Light: 4.94 % |
| Mixing time (Predicate) | 2'~4' | Heavy: 22.6", Medium: 38", Light: 26.8" |
| Flow properties (Predicate) | Low viscosity | Low viscosity |
| Keeping qualities (Predicate) | Cool and dry place (18 | Cool and dry place (18 |
Putty Type:
| Test Item | Standard/Predicate Performance (Acceptance Criteria) | i-Sil Performance (Reported Device Performance) |
|---|---|---|
| Mixing time (Predicate) | 30"~40" | 41" |
| Consistency (Predicate) | 25.83 mm | 31.75 mm |
| Detail reproduction (Predicate) | Pass | Pass |
| Linear dimensional change (Predicate) | -0.213 % | 0.35 % |
| Compatibility with gypsum (Predicate) | Pass | Pass |
| Elastic recovery (Predicate) | 99.75 % | 99.01 % |
| Strain-in-compression (Predicate) | 3.28 % | 3.26 % |
| Flow properties (Predicate) | High viscosity | High viscosity |
| Keeping qualities (Predicate) | Cool and dry place (18 | Cool and dry place (18 |
Bite Type:
| Test Item | Standard/Predicate Performance (Acceptance Criteria) | i-Sil Performance (Reported Device Performance) |
|---|---|---|
| Working time (Predicate) | 15" ↑ | 30" ↑ |
| Flexural strength (Predicate) | Pass | Pass |
| Hardness (Predicate) | Pass | 87.4 HD |
| Linear dimensional change (Predicate) | Pass | 0.064 % |
| Safety (Predicate) | Safe | Safe |
| Keeping qualities (Predicate) | Cool and dry place (18 | Cool and dry place (18 |
| Curve of the shrinkage (Predicate) | Brittle feature | Brittle feature |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "Bench test" data. It does not explicitly state the sample sizes used for each test. The data provenance is not explicitly mentioned as retrospective or prospective, but bench tests are typically conducted in a controlled laboratory environment. The company, SPIDENT Co.,Ltd., is located in Incheon, Korea, suggesting the bench testing may have been conducted there.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This is a materials science bench test, not a clinical study involving human assessment of images or diagnoses. Therefore, there are no "experts" in the sense of clinicians establishing ground truth. The "ground truth" for these tests is based on the adherence to objective physical and chemical properties as defined by the ISO 4823 standard and comparison to the predicate device's reported characteristics.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No. This is a bench test for a dental impression material, not a diagnostic imaging device that would involve MRMC studies or human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
No. This terminology applies to AI/software as a medical device (SaMD), not to a physical impression material.
7. The Type of Ground Truth Used:
The ground truth used for these bench tests is derived from:
- ISO 4823 Dentistry-Elastomeric impression materials standard: This standard defines the methodologies and acceptable ranges for various physical and chemical properties of impression materials.
- Predicate device performance data: The reported performance characteristics of the legally marketed predicate device (K152766, CharmFlex products) serve as a comparative benchmark to demonstrate substantial equivalence.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical impression material, not an artificial intelligence or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).