(126 days)
HySil Heavy is to be used as heavy-bodied materials for:
- One-step impression technique (simultaneous technique) using single or dual viscosities
- Two-step impression technique using dual viscosities
- Functional impressions
HySil Mono is to be used as a medium-bodied tray or syringeable impression material for:
- Taking impressions over fixed/removable restorations and implants (i.e., transferring impression posts and bridge components)
- Functional impressions
- Fabricating crown and bridgework or inlays
- Fabricating full or partial dentures
- Reline impressions
- Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques
- Transferring root posts when fabricating posts and cores indirectly
HySil Bite is used for impression as below.
- Taking occlusal surfaces
- Confirming occlusal surfaces
- Recording after putting the articulator
HySil Impression materials are intended to be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums.
HySil Heavy and HySil Mono are addition-curing, elastomeric materials with hydrophilic property, high tear strength, dimensional accuracy, and a high resistance to permanent deformation. HySil Heavy and HySil Mono are available in an assortment of delivery systems of traditional 1:1 50 ml automix cartridge (predicated, K170736) and 5:1 380 ml automix cartridge version for use in most automatic dispensing and mixing system. HySil Heavy and HySil Mono are classified into Type 1 and Type 2 according to ISO 4823 each.
HySil Bite is an addition-curing silicone bite registration materials in a 50 ml cartridge type to measure accurate bite. HySil Bite is suitable for bite registration as it has a short setting time, high final hardness after curing for user convenience, and less elastic deformation when eliminated. HySil Bite is classified into jaw relation recording material according to DIN 13903.
The provided documents are a 510(k) Premarket Notification for a dental impression material named HySil Impression Materals (Heavy, Mono, and Bite). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study in the way an AI/ML device would.
Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, and how training ground truth was established) are not applicable to this submission.
However, I can still extract the acceptance criteria as described in the benchmark standards and the reported performance (which is that it passed these criteria).
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Standard | Reported Device Performance |
|---|---|---|
| HySil Heavy & Mono | ||
| Visual | ISO 4823 | Passed requirements |
| Weight | ISO 4823 | Passed requirements |
| Package | ISO 4823 | Passed requirements |
| Component Color | ISO 4823 | Passed requirements |
| Consistency | ISO 4823 | Passed requirements |
| Detail Reproduction | ISO 4823 | Passed requirements |
| Compatibility with Gypsum | ISO 4823 | Passed requirements |
| Linear Dimensional Change | ISO 4823 | Passed requirements |
| Elastic Recovery | ISO 4823 | Passed requirements |
| Strain-in-Compression | ISO 4823 | Passed requirements |
| Working Time | ISO 4823 | Passed requirements |
| HySil Bite | ||
| Working Time (Longer than 15s) | DIN 13903 | Passed requirements (≥ 30 seconds) |
| Physical Tests | DIN 13903 | Passed criteria |
| Biocompatibility | ||
| Cytotoxicity | ISO 10993-5 | Assured biological safety |
| Skin Sensitization | ISO 10993-10 | Assured biological safety |
| Oral Mucosa Irritation | ISO 10993-10 | Assured biological safety |
| Acute Systemic Injection | ISO 10993-11 | Assured biological safety |
| Shelf Life | Real-time shelf-life tests | 2 years (HySil Heavy/Mono), 3 years (HySil Bite) |
2. Sample size used for the test set and the data provenance
This is a material science and biocompatibility study, not a clinical trial or AI/ML study. Sample sizes for the bench tests are generally defined by the relevant ISO/DIN standards, but specific numbers are not provided in this summary. Data provenance is implied to be from laboratory testing conducted by the manufacturer (OSSTEM IMPLANT Co., Ltd.) for the purpose of this submission. The tests are retrospective as they were conducted prior to the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for material properties testing is based on objective measurements and adherence to international standards (ISO and DIN), not expert consensus in the diagnostic sense. Biocompatibility results are interpreted by qualified toxicologists/biologists according to ISO standards.
4. Adjudication method for the test set
Not applicable. Test results are based on objective measurement against predefined standard criteria, not human adjudication.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The ground truth for the performance claims (mechanical properties, biocompatibility, shelf life) is based on:
* Objective Measurements: Laboratory measurements of physical and chemical properties of the material.
* International Standards: Adherence to the requirements specified in ISO 4823 (for HySil Heavy and Mono) and DIN 13903 (for HySil Bite).
* Biocompatibility Standards: Compliance with ISO 10993-5, 10993-10, and 10993-11.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML 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).