(104 days)
HySil Heavy Super Fast 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 Super Fast 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 Light Super Fast is to be used as syringeable impression materials for:
- Two-step putty-wash impression technique
- One-step putty-wash impression technique
- Two-step impression technique using dual viscosities
- Reline impressions
- Fabricating full or partial dentures
HySil Super Fast Impression Materials are addition-curing, elastomeric materials with hydrophilic property. They 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 Super Fast Impression Materials meet ISO 4823 standard and consist of three different viscosities (heavy-bodied, medium-bodied, and light-bodied) in delivery system as standard 1:1 50 ml cartridges.
This document is a 510(k) Pre-Market Notification from Osstem Implant Co., Ltd. for their HySil Super Fast Impression Materials. The purpose of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (HySil Impression Materials, K170736).
Based on the provided text, the device is HySil Super Fast Impression Materials (Heavy, Mono, Light viscoisties).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the proposed devices meet the ISO 4823 standard. This standard dictates various mechanical and physical properties for elastomeric impression materials. The "Acceptance Criteria" are implied by adherence to this standard and the predicate device's performance.
| Acceptance Criteria (Implied by ISO 4823 and Substantial Equivalence Goal) | Reported Device Performance (HySil Super Fast Impression Materials) |
|---|---|
| Compliance with ISO 4823 Standard for Impression Materials | The proposed devices meet ISO 4823 standard |
| Biocompatibility (following ISO 10993-1) | Passed biocompatibility requirements |
| Shelf-life of 2 years | Determined shelf-life is 2 years |
| Mechanical Properties equivalent to predicate device | Found to be substantially equivalent to predicate devices from bench test results |
| Working Time over 1 min 15 sec. | Over 1 min. 15 sec. |
| Composition: Vinylpolysiloxane | Vinylpolysiloxane |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the test set used in the non-clinical performance evaluations (biocompatibility, shelf-life, mechanical properties).
The data provenance is not explicitly stated as "country of origin." However, the submitter, Osstem Implant Co., Ltd., is based in Busan, Republic of Korea. The studies are non-clinical, meaning they are laboratory or bench tests, not clinical trials on human subjects. Therefore, the data is retrospective in the sense that it's generated from lab tests, not from ongoing patient recruitment.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the studies described are non-clinical (bench tests) focusing on material properties rather than diagnostic performance or human interpretation. Therefore, there's no "ground truth" to be established by experts in the context of interpretation, nor are there experts evaluating the test results in a human-in-the-loop scenario. The ISO standards themselves define the "ground truth" for material properties.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (like 2+1, 3+1) is typically associated with clinical studies where multiple human readers interpret data, and their disagreements need to be resolved to establish ground truth.
Since the studies described are non-clinical bench tests (biocompatibility, shelf-life, mechanical properties against ISO standards), an adjudication method is not applicable. The outcome of these tests is usually objective measurement against predefined criteria in the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies are submitted."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is an impression material, not an algorithm or AI software. Therefore, the concept of a "standalone" or "algorithm only" performance study is not applicable.
7. The Type of Ground Truth Used
The ground truth for the non-clinical performance tests is based on established international standards:
- ISO 4823: For various mechanical and physical properties of elastomeric impression materials.
- ISO 10993-1: For biocompatibility evaluation.
- ISO 3417: Likely related to some aspect of impression material testing, though not explicitly detailed.
- "FDA Guidance Document Use of International Standard ISO 10993-1" and "FDA Guidance Document Shelf Life of Medical Device."
These standards define the objective criteria and methodologies for assessing the material's properties.
8. The Sample Size for the Training Set
This document describes a non-clinical evaluation for substantial equivalence of an impression material. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of device, this point is not applicable.
§ 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).