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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

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.

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HySil Putty is to be used as preliminary materials for:

• Two-step Putty-wash impression technique .
• · One-step Putty-wash impression technique

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 Light 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 Extra Light 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 Bite is used for impression as below.

• Taking occlusal surfaces
• Confirming occlusal surfaces
• · Recording after putting the articulator

HySil Impression Materials are addition-curing, elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The HySil impression materials family consists of six different viscosities (putty, heavy, mono, light. Extra-light and Bite) available in an assortment of delivery systems: standard 1:1 50 ml automix cartridges, and traditional 1:1 putty jars.
Putty, Heavy, Mono, Light and Extra-light of this proposed devices are classified into Type 0, Type 1, Type 2, and Type 3 according to ISO 4823, and Bite is classified as Dentistry - Jaw relation recording material according to DIN 13903 HySil Bite is an addition-curing silicone bite registration materials in a 50ml 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.

This is a 510(k) premarket notification for a dental impression material, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (e.g., sample sizes for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance) are not applicable.

The submission focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance testing and biocompatibility.

Here's the information that can be extracted from the provided text, aligning with the categories where applicable for a non-AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance

For HySil Extra Light and HySil Putty (ISO 4823 and ISO 10993 family):

For HySil Bite (DIN 13903 and ISO 10993 family):

2. Sample size used for the test set and the data provenance:

• The document implies that testing was performed on the HySil Impression Materials as the "subject device" against predicate devices.
• The exact sample sizes for each specific test (e.g., how many specimens were tested for linear dimensional change) are not explicitly stated in the provided text.
• Data Provenance: The manufacturer is Osstem Implant Co., Ltd., located in Busan, Republic of Korea. The testing was conducted as part of their 510(k) submission, suggesting it was internal testing by the manufacturer or a contracted lab. The data would be considered prospective as it was generated to support this specific regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• This question is not applicable as the submission is for a material, not an AI/ML device that generates diagnoses or interpretations requiring expert ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• This question is not applicable as this is not an AI/ML device involving human interpretation requiring 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:

• This question is not applicable as this is not an AI/ML device. No MRMC study was performed.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

• This question is not applicable as this is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the physical and mechanical properties, the "ground truth" or acceptance criteria are based on recognized international standards:
  • ISO 4823 for general impression materials.
  • DIN 13903 for jaw relation recording materials (HySil Bite).
• For biocompatibility, the "ground truth" is based on ISO 10993 family standards (e.g., ISO 10993-5 for cytotoxicity, ISO 10993-10 for sensitization and irritation).
• The device performance is compared directly to the specified requirements within these standards and the reported performance of legally marketed predicate devices.

8. The sample size for the training set:

• This question is not applicable as this is not an AI/ML device. No training set was used.

9. How the ground truth for the training set was established:

• This question is not applicable as this is not an AI/ML device. No training set was used.

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