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Chemi-SiL (HB, MB, LB, LBS) - Crown and bridge impression, inlay and onlay impressions

Chemi-SiL Bite-Blu - Impression of the occlusal surface

Chemi-SiL of silicone impression materials are hydrophilic impression materials based on polyvinylsiloxane and it is used for impression of teeth or gingiva. It consists of three different consistencies (heavy body, light body, bite registration material) according to ISO 4823. And it is supplied base and catalyst in contrasting color. Each product is consisted of 1:1 base and catalyst component, packaged in two 50 mL catridges.

This document is a 510(k) Premarket Notification from B&E Korea Co., Ltd. for their dental impression materials, Chemi-SiL (HB, MB, LB, LBS) and Chemi-SiL Bite-Blu. The key focus of this notification is to demonstrate substantial equivalence to previously cleared predicate devices.

Acceptance Criteria and Device Performance:

The primary method for demonstrating acceptance criteria and performance is through non-clinical testing based on recognized international standards, specifically ISO 4823 for impression materials and ISO 10993 for biocompatibility. The acceptance criteria are the performance requirements specified by these standards and the reported values of the predicate devices. The device performance is the measured performance of the Chemi-SiL products.

Here's a table summarizing the acceptance criteria (defined by ISO standards and predicate device performance) and the reported device performance for Chemi-SiL. Note that the document compares the subject devices to two different predicate devices based on their specific uses.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes non-clinical testing based on referenced standards (ISO 4823, ISO 7405, ISO 10993). This implies laboratory-based, controlled experiments rather than a "test set" of patient data in the typical sense of AI/ML models.

• Sample Size: The specific sample sizes for each physical property test are not explicitly stated (e.g., number of specimens tested for consistency). However, compliance with ISO standards usually implicitly requires a minimum number of samples for statistically valid results.
• Data Provenance: The data is generated from prospective laboratory testing of the new device (Chemi-SiL HB, MB, LB, LBS, and Bite-Blu) and compared against reference properties of the predicate devices and the requirements of international standards. The country of origin for the testing itself is not explicitly stated, but the manufacturer is B&E KOREA Co., Ltd. (SOUTH KOREA). The data is not retrospective patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This type of testing (ISO standard compliance for physical and biocompatibility properties of impression materials) does not involve experts establishing "ground truth" through interpretation of cases like in medical imaging AI. The "ground truth" or "reference" is derived from:

• The defined physical property metrics and their acceptable ranges as specified in ISO 4823 (e.g., consistency in mm, strain in compression as a percentage).
• The biocompatibility criteria defined by ISO 10993 (e.g., absence of cytotoxicity).
• The performance characteristics of the legally marketed predicate devices, which are assumed to meet regulatory and performance requirements.

Therefore, the concept of qualified experts adjudicating a test set is not applicable here.

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

As explained above, this concerns material properties and biocompatibility, not diagnostic or clinical interpretation. Therefore, no adjudication method (like 2+1 or 3+1) was used for establishing ground truth for a test set. The results are obtained directly from standardized laboratory measurements.

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:

No MRMC comparative effectiveness study was done or is relevant here. This document is for a dental impression material, not an AI or imaging diagnostic device. The study proves the physical and biological characteristics of the material, not the performance of human readers assisted by AI.

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

Not applicable. This is not an algorithm or AI device. The "standalone" performance here refers to the intrinsic physical and chemical properties of the material itself.

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

The "ground truth" for this device's performance is established by:

• International standards (ISO 4823, ISO 10993, DIN 13903): These standards define the acceptable range or threshold for various physical, chemical, and biological properties.
• Performance data of legally marketed predicate devices: The tested characteristics are compared directly to those of the predicate devices, which are deemed safe and effective.

This is a bench testing/laboratory data type of ground truth, not one derived from clinical outcomes, pathology, or expert consensus on patient cases.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a "training set." The materials are developed and characterized through traditional chemical and material science processes, not machine learning.

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

Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

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