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Adhesive cementation of:

• Crown & Bridges (Ceramic, Composite, Porcelain, Metal)
• Inlay / Onlay cementation
• Bonding for porcelain veneers
• Endodontic posts cementation
• Core build up

Metacem is a high strength, permanent visible light cured (VLC), dual cured or self-cured resin cement for use with dentin/enamel adhesive prime and bone systems, to adhesively bond and lute indirect restorations to tooth structure. Metacem consists of a methacrylate base paste and catalyst paste which in use are instantly mixed from a dual syringe of form a dual-cured cement. This mixed version of the cement will self-cure or can be light cured, or both. The dual cure is effective for dark shade, thick or opaque cementation.

The provided document is a 510(k) Summary for a dental cement called Metacem. It aims to demonstrate substantial equivalence to a predicate device, also named Metacem (K081913). The document focuses on regulatory approval rather than providing a detailed study report with acceptance criteria for an AI/ML device. Therefore, a direct answer to the request regarding acceptance criteria and a study proving a device meets acceptance criteria (in the context of an AI/ML device) cannot be fully provided based on the given text.

The document describes performance tests for a dental cement, not an AI/ML device. The "acceptance criteria" discussed are primarily based on relevant ISO standards for dental materials.

However, I can extract the relevant performance data and address the components of your request that are applicable to this type of medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance

For a dental cement, acceptance criteria are typically defined by international standards like ISO 4049 and ISO 11405. The document presents the performance of the subject device (Metacem, K171449) against these standards and compares it to a predicate device (Metacem, K081913).

Note: For some metrics, the wording implies "meets" by being substantially equivalent or demonstrating favorable characteristics compared to the predicate device, or by complying with the specified ISO standard.

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

• Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., how many specimens for flexural strength, etc.). It only lists the tests performed according to ISO standards.
• Data Provenance: The tests were conducted by Meta Biomed Co., Ltd. (South Korea) for their product Metacem. The data is retrospective in the sense that it's reported from completed tests for the 510(k) submission.

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

This question is not applicable to this document. The "ground truth" for a dental cement's performance is established through standardized physical and chemical property testing (e.g., ISO standards), not through expert clinical consensus or interpretation of images. There are no "experts" in the context of interpreting data for ground truth in this type of submission.

4. Adjudication method for the test set

This question is not applicable to this document. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical or imaging data, which is not relevant for the physical and chemical testing of a dental cement.

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 to this document. This is a submission for a dental cement, not an AI/ML device. Therefore, no MRMC study involving human readers or AI assistance would have been performed.

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

This question is not applicable to this document. This is a submission for a dental cement, not an AI/ML device.

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

The "ground truth" for the performance of this dental cement is established by objective measurements against internationally recognized standards (e.g., ISO 4049, ISO 11405, ISO 10993). For example:

• Flexural strength is measured by breaking specimens and recording the force.
• Water sorption is measured by changes in specimen weight after immersion.
• Biocompatibility is assessed through specific in-vitro and in-vivo tests outlined in the ISO 10993 series.

8. The sample size for the training set

This question is not applicable to this document. This is a submission for a dental cement, not an AI/ML device. There is no concept of a "training set" for such a product.

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

This question is not applicable to this document. As there is no AI/ML component, there is no training set or ground truth established for it.

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Adhesive cementation of:

• Crowns & Bridges (ceramic, porcelain, composite and metals), .
• Inlays/onlays cementation , ●
• Bonding of veneers or crown; PFM, also alumina & zirconia, .
• Endodontic post cementation, .
• Core build up.

A dental adhesive formulated to adhesively bond to hard tissues of the oral . cavity, enamel and dentin,

• Dentin-enamel primer/bonding agent for direct composite restorations .
• Indirect composite restorative luting system .
• Porcelain veneer luting system .
• Bonding composite to composite .
• Bonding composite to metal/amalgam .
• Adhesive amalgam restoration. .

Primer for surfaces of:

• Crowns and bridges, ceramic, composite, porcelain, metal, .
• Pre-cured composite inlays and onlays, ●
• t Ceramic inlays and onlays.
• . Porcelain veneers,
• Porcelain and metal prosthesis

Metacem is a high strength, permanent visible light cured (VLC), dual cured or self-cured resin cement for use with dentin/enamel adhesive prime and bond systems, to adhesively bond and lute indirect restorations to tooth structure. Metacem consists of a methacrylate base paste and catalyst paste which in use are instantly mixed from a dual syringe to form a dual-cured cement. This mixed version of the cement will self-cure or can be light cured, or both. The dual cure is effective for high shade, thick or opaque cementation.

Metacem is meant to be used with the Meta P&Bond system (or other equivalent system which should be tested before use) and with Metacem Silane Ceramic Primer for priming ceramic surfaces before use of Meta P&Bond, then Metacem.

Meta P&Bond is a wet bond adhesive system that is activated by visible light curing. This bonding agent is one-step for priming and bonding. It is formulated to adhesively bond to hard surfaces of the oral cavity, namely enamel and dentin, for use with dental cements like Metacem. It is useful as a primer for use with other methacrylate cements such as Calibra and equivalent products. It is intended to be painted on the interior of a prepared cavity or surface of a tooth to improve retention of a restoration such as a filling or crown. It also is useful as a prime and bonder for porcelain veneer luting, bonding composite to composite, and composite to metal/amalgam.

Metacem Silane Ceramic Primer is an organic substituted silicone material especially designed to provide an improved surface on porcelain, ceramics, composite resins that are to be treated with Meta P&Bond and then cemented to tooth structure. It also is designed to improve the adhesivity of surfaces involved in the repairs of fractured porcelain, ceramics or composite resin crowns or bridges. It is a low viscosity liquid with high volatility.

The provided text is a 510(k) summary for three dental devices: Metacem, Meta P&Bond, and Metacem Silane Ceramic Primer. It primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, device description, and compliance with general performance standards and biocompatibility tests. It does not contain information about a study proving the device meets specific acceptance criteria in the format requested.

The document states that the devices meet certain ISO standards for physical properties and biocompatibility. However, it does not present these standards as "acceptance criteria" in a table alongside "reported device performance" from a study. Instead, it makes a general claim of compliance.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a breakdown of what can and cannot be answered based on the provided input:

1. A table of acceptance criteria and the reported device performance:

• Cannot be provided in the requested format. The document states compliance with ISO standards, but it does not list specific numerical acceptance criteria from those standards, nor does it provide a table of actual device performance data to compare against such criteria.
  • Metacem: Meets ISO 4049:2000(E)7.5, 7.7, 7.8, 7.11, 7.12. 7.13, and 7.14 for physical properties and ISO 10993-5, -6, -10, and -11 for biocompatibility.
  • Meta P&Bond: Meets applicable parts of ISO 4049:2000 and ISO 11405, for properties, and ISO 10993 for biocompatibility.
  • Metacem Silane Ceramic Primer: No Section 514 performance standards are applicable (implies primary reliance on substantial equivalence to predicates without specific performance criteria in this summary).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not provided. The document does not describe any specific performance study with a test set. The compliance with ISO standards generally implies testing was done, but details of sample size and provenance are absent.

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):

• Not applicable/Not provided. Since no specific performance study with a test set is detailed, there is no mention of experts establishing ground truth for such a test set.

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

• Not applicable/Not provided. As above, no performance study implies no adjudication method.

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 section is for a medical device that might assist human readers (e.g., AI in radiology). The devices described (dental cements, primers, bonding agents) are materials, not AI-assisted diagnostic tools. No MRMC study was conducted or mentioned.

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

• Not applicable. These are physical dental materials, not algorithms.

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

• Not applicable/Not provided. No specific performance study with "ground truth" data is described. Compliance with ISO standards typically involves laboratory testing against established specifications.

8. The sample size for the training set:

• Not applicable/Not provided. No AI/machine learning component is described, thus no "training set."

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

• Not applicable/Not provided. As above.

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