(363 days)
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).
| Acceptance Criteria (Standard Reference) | Predicate Device Performance (K081913) | Subject Device Performance (K171449) | Met Acceptance Criteria (Yes/No) |
|---|---|---|---|
| Film thickness (ISO 4049:2009) | 0.034 ± 0.006 mm (34 µm) | 26.4 µm | Yes (Lower is generally better for film thickness) |
| Working time (ISO 4049:2009) | 2 min 32 sec | Homogeneous (No specific time given, but implies consistent working properties similar to predicate) | Implied Yes (similar to predicate) |
| Setting time (ISO 4049:2009) | 5 min 17 sec | A1: 3min 14sec, A3: 3min 04sec, B2: 3min 57sec, OP: 3min 34sec, TL: 2min 28sec | Yes (Within expected ranges for dental cements, variations expected for different shades) |
| Flexural strength (ISO 4049:2009) | 99 ± 16.1 MPa | 120.5 MPa | Yes (Subject device shows higher flexural strength, which is favorable) |
| Water sorption (ISO 4049:2009) | 29.31 ± 6.81 µm/mm³ | 14.0 µg/mm³ | Yes (Lower water sorption is favorable) |
| Solubility (ISO 4049:2009) | 2.33 ± 1.30 µm/mm³ | 0.5 µg/mm³ | Yes (Lower solubility is favorable) |
| Radio-opacity (ISO 4049:2009) | 2.33 ± 0.34 mm | 2.3 mm | Yes (Comparable to predicate) |
| Color/Color stability (ISO 4049:2009) | Consistency | Consistency | Yes (Implied similar to predicate) |
| Tensile Bond Strength - Enamel (ISO 11405) | 28.3 MPa | 27.5 MPa | Yes (Comparable to predicate) |
| Tensile Bond Strength - Dentin (ISO 11405) | 7.6 MPa | 6.1 MPa | Yes (Comparable to predicate - though slightly lower, FDA deemed it substantially equivalent) |
| Shear Bond Strength - Dentin (ISO29022:2013) | N/A | 3MPa | N/A (Predicate data not available in this table) |
| Shear Bond Strength - Enamel (ISO29022:2013) | N/A | 15MPa | N/A (Predicate data not available in this table) |
| Biocompatibility (ISO 10993 series) | Not explicitly listed, but implied through prior approval | Tested according to ISO 10993-1, -5, -10, -11 | Yes |
| Shelf life | 2 years | 2 years | Yes |
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.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.