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The indications for use for Livento® press, Soprano® 10 and Soprano® are:

-Veneers

-Inlays and onlays

-Partial crowns

-Anterior and posterior tooth crowns

-Hybrid abutment crown

• -3-pontic bridge in anterior tooth region
  -3-pontic bridge in the premolar region up to max. 2nd premolar as a permanent abutment

The Livento/Soprano dental ceramic system comprise pressable ingots and compatible layering ceramic powders used in dental laboratories by the dental technician to create all ceramic restorations.

Livento® press is a pressable lithium disilicate glass-ceramic supplied in ingots of 3 grams. The material is supplied in different levels of translucency (MT, LT, ET, HQ, Opal and Bleach) each in different dental shades of Vita A, B, C and D.

Soprano® 10 is a layering fluorapatite glass-ceramic supplied as powder suitable for veneering substructures made from Livento® press lithium disilicate glass-ceramic and zirconium oxide. It has a range of different translucency levels (Frame Modifier, Opaque Dentine, Incisal/Enamel, Transparent, Clear) and is available in the Vita classic colors A, B, C and D as well as Bleach shades and Modifiers.

Soprano® shades, stains and glaze are glass ceramic dental porcelain material. They are intended to finish dental restorations and are offered in a variety of shades.

All Livento/Soprano dental ceramics meet the requirements of ISO 6872:2015.

The provided text describes a 510(k) premarket notification for a dental ceramic system (Livento® press, Soprano® 10, and Soprano®). The notification aims to demonstrate substantial equivalence to a predicate device, the DCceram System (K141400). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance data presented to show compliance with relevant standards and justify substantial equivalence.

Here's a breakdown of the requested information based on the provided document:

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

The document states that the Livento/Soprano dental ceramic system meets the requirements of ISO 6872:2015. This standard sets the acceptance criteria for dental ceramic materials. While specific numerical acceptance criteria from ISO 6872:2015 are not explicitly listed in the document, the tested parameters and the general statement of compliance serve as the reported performance against those criteria.

The document explicitly states: "The results show product compliance to the requirements of ISO 6872:2015."

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

The document mentions testing was done on "a representative sample of the products." However, it does not specify the exact sample size used for the performance testing.

Regarding data provenance:

• Country of Origin: Not explicitly stated, but the submitter (Cendres+Metaux SA) is located in Biel/Bienne, Switzerland. The testing would logically be conducted by or for a company based in Switzerland, or a contract lab.
• Retrospective or Prospective: This is a performance testing study, not a clinical study on patients. It's a laboratory study to characterize the material, so these terms (retrospective/prospective clinical data) do not directly apply. It's a prospective laboratory evaluation of material properties.

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 type of information (experts establishing ground truth) is typically relevant for studies involving human interpretation (e.g., medical imaging AI). For this submission, which focuses on the material properties of dental ceramics tested against a recognized international standard (ISO 6872:2015), the "ground truth" is defined by the physical and chemical properties of the material as measured by standardized laboratory methods, not by expert consensus. Therefore, this question is not applicable in the context of this device and submission.

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

As this is a laboratory performance study of material properties, not a study involving human readers or interpretations needing adjudication, the concept of an adjudication method is not applicable. The "ground truth" is established by the measurements themselves, evaluated against the specified criteria of ISO 6872:2015.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical image analysis devices, particularly those involving Artificial Intelligence (AI) to assist human readers. The device in question is a dental ceramic material used by dental technicians to create restorations, not a diagnostic imaging device or an AI application. Therefore, this question is not applicable.

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

No, a standalone performance study (in the context of AI algorithms) was not done. As stated, this is a material property evaluation, not an AI or software device. Therefore, this question is not applicable.

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

The "ground truth" for this device is the physical and chemical properties of the dental ceramic materials, as measured and characterized by standardized laboratory testing methods in accordance with ISO 6872:2015. This is a material science "ground truth."

8. The sample size for the training set

This question is typically relevant for AI/machine learning models where data is used to train an algorithm. Since this is a submission for a physical dental material with performance verified through adherence to an international standard, there is no "training set" in the sense of machine learning. The testing performed is for verification and validation of the product's physical properties.

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

As there is no "training set" in the context of this device submission, this question is not applicable.

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