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Choice 2 DC is a dual-cured, resin luting/veneering cement. The indications for use are to cement:

1. Indirect restorations (i.e. crowns, fixed prostheses (bridges), inlay, onlays
2. Endodontic posts
3. Cement-retained implant restorations/abutments (i.e. screws and crowns)
4. Veneers

Choice 2 DC is a color stable dual-cured, resin luting/veneering cement that is specially formulated for the cementation of indirect restorations made from Glass Ceramic, Lithium Disilicate, Porcelain, Composite, Metal, or Zirconia.

The provided FDA 510(k) clearance letter for Choice 2 DC, a dental cement, does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML algorithm or similar diagnostic device. The document explicitly states:

"Clinical testing is Not Applicable."

Instead, the submission relies on non-clinical testing to demonstrate substantial equivalence to predicate and reference devices. The acceptance criteria for this device are based on performance metrics defined by ISO standards for dental cements, rather than diagnostic accuracy metrics.

Therefore, many of the requested elements for describing an acceptance criteria study related to AI/ML or diagnostic performance (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this specific 510(k) clearance.

However, I can still extract details about the non-clinical testing and the "acceptance criteria" as implied by the standards chosen for comparison:

Non-Clinical Performance Study Details for Choice 2 DC Dental Cement

The provided FDA 510(k) summary for Choice 2 DC Dental Cement describes non-clinical testing performed to demonstrate substantial equivalence to predicate and reference devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this dental cement, "acceptance criteria" are implied by adherence to established ISO standards and performance at least equal to predicate devices. The document does not provide specific numerical "reported device performance" values for each test, but states that the device met the requirements of the ISO standard and performed at least equal to predicate and reference devices.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in the 510(k) summary. These details would typically be found in the full test reports referenced by the ISO standards.
• Data Provenance: The testing was non-clinical (laboratory testing of material properties). Therefore, concepts like country of origin or retrospective/prospective collection are not applicable.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Not applicable. This was non-clinical material testing based on ISO standards, not a diagnostic study requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

• Not applicable. This was non-clinical material testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• Not applicable. This applies to diagnostic devices, not dental cements.

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

• Not applicable. This applies to diagnostic algorithms, not dental cements.

7. The Type of Ground Truth Used

• The "ground truth" (or reference standard) was defined by the methodologies and reference materials/procedures specified in the international standards ISO 4049:2019 (Dentistry — Polymer-based restorative materials) and ISO 29022:2013 (Dentistry — Adhesion — Notched-edge shear bond strength test). This involves standardized laboratory measurements of material properties.

8. The Sample Size for the Training Set

• Not applicable, as this is not an AI/ML device or a clinical study requiring training data.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set mentioned or implied.

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