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The Sulzer Dental Ceramic System - Spline is intended for use specifically for anterior and premolar, single-unit cement-retained restorations. This product should not be used in the molars and should not be splinted together for multiple unit cases. partials or bridgework.

The Ceramic System-Spline uses a titanium Spline core (abutment) and a ceramic coping. The core is attached to the implant with a titanium retaining screw. The coping is comented to the core for a final restoration. The core will be offered in three implant interface diameters, 3.25mm, 4.0mm, and 5.0mm. The Ceramic System coping is available in six shapes: small incisor, 17º small incisor, large incisor, 17º large incisor, canine, and premolar.

The provided document is a 510(k) summary for a dental implant abutment (Sulzer Dental Ceramic System - Spline) seeking substantial equivalence to existing predicate devices. It does not describe a study involving algorithms, AI, or performance metrics typically associated with device acceptance criteria in the context of AI/ML.

Instead, this document focuses on demonstrating that a new medical device (a physical dental implant component) is substantially equivalent to legally marketed predicate devices. The "acceptance criteria" here refer to the criteria for substantial equivalence under FDA regulations, which involve comparing the new device's intended use, technological characteristics, and safety/effectiveness concerns to those of existing devices.

Therefore, I cannot provide the requested information regarding AI/ML device performance, sample sizes for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, or training set details because this submission is not about an AI/ML device.

The "acceptance criteria" in this context are established by the FDA's regulatory framework for 510(k) submissions, primarily evaluating substantial equivalence. The "study that proves the device meets the acceptance criteria" is the comparison analysis presented in the document, which argues for substantial equivalence based on a comparison to predicate devices, rather than a clinical trial or AI model validation study.

Here's a breakdown of what the document does provide, reframing the request to fit the content:

1. Table of Acceptance Criteria (for Substantial Equivalence) and Reported Device Performance (Characteristics):

The "study" demonstrating this device meets "acceptance criteria" is the comparison analysis itself, which asserts that differences do not raise new questions of safety or effectiveness.

The following points are not applicable to this document as it pertains to a physical device approval based on substantial equivalence, not an AI/ML model.

2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of AI/ML validation is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML-based test set is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "ground truth" for the substantial equivalence claim is the performance and characteristics of the legally marketed predicate devices.
8. The sample size for the training set: Not applicable. No AI model is being trained.
9. How the ground truth for the training set was established: Not applicable.

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