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SICtapered Implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICtapered Implants are indicated for when adequate primary stability is achieved and with appropriate occlusal loading. Only applicable for SICtapered implants with Ø 3.7 mm Use without splinting is permissible in the anterior and premolar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme. SICvantage tapered Implants are intended for use during dental implantation and oro-maxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICvantage tapered Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading. Only applicable for SICvantage tapered implants with Ø 3.0 mm Use without splinting is permissible in the anterior replacement of maxillary lateral incisors and mandbular incisors. In the premolar and molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.

The SICtapered is a two-part, self-tapping, endosteal threaded implant. The basic shape is conical with an initially tapered "apical cutting edge". The cortical area is cylindrical, and the core diameter is increased. On the top of the implant, there is a decompression zone to reduce the compression on the bone and a crestal bevel designed for "platform switching". The apex has an aggressive cut with a large flute for good chip clearance. The vertical fixation screw is secured with a torque of 20 Ncm. The implants are manufactured from medical-grade pure titanium (ISO 5832-2). The microstructuring of the surface is achieved by abrasive processes. Surgical accessories and prosthetic abutments are usually color-coded by means of anodized oxidation. The SICvantage tapered is a two-part, self-tapping, endosteal threaded implant. The basic shape is conical with an initially tapered "apical cutting edge". The cortical area is cylindrical, and the core diameter is increased. On the top of the implant, there is a decompression zone to reduce the compression on the bone and a crestal bevel designed for "platform switching". The apex has an aggressive cut with a large flute for good chip clearance. The SICvantage tapered can be used in all bone qualities (D1 – D4). The implants are manufactured from medical-grade pure titanium (ISO 5832-2). The microstructuring of the surface is achieved by abrasive processes. Surgical accessories and prosthetic abutments are usually color-coded by means of anodized oxidation.

The provided text is a 510(k) Premarket Notification summary for dental implants, specifically the SICtapered and SICvantage tapered models. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than detailing a clinical study with acceptance criteria and performance metrics for an AI-powered diagnostic device.

Therefore, most of the requested information regarding acceptance criteria, performance studies, sample sizes, expert involvement, ground truth establishment, MRMC studies, or standalone algorithm performance cannot be extracted from this document. The document explicitly states: "Non-clinical testing has been performed showing that the device (SICtapered & SICvantage tapered) performs as intended and are substantially equivalent to the predicate device (K173207)." The "tests" listed are related to biocompatibility, sterilization, shelf life, and mechanical fatigue, which are typical for medical devices like implants, not for an AI diagnostic tool.

However, I can provide a very limited interpretation based on the closest relevant information, acknowledging that it does not fit the typical pattern of an AI diagnostic device study.

Based on the provided document, the "acceptance criteria" and "study" are interpreted in the context of demonstrating substantial equivalence for a dental implant, not an AI diagnostic device.

The primary "study" performed is a comparison to predicate devices and non-clinical testing (material, sterilization, mechanical). The "acceptance criteria" is that the new device performs "as intended" and is "substantially equivalent" to the predicates, meaning it does not raise new issues of safety or effectiveness.

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

2. Sample sizes used for the test set and the data provenance:

• Test Set (for non-clinical tests): Not explicitly stated in terms of patient or imaging data. The "sample size" here refers to the number of physical implants or test specimens used for lab testing (e.g., fatigue tests, biocompatibility tests). These numbers are not detailed in the summary document.
• Data Provenance: The data provenance for these non-clinical tests would be the specific accredited labs where the tests were performed. The document implies reliance on previous testing for predicate devices ("leveraged for the new device"), suggesting the data is retrospective in the sense of using prior test results. No information on country of origin of testing is provided, beyond the applicant being Switzerland-based.

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

• Not applicable. This document describes the testing of a physical medical device (dental implant), not an AI diagnostic algorithm that requires expert-established ground truth from medical images. The "ground truth" for these tests are objective, measurable physical and chemical properties (e.g., material composition, sterility levels, mechanical load limits).

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

• Not applicable. Adjudication methods are used to establish consensus ground truth from multiple human readers for diagnostic studies. The non-clinical tests described in this document rely on established scientific and engineering methodologies for their "ground truth."

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 information pertains to an AI diagnostic device. The current document is for a dental implant.

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

• Not applicable. This information pertains to an AI diagnostic device.

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

• Analytical/Physical/Chemical Measurements: The ground truth for the non-clinical tests (biocompatibility, sterilization, mechanical fatigue) would be derived from the objective results of the standardized laboratory tests rather than human interpretation or patient outcomes. For example:
  • Biocompatibility: Absence of cytotoxic effects, reaction to specific extracts.
  • Sterility: Sterility Assurance Level (SAL) measurement.
  • Fatigue: Number of cycles to failure under specified loads.

8. The sample size for the training set:

• Not applicable. This document is not describing an AI model and therefore does not have a training set.

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

• Not applicable. As there is no AI model or training set, this information is irrelevant to the provided document.

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