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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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SICmax onepiece 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. SICmax onepiece Implants are indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. Splinting with several implants or the residual dentition is possible. SICmax onepiece implants are also indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.

SICace 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. SICace Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.

• Only applicable for SICace implants with Ø 3.4 mm: Use without splinting is permissible in the anterior and premolar region. In the molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.

SICmax 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 the patient's chewing function. SICmax Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.

• Only applicable for SICmax implants with Ø 3.7 mm: Use without splinting is permissible in the anterior and premolar region. In the molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.

SIC vantage max 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. SICyantage max Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.

• Only applicable for SIC vantage max implants with Ø 3.0 mm: Use without splinting is permissible in the anterior region for replacement of maxillary lateral incisors and mandibular 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.

SIC Prosthetic Components are intended for use with SIC Dental Implants for prosthetic restorations from single tooth replacements to full arch restorations with fixed or removable superstructures. SIC Prosthetic Components with a post height less than 4 mm are intended for multi-unit loaded restorations only.

SICmax onepiece 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. SICmax onepiece Implants are indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. Splinting with several implants or the residual dentition is possible. SICmax onepiece implants are also indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.

SICace 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. SICace Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.

• Only applicable for SICace implants with Ø 3.4 mm: Use without splinting is permissible in the anterior and premolar region. In the molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.

SICmax 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 the patient's chewing function. SICmax Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.

• Only applicable for SICmax implants with Ø 3.7 mm: Use without splinting is permissible in the anterior and premolar region. In the molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.

SIC vantage max 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. SICyantage max Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.

• Only applicable for SIC vantage max implants with Ø 3.0 mm: Use without splinting is permissible in the anterior region for replacement of maxillary lateral incisors and mandibular 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.

SIC Prosthetic Components are intended for use with SIC Dental Implants for prosthetic restorations from single tooth replacements to full arch restorations with fixed or removable superstructures. SIC Prosthetic Components with a post height less than 4 mm are intended for multi-unit loaded restorations only.

Based on the provided text, the document is a 510(k) premarket notification decision letter from the FDA to SIC invent AG regarding their Dental Implant Systems. It is a regulatory clearance document, not a study report or a technical performance evaluation for a device, especially an AI/ML powered one.

Therefore, none of the requested information regarding acceptance criteria, study details, sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details can be found in this document.

The document primarily focuses on:

• Device Classification: Class II
• Product Codes: DZE (Endosseous Dental Implant), NHA (Endosseous Unthreaded Titanium Dental Implant)
• Regulation Number: 21 CFR 872.3640 (Endosseous Dental Implant)
• Substantial Equivalence: Concludes the device is substantially equivalent to legally marketed predicate devices.
• Indications for Use: Detailed descriptions for SICmax onepiece implants, SICace Implants, SICmax Implants, SIC vantage max Implants, and SIC Prosthetic Components. These indications specify the types of implants, their intended use in the jaw, support for prosthetics, and conditions for immediate loading or splinting.

To answer your request, a different type of document, such as a clinical study report, a bench test report, or a detailed device design specification, would be needed. This 510(k) clearance letter does not contain the technical performance study details you are asking about, as it is a summary of the FDA's regulatory decision based on submitted data, rather than the data itself.

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The SICace System Dental Implant is a root form endosseous dental implant system that is indicated to be implanted in the upper and/or lower jaw arches. The implants may be used in combination with various SICace System Abutments for single or multiple unit prosthetic attachment to restore a patient's chewing function.

Patient's must be applicable for dental treatment with endosseous implants.

In cases where the ridge is too narrow to receive a 4.0 mm or a 5.0 mm diameter implant, the 3.4 mm implant can be used. Because of reduced strength due to the small diameter, these implants should be rigidly joined to other implants and used only where loads are not extreme.

The SICace System Abutment is intended to be placed into the SICace System Implant to provide a safe and effective fit of screw retained and/or cementable crowns and bridges.

SICace dental implant system is a root-form endosseous dental implant device made out of grade 4 titanium according ASTM F 67. The implants are available in three different diameters (ø3.4 mm, ø4.0 mm, ø5.0 mm) and various lengths from 9.5 mm. The anchorage surface is grit blasted and acid etched for faster osseointegration and secondary stability.

Equal to the predicate device SICpro dental implant, the face side of the SICace dental implant has a hexagon drill hole and a standard screw thread to ensure and anti-rotational connection of the congruent abutment and the implant. Throughout the different diameters the hexagon drill hole has identical measurements.

SICace dental implants are delivered single packed in combination with an implant cover screw and supplied in sterile condition (sterilized by gamma-radiation).

SIC angled abutments are various in lengths and diameters and made out of titanium ASTM F 136. Through a hexagon socket and a vertical drill hole, the abutments can be connected with the implant secure and anti-rotational.

SIC angled abutments are supplied in non sterile condition. These parts of the system can be sterilized by the user by using a standardized and validated sterilization process.

The provided text does not contain information about acceptance criteria for device performance, a study to prove meeting acceptance criteria, or any of the detailed study parameters (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).

The document is a 510(k) summary for the SICace Dental Implant System, focusing on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study data against specified acceptance criteria. It describes the device, its classification, predicate devices, and indications for use, ultimately concluding that it is substantially equivalent.

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The SIC pro System Dental Implant is a root form endosseous dental implant system that is indicated to be implanted in the upper and/or lower jaw arches. The implants may be used in combination with various SIC pro System Abutments for single or multiple unit prosthetic attachment to restore a patient's chewing function.

Patient's must be applicable for dental treatment with endosseous implants. In cases where the ridge is too narrow to recieve a 4.2mm or 5.3mm diameter implant, the 3.3mm implant can be used. Under such conditions, we highly recommend the placement of additional fixtures to share the occlusal load of the prosthetic restoration. The SIC pro System Abutment is intended to be placed into the SIC pro System Implant to provide a safe and effective fit of screw retained and/or cementable crowns and bridges.

SIC pro System solid screw dental implants are root-form endosseous dental implant devices ono of of grade 4 titanium according ASTM F 67. The implants are available in three different diameters (ø3.3 mm, ø4.2 mm, ø5.3 mm) and various length from 7.5 mm up to 16 mm. All ø3.3 mm diameter implants are cylindrical as well as the implants in diameter ø4.2 mm and ø5.3 mm in length of 7.5mm. All other implants in diameter ø4.2 mm and ø5.3 mm are partly tapered. The rength of 7.3mm. All other implants in acid etched for faster osseointegration and secondary stability.

The face side of the implant has a hexagon drill hole and a standard screw thread to ensure a The face side of the implant not a noxagon and the implant. Throughout the implant. Throughout the different diameters the hexagon drill hole has identical measurements.

SIC pro System Implants are delivered single packed in combination with a implant cover screw and supplied in sterile condition (sterilized by gamma-radiation).

SIC pro System Abutments & Accessories are various in shape, length and diameters and made out of three different materials (titanium grade 5, implant steel 316L, zirconium oxide). Through a hexagon socket and a vertical drill hole, the abutments can be connected with the implant secure and anti-rotational.

SIC pro System Abutments & Accessories are supplied single packed in non-sterile condition. These parts of the system are intended to be sterilized by the user by and have been validated by These parts of the system are intoneed steam (autoclave) sterilization process (15 min., 136°C, 3 bar).

This K040757 submission describes a dental implant system. The document is a 510(k) summary and subsequent FDA clearance letter, which means rather than a study with acceptance criteria and device performance as one might find for a novel device, it asserts substantial equivalence to predicate devices already on the market. Therefore, the information you're looking for will not be presented in the typical format of a new device study.

Here's an interpretation based on the provided document:

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

Since this is a substantial equivalence submission, direct "acceptance criteria" for performance are not explicitly stated in the document in the way they would be for a de novo device. Instead, the "acceptance criteria" are implicitly met by demonstrating that the SIC pro System Dental Implants, Abutments, and Accessories are equivalent to the existing legally marketed predicate devices. The reported "performance" is that the device is substantially equivalent.

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

This document is a 510(k) summary for substantial equivalence. It does not describe a clinical study or a test set with a specific sample size. The "data" used for comparison would be technical specifications, material properties, and intended use as compared to the predicate devices. There is no mention of country of origin of "data" in the context of a study.

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)

Not applicable. As this is a substantial equivalence claim based on comparison to predicate devices, there isn't a "test set" requiring expert ground truth establishment in the traditional sense of a clinical or performance study. The "experts" involved are presumably the engineers and regulatory specialists who compiled the technical comparison and the FDA reviewers who assessed the submission.

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

Not applicable. There was no test set requiring adjudication in this 510(k) submission.

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 device is a physical dental implant system, not an AI-powered diagnostic tool, and therefore an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. The "ground truth" for a substantial equivalence submission is the features, materials, and intended use of the legally marketed predicate devices. The applicant needs to demonstrate that their new device shares these fundamental characteristics with the predicates, and that any differences do not raise new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. No training set is mentioned or relevant for this type of submission.

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

Not applicable. As there is no training set, there is no ground truth to establish for it in this document.

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