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REVOIS PRO Implant System is an implant system recommended for surgical placement in the edentulous or partially edentulous jaw bone (upper or lower jaw bone) to create support for prosthetic devices such as single artificial teeth, fixed or removable bridges, or dentures.

The titanium implant can be applied either in a one-stage surgical procedure with immediate loading (with good primary stability and appropriate occlusal loading) or in a two-stage surgical procedure (after osseointegration of the implant).

The REVOIS® PRO Implant System is a self-contained, modular dental implant system for placement into the jaw bone (upper or lower jaw bone) to support prosthetic devices for dental restoration. The system is designed for one-stage or two-stage surgical procedures.

The REVOIS® PRO Implant System is composed of a titanium screw type cylindrical implant. It is a screw form implant with cylindrical thread and a progressive thread near the apex. The double thread of the implant body is contiguous with the triple thread (fine thread) at the implant neck. Together with the conical implant body of the REVOIS®: PRO implant, the progressive thread makes sure that the implant is well anchored in the host bone of the alveolar crest. The incremental pitch of the thread upwards evenly distributes the forces so that implants heal well and can be loaded immediately.

The implant system is delivered in a sterile insert blister and comprises an implant, an impression abutment, an impression screw and a cover screw (sterile packed as a set in a blister packaging). The impression screw serves as a connector between impression abutment and implant so that the pre-assembled parts fit tightly into the inlay for sterility reasons. The system offers implants in various diameters and lengths (3.8; 4.3; 5.0 mm diameter; 9; 11; 13; 15 mm lengths). For ease of identification the implants are color coded according to diameter.

The dental abutment portions of the REVOIS® : PRO implant system include several abutments described subsequently:

• Healing Abutments of diameter 4.4 mm and 5.2 mm in height 2 mm, 3mm and 5 mm each, made of Titanium Grade 5
• Standard abutment (incl. retaining screw) of diameter 4,4 mm in height 5 mm and 7 mm each, made of Titanium Grade 5
• Individual aesthetic abutment of diameter 4,4 mm, made of CERAMICOR®, a gold- platinium alloy
• Impression abutment, multi (pre-mounted with impression screw) made of Titanium Grade 5
• Impression abutment open tray of diameter 4.4 mm, made of Titanium Grade 5
• Locator* abutment, made of Titanium Grade 5
• Locatore Replacement set, consists of several components made of plastic and Titanium Grade 5
• Locator® impression coping, made of the Aluminium Alloy 6061
• Dalbot ball attachment of diameter 4.4 mm and in height 3 mm and 5mm, made of Titanium Grade 5

The REVOIS® PRO Implant System is provided with a variety of prosthetic components and tool which are definitely 510(K)-exempt or still cleared by the submission K063106.

The main components of the implant system are made of Grade V Titanium (implant, abutment). The materials comply with the ASTM standards ASTM F067 (implant) and ASTM F0136-2a (abutment). The implant surface is blasted with luminium oxide particles (Corundum) and then acid-etched for micro-roughness.

The REVOIS® PRO titanium implant is sterile packed for single use only. The sterility is indicated by the color on the sterility indicator attached to the inner Tyvek® foil.

The acceptance criteria and study proving the device meets them are not explicitly detailed in the provided text in the format typically expected for AI/medical device performance evaluation reports (e.g., sensitivity, specificity, accuracy against a gold standard).

This document is a 510(k) summary for a dental implant system (REVOIS® PRO Implant System), which primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, not on presenting novel performance study results for a new AI algorithm.

Here's a breakdown based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with performance metrics like accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" for this 510(k) submission are implicitly met by demonstrating substantial equivalence to predicate devices in:

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

• Sample Size: Not applicable in the context of this 510(k) summary for a dental implant. The "test set" here refers to non-clinical performance testing of mechanical properties:
  • Fatigue Testing was done according to ISO 14801. The standard specifies the number of samples required for fatigue testing, which typically involves a set number of test pieces (e.g., 5-10 samples per condition) to establish fatigue limits. The exact number of implants tested is not specified in the summary but would follow the ISO standard.
  • Bench Testing with Animal Model was also performed. The summary does not specify the number of animals or implants used in this animal model bench test.
• Data Provenance: The document does not explicitly state the country of origin for the non-clinical tests' data, nor whether it was retrospective or prospective. Given that RIEMSER Arzneimittel AG is a German company, it's highly probable the testing was conducted in Germany or Europe. Non-clinical tests like fatigue testing are inherently prospective at the time of execution.

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

This question is not applicable to this 510(k) summary. The "ground truth" for a dental implant system like this is established through objective engineering and biological testing (mechanical fatigue, biocompatibility, and animal/human clinical studies for osseointegration and loading), not expert consensus on image interpretation or diagnostic accuracy. The listed studies (e.g., FRIATEC, 1998; Cia et al., 2003) are scientific publications and clinical trials, where the "ground truth" for success or failure would be determined by clinical outcomes, radiographic assessment, or histological analysis, as defined by the methodologies of those studies.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

Not applicable. This is not a study assessing diagnostic accuracy requiring expert adjudication.

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 dental implant, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a dental implant.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the REVOIS® PRO Implant System, the "ground truth" for its performance and safety is derived from:

• Mechanical Integrity/Fatigue Testing: Compliance with ISO 14801 standards, which inherently defines "ground truth" for mechanical performance.
• Biocompatibility: Conformance to ASTM material standards (ASTM F067, ASTM F0136-2a).
• Bench Testing with Animal Models: Histological and biomechanical outcomes observed in animal models (e.g., osseointegration, bone-implant contact) serve as a form of "ground truth" for biological response before human trials.
• Clinical Outcomes Data (from referenced studies): The numerous referenced studies (e.g., Cia et al., 2003; Striezel et al., 1998) would have established their "ground truth" through clinical success rates, survival rates, bone loss measurements, clinical evaluations by dentists/surgeons, and patient outcomes over time.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical dental implant, not an AI algorithm requiring a training set.

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

Not applicable.

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The REVOIS® Implant System is an implant system recommended for: Surgical placement in the edentulous or partially edentulous jaw bone (upper or lower jaw bone) to create support for prosthetic devices such as single artificial teeth, fixed or removable bridges or dentures. The titanium implant can be applied either in a one-stage surgical procedure with immediate loading when good primary stability is achieved and with appropriate occlusal loading, or in a two-stage surgical procedure (after osseointegration of the implant).

The REVOLS® Implant System is a self-contained, modular dental implant system for placement into the jaw bone (upper or lower jaw bone) to support prosthetic devices for dental restoration. The system is designed for one-stage or two-stage surgical procedures. The REVOIS® Implant System is composed of titanium, screw type implant, preassembled with a multifunctional precision abutment and a transfer tool that snaps onto the abutment (Snap-on-tool). The implant is also available with a transfer tool only. A cover screw is contained in the top of the snap-on or transfer tool. The system offers implants in various diameters and lengths (3.8; 4.3; 5.0 mm diameter; 9; 11; 13; 15 mm lengths). The REVOIS® Implant System is provided with a number of corresponding tools and surgical instruments, as well as a variety of prosthetic components which are definitely 510(K)-exempt or still cleared by the submission K063106. For ease of identification the implants and corresponding tools are color coded according to diameter. The main components of the implant system are made of Grade V Titanium. The used materials comply with the ASTM standards ASTM F067, ASTM F0136-2a, and ASTM F2026. The implant surface is blasted with aluminium oxide and then acid-etched for microroughness. Blasting and acid -etching contributes to the implant surface characteristics. Furthermore grooves increase resistance to shear forces in difficult clinical cases. The REVOIS® titanium implant (pre-assembled with the multifunctional precision abutment and snap-on-tool or with the transfer tool only) is supplied in double sterile packages (sterile inner plastic vial in a sterile glass vial, which is sealed in a blister) and is for single use only. Tools and other re-usable instruments must be sterilized prior to use.

This document is a 510(k) summary for the REVOIS® Implant System. It describes a medical device, specifically a dental implant system, and its substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request:

1. Acceptance Criteria and Reported Device Performance

The submission for the REVOIS® Implant System is a Special 510(k) Summary, not a de novo submission or a traditional PMA application that typically requires defining and meeting specific performance acceptance criteria for clinical outcomes.

Instead, the primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device already legally marketed. The submission aims to show that the new REVOIS® Implant System is as safe and effective as its predicate.

The reported device performance is based on demonstrating this substantial equivalence. The document states:

• "The stability of the implant body of the REVOIS® implant system thread was tested in non-clinical performance testing as fatigue testing according to ISO 14801 and Bench testing with Animal Model." This indicates mechanical performance testing was conducted.
• Essential similarity conclusion: The document emphasizes the comparability in "main and most important characteristics" and that "differences between the systems represent minor updates as described and do not affect the device safety or effectiveness."

Therefore, a table of acceptance criteria and reported numeric device performance as typically expected for clinical validation studies (e.g., sensitivity, specificity, accuracy) cannot be directly extracted from this document because the regulatory pathway chosen (Special 510(k)) does not require such criteria in this format. The performance is implicitly "accepted" if substantial equivalence to the predicate is shown through design, materials, and non-clinical testing.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: The document mentions "fatigue testing according to ISO 14801" and "Bench testing with Animal Model." However, it does not specify the sample size (e.g., number of implants, number of animals) for these tests.
• Data Provenance:
  • Country of Origin: The manufacturing company is Riemser Arzneimittel AG, located in Greifswald-Insel Riems, Germany. The tests mentioned (ISO 14801 and animal model) would likely have been conducted in Germany or a location compliant with international standards, but this is not explicitly stated.
  • Retrospective or Prospective: The "fatigue testing" and "Bench testing with Animal Model" are by nature prospective non-clinical studies. They are laboratory or controlled animal experiments designed to evaluate specific aspects of the device's physical performance before widespread clinical use.

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

The concept of "ground truth" and expert consensus as applied to diagnostic or AI-driven devices for medical image interpretation is not applicable to this submission.

• This is a submission for a dental implant system, a physical medical device.
• The "testing" referenced (ISO 14801, animal model) relates to the mechanical and biological properties of the implant, not to the interpretation of medical data by experts.
• Therefore, there were no experts establishing "ground truth" concerning diagnostic accuracy in the context you describe.

4. Adjudication method for the test set

Not applicable for the same reasons as #3. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among human readers interpreting data, which is not the type of testing described here.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.

• This type of study is relevant for AI-powered diagnostic or assistive devices where human readers (e.g., radiologists) interact with or are assisted by AI.
• The REVOIS® Implant System is a physical dental implant. There is no AI component that would assist human readers in, for instance, interpreting dental images.

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

No, a standalone algorithm-only performance assessment was not done.

• This type of assessment is also specific to AI/software as a medical device (SaMD). The REVOIS® Implant System is a physical surgical implant device.

7. The type of ground truth used

The relevant "ground truth" for this device would be established by:

• Defined engineering standards and physical measurements: For fatigue testing (ISO 14801), the "ground truth" is whether the implant can withstand specified forces for a certain number of cycles without failure, as defined by the standard.
• Histopathological or biological outcome measures: For the "Bench testing with Animal Model," the "ground truth" would involve histological examination of bone integration, absence of inflammation, mechanical stability post-implantation, etc., compared to established benchmarks or the predicate device.
• Clinical outcomes (implicitly): While not directly part of the substantial equivalence argument summarized here, the predicate device's existing safety and effectiveness in clinical use forms an implicit "ground truth" that the new device aims to match.

8. The sample size for the training set

Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant to the provided document.

In summary, the provided document is a regulatory submission for a physical medical device (dental implant) seeking clearance via the 510(k) pathway. It focuses on demonstrating substantial equivalence to an existing predicate device through design, materials, and non-clinical performance testing, not on clinical performance metrics or AI algorithm validation using expert ground truth or training/test sets.

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CERASORB® Plus is recommended for:

• · Defects after extirpation of bone cysts
• · Augmentation of the atrophied jaw ridge
• · Sinus lift or sinus base elevation respectively
• · Filling alveolar defects after tooth extraction for jaw ridge support
• · Filling extraction defects to create an implant site
• · Filling of two or multi-walled infrabony pockets, and bifurcation and trifurcation defects
• · Defects after operative removal of retained teeth or corrective osteotomes

CERASORB® Plus is a sterile, synthetic, porous and biocompatible ceramic matrix roundish and polygonal crushed shaped morsels. This modification consists of purephase Beta-Tricalcium Phosphate with a phase purity of ≥ 99% and complies with the ASTM F 1088-04. The devices, when applied to a bony defect, create a network of large, smoothly interconnected pores providing different porosities (CERASORB® Plus mixture of granules with porosity of 35% and of 65%).

CERASORB® Plus is manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility. Due to their synthetic nature CERASORB® Plus does not pose any risk of potential allergic reactions and are neither locally nor systemically toxic.

In contact with vital bone the CERASORB® Plus granules, morsels or granulate is reabsorbed and gradually replaced by new bone.

CERASORB® Plus is provided in double sterile packages (sterilization via gamma irradiation) and are for single-use only.

The use of Beta-Tricalcium Phosphate in vivo is well known and has been studied and evaluated in numerous animal and human studies over the vears. These studies indicate overall excellent performance, biocompatibility, resorption and bone regeneration with CERASORB® derived thereof the performance of CERASORB® Plus in the areas of its intended use and have proven that the material is non-toxic, biocompatible, resorbable while in contact with vital bone over time is replaced by new bone at the defect size.

The provided document is a 510(k) summary for CERASORB® Plus, a bone void filler. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the format typically expected for medical device performance evaluation.

Instead, the submission relies on the concept of substantial equivalence to predicate devices (CERASORB® DENTAL and CERASORB® M DENTAL) which have already established safety and effectiveness. The “study” proving the device meets criteria is primarily the comparison to these predicate devices and the existing knowledge on Beta-Tricalcium Phosphate (В-ТСР).

Here's an attempt to extract and synthesize the information based on your request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria (e.g., minimum tensile strength, specific resorption rate) are not explicitly stated within the provided text, they cannot be presented in a table. The primary "acceptance criteria" appear to be:

Study Proving Acceptance Criteria:

The primary "study" or basis for proving these criteria is the claim of substantial equivalence to previously cleared/approved predicate devices (CERASORB® DENTAL PMA800035/ K051443 and CERASORB® M DENTAL K051443) and the established scientific understanding and historical use of Beta-Tricalcium Phosphate.

The document states: "The use of Beta-Tricalcium Phosphate in vivo is well known and has been studied and evaluated in numerous animal and human studies over the years. These studies indicate overall excellent performance, biocompatibility, resorption and bone regeneration with CERASORB® derived thereof the performance of CERASORB® Plus in the areas of its intended use and have proven that the material is non-toxic, biocompatible, resorbable while in contact with vital bone over time is replaced by new bone at the defect size."

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

• The document does not describe a specific "test set" or clinical study with a defined sample size for CERASORB® Plus.
• Instead, it leverages existing literature and studies on Beta-Tricalcium Phosphate and the predicate devices. The "data provenance" mentioned is the general body of "numerous animal and human studies over the years" related to В-ТСР and the predicate devices, implying retrospective analysis of existing data. No specific country of origin is mentioned for these historical studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not provided as there isn't a new clinical study described for CERASORB® Plus with a ground truth established by a panel of experts.
• The "ground truth" for the safety and efficacy of Beta-Tricalcium Phosphate is implicitly established by the collective scientific and medical community's acceptance of the material through "numerous animal and human studies."

4. Adjudication Method for the Test Set

• An adjudication method is not applicable as there is no specific new test set or clinical study described in this 510(k) summary for CERASORB® Plus.

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

• No, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. This type of study is typically for evaluating diagnostic imaging systems or AI tools. CERASORB® Plus is a physical bone void filler.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• Not applicable. This device is a physical bone graft material, not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" is based on scientific consensus and established clinical outcomes from "numerous animal and human studies" on Beta-Tricalcium Phosphate, as well as the regulatory clearance/approval of predicate devices. This falls under the category of outcomes data and expert consensus derived from years of research and clinical use of the material.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of an AI/algorithm for this physical medical device. The "training" for the understanding of the material's properties comes from the body of scientific literature and studies mentioned.

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

• Not applicable. As there is no training set for an AI/algorithm, this question is not relevant to the provided submission. The scientific understanding of Beta-Tricalcium Phosphate's properties (its "ground truth") was established incrementally over time through experimental research, animal studies, and human clinical observations.

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