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CAMLOG®/CONELOG® PROGRESSIVE-LINE implants are intended for the restoration of edentulous and partially edentulous jaws with prosthetic restorations such as implant-supported single crowns, bridges and full dentures. Specifically for:

• · single-tooth gaps,
• · partially edentulous jaws with several missing teeth or
• · edentulous jaws.

CAMLOG®/CONELOG® PROGRESSIVE-LINE implants are suitable for oral endosseous implantation in the maxillary and/or mandibular bone and are intended for immediate or delayed implantation. They are indicated for transgingival healing (one-stage, using healing caps or abutments) or subgingival healing (two-stage, using cover screws). If single-phase healing is intended, the implants can be loaded immediately if the primary stability achieved is adequate for functional loading. In conjunction with the corresponding abutments, the implants can be used for screw-retained or cemented restorations such as single crowns, bridges and full dentures.

CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants with a diameter of 3.3 mm have the following additional specific indications:

Implants with a diameter of 3.3 mm are indicated as an alternative in cases where the alveolar ridge width is only 5-6 mm. Because of their lower tensile strength compared with larger diameter implants, they should only be used under the following conditions:

• As single implants, they should be used only to replace mandibular incisors and/or . maxillary lateral incisors.
• . An edentulous arch can only be restored with a bar retained superstructure with at least four implants of 3.3 mm diameter without distal extensions.
• . Implants of Ø 3.3 mm are suitable for a partially edentulous arch when combined with implants of larger diameter for splinted superstructures. However, the limited strength of the implants with Ø 3.3 mm must be taken into account.
• . Avoid excessive mechanical stressing of the implants when using ball abutments in combination with Ø 3.3 mm implants.
• . The healing time for diameter 3.3 mm implants is at least 12 weeks.

CONELOG® implants with 7 mm length have the following additional specific indications:

These Implants should only be used when there is not enough space for a longer implant. Delayed loading in single tooth replacement is indicated with these implants. If the ratio of crown length to implant length is unfavorable the biomechanical risk factors have to be considered and appropriate measures have to be taken by the dental professional.

The CONELOG® PROGRESSIVE-LINE Implants and the CAMLOG® PROGRESSIVE-LINE Implants represent an extension of the range of implants which are based on the welldocumented technology used for implants offered by CAMLOG Biotechnologies GmbH / Altatec GmbH.

Altatec GmbH CAMLOG®CONELOG® PROGRESSIVE-LINE Implants are titanium (CPTi Grade 4), screw-form endosseous dental implants and have a conical outer geometry in the apical area. The outer implant surface is abrasive-blasted and acid-etched - medium rough surface (Promote® surface structure). The implant shoulder of the CONELOG®/CAMLOG® PROGRESSIVE-LINE implants is machined. CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants are supplied in different diameters and lengths (See Table 1. below).

The Altatec GmbH CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants are placed surgically in the maxillary and/or mandibular bone and serve as anchors for functional and esthetic oral rehabilitations in partially and fully edentulous patients. The prosthetic rehabilitation is carried out with single crowns, bridges, or full arch prostheses, which are fastened to the implants by corresponding secondary parts (i.e. abutments).

The implant-abutment connection consists either of a Tube-in-Tube™ configuration with three cams for abutment positioning and rotational stability (CAMLOG® PROGRESSIVE-LINE) or an inner conical section and an indexing section with three cams for abutment positioning and as an antirotational mechanism (CONELOG® PROGRESSIVE-LINE). This means that the respective implant-abutment connections are identical to the connections of the respective equivalent systems (i.e. CONELOG®/CAMLOG® prosthetic product lines).

CAMLOG® CONELOG® PROGRESSIVE-LINE Implants are intended for one stage (transgingival / non-submerged) or two stage (submerged) protocols. The CONELOG® PROGRESSIVE-LINE implants are placed at bone level (epicrestally) and the CAMLOG® PROGRESSIVE-LINE implants are placed 0.4mm supracrestally. The CAMLOG®CONELOG® PROGRESSIVE-LINE Implants are made of the same implant grade material as the predicate devices (commercially pure titanium. CPTi Grade 4. meeting the requirements of ASTM F67-13. Standard Specification for Unalloyed Titanium for Surgical Implant Applications).

The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10°, validated in compliance with ISO 11137-1 Sterilization of healthcare products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

The provided text is a 510(k) Premarket Notification from the FDA for dental implants. It does not describe an AI medical device or a study that uses a test set, expert ground truth, or addresses human-in-the-loop performance. Therefore, I cannot generate the requested information about acceptance criteria and study details for an AI medical device.

The document focuses on demonstrating substantial equivalence of the "Altatec GmbH CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants" to existing legally marketed predicate devices. The "Summary of Testing" section (page 7-8) details mechanical fatigue testing, sterilization validation, endotoxin testing, and accelerated aging for shelf-life, which are relevant to the physical and biological properties of the dental implants, not AI performance.

To provide the requested information, I would need a document describing an AI medical device and its performance study.

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CAM Titanium Blanks are intended for the fabrication of abutments and healing caps on CAMLOG® SCREW-LINE and CAMLOG® ROOT-LINE implants in the maxilla and mandible for the purpose of supporting single or multiple tooth prostheses of a partially or fully edentulous patient. Digitally designed abutments fabricated with CAD/CAM techniques for use with CAMLOG® CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for manufacture.

CAM Titanium Blanks are intended for the fabrication of abutments and healing caps on CONELOG® SCREW-LINE implants in the maxilla and mandible for the purpose of supporting single ooth prostheses of a partially or fully edentulous patient. Digitally designed abutments fabricated with CAD/CAM techniques for use with CONELOG® CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for manufacture.

CAM Titanium Blanks are intended for the fabrication of abutments and healing caps/gingiva former on iSy® implants in the maxilla and mandible for the purpose of supporting single or multiple tooth prostheses of a partially or fully edentulous patient. Digitally designed abutments fabricated with CAD/CAM techniques for use with iSy CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for manufacture.

CAM Titanium Blanks are abutments with a prefabricated, precision interface (implant/abutment connection) and a screw channel suitable for the respective implant system. CAM Titanium Blanks are to be used by a CAMLOG validated milling center with CAD/CAM technology to fabricate a final finished customized abutment made of titanium alloy. Each patient-specific abutment is individually prescribed by the clinician as a temporary, permanent, single, or multi-unit abutment. Computer-aided manufacturing (CAM) techniques are used to process the cylinder portion above the implant connection into an individual abutment or healing cap/gingiva former design. The healing cap/gingival former is temporary and used during healing. Permanent abutments have straight and angled designs that can be used for crowns, bridges or overdentures.

CAM Titanium Blanks are available for CAMLOG SCREW-LINE and ROOT-LINE implants fitting five implant diameters (3.3. 3.8. 4.3. 5.0. 6.0 mm), for CONELOG SCREW-LINE implants fitting four implant diameters (3.3. 3.8, 4.3, 5.0 mm), and for the iSy implants with one connection fitting three implant diameters (3.8, 4.4, 5.0 mm).

This document is a 510(k) summary for the "CAM Titanium Blanks" dental device, which is related to endosseous dental implant abutments. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting a performance study with specific acceptance criteria and detailed quantitative results.

Therefore, much of the requested information regarding acceptance criteria and performance study specifics for an AI/ML device (like sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not applicable or present in this regulatory submission.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide specific quantitative acceptance criteria or corresponding reported device performance values in the way one might see for an AI/ML diagnostic or predictive device (e.g., sensitivity, specificity, AUC thresholds). Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence through:

• Non-clinical testing: This includes sterilization validation, biological evaluation, and mechanical testing. The acceptance here is successful completion according to the referenced standards.
• Comparison of Indications for Use: The claim is that the indications are "substantially equivalent."
• Comparison of Technological Characteristics: The claim is that the characteristics are "similar" or "substantially equivalent."

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

• This document is for a mechanical dental device (titanium blanks for abutments), not an AI/ML-driven device that typically uses test sets of data.
• The "test set" here refers to the actual physical devices subjected to non-clinical tests. The sample sizes for these specific non-clinical tests (sterilization, biological, MR, mechanical) are not explicitly stated in this summary, but would be defined by the relevant ISO/ASTM standards referenced.
• Data provenance (country of origin, retrospective/prospective) is not applicable in the context of this summary for a mechanical device.

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 mechanical device, not an AI/ML device relying on expert-labeled ground truth data. The "ground truth" for mechanical properties would be derived from standard test methods and measurements, not expert consensus on interpretations.

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

• Not applicable. This is a mechanical device.

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/ML diagnostic tools that assist human readers, which this device is not.

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

• Not applicable. This is a mechanical device, not an algorithm.

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

• The "ground truth" for demonstrating the safety and effectiveness of this mechanical dental device is based on established engineering standards and material properties testing. For example, the "ground truth" for mechanical strength is whether the device withstands specified forces according to ISO 14801. The "ground truth" for biocompatibility is conformance to ISO 10993-1.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI/ML device trained on data.

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

• Not applicable.

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CAMLOG® and CONELOG® Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CAMLOG® and CONELOG® implants to support prostheses in the maxillary and/or mandibular arch.

iSy® Abutments are intended to be used to fabricate prosthetic restorations in conjunction with iSy implants to support prostheses in the maxillary and/or mandibular arch.

Abutment for Bridges is a straight abutment designed for multi-unit, cement-retained restorations. It is available with two gingival heights (0.8 and 2.0 mm) for CONELOG and iSy and one gingival height for CAMLOG.

Abutment for Bridges is available for CAMLOG, CONELOG and iSy Implant Systems. It is available in five CAMLOG platform diameters (3.3 mm, 4.3 mm, 5.0 mm, and 6.0 mm), four CONELOG platform diameters (3.3 mm, 3.8 mm, 4.3 mm and 5.0 mm), and one iSy interface connection.

The Temporary Abutment is a straight, one-piece titanium abutment for cement-retained provisional restorations. It is available in a non-indexed bridge version for CAMLOG, CONELOG and iSy, and an indexed crown version for CAMLOG implant system.

This document is a 510(k) premarket notification from the FDA regarding a dental device called "Abutment for Bridges" by ALTATEC GmbH. It does not provide information about acceptance criteria and performances of an AI/ML-based medical device. Therefore, I cannot extract the requested information like acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods related to an AI device.

The document discusses the substantial equivalence of the "Abutment for Bridges" to previously marketed predicate devices. It includes:

• Device Name: Abutment for Bridges
• Regulation Number: 21 CFR 872.3630
• Regulation Name: Endosseous dental implant abutment
• Regulatory Class: II
• Product Code: NHA
• Intended Use: To fabricate prosthetic restorations in conjunction with CAMLOG®, CONELOG®, and iSy® implants to support prostheses in the maxillary and/or mandibular arch.
• Performance Data (Non-clinical): Sterilization validation (ISO 17665-1, ISO 17665-2), biological evaluation (ISO 10993-1), and reference to biocompatibility of the applicant's predicate devices (K113779, K133991, K0823496).
• Clinical Data: "No clinical data were included in this submission."

The document focuses on demonstrating substantial equivalence based on material, design, intended use, operating principle, and sterilization processes compared to predicate devices, not on evaluating performance against specific acceptance criteria for a new functionality through a clinical study.

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CAMLOG® and CONELOG® Abutments for Screw-retained Restorations (ASR) are intended to support occlusal screw- retained prosthetic restorations in the upper jaw and lower jaw in conjunction with CAMLOG® and CONELOG® Implants.

Abutment for Screw-retained Restorations (ASR) is available with the Camlog or the Conelog implant/abutment interface. ASR Straight is provided in five platform diameters (3.3. 3.8. 4.3. 5.0 and 6.0 mm) and three gingival heights (0.5, 2.0 and 4.0 mm), for a total of 15 abutment options. ASR Angled is provided in four platform diameters (3.3, 3.8, 4.3, and 5.0 mm), four gingival heights (2.5, 3.5, 4.0 and 5.0 mm), and two angles (17° and 30°). Each of the angled designs is provided in a Type A option (anti-rotation cam alignment away from the abutment cone angle) or Type B option (anti-rotation cam alignment in the direction of the abutment cone angle), for a total of 32 abutment options. A healing cap, and a titanium cap for temporary or permanent restoration fabrication are available for all sizes. All ASR components are made from titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

This document describes the premarket notification (510(k)) for the CAMLOG® and CONELOG® Abutments for Screw-retained Restorations (ASR). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct clinical effectiveness against specific acceptance criteria. Therefore, the information typically requested regarding acceptance criteria and a study proving those criteria are met is not directly applicable in the same way as for a novel device or a clinical trial.

However, based on the provided text, we can infer the equivalence criteria and the studies performed to demonstrate substantial equivalence, which serves a similar purpose in the 510(k) process.

Here's the breakdown of the information related to acceptance criteria and supporting studies, interpreted within the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the "acceptance criteria" are predominantly related to demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and material. The "reported device performance" is the comparison made against the predicate devices.

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

For a 510(k) submission focused on substantial equivalence through non-clinical testing, there isn't a "test set" in the traditional sense of a clinical study with a patient cohort.

• Non-Clinical Tests: The sample sizes for each non-clinical test (sterilization, biocompatibility, mechanical fatigue) would be determined by the specific ISO standards referenced (e.g., ISO 14801 for fatigue testing often specifies sample sizes for statistical significance). These details are not provided in the document.
• Data Provenance: The data provenance is from non-clinical laboratory testing conducted by the manufacturer (Altatec GmbH). The country of origin for the data is Germany (manufacturer's location). The data is prospective in the sense that these tests were conducted specifically for this submission.

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

This information is not applicable as there was no clinical test set requiring expert ground truth establishment. The ground truth for the non-clinical tests is based on the specific requirements and methodologies outlined in the referenced ISO standards.

4. Adjudication Method for the Test Set

This information is not applicable as there was no clinical test set.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data were not submitted in this premarket notification."

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

This question is not applicable as the device is a physical dental abutment and not an AI algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is defined by the established international standards (ISO standards) referenced. For example:

• For sterilization, the ground truth is achieving the specified Sterility Assurance Level (SAL) per ISO 11137.
• For biocompatibility, the ground truth is demonstrating no unacceptable biological responses based on ISO 10993-1.
• For dynamic fatigue, the ground truth is withstanding specified loads for a defined number of cycles, as per ISO 14801.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical dental abutment and not an AI algorithm.

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

This question is not applicable as the device is a physical dental abutment and not an AI algorithm.

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iSy® Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. iSy" Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

iSy Implant System implants are self-tapping, root form, tapered endosseous dental implants made of titanium. The implant has a smooth machined surface in the transgingival portion, and a Promote surface on the endosseous portion. The subject device implants are provided in two lengths (7.3 and 16 mm) and three diameters (3.8, 4.4 and 5.0 mm). The subject device includes four abutment types, gingiva former, temporary abutment, Locator® and Esthomic Abutment. Abutments are compatible with all three diameters (3.8, 4.4 and 5.0 mm). The Esthomic abutment is available with three design angulations (0°, 15°, 20°). iSy® Implant System Abutments are intended for use as support for crowns, bridges or overdentures.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) premarket notification clearance letter for the iSy® Implant System, which establishes its substantial equivalence to previously marketed devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given text.

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CONELOG® Titanium base CAD/CAM

• Implant-prosthetic titanium abutment for CONELOG® implants with connection, as a bonding base for hybrid abutments.
• The Titanium base CAD/CAM for implant Ø 3.3 mm is designed only for hybrid abutments in the area of the upper lateral incisors and lower central and lateral incisors.

CONELOG Titanium base CAD/CAM is an abutment designed to be used with the Sirona CAD/CAM System in Coris ZI meso L and meso S to fabricate a hybrid abutment with an angle up to 20°.The Titanium base CAD/CAM is available in four implant platform sizes (3.3 mm 3.8 mm, 4.3 mm, and 5.0 mm), two gingival heights (0.8 mm or 2.0 mm) and is supplied with the corresponding screw. All design parameters are according to the cleared Sirona CAD/CAM System parameters.

This document is a 510(k) summary for the CONELOG® Titanium base CAD/CAM. It describes the device, its intended use, and the data submitted to demonstrate substantial equivalence to legally marketed predicate devices.

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

The document does not specify quantitative acceptance criteria. Instead, it relies on performance testing designed to demonstrate mechanical integrity under relevant dental conditions.

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

The document does not specify the exact sample size for the non-clinical testing. It only states that "non-clinical testing data submitted" was used. The provenance of the data (country of origin, retrospective/prospective) is not mentioned.

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)

This is a medical device submission for a physical implant component, not an AI or imaging-based diagnostic tool. Therefore, there is no "ground truth" in the diagnostic sense, and no experts were used to establish such. The "ground truth" for this type of device is its mechanical robustness and compliance with established standards.

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

Not applicable, as this is not an imaging or diagnostic study requiring adjudication for 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 is a submission for a physical dental implant component, not an AI-assisted diagnostic tool.

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

Not applicable. This is a submission for a physical dental implant component, not an algorithm.

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

The "ground truth" in this context is the successful completion of established mechanical performance tests (ISO 14801) designed to simulate in-vivo conditions. The device is expected to withstand specified static and dynamic forces without failure, demonstrating its structural integrity and safety.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no training set in the conventional sense.

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

Not applicable. See point 8.

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iSy® Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. iSy® Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

The iSy Implant System is an endosseous dental implant system designed for ease of use. Each product package contains the components needed for implant placement, impression taking, gingival contouring, and temporization. Components available with the iSy Implant System include the implant base, cover cap, multifunctional cap, gingiva former, universal abutment and Titanium base CAD/CAM. The implants are provided in three diameters (3.8, 4.4 and 5.0 mm) and three lengths (9, 11, and 13 mm). The implant/abutment interface is identical for all sizes and, therefore, only one abutment connection is necessary. The implant base is a mount, supplied with the implant, that also can be used for temporary restoration. Titanium base CAD/CAM is an abutment designed to be used with the Sirona CAD/CAM System in Coris ZI meso L and meso S to fabricate a hybrid abutment with an angle up to 20°. The cover cap, multifunctional cap and gingiva former are temporary abutments used during healing. The universal abutment and titanium base CAD/CAM are abutments used for final restoration. The iSy implants are made of unalloyed titanium, iSy implant base, universal abutment and Titanium base CAD/CAM are made of titanium alloy, and iSy cover cap, multifunctional cap and gingiva former are made of polyetheretherketone.

The provided document is a 510(k) premarket notification for the Altatec GmbH iSy® Implant System. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

However, the document does not contain information related to acceptance criteria, device performance, ground truth establishment, sample sizes for test/training sets, adjudication methods, or MRMC studies for an AI/ML powered medical device. The device described is an endosseous dental implant system, which is a physical medical device, not a software or AI/ML product.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. The document refers only to non-clinical testing data such as engineering analysis, dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801. It explicitly states: "Clinical data were not submitted in this premarket notification."

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CONELOG® Implant System Implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. CONELOG® Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

CONELOG® Implants with 3.3 mm diameter have the following additional specific indications:
These are an alternative in cases where the alveolar ridge width is only 5 - 6 mm. Because of their lower mechanical strength compared with larger diameter implants, they should only be used under the following conditions:

• As single implants, they should be used only to replace mandibular incisors and/or maxillary lateral incisors.
• An edentulous arch can only be restored with a bar retained superstructure with at least four implants of 3.3 mm diameter without distal extensions.
• Implants of Ø 3.3 mm are suitable for a partially edentulous arch when combined with implants of larger diameter for splinted superstructures. However, the limited strength of the implants with Ø 3.3 mm must be taken into account.
• Avoid excessive mechanical stressing of the implants when using ball abutments in combination with Ø 3.3 mm implants.
• The healing time for Ø 3.3 mm implants is at least 12 weeks.

CONELOG® Implants with 7 mm length have the following additional specific indications:
CONELOG® SCREW-LINE Implants should only be used when there is not enough space for a longer implant. Delayed loading in single tooth replacement is indicated with these implants. If the ratio of crown length to implant length is unfavorable the biomechanical risk factors have to be considered and appropriate measures have to be taken by the dental professional.

Abutment Indications for Use
CONELOG® Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch.

Vario SR Indications for Use
CONELOG® Vario SR components for crown and bridge restorations:

• Occlusal screw-retained crown, bridge and bar constructions on CONELOG® implants in the anterior and posterior region of the maxilla and mandible
  CONELOG® Vario SR components for bar restorations:
• Anchorage of implant-supported full dentures for the edentulous maxilla in conjunction with 4 or more CONELOG® implants and in the edentulous mandible in conjunction with 2 or 4 or more CONELOG® implants.

The purpose of this submission is to add an alternative to the CAMLOG® Implant System by the introduction of an implant line with a tapered implant abutment interface. The new line of implants and abutments is named the CONELOG® Implant System. The primary features of the current CAMLOG Implant System are a change from the tube-in-tube interface with a square cam design for anti-rotation to the tapered implant/abutment interface connection with three positioning cams and the addition of a 7.0 mm long implant. The three positioning cams of the CONELOG abutments are placed more apically on the abutment shaft but are comparable in design principle to the three positioning cams of the CAMLOG Implant System. All other design features of the system remain the same.

The CONELOG implant system features an implant/abutment interface that includes a 7.5° taper with anti-rotation cams at the base of the connection. Components available with the CONELOG implant/abutment interface include the SCREW-LINE Promote® plus implant and cover screw, healing caps, Universal abutments, Telescope abutments, Esthomic" abutments, the Esthomice abutment inset, temporary abutments, Gold-plastic abutments, Logfit® abutments, ball abutments, bar abutments and Vario SR abutments. All components correspond to previously cleared CAMLOG components with the tube-in-tube interface.

The provided document is a 510(k) summary for a medical device (dental implant system) and does not contain information about acceptance criteria or a study proving device performance against such criteria. The document describes the device, its intended use, its equivalence to previously marketed devices, and the administrative information for its 510(k) clearance.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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CAMLOG® Vario SR components for crown and bridge restorations:

• Occlusal screw-retained crown, bridge and bar constructions on CAMLOG® implants (with J and K article numbers) in the anterior and posterior region of the maxilla and mandible
  CAMLOG® Vario SR components for bar restorations:
• Anchorage of implant-supported full dentures for the edentulous maxilla and mandible in combination with 2, 4 or more CAMLOG® implants (with J and K article numbers)

CAMLOG® Vario SR Abutments are titanium dental implant abutments for use with the CAMLOG® Dental Implant System. They have an internal connection to the implant, a conical interface with the prosthetic attachment, and are used for single and multi-unit screw-retained, prefabricated restorations. They are appropriate for supporting laboratory cast frameworks as well as laser-welded bar constructions and have dedicated prosthetic components.

The provided text describes the 510(k) summary for Altatec GmbH CAMLOG® Vario SR Abutments. This is a medical device submission, and the information requested pertains to the evaluation of AI/ML-driven medical devices. Unfortunately, the provided document does not contain any information about an AI/ML-driven device or its performance evaluation.

Instead, the document details a traditional medical device (dental implant abutments) and its substantial equivalence to other legally marketed predicate devices. The "testing" mentioned refers to mechanical testing according to ISO 14801 for static and dynamic fatigue properties of the physical device.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about studies involving sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as these concepts are not applicable to the content provided.

I can, however, extract the relevant "testing" information for this specific device from the provided text, which focuses on mechanical performance:

Acceptance Criteria and Device Performance (for mechanical properties of the physical device):

Regarding the other requested information (AI/ML specific details):

1. Sample size used for the test set and the data provenance: Not applicable as the device is not AI/ML-driven.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device would be its physical strength and material properties.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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CAMLOG® Abutments PS are intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch.

The CAMLOG Implant System CAMLOG Abutments PS (Platform Switching) allows the treatment option of using a smaller abutment interface diameter than the platform diameter of the implant. The system includes a series of permanent abutments, temporary abutments and healing caps.

The provided text is a 510(k) summary for the Altatec GmbH CAMLOG® Abutments PS, which is a dental implant abutment. This type of regulatory submission is focused on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or performance through clinical studies with acceptance criteria in the way a novel drug or high-risk medical device might.

Therefore, the document does not contain information regarding a study with specific acceptance criteria, sample sizes for test or training sets, expert ground truth establishment, or comparative effectiveness studies in the way you've outlined. The FDA 510(k) process for a device like this relies heavily on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through design, material, and manufacturing similarities, and often through bench testing rather than human-centric clinical trials.

The provided text only includes the following relevant information to your request:

1. A table of acceptance criteria and the reported device performance:
This information is not present in the document. The 510(k) focuses on equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information on a test set sample size or data provenance is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
No information on experts establishing ground truth is provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
No information on an adjudication method is provided.

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 MRMC study information is provided. This device is a physical dental abutment, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
No information on ground truth is provided.

8. The sample size for the training set:
No information on a training set sample size is provided.

9. How the ground truth for the training set was established:
No information on ground truth for a training set is provided.

Summary of available information:

• Intended Use: Used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch.
• Device Description: The CAMLOG® Abutments PS (Platform Switching) allows the treatment option of using a smaller abutment interface diameter than the platform diameter of the implant. The system includes a series of permanent abutments, temporary abutments, and healing caps.
• Equivalence to Marketed Product: The submission demonstrates that the device is substantially equivalent to predicate devices based on:
  • Same operating principle.
  • Same basic design.
  • Same materials.
  • Same packaging and sterilization methods.

In conclusion, the 510(k) summary for Altatec GmbH CAMLOG® Abutments PS does not contain the type of detail you are requesting regarding acceptance criteria, study methodologies, and ground truth establishment because it's a submission focused on substantial equivalence for a physical medical device, not an AI/diagnostic tool.

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