Search Results

Implant:
The ELEMENT PF 3.0 is suitable for use in one-stage or two-stage surgical techniques for restoring chewing function. The ELEMENT PF 3.0 is suitable for immediate implantation in case of replacement of several teeth; prerequisites are good primary stability and appropriate occlusal loading. The ELEMENT PF 3.0 must only be used for replacement of the lateral incisors of the upper jaw and lateral incisors of the lower jaw.

VARIOunite PF 3.0:
Thommen Medical VARIOunite abutments PF 3.0 are only used in conjunction with the ELEMENT PF 3.0 and are for fabrication of provisional and final crowns in the anterior maxilla and mandible (upper lateral incisors, lower anterior teeth).
Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.

VARIOunite:
Thommen Medical VARIOunite abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.
Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.

ELEMENT Ø 3.0 is a self-tapping, root form, endosseous dental implant made of commercially pure titanium. It is provided in two surfaces (TST and INICELL) and five lengths (8.0, 9.5, 11.0, 12.5, and 14 mm). Subject device components available for the ELEMENT Ø 3.0 implant are the healing cap, gingiva former and VARIOunite abutments. VARIOunite abutments can be used for temporary restorations, permanent restorations, or CAD/CAM zirconia superstructures. The indications for previously cleared VARIQunite abutments have been expanded to include angulation of the CAD/CAM zirconia superstructures.

This document describes a 510(k) premarket notification for the Thommen Implant System, specifically focusing on the ELEMENT PF 3.0 dental implant and VARIOunite abutments.

Here's an analysis of the acceptance criteria and the study used to demonstrate equivalence, based on the provided text:

No specific acceptance criteria in terms of performance metrics (e.g., success rates, survival rates, specific mechanical thresholds for clinical outcomes) are explicitly stated in this document for the device. The submission focuses on demonstrating substantial equivalence to predicate devices. This means the device is considered safe and effective because it is as safe and effective as a legally marketed device (predicate device).

The "study" or rather, the evidence provided, primarily consists of non-clinical testing data and comparisons to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, no explicit quantitative acceptance criteria or corresponding clinical performance metrics are provided in the document. The general "acceptance criteria" for a 510(k) submission are that the new device is "substantially equivalent" to predicate devices in terms of intended use, technological characteristics, and materials, and that any differences do not raise new questions of safety or effectiveness.

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

• Sample Size: Not applicable in the context of clinical trials. For non-clinical testing (mechanical, sterilization, etc.), specific sample sizes are not detailed in this summary. These tests typically involve a pre-defined number of units/samples for each test type according to the relevant standard.
• Data Provenance: The data is non-clinical, originating from laboratory testing conducted to international (ISO, ASTM) and FDA guidance standards. The manufacturer is Thommen Medical AG, Switzerland. The data is not derived from human subjects or patient populations.

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

• This is not applicable as the submission did not include clinical data or studies requiring expert review of patient cases to establish ground truth.

4. Adjudication Method for the Test Set

• This is not applicable as the submission did not include clinical data requiring adjudication.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical data were included in this submission." This type of study is typically used for diagnostic or imaging devices, not for dental implants which rely on mechanical and biological performance demonstrated through non-clinical testing and clinical experience with similar devices.

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

• This is not applicable. The device is a physical dental implant system, not a software algorithm.

7. The Type of Ground Truth Used

• For the non-clinical tests, the "ground truth" is defined by the specifications and acceptable limits set by recognized international standards (ISO, ASTM) and FDA guidance documents for each specific test (e.g., sterilization effectiveness, material strength, biocompatibility, packaging integrity).

8. The Sample Size for the Training Set

• This is not applicable. There is no software algorithm or AI model being trained for this device.

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

• This is not applicable as there is no software algorithm or AI model being trained for this device.

Ask a specific question about this device

VARIOflex Thommen Medical VARIOflex Abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures. VARIOtemp Thommen Medical VARIOtemp Abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.

VARIOunite is a straight titanium dental implant abutment with retention groves that can be used for either permanent or temporary screw-retained or cement-retained restorations. Labeled as VARIOflex, it is provided with a burn-out sleeve for fabrication of a permanent restoration. Labeled as VARIOtemp, it is provided with a fabrication screw for fabrication of a temporary restoration. VARIOunite can be prepared to the appropriate occlusal height prior to fabrication of the restoration using the retention rings for guidance. VARIOunite is available with an indexed connection for crowns or a non-indexed connection for bridges. It is available in five platform diameters (3.5, 4.0, 4.5, 5.0 and 6.0 mm) corresponding to existing platform diameters of the Thommen System dental implants.

The provided text does not contain information about acceptance criteria for a medical device or a study proving its performance against such criteria. The document is an FDA 510(k) premarket notification letter for a dental implant abutment called "VARIOunite."

It focuses on establishing substantial equivalence to previously marketed predicate devices, rather than presenting a performance study with acceptance criteria.

The document discusses:

• Device Name: VARIOunite
• Regulation Number/Name: 21 CFR 872.3630, Endosseous Dental Implant Abutment
• Product Code: NHA
• Predicate Devices: K121334 (VARIOeco) and K120414 (OsseoSpeed™ Plus)
• Indications for Use: Support for crowns, bridges, and overdentures in conjunction with Thommen System dental implants.
• Device Description: Straight titanium dental implant abutment, available as VARIOflex (for permanent restorations) and VARIOtemp (for temporary restorations).
• Performance Data (Non-clinical): Sterilization validation (ISO 17665-1, ISO/TR 17665-2) and biocompatibility evaluation (ISO 10993-1).
• Clinical Data: Explicitly states, "Clinical data were not submitted in this premarket notification."
• Equivalence Comparison: A table comparing the subject device (VARIOunite) with the primary and reference predicate devices in terms of indications, design (straight, prepable/non-prepable), diameter, restoration type, implant connection, and material.

Therefore, I cannot provide the requested table or details about a performance study, sample sizes, experts, adjudication methods, or MRMC studies, as this information is not present in the provided text. The document clearly states that "Clinical data were not submitted in this premarket notification." and instead relies on non-clinical testing and comparison to predicate devices to establish substantial equivalence.

Ask a specific question about this device

Thommen Milling abutments for CAD/CAM are intended to be used in conjunction with Thommen System dental implants in the maxillary and /or mandibular arch to provide support for crowns, bridges and overdentures.

All digitally designed abutments for use with Thommen Milling abutments for CAD/CAM are intended to be sent to a Thommen validated milling center for manufacture.

The Milling Abutment for CAD/CAM is an abutment used by a dental laboratory equipped with the 3Shape CAD/CAM System to fabricate a customized abutment made of titanium. Each patient-specific abutment is individually prescribed by the clinician. Minimum wall thickness allowed for the final abutment is 0.4 mm, maximum angulation is 20°, maximum gingival height is 7.0 mm, and total height of the abutment is no greater than 15 mm and no shorter than 4.5 mm. All digitally designed abutments for use with Thommen Milling abutments for CAD/CAM are intended to be sent to a Thommen validated milling center for manufacture. Final abutments are to be sterilized prior to intraoral placement.

Milling Abutment for CAD/CAM is available in five diameters (3,5 mm, 4,0 mm, 5,0 mm, 6,0 mm) and two heights (12 mm and 15 mm). The Ø3.5 mm abutment is provided in the 12 mm height. All other diameters are provided in the 15 mm height. Each abutment is supplied with a corresponding screw. Milling Abutment for CAD/CAM is compatible with the Thommen Implant System ELEMENT and CONTACT implants.

This document is a 510(k) Summary for a medical device called "Milling Abutment for CAD/CAM". It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and detailed performance studies with statistical analysis as typically seen for AI/ML devices or novel technologies.

Therefore, much of the requested information cannot be directly extracted from this document, as it pertains to a different type of regulatory submission and device.

However, I can provide the information available that is relevant to "acceptance criteria" in the context of this 510(k) submission, and the "study" (non-clinical testing) used to support its substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" in the way one might expect for a diagnostic AI device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by the performance standards and regulations the device must meet for substantial equivalence, and the "reported device performance" is the confirmation that these standards were met.

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

• Sample Size: The document does not specify a "test set" sample size in the context of an AI/ML algorithm evaluation. The non-clinical testing mentioned (sterilization, biocompatibility, input/output validation, mechanical testing) would have involved a sample of the manufactured devices or components, but the specific numbers are not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data for an AI/ML device. The "data" here refers to non-clinical test results from the manufacturer (Thommen Medical AG, Switzerland).

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

• This is not applicable as the device is not an AI/ML diagnostic algorithm that requires expert-established ground truth from a test set of images or medical records. The "ground truth" for this device's performance is established by adherence to engineering standards, material properties, and manufacturing specifications.

4. Adjudication Method for the Test Set

• Not applicable for this type of device and 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 dental abutment, a physical component, not an AI/ML software for assisting human readers.

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

• Not applicable, as this is a physical medical device, not an algorithm.

7. The type of ground truth used

• The "ground truth" for validating this device's performance relies on:
  • Engineering Standards: ISO 17665-1, ISO 17665-2 (for sterilization); ISO 10993-1 (for biocompatibility); ISO 14801 (for mechanical testing).
  • Manufacturing Specifications: Established design parameters for wall thickness, angulation, height, etc., and the accuracy of the CAD/CAM library output.
  • Predicate Device Characteristics: The established safety and effectiveness of the legally marketed predicate devices to which this device is claiming "substantial equivalence."

8. The sample size for the training set

• Not applicable. This device does not use an AI/ML algorithm that requires a "training set."

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

• Not applicable.

Ask a specific question about this device

Thommen VARIOeco dental implant abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.

VARIOeco abutments are titanium dental implant abutments for use with Thommen System dental implants for fabrication of porcelain-fused-to-metal (PFM) restorations. VARIOeco includes two abutment designs, one for single tooth (crown) and one for multi-tooth (bridge) restorations. A laboratory burn-out cap and abutment screw are provided together with the abutment in the VARIOeco set. Both VARIOeco abutment designs are provided in five platform diameters (3.5, 4.0, 4.5, 5.0 and 6.0 mm) corresponding to Thommen System dental implants (ELEMENT, CONTACT and ONETIME).

This document is a 510(k) summary for the Thommen Medical AG VARIOeco dental implant abutment. It establishes substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a formal study with statistical endpoints. Therefore, most of the requested information regarding acceptance criteria, study sample sizes, expert involvement, and ground truth establishment is not present in this type of submission.

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific performance acceptance criteria for the VARIOeco abutment in the way a clinical trial or performance study would. Instead, it focuses on demonstrating substantial equivalence to legally marketed predicate devices. The "performance" assessment is primarily a comparison of intended use, technological characteristics, and materials to established devices.

2. Sample Size for Test Set and Data Provenance

Not applicable. This is a 510(k) premarket notification for demonstrating substantial equivalence based on a comparison of device characteristics, not a study involving a test set of data or human subjects.

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

Not applicable. Ground truth as typically understood in a study context (e.g., for diagnostic accuracy) is not established in this type of submission. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There is no test set in the context of a performance study to adjudicate.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This device is a dental implant abutment, and its approval process does not typically involve such studies.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

No, a standalone performance study in the context of an algorithm or AI is not applicable. This is a physical medical device.

7. Type of Ground Truth Used

The "ground truth" in this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The U.S. FDA's substantial equivalence determination means that the new device (VARIOeco) is as safe and effective as a legally marketed device (predicate device).

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

Not applicable.

Ask a specific question about this device

Thommen SPI® VARIO Angled Abutments are intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for crowns or bridges.

SPI® VARIO Angled Abutments are titanium dental implant abutments for use with the SP1® Dental Implant system. They connect with the internal hex feature of the implant, have a precision fit interface with the prosthetic attachment, and are intended for screw retained restorations in single unit and small multi-unit solutions. SPI VARIO Angled Abutments are designed for correction of implant divergence and can be used in combination restorations with SPI VARIO abutments.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SPI® VARIO Angled Abutment.

It's important to note that the provided text is a 510(k) Summary, which focuses on demonstrating substantial equivalence to predicate devices, not on proving new clinical effectiveness or performance against specific acceptance criteria in the way an AI/ML device study might. Therefore, many of the typical questions for AI/ML device studies (like sample sizes for test/training sets, expert qualifications, adjudication, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.

The "acceptance criteria" here are implicitly tied to demonstrating substantial equivalence through performance testing, primarily mechanical, rather than predictive accuracy.

Acceptance Criteria and Reported Device Performance

Study Details (Based on available 510(k) Summary Information)

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

   • Test Set Sample Size: Not explicitly stated. The "performance testing" referenced is mechanical testing (ISO 14801), which would involve a certain number of physical units subjected to cyclic loading. This is physical device testing, not a clinical data test set.
   • Data Provenance: Not applicable in the sense of clinical data. This refers to laboratory-based mechanical testing of the device itself.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on objective measurements against engineering standards (like ISO 14801), not expert interpretation.

3. Adjudication method for the test set: Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication.

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. This is not an AI/ML device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

6. The type of ground truth used: For the mechanical aspects, the ground truth is established by the specified ISO 14801 standard and the physical properties and failure points observed during testing. For biological aspects, it's the known biocompatibility and safety profile of the titanium material used, supported by the predicate devices.

7. The sample size for the training set: Not applicable. This is not an AI/ML device with a training set.

8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device with a training set.

Summary of the Study:

The "study" described in this 510(k) summary is not a clinical trial or an AI/ML performance study. Instead, it's a benchtop performance testing study focused on mechanical properties. The central purpose of the submission is to demonstrate substantial equivalence to already legally marketed predicate devices, not to establish novel clinical effectiveness or safety from a blank slate.

The key study mentioned is:

• Method: Performance testing "included methods described in ISO 14801." ISO 14801 is an international standard for dynamic loading of endosseous dental implants. This standard specifies methods for fatigue testing, which is crucial for dental implant components that experience cyclic forces during chewing.
• Purpose: To show that the SPI® VARIO Angled Abutment performs mechanically at a level comparable to the predicate devices and meets established industry standards for durability and strength.
• Conclusion: The results of this testing, combined with the similarity in materials, design principles, and intended use, were deemed sufficient by the FDA to demonstrate substantial equivalence to the predicate devices (K031747, K072856, K090153), leading to the clearance of the device.

Ask a specific question about this device

Thommen Titanium Base for CAD/CAM abutments are intended to be used in conjunction with Thommen implants and the 3M ESPE Lava™ System in the maxillary and/or mandibular arch to provide support for crowns and bridges.

Titanium Base for CAD/CAM provides a foundation for a customized CAD/CAM abutments and restorations. It is suitable for precision fit custom abutments or crown and bridge restorations fabricated with CAD/CAM technology provided separately by 3M ESPE as the Lava System. The Titanium Base for CAD/CAM in conjunction with the 3M ESPE Lava System is not intended to be used to fabricate angled abutments. Titanium Base for CAD/CAM is made from commercially pure titanium, grade 4 conforming to ASTM F67, and the corresponding abutment screw (cleared under K031747) is made of titanium alloy, Ti-6Al-7Nb conforming to ASTM F1295.

The provided text is a 510(k) Summary for a medical device called "SPI® Titanium Base for CAD/CAM". This document aims to demonstrate substantial equivalence to legally marketed predicate devices, not to present a study proving the device meets specific acceptance criteria in the manner one might describe for a diagnostic or AI-driven device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set size) are not applicable to this type of regulatory submission.

The "acceptance criteria" in this context refer to the demonstration of "substantial equivalence" to predicate devices based on design, materials, intended use, and operating principles, rather than performance metrics from a formal clinical or technical study against predefined thresholds.

Here's a breakdown based on the information provided and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This submission is for a dental abutment demonstrating substantial equivalence to predicate devices, not a diagnostic or AI device requiring a test set of data. The "study" here refers to the comparison of the device's characteristics against those of already cleared devices.

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

• Not Applicable. See point 2.

4. Adjudication method for the test set

• Not Applicable. See point 2.

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 hardware device (dental abutment), not an AI-driven or diagnostic system.

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

• Not Applicable. This is a hardware device, not an algorithm.

7. The type of ground truth used

• Not Applicable in the traditional sense of a diagnostic study. The "ground truth" for this submission is established by the known characteristics and regulatory clearance of the predicate devices. The new device's characteristics are compared against these established devices.

8. The sample size for the training set

• Not Applicable. No training set is used for this type of submission.

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

• Not Applicable. See point 8.

Ask a specific question about this device

Thommen SPI® VARIOmulti Angled Abutments are intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for splinted crowns, bridges or overdentures.

SPI® VARIOmulti Angled Abutments are dental implant abutments for use with the SPI® Dental Implant System. They have an internal connection to the implant and are used for multi-unit, screw-retained, prefabricated restorations. VARIOmulti Angled Abutments are made of titanium and are available in diameters from 3.5 to 4.5 mm with an angle of 30° to the implant. The system includes dedicated prosthetic components including protective and temporary caps. SPI® VARIOmulti Angled Abutments are compatible with the Nobel Biocare Multi-unit Abutment System.

The provided text is for a 510(k) premarket notification for a dental implant abutment (SPI® VARIOmulti Angled Abutment). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable to this document. The focus here is on performance testing to show equivalence to a predicate device, not on a clinical trial with a defined acceptance threshold for performance metrics like sensitivity, specificity, etc.

Here's a breakdown of what can be extracted and what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document only states "Fatigue testing was performed." It doesn't mention the number of units tested.
• Data Provenance: Not specified. The testing was performed according to an international standard (ISO 14801), but the location of the testing facility or the origin of any "data" beyond the test results is not mentioned. It is not a clinical study, so concepts like "prospective" or "retrospective" are not relevant here.

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

Not applicable. This was a physical performance test for fatigue, not a study requiring expert clinical assessment or ground truth establishment in a diagnostic context.

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

Not applicable. This was a physical performance test for fatigue, not a study requiring adjudication of expert opinions.

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 document describes a dental implant abutment, not an AI-powered diagnostic device. An MRMC study is not relevant here.

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

Not applicable. This is a medical device (dental abutment), not an algorithm or AI system.

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

Not applicable. For the fatigue testing, the "ground truth" would be the engineering standard (ISO 14801) and the performance of the predicate device. There is no biological or outcome-based ground truth in this context.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. This device does not involve a "training set" or "ground truth" in the context of machine learning or AI.

Summary specific to this document:

The provided 510(k) summary focuses on demonstrating substantial equivalence of the new SPI® VARIOmulti Angled Abutment to previously cleared predicate devices (K090153 and K072856). The primary method used to support this claim, beyond shared materials and design, was fatigue testing according to ISO 14801. The acceptance criterion for this testing was that the device should have "sufficient resistance to fatigue and performed comparably to the predicate device." The study stated that this criterion was met. No other formal studies with clinical acceptance criteria, sample sizes, or ground truth establishment (as would be seen in diagnostic device submissions) are presented in this document.

Ask a specific question about this device

SPI® Dental Implant, ELEMENT is for one-stage or two-stage surgical procedures. SPI Dental Implant, ELEMENT is intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.

Contraindications for the use of SPI ELEMENT implant Ø 3.5 mm: These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements.

• Restoration of posterior teeth in the upper and lower jaw .
• Single-tooth restoration of canines and central incisors in the upper jaw .
• Any application involving retentive anchors .

The design of the Thommen Medical AG SPI® Dental Implant System implants has been modified to include new sizes and corresponding abutments that will be marketed as the SPI® Dental Implant, ELEMENT. All features other than these implant sizes remain the same as the currently marketed SP1® ELEMENT implants. Other components of the SP10 Dental Implant System have not been modified, are suitable for use with the modified implants, and will be sold under the SPI Dental Implant System name.

I am sorry, but the provided text describes a 510(k) summary for a dental implant device (SPI® Dental Implant, ELEMENT) and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is primarily focused on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than detailing performance studies with specific statistical metrics.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study details.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device

The SPI® Customizable Gingiva Former is intended to be used in conjunction with SPI® System dental implants to provide temporary support for crowns or bridges in the maxillary and/or mandibular arch.

The Thommen SPI® Customizable Gingiva Former is a temporary endosseous dental implant component made from an acrylic-based polymer with a titanium base at the implant/abutment interface for a stable, precise connection. The SPT® Customizable Gingiva Former is used for maintaining gingival contour and as a base for fabrication of a temporary restoration.

This 510(k) submission (K092248) for the Thommen Medical AG SPI® Customizable Gingiva Former does not contain the type of study data and acceptance criteria that would typically be found for a device requiring performance evaluation against specific metrics, especially for AI/ML-enabled devices.

This submission is a Special 510(k) for a device modification, specifically for an "Endosseous dental implant abutment." Special 510(k)s often involve modifications to already cleared devices where the changes do not significantly alter the fundamental scientific technology or intended use. In such cases, the review focuses on ensuring that the modifications do not raise new questions of safety and effectiveness, often relying on comparisons to the predicate device and established performance standards, rather than new extensive clinical or performance studies with detailed acceptance criteria and statistical analysis.

Therefore, many of the requested data points (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone algorithm performance, etc.) are not applicable or present in this document.

Here's an analysis based on the provided text, addressing the requested information where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly stated or applicable in the provided document. The submission focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance metrics with acceptance criteria for a new type of study.

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

Not applicable. This document does not describe a performance study with a test set of data in the context of an AI/ML device. The evaluation relies on the device description, intended use, and comparison to predicate devices, along with adherence to general controls.

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

Not applicable. No ground truth establishment process is described, as there isn't a performance study generating new data for evaluation.

4. Adjudication Method

Not applicable. No performance study data requiring adjudication is presented.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI-assisted diagnostic or therapeutic device that would undergo such a study.

6. Standalone (Algorithm Only) Performance Study

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

7. Type of Ground Truth Used

Not applicable. There is no ground truth data in the context of a performance study for this device type.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable.

Summary of Device and Approval Context:

• Device Name: SPI® Customizable Gingiva Former
• Intended Use: Used with SPI® System dental implants to provide temporary support for crowns or bridges in the maxillary and/or mandibular arch.
• Classification: Class II (Endosseous Dental Implant Abutment)
• Nature of Submission: Special 510(k) for a device modification. This implies the core technology and safety/effectiveness principles were established by previous predicate devices.
• Key Argument for Equivalence:
  • Same intended use
  • Same operating principle
  • Same or similar materials
  • Same basic design
  • Same packaging materials and processes

The FDA's letter explicitly states that they "have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination is the primary "acceptance criterion" for a 510(k) submission, and it is "proven" by demonstrating that the modified device does not raise new questions of safety or effectiveness compared to the predicates, as outlined in the "Equivalence to Marketed Product" section.

No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical strength limits with associated test results) are detailed in the provided portion, which is common for Special 510(k)s focusing on material or design modifications where existing general controls and predicate device performance are considered sufficient. If mechanical testing (e.g., fatigue, fracture) was performed to support the modification, the specific acceptance criteria and results would typically be in a separate section of the 510(k) submission, often referencing ISO or ASTM standards, but they are not provided in this excerpt.

Ask a specific question about this device

SPI® Dental Implant, INICELL® is for one-stage or two-stage surgical procedures. SPI Dental Implant, INICELL is intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.

Contraindications for the use of SPI ELEMENT INICELL implant Ø 3.5 mm and SPI CONTACT INICELL implant Ø 3.5 mm:

These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements.

• Restoration of posterior teeth in the upper and lower jaw
• Single-tooth restoration of canines and central incisors in the upper jaw
• Any application involving retentive anchors

The design of the Thommen Medical AG endosseous dental implants has been modified to include a new surface treatment that will be marketed as the SP1® Dental Implant, INICELL® All features other than this surface treatment of the implants remain the same as the TST Surface implants. Other components of the SP1® Dental Implant System have not been modified, are suitable for use with the modified implants, and will be sold under the SPI Dental Implant System name.

The provided 510(k) summary for the Thommen Medical AG SPI® Dental Implant, INICELL® does not contain information related to acceptance criteria, device performance, or any studies proving the device meets specific acceptance criteria.

Instead, the document focuses on establishing substantial equivalence to previously marketed predicate devices based on similarities in intended use, operating principle, basic design, materials, packaging, and sterilization processes.

Therefore, I cannot provide the requested information in the format specified. The document primarily functions as a regulatory submission demonstrating equivalence, not as a report on a clinical or performance study with defined acceptance criteria and statistical outcomes.

Ask a specific question about this device