Search Results

DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed custom abutments for use with DESS Bases or Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture, or to be designed and manufactured according to the digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine, and associated tooling and accessories.

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K221301 and K240982 to allow additional options of zirconia material, scanners, CAM software, and milling machines to the digital dentistry workflow. The subject devices are to be sent to Terrats Medical validated milling centers for manufacture, or to be designed and manufactured via a digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, titanium and ceramic material, milling machine, and associated tooling and accessories. There are no changes to the abutment design, implant compatibilities, or design parameters. All part numbers have been cleared for manufacturing via a validated milling center and digital dentistry workflows (also referred to as point of care) under K221301 and K240982.

The subject device DESS Dental Smart Solutions abutments provide a range of prosthetic solutions for dental implant restoration. DESS abutments are offered in a variety of connection types to enable compatibility with currently marketed dental implants. All abutments are provided non-sterile, and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant.

Subject device Base Abutments are designed for fabrication of a patient-specific CAD/CAM zirconia superstructure on which a crown may be placed. They are two-piece abutments for which the second part (or top half) is the ceramic superstructure. They also may be used for support of a crown directly on the abutment.

All patient-specific custom abutment fabrication for Base Abutments and Pre-milled (Blank) Abutments is by prescription on the order of the clinician. The subject device Pre-milled (Blank) Abutments and all zirconia superstructures for use with the subject device Ti Base Interface, DESS Aurum Base, ELLIPTIBase, and DESS C-Base will be manufactured using a validated milling center or a digital dentistry workflow. A validated milling center will be under FDA quality system regulations. The digital dentistry workflow scans files from intra-oral and lab (desktop) scanners, CAD software, CAM software, titanium and ceramic material, milling machine and associated tooling and accessories.

The digital dentistry workflow uses scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

The provided 510(k) summary for DESS Dental Smart Solutions focuses on demonstrating substantial equivalence to predicate devices for dental implant abutments. It primarily addresses the expansion of compatible materials, scanners, CAM software, and milling machines within an existing digital dentistry workflow. The document does not describe an AI/ML-based device that would typically have acceptance criteria related to diagnostic performance.

Therefore, many of the requested items related to AI/ML device performance (like acceptance criteria for diagnostic metrics, sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this submission.

The acceptance criteria and supporting "study" (non-clinical data) for this device are related to its mechanical performance, biocompatibility, and integration within the digital workflow, demonstrating that the expanded components maintain the safety and effectiveness of the previously cleared predicate devices.

Here's a breakdown based on the information provided and the non-applicability of AI/ML-specific questions:

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

Since this is not an AI/ML diagnostic device, the acceptance criteria are not in terms of traditional diagnostic metrics (sensitivity, specificity, AUC). Instead, they are related to material properties, mechanical integrity, and the digital workflow's accuracy.

• Abutment design library validated to demonstrate established design limitations are locked and cannot be modified by the user. (Implies successful implementation and verification of design constraints.) |
  | CAM Restriction Zones / Manufacturing Accuracy | - Validation testing of CAM restriction zones conducted, including verification to show avoidance of damage or modifications of the connection geometry, and locking of restriction zones from user editing in CAM software. (Implies successful validation to ensure manufacturing precision and prevent damage.) |
  | Material Conformance | - Zirconia materials conform to ISO 6872.
• Titanium alloy conforms to ASTM F136.
• Co-Cr-Mo alloy conforms to ASTM F15337. (Implies materials meet standards.) |
  | Physical Dimensions | - Device encompasses the same range of physical dimensions as the predicate device. (Implies dimensional equivalence.) |

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 explicitly stated in terms of a "test set" for diagnostic performance. The validation involved physical testing of components (e.g., fatigue testing) and software verification. The specific number of abutments or digital design instances used for these non-clinical tests is not detailed in this summary.
• Data Provenance: Not applicable in the context of patient data for an AI/ML device. The "data" here refers to engineering and material testing results, likely conducted in controlled lab environments (implied to be in accordance with international standards like ISO and ASTM). The manufacturer is Terrats Medical SL, in Spain, so testing would likely originate from their facilities or contracted labs.

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. This is not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for this device relates to engineering specifications and material science.

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

Not applicable. This is not a diagnostic device involving expert review 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 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 not an AI/ML algorithm.

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

For this device, the "ground truth" is based on:

• Engineering Specifications: Defined design parameters (e.g., minimum wall thickness, post height, angulation limits).
• Material Standards: Conformance to international standards such as ASTM F136, ISO 6872.
• Benchmarking/Predicate Equivalence: Performance is assessed against established performance of the predicate devices and OEM implant systems.
• Software Validation Logic: Verification that software correctly enforces design rules and CAD/CAM restrictions.

8. The sample size for the training set

Not applicable. This device does not involve a machine learning training set.

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

Not applicable. This device does not involve a machine learning training set.

Ask a specific question about this device

DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K221301 to add the ability for the subject device Base Abutments and Pre-milled (Blank) Abutments to be designed using AbutmentCAD software in the digital dentistry workflow, as well as add angulation to some of the Pre-Milled (Blank) Abutments. The subject devices are to Terrats Medical validated milling centers for manufacture, or to be designed and manufactured via a digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, titanium and ceramic material, milling machine, and associated tooling and accessories. The proposed change is to allow the subject devices to be designed using AbutmentCAD by exocad GmbH, the current workflow allows only the use of 3Shape by 3Shape A/S for the design software. Another purpose of this submission is to expand the design parameters to allow angulation (up to 30°) on Pre-milled (Blank) Abutments that are compatible with Neodent Grand Morse, Nobel Active/Nobel Parallel Conical 3.0 mm, and Straumann BLX implants. There are no changes to the abutment design or implant compatibilities. All part numbers have been cleared for manufacturing via a validated milling center and digital dentistry workflows in under K221301.

The subject device DESS Dental Solutions abutments provide a range of prosthetic solutions for dental implant restoration. DESS abutments are offered in a variety of connection types to enable compatibility with currently marketed dental implants. All abutments are provided non-sterile, and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant.

Subject device Base Abutments are designed for fabrication of a patient-specific CAD/CAM zirconia superstructure on which a crown may be placed. They are two-piece abutments for which the second part (or top half) is the ceramic superstructure. They also may be used for support of a crown directly on the abutment.

All patient-specific custom abutment fabrication for Base Abutments and Pre-milled (Blank) Abutments is by prescription on the order of the clinician. The subject device Pre-milled (Blank) Abutments and all zirconia superstructures for use with the subject device Ti Base Interface, DESS Aurum Base, ELLIPTIBase, and DESS C-Base will be manufactured using a validated milling center or a digital dentistry workflow. A validated milling center will be under FDA quality system regulations. The digital dentistry workflow scans files from intra-oral and lab (desktop) scanners, CAD software, titanium and ceramic material, milling machine and associated tooling and accessories.

The digital dentistry workflow uses scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The digital workflow includes the following products (not subject devices of this submission):

• Ceramic material: VITA YZ ST and VITA YZ XT (K180703)
• . Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436)
• . Intraoral Scanner: 3Shape TRIOS A/S Series Intraoral Scanner (510(k) exempt under 21 CFR 872.3661)
• Desktop scanner: 3Shape D900 Dental Lab Scanner (510(k) exempt under 21 CFR 872.3661)
• Abutment design software: 3Shape Abutment Designer Software (K151455) and AbutmentCAD ● (K193352)
• . Milling machine: VHF R5 by vhf camfacture AG with DentalCAM and DentalCNC 7 software

The provided text describes a 510(k) premarket notification for DESS Dental Smart Solutions, which are dental implant abutments. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's effectiveness through clinical performance studies with specific statistical acceptance criteria for accuracy, sensitivity, or specificity.

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance (in terms of clinical metrics like accuracy, sensitivity, specificity).
• Sample size used for the test set or its provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study or its effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How the ground truth for the training set was established.

The study described in this document focuses on non-clinical performance data to demonstrate substantial equivalence, specifically:

1. Sterilization validation: According to ISO 17665-1, ISO 17665-2, and ISO 14937.
2. Biocompatibility testing: According to ISO 10993-5 and ISO 10993-12.
3. Fatigue testing and reverse engineering analysis: Of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility. This includes fatigue testing of OEM implant bodies with patient-specific abutments made at worst-case angled conditions.
4. MR Conditional labeling.
5. Validation testing of CAM restriction zones: Including verification to show avoidance of damage or modifications of the connection geometry, and locking of restriction zones from user editing in the CAM software.
6. Software verification: Included testing of restrictions that prevent design of components outside of the stated design parameters. The abutment design library was validated to demonstrate that established design limitations and specifications are locked and cannot be modified by the user.

The acceptance criteria and reported "performance" for this submission are based on these engineering and design validations, ensuring the device meets safety and performance standards equivalent to the predicate device, K221301. The key "performance" metrics are about maintaining physical and material integrity and compatibility.

The core of the submission is to expand the DESS Dental Smart Solutions abutment system to:

• Allow design using AbutmentCAD software (in addition to 3Shape software).
• Add angulation (up to 30°) to some Pre-milled (Blank) Abutments for specific implant systems.

The document explicitly states: "No clinical data were included in this submission." and "The subject device, the predicate device, and reference devices have the same intended use, technological characteristics, and are materials. The subject device, the predicate device, and reference devices encompass the same range of physical dimensions, manufactured by similar methods, are packaged in similar materials, and are to be sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above."

Therefore, this FDA submission is for a physical medical device (dental implant abutment) and its manufacturing/design software modifications, not an AI or diagnostic device that would involve clinical performance metrics like sensitivity or specificity.

Ask a specific question about this device

Duranext Abutments are intended for use with dental implants as a support for single or multiple toth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Duranext Abutments from Elegant Direct Corp. are a line of machinable blanks incorporating interface features compatible with eleven (11) endosseous dental implant system platforms (three (3) designs from two (2) manufacturers) and intended to be milled at an Elegant Direct Corp. validated milling center to produce patient-specific dental implant abutments. The subject device platform diameters range from 3.0 mm to 6.0 mm, and the corresponding compatible implant body diameters range from 3.0 mm to 6.0 mm.

Duranext Abutments are designed for fabrication of custom titanium alloy dental implant abutments by a CAD/CAM process. All patient-specific custom abutment fabrication is by prescription on the order of the clinician. The portion of each abutment available for milling is 9.5 mm in diameter and 20 mm long. The apical end is premanufactured to fit the compatible implant platform, as shown above, and is available in an engaging (anti-rotation) design. A feature at the coronal end of the abutment is provided to interface with the milling equipment. Each abutment is provided with a screw designed to fit the compatible implant. The patient-specific abutment is intended to support a cement-retained single crown or multi-unit restoration.

The provided document is a 510(k) summary for the Duranext Abutments, a dental device. It does not describe a study involving an AI algorithm or human-in-the-loop performance. Therefore, I cannot extract the information required for questions about AI performance, multi-reader multi-case studies, or specific details of ground truth establishment for AI training/testing.

However, I can provide information about the acceptance criteria and the non-clinical study that proves the device meets those criteria, as well as general device information.

Here's what can be extracted based on the document:

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

The document does not explicitly present a table of "acceptance criteria" in the format of a diagnostic test (e.g., sensitivity, specificity). Instead, substantial equivalence is claimed based on performance testing and comparison to predicate devices for mechanical properties, biocompatibility, and sterilization. The acceptance criteria are implicitly met by successful completion of these tests in accordance with relevant ISO standards.

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 mention "test sets" in the context of diagnostic data. The "testing" refers to non-clinical performance testing of the physical abutment blanks. The sample sizes for these specific engineering tests (e.g., number of abutments tested for fatigue) are not provided in this summary. The provenance is implied to be from the manufacturer's testing or a contracted lab.

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 physical medical device (dental abutment) and the evaluation is based on non-clinical performance testing against engineering standards, not diagnostic interpretation by experts.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies, which is not what this document describes.

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, not an AI-powered diagnostic tool. No MRMC study was conducted.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" for this device's performance is established by engineering standards and physical measurements. For example:

• Biocompatibility: Established by adherence to ISO 10993 series standards, which involves methods like cytotoxicity testing.
• Mechanical Strength: Established by dynamic fatigue testing according to ISO 14801, which defines acceptable load cycles and failure modes.
• Dimensional Compatibility: Established by reverse engineering and direct measurement against OEM specifications.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm, so there is no training set in the context of machine learning.

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

Not applicable. As above, there is no training set. The "ground truth" for the device's design and manufacturing parameters is established via engineering specifications, material properties, and adherence to relevant ISO standards, rather than a labeled dataset.

Ask a specific question about this device

The Zimmer Dental Tapered Screw-Vent®T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional or delayed healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

The Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated are a self-tapping, screw type endosseous dental implant designed for bone level placement and can be used in a single or two stage protocol. The implant is composed of titanium alloy with hydroxylapatite (HA) coating, and has a tapered body with an external triple lead thread design. Identical to predicate #1, the new device has the same implant to abutment internal hex friction-fit connection. The new device will have coronal microgrooves that extend to the collar within 0.64mm of the top of the implant identical to predicate #2.

The new implant will be offered in two surface finish configurations at the coronal end: full MTX texturing to the top of the implant and partial MTX texturing to 0.5mm from the top of the implant leaving a machined collar. Both coronal configurations are identical to the currently marketed predicate #2 device (K101977, K111889).

The Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated family is composed of tapered implants with a choice of diameters and lengths. Both implant configurations, machined and fully textured collar, will be available in diameters of 3.7mm, 4.1mm, 4.7mm, and 6.0mm and in five lengths: 8, 10, 11.5, 13, and 16mm. The implant/abutment interface platform diameter will be offered in sizes of 3.5mm, 4.5mm, or 5.7mm depending on the outside implant thread diameter. The drilling sequences and drills that will be utilized to place the new device are pre-existing sequences and drills that are listed in the previous 510(k) K011028.

The provided document describes a pre-market notification (510(k)) for dental implants. It does not contain information about acceptance criteria or a study that proves a device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity, as would be typical for AI/Software as a Medical Device (SaMD).

Instead, this K133339 submission focuses on demonstrating substantial equivalence of a new dental implant (Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated) to existing predicate devices already on the market.

Therefore, many of the requested criteria in your prompt are not applicable to this type of medical device submission.

Here's an analysis based on the information available:

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

The document does not specify performance-based acceptance criteria (e.g., accuracy, sensitivity, etc.) because it is for a physical dental implant, not AI/SaMD. The "acceptance criteria" here are related to demonstrating substantial equivalence in terms of design, materials, indications for use, and mechanical performance compared to predicate devices.

The non-clinical testing sections hint at the performance criteria:

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

For the non-clinical mechanical testing (fatigue and compression), the document does not specify the sample size used. It only states that "Non-clinical test data was used to support the decision of substantial equivalence." Details like the number of implants tested or the specific test conditions (e.g., cycles for fatigue) are not provided in this summary.

Data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided for this type of mechanical device testing.

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

This is not applicable. The "ground truth" for mechanical testing of implants involves engineering specifications and performance standards, not expert clinical interpretation.

4. Adjudication method for the test set

Not applicable for mechanical testing.

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 physical dental implant, not an AI/SaMD. No MRMC study was conducted.

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

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

7. The type of ground truth used

For the mechanical tests (fatigue and compression), the "ground truth" would be established by specified engineering standards and regulatory guidance documents (e.g., FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments). For MRI safety, it relates to the FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/SaMD.

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

Not applicable. There is no training set as this is not an AI/SaMD.

In summary:

This 510(k) submission primarily relies on demonstrating substantial equivalence to already legally marketed devices through:

• Design comparison: Showing the new device has the same fundamental technology, materials, and intended use as predicate devices. The key differences (coronal microgrooves, surface finish configurations) were shown to be identical to different aspects of existing predicate devices.
• Non-clinical testing: Mechanical tests (fatigue and compression) and MRI compatibility were performed to ensure the new device meets established performance standards and is safe. The document states these tests "demonstrated improvements over the predicate device" in mechanical strength, suggesting the new design's modifications did not negatively impact performance and might have enhanced it.
• No clinical testing: The submission explicitly states, "No clinical testing was performed. Non-clinical testing was used to support the decision of substantial equivalence." This is common for devices demonstrating substantial equivalence where the risks are well understood and adequately addressed by non-clinical means.

Ask a specific question about this device

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.

Ask a specific question about this device

The Tapered Screw-Vent® X Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. The 4.1mmD Tapered Screw Vent X Implants should be splinted to additional implants when used in the posterior region.

The Tapered Screw-Vent®X Implant is an endosseous dental implant. The implant is composed of titanium alloy and Trabecular metal. The implant section is designed for ease of implantation and with greater surface area for osseointegration. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with triple-lead threads. The Tapered Screw-Vent X implants will be offered in two different texturing configurations: full texture to the top of the implant and texture to 0.5mm from the top of the implant. In addition, both texturing configurations of the implant will have coronal grooves on the collar to within 0.64mm of the top of the implant similar to the predicate Tapered Screw-Vent P Dental implant. The implant/abutment interface platform diameter will be offered in sizes of 3.5mm, 4.5mm, or 5.7mm depending on the outside implant thread diameter. The new device will feature MTX surface equivalent to existing Zimmer Dental implants. The MTX surface is used on the titanium body and is exposed on surfaces apical and coronal to the Trabecular Metal.

The provided text describes a dental implant device, the Tapered Screw-Vent® X Implant, and outlines its characteristics, comparison to predicate devices, and testing performed. However, it does not contain information regarding acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI/ML algorithm or software.

The document is a 510(k) summary for a medical device (endosseous dental implant) and focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing (mechanical performance) and some clinical data on safety and basic performance.

Therefore, for the requested information related to acceptance criteria and an AI/ML study, the answer is: Not applicable / Not provided in the document.

Here’s a breakdown based on the document's content, highlighting why the requested information for AI/ML performance is not available:

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

• Not applicable for AI/ML performance. The document does not mention any AI/ML components or software.
• The "Non-clinical Testing" section states: "Testing was performed following 'Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.' Performance testing demonstrated that the device performs appropriately for the proposed indications for use." This general statement refers to mechanical and material performance, not AI/ML metrics.

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

• Not applicable for AI/ML test sets. The document refers to clinical studies for human subjects, not a dataset for software testing.
• Clinical Study Sample Size (for device performance): Not explicitly stated in terms of number of patients for the studies, only that a "controlled population" and "normal patients and subjects with elevated risk factors" were included.
• Data Provenance (for clinical studies): Not specified (e.g., country of origin).
• Study Type: "A prospective clinical study" and "A second, longitudinal data collection study" were conducted.

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 for AI/ML ground truth. The document describes clinical studies evaluating implant performance in patients, where "ground truth" would likely be clinical outcomes observed by treating clinicians, not expert consensus on an image or data set for an AI algorithm. No information is provided about expert panels or their qualifications for establishing ground truth as requested for AI/ML evaluation.

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

• Not applicable. No adjudication method for an AI/ML test set is mentioned.

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. No MRMC study is mentioned, as this device is a physical implant, not an AI-assisted diagnostic tool.

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

• Not applicable. No AI algorithm is part of this submission.

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

• Not applicable in the AI/ML context. For the clinical studies mentioned, the "ground truth" would be related to clinical outcomes such as implant loading success, osseointegration, absence of adverse events, etc. The document states: "No device related adverse events were reported in either study to date." This implies observed clinical outcomes.

8. The sample size for the training set:

• Not applicable. No AI training set is mentioned.

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

• Not applicable. No AI training set is mentioned.

In summary: The provided document is for a physical medical device (dental implant) and does not contain any information related to AI/ML algorithms, their acceptance criteria, performance studies, or associated ground truth establishment.

Ask a specific question about this device

The iMARK™ Internal Hexagon Dental Implant System is used in indications for oral endosseous implants in the maxilla and/or mandible as part of a functional and aesthetic oral rehabilitation in partial or fully edentulous patients.

The IMARK™ Internal Hexagon Dental Implant System is designed for use in totally edentulous mandibles or maxillae or as a terminal or intermediary abutment for fixed or removable bridgework. The system can also be used for single tooth restorations. The IMARK™ Internal Hexagon Dental Implant System uses a two-stage implantation process.

The iMARK™ Internal Hexagon Dental Implant System is compatible with Zimmer® Tapered Screw Vent prosthetics.

The ACE Surgical iMARK™ Internal Hexagon Dental Implant System is a screw type dental implant system designed with technology established with the ACE Surgical Screw Dental Implant System (K954513) and the Zimmer® Tapered Screw Vent Dental Implant (K011028). The ACE Surgical iMARK™ Internal Hex dental implant screw raw material is made of Ti-6-AL-4V ELI per ASTM F13& standard and surface treated with resorbable blast media (RBM). The self tapping internal horning and features tapered external thread geometry consistent with industry standard screw implant fixtures. The implants are provided sterile and sterility is achieved by gamma radiation pursuant to ISO 11137

The provided text describes the 510(k) summary for the ACE Surgical iMARK™ Internal Hexagon Dental Implant System. This document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than an AI-based device's performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not applicable to this type of submission.

However, I can extract the relevant performance characteristics that were tested and the type of ground truth used (in this case, mechanical test standards and predicate device performance).

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the document (typical for mechanical testing, usually a small number of samples per test type to meet standard requirements).
• Data Provenance: Not specified, but generally, mechanical testing is performed in a controlled laboratory environment. Retrospective/prospective distinction is not applicable here.

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

• Not applicable. The "ground truth" for mechanical testing is established by adherence to recognized industry standards (e.g., ASTM F13, ISO 11137) and comparison to predicate device performance, not by expert consensus on data interpretation.

4. Adjudication method for the test set

• Not applicable. Adjudication methods (like 2+1, 3+1) are used for expert review of clinical data, not for mechanical performance testing.

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 not an AI-based device, and therefore no MRMC study was performed.

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

• Not applicable. This is a medical implant, not an algorithm.

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

• The "ground truth" or reference for the mechanical testing was primarily based on:
  • Industry Standards: Adherence to established mechanical testing standards (e.g., relevant ASTM standards for materials and ISO standards for sterilization).
  • Predicate Device Performance: Comparison of the new device's mechanical performance to that of legally marketed predicate devices (ACE Surgical Screw Dental Implant System K954513 and Zimmer® Tapered Screw Vent Dental Implant K011028) to demonstrate "substantial equivalence."

8. The sample size for the training set

• Not applicable. This is a medical implant, not a machine learning model, so there is no training set.

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

• Not applicable. There is no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets its acceptance criteria involved a series of mechanical tests designed to demonstrate the material properties, structural integrity, and functional performance of the ACE Surgical iMARK™ Internal Hex Dental Implant System. These tests included:

• Torsional insertion: To assess the torque required for placement/insertion.
• Shear (coaring): To evaluate resistance to shearing forces.
• Compressive bending: To test the implant's ability to withstand compressive and bending loads.
• Fatigue strength: To determine the implant's durability under repeated stress cycles, simulating physiological conditions over time.

These tests were performed to support the substantial equivalence of the iMARK™ system to two predicate devices: the ACE Surgical Screw Dental Implant System (K954513) and the Zimmer® Tapered Screw Vent Dental Implant (K011028). The implicit "acceptance criteria" for these tests were that the new device's performance characteristics must be comparable to or better than those of the predicate devices, thereby demonstrating that it is as safe and effective.

Additionally, material composition (Ti-6-AL-4V ELI per ASTM F13 standard) and sterilization methods (gamma radiation per ISO 11137) were confirmed to meet recognized standards, further supporting the device's safety and effectiveness. The successful completion of these tests, leading to a determination of substantial equivalence by the FDA, indicates that the device met the necessary performance characteristics for market clearance.

Ask a specific question about this device

Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The threaded implants should only be immediately loaded when good primary stability is achieved and the functional load is appropriate.

The 3.25mm Spline Twist Implant, HA Coated is a self-tapping, screw type endosseous dental implant design for bone level placement and can be used in a single or two stage protocol. Refer to Figure 1, product renderings. The implant will have a straight body with an external single lead thread design. The new device implant body, fabricated from 6Al-4V titanium alloy, features single lead threads that begin 0.75mm apical of the base of the implant Spline tines and continue to the apex of the implant. The flute are formed by a helical cuts that "twist" or spiral the cutting flutes around the long axis of the implant in the same sense as the threads. The flutes tend to pull the implant into the site and present a positive rake andle to the osteotomy in a manner similar to a spiral flute thread tap. It has a Spline interface that consists of six tines. These tines interdigitate with like tines on abutments used in the system to create an anti-rotation interface. The new device will feature hydroxylapatite (HA) coating , hydroxylapatite coating with additional Zimmer Dental MP-1® processing equivalent to existing Zimmer Dental implants (K953101, K011028, K013227, K061410, K072589),

The provided text describes a 510(k) premarket notification for a dental implant and focuses on establishing substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data for a new device.

Therefore, the requested information cannot be fully extracted from the provided document as it does not contain details about a study that proves the device meets specific acceptance criteria in the format requested. Specifically:

• Acceptance Criteria and Device Performance Table: The document does not provide a table of acceptance criteria and reported device performance metrics in the context of a performance study. It discusses similarity to predicate devices.
• Sample size for test set and data provenance: No test set is described.
• Number of experts and their qualifications: Not applicable, as no ground truth establishment for a test set is mentioned.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not mentioned. The document is about establishing substantial equivalence, not conducting a comparative effectiveness study.
• Standalone (algorithm only) performance: Not applicable as this is a physical dental implant, not an algorithm.
• Type of ground truth used: Not applicable, as there's no diagnostic or screening study described.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

The document is a regulatory submission for a dental implant (3.25mm Spline® Twist™ Implant, HA Coated), asserting its substantial equivalence to existing predicate devices (Integral VI Biointegrated Dental Implant System, Small Diameter Spline Twist Implant, and Calcitek HA-Coated Endosseous Dental Implants). This is a common pathway for medical device approval where the new device is shown to be as safe and effective as a legally marketed device.

The "study" in this context is the comparison made for substantial equivalence, which primarily focuses on design, materials, indications for use, and a comparison of their characteristics to demonstrate that the new device does not raise new questions of safety or effectiveness.

Key information from the document related to comparison/equivalence:

• Device Description: The 3.25mm Spline Twist Implant, HA Coated is a self-tapping, screw-type endosseous dental implant for bone level placement. It features a straight body, external single lead thread design, helical cuts (flutes) for self-tapping, a Spline interface with six tines for anti-rotation, and a hydroxylapatite (HA) coating.
• Comparison Statement: "The new device is substantially equivalent to the predicate devices. The device's, general structure, and function in the endosseous implant system remains the same as the predicate devices." (Page A5-3)
• Specific Similarities Highlighted:
  • Design: Similar to the previously cleared Small Diameter Spline Twist Implant, including the Spline interface and its tines.
  • Body Dimensions: Body is "identical" to the Small Diameter Spline Twist Implant, with a .1240" (3.15mm) major diameter for single lead threads.
  • Material: Fabricated from the same 6AL-4V titanium alloy as the Small Diameter Spline Twist Implant and the Integral VI Biointegrated Dental Implant System, specified to ASTM B328 and ISO 5832-3.
  • HA Coating: Features the same HA coating as the predicate Integral VI Biointegrated Dental Implant System, applied via plasma spray and processed with hydro-thermal treatment (MP-1) similar to Calcitek HA-Coated Endosseous Dental Implants.
  • Prosthetics: Uses the same prosthetics (engaging and non-engaging abutments, copings) as the predicates, made from titanium alloy, gold alloy, and plastic.
  • Surgical Instruments: Will use similar surgical instruments, with an added 2.7 mm intermediate drill and utilizing existing taps and driving tools.
  • Indications for Use: The stated Indications for Use on page A5-2 are consistent with general dental implant applications (edentulous mandibles/maxillae for denture prostheses, bridgework, single tooth replacement, immediate or conventional loading under appropriate conditions).

In summary, the document serves as evidence for regulatory clearance based on substantial equivalence to predicate devices, rather than a performance study against predefined acceptance criteria for a novel device.

Ask a specific question about this device