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510(k) Data Aggregation
(80 days)
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.
| Acceptance Criteria Category | Reported Device Performance (Summary from Submission) |
|---|---|
| Mechanical Integrity / Compatibility | - Fatigue testing of OEM implant bodies with patient-specific abutments made at worst-case angled conditions. (Implies successful completion to similar or better standards than predicate.) |
| Biocompatibility | - Biocompatibility testing according to ISO 10993-5 and ISO 10993-12. (Implies successful demonstration of biocompatibility.) |
| Sterilization | - Sterilization validation according to ISO 17665-1, ISO 17665-2, and ISO 14937. (Implies successful validation for sterilization.) |
| CAD Design Restrictions | - Software verification included testing of restrictions that prevent design of components outside of the stated design parameters. |
- 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.
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(138 days)
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:
- Sterilization validation: According to ISO 17665-1, ISO 17665-2, and ISO 14937.
- Biocompatibility testing: According to ISO 10993-5 and ISO 10993-12.
- 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.
- MR Conditional labeling.
- 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.
- 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.
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(98 days)
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 by a change in sterilization status to provide products sterile to the end user that were previously cleared to be provided non-sterile. The subject device abutments and abutment screws were cleared previously to be provided non-sterile to the end user in K170588, K191986, K212628, and K22288. All subject device components will now be provided sterile.
The subject device components include Healing Abutments, Multi-Unit Abutments (0, 17°, and 30°), and abutment screws.
The provided text is a 510(k) summary for the DESS Dental Smart Solutions, an endosseous dental implant abutment. It details the device, its intended use, and its substantial equivalence to previously cleared predicate and reference devices. However, this document does not contain the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
The 510(k) submission for this dental abutment focuses on establishing substantial equivalence based on:
- Design and Material: The subject device components are identical in design, material (Ti-6Al-4V alloy, DLC coating), and technological characteristics to previously cleared devices.
- Manufacturing: The manufacturing process is consistent with previously cleared devices.
- Biocompatibility: Referenced from previous K-clearances.
- Sterilization: The main change in this submission is expanding the system to provide products sterile to the end-user via gamma irradiation, which was validated by referencing a previous K-clearance (K212538).
- MR Environment Testing: Non-clinical analysis was performed to evaluate the subject devices in the MR environment, referencing published literature and FDA guidance.
- Shelf Life Testing: Referenced from a previous K-clearance (K212538) for samples after accelerated aging.
Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving an AI/ML device meets them based on the provided text, as this document is not about an AI/ML medical device. It's about dental implant abutments and establishes substantial equivalence through non-clinical performance data and comparison to predicate devices, not through AI/ML performance metrics.
To provide the information you requested, I would need a document detailing the validation of an AI/ML medical device, which would include definitions of acceptance criteria (e.g., accuracy, sensitivity, specificity), details of training and test datasets, ground truth establishment, and potentially clinical effectiveness studies if applicable.
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(216 days)
The implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:
- Replacing missing teeth in single or multiple unit applications in the mandible or maxilla.
- Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
- Especially indicated for use in soft bone applications with other implant surface treatments may be less effective.
- Immediate and early loading for all indications, except in single tooth situations on implants shorter than 8 mm or in soft bone (type 4) where implant stability may be difficult to obtain and immediate loading may not be appropriate.
- The intended use for OmniTaper EV Ø3.0 implant is limited to replacement of maxillary lateral incisors and mandibular incisors.
DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.
MultiBase Abutments EV:
DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.
The proposed (A) OmniTaper EV Dental Implants are root form endosseous implants intended for use by a dental clinician in the prosthetic restoration of chewing function in edentulous human jaws. The proposed (A) OmniTaper EV Dental Implants have the identical implant-abutment connection geometry as predicate (A) Astra Tech EV Implants (K120414). The proposed (A) OmniTaper EV Dental Implants are therefore compatible with the Astra Tech EV Abutments (K120414).
The proposed (B) DS Implant abutments with EV connection include the following abutments and accessories:
- TempBase EV, and its accessory component TempBase Cap
- Cover Screw EV
- Healing Abutment EV
- HealDesign EV
- TempAbutment EV
- TiDesign EV
- CastDesign EV
- MultiBase Abutment EV
- Abutment Screw EV
The proposed (B) DS Implants abutments with EV connection are used in conjunction with an endosseous dental implant with EV connection to aid in prosthetic rehabilitation in fully edentulous or partially edentulous maxillary and/or mandibular arches. They are prosthetic abutments that are:
- Compatible with the proposed (A) OmniTaper EV implants,
- Represent an additional abutment type (TempBase EV abutment and cap),
- Introduce additional abutment sizes (XS Extra Small and XL Extra Large) to the predicate (B) DS Implants abutments with EV Connection in sizes S (Small), M (Medium) and L (Large) (K213449).
The proposed (B) DS Implant abutments with EV connection have the identical implantabutment connection geometry as predicate (B) DS Implants abutments with EV connection (K213449) and the Astra Tech EV Abutments (K120414), and are therefore also compatible with predicate (A) Astra Tech EV Implants (K120414).
The proposed (A) OmniTaper EV Dental Implants and proposed (B) DS Implants abutments with EV connection are single-use devices.
The proposed (A) OmniTaper EV implant with pre-mounted proposed (B) TempBase EV abutment, and the proposed (B) devices Cover Screw EV, Healing Abutment EV, HealDesign EV and (B) Multibase Abutment EV are provided sterile via Electronic-Beam (E-beam) irradiation.
The proposed (B) TiDesign EV, CastDesign EV, TempAbutment EV, TempBase Cap and Abutment Screw are provided non-sterile. Devices provided non-sterile are to be sterilized via steam sterilization, or as in the case of the TempBase Cap, cleaned/disinfected, by the end user prior to use per the Instructions for Use.
This response addresses the requested information based on the provided text, but it's important to note that the document describes a dental implant and abutment system, not an AI-powered diagnostic device. Therefore, many of the requested categories related to AI performance (e.g., effect size of human readers with AI, standalone algorithm performance, number of experts for ground truth, adjudication methods) are not applicable and will be marked as "Not Applicable (N/A)".
Device Name: OmniTaper EV Dental Implants and DS Implants abutments with EV connection
Device Type: Endosseous Dental Implants and Abutments
1. Table of Acceptance Criteria and the Reported Device Performance
Given that this is a 510(k) submission for dental implants and abutments, the "acceptance criteria" are demonstrated through substantial equivalence to predicate and reference devices, supported by non-clinical performance data (e.g., sterilization, biocompatibility, fatigue, MRI testing) and clinical literature review. There are no explicit performance metrics in the format of a typical diagnostic device's acceptance criteria, but rather a demonstration that the new devices are as safe and effective as existing legally marketed devices.
| Acceptance Criteria Category | Specific Criteria (Implicitly met by substantial equivalence) | Reported Device Performance |
|---|---|---|
| Material Composition | Commercially pure titanium (Grade 4) for implants (A) | Same as predicate (A) device (K120414), differs from reference device (Grade 2). |
| Surface Treatment | TiO2 blasted and acid etched for implants (A) | Same as predicate (A) device (K120414). |
| Connection Type | Conical connection with indexes (EV Connection) for implants (A) | Same as predicate (A) device (K120414). |
| Implant Design | Cylindrical, threaded, self-tapping apical thread, (micro)extended implant shoulder (for implants A) | Same as reference device (K073075). Supported by fatigue testing compared to predicate. |
| Dimensions (Implants) | Specific diameters and lengths for OmniTaper EV (A) | Same as reference device (K073075) with minor material thickness modification for certain 8mm implants. Supported by fatigue testing compared to predicate. |
| Abutment Connection Size | Compatibility with XS, S, M, L, XL sizes for abutments (B) | Expansion of offering to include XS and XL. TempBase EV abutment and Cap in all sizes. Supported by fatigue testing. |
| Prosthesis Attachment | Cement-retained and Screw-retained for abutments (B) | Same as predicate (B) device (K213449). |
| Abutment Angulation | TiDesign EV: 0°, 15°; MultiBase EV: 0°; TempBase EV: 0°; CastDesign EV: 0° (for abutments B) | TiDesign EV and CastDesign EV same as predicate. TempBase EV same as reference. MultiBase EV (XS, XL) not available as angulated abutment. |
| Sterility Assurance Level (SAL) | 10^-6 for sterile devices | Validated in accordance with ISO 11137-1:2006 and ISO 11137-2:2013 (E-beam irradiation). |
| Biocompatibility | Conformance with ISO 10993-1, -5, -18 | Confirmed by cytotoxicity, gas chromatography (GC-MS), Fourier transformation infrared spectroscopy (FT-IR), and pyrogenicity testing. |
| Dynamic Fatigue Performance | Meet requirements of ISO 14801:2016 for worst-case implant-abutment combinations | Test results demonstrate performance as intended, comparable to predicate devices. |
| MRI Safety | MRI Conditional for implant and abutments, MR Safe for TempBase Cap | Supported by testing for magnetically induced displacement force, torque, image artifact, and RF Induced Heating Simulation. |
| Shelf Life | 5 years for implants and sterile/non-sterile abutments | Packaging integrity confirmed by testing to ASTM F 1929-15, ISO 11607-1:2019, EN 868-10:2018 for implants; existing validation for abutments. |
| Pyrogenicity | Meet established pyrogen limit | Confirmed by Limulus amebocyte lysate (LAL) test (USP ). |
| Cleaning/Disinfection (TempBase Cap) | Efficacy of cleaning and disinfection processes | Validation performed according to ASTM E 1837:2014 and ASTM E 2314:2014, leveraging reference device validation. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Non-Clinical Test Set: The document describes various non-clinical tests (sterilization, biocompatibility, fatigue, MRI) but does not specify numerical sample sizes for these tests. It indicates that "worst-case" implant-abutment combinations were tested. The provenance of this data is internal to Dentsply Sirona or their contracted labs, as it states "Non-clinical testing data submitted, referenced, or relied upon..."
- Clinical Literature Review (Test Set): For the clinical relevance of the Ø3.0 implant, four peer-reviewed scientific publications were referenced. These studies presented 1 to 4 years of prospective clinical follow-up data on over 580 Xive S Plus D 3.0 implants. The country of origin for these publications is not specified, but they are peer-reviewed scientific literature.
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)
N/A. This device is a dental implant system, not a diagnostic AI device requiring expert-established ground truth for a test set. Clinical relevance was supported by published peer-reviewed literature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. This information is for AI performance evaluation. The device is a physical medical 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
N/A. This information is for AI performance evaluation. The device is a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This information is for AI performance evaluation. The device is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Non-Clinical Testing: Ground truth is established by standardized testing protocols and existing predicate device performance, ensuring properties like sterility, biocompatibility, and mechanical strength meet established engineering and safety standards.
- Clinical Literature Review: The clinical "ground truth" for the 3.0mm implant's effectiveness and safety (survival rates, stable marginal bone) is derived from outcomes data reported in multiple peer-reviewed scientific publications with prospective clinical follow-up.
8. The sample size for the training set
N/A. This device does not involve a "training set" in the context of machine learning or AI algorithms. Its development and validation rely on engineering design, materials science, and non-clinical testing, followed by comparisons to predicate devices and review of existing clinical literature.
9. How the ground truth for the training set was established
N/A. This device does not involve a "training set" in the context of machine learning or AI algorithms.
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(247 days)
The Conometric Abutments are intended to be used in conjunction with the Conometric Final Cap and Ankylos C/X implants, OsseoSpeed EV implants and Xive S implants to support fixed friction retained single or maxilla, in a partially or completely edentulous patient. This system is intended for delayed loading. The Conometric Abutment including the abutment screw and the Conometric Final abutment. The abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The proposed Conometric Abutments are intended for use by dental clinicians in the support of prosthetic dental restorations. The conometric concept provides conical friction retention for fixed single tooth restorations. The Conometric Abutments are provided together with prosthetic conometric caps, impression laboratory devices, and insertion and fixation instruments. The abutments are provided with an angulation of 0° and 15° at gingival heights of 1.5, 3.0 and 4.5 mm for Ankylos® Conometric Abutments and with 1.0, 2.0 and 3.0 mm for Xive® and Astra Tech Implant System EV® Conometric Abutments. They are manufactured of Titanium Alloy. The Conometric Final Caps are to be cemented into the final crown to provide friction retention to the abutment. They are made of gold-shaded titanium and are available in the diameter of 3.3 and 4.5 mm. The Conometric Temporization Caps provide support of immediate and short term provisional prosthetic restorations on Conometric Abutments up to 6 months. The temporary caps are provided with the diameter 3.3 mm and 4.5 mm and are manufactured of PEEK material. The smaller cap (Ø 3.3 mm) also contains titanium alloy. The Conometric Healing Caps protect the Conometric Abutment until a crown is placed and serve for the shaping of the gingiva. The Healing Caps are made of PEEK polymer and available with an diameter of 3.3 mm and 4.5 mm. Regarding the outer geometries, the Healing Caps are presented as a wide variant with an maximum outer diameter of 6.0 mm and - for the Healing Cap Ø 3.3 mm - also as a small version with an maximum outer diameter of 4.8 mm.
This document is a 510(k) premarket notification for Dentsply Sirona's Conometric Abutments. It focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance data.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study Type |
|---|---|---|
| Fatigue Testing: Conformity to ISO 14801: Dynamic Fatigue Test for Endosseous Dental Implants for worst-case construct. | The defined acceptance criteria were fulfilled. | Dynamic Fatigue Testing |
| Friction-based Retention: The friction-based retention must perform as intended under dynamic load. | The defined acceptance criteria were fulfilled. | Dynamic Load Testing for Friction Retention |
| Pull-out Test: Removal torque of implants after several removal procedures of the Final Cap from the Conometric Abutment should be comparable to or perform better than insertion torque of Final Cap, removal torques of standard prosthetic restorations, and pull-out forces of osseointegrated implants. | The results showed that the proposed Conometric Abutment system perform as intended. | Pull-out Test |
| Biocompatibility: Conformity to ISO 10993-5 (in vitro cytotoxicity) and ISO 10993-18 (chemical characterization of materials) for materials. | Biocompatibility data are referenced to support substantial equivalence to predicate device materials. (Conometric Final Cap, Conometric Temporization Cap, Conometric Healing Caps demonstrated biocompatibility by testing if material was not identical.) | Biocompatibility Testing (referenced for identical materials, explicit testing for non-identical materials) |
| Sterilization: Sterility Assurance Level (SAL) of 10^-6 according to ISO 11137-1 and ISO 11137-2 for sterile devices. | Achieved an SAL of 10^-6 under the sterilization process parameters utilized (by equivalence to existing worst-case challenge validations). | Sterilization Validation (referenced by equivalence) |
| Moist Heat Sterilization (Non-sterile components): Sterility Assurance Level (SAL) of 10^-6 according to ISO 17665-1 and ISO 17665-2. | Demonstrated an SAL of 10^-6 (by equivalence to existing worst-case challenge validations). | Moist Heat Sterilization Validation (referenced by equivalence) |
| Packaging and Materials: Must be equivalent to predicate devices to support shelf-life. | Packaging and materials are the same as used for the predicate devices. Shelf life data are referenced to support substantial equivalence. | Materials and Packaging Equivalence / Shelf-life Data (referenced) |
| Compatibility with Implants: Performance with predicate and reference device implants in worst-case configuration. | Performance testing is included to support the compatibility of the subject Conometric Abutments, in their worst-case configuration, with the predicate and reference device implants. | Compatibility Testing |
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 sizes for the test sets in the non-clinical performance studies (Fatigue Testing, Pull-out Test, Dynamic Load Testing for Friction Retention). It generally refers to "worst-case construct" and "implants," implying specific setups for testing but not the number of units tested.
The data provenance is internal testing performed by Dentsply Sirona or its subsidiaries, as implied by the submission document. The country of origin of the data is not explicitly stated. The studies are prospective bench tests, not studies involving patients or real-world data.
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 information is not applicable as the studies are entirely non-clinical bench tests. There is no human interpretation of medical images or expert consensus required to establish ground truth for mechanical, material, or sterilization performance. The ground truth is defined by the objective measurement of physical properties against established engineering and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the studies are entirely non-clinical bench tests. Adjudication methods are typically used in clinical studies or studies involving expert interpretation where there might be disagreement in assessing outcomes.
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 was done. This device is a dental implant abutment, a physical medical device, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical device; there is no algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the non-clinical studies is based on established engineering standards (e.g., ISO 14801, ISO 10993, ISO 11137, ISO 17665) and objective measurements of physical and mechanical properties. For example:
- Fatigue Testing: Ground truth is defined by the device's ability to withstand dynamic loads without failure, as per ISO 14801.
- Pull-out and Friction Retention Tests: Ground truth is defined by the measured forces/torques being within an acceptable performance range considered safe and effective for dental abutments.
- Biocompatibility: Ground truth is defined by the material's conformity to biological safety standards (e.g., cell viability in cytotoxicity tests).
- Sterilization: Ground truth is defined by achieving a specific Sterility Assurance Level (SAL) per ISO standards.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above.
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(142 days)
MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.
Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
The long MIS (18 & 20 mm) implants can be used in a tilted manner.
MIS short implants are to be used only with straight abutments.
M4 short implants are indicated for delayed loading only.
The MIS internal hex implant system includes two implant families: M4 and SEVEN. The subject implants system are endosseous dental implants and Endosseous dental implant abutments, manufactured from titanium TI-6Al-4V ELI. The implants are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. The root-shaped, screw-type implants are designed for both two-stage and single stage procedures, with one internal thread for screwed abutment. The two implant families have the same internal hex connection and differ in regards to external geometry. Accordingly, the implants are used with the same abutments.
The implants are self-tapping, root-form with tapered threads and their surface is sand blasted and acid etched. The implants are supplied sterilized by gamma irradiation.
MIS M4 implants are cylindrical and conical shaped, self-tapping, have a V shaped thread design with three spiral channels and a flat, cutting tapered apex.
The MIS M4 Implants are available in the following diameters, platforms and lengths:
- Narrow platform: 3.3 mm diameter: 10mm, 11.5mm, 13mm and 16 mm
- Standard platform: 3. 75 mm diameter: 8mm, 10mm, 16mm, 16mm, 18mm, 18mm and 20mm
- . Standard platform: 4.2 mm diameter: 6mm, 8mm, 10mm, 16mm, 16mm, 18mm and 20mm
- Wide platform: 5.0 mm diameter: 6mm, 8mm, 11.5mm, 13mm and 16mm
- . Wide platform: 6.0 mm diameter: 6mm, 8mm, 10mm, 11.5mm, 13mm
MIS SEVEN implants are conical shaped with a domed apex. Their geometric design includes dual threads, three spiral channels stemming from the apex for self-tapping, micro rings on the implant neck, and a changing thread thickness along the implants are color coded for platform identification. The MIS SEVEN Implants are available in the following diameters, platforms and lengths:
- Narrow platform (yellow): 3.3 mm diameter: 10mm, 11.5mm, 13mm and 16 mm
- Standard platform (purple): 3. 75mm diameter: 8mm, 10mm, 16mm, 16mm, 18mm and 20mm
- Standard platform (purple): 4.2mm diameter: 8mm, 13mm, 16mm, 16mm, 18mm and 20mm
- Wide platform (green): 5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
- . Wide platform(green): 6.0 mm diameter: 8mm, 10mm, 11.5mm, 13mm
- The implants are designed for both two-stage procedures, with one internal thread for screwed abutment.
The MIS Internal Hex Dental Implant System is a two-piece device to be used in combination with a wide range of abutments provided in order to aid in the prosthetic rehabilitation.
Components:
The MIS Internal Hex Dental Implant System is to be used in combination with variety of the internal hex abutments (cover screws, healing caps, cement- retained abutments, gold abutments, OT-Equators & ball attachments, Multi unit abutments and Temporary Ti and Peek Abutments), including up to 300 angulated abutments.
Cover screws and healing caps are premanufactured prosthetic components directly connected to the endosseous dental implants and are indicated as temporary components to allow healing of the soft tissue. They are made of TI 6AL 4V ELI, and supplied sterile to the user, for single use.
Cement- Retained Abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant by a prosthetic screw, which is supplied with the abutments. Cement retained abutments are available straight or angulated, in different heights and diameters to accommodate the patients specific needs. They are available in 0, 10 or 20 degrees angulation in narrow platform, 0, 15 or 25 degrees angulation in standard platform and 0 or 15 degrees angulation for wide platform. They are made of TI 6AL 4V ELI, and supplied non sterile, to be steam sterilized by the user according to the labeling, intended for single use.
CPK abutments are premanufactured abutments directly connected to the endosseous dental implant by a prosthetic screw, which is supplied with the abutments. They are cement retained abutments intended to be used in temporary and permanent prosthetic rehabilitation. CPK abutments indicated for 0 degree angulation for straight implantation only. They are sold either on their own, or with additional components for impression taking and prosthetic fabrication. The abutments and prosthetic screw are made of TI 6AL 4V ELI. Their additional components intended for impression taking and casting are made of POM. Plastic healing caps intended to cover the CPK abutment until final restoration placement are made of PEEK. They are supplied non sterilized by the user according to the labeling, and intended for single use.
Gold Plastic abutments are pre-manufactured prosthetic abutments directly connected to the endosseous dental implant intended for permanent restoration, for either single or multiple tooth screw retained restorations. The lower part of the abutment which connects directly to the implant is made of gold AU, and the upper part is made of plastic (POM). The plastic part is burned out for casting with precious metals.. The abutment is connected to the implant by a prosthetic screw, supplied with the abutment, and made of TI 6AL 4V ELI. Gold abutments are straight abutments intended for 0 degree angulation for straight implantation only. The abutments are supplied non sterilized by the user according to the labeling, and intended for single use.
Multi-Unit abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant. They are intended for use in a completely edentulous jaw when screw retained prosthetis is preferred, for anchoring a fixed overdenture. Multi-units are available in 0 degrees for narrow platform, and in 0, 17 or 30 degrees for standard and wide platforms. The straight multi units' lower part is threaded and tightened directly to the implant, while the angulated multi-unit is connected to the implant by a prosthetic screw, supplied with the multi-unit and made of TI 6AL 4V ELI. The overdenture is connected to the multiunit by a screw. All multi units are made of TI 6AL 4V ELI. They are supplied sterile and intended for single use.
OT-Equators & Ball Attachments are premanufactured dental implant abutments directly connected to the endosseous dental implant by their lower threaded part, and are mostly used in completely edentulous jaws to connect to an overdenture bar to allow its insertion and removal. Ball attachments have a higher profile and ball shaped head, while the OT equators have a lower profile and a truncated head. Ball attachments are available straight for narrow and wide platforms, and in 0, 15 or 25 degrees for standard platform. OT Equators are available straight only. Both are made from TI 6AL 4V ELI, feature a Titanium Nitride (TiN) coating and are supplied with small-scale metal housing and replaceable nylon caps, offering various retention levels. The abutments are supplied non sterilized by the user according to the labeling and intended for single use.
Temporary abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant, intended for use as an aid in temporary prosthetic rehabilitation. They are straight abutments. They are available in TI 6AL 4V ELI and in natural PEEK. Both are attached to the implant by a prosthetic screw made from TI 6AL 4V ELI, supplied with the abutments, and are intended to be used for up to 6 months, and then replaced by permanent abutments. The post height is adjusted by the doctor to the appropriate height according to the intended restoration, as directed in the instructions for use supplied with the abutments are supplied non sterile, to be steam sterilized by the user according to the labeling and intended for single use.
There are two types of emergence profiles among the abutments, concave or straight emergence profile.
This document is a 510(k) Summary for the MIS Internal Hex Dental Implant System. It describes the device, its intended use, and how it demonstrates substantial equivalence to legally marketed predicate devices through non-clinical performance data.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document focuses on demonstrating substantial equivalence to predicate devices rather than listing specific acceptance criteria with quantifiable metrics for each device performance aspect. Instead, it states that the device's performance is "at least equivalent" to the predicates. The primary performance metric mentioned is fatigue testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet biocompatibility standards. | Not explicitly tested for the subject device; deemed equivalent to predicate K040807 due to identical manufacturing, materials, facility, and intended use. |
| Fatigue Strength (per ISO 14801:2016): Withstand required cyclic loading without failure. | Worst-case implants and abutments withstood 5,000,000 cycles without failure at a "substantially equivalent load to the cited predicates." The test on standard platform worst-case implant-abutment assembly supports wide platform implants. |
| Sterility Assurance Level (SAL): Achieve SAL of 10⁻⁶ for sterile products (ISO 11137-1, -2). | Achieved SAL of 10⁻⁶ for gamma-irradiated products (implants, cover screws, healing caps, etc.). |
| Steam Sterilization Validation: Validate steam sterilization parameters for non-sterile products (ANSI/AAMI/ISO 17665-1, -2). | Validated for two methods: gravity displacement and pre-vacuum steam sterilization. |
| Endotoxin Limit: Meet endotoxin limits (USP 85, 161, ANSI/AAMI/ST72). | LAL test conducted periodically to verify endotoxin limit is within acceptance criteria for sterile products. |
| Disinfection Efficacy: Achieve at least 10⁶ reduction of microbiological challenge for non-sterile products (ANSI/AAMI/ISO 11737-1, AAMI TIR 30, AAMI TIR 12). | Disinfection procedure validated by demonstrating a reduction of at least 10⁶ of the microbiological challenge. |
| Shelf Life: Maintain integrity for a specified shelf life (ISO 11607-1). | Successfully supported a 5-year shelf life for sterilized products. |
| Risk Acceptability: All risks associated with the device are acceptable and as low as reasonably possible (ISO 14971). | Risk analysis conducted, and all risks were determined to be acceptable and as low as reasonably possible. |
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 explicitly state the sample sizes used for the non-clinical tests (e.g., number of implants/abutments tested for fatigue). It mentions "worst case implants and abutments chosen for the tests" but no specific numbers.
- Sample Size: Not specified (implied to be sufficient for engineering testing validation).
- Data Provenance: The tests were conducted by MIS Implants Technologies Ltd. (Israel) or an "independent testing laboratory" for shelf life. No country of origin is explicitly stated for each test, but the submitter is based in Israel and the US Agent in the USA.
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 section is not applicable. The study involves non-clinical engineering and laboratory testing (mechanical, sterilization, biocompatibility, shelf-life, risk analysis) of a dental implant system, not a diagnostic or AI-driven device requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reasons as point 3.
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 or human-in-the-loop study was conducted. This device is a dental implant system, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This device is a physical dental implant system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests conducted, the "ground truth" refers to established engineering and regulatory standards:
- Fatigue: ISO 14801:2016 standard.
- Sterilization: ANSI/AAMI/ISO 11137-1, -2; ANSI/AAMI/ISO 17665-1, -2.
- Endotoxin: USP 85, USP 161, ANSI/AAMI/ ST72.
- Disinfection: ANSI/AAMI/ISO 11737-1:2006 (R)2011, AAMI TIR 30:2011 and AAMI TIR 12:2010.
- Shelf Life: ISO 11607-1.
- Risk Analysis: ISO 14971.
8. The sample size for the training set
This section is not applicable. There is no training set as no AI/machine learning component is involved.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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(175 days)
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 Aurum™ Abutment or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture.
DESS Dental Smart Solutions subject devices include four abutment design types (Aurum Base, Pre-milled Blank, CoCr Pre-milled Blank, CoCr Abutment) and one screw type (Aurum Base Screw). Abutments are provided in ten abutment connections compatible with eleven implant platform diameters range from 3.3 mm to 6.5 mm. Corresponding implant body diameters range from 3.25 mm to 6.0 mm. All abutments are provided non-sterile.
The document describes the DESS Dental Smart Solutions, which are dental implant abutments. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a typical tabular format with specific numerical targets. Instead, it relies on demonstrating equivalence to predicate devices through various performance tests and comparisons. The "acceptance criteria" are implied by the successful completion of these tests and the determination that the device is "substantially equivalent" to already marketed devices.
However, some design parameters are mentioned as remaining the same or being comparable to the predicate devices, which can be seen as implicit performance criteria:
| Feature / Performance Metric | Acceptance Criteria (Implied by Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Sterilization | SAL of 10^-6 according to ISO 17665-1 and ISO 17665-2 | "Sterilization to an SAL of 10^-6 according to ISO 17665-1 and ISO 17665-2 to ensure sterilization of the final finished device" (Successful) |
| Biocompatibility | Non-cytotoxic according to ISO 10993-1 and ISO 10993-5 | "Biological evaluation according to ISO 10993-1 and cytotoxicity testing to ISO 10993-5 to demonstrate that all devices are non-cytotoxic" (Successful) |
| Minimum Wall Thickness | Aurum Abutment: 0.4 mm | |
| Pre-milled Blank: 0.45 mm | ||
| CoCr Abutment: 0.4 mm (Same as primary predicate K170588) | Aurum Abutment: 0.4 mm | |
| Pre-milled Blank: 0.45 mm | ||
| CoCr Abutment: 0.4 mm (Stated to remain the same as primary predicate K170588, implying conformity to existing successful designs) | ||
| Minimum Post Height (single-unit) | Aurum Abutment: 4.0 mm | |
| Pre-milled Blank: 4.0 mm | ||
| CoCr Abutment: 4.0 mm (Increased from previous version, but deemed substantially equivalent to K092341 at 4mm) | Aurum Abutment: 4.0 mm (Stated as the new minimum for single-unit restorations, deemed substantially equivalent to K092341's titanium post height which also requires additional castable component to create 4mm) | |
| Pre-milled Blank: 4.0 mm | ||
| CoCr Abutment: 4.0 mm (Stated to remain the same as primary predicate K170588) | ||
| Maximum Gingival Height | Aurum Abutment: 6.0 mm | |
| Pre-milled Blank: 6.0 mm | ||
| CoCr Abutment: 6.0 mm (Same as primary predicate K170588) | Aurum Abutment: 6.0 mm | |
| Pre-milled Blank: 6.0 mm | ||
| CoCr Abutment: 6.0 mm (Stated to remain the same as primary predicate K170588) | ||
| Maximum Total Abutment Height | Pre-milled Blank: 19 mm | Pre-milled Blank: 19 mm |
| Angulation Correction | No angulation correction (Same as primary predicate K170588) | All abutments are for straight abutments only (implies no angulation correction, same as primary predicate K170588) |
| Chemical Composition | Materials used are comparable to predicate devices (Titanium Alloy, CoCr, Zirconia) | Aurum Base (Titanium Alloy ASTM F136), CoCr Pre-milled Blank (CoCr ASTM 1537), Ti Pre-milled Blank (Titanium Alloy ASTM E136), CoCr Abutment (CoCr ASTM 1537). Screws are Titanium Alloy. (Found to be substantially equivalent to predicates) |
| Physical Dimensions | Encompasses the same range of physical dimensions including diameter and design of abutments as predicate devices. | "The subject device and predicate devices encompass the same range of physical dimensions, including diameter and design of the abutments." (Stated as a conclusion of equivalence) |
| Packaging/Sterilization Methods | Similar to predicate devices. | "The subject and predicate devices are packaged in similar materials and are to be sterilized using similar methods." (Stated as a conclusion of equivalence) |
2. Sample Size Used for the Test Set and the Data Provenance
The document states: "Non-clinical testing data submitted to demonstrate substantial equivalence included: sterilization... biological evaluation... and compatibility analysis by reference to K170588."
- The report does not specify sample sizes for the sterilization or biocompatibility tests.
- The data provenance is implied to be from the manufacturer's (Terrats Medical SL) internal testing as part of their submission for regulatory clearance. It's not explicitly stated whether the data is retrospective or prospective, or the country of origin of the raw data, beyond the manufacturer being from Spain. The "compatibility analysis by reference" means using existing data/information from the predicate device (K170588).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information – number and qualifications of experts for ground truth – is typically relevant for studies involving subjective assessments, like image interpretation in AI/ML medical devices. This document is for a physical dental implant abutment, and the tests performed are objective, non-clinical tests (sterilization, biocompatibility, mechanical properties based on design parameters). Therefore, this information is not applicable and not provided in the submission.
4. Adjudication Method for the Test Set
As the tests are objective non-clinical tests, an adjudication method for a "test set" (in the context of expert review) is not applicable and not mentioned. The results of the non-clinical tests would either meet or not meet the specified standards (e.g., SAL, non-cytotoxicity).
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 comparative effectiveness study was done. This type of study is specifically relevant for AI/ML-driven diagnostic or interpretative devices involving human readers. The device described here is a physical dental implant abutment, not an AI/ML diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This is not an AI/ML device. The "CAD/CAM process" mentioned refers to computer-aided design and manufacturing for custom abutments, which is a manufacturing process, not an analytical algorithm for diagnosis or interpretation.
7. The Type of Ground Truth Used
For the non-clinical tests conducted:
- Sterilization: The ground truth is the scientific standard for sterility, defined as a Sterility Assurance Level (SAL) of $10^{-6}$ based on ISO 17665-1 and ISO 17665-2.
- Biocompatibility: The ground truth is the absence of cytotoxicity, determined by adherence to ISO 10993-1 and ISO 10993-5.
- Design Parameters/Mechanical Equivalence: The "ground truth" for design parameters (e.g., wall thickness, post height) is derived from engineering specifications and comparison to the proven safety and effectiveness of the legally marketed predicate devices (K170588 and other reference devices). The ultimate ground truth effectively is that the device performs equivalently to previously approved devices.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process in that context.
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(267 days)
Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Medentika PreFace CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
The subject device includes two CAD/CAM abutment designs, the Medentika TiBase and the Medentika PreFace. The TiBase is a two-piece abutment used as a base when fabricating a zirconia superstructure and the PreFace is an abutment used in fabricating a full patient-specific abutment in titanium alloy. Both abutment designs are provided non-sterile and are intended to be sterilized by the clinician. Medentika Preface Abutment is available in diameters 3.0 mm to 7.0 mm. Medentika TiBase Abutment is available in diameters 3.25 mm to 7.0 mm. The specific diameters for each Series coordinate with the compatible implant systems and sizes listed below.
TiBase is available in two post designs. TiBase Generation 1 has a conically shaped post that is 4.0 mm high and TiBase Generation 2 has a parallel walled post shape that is 5.5 mm high. PreFace is available in one cylinder height of 20 mm. The maximum angle for abutments fabricated using TiBase or PreFace is 30°, the maximum gingival height is 6 mm and the minimum post height is 4 mm.
Medentika CAD/CAM Abutments are compatible with eleven dental implant systems. Each Medentika abutment series has a precision implant/abutment interface corresponding to the implant system predicate for that series.
The provided document is a 510(k) premarket notification for Medentika CAD/CAM Abutments, asserting substantial equivalence to legally marketed predicate devices. It does not describe a study involving an AI/ML powered device, nor does it detail acceptance criteria related to such a device's performance. Instead, it focuses on non-clinical testing to demonstrate safety and effectiveness for a dental abutment. Therefore, I cannot extract the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, or human-in-the-loop studies from this document.
The "Performance Data" section (Page 6/7) explicitly states the types of non-clinical testing conducted:
- Engineering analysis and dimensional analysis: To determine compatibility with original manufacturers' components.
- Static and dynamic compression-bending testing: According to ISO 14801 (Dentistry – Implants – Dynamic fatigue test for endosseous dental implants).
- Sterilization testing: According to ISO 17665-1 and ISO 17665-2 to demonstrate an SAL of 10^-6.
- Biocompatibility testing: For cytotoxicity according to ISO 10993-5.
The acceptance criteria would be the successful completion of these tests in accordance with the specified ISO standards and demonstrating compatibility and performance comparable to the predicate devices. However, the document does not list the quantitative acceptance criteria or the specific numerical results obtained for each test (e.g., specific fatigue life, or precise dimensional tolerances met).
In summary, the document does not contain the information required to answer the prompt as it pertains to AI/ML device performance. The device is a physical medical device (dental abutments), and the review is for substantial equivalence based on physical and mechanical properties, not an AI/ML algorithm.
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(264 days)
"ComMed" Series Dental Implant System is intended for surgical placement in the maxilla or mandible to provide for prosthetic attachment to restore a patient's chewing function. "ComMed" Series Dental Implants are intended only for delayed loading.
The Chang Gung "ComMed" Series Dental Implant System includes threaded root-form endosseous dental implants (fixtures) and dental implant abutments (healing abutment, standard abutment, angle abutment). The implants are cylindrical and tapered posts made of Grade 4 Pure Titanium. The abutments are made of Ti6Al4V. The system features an internal hex with Morse Taper 8° connection, platform switching, and fine thread in the neck. Various diameters (3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm) and lengths (10, 11, 12, 13, 14, 15, 16 mm) are available for the implants. The surface treatment is blasted with Aluminum Oxide and Acid Etched, and it is also anodized. Implants are sterilized by Gamma irradiation, and abutments are sterilized by moist heat sterilization before use by clinicians.
The provided text describes the Chang Gung "ComMed" Series Dental Implant System and its clearance through the 510(k) pathway, which establishes substantial equivalence to legally marketed predicate devices. This type of submission relies on demonstrating that the new device is as safe and effective as existing ones, rather than providing extensive de novo clinical trials typical for novel medical devices. Therefore, the information provided focuses on non-clinical testing rather than studies involving human subjects, AI performance, or expert ground truth.
Here's a breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in numerical terms for the non-clinical tests. Instead, it refers to conformity with relevant ISO and ASTM standards. The reported device performance is that it met these standards, supporting substantial equivalence.
| Test Category | Test Performed | Relevant Standard(s) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | In vitro cytotoxicity study, Intracutaneous reactivity study, Skin sensitization study, Acute systemic toxicity, Pyrogenicity study, 14-day repeated dose systemic toxicity study, In vitro haemolysis study, In vitro bacterial reverse mutation (AMES) study, In vitro chromosome aberration study, In vitro mammalian cell gene mutation study, Bone formation and histological study (for Implant/Abutment) | ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-4, ISO 10993-3, ISO 10993-6 | Conformed to relevant ISO standards, supporting biocompatibility. (Implied: accepted by FDA) |
| Static and Dynamic Fatigue Loading | Static and dynamic fatigue test (for Implant and standard abutment) Static and dynamic fatigue test (for Implant and angle abutment) | ISO 14801 | Conformed to ISO 14801, indicating mechanical durability. (Implied: accepted by FDA) |
| Sterilization Validation | Sterilization validation of Gamma irradiation (for Implant) Moist heat validation - microbiological performance qualification (for Abutment) | ISO 11737-1, ISO 11737-2, ISO 17665-1 | Conformed to relevant ISO standards, ensuring sterility. (Implied: accepted by FDA) |
| Packaging Shelf Life Validation | Burst and creep tests, Dye penetration test, Seal peel test, Microbial ranking test (initially and after 2, 3, and 5 years of accelerated aging) | ASTM F1140, ASTM F1929, ASTM F88/F88M, ASTM F1608, ASTM F1980 | Conformed to relevant ASTM standards, ensuring packaging integrity and shelf life. (Implied: accepted by FDA) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in the provided text. The non-clinical testing described typically involves specific numbers of samples (e.g., implants, abutments, packaging units) tested in a lab setting, but these quantities are not detailed.
- Data Provenance: The tests are non-clinical, meaning they are lab-based or in-vitro/in-vivo animal studies (for biocompatibility in some cases, though specific animal models are not detailed). The testing was conducted to support the substantial equivalence submission for a device manufactured by Chang Gung Medical Technology Co., Ltd. in Taiwan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this 510(k) submission. The "test set" here refers to the physical devices and materials subjected to non-clinical tests, not a dataset requiring human expert annotation for ground truth. The evaluation of compliance with standards is done by testing laboratories and regulatory bodies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept typically refers to how disagreements among human reviewers (e.g., radiologists) are resolved in clinical studies or AI evaluations. For engineering and biocompatibility testing, the "adjudication" is based on whether the test results meet the specified criteria of the referenced standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a dental implant system (hardware), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or AI performance metrics are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's non-clinical testing is adherence to the specified performance characteristics as defined by international standards (ISO, ASTM) for mechanical strength, biocompatibility, sterility, and packaging integrity.
8. The sample size for the training set
Not applicable. Training sets are relevant for machine learning algorithms, which this device is not.
9. How the ground truth for the training set was established
Not applicable.
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