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510(k) Data Aggregation
(232 days)
Ticare Dental Implant Systems are endosseous dental implanted in the maxilla or mandble jaw bone to serve as a union between the jaw bone and a dental prosthesis for partial or total replacement of teeth in edentulous patients. They are indicated for single-stage or two-stage procedures to support screw-retained restorations and can be used for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Small diameter (3.3mm) implants are indicated to replace a lateral incisor in the maxilla and/or a central incisor in the mandible and should not be used in the molar region. Ti care Osseous Quattro implants are indicated to support permanently fixed restorations.
Ticare Inhex and Osseous implants of 6 mm length are in a two-stage surgical procedure and are indicated for delayed loading to support permanently fixed restorations. These implants are indicated only for straight abutments.
The subject device is a dental implant system including threaded, root-form endosseous dental implants of various diameters and lengths, straight, angled, tapered, UCLA and ball abutments + retention cap as well as healing abutments, cover screws and retaining screws to secure prosthetic restorations. Implants are commercially pure Grade IV titanium except for InHex "Mini" and InHex Quattro "Mini" implants which are Grade V titanium alloy. Abutments and screws are grade V titanium alloy 6Al 4V. Retention cap is Vestakeep D4 R. All implants have an RBM surface. Abutments must be matched to implant design and platform size. Provisional and temporary abutments are for use no more than 2-3 months. Some Inhex abutment designs have a narrow neck alternative version to allow the clinician more choices for soft tissue management.
Osseous dental implants have an external hex connection and are available in three platforms, standard, mini and maxi. Mini platform comes in a diameter of 3.3mm with lengths of 10, 11.5, 13 and 15mm. Standard platform comes in diameters of 3.4, 3.75, and 4.25mm with lengths of 8, 10, 11.5, 13, 15mm (no 8mm in 3.4). There is also a 5.0 standard platform implant which comes in lengths of 6, 8, 10, 11.5, 13 and 15mm. Maxi comes in a diameter of 5.0mm and lengths of 6, 8, 10, 11.5, 13 and 15mm.
InHex dental implants have an internal hex connection and are available in three platforms, standard, mini and maxi. Mini platform comes in a diameter of 3.3mm with lengths of 10, 11.5, 13, 15mm. Standard platform comes in diameters of 3.75, and 4.25mm in lengths of 6 (not in 3.75), 8, 10, 11.5, 13 and 15mm. There is also a 5.0mm diameter implant in standard platform which only comes in a 6mm length. Maxi platform comes in a diameter of 5.0mm with lengths of 9, 10, 11.5, 13, 15mm.
The Osseous Quattro and InHex Quattro implant thread design enables them to be used in softer bone types. Osseous Quattro dental implants have an external hex connection in standard platform and are available in diameters 3.75mm and 4.25mm and lengths of 8, 10, 11.5, 13 and 15mm. InHex Quattro dental implants have an internal hex connection in mini and standard platform and are available in diameters of 3.3mm (mini platform), 3.75mm and lengths 8 (not in 3.3), 10, 11.5, 13 and 15mm.
Maxi platform implants and abutments are for use in the molar region. Mini platform implants and abutments are for use in lateral incisors and lower central incisors. Standard platform implants and abutments are for use in all tooth locations.
Osseous straight abutments come in six designs. Prepable abutments come in hexed with a gingival height of 2mm in standard, mini, and maxi platforms. Tall straight abutments come in hexed with gingival heights of 0.5, 1, 2, 3, 4mm in standard, mini and maxi platforms. Short straight abutments come in hexed and non-hexed with gingival heights of 0.5, 1, 2, 3mm in standard and mini platforms. Multitask abutments comes in maxi platform and has a gingival height of 2mm. One piece abutments are non-hexed with gingival heights of 1, 2, 3, 4mm in standard, mini, and maxi platforms. Aesthetic abutments are hexed with gingival heights of 3 or 4mm in standard platform.
Inhex straight abutments come in six designs. Prepable abutments come in hexed (not in mini) with a gingival height of 2mm in standard, mini, and maxi platforms. There is an additional hexed standard platform prepable abutment with a smooth exterior for cementing. Tall straight abutments come in hexed and non-hexed with gingival heights of 0.5, 1, 2, 3, 4mm (4mm not in mini) in standard, mini and maxi platforms. There are also tall abutments with smooth surfaces for 5.0 implants which come in gingival heights of 3 or 4mm for both standard and maxi platforms. Short straight abutments come in hexed and non-hexed with gingival heights of 0.5, 1, 2, 3mm in standard, mini and maxi platforms. Multitask abutments comes in standard and has a gingival height of 2mm. One piece abutments are non-hexed with gingival heights of 1, 2, 3, 4mm in standard and maxi platforms. Aesthetic abutments are hexed with gingival heights of 3 or 4mm in standard and maxi platform. Inhex narrow neck tall straight abutments hexed and non-hexed come in mini platform with gingival heights of 2, 3mm and maxi & standard platforms with gingival heights of 2, 3, 4mm. Narrow neck short straight abutments hexed come in mini platform with gingival heights of 2, 3m and maxi & standard platforms with gingival heights of 2, 3, 4mm.
Osseous healing screws come in gingival heights of 2, 3, 4, 5, 6, 7mm (no 2mm in mini) in standard, mini, and maxi platforms. Osseous aesthetic healing screws come in gingival heights of 3, 4, 5, 6, 7mm in standard and maxi platforms. There is an additional model in standard platform which has a tapered seating area.
Inhex healing screws come in gingival heights of 1, 2, 3, 4, 5, 6, 7mm (no 1mm in maxi) in standard and maxi platform. Inhex mini platform healing screws come in gingival heights of 3 or 4mm.There is an additional shorter design of healing screw for 5.0mm implants in gingival heights of 3, 4, 5, 6, 7mm in standard and maxi platform. Inhex aesthetic healing screws come in gingival heights of 3, 4, 5, 6, 7mm in standard and maxi platforms. Narrow neck healing screws come in mini platform with gingival heights of 2, 3, 4mm and maxi & standard platform with gingival heights of 2, 3, 4, 5mm.
Osseous angled abutments come in 15° and 20° in standard, maxi, and mini platforms.
Inhex angled abutments come in 15° and 20° in gingival heights of 1, 3, 5mm for standard and maxi platforms and gingival height of 2mm for mini platform. For 5mm implants there is also a shouldered design of 15° and 20° abutment in gingival heights of 1, 3, 5mm for standard and maxi platforms.
Osseous UCLA come in hexed and non-hexed in models for casting temporary or permanent abutments in standard, maxi and mini platforms. Osseous UCLA are for casting straight abutments with a minimum height of 4mm above the gingival collar and with a post height of no more than 9mm. The wall thickness of cast abutments should be at least 0.6mm. The angulation, wall thickness, and diameter of the gingival collar portion are not intended to be modified.
Inhex UCLA come in hexed and non-hexed in models for casting temporary or permanent abutments in standard, and maxi platforms. Inhex UCLA are for casting straight abutments with a minimum height of 4mm above the gingival collar and with a post height of no more than 9mm. The wall thickness of cast abutments should be at least 0.6mm. The angulation, wall thickness, and diameter of the portion from the gingival collar portion to the bottom of the UCLA are not intended to be modified.
Osseous ball attachments in standard, maxi and mini platforms come in gingival heights of 1, 2, 3, 4, 5.5mm (no 1mm in maxi or mini). The retention cap made of Vestakeep D4 R allows implants to be placed off vertical by no more than 10°. Ball attachments are for multiple restorations only.
Inhex ball attachments in standard and maxi platforms come in gingival heights of 1, 2, 3, 4, 5.5mm. The retention cap made of Vestakeep D4 R allows implants to be placed off vertical by no more than 10°. Ball attachments are for multiple restorations only.
Osseous tapered abutments come in six different cone configurations on the top. 10° tapered abutments come in standard platform gingival heights of 2, 3, 4, 5mm with cone type 2, mini platform gingival heights 3, 4, 5mm cone type 1 and maxi platform gingival heights of 2, 3, 4, 5mm with cone type 3. 30° tapered abutments come in gingival heights of 4 or 5mm in standard platform with cone type 4 and maxi platform with cone type 5. Straight tapered abutments come in standard platform with cone type 6 in gingival heights of 2, 3, 4, 5mm. Angled tapered abutments come in standard platform with cone type 6 with 17° in gingival heights 2, 3, 4mm and 30° in gingival heights 3, 4, 5mm. Tapered abutments are for multiple restorations only and for implants which diverge from the occlusion axis by no more than 30°.
Inhex tapered abutments come in five of the possible six cone configurations. 10° tapered abutments come in standard platform gingival heights 0, 1, 2, 3, 4, 5mm in cone type 2 and mini platform gingival heights 1, 2, 3mm in cone type 1. 10° tapered non-hexed abutments come in maxi platform gingival heights 0, 1, 2, 3, 4, 5mm in cone type 2. 30° tapered abutments in cone type 4 gingival heights 1, 2, 3, 4, 5mm come in standard platform and non-hexed maxi platform. Straight tapered abutments in cone type 6 with gingival heights 2, 3, 4, 5mm come in standard and maxi platform. Angled tapered abutments with cone type 6 come in standard and maxi platform with 17° in gingival heights of 2, 3, 4mm and 30° in gingival heights 3, 4, 5mm. Narrow neck 10° tapered abutments come in mini platform with gingival heights of 2, 3mm and standard platform with gingival heights of 2, 3, 4, 5mm. Narrow neck 10° tapered abutments non-hexed come in maxi platform with gingival heights of 2, 3, 4, 5mm. Narrow neck 30° tapered abutments come in standard platform with gingival heights of 2, 3, 4, 5mm. Narrow neck 30° tapered abutments non-hexed come in maxi platform with gingival heights of 2, 3, 4, 5mm. Tapered abutments are for multiple restorations only and for implants which diverge from the occlusion axis by no more than 30°.
Healing abutments for tapered abutments include ones for 10° tapered abutment in standard and maxi platforms which is used with both Osseous and Inhex, angled tapered abutments for Osseous and Inhex, and 30° angled tapered abutment specific ones which fit Osseous maxi platform or Osseous standard and Inhex standard & maxi platforms.
Covers for provisional restoration of tapered abutments come in designs for 10° tapered abutments for Osseous and Inhex, mini and standard platform specific designs for 10° tapered abutments for Osseous and Inhex, and a design for 30° angled tapered abutments for Osseous and Inhex.
Posts for use with tapered abutments come in temporary and permanent restoration versions. Temporary ones come in standard and maxi platform versions for 10° and 30° tapered abutments which can be used with Osseous or Inhex. A temporary restoration post is also available for angled tapered abutments of Osseous or Inhex and an Osseous specific mini platform for 10° tapered abutments. Posts for permanent restoration come in versions for angled tapered abutments used for Osseous and Inhex, 10° tapered abutments used for Osseous and Inhex in standard platform, 30° tapered abutments used for Osseous and Inhex in maxi and standard platforms, non-hexed for 10° tapered abutments used for Osseous and Inhex in maxi platform, and non-hexed for 10° tapered abutment for Osseous mini platform. Titanium interfaces (shorter posts) are available for 10° and 30° tapered abutments for Osseous and Inhex, angled tapered abutments for Osseous and Inhex and 10° tapered abutments for Osseous mini platform.
The provided document is a 510(k) Premarket Notification Submission for Ticare Dental Implant Systems. It is a regulatory document seeking to demonstrate substantial equivalence to legally marketed predicate devices, rather than a study proving the device meets acceptance criteria.
Therefore, the requested information cannot be fully provided as it pertains to a study demonstrating performance against acceptance criteria, which is not the primary focus of this type of regulatory submission.
However, I can extract information regarding the non-clinical testing performed to support substantial equivalence, which serves as a proxy for demonstrating that the device meets certain performance specifications.
Here's a breakdown of what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in a direct table format as acceptance criteria vs. specific quantitative performance values for each test. Instead, the document states that tests "met the criteria of the standards" or "demonstrated substantial 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 for Test Set: Not explicitly stated for each individual test. The document mentions "worst-case scenario" for selection of implants/abutments for certain tests (e.g., shortest implant, largest abutments).
- Data Provenance: Not explicitly stated. The tests were performed by the manufacturer, Mozo Grau, S.A., based in Spain.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This is not applicable as the document describes non-clinical bench testing, not clinical studies involving expert annotation or ground truth establishment in a medical imaging context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this is related to clinical interpretation and ground truth establishment, which did not occur in this non-clinical 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 non-clinical submission for a dental implant system, not an AI/software device involving human readers or comparative effectiveness studies of that nature.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" in this context is adherence to validated engineering and material standards for dental implants.
8. The sample size for the training set:
Not applicable, as this is not an AI/machine learning model.
9. How the ground truth for the training set was established:
Not applicable.
However, I can summarize the non-clinical testing performed as evidence of meeting performance expectations (implicitly serving as 'acceptance criteria' in a regulatory context for substantial equivalence):
Summary of Non-Clinical Data / Testing Performed:
The Ticare Dental Implant Systems underwent various bench tests to demonstrate conformance to performance specifications and requirements, following the FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The results of these tests were reported to have met the criteria of the standards and demonstrated substantial equivalence to the predicate devices.
Non-Clinical Tests Performed (and how they relate to acceptance):
| Test Category | Standard(s) / Description | Reported Performance / Outcome (Implicit Acceptance) |
|---|---|---|
| Mechanical / Durability | Fatigue testing: Under worst-case scenario in accordance with ISO 14801. | "met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." |
| Sterilization | Gamma Sterilization Validation: ISO 11137-1 and ISO 11137-2 (for devices delivered sterile). A Sterility Assurance Level (SAL) of 10^-6 was validated. | "The validation took into account the worst-case scenario, and the results prove equivalence to the predicate device." |
| Steam Sterilization Validation: ISO 17665-1 (for devices delivered non-sterile, e.g., abutments, for end-user sterilization). Two steam sterilizations were conducted on worst-case abutments. | "The results showed equivalence to the predicate device." | |
| Shelf-Life | Shelf-life testing: ASTM F1980 (for accelerated aging of sterile barrier systems and medical devices). | "The worst-case scenario was tested, and the results demonstrated that the devices are equivalent to the predicate devices. The shelf-life is guaranteed up to 5 years, and the devices will function adequately as intended without any degradation during the shelf-life." |
| Packaging Integrity | Packaging Tests: ASTM F88 (seal strength of flexible barrier materials) and ASTM F1929 (dye penetration for seal leaks). | "The results guarantee shelf life up to 5 years under transport and storage conditions during the shelf-life of and USP . Performed on worst-case product. |
| Surface Characterization | SEM (Scanning Electron Microscope) and EDS (Energy-dispersive X-ray spectroscopy): To evaluate final cleaning after surface treatment. | "Implants are completely clean with no residues from the blasting processes on the implant surface, confirming the effectiveness of the cleaning process applied to Mozo Grau dental implants." |
| Dimensional & Mechanical (Short Implants) | Dimensional and mechanical tests: Performed for the shortest implant (6 mm long) from Mozo Grau's system, compared to K172576. This included Bone-to-Implant Contact (BIC) under bone level and 3mm resorption conditions, insertion/removal torque, and pull-out strength. | "All test results have indicated that the subject device is less critical, having more BIC in all conditions, higher insertion and removal torque and higher pull-out forces, indicating favorable substantial equivalence." (i.e., performance met or exceeded predicate/expectations, indicating safety and effectiveness comparable to existing devices). |
| MR Safety | Non-clinical worst-case MRI review: Evaluation of metallic Ticare devices in the MRI environment using scientific rationale and published literature. Rationale addressed magnetically induced displacement force and torque. | This review was performed to support the safety labeling related to MRI compatibility. (No direct "acceptance criteria met" statement, but the performance of the review supports the safe use.) |
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(246 days)
The Zfx Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandbular arch to provide support for prosthetic restorations.
All digitally designed custom abutments or superstructures and/or hybrid abutment crowns for use with Zfx TiBase or Pre-Milled Blank Abutments are intended to be sent to a Zfx validated milling center for manufacture.
The Zfx TiBase abutments for the 03.25 mm Certain implant bodies, and 03.1 mm Eztetic implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
The subject device, Zfx Abutments, consists of two abutment types, a TiBase and a Pre-milled Abutment Blank, with corresponding retaining screws. Zfx Abutments are offered in a variety of connections compatible with ZimVie dental implants. All abutments and screws are provided non-sterile.
TiBase Abutments: Subject device TiBases are two-piece abutments. The pre-manufactured titanium base component is the apical part. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. The subject device TiBase abutments are available in hexed/engaging and non-hexed/nonengaging configurations. The engaging TiBase abutments are intended for single and multi-unit restorations and the non-engaging TiBases are intended for multi-unit restorations. The superstructure is intended to be manufactured at a Zfx validated milling center.
Pre-milled Abutment Blanks: The Pre-milled Abutment Blank is a cylindrical titanium alloy abutment designed for patient-specific abutment fabrication with CAD/CAM technology. The patient-specific abutment milled from a Pre-milled Abutment Blank is secured directly to the implant using a retaining screw. Pre-milled Abutment Blanks are available in an engaging/hexed design only for single-unit and multi-unit restorations.
Retaining Screws: Corresponding retaining screws are packaged with the abutment and replacement screws are available individually. All screws are compatible with the corresponding ZimVie dental implants.
Material Composition: All subject device abutments are made of titanium alloy Ti-6Al-4V ELI conforming to ASTM F136. Screws are made of either titanium alloy Ti-6A1-4V ELI conforming to ASTM F136, or Gold-Tite® screws with stainless steel conforming to ASTM F138. Gold-Tite screws have a gold-plating conforming to ASTM B488 and ASTM B571. Zirconia superstructures for use with the TiBase Abutments are made of zirconia conforming to ISO 13356.
The provided text is an FDA 510(k) clearance letter for Zfx Abutments, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and supporting data in the way a clinical study report or a formal performance evaluation report would.
Therefore, the information required to answer many of the questions regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not present in this document. The document primarily outlines the device's technical specifications, indications for use, and a comparison to predicate devices, supported by non-clinical testing data (mechanical testing, biocompatibility, sterilization, etc.).
However, I can extract the information that is available and explain why other requested details are missing.
Acceptance Criteria and Device Performance (Based on "Equivalence to Marketed Devices" and "Performance Data" sections):
This document describes a substantial equivalence submission, meaning the acceptance criteria are primarily demonstrated by showing the device is as safe and effective as a legally marketed predicate device. The performance is assessed through non-clinical testing to ensure it meets established standards comparable to the predicate.
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (Non-Clinical/Design) |
|---|---|
| Indications for Use Equivalence | "Zfx Abutments (subject device) are substantially equivalent in design, function, material, and Indications for Use to the Primary Predicate, DESS Dental Smart Solutions abutments cleared in K222288. All are intended for use with endosseous dental implants in the maxilla and mandible to provide support for single and multi-unit restorations." |
| Material Equivalence | "All subject device abutments are made of titanium alloy Ti-6Al-4V ELI conforming to ASTM F136." "Screws are made of either titanium alloy Ti-6A1-4V ELI conforming to ASTM F136, or Gold-Tite® screws with stainless steel conforming to ASTM F138." "Zirconia superstructures for use with the TiBase Abutments are made of zirconia conforming to ISO 13356." This is compared to comparable materials in the predicate. |
| Product Design and Manufacturing Process Equivalence | "All digitally designed subject device abutments and primary predicate abutments are to a validated milling center for manufacture. Subject device abutments are similar in range of sizes, connections, and technological characteristics to the DESS Dental Smart Solutions, K22288." "Design parameters for the TiBase CAD/CAM zirconia superstructure are listed in the following tables (Tables 2-5)." "Design parameters for the CAD/CAM patient-specific abutment using a Pre-milled Abutment Blank are included in Table 6." |
| Sterilization Efficacy (Non-clinical) | "sterilization validation according to ISO 17665-1" |
| Biocompatibility (Non-clinical) | "biocompatibility testing according to ISO 10993-1 Table A-1, ISO 10993-5, and ISO 10993-10" |
| Reprocessing Validation (Non-clinical) | "reprocessing validation according to ISO 17665-2" |
| Mechanical Strength/Fatigue (Non-clinical) | "mechanical testing according to ISO 14801 to determine that the subject device has sufficient strength for its intended use." |
| MR Safety (Non-clinical) | "MR Safety testing was conducted according to ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119 for a determination of MR Conditional." |
| Compatibility with Existing Systems | "reverse engineering analysis to confirm compatibility with the Sirona inCoris Meso Blocks" (for TiBase). |
Missing Information and Explanations:
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. This document details a 510(k) submission based on non-clinical testing for substantial equivalence, not a clinical trial or performance study with human data. The "Performance Data" section explicitly states: "No clinical data were included in this submission." Therefore, there is no "test set" in the context of clinical images or patient data to analyze. The "samples" used were physical samples for mechanical, sterilization, and biocompatibility testing. The data provenance would be from laboratory tests.
-
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/Not provided. As no clinical data or clinical "test set" was used, there was no need for expert adjudication to establish ground truth from patient data. The ground truth for mechanical and material properties is established by engineering specifications and industry standards.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/None. No clinical test set to adjudicate.
-
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 (Zfx Abutments) is a physical dental implant component, not an AI software/device. Therefore, an MRMC study or AI assistance is not relevant to its performance evaluation for this submission.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As above, this is a physical medical device, not an algorithm or AI.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for demonstrating substantial equivalence for this device relies on engineering specifications, material standards (e.g., ASTM, ISO), mechanical test results (e.g., forces to fracture), and comparative analysis with the predicate device's established safe and effective performance. There is no clinical outcomes ground truth cited here.
-
The sample size for the training set:
- Not applicable. This refers to a dataset for training an AI model. This device is not an AI/software.
-
How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI model.
In summary, this document is a regulatory clearance letter focused on substantial equivalence for a physical dental device. The "study" proving it meets acceptance criteria consists of various non-clinical bench tests and a comparison to a predicate device's specifications and performance, rather than a clinical study with patients or an AI model's performance evaluation.
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(89 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 add components to the DESS Dental Smart Solutions system, which includes abutments compatible with a variety of original equipment manufacturers (OEM) of dental implants. This submission adds abutments, designated DESS Multi-Unit Abutments, for implant lines from Zimmer Dental and Biomet 31 (now collectively, ZimVie Dental). The subject device abutments include Multi-Unit Abutments in straight, 17° angled, and 30° angled designs, which are compatible with implants having internal hex connections. This submission is also to change how previously cleared devices are provided; the change is from previously provided nonsterile to now provided sterile. All abutments are provided with the appropriate abutment screw (if applicable) for attachment to the corresponding implant. The subject device is only intended for multi-unit restorations such as bridges and bars.
It appears there might be a misunderstanding of the provided text. The document is a 510(k) premarket notification for a dental implant abutment, not an AI/ML medical device. Therefore, the information typically required for describing an AI/ML device's acceptance criteria and study data (like sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance) is not present.
The document discusses the substantial equivalence of the DESS Dental Smart Solutions abutment to legally marketed predicate devices. The "performance data" section refers to non-clinical testing to demonstrate the device's physical properties and compatibility, not a study evaluating an AI algorithm's diagnostic or predictive performance.
Let's break down what can be extracted from the provided text relevant to the device's acceptance, and then explain why the AI/ML specific questions cannot be answered.
Understanding the Device and its "Acceptance":
The "acceptance" in this context refers to the FDA's determination that the new DESS Dental Smart Solutions abutments are "substantially equivalent" to predicate devices already on the market. This determination is based on the device having the same intended use and similar technological characteristics (design, materials, performance via non-clinical testing).
Here's a summary of the information available in the document:
1. Table of Acceptance Criteria (or rather, Equivalence Criteria) and Reported Device Performance:
The document doesn't present acceptance criteria in a quantitative table with performance metrics like sensitivity, specificity, or accuracy, as would be common for an AI/ML device. Instead, "acceptance" is based on demonstrating substantial equivalence to predicate devices across several characteristics. The performance is shown through non-clinical testing to ensure safety and functionality.
| Characteristic | Subject Device (DESS Dental Smart Solutions, K231434) | Primary Predicate (K230143, DESS Dental Smart Solutions) | Reference Device (K213063, TLX SRAs and TLX Gold Abutments) | Reported Performance (Non-Clinical Data) |
|---|---|---|---|---|
| Intended Use | 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. | DESS Multi-Unit Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. | Functional and esthetic rehabilitation of the edentulous mandible or maxilla | Stated as "same intended use" as predicates. |
| Abutment Designs/Types | Multi-Unit, straight (0°), 17° angled, 30° angled | Multi-Unit, straight (0°), 17° angled, 30° angled | Multi-Unit, TLX SRA: 17°, 30°; TLX Gold: 0°, and up to 30° | Similar to predicates. |
| Prosthesis Attachment | Screw Retained | Screw Retained | Screw Retained | Similar to predicates. |
| Restoration | Multi-unit | Multi-unit | Multi-unit | Similar to predicates. |
| Prosthetic Interface Connections | Internal hex, External hex | Internal hex, Internal conical | Internal conical | Similar to predicates, with some variations noted and justified. |
| Abutment/Implant Platform Diameter | 2.9 - 5.7 mm | 3.0 - 4.5 mm | TLX SRA: 6 mm; TLX Gold: 4.0 (NT), 5.0 (RT), and 7.0 (WT) | Within similar ranges or justified compatibility. |
| Prosthetic Platform Diameter | 4.8 mm | 4.8 mm | TLX SRA: 4.6 mm; TLX Gold: not provided in 510(k) Summary | Similar to predicates. |
| Gingival Height | 1 mm - 5 mm | 1 mm - 5 mm | Not provided in 510(k) Summary | Similar to predicates. |
| Abutment Material | Ti-6Al-4V ELI (Titanium alloy) | Ti-6Al-4V ELI (Titanium alloy) | TLX SRA: Ti-6Al-7Nb; TLX Gold: Ceramicor® | Similar (titanium alloys). Biocompatibility tested (ISO 10993-5 referenced). |
| Abutment Screw Material | Ti-6Al-4V ELI (Titanium alloy) | Ti-6Al-4V ELI (Titanium alloy) | Ti-6Al-7Nb | Similar (titanium alloys). |
| How Provided (Sterilization) | Non-sterile, and sterile by gamma irradiation | Non-sterile | TLX SRA: Sterile by gamma irradiation; TLX Gold: non-sterile | Both non-sterile and sterile options justified via reference devices/testing (e.g., K212538 for gamma, K22269 for moist heat). |
| Usage | Single patient, single use | Single patient, single use | Single patient, single use | Identical. |
| Mechanical Performance | Evaluated according to ISO 14801 (mechanical testing); Engineering analysis for new worst-case constructs. | Referenced | - | Demonstrated to not create a new worst-case or met ISO 14801. |
| MR Safety | Evaluated according to ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119. | - | - | Non-clinical analysis provided to evaluate metallic devices in MR environment. |
| Sterility & Shelf Life | Refer to K22269 (moist heat), K212538 (gamma irradiation, bacterial endotoxin, shelf life). | Referenced | - | Validated to SAL of 10^-6, met bacterial endotoxin limits, and 5-year shelf life after accelerated aging. |
Important Note: The "acceptance criteria" here are qualitative statements of substantial equivalence, backed by quantitative non-clinical engineering and materials testing, not performance metrics from a clinical study or an AI model's accuracy.
Regarding the AI/ML Specific Questions:
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable. This document is for a physical medical device (dental implant abutment), not an AI/ML algorithm. There is no "test set" in the context of data for an AI/ML model. The "testing" refers to mechanical, material, and sterilization validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth establishment by experts is relevant for AI/ML diagnostic devices. This device's performance is assessed through engineering standards and material properties. Compatibility with implant systems is established through design agreements and reverse engineering data (referenced from K170588).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used in clinical studies or for establishing ground truth labels for AI/ML datasets.
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. MRMC studies are for evaluating diagnostic efficacy, particularly with AI assistance. This device is a passive prosthetic component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for this device's performance is its adherence to engineering standards (e.g., ISO 14801 for mechanical properties, ASTM for materials/MR safety) and its demonstrated compatibility with specified implant systems, rather than a clinical ground truth like disease presence.
8. The sample size for the training set:
- Not applicable. There is no AI model or training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no AI model or training set.
Conclusion from the document:
The provided document describes a 510(k) submission for a Class II medical device, DESS Dental Smart Solutions abutments. The "acceptance criteria" revolve around demonstrating substantial equivalence to existing legally marketed predicate devices. This is achieved through:
- Identical intended use.
- Similar technological characteristics: This includes materials (Titanium alloy), design (multi-unit, screw-retained), and geometric parameters (diameters, gingival heights).
- Performance via non-clinical testing: This includes mechanical testing (ISO 14801), MR safety testing (ASTM standards), sterilization validation (ANSI/AAMI/ISO standards), bacterial endotoxin testing (ANSI/AAMI ST72), shelf-life testing (ASTM F1980), and biocompatibility testing (ISO 10993-5).
- Compatibility with specified implant systems: This is supported by contractual agreements with OEMs (ZimVie/Terrats Medical SL) and referenced reverse engineering data.
The document explicitly states: "No clinical data were included in this submission." This further confirms that the evaluation framework is entirely non-clinical and does not involve AI/ML performance metrics, studies with human readers, or expert ground truthing as one would see for an AI-powered diagnostic tool.
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(93 days)
Rodo Abutment System is intended to be used in conjunction with compatible implant systems in the maxillary or mandibular arch to provide support for crowns, bridges or overdentures.
The Rodo Abutment System includes the Rodo Abutment, Smileloc Sleeve, Titanium Coping, Temporary Cap, abutment screws, the Smileloc Activator (or Smileloc Remover) (all cleared under K160786) and Smilekey (cleared under K180609). The Smileloc Sleeve is used to lock and unlock the Titanium Coping for final restoration to or from the abutment. This makes the prosthesis removable. The Rodo Abutment System eliminates the need for an access hole on the occlusal surface of a screw-retained restoration and also eliminates the possibility of prosthetic screw loosening. The Smilekey is an induction heating device for dental prosthesis removal of the Smileloc Sleeve in the Rodo Abutment System. The Smilekey was cleared as an accessory to the Abutment System in K180609, and there have been no changes to the Smilekey since this clearance.
The Rodo Abutment is provided in five series designs (100 F, 200 P, 300 S, 400 M, 500 D) with the 200 P and 500 D series having angled abutments (17°, 30°), for a total of nine designs. The 300 S series is designed for limited occlusal space and the 400 M series is designed for large interproximal spaces. Abutments are available in sizes ranging from 3.0 mm to 6.0 mm depending on the compatible implant system in use. Designs are available with engaging and non-engaging implant-abutment interfaces.
The provided text describes a 510(k) premarket notification for the Rodo Abutment System, focusing on adding compatibility with new implant lines. However, it does not contain the detailed information typically found in a study proving a device meets specific performance acceptance criteria for an AI/ML medical device.
The Rodo Abutment System is a hardware dental device, not an AI/ML software device. The "performance data" section discusses non-clinical testing such as dimensional analysis, reverse engineering, and fatigue testing according to ISO 14801. It does not refer to AI/ML model performance metrics, ground truth establishment, or human reader studies.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or multi-reader multi-case studies, as the provided document pertains to the clearance of a mechanical dental device and not an AI/ML-driven diagnostic tool.
Specifically, the document does NOT contain information on:
- A table of acceptance criteria and reported device performance for an AI/ML model (e.g., sensitivity, specificity, AUC).
- Any sample sizes used for a test set in the context of AI/ML performance.
- Data provenance for AI/ML data (country of origin, retrospective/prospective).
- Number of experts used to establish ground truth for an AI/ML model.
- Adjudication method for an AI/ML test set.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone (algorithm-only) performance of an AI/ML model.
- Type of ground truth used (pathology, outcomes data, etc.) for an AI/ML model.
- Sample size for a training set in the context of AI/ML.
- How ground truth for a training set was established for an AI/ML model.
The document's "Performance Data" section solely refers to non-clinical bench testing for a mechanical device.
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(210 days)
EBI Dental Implant System is intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
An endosseous dental implant is a device made of a material such as Pure Titanium Grade 4 and Titanium alloy (Ti-6A1-4V ELI). EBI Implant system has been designed to accommodate the following dental implant restoration protocols; Immediate or Early loading, immediate placement or one or two stage placement. EBI Implant systems help patients who have partial or whole teeth loss mastication to chew as dental implant. The EBI External Implant System has an external connection.
The surface of the system has been treated with RBM (Resorbable Blasted media).
The Fixture diameters are 3.25, 3.3, 3.75, 4, 4.1, 4.8, 5, 5.5, 6, 6.5, 7mm and lengths are 7, 8, 8.1, 8.5, 9, 9.6, 10, 11, 11.5, 12, 12.6, 13, 14, 14.6, 15mm in this system.
The contained various abutments and accessories in the system are cover screw, healing abutment, cemented abutment, temporary abutment, healing cap, impression coping, analog, fixture mount, Ti-screw, angled abutment, impression guide pin, gold UCLA abutment and locator.
Fixtures and abutments are packaged separately. The Fixtures are supplied sterile and the abutments and accessories are provided non-sterile. The abutments and accessories should be sterilized before use.
The EBI External Implant System is a dental implant system. The provided document is a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices rather than proving specific acceptance criteria with detailed studies in the manner typically seen for novel AI/software devices. Therefore, the information typically requested for AI/software-based devices regarding acceptance criteria, ground truth, sample sizes, and expert adjudication for performance studies is not directly applicable or available in this document.
However, based on the provided text, we can glean information about the performance testing conducted and how it demonstrates "safety and effectiveness" in the context of a dental implant.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or F1-score, as would be expected for a diagnostic or AI-driven decision support system. Instead, for a dental implant, performance is assessed through bench testing demonstrating structural integrity and compliance with recognized standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Fatigue Resistance (to ensure durability under physiological loads) | Fatigue Testing was performed in accordance with ISO 14801:2007 |
| Biocompatibility (materials used are safe for implantation) | Fabricated from CP Titanium (Grade 4) conforming to ASTM F67 and Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 |
| Sterility (implants are sterile) | Fixtures are supplied sterile; abutments and accessories are provided non-sterile but should be sterilized before use; Gamma Sterilization: Yes |
| Shelf Life (maintaining integrity over time) | 5 years |
2. Sample size used for the test set and the data provenance
The document doesn't provide specific sample sizes for the fatigue testing in terms of the number of tested devices. It only states that "Fatigue Testing was performed in accordance with ISO 14801:2007." ISO 14801 specifies test methods for dental implants, which would inherently include a defined number of samples to ensure statistical validity, but this detail is not explicitly stated in the 510(k) summary.
Data Provenance: The testing was conducted by EBI Inc., a South Korean company.
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 device and testing. The "ground truth" for a dental implant's mechanical performance is defined by adherence to engineering standards and material specifications, not expert consensus on an image or diagnosis.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts in clinical performance studies, typically for diagnostic devices. Mechanical bench testing of an implant does not involve such human-based 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 is a medical device (dental implant), not an AI or software-assisted diagnostic system. Therefore, MRMC studies examining human reader performance with or without AI are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm. The device is a physical dental implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the EBI External Implant System is based on established engineering and material standards, specifically:
- ISO 14801:2007 for fatigue testing of dental implants.
- ASTM F67 for unalloyed titanium (CP Titanium Grade 4) used in dental implants.
- ASTM F136 for wrought titanium-6aluminum-4vanadium alloy (Ti-6Al-4V ELI) for surgical implant applications.
- General device safety and effectiveness principles outlined in FDA's Class II special controls guidance document for root-form endosseous dental implants and abutments.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a learning algorithm or AI/ML device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply.
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