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510(k) Data Aggregation
(463 days)
ICX-Implant System is indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. ICX- Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7.0 mm are indicated for delayed loading only.
ICX-Implant System CAD CAM abutments are intended for use with dental implants as a support for single unit or multiple unit prostheses in the maxilla of a partially or fully edentulous patient. All digitally designed abutments for use with ICX-Implant System CAD CAM abutments are intended to be manufactured at a medentis medical GmbH validated milling center.
The purpose of this submission is to obtain marketing clearance for an endosseous dental implant and abutment system. ICX-Implant System, from medentis medical GmbH. The ICX-Implant System includes a range of endosseous dental implants and prosthetic components. All implants have a selftapping apical thread with a tapered body and root-form designs with an internal hex implant/abutment connection. The implant body surface is blasted and acid-etched.
Abutments are available in multiple designs, including straight and angled abutments intended for single tooth and multi-unit restorations.
The provided text is a 510(k) summary for the "ICX-Implant System." This document is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to previously cleared devices rather than proving the device meets specific acceptance criteria through a standalone performance study.
Therefore, the document does not contain the detailed information required to fully answer all aspects of your request, especially regarding specific acceptance criteria for AI/algorithm performance, multi-reader multi-case studies, or detailed ground truth establishment for a test/training set in the context of an AI device.
The document does describe non-clinical performance data for the dental implant system itself (e.g., sterilization, biocompatibility, mechanical testing) to show its safety and effectiveness, but not for an AI component.
Here's an analysis based on the provided text, highlighting what is present and what is missing:
1. A table of acceptance criteria and the reported device performance:
- Missing: The document does not define "acceptance criteria" in the context of an AI/algorithm's performance (e.g., sensitivity, specificity, AUC). Instead, it discusses the substantial equivalence of the ICX-Implant System and its components to predicate devices based on technological characteristics, materials, and indications for use.
- The "Performance Data" section (Page 7) lists non-clinical tests performed, such as:
- Validation of gamma irradiation sterilization to a sterility assurance level (SAL) of 10⁻⁶.
- Bacterial endotoxin testing:
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(258 days)
Paltop Short Implants (Internal Hex and Conical Connections) are in surgical and restorative applications for placement in the bone of the upper or lower jaw as an artificial root structure for single tooth replacement or for fixed bridgework to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Paltop Short Implants are indicated to be used only with straight abutments and are for delayed loading only.
The purpose of this submission is for the marketing clearance for the Paltop Short Implants which comprises endosseous root-form dental implants, cover screw, and compatible abutments.
The Subject device abutments are compatible with prior cleared implant bodies, and abutments from prior clearances are compatible with new Subject device implant bodies. Subject device abutments are also compatible with previously cleared implant bodies in K112795. Subject device are compatible with straight abutments previously cleared in K112795, K131451, K220200, and K221381.
Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
The Paltop Short Implant System includes endosseous screw type dental implant bodies, which can be used in twostage surgeries with associated compatible abutments. The Subject device abutments provide a range of cementretained and screw-retained prosthetic solutions for dental implant restoration. Paltop Short Implant System includes six compatible implant abutment designs: Healing Caps, Straight, Temporary, Snap-On Abutment System (SAS) Abutment, and Straight Ball Abutment.
The implant bodies, titanium abutments and cover screw are fabricated from a Titanium 4 Vanadium ELI titanium alloy (Grade 23) which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium EU (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Subject device implant bodies are surface treated with SLA (Sand-blasted, Large Grit, Acid Etched). The Snap On Abutment System(SAS) Abutments are supplied sterile with a PEEK cap.
All implants and prosthetic components are one-time use device components are provided sterile and sterilized by gamma irradiation except for the replacement cover screws which are provided nonsterile. Devices provided as non-sterile are sterilized by steam.
I am sorry, but the provided text does not contain the specific details about the acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) summary for Paltop Short Implants, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and study results for device performance in the way you've requested.
The text does mention "Comparative testing in the form of Pull-Out, surface area and BIC testing was performed to ensure that the performance of the subject device is appropriate for its intended use," but it does not provide the acceptance criteria for these tests, nor does it present the reported device performance values from these tests. It also states that "static and dynamic testing were not required" because the device is not significantly different from predicate devices.
Therefore, I cannot fulfill your request for the detailed table and study information as the necessary data is not present in the provided document.
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(247 days)
The Tatum Surgical Integrity Tapered, "T" and "S" Dental Implant Systems are intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prothesis to restore chewing function. It may be used with single-stage or two- stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
The Tatum Surgical Dental "P" Plateau Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prosthesis to restore chewing function. It may be used for single or multiple unit restorations and is indicated for delayed loading, placed with conventional two-stage surgical process with secondary and transmucosal healing.
The Tatum Surgical One-Piece Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prosthesis to restore chewing function. It may be used for single or multiple unt restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The 3.0 mm diameter Tatum Surgical One-Piece Implant must be splinted if two or more are used adjacent to each other.
The subject device includes three (3) two-piece implant systems that have connections and prosthetic components in multiple designs unique to each system, including straight and angled abutments intended for single-unit and multiple-unit restorations. The subject device also includes one (1) one-piece implant system, in which the abutment portion is integral with the implant portion.
This document describes the Tatum Surgical Dental Implant System, a Class II medical device, and its substantial equivalence to previously cleared predicate devices. It focuses on the technical specifications and performance data rather than diagnostic or AI-assisted performance for an acceptance criterion.
Therefore, the requested information regarding acceptance criteria and studies proving the device meets them, particularly concerning human reader improvement with AI assistance, standalone algorithm performance, number of experts for ground truth, sample sizes for training and test sets, and data provenance, cannot be extracted from this document.
The document details the following technical and performance aspects:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present acceptance criteria in a quantitative table format with corresponding reported device performance, as would be typical for an AI/diagnostic device. Instead, it provides:
-
Indications for Use (IFU) Statement Comparison: (Pages 9-10) This section compares the IFU of the subject device (Tatum Surgical Dental Implant System) against several predicate devices (e.g., Neodent Implant System, Blue Sky Bio Dental Implant System, MIS Internal Hex Dental Implant System). The acceptance criterion implicitly is "substantial equivalence" of the IFU. The reported performance is that "The IFUS for the subject device is substantially equivalent to that of the primary predicate K133510 and the additional predicate devices."
-
Technological Characteristics Comparison: (Pages 11-15) This extensive table compares various features of the subject device (Tatum Surgical Dental Implant System) across its different implant lines (Integrity Tapered, "T" and "S" Implants, "P" Plateau Implant System, One-Piece Implant System) with numerous predicate devices. The features compared include:
- Product Code
- Implant Placement (Bone Level, Tissue Level)
- Prosthetic Interface Connection (Internal pentagon, Internal hex, Morse taper)
- Body/Platform Diameter (mm)
- Total Lengths (mm)
- Endosseous Length (mm)
- Apical Hole (Yes/No)
- Implant Material (Titanium alloy (Ti6Al-4V), CP Titanium, Gr.4, Titanium TI-6Al-4V ELI, Zirconia)
- Implant Endosseous Surface (Aluminum oxide blasted and passivated, Grit blasted and acid etched, Blasted with resorbable medium, etched, Sand blasted and acid etched, MTX Blasted, Sand-blasted, Large grit, Acid-etched (SLA), Roughened - blasted and acid Etched, Blasted and clean, None)
- Healing Components (Coronal Ø, Gingival Height, Connection, Material)
- Abutments (Coronal Ø, Gingival Height, Angulation, Connection, Material)
- Ball Abutments (Coronal Ø, Gingival Height, Connection, Material)
- Abutment Type (Straight)
- Sterility
- Usage (Single patient, single-use)
The reported device performance for these features is stated directly in the table, demonstrating the similarities or minor differences to the predicate devices, thereby supporting the claim of substantial equivalence.
2. Sample size used for the test set and the data provenance:
- This information is not provided in the document. The document describes a medical device (dental implants) and its substantial equivalence based on material properties, design, and mechanical testing, not a diagnostic algorithm or AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided as this document does not concern a diagnostic device requiring expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable and not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This information is not applicable and not provided.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This information is not applicable and not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This information is not applicable and not provided. The ground for this device's acceptance is based on demonstrating substantial equivalence to predicate devices through technical characteristics and mechanical performance testing, not through diagnostic accuracy against a ground truth.
8. The sample size for the training set:
- This information is not provided. The acceptance of this device is based on "substantial equivalence" to existing cleared devices, supported by performance testing (mechanical, surface analysis, sterilization, shelf-life, biocompatibility), rather than a machine learning training and test set paradigm.
9. How the ground truth for the training set was established:
- This information is not applicable and not provided as there is no mention of a training set or ground truth in the context of an AI/diagnostic device.
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(586 days)
The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.
The LOTA SLA Dental Implant system and LOTA HA Dental Implant System are dental implant systems made of Titanium 6AL 4V ELI alloy, which confirms to ASTM F136, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. All diameters are available with all lengths. The implants are used with the following abutments. The Shouldered Abutments and the Shouldered Hex Abutments have internal connection structure, and they adopt locking taper connection. They restore fixed crown and bridge restorations. The Shouldered Removal Abutment uses screw and locking taper connection to be connected with the fixture. It has the same intended use as the other abutments. All the abutments are not intended for angulation.
This document is a 510(k) premarket notification for the LOTA SLA Dental Implant System and LOTA HA Dental Implant System. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study that proves the device meets specific performance acceptance criteria for a new and innovative AI/software functionality.
Therefore, many of the requested items (e.g., sample size for training/test sets, expert adjudication methods, MRMC studies, standalone performance, ground truth for AI, effect size of human reader improvement with AI) are not applicable or extractable from this document as it pertains to a medical device (dental implant system), not an AI/Software as a Medical Device (SaMD).
However, I can extract information related to the non-clinical testing performed to establish substantial equivalence for this physical device.
Summary of Acceptance Criteria and Proving the Device Meets Them (Based on the Provided Document which is for a Physical Medical Device - Dental Implant System)
This 510(k) submission establishes substantial equivalence for the LOTA SLA Dental Implant System and LOTA HA Dental Implant System to legally marketed predicate devices. The "acceptance criteria" here are not about software performance metrics but rather about demonstrating that the new device shares fundamental scientific technology, materials, design, and performance characteristics with existing devices, and that any differences do not raise new questions of safety or effectiveness. The "study" largely refers to non-clinical testing and comparison to predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Demonstrated) | Reported Device Performance / Assessment |
|---|---|---|
| Intended Use | The device is used in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cemented, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework, for single and two-stage surgical procedures, intended for delayed loading. | Demonstrated Equivalence: The subject device (LOTA SLA/HA Dental Implant System) has the same indications for use as the primary predicate device (KJ Submerged System, K103810). |
| Fundamental Scientific Technology | The device should employ similar principles and mechanisms as legally marketed devices. | Demonstrated Equivalence: The subject device and the predicate device (KJ Submerged System, K103810) have the same fundamental scientific technology. |
| Materials | Biocompatibility and mechanical properties of materials (Titanium 6AL 4V ELI alloy, ASTM F136). | Demonstrated Equivalence: The subject and predicate devices employ the same materials (Titanium 6AL 4V ELI alloy, ASTM F136). |
| Design | Similar design elements (Implant Type: Bone Level, Connection Type: Internal Locking Taper, Neck Design: Straight walled neck, Body Design: Tapered) and dimensional ranges (diameters, lengths). | Demonstrated Similarity/Mitigation: The subject and predicate devices have very similar in design. Differences identified (fixture thread design, fixture size, abutment design) were addressed by identifying reference devices with similar features and size ranges (Bicon Implants K092035, J2a/J2c Dental Implant System K150060, MegaGen AnyRidge® Implant System K170044) to demonstrate these changes do not raise new concerns. |
| Surface Treatment | The SLA treatment should not introduce new safety concerns (e.g., biocompatibility, residual contaminants). | Mitigation/Equivalence: The SLA treatment is a difference from the primary predicate's RBM Treatment/HA Coating. This was addressed by identifying a reference device made by the same company (J2A SLA Dental Implant System, K161923) that goes through the same manufacturing processes and has the same material/surface treatment. Additionally, SEM analysis was performed to validate no residual contaminants remained on the implants. |
| Sterilization & Shelf Life | The device must be adequately sterilized and maintain sterility and integrity over its shelf life. | Testing Performed: Sterilization validation testing was conducted in accordance with ISO 11137-1 and 11137-2 (Gamma sterilization). Shelf life validation tests were performed in accordance with ASTM F1980-7, ASTM F88, ISO 11607, and ISO 11737-2. The results support substantial equivalence. |
| Endotoxins | Endotoxin levels must be within acceptable limits for lot release. | Testing Performed: Endotoxin testing for lot release was evaluated in accordance with USP 39 , confirming the endotoxin limit is 0.5 EU/mL. |
| Risk Management | Risks associated with modifications must be identified and mitigated. | Risk Analysis Conducted: Risk analysis was conducted according to ISO 14971 to evaluate the effect of the modifications. The activities/tests listed above (identification of reference devices, sterilization/shelf-life validation, endotoxin testing, SEM analysis) were performed based on this analysis to mitigate identified potential risks. |
Regarding AI/Software specific criteria (not applicable for this document):
The provided document is a 510(k) premarket notification for a physical medical device (dental implants). It is not for a software or AI device. Therefore, the specific questions related to AI/Software performance, test sets, ground truth establishment by experts, MRMC studies, or standalone algorithm performance are not detailed or relevant in this context.
If this were an AI/Software as a Medical Device (SaMD) submission, these sections would be crucial. Since it's for a physical implant, the "acceptance criteria" are based on material properties, design, manufacturing processes, intended use equivalence to predicates, and standard biological and physical testing.
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(100 days)
SuperLine® implants are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. SuperLine® implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Single tooth cases on 7 mm length implants are indicated for delayed loading.
The purpose of this submission is to add dental implants to the SuperLine components cleared in K160965. This submission includes two series of implants: SuperLine FXSxxxxB Series and SuperLine FXSxxxx Series.
The FXSxxxB Series has a machined collar height that ranges from 0.03 mm (on the 3.6 mm body diameter implant) to 0.6 mm (on the 5.0 mm body diameter implant). All FXSxxxxB Series implants have an endosseous length of 7 mm, and threaded lengths ranging from of 6.98 mm to 6.4 mm. Other than the endosseous length of 7 mm, the subject device FXSxxxB implants are identical in design and sizes to SuperLine implants cleared in K160965.
The FXSxxxx Series has machined collar 1.5 mm in height for all implant body diameter sizes. For body diameters 4.0 mm to 5.8 mm, the collar has a reverse taper. All FXSxxxx Series implants have an endosseous length of 7 mm, and a threaded length of 5.5 mm. The FXSxxxx series implant design has not been cleared previously by FDA for any body diameter or length.
All subject device implants are manufactured from the same unalloyed titanium conforming to ASTM F67 and have the same surface treatment (S.L.A., Al2O3 blasted and acid etched) as the dental implants cleared in K160965.
All subject device implants are compatible with previously-cleared abutments and prosthetic components from Dentium Co., Ltd., including those cleared in K192436, K141457, and K041368.
The provided document is a 510(k) summary for a medical device (SuperLine dental implants) and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document discusses substantial equivalence to predicate devices based on non-clinical data and design comparisons.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study demonstrating device performance against those criteria.
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(131 days)
Straumann® 4 mm Short Implants are intended for oral endosteal implantation in the jaw and for the functional oral rehabilitation of edentulous and partially edentulous patients.
Straumann® 4 mm Short Implants are indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone and with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks. The 4 mm Short Implants are specifically recommended for:
- Fixed partial dentures/splinted units (one implant per unit)
- Pontic cases in combination with at least one longer implant
- Fully edentulous cases with at least one 4 mm Short Implant in combination with 2 longer implants in the anterior region and at least four total implants
The Straumann® Dental Implant System is an integrated system of endosseous dental implants with corresponding abutments, healing abutments, closure screws and surgical and prosthetic parts and instruments. Straumann® Roxolid® dental implants are solid screw implants comprised of a titanium-zirconium alloy with the hydrophilic SLActive® bone anchorage surface that is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a NaCI solution.
This premarket notification serves to add new dental implants to the Straumann Dental Implant System portfolio that are 4 mm in length. Other than the implant length, the subject devices are physically identical to the primary predicate tissue level devices except for the implant thread which is identical to the bone level primary predicate devices cleared under K130222.
The Straumann® 4 mm Short Implants are manufactured from the Roxolid® material with the SLActive® surface and are available in Ø4.1 mm with a Regular Neck (RN) Tissue Level implant/abutment interface and in Ø4.8 mm with an RN or Wide Neck (WN) Tissue Level implant/abutment interface.
The provided text does NOT describe an AI/ML powered device, therefore, the requested information elements related to AI/ML device performance and testing (such as AI assistance effect size, ground truth for training/test sets, sample sizes for training/test sets, adjudication methods, and expert qualifications) cannot be extracted or fulfilled.
The document pertains to the 510(k) summary for Straumann® 4 mm Short Implants, a medical device, and the evaluation details focus on the physical and mechanical performance of the implant, biocompatibility, sterilization, and clinical literature review of implant survival rates, not on an AI system's performance.
Therefore, the table of acceptance criteria and reported device performance, and the other requested information points are not applicable in the context of an AI/ML device. The document describes a dental implant, not an AI or imaging device.
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(255 days)
DenTack PYRAMIDION Dental Implants and Prostheses are intended for surgical placement in the maxilla and/or in the mandible to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous jaws utilizing conventional, delayed or immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants in 5-6mm length are indicated for delayed loading only.
DenTack has developed a range of expandable dental implants made of titanium (the most common material for dental implants) to serve the need of patients that require partial or complete tooth restoration.
The implant is placed so its end is in the trabecular (spongy) bone like any other implant. Once in place, the apical portion of the implant is expanded to achieve increased contact surface area with the surrounding bone.
The system also includes various accessories that are attached to the implant. The PYRAMIDION has an external hex connection with 0.7mm height and 2.7mm hex with a distinct projection externally to the implant body. The connection between the prosthetic part to the upper platform of the implant interacts with a recessed plain of 15-degrees into the upper platform of the implant body while it is projected from the prosthetic part.
All DenTack's implants are made of biocompatible Titanium. Prostheses and Surgical components are made of same Titanium alloy, stainless-steel and polymers.
DenTack's PYRAMIDION Implants with are the subject of this submission are available in outer diameter (OD) of 4.1 mm and in length of 5 and 6 mm.
DenTack's Prostheses and dimension ranges are identified as follows:
Metal Housing: 3.3 mm Height
Plastic Cup: 2.7 mm Height
Straight Multi-Unit Sleeve: 11 mm Height
Straight Multi-Unit Screw: 2.3 mm Diameter
Angled Abutments 15° And 22.5°: Length: 7 mm – 9 mm
Angled Abutments 15° Large: Total Length: 9 mm – 12 mm
Ball Attachments: 2, 3 and 4 mm Height
Direct Screw Platform
Straight Abutments 2, 3, 8.5 mm Length
Straight Multi-Unit Abutments 2, 3 and 4 mm Length
Angled Multi Unit Abutments 17° and 1.5 and 3 mm Length
Healing Caps 3, 4, 5 and 6 mm
Cover Screw
The Direct Screw Platform is to be used with a burn-out plastic sleeve for ensuring a minimum post height of 4 mm (with no angular correction).
Like the QUAD implants cleared under K152188, the subject PYRAMIDION implants expansion is performed using a reusable Expansion Tool and Ratchet Torque).
The provided text is a 510(k) summary for the DenTack PYRAMIDION Dental Implants and Prostheses. It describes the device, its intended use, and comparative testing performed to demonstrate substantial equivalence to predicate devices. However, this document does not describe a study involving an AI/Machine Learning device or its acceptance criteria and performance metrics.
The document primarily focuses on mechanical, physical, and biocompatibility testing of dental implants and prostheses, comparing them to legally marketed predicate devices. It covers aspects like:
- Fatigue testing (ISO 14801): To assess durability.
- Surface analysis (SEM): To characterize the implant surface.
- Implant removal after expansion: To evaluate interaction with artificial bone.
- Minimal rotation torque after placement and expansion: To assess stability.
- Partially expanded implant reciprocating effect test: To evaluate effects of rotation.
- Biocompatibility (ISO 10993): To ensure biological safety.
- Sterilization validation (Gamma and Steam): To ensure sterility.
- Cleaning validation: For reusable tools.
- Shelf life validation: To confirm sterility maintenance over time.
- Comparative pull-out test (ASTM F543): To assess mechanical strength.
- Comparative bone to implant contact surface area analysis: To compare integration potential.
- Implant surface area analysis: For physical characteristics comparison.
Therefore, I cannot provide the requested information regarding AI/ML device acceptance criteria and performance, as the document does not contain any details about an AI/ML component or study.
The questions posed (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance) are highly specific to AI/Machine Learning model validation in a medical context, which is not described in this 510(k) summary for dental implants.
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(296 days)
S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7 mm are intended for delayed loading only.
The subject device consists of four Morse taper connection product lines: Unitite, Unitite Compact, and Strong SW CM. All implants are threaded cylindrical root-form designs. The Unitite provided with an acid-etched and HA surface, the Strong SW CM is provided with an acid-etched surface, Each product line has abutments available in multiple designs (temporary, cementable, angled, UCLA, ball, multi-unit). Subject device abutments are straight only.
Unitite implants are available in six implant body diameters (2.9. 3.5. 4.0. 4.3. 5.0 and 6.0 mm) and eight lengths (5, 6, 7, 8.5, 10, 11.5, 13, and 15 mm). Strong SW CM implants are available in four implant diameters (3.5, 3.8, 4.5.5.0 mm) and five lengths (8.5. 10. 11.5. 13. and 15 mm). Unitite abutments are available in five prosthetic platform diameters (3.3, 3.5, 4.0, 4.5, and 4.8 mm). Strong SW CM abutments are available in four prosthetic platform diameters (3.3, 3.5, 4.5 and 4.8 mm). Subject Device components are made of commercially pure titanium, titanium alloy, cobalt-chromium, or polycarbonate.
The provided text is a 510(k) Summary for the S.I.N. Dental Implant System (K170392). It details the device, its intended use, and a comparison to predicate devices, but does not contain any information about clinical studies with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies related to device performance.
The document states: "No clinical data were included in this submission."
Therefore, based on the provided text, I cannot complete the requested information. However, I can extract the information provided about performance data (non-clinical) and the device's characteristics.
Here's what I can provide based on the given text:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the traditional sense of performance metrics for a clinical study with a device output. Instead, it describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices.
| Non-Clinical Test Category | Reported Performance (Demonstrated Equivalence) |
|---|---|
| Sterilization Validation | Radiation sterilization validated according to ISO 11137-1 and 11137-2. Steam sterilization according to ISO 17665-1 and ISO 17665-2. Both demonstrating a sterility assurance level (SAL) of 10-6. |
| Endotoxin Testing | Limulus amebocyte lysate (LAL) testing according to AANSI/AAMI ST 72. |
| Shelf Life Testing | According to ASTM F1980, ASTM F1929, and ASTM F88/F88M. |
| Biocompatibility Testing | According to ISO 10993-3 (genotoxicity), ISO 10993-5 (cytotoxicity), ISO 10993-6 (implantation), ISO 10993-10 (sensitization and irritation), and ISO 10993-11 (systemic toxicity), demonstrating acceptable biocompatibility. |
| Surface Area Analysis | Showing substantial equivalence to a predicate device. |
| Performance Testing | For insertion, showing substantial equivalence to the predicate device. |
2. Sample sized used for the test set and the data provenance
Not applicable. No clinical test set. Non-clinical tests were conducted; however, specific sample sizes for these tests are not provided in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set or ground truth established by experts is mentioned.
4. Adjudication method for the test set
Not applicable. No clinical test set or adjudication process is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was done. The device is a dental implant system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical dental implant system, not an algorithm or AI.
7. The type of ground truth used
Not applicable. No clinical ground truth is mentioned.
8. The sample size for the training set
Not applicable. No training set is mentioned as this device is not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth for it is mentioned.
Summary of what the document implies about meeting acceptance criteria:
The document demonstrates that the "S.I.N. Dental Implant System" meets the requirements for substantial equivalence to its predicate devices through a series of non-clinical tests. These tests cover aspects like sterilization, shelf-life, biocompatibility, and physical performance (e.g., insertion). The "acceptance criteria" here implicitly refer to the successful completion of these standard tests demonstrating that the device is as safe and effective as the legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. The absence of clinical data in the submission indicates that the FDA deemed the non-clinical evidence sufficient for a finding of substantial equivalence.
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(285 days)
S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Revolution Compact with a 6 mm length is intended for delayed loading only.
The subject device includes six product lines (Revolution Compact, Micro-Mini Revolution, Strong SW HE, TryOn, Strong SW HI). Five of the product lines have an external hex implant/abutment connection (HE) and one has an internal hex implant/abutment connection (HI). Each product line includes implants with an acid-etched surface and abutments in multiple designs (healing, provisional, cemented, UCLA, overdenture, conical and mini).
Revolution implants (Revolution Compact, Micro-Mini Revolution) are cylindrical implants with apical cutting flutes and are placed with the Revolution Assembler mount. Strong SW HI are cvlindrical implants with apical cutting flutes and micro-threads on the collar. Strong SW HE has and external connection and Strong SW HI has an internal connection. TryOn implants with apical cutting flutes and a machined collar. Subject Device components are made of commercially pure titanium, titanium alloy or cobalt-chromium alloy. All subject device abutments have 0° angulation.
This document is a 510(k) summary for the S.I.N. Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use and technological characteristics, rather than presenting a performance study with acceptance criteria in the typical sense for a medical device with an AI/ML component.
Therefore, many of the requested details about acceptance criteria, study design, and AI performance metrics are not available in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present acceptance criteria for a performance study in the way a clinical trial or AI validation study would. Instead, it demonstrates "substantial equivalence" of the S.I.N. Dental Implant System to existing predicate devices based on:
- Indications for Use: The subject device's indications align with those of multiple predicate devices.
- Technological Characteristics: Comparison of design (prosthesis attachment, restoration, implant/abutment interface, dimensions) and material composition (implant, surface, abutment, abutment screw) to predicate devices.
- Non-clinical Testing Data: This includes validation of sterilization, biocompatibility, endotoxin testing, and shelf-life testing. These are regulatory compliance criteria, not performance metrics related to diagnostic or predictive accuracy.
Reported Device Performance (in terms of substantial equivalence):
| Feature/Test | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Performance (Stated Equivalence/Compliance) |
|---|---|---|
| Indications for Use | Similar to predicate devices: placement in maxillary/mandibular arch for single/multi-unit restorations, immediate/delayed loading. | "Substantially equivalent in indications and design principles to the predicate devices." "Small differences... do not change the intended use." |
| Design Characteristics (e.g., diameters, lengths, connections) | Within common ranges and similar to predicate devices. | "Encompass the same range of physical dimensions." |
| Materials | Same or similar materials as predicate devices (e.g., CPTi Gr 4, Ti-6Al-4V, CoCr). | "Made of the same or similar materials." |
| Sterilization | SAL of 10^-6 according to ISO 11137-1, ISO 11137-2 (radiation); SAL of 10^-6 according to ISO 17665-1 and ISO 17665-2 (steam). | Validated to SAL of 10^-6 for both radiation and steam sterilization. |
| Biocompatibility | Acceptable biocompatibility according to ISO 10993-1. | Acceptable biocompatibility demonstrated by reference to K051859 and testing per ISO 10993-5 (cytotoxicity). |
| Endotoxin Testing | In accordance with FDA Guidance documents. | Limulus amebocyte lysate (LAL) endotoxin testing performed. |
| Shelf-Life Testing | Seal leaks according to ASTM F88/F88M, seal integrity according to ASTM F1929, accelerated age testing according to ASTM F1980. | Shelf-life testing including seal leak, seal integrity, and accelerated aging reported. |
| Surface Area Analysis | Substantially equivalent to a predicate. | Surface area analysis showed substantial equivalence to a predicate. |
2. Sample Size for Test Set and Data Provenance
- Sample Size: Not applicable. This document does not describe a performance study involving a "test set" of patient data for evaluating diagnostic or predictive accuracy. The testing mentioned is for non-clinical aspects (sterilization, biocompatibility, etc.), which would involve material samples or batches.
- Data Provenance: Not applicable in the context of patient data. The "data" refers to non-clinical testing results.
3. Number of Experts for Ground Truth and Their Qualifications
- Not applicable. This document pertains to the substantial equivalence of a physical dental implant system and does not involve AI/ML or a ground truth established by experts for diagnostic performance.
4. Adjudication Method
- Not applicable. There is no "adjudication method" described as it relates to expert consensus for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This document explicitly states: "No clinical data were included in this submission." An MRMC study would fall under clinical effectiveness.
6. Standalone (Algorithm Only) Performance Study
- No. The device is a physical dental implant system, not a software algorithm.
7. Type of Ground Truth Used
- Not applicable. Not relevant for this type of device submission. The "truth" here relates to the physical and material properties meeting regulatory standards and being substantially equivalent to legally marketed devices, verified through laboratory testing and predicate comparisons.
8. Sample Size for the Training Set
- Not applicable. There is no "training set" as this device is not an AI/ML product.
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no "ground truth for a training set" as this device is not an AI/ML product.
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(158 days)
The TRI® Dental Implant System is intended for placement in the bone of the maxillary or mandibular arch for the rehabilitation of edentulous and partially edentulous patients. TRI® Dental Implant System allows for one and two-stage surgical procedures. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading.
TRI Dental Implant System 6.5 mm implants are intended for delayed loading only.
The TRI-Narrow and TRI-Vent implants are root form endosseous dental implants. They are available with two collar options, blasted or machined. TRI-Narrow is available in one implant diameter (3.3 mm) and three lengths (11.5, 13, and 16 mm). TRI-Narrow abutments include all abutment options with the exception of the Gingiva Former and the angled Screw Retained Abutment.
TRI-Vent is available in three implant diameters (3.75, 4.1 and 4.7 mm) and six lengths (6.5, 8, 10, 11.5, 13, and 16 mm). Only the 4.1 mm and 4.7 mm diameter implant bodies are available in the 6.5 mm length. All three TRI-Vent implant diameters have the same platform diameter (3.5 mm). TRI-Vent abutments include Healing Collar, Straight Temporary PEEK Abutment, Straight and 20° Angled Abutments, Straight and 30° Angled Screw Retained Abutment, PEEK Gingiva Former, Straight and 15° Angled Contoured Abutment, Gold-castable Abutment, Screw- retained Abutment, Ball Abutment, and applicable abutment fixation screws.
The TRI-Octa implants are root form endosseous dental implants. They have a pink, transgingival collar. TRI-Octa is available in three implant diameters (3.75, 4.1 and 4.7 mm) and six lengths (6.5, 8, 10, 11.5, 13, and 16 mm). Only the 4.1 mm and 4.7 mm diameter implant bodies are available in the 6.5 mm length. All three TRI-Octa implant diameters have the same platform diameter (4.8 mm). TRI-Octa abutments include Healing Collar, Straight PEEK Temporary Abutment, Straight and 20° Angled Abutments, Straight Screw Retained Abutment, Ball Abutment, and applicable abutment fixation screws.
Here's a breakdown of the acceptance criteria and study information for the TRI® Dental Implant System, based on the provided text:
Preamble: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to existing legally marketed devices. It typically describes non-clinical testing performed to show that the new device performs as safely and effectively as predicates, rather than extensive clinical efficacy studies with specific acceptance criteria in the clinical sense. Therefore, the "acceptance criteria" here refer more to the performance standards the device was tested against to prove equivalence, particularly in mechanical and biological compatibility. Clinical outcomes data (e.g., success rates in patients) often come from post-market surveillance or larger clinical trials not detailed in a 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Sterilization | ISO 11137-1, ISO 11137-2, ISO 17665-1, ISO 17665-2 | Sterilization validation performed (demonstrates substantial equivalence to predicate processes). |
| Biocompatibility | ISO 10993-1, ISO 10993-5 | Biocompatibility evaluation and testing performed (demonstrates substantial equivalence to predicate materials). |
| Mechanical Performance | ISO 14801: Dentistry – Implants – Dynamic fatigue test for endosseous dental implants | Fatigue testing demonstrates increased abutment angulation is substantially equivalent to identified predicates with respect to performance. |
| Dimensional Analysis | N/A (Engineering dimensional analysis) | Engineering dimensional analysis performed (implied to match or be acceptably similar to predicates). |
| Material Composition | Titanium Alloy, CPTi, PEEK, Gold alloy | "Slight differences in material composition... are demonstrated substantially equivalent by biocompatibility testing." The device utilizes Titanium Alloy and other materials consistent with predicates. |
| Surface Area (Osseointegration) | N/A (Surface area analysis) | Surface area analysis demonstrates smallest diameter/shortest length combinations are substantially equivalent to reference predicate K092035. |
| Overall Equivalence | Same intended use, operating principle, basic design, similar/same materials, similar packaging/sterilization process as predicates. | Concluded that the data demonstrate substantial equivalence to predicate devices. |
Detailed Study Information:
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Sample size used for the test set and the data provenance:
- The document does not explicitly state sample sizes for each non-clinical test (e.g., number of implants tested for fatigue). It only mentions that "Non-clinical testing data submitted, referenced, or relied upon" was provided.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). Given it's non-clinical lab testing against ISO standards, it would be prospective data generated for the submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. The "ground truth" for non-clinical performance data is defined by the technical specifications outlined in the ISO standards themselves (e.g., a specific fatigue load, or a cytotoxicity response in a cell culture). There isn't typically expert consensus to establish a "ground truth" for these types of engineering and biocompatibility tests.
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Adjudication method for the test set:
- Not applicable as this is non-clinical testing against ISO standards, not a study involving human readers or clinical adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This document describes a dental implant system, not an AI-powered diagnostic device. No MRMC studies were conducted or reported.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (dental implant), not an algorithm.
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The type of ground truth used:
- For non-clinical testing: The "ground truth" is defined by the physical, chemical, and biological properties and performance metrics specified in the referenced ISO standards (e.g., mechanical strength requirements, cytotoxicity levels, sterility assurance levels). It's based on established scientific and engineering criteria.
- For demonstrating equivalence: The ultimate "ground truth" for the 510(k) process is the safety and effectiveness of the legally marketed predicate devices.
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The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning algorithm requiring a "training set."
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How the ground truth for the training set was established:
- Not applicable, for the same reason as above.
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