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510(k) Data Aggregation
(80 days)
Ditron's Dental Implants and Abutments 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 chewing function of patients with fully or partially edentulous:
- Two stages: MPI, ULT, API, CPI, MPC, APC, CPC and UPC models .
- . One stage: OPI and TPI models
The 3.3mm and 3.0mm diameter implants (OPI and TPI. MPI and API) are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants.
The Two stages and One stage implants are indicated for temporary or long-term use. They are selftapping titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and long-term fixation of new or existing crown, bridge and prosthesis and protection of graft sites.
MPI, ULT, API, CPI, OPI, TPI, MPC, APC, CPC and UPC models are indicated for immediate loading (except for MPI. and API 6mm length) in single- and multi-tooth restoration, when good primary stability is achieved and with appropriate occlusal loading.
The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration.
The 17-degree multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.
The Temporary Titanium and PEEK Abutments are indicated to be used on Ditron implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.
This submission covers changes related to Ditron's Dental implants and abutments. The inclusion of additional product variations aims to provide dental surgeons with a broader range of implant and abutment options for patient treatment.
The requested additions to Ditron's Dental Implants and Abutments within this 510(k) are hereby described:
. An additional implant types:
- MPC (Conical Connection Molecular Precision Implant) o
- O APC (Conical Connection Advanced Precision Implant)
- UPC (Conical Connection Ultimate Precision Implant) O
- CPC (Conical Connection Cylindrical Precision Implant) O
The Conical Connection (CC) implants include a conical connection platform (Morse taper). The intended use, materials, drilling protocol, thread designs and bone interface of the subject Conical Connection implants (MPC, UPC, APC and CPC) are identical to Ditron's cleared Internal Hex connection platform implants (MPI, ULT, API and CPI, respectively). The CC implants include color anodization for aesthetic purposes. The CC compatible Cover and Prosthetic Screws are color anodized as well.
The MPC/APC/CPC/UPC Implants are available in diameters of 3.5mm, 4.2mm, 5.0mm, and 6.0mm, with lengths of 8.0mm, 11.5mm, 12mm, 13mm, 14mm, and 16mm. Additionally, a 6.5mm length is offered for MPC/APC/CPC implants in 4.2mm, 5.0mm, and 6.0mm diameters, and a 7.0mm length is available for UPC implants in 4.2mm, 5.0mm, and 6.0mm diameters.
- An additional Abutment type: CC Healing Caps and SRA Healing Caps Abutments The CC Healing Caps are color-anodized for aesthetic purposes. They are used for the maintenance of the soft tissue during the osseointegration phase of Ditron CC implants to be rehabilitated using technique. They are available in diameters of 3.5, 4.5 and 5.5mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5 and 4.5mm.
- An additional Abutment type: CC Cement Retained Abutments the CC Anatomic/Universal . straight/angulated abutments are Cement-Retained Abutments. They are intermediary prosthetic components to be installed onto Ditron's CC implants to support the final prosthesis. They are available as straight (0°) or angulated (15° and 25°) in diameters: 3.5, 4.5 and 5.5mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5 mm.
- . An additional Abutment type: CC Single-Unit and Multi-Unit Abutments - The CC Screw-retained Single Unit Abutment and Multi Unit Abutments are intermediary prosthetic components to be installed onto CC Ditron's implants to support the final prosthesis. They are available as straight (0°) or angulated (17° and 30°) and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.0 mm. The Single Unit abutment height is up to 4.5mm only.
- An additional Abutment type: CC Temporary Titanium Abutments The CC Temporary Titanium Abutments are temporary intermediary prosthetic components to be installed onto the Ditron's CC implants to support the provisional prosthesis for up to 6 months. They are available as straight (0°) in diameters: 3.5 and 4.5mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5mm.
- An additional Abutment type: CC Temporary PEEK Abutments The CC Temporary PEEK Abutments are temporary intermediary prosthetic components to be installed onto Ditron's CC implants to support the provisional prosthesis for up to 6 months. They are composed of a customizable cylindrical body made of PEEK and a non-customizable base made of titanium. They are available in diameters of 4.5 and 6.0mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5mm.
- An additional Abutment type: CC Liberator Overdenture Abutment The CC Liberator Overdenture Abutment is similar in design to Ditron's cleared Liberator abutment, except for the addition of Titanium Nitride (TiN) coating on the subject device. It is available in the following gingival heights: 0.5, 1.0, 2.0, 3.0, 4.0, 5.0 and 6.0mm.
- An additional Abutment type: SRA Titanium Coping Abutments The SRA Titanium Coping . Abutment is suitable for use with the CC Screw-retained single Abutments. It connects to the abutment using one of the designated abutment screws. They are available in short (L4.85mm) and long (L11mm) versions.
- Modification to Cleared Titanium Abutments Addition of Laser Marking for identification as an option for all of the Ditron Dental cleared Titanium Abutments (K140728, K161497, K233231).
- Modification to Cleared Liberator and TPI Overdenture Abutments Addition of TiN coating to . Ditron's cleared Liberator abutment (K161497) and the cleared TPI Liberator Overdenture Abutment (K233231).
The provided text does not contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria. The document is a 510(k) summary for Dental Implants and Abutments, focusing on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical performance data. It does not mention any AI/ML components or related studies.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results (effect size).
- Standalone performance study for an algorithm.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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(208 days)
The LOCATOR Angled Abutment is indicated for the attachment of full or partial, fixed and removable, restorations retained by endosseous implants to restore masticatory function for the patient.
The LOCATOR Angled Abutment is designed to be used with LOCATOR FIXED and LOCATOR Attachment Systems for the attachment of full or partial, fixed and removable, restorations retained by endosseous implants in the mandible or maxilla. The LOCATOR Angled Abutment consists of various height abutment bodies with an integrated abutment screw. The attachment features are identical compared to LOCATOR Abutments of the LOCATOR High Retention Attachment System (LOCATOR FIXED), cleared in K213391. The LOCATOR Angled Abutment is compatible with Straumann BLX Implant System cleared in K173961. The LOCATOR Angled Abutment will be used with the accessories of the LOCATOR Implant Attachment System (retention inserts, denture attachment housing, and ancillary processing parts) and LOCATOR FIXED Attachment System (fixed inserts, denture attachment housing) for the attachment of a restoration. The LOCATOR Angled Abutment uses identical attachment features as the LOCATOR Abutments, but instead of the attachment features being aligned coaxially, the interfacing features are provided at a 15 degree angle to allow for angle correction, substantially equivalent to the device of K190040. The LOCATOR Angled Abutments and integrated abutment screw are manufactured from titanium (Ti-6Al-4V). The LOCATOR Angled Abutment body is titanium nitride (TiN) coated, identical to LOCATOR Abutments.
The provided FDA 510(k) summary for the "LOCATOR Angled Abutment" does not describe a study involving an AI/Machine Learning (ML) device or any specific performance metrics for such a device like sensitivity, specificity, or AUC, or a comparative effectiveness study involving human readers.
This submission is for a medical device (dental implant abutment) and focuses on demonstrating substantial equivalence to a predicate device through physical and mechanical testing, material compatibility, and intended use.
Therefore, I cannot provide a detailed answer to your request based on the provided text, as the information required (acceptance criteria for an AI/ML device, details of an AI/ML study, ground truth establishment, expert adjudication, MRMC studies, etc.) is not present.
In summary, the document does not contain the information needed to answer your questions regarding acceptance criteria and performance of an AI/ML device.
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(617 days)
The INNO SLA Submerged Implant System is 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 INNO SLA Submerged Implant System offers Healing Abutment (Type A and Type B), Angulated Abutment, Temporary Abutment, Sonator S Abutment, Sonator A Abutment, and Screws. These components are used with the fixtures and cover screws cleared under K132242.
The provided text is a 510(k) summary for the INNO SLA Submerged Implant System. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.
However, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/ML-driven device performance study. The device described, the "INNO SLA Submerged Implant System," is a physical dental implant system and not an AI/ML-based medical device. Therefore, the questions related to AI/ML device performance (like sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are not applicable to this document.
The document does mention "Non-Clinical Testing" which includes:
- Surface Modification: Leveraging specifications and processes from a predicate device (K132242) for TiN coating.
- Cytotoxicity Testing: Performed on representative abutments with TiN coating according to ANSI/AAMI/ISO 10993-5 and ISO 10993-12. This type of testing ensures the material is not harmful to cells.
- Mechanical performance testing: Conducted according to ISO 14801. This test establishes the fatigue limit to ensure structural integrity and sufficient strength for intended use. The "worst-case scenario" was chosen based on FDA Guidance.
- End-user sterility validation: Conducted according to ISO 17665-1 and ISO 17665-2 for a prior clearance (K132242) and leveraged for the subject devices.
These tests are standard for physical medical devices and confirm material compatibility, mechanical robustness, and effective sterilization, which are relevant "acceptance criteria" for such devices. The document explicitly states that the mechanical performance test demonstrated "sufficient strength for their intended use and are substantially equivalent to predicate devices with regard to mechanical performance."
In summary, the requested information regarding AI/ML device performance cannot be extracted from this document because it pertains to a physical dental implant system, not an AI/ML system.
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(88 days)
The High Retention Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory function. It is used in fixed hybrid restorations that can be attached with a snap-in system.
The High Retention Attachment System is a system that provides rigid connection of fixed partial and full arch restorations (fixed/detachable hybrid dentures) to endosseous dental implants. It is designed to accommodate a path of insertion on implants to accommodate a divergence of up to 20° per implant and no more than 40° of divergence between implants. The components are similar to the LOCATOR Implant Anchor Abutment, cleared in K072878; however, the retention and removal of the inserts is similar to that of the LOCATOR F-Tx Attachment System cleared in K151789.
The High Retention Attachment System consists of abutment housings, inserts, laboratory processing tools and seating and removal tools. Abutments, attachment housings and inserts are Class II subject devices (Product Code NHA) and laboratory processing tools and seating and removal tools are Class I accessories (Product Code NDP). The abutments are provided in various cuff heights with the implant/abutment connection specific to the OEM implant. The subject device abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications (UNS R56401) and are TiN (titanium nitride) coated.
This is a medical device, not an AI/ML device, so the requested information about acceptance criteria, study details, and training data for AI/ML models is not directly applicable.
Here's an analysis based on the provided document, addressing the principles of demonstrating substantial equivalence for a medical device:
The Zest Anchors, LLC "High Retention Attachment System" (K213391) is a Class II medical device (Endosseous Dental Implant Abutment, Product Code NHA). The FDA has determined it is substantially equivalent to legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in the way one might for a specific performance metric of an AI/ML model (e.g., AUC > 0.9). Instead, substantial equivalence is demonstrated by comparing the new device's characteristics and performance to those of legally marketed predicate devices.
The table on page 7 outlines a comparison of the subject device with its primary predicate (K151789, LOCATOR F-Tx Attachment System) and two reference devices (K072878, LOCATOR Implant Anchor Abutment; K200827, LOCATOR R-Tx Attachment System).
| Feature | Subject Device (High Retention Attachment System) | Primary Predicate (LOCATOR F-Tx Attachment System, K151789) | Reference Device (LOCATOR Implant Anchor Abutment, K072878) | Reference Device (LOCATOR R-Tx Attachment System, K200827) | Comparison (Reported Performance) |
|---|---|---|---|---|---|
| Indications for Use | Supports fixed, partial or full arch restorations on endosseous dental implants for masticatory function; used in fixed hybrid restorations with a snap-in system. | Same | Appropriate for overdentures or partial dentures retained by endosseous implants. | Designed for overdentures or partial dentures retained by endosseous implants. | Same as Predicate and Reference |
| Design: Abutment Platform Diameter | 2.3 mm to 7.0 mm, Multiple Systems | 3.0 mm to 7.0 mm; Multiple Systems | 2.3 mm to 7.0 mm, Multiple Systems | 3.0 mm to 7.0 mm; Multiple Systems | Same as Reference (K072878) |
| Design: Abutment Angle | Straight | Straight | Straight | Straight | Same |
| Design: Abutment/Implant Interface | Conical, External Hex, Internal Hex, Internal Multi Lobe | Conical, External Hex, Internal Hex, Internal Multi Lobe | Conical, External Hex, Internal Hex, Internal Multi Lobe | Conical, External Hex, Internal Hex, Internal Multi Lobe | Same |
| Design: Divergence Allowance | 20°/40° (except when not allowed by the implant manufacturer) | 20° | 20° | 30°/60° | Same |
| Design: Prosthesis Attachment Type | PEEK Insert retained in Denture Attachment Housing | PEEK Retention Ball attached to Denture Attachment Housing | Nylon Insert retained in Denture Attachment Housing | Nylon Male Retention Cap | Same as Predicate (K151789) |
| Materials: Abutment | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Same |
| Materials: Abutment Coating | TiN | TiN, TiCN | TiN | TiN, TiCN | Same |
| Materials: Prosthetic Retention | PEEK | PEEK | Nylon | Nylon | Same as Predicate (K151789) |
Key Performance Demonstrations:
- Sterilization Validation and Biocompatibility Testing: The device undergoes these standard tests for medical devices. The materials and TiN coating are stated to have the "same specifications, processes, and are manufactured in the same facilities" as the predicate F-Tx Attachment System (K151789) and LOCATOR device (K072878). This implies the acceptance criteria for these tests were met as per established standards for similar devices.
- Mechanical Denture Retention Testing: This was a specifically conducted non-clinical test. The reported performance is that "The mechanical testing demonstrated that the retention force of the High Retention Attachment System was greater than retention force of the predicate device K151789." This indicates superior performance in this regard.
- Abutment-Implant Interface Compatibility: Verified through OEM signed abutment drawings, OEM implant drawings, or contractual agreements, and "engineering analysis." No specific performance testing was required due to this established compatibility and demonstrated equivalence to the LOCATOR R-Tx Attachment System (K200827).
2. Sample size used for the test set and the data provenance
For the mechanical denture retention testing, the document states tests were conducted, but it does not specify the sample size used for this testing. It is a non-clinical test, so "data provenance" in terms of country of origin or retrospective/prospective is not applicable in the typical sense for patient data. It refers to laboratory/bench testing.
For sterilization validation and biocompatibility testing, these are typically conducted according to international standards (e.g., ISO standards) and involve specific sample sizes and protocols, but these details are not provided in this summary.
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 as the device is not an AI/ML diagnostic tool that relies on expert interpretation to establish ground truth from patient data. The "ground truth" for this physical device is assessed through engineering specifications, material properties, and mechanical performance tests, not expert clinical interpretation of images or patient outcomes in the context of an AI study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the same reasons as point 3. There is no "test set" of clinical cases requiring expert 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
This question is not applicable. The device is a dental implant attachment system, not an AI-assisted diagnostic or treatment planning tool. Therefore, MRMC studies and "human readers improving with AI assistance" are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as there is no algorithm, nor is it an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained above, "ground truth" for this device is established through:
- Engineering specifications and drawings: For device design, dimensions, and implant compatibility.
- Material specifications and standards: Conformance to ASTM standards (e.g., ASTM F136 for titanium alloy).
- Laboratory performance testing: Such as mechanical denture retention force testing.
- Biocompatibility and sterilization standards: Demonstrating safety.
8. The sample size for the training set
This question is not applicable as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set.
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(205 days)
The BEGO Semados® RS/RSX implant is indicated for single or multiple unit restorations on splinted or non-splinted applications both in the upper and lower jaw. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading on sufficient primary stability and appropriate occlusal loading.
The BEGO Semados® RS/RSX implant 3.0 is only indicated for single unit restorations of the lower lateral, central incisors or upper lateral incisors.
The healing posts are indicated for patients treated with BEGO Semados® RS/RSX implants for the time during healing of the surrounding soft tissue.
The abutments are indicated for patients treated with BEGO Semados® RS/RSX implants as an aid in prosthetic rehabilitation.
PS ITA, PS TTiA and PS TTiA NH are intended to be used for a maximum period of 6 months.
The BEGO Semados® RS/RSX Implant System consists of implants, healing posts and abutments.
BEGO Semados® RS/RSX implants are self-tapping, conical endosseous dental implants made of commercially pure titanium Grade 4. In contrast to the RSX implant family, the RS implant family has a 0.5 mm machined neck region. BEGO Semados® RS/RSX implants are marketed together with cover screws and insertion posts.
The healing posts are sterile packaged Titanium Grade 5 dental healing abutments that are available in two different sizes. Healing posts can be used either to shape the soft tissue after sub-merged healing of an implant (two-stage) or to keep the shape of the soft tissue after having placed the implant (one-stage).
The abutments are prefabricated prosthetic components made of Titanium Grade 5 directly connected to BEGO Semados® implants with Platform Switch design such as BEGO Semados® RS/RSX implants. They are delivered non-sterile but have to be sterilized by the end-user. They serve as an aid in temporary (provisional) and permanent prosthetic rehabilitation. The abutments are used for single or multiple tooth restorations. There are two types of abutments regarding the duration of use: provisional abutments intended for a limited period of ≤ six months and permanent abutments. The abutments are marketed with the compatible prosthesis and a technician screw.
The MultiPlus system consists of the PS MultiPlus abutments, the MultiPlus Titanium abutment, the MultiPlus Healing posts, the MULTI PLUS UNIVERSAL component and various supporting tools. The MultiPlus system is intended for occlusal screw-retained bridge, full dentures and bar constructions in the mandible and maxilla.
The Easy-Con system consists of the PS Easy-Con abutment and the Easy-Con laboratory set. The Easy-Con system is used to retain full supported dentures in the mandible or maxilla on two to four implants.
The provided document is a 510(k) Premarket Notification for the BEGO Semados® RS/RSX Implant System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials with pre-defined acceptance criteria.
Therefore, the document does not contain the kind of information requested in your prompt (e.g., acceptance criteria for an AI/ML model's performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, or training set details). The "performance data" section (Section 11) refers to non-clinical testing of the physical implant system, such as biocompatibility, mechanical properties (fatigue, corrosion), and sterilization, typical for traditional medical devices. Section 12 explicitly states that "no human clinical testing was required."
This submission is about demonstrating that a new dental implant system is as safe and effective as existing, legally marketed implant systems, based on similar technology, materials, and non-clinical performance characteristics. It is not an AI/ML device submission.
Thus, I cannot extract the requested information as it is not present in the provided text.
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(274 days)
Ziacom Dental Implant Systems are intended to be surgically placed in the bone of the mandibular or maxillary jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function and to aid in prosthetic rehabilitation. Ziacom Dental Implant Abutments are intended to be used with Ziacom Dental Implants to aid in prosthetic rehabilitation.
The intended use for Ziacom Dental Implant Zinic® NP 3.30mm diameter is limited to replacement of mandibular incisors.
Zinic® and Zinic MT implants are threaded, self-tapping, root-form dental implants manufactured from CP titanium Grade 4 conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700). The implants have apical flutes, an internal hexagonal abutment interface and a conical bevel at the abutment interface. They are threaded internally for attachment of mating abutments, cover screws, healing abutments or temporary abutments. The coronal portion of the implant has a microthread design. The Zinic design is a straight implant, while Zinic MT implants are tapered in the apical 40% of the implant length. All implants have a grit blasted and acid etched surface, designated Osseonova Surface.
Implants and abutments with the same platform connection are compatible. Zinic and ZinicMT implants are available with following sizes: (Table of sizes provided in the document).
Zinic and ZinicMT implants are provided sterile to the end-user in a single-unit package, and are for single-patient, single-use only. They are provided in ZPlus packaging or Z2Plus packaging, attached to the ZPlus or Z2Plus Mount, respectively, or in NoMount packaging, without an implant mount. Packaging facilitates the aseptic handling and placement of the implant, with the mounts also capable of serving either as a provisional abutment or a definitive abutment. Z2Plus also can serve as a transfer for a Snap-On impression technique.
Subject device abutments include cover screws, healing abutments, provisional abutments, sculptable (prepable) abutments, conical abutments in straight and angled (15°, 25° and 30°) designs, castable abutments (CoCr base plus burn-out sleeve) in straight and angled (15°, 20°) designs, Basic and Unitary Basic abutments to serve as intermediate abutments between the implant and the prosthesis. XDrive multi-unit abutments in straight and angled (17°, 30°) designs.
All subject device abutments have the universal internal implant connection and are compatible with both implant lines, except that NP abutments are compatible only with Zinic NP implants (there are no ZinicMT NP implants). Abutments are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), polyetheretherketone (PEEK) conforming to ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications or cobalt-chromium-molybdenum alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539).
Subject device abutments include two overdenture abutments (Kirator,ZM-Equator). Kirator overdenture abutments are straight prosthetic abutments that are used for the retention of preexisting or newly fabricated full dentures (classified as implant-retained mucosupported overdentures). ZM-Equator abutments are straight prosthetic abutments used for the retention of tissue-supported implantretained prostheses. Its is indicated in rehabilitation of narrow ridges and/or reduced vertical dimension Each overdenture abutment is the "male" part of a removable prosthesis retention which contains a metal housing cap that incorporate plastic retention with different degrees of elastic retention. Abutments and housing caps are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The different plastic retentions are manufacture from Kepital, Rilsan bmno and Pebax.
All abutments are provided non-sterile to the end-user in a single-unit package, and are for singlepatient, single-use only.
Clinical screws used to attach abutments and prosthetic components to implants are available with an M1.6 thread and 8 mm length to fit NP abutments and implants and with an M1.8 thread and 7.85 mm length to fit RP and WP abutments and implants. They are available in a machined Ti-6AI-4V design and in a design that is hard anodized to provide anti-loosening characteristics, designated Kiran®. Machined titanium alloy screws are anodized for identification, with the M1.6 thread screw that fits NP abutments and implants colored yellow and the M1.8 thread screws that fit RP and WP abutments and implants colored blue. Kiran screws are dark grey.
A TX30 Torx screw is available for retention of the TX30 Mechanized Abutment. It incorporates a 6-lobed internal feature mating with a 6 lobed spherical tip screwdriver to permit driving the screw with the driver inserted through the angled portion of the restoration. It is provided with the Kiran hard anodizing treatment.
Additional screws are available to attach prosthetic components to Basic abutments and to XDrive abutments. Basic screws have an M1.8 thread and are 4.3 mm long, while XDrive screws have an M1.4 thread and are 3.5 mm long. Each is available as an anodized titanium alloy screw or as a Kiran screw with the hard anodizing treatment.
The provided text describes the Ziacom Dental Implant Systems and its substantial equivalence to predicate devices, but it does not contain information about an AI/ML-enabled medical device study or acceptance criteria for such a device.
The document is a traditional 510(k) premarket notification for a Class II medical device (endosseous dental implant). The performance data presented focuses on mechanical strength testing, material characterization (surface roughness, chemistry), biocompatibility (cytotoxicity), and sterilization validation, which are standard for dental implants.
Therefore, I cannot fulfill your request for the following sections as the necessary information is not present in the provided document:
- A table of acceptance criteria and the reported device performance (for an AI/ML device)
- Sample sizes used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method for the test set
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study details
- Standalone (algorithm-only) performance
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
The document describes the device's technical specifications and how it is demonstrated to be substantially equivalent to existing predicate devices based on non-clinical performance data (mechanical and biological testing), rather than clinical or AI/ML performance.
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(165 days)
MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.
Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
The long MIS (18 & 20 mm) implants can be used in a tilted manner.
MIS short implants are to be used only with straight abutments.
M4 short implants are indicated for delayed loading only.
a. MIS LOCKiT Abutments System
MIS LOCKiT abutments system contains titanium abutments coated with titanium nitride (TiN). MIS LOCKIT abutments system is intended to be used in completely edentulous jaws and connects to an overdenture to allow its insertion and removal.
MIS LOCKiT abutments connect directly to the implant by their threading. MIS LOCKiT abutments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP)) and two connection types (conical connection and internal hex connection). LOCKiT abutments system contains straight abutments only.
MIS LOCKiT abutments are provided in the following gingival heights:
- . Narrow platform: 1, 2, 3, 4, 5 mm
- . Standard platform: 1, 2, 3, 4, 5 mm
- Wide platform: . 1, 3, 5 mm
MIS LOCKIT internal hex connection abutments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems).
MIS LOCKiT conical connection abutments are compatible with MIS implants cleared under K112162, K163349 and K172505 (C1 and V3 Systems).
b. OT-Equators and Ball Attachments
Ball Attachments and OT-Equators are used to connect to an overdenture bar to allow its insertion and removal. They are connected directly to the implant by their distal threading, and are mostly used in complete edentulous jaws. The main difference between them is that ball attachments have a higher profile and ball shaped head, while the OT-equators have a lower profile and a truncated head. Both are made from Titanium 6Al-4V ELI and feature a Titanium Nitride (TiN) coating for increased resistance to wear.
Internal hex OT-Equators and Ball Attachments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP) and are available in the following gingival heights:
- . Narrow platform: 1, 2, 3, 4, 5 mm
- . Standard platform: 1, 2, 3, 4, 5 mm
- Wide platform: 1, 3, 5 mm .
MIS Internal hex OT-Equators and Ball Attachments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems).
The provided text is a 510(k) Premarket Notification from the FDA for dental implant abutments. It details the device, its intended use, and how it is substantially equivalent to legally marketed predicate devices. The document explicitly states that no clinical performance data was required or conducted for this device submission. Instead, the substantial equivalence was demonstrated through non-clinical performance data, primarily mechanical testing (fatigue testing), and comparisons to predicate devices.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of clinical performance (human-in-the-loop, MRMC, expert ground truth, training/test sets for AI models, etc.) is not applicable to this document. The device in question is a physical dental abutment, not an AI/software device that would typically undergo the kind of clinical validation described in the prompt.
However, I can extract the acceptance criteria and performance data for the mechanical testing which was used to demonstrate substantial equivalence:
Acceptance Criteria and Reported Device Performance (Non-Clinical / Mechanical Testing)
| Acceptance Criteria (Equivalent to Predicate) | Reported Device Performance |
|---|---|
| Withstand 5,000,000 cycles without failure at a substantially equivalent load to cited predicates (for MIS Internal Hex LOCKiT abutments). | The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load to the cited predicates. |
| Equivalent mechanical properties to MIS Conical Connection CONNECT abutments (K173326) and Zest Locator® Implants Attachments (K072878) in terms of fatigue limit for MIS LOCKiT abutments. | Fatigue testing was conducted on MIS conical connection CONNECT abutments, which represent a worst-case in terms of mechanical properties due to geometric design, supporting the performance of MIS Conical Connection LOCKiT abutments. The endurance limit for the LOCKiT assembly was compared with the corresponding worst case for CONNECT and Zest Locator® systems. (Implicitly, the LOCKiT met or exceeded these limits if "substantially equivalent" was claimed). |
| Equivalent mechanical strength to narrower emergence profile devices for MIS internal hex OT-Equators and Ball Attachments. | Mechanical performance of MIS internal hex OT-Equators and Ball Attachments is supported by fatigue testing conducted on MIS Internal Hex LOCKIT abutments, which are a worst case in terms of mechanical strength as they have a narrower emergence profile than the OT-Equators and Ball Attachments. |
| Sterilization validated according to ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 17665-2:2009 for gravity displacement and pre-vacuum steam sterilization. | Steam sterilization parameters were validated according to ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 17665-2:2009 for two methods: gravity displacement steam sterilization and pre-vacuum steam sterilization. |
| Disinfection procedure validated with a reduction of at least 10^6 of the microbiological challenge according to ANSI/AAMI/ISO 11737-1:2006 (R) 2011, AAMI TIR 30:2011 and AAMI TIR 12:2010. | The disinfection procedure was validated in accordance with ANSI/AAMI/ISO 11737-1:2006 (R) 2011, AAMI TIR 30:2011 and AAMI TIR 12:2010 by demonstrating a reduction of at least 10^6 of the microbiological challenge. |
Regarding the other points of the prompt, as applied to this document:
- Sample size used for the test set and the data provenance: For mechanical testing, the "test set" would be the physical samples of the abutments and implants. The document mentions "worst case implants and abutments" being chosen for testing, such as "narrowest implants loaded with the abutments which have the maximum gingival height." The exact number of samples tested for each configuration is not explicitly stated in this summary, but would be detailed in the full test reports. The provenance is the manufacturer, MIS Implants Technologies Ltd., located in Israel. The studies are prospective in the sense that they were conducted for the purpose of this submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by physical measurement and engineering standards (e.g., ISO 14801:2016 for fatigue testing), not expert consensus.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a physical device, not an AI/software for diagnostic imaging interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
- The type of ground truth used: For mechanical testing, the ground truth is defined by the performance standards (e.g., ISO 14801:2016) and direct physical measurement of fatigue, tensile strength, etc.
- The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, this FDA 510(k) submission focuses on demonstrating substantial equivalence through non-clinical (mechanical and biocompatibility) testing, as is typical for Class II physical medical devices like dental abutments. It does not involve AI/software validation or human-reader studies.
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(161 days)
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with TiBase or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture.
DESS Dental Smart Solutions is a dental implant abutment system that includes seven abutment design types (Healing, Temporary, Straight, TiBase, Pre-milled Blank, DESS LOC, Multi-Unit), and ten abutment connections compatible with eleven implant systems. Platform diameters range from 3.3 mm to 5.7 mm. Corresponding implant body diameters range from 3.25 mm to 6.0 mm. Abutments are offered in a variety of connection types to enable compatibility with a large number of currently marketed implants. Straight, Temporary and TiBase abutments have a SelectGrip® surface. DESS LOC Abutments have a ZrN coating. Selected DESS screws include DLC coating. DESS Dental Smart Solutions abutments are straight abutments. All abutments are provided non-sterile.
This document describes the premarket notification for the DESS Dental Smart Solutions, an endosseous dental implant abutment. The information provided is for regulatory clearance based on substantial equivalence, not a standalone performance study of the device. Consequently, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based medical device are not applicable or find direct answers within this document.
However, I can extract the relevant information from this regulatory document concerning the device's performance evaluation to demonstrate its substantial equivalence to predicate devices, which serves as its "acceptance criteria" for market clearance.
Here's an analysis of the provided text in relation to your questions, focusing on the available "performance data":
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for this device are based on demonstrating substantial equivalence to legally marketed predicate devices, rather than meeting specific performance metrics of an AI algorithm like sensitivity, specificity, or accuracy. The "performance" is shown through engineering and dimensional analysis, and material compatibility, to ensure it functions similarly to the predicate devices.
| Acceptance Criteria (based on Substantial Equivalence) | Reported Device Performance (as demonstrated by non-clinical testing) |
|---|---|
| Sterilization: Ensure sterilization of the final finished device. | Sterilization validation to an SAL of 10^-6 according to ISO 17665-2. |
| Biocompatibility: Demonstrate devices are non-cytotoxic. | Biological evaluation according to ISO 10993-1 and cytotoxicity testing according to ISO 10993-5 for all surfaces. |
| Surface Suitability: Demonstrate suitability of specialized surfaces (ZrN and SelectGrip). | SEM evaluation and measurement of the ZrN and SelectGrip surfaces. |
| Compatibility with OEM Implant Systems: Confirm compatibility with various OEM implant bodies, abutments, and abutment fixation screws. | Engineering and dimensional analysis of OEM implant bodies, OEM abutments, and OEM abutment fixation screws. |
| Design, Function, Material, Size, and Indications for Use: Be substantially equivalent to predicate devices. | Detailed comparison tables demonstrating similarity in Indications for Use and Technological Characteristics (Prosthesis Attachment, Restoration, Abutment Platform Diameter, Abutment Angle, Abutment/Implant Interface, Material for Abutment and Screw). |
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 in terms of a "test set" as one would define it for an AI/algorithm study. The "test set" here refers to the actual physical devices (parts, materials) subjected to engineering, dimensional, and biological evaluations. The document does not specify the number of individual abutments or components tested for each non-clinical evaluation.
- Data Provenance: The document states that Terrats Medical SL is located in Montcada i Reixac, Spain. The testing was non-clinical. No information is provided regarding the country of origin of testing data beyond the manufacturer's location.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable: This type of expertise for establishing ground truth is relevant for AI/algorithm studies involving image interpretation or clinical diagnosis. For a dental implant abutment, "ground truth" is based on established engineering and material science standards (e.g., ISO standards, dimensional specifications, material composition), which do not typically involve human expert consensus in the same way as an AI diagnostic study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers interpret data (e.g., medical images) and their discrepancies need to be resolved. This document pertains to the physical and material properties of a medical device, which are evaluated against defined engineering and biological standards, not subjective interpretations requiring 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: No MRMC study was performed. This document concerns the regulatory clearance of a physical medical device (dental abutment), not an AI-assisted diagnostic tool. The document explicitly states: "No clinical data were included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an AI algorithm. The device "DESS Dental Smart Solutions" refers to a system of dental implant abutments, which are physical components. The document indicates that "All digitally designed custom abutments... are to be sent to a Terrats Medical validated milling center for manufacture," implying a digital design process, but the device itself is a physical product, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance relies on established engineering standards, material specifications, and biological safety standards (e.g., ISO 17665-2 for sterilization, ISO 10993-1/5 for biocompatibility), and dimensional compatibility with OEM implant systems. It is a physical and material "ground truth" rather than a clinical or diagnostic "ground truth."
8. The sample size for the training set
- Not Applicable: This device is a physical product, not an AI model that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable: As there is no training set for an AI model, this question is not relevant.
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(112 days)
iSy® Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. iSy" Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.
iSy Implant System implants are self-tapping, root form, tapered endosseous dental implants made of titanium. The implant has a smooth machined surface in the transgingival portion, and a Promote surface on the endosseous portion. The subject device implants are provided in two lengths (7.3 and 16 mm) and three diameters (3.8, 4.4 and 5.0 mm). The subject device includes four abutment types, gingiva former, temporary abutment, Locator® and Esthomic Abutment. Abutments are compatible with all three diameters (3.8, 4.4 and 5.0 mm). The Esthomic abutment is available with three design angulations (0°, 15°, 20°). iSy® Implant System Abutments are intended for use as support for crowns, bridges or overdentures.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) premarket notification clearance letter for the iSy® Implant System, which establishes its substantial equivalence to previously marketed devices.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given text.
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(198 days)
Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Medentika Abutment System is an abutment system including ten abutment designs compatible with eleven currently marketed implant systems. The abutment designs include abutments for single-tooth and multiple-tooth restoration for supporting cement-retained, screw-retained or overdenture prostheses. Platform diameters range from 3.3 mm to 7.0 mm. Corresponding implant diameters range from 3.25 mm to 7.0 mm. Angled abutment designs for connections with anti-rotational features are available in two orientations, Type 1 and Type 2. Type 1 is for abutments with the cone angle oriented toward the flat of the anti-rotational feature and Type 2 is for abutments with the cone angle oriented toward the corner or lobe of the anti-rotational feature. The maximum angle for any abutment within the eleven systems is 21 °
The provided text is a 510(k) summary for the Medentika Abutment System, a medical device. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
The context of this type of document is a regulatory submission, not a study evaluating AI performance or a diagnostic device. Therefore, the questions related to AI, ground truth establishment, expert consensus, sample sizes for AI training/testing, adjudication methods, and MRMC studies are not applicable to the information contained in this document. The document describes a "substantial equivalence" claim for a physical medical device (dental abutments), meaning it demonstrates the device is as safe and effective as a legally marketed device.
Here's the information that can be extracted or inferred based on the provided text, with responses to your questions where applicable and an explanation when not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with defined thresholds. Instead, it refers to regulatory compliance and equivalence to predicate devices. The "reported device performance" is demonstrated through various non-clinical tests designed to show the physical and mechanical properties are comparable to existing, legally marketed devices.
| Acceptance Criteria (Implied by Regulatory Standards & Equivalence) | Reported Device Performance (Demonstrated by Testing) |
|---|---|
| Sterilization Validation (ISO 17665-1, ISO 17665-2) | Sterilization validated according to ISO 17665-1 (Requirements for the development, validation and routine control of a sterilization process for medical devices) and ISO 17665-2 (Guidance on the application of ISO 17665-1). (Specific performance outcomes not detailed, but compliance is implied by meeting the standard). |
| Biocompatibility Testing (ISO 10993-5) | Biocompatibility testing performed according to ISO 10993-5 (Tests for in vitro cytotoxicity). (Specific performance outcomes not detailed, but compliance is implied by meeting the standard). |
| Mechanical Strength/Durability (ISO 14801) | Static and dynamic compression-bending testing performed according to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants). (Specific performance outcomes not detailed, but the data is stated to demonstrate substantial equivalence to predicate devices, implying comparable mechanical performance). |
| Engineering and Dimensional Characteristics | Engineering analysis and dimensional analysis were performed. (Specific details not provided, but these analyses would confirm the device's design and measurements meet specifications and are comparable to predicate devices). |
| Overall Substantial Equivalence to Predicate Devices | The data demonstrates substantial equivalence to "K020646 Replace™ HA Coated Implant", "K071370 NobelActive Internal Connection Implant", "K063341 3i OSSEOTITE Certain® Dental Implants", "K063286 OSSEOTITE Dental Implants", "K022562 Various Brånemark System Implants – Immediate Function Indication", "K062129 P.004 Implants", "K130222 Straumann Dental Implant System SLActive and Roxoid Product Families", "K061410 Zimmer Dental Implant System", "K101732 Astra Tech Implant System", "K073075 FRIADENT Implant Systems", "K041509 ANKYLOS® Dental Implant System", "K072570 NobelActive Multi-Unit Abutment", "K093643 Multi-Unit Abutments for Straumann and Astra Tech Implant Systems", "K072878 Locator Implant Anchor", "K092434 2.2 mm Angled Micro ERA Dental Implant System", "K120414 OsseoSpeed™ Plus", "K083496 CAMLOG Implant System Modified Implants and Abutments", and "K080239 P.004 RC/NC Bar and Bridge Abutments Line". This implies that the safety and efficacy profiles are comparable. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "non-clinical testing data" for sterilization, biocompatibility, engineering, dimensional, and static/dynamic compression-bending tests. These types of tests typically involve a sample of units for each test, but the specific number of units is not detailed in this summary. The data provenance is also not specified, though the manufacturer (Medentika GmbH) is based in Germany. The tests are prospective in nature, as they involve testing the actual device components.
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 question is not applicable. This document describes a medical device approval based on physical properties and comparison to predicate devices, not an AI or diagnostic study requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. There is no "test set" in the context of expert review or diagnostic assessment for this type of device approval.
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 question is not applicable. This is a physical medical device (dental abutment), not an AI-assisted diagnostic or imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This question is not applicable in the context of expert-determined ground truth for a diagnostic task. For this device, the "ground truth" equivalent would be established by:
- Established ISO standards: For sterilization (ISO 17665-1, ISO 17665-2), biocompatibility (ISO 10993-5), and mechanical fatigue (ISO 14801). Compliance with these standards is considered the "truth" for safety and performance in their respective domains.
- Performance of predicate devices: The "truth" is that the predicate devices are legally marketed and considered safe and effective. The subject device demonstrates comparable performance to these established devices.
8. The sample size for the training set
This question is not applicable. This document describes the approval of a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This question is not applicable. There is no "training set" in the context of AI for this device approval.
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