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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:

1. A table of acceptance criteria and the reported device performance (for an AI/ML device)
2. Sample sizes used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method for the test set
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study details
6. Standalone (algorithm-only) performance
7. Type of ground truth used
8. Sample size for the training set
9. 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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The s-Clean TiN Coating Abutments is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

The s-Clean TiN Coating Abutments are device made of pure titanium and titanium alloy intended for use as an aid in prosthetic restoration. The system consists of s-Clean TiN Half Coating Angled Abutment, s-Clean TiN Half and partial Coating Couple Abutment, s-Clean TiN Half Coating Free Abutment, s-Clean TiN Half Coating FreeMill Abutment, s-Clean TiN Half Coating MOA Abutment, s-Clean TiN Partial Sub-Octa Abutment, s-Clean TiN Partial Coating Sole Abutment, s-Clean DOA Ball Abutment, s-Clean DOA Snap Abutment, and s-Clean Sole Abutment Healing Cap. The surface of the abutments is partially or half TiN Coated by using PVD (Physical Vapor Deposition). The subject device is provided non-sterile and should be sterilized before use (End user sterilization).

This document is a 510(k) summary for a dental implant abutment, and as such, it focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets acceptance criteria through a standalone clinical study with detailed performance metrics.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission. The information provided heavily relies on non-clinical testing and comparison to predicates.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on meeting the requirements of specific international and FDA guidance standards for medical devices, particularly for dental abutments. The reported device performance is that these tests were met.

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

• Not Applicable (N/A) for clinical data. This submission relies on non-clinical (laboratory) testing, not a clinical test set with patient data.
• The non-clinical tests (biocompatibility, fatigue, sterilization) are laboratory-based and would use a sample size appropriate for those specific engineering and biological tests, but this detail is not provided. The data provenance for these tests would be internal laboratory testing by the manufacturer or a contracted lab.

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

• N/A. As mentioned, this is a non-clinical submission. Ground truth, in the context of clinical studies and expert consensus, is not relevant here. Decisions are made based on adherence to engineering and biocompatibility standards.

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

• N/A. No clinical test set requiring expert adjudication was conducted or described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• N/A. This is a dental implant abutment, not an AI-powered diagnostic or assistive device. MRMC studies are not relevant here.

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

• N/A. This is a physical medical device (dental abutment), not an algorithm or AI system.

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

• For the non-clinical tests, the "ground truth" is defined by the validated and accepted international standards (e.g., ISO, ANSI/AAMI) for mechanical performance and biocompatibility. Passing these tests according to the established metrics within the standards constitutes meeting the "ground truth" of safety and performance.

8. The sample size for the training set

• N/A. There is no "training set" as this is not a machine learning or AI product.

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

• N/A. There is no "training set" as this is not a machine learning or AI product.

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GMI Frontier Dental Implant System model is intended to be used for surgical placement in upper or lower jaw to provide a support for prosthetic devices such as artificial teeth, in order to restore the patient's chewing function. The GMI Frontier Dental Implants System is intended for delayed loading.

GMI Frontier consists of dental implant, attachments (straight and angled abutments, healing abutments, ball abutments, temporary cylinders, straight and angled multi-esthetic abutments and their accessories), and clinical screws.

I'm sorry, but this document (K161593 510(k) Premarket Notification for the GMI Frontier Dental Implant System) relates to a dental implant system and does not contain information about an AI/ML (Artificial Intelligence/Machine Learning) device.

Therefore, I cannot provide the specific details you requested regarding the acceptance criteria and study proving a digital health or AI/ML device meets those criteria. The provided text details the substantial equivalence of a physical medical device (dental implants) to existing predicate devices based on non-clinical performance data (biocompatibility, mechanical properties, sterilization, etc.).

No mention of AI, machine learning, deep learning, algorithms for image analysis, or any form of digital diagnostic assistance is present in this document.

To provide the requested information, I would need a document related to an AI/ML medical device.

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