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DENTCA Base Resin is a light-curable resin indicated for the fabrication and repair of removable denture bases in dental laboratories, including full and partial dentures as well as immediate dentures, and baseplates. DENTCA Base Resin can also be used for the fabrication of try-in dentures for the evaluation before fabricating the final dentures. Fabrication of these prostheses with DENTCA Base Resin requires a digital denture file, additive printer, and curing light equipment. DENTCA Base Resin can be utilized as an aid in bonding the denture teeth onto denture base.

DENTCA Base Resin is a light-curable resin intended to fabricate removable dentures in a CAD/CAM system using an additive printing process. This material is used as an alternative to traditional heat cured and auto polymerizing denture base resins and is available in multiple shades. DENTCA Base Resin can also be utilized to repair the printed denture and to bond printed teeth onto denture base.

The provided text does not contain information about an AI/ML powered device, but rather a dental resin material. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets these criteria for an AI/ML device.

The document is a 510(k) premarket notification for a dental resin called "DENTCA Base Resin," which is a light-curable resin for fabricating and repairing removable denture bases. The "Performance Data" section discusses:

• Biocompatibility Testing: Conducted according to ISO 7405:2018 and FDA Guidance for medical devices in dentistry.
• Software Verification and Validation Testing: For the additive printing (3D printer) operation software, in accordance with FDA guidance for "Off-The-Shelf Software Use in Medical Devices" and "Technical Considerations for Additive Manufactured Medical Devices."
• Performance Bench Test: Conducted according to ISO 20795-1:2013, which specifies requirements for denture base polymers.

The table 5.2 "Comparison of Performance Bench Test" shows the acceptance criteria (specifications of Type 4 resin) and the reported performance of the subject device (DENTCA Base Hi-Impact and Premium), the predicate device (Halley Resin), and a reference device (DENTCA Denture Base II). All listed devices "Meet the consensus STD" or are "Not Detectable" for Residual Methylmethacrylate, indicating they meet the specified physical properties.

This document describes the testing for a physical material, not an AI/ML algorithm. Therefore, the requested details about multi-reader multi-case studies, ground truth establishment for AI, sample sizes for training sets, or expert qualifications are not applicable and not present in the provided text.

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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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Implant:
The ELEMENT PF 3.0 is suitable for use in one-stage or two-stage surgical techniques for restoring chewing function. The ELEMENT PF 3.0 is suitable for immediate implantation in case of replacement of several teeth; prerequisites are good primary stability and appropriate occlusal loading. The ELEMENT PF 3.0 must only be used for replacement of the lateral incisors of the upper jaw and lateral incisors of the lower jaw.

VARIOunite PF 3.0:
Thommen Medical VARIOunite abutments PF 3.0 are only used in conjunction with the ELEMENT PF 3.0 and are for fabrication of provisional and final crowns in the anterior maxilla and mandible (upper lateral incisors, lower anterior teeth).
Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.

VARIOunite:
Thommen Medical VARIOunite abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.
Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.

ELEMENT Ø 3.0 is a self-tapping, root form, endosseous dental implant made of commercially pure titanium. It is provided in two surfaces (TST and INICELL) and five lengths (8.0, 9.5, 11.0, 12.5, and 14 mm). Subject device components available for the ELEMENT Ø 3.0 implant are the healing cap, gingiva former and VARIOunite abutments. VARIOunite abutments can be used for temporary restorations, permanent restorations, or CAD/CAM zirconia superstructures. The indications for previously cleared VARIQunite abutments have been expanded to include angulation of the CAD/CAM zirconia superstructures.

This document describes a 510(k) premarket notification for the Thommen Implant System, specifically focusing on the ELEMENT PF 3.0 dental implant and VARIOunite abutments.

Here's an analysis of the acceptance criteria and the study used to demonstrate equivalence, based on the provided text:

No specific acceptance criteria in terms of performance metrics (e.g., success rates, survival rates, specific mechanical thresholds for clinical outcomes) are explicitly stated in this document for the device. The submission focuses on demonstrating substantial equivalence to predicate devices. This means the device is considered safe and effective because it is as safe and effective as a legally marketed device (predicate device).

The "study" or rather, the evidence provided, primarily consists of non-clinical testing data and comparisons to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, no explicit quantitative acceptance criteria or corresponding clinical performance metrics are provided in the document. The general "acceptance criteria" for a 510(k) submission are that the new device is "substantially equivalent" to predicate devices in terms of intended use, technological characteristics, and materials, and that any differences do not raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable in the context of clinical trials. For non-clinical testing (mechanical, sterilization, etc.), specific sample sizes are not detailed in this summary. These tests typically involve a pre-defined number of units/samples for each test type according to the relevant standard.
• Data Provenance: The data is non-clinical, originating from laboratory testing conducted to international (ISO, ASTM) and FDA guidance standards. The manufacturer is Thommen Medical AG, Switzerland. The data is not derived from human subjects or patient populations.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• This is not applicable as the submission did not include clinical data or studies requiring expert review of patient cases to establish ground truth.

4. Adjudication Method for the Test Set

• This is not applicable as the submission did not include clinical data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical data were included in this submission." This type of study is typically used for diagnostic or imaging devices, not for dental implants which rely on mechanical and biological performance demonstrated through non-clinical testing and clinical experience with similar devices.

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

• This is not applicable. The device is a physical dental implant system, not a software algorithm.

7. The Type of Ground Truth Used

• For the non-clinical tests, the "ground truth" is defined by the specifications and acceptable limits set by recognized international standards (ISO, ASTM) and FDA guidance documents for each specific test (e.g., sterilization effectiveness, material strength, biocompatibility, packaging integrity).

8. The Sample Size for the Training Set

• This is not applicable. There is no software algorithm or AI model being trained for this device.

9. How the Ground Truth for the Training Set Was Established

• This is not applicable as there is no software algorithm or AI model being trained for this device.

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