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Adin Customized Abutments are intended for use with Adin dental implants in partially or fully edentulous mandibles and maxillae, as a support for single-unit or multiple-unit screw-retained or cement-retained restorations.

All digitally designed abutments for use with Adin Ti-base and Adin Ti-blanks are intended to be sent to an FDA-registered Adin Dental Implants validated milling center for manufacture or to be manufactured according to the digital dentistry workflow, which integrates multiple components: scans from desktop and intraoral scanners, CAD and CAM software and a milling machine with associated accessories.

The purpose of this submission is to obtain marketing clearance for Adin Customized Abutments, a series of components compatible with dental implants from Adin Dental Implant Systems Ltd., intended for use in the fabrication of patient-specific abutments. The subject device components include CAD CAM abutments (Ti-bases, Ti-blanks). All patient-specific abutment fabrication is by prescription on the order of the clinician. Fabrication of patient-specific abutments will be performed at validated milling centers or, by using a validated digital dentistry workflow, at point-of-care facilities.

The design and fabrication of the zirconia superstructure for Ti-bases or of patient-specific abutments from Ti-blanks will be conducted using a digital dentistry workflow requiring the use of the following equipment and software:

Scanner: iTero Intra Oral Scanner or Medi Corp. Identica 3D Desktop scanner
Design Software: EXOCAD AbutmentCAD design software (K193352)
CAM Software: WORKNC Dental
Milling Machine: Ceramill Motion 2.

The superstructures to be used on Ti-bases are to be made from the following material and are to be cemented as follows:

Zirconia Material: ArgenZ Ultra (K071410)
Cement: PANAVIA V5 (K150704).

The abutments are provided non-sterile and are intended to be cleaned and steam-sterilized by the clinician prior to use according to the instructions given in the Instructions for Use (IfU) accompanying the device.

No compatibility with implants other than those from Adin Dental Implant Systems Ltd. is claimed or intended. Ti-bases are compatible with Adin Dental implants cleared in K081751 and K223714. Ti-blanks are compatible with Adin Dental implants cleared in K081751, K153111, K140293, and K112585.

Ti-base abutments are two-piece abutments, with the base component cemented to a CAD CAM fabricated zirconia superstructure. The final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration. Each patient-specific superstructure is individually prescribed by the clinician.

Ti-base abutments are provided with a compatible abutment screw that retains the base to the implant (the restoration is screw-retained on the implant level). The manufactured superstructure is attached to the Ti-base.
Engaged Ti-bases include anti-rotational connections that engage with the dental implant and are intended for single tooth restorations. Non-engaged Ti-bases include round connections that do not limit rotation and are intended for multi-unit/bridge restorations. Ti-base Angular are provided only in engaging designs.

The all-metal Ti-base components are straight with regard to the implant axis. Angular Ti-base includes an angled upper portion that allows the screw channel either to be straight relative to the implant axis or to be angled to allow for moving the screw channel in an oral direction (up to 20°) for esthetic purposes.

All Ti-bases are color coded per platform by an anodizing process for easier identification. Adin Ti-bases are available for Adin implant platform connections (standard internal hex – RS, and UniFit - UF)

The all-metal Ti-base components are provided in engaging and non-engaging versions with gingival heights ranging from 0.65 mm to 4.0 mm. They are provided with post heights of 4.0, 6.0, and 8.0 mm. Ti-base Angular is a component with gingival heights ranging from 1.0 mm to 3.0 mm, provided in an engaging design. Ti-base Angular includes an angular cutout in the post to allow for moving the screw channel in an oral direction for esthetic purposes. It is provided with post heights from 4.0 mm to 8.0 mm.

The design parameters for the CAD CAM zirconia superstructure to be used on Ti-base and Ti-base Angular, are:

• Minimum wall thickness – 0.5 mm
• Minimum post height for single unit restorations – 4.0 mm
• Minimum gingival height – 0.0 mm
• Maximum gingival height – 4.5 mm
• Maximum angulation of the final abutment - 20°

Adin Ti-blank abutments include on one side a pre-fabricated connection for the dental implant and on the other side a pre-fabricated connection to the milling machine blank holder. They are available in diameters of 11.5 mm and 15.8 mm and are provided with a compatible abutment screw.

All Ti-blank designs are subject devices to be manufactured using a CAD CAM workflow. Ti-blank abutments are provided in engaging and non-engaging designs, are available for all Adin implant platform connections, and are made of titanium alloy (Ti 6Al 4V).

The design parameters for Ti-blanks are:

• Minimum wall thickness – 0.7 mm for RS; 0.5 mm for UNP, NP, RP, WP
• Minimum post height for single unit restorations – 4.0 mm
• Maximum milled abutment height above implant level – 10 mm
• Minimum gingival height – 0.5 mm
• Maximum gingival height – 4.0 mm for RS; 1.0 mm for UNP; 3.0 mm for NP, RP, WP
• Maximum angulation of the final abutment – 25° for RS, NP, RP, WP; 15° for UNP

N/A

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Adin Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in fully or partially edentulous patients in order to restore a patient's chewing function. Adin Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. Adin short implants are to be used only with straight abutments.

Adin Short Implants are self-tapping root-form two-piece screw type dental implants, indicated for use in Surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Adin's Short Implants are provided in 6.25mm length and 4.2mm, 5.0 mm, and 6.0mm diameters. As two-piece devices, like the predicate devices, Adin Short Implants are to be used in combination with cover screws, healing caps and straight abutments. The Adin Short Implants are made of Titanium 6AL-4V-ELI Alloy, complying with ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

The provided text describes a 510(k) premarket notification for a medical device, Adin Short Implants. However, this document does NOT contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML medical device and its performance metrics.

The document details the substantial equivalence of the Adin Short Implants to predicate dental implants through a comparison of their technological characteristics and non-clinical performance data. This includes:

• Device Description: The physical characteristics of the Adin Short Implants (self-tapping, root-form, two-piece screw type, made of Titanium 6AL-4V-ELI Alloy, specific lengths and diameters, surface treatments).
• Intended Use: Surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients to restore chewing function, with immediate loading possible under certain conditions.
• Substantial Equivalence: A detailed comparison table (pages 8-9) of the subject device with several predicate devices, highlighting similarities in classification, indications for use, patient population, sterility, body contact, prescription status, single use, operation principle, placement method, self-tapping, implant material, biocompatibility, shape, connection (with some variations), surface treatment, implanted length, outer diameter, abutment angulation, packaging, and shelf-life.
• Non-Clinical Performance Data (Page 6-7):
  • Pull-Out Testing: Measured axial pull-out strength compared to predicate devices, according to ASTM F543.
  • Comparative Bone to Implant Contact Surface Area Analysis: Compared to predicate devices.
  • Comparative Surface Analysis Before Surface Treatment: Compared to predicate devices.
  • Biocompatibility: Tests conducted according to FDA Guidance for ISO 10993-1, ISO 10993-5, ISO 10993-11, and ISO 10993-18.
  • Surface Analysis After Surface Treatment: Using SEM/EDS.
  • Gamma Sterilization Validation: According to ISO 11137-2 and ISO/TS 13004.
  • Shelf-life validation: According to ISO 11607-1.
  • MR Environment Condition: Non-clinical worst-case MRI review based on scientific rationale and published literature.

The document concludes that the Adin Short Implants are substantially equivalent to the predicate devices and do not introduce new risks.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves the device meets the acceptance criteria with respect to AI/ML device performance metrics because the provided text is for a mechanical dental implant and does not involve AI/ML.

If you have a document pertaining to an AI/ML medical device, please provide that, and I will be happy to extract the requested information.

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TOUAREG CloseFit™ UNP 2.75mmD implants are indicated to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. For single-stage or two-stage procedures. For immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When an one-stage surgical is applied, the implant maybe immediately loaded when good primary stability is achieved and thefunctional load is appropriate.

The TOUAREG CloseFit™ UNP 2.75mmDDental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.

The TOUAREG CloseFit™ UNP 2.75mmD spiral implant system is comprised of a tapered core implant with a spiral tap, with unique tip and triple lead thread design (3x1mm).

The TOUAREG CloseFit™ UNP 2.75mmD spiral implant system offers a unique, strong and solid conical-hex connection.

All Touareg CloseFit™ implants feature the OsseoFix™ surface treatment The TOUAREG CloseFit™ UNP 2.75mmD implant is provided with a diameter of 2.75mm and lengths of 10, 11, 13, 16 and 18 mm.

The TOUAREG CloseFit™ UNP 2.75mmD implants are two piece devices whereas the implant is to be used in combination with cover screws, healing abutments and abutments.

The TOUAREG CloseFit™ UNP 2.75mmD implants, abutments, and abutment fixation screw are made of Ti6AL4V ELI complying with standard ASTM F 136-08- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.

The provided document is a 510(k) premarket notification for a dental implant device, the TOUAREG CloseFit™ UNP 2.75mmD. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices.

Based on the information provided, the following can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/CADe device. Instead, it demonstrates equivalence to predicate devices through non-clinical performance data (fatigue testing). The "performance" here refers to the device's mechanical integrity under simulated conditions.

2. Sample Size for Test Set and Data Provenance

The document does not describe a "test set" in the context of evaluating an AI/CADe device. The performance evaluation is based on non-clinical fatigue testing of the physical dental implant device. The sample size for this physical testing is not specified.

Data provenance (country of origin, retrospective/prospective) is not applicable or provided, as this is laboratory testing of a manufactured medical device, not analysis of patient data.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable as the evaluation is not for an AI/CADe system requiring expert-established ground truth from medical images or clinical data. The judgment of "equivalence" is made by the FDA based on the submitted non-clinical test reports.

4. Adjudication Method for the Test Set

This information is not applicable as there is no "test set" requiring expert adjudication in the context of an AI/CADe device performance study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not done. This section is not relevant as the device is a physical dental implant, not an AI/CADe system intended to assist human readers.

6. Standalone Performance Study (Algorithm Only)

A standalone performance study was not done. This section is not relevant as the device is a physical dental implant, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is established by conformance to a recognized international standard (ISO 14801:2007 for fatigue testing) and comparison to predicate devices, demonstrating mechanical equivalence. There is no biological or pathological "ground truth" in the typical sense for an AI/CADe device.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical dental implant, not an AI algorithm that requires a training set.

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

This information is not applicable. The device is a physical dental implant, not an AI algorithm.

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