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The TSX Implants are designed for use in the maxilla or mandible for immediate loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical) and provide good primary stability.

The 3.1mmD TSX Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.

TSX Dental Implants are manufactured from biocompatible titanium alloy. TSX Dental Implants surface consists of a Contemporary Hybrid Surface Treatment (Dual Acid Etch + MTX™ Textured Surface). The implants are available in different platform diameters and feature an internal hex connection for mating with associated Zimmer Dental and Biomet 3i internal connection restorative components.

For specific product descriptions, please refer to individual product labels.

The provided text is a Premarket Notification (510(k)) for the Biomet 3i LLC TSX Implants. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing. It does not contain information about an AI/ML powered device, nor does it include data from a clinical study on device performance against acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample size for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types.

The document explicitly states: "No clinical data were included in this submission." This means that the information needed to answer most of your detailed questions about device performance validation against specified criteria is not present in the provided text.

The closest relevant information is under "XI. Non-Clinical Testing," which describes mechanical testing (ISO 14801:2016), sterility validation, pyrogenicity testing, SEM/EDS imaging for surface assessment, and biocompatibility testing. These are non-clinical tests to show the device's physical and biological properties are equivalent to predicate devices, not performance against clinical acceptance criteria for an AI/ML algorithm.

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The T3 Pro Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

The T3 Pro Implants may also utilize immediate loading for these indications. The T3 Pro Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

The T3 Pro Implants are basic screw-type designs available in tapered body geometry. The devices are manufactured from Commercially Pure Titanium (ASTM F67) and feature a roughened apex and traditional OSSEOTITE® coronal surface. The device is packaged in a Titanium sleeve that is inserted into a polypropylene inner tray, covered with a Tyvek lid and heat-sealed. This assembly is then placed inside a larger polyethylene thermoformed outer tray, covered with a Tyvek lid and heat-sealed. The outer tray is packaged inside a box. The device is sold sterile. The shelf life of the T3 Pro Implants is 5 years and they are intended for single use only. The device is sterilized using gamma irradiation method. The implants are available in various platform options and feature an internal hex connection for mating with associated Biomet 3i internal connection restorative components. The implants are offered in a variety of diameters and lengths to accommodate varying patient anatomy.

The provided document is a 510(k) summary for a medical device (T3 Pro Implants) and does not contain information regarding software or AI performance.

Therefore, I cannot provide an answer addressing the acceptance criteria and study proving device performance for AI/software, as the document does not pertain to such a device.

The document discusses the substantial equivalence of the T3 Pro Implants to predicate devices based on non-clinical testing rather than AI/software performance evaluations.

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The BellaTek Encode Emergence Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.

The BellaTek Encode Emergence Healing Abutment is a two-piece healing abutment (abutment with a retaining screw) designed to facilitate gingival tissue healing before a final restoration is placed. It consists of an abutment and a retaining screw that are assembled and packaged together and provided sterile. Both components are machined from Titanium Alloy Ti-6Al-4V ELI (ASTM F136). They are available in pre-defined diameters, emergence profiles and heights to accommodate varying patient anatomies. The shelf life of the TSV BellaTek Encode Healing Abutment is 5 years from the date of manufacture and they are intended for single use only. The device is packaged in a blister tray with Tyvek Lid and sold sterile. The device is sterilized using the gamma irradiation method. The BellaTek Encode Emergence Healing Abutments are color anodized for aesthetic purposes.

This document is a 510(k) Premarket Notification from the FDA regarding the "BellaTek Encode Emergence Healing Abutments". It does not describe an AI/ML device, therefore the requested information regarding acceptance criteria and study details for AI/ML performance is not present.

The document focuses on demonstrating substantial equivalence to previously approved predicate devices, rather than an AI/ML device's performance.

Here's why the requested information cannot be extracted:

• No AI/ML Component: The device is a physical dental implant component (healing abutment), not a software algorithm or AI-powered system.
• Substantial Equivalence: The approval process here is based on showing that the new device is as safe and effective as a legally marketed predicate device, not on meeting specific performance metrics for an AI algorithm.
• Non-Clinical Testing: The "Non-Clinical Testing" section describes tests related to physical properties, biocompatibility, sterilization, and shelf-life, which are typical for physical medical devices. It does not mention any studies related to AI/ML performance metrics like accuracy, sensitivity, specificity, etc.

Therefore, since the input document describes a physical medical device and not an AI/ML device, it does not contain the information requested in the prompt about AI/ML acceptance criteria and study details.

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TSV BellaTek® Express and BellaTek® Flex Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained.

All digitally designed superstructures and/or hybrid abutment crowns for use with TSV BellaTek Express or BellaTek Flex Abutments are intended to be sent to a Biomet 3i validated milling center for manufacture.

The TSV BellaTek Express Abutment and BellaTek Flex Abutment (subject devices) are Titanium-base type abutments to be used as the apical part of two-piece abutments. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. All digitally designed superstructures manufactured in zirconia conform to ISO 13356:2015 and ISO 6872:2015. Biomet 3i recommends the use of Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436) to affix the zirconia superstructure and/or hybrid abutment crown to the Certain BellaTek Express and BellaTek Flex abutments. TSV BellaTek Express Abutment and BellaTek Flex Abutment are intended to be used with Zimmer Dental's Tapered Screw-Vent, Screw-Vent and Trabecular Metal dental implants for single and multi-unit restorations. The subject device abutments are available in hexed (single-unit) and non-hexed (multi-unit) configurations. They are available in pre-defined platform diameters, emergence profiles and heights to accommodate varying patient anatomies. They are machined from Titanium Alloy. They are intended for single use only. The device is packaged in a sealed nylon bag and sold non-sterile.

The TSV Titanium ASC screw used with the subject device is also machined from Titanium Alloy and anodized pink. The device is packaged individually in a sealed nylon bag and sold sterile. When the TSV BellaTek Express or BellaTek Flex Abutment is placed on the corresponding implant, the retaining screw will mate with the internal thread feature of the dental implant to hold the abutment in place.

The provided document is a 510(k) summary for a medical device (dental abutments) and does not describe a study involving an algorithm or AI. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and performance of an AI/algorithm-based device.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through a comparison of design, function, materials, indications for use, and non-clinical testing.

Here's a breakdown of the available information relevant to product acceptance, though it's for a physical medical device, not an algorithm:

1. A table of acceptance criteria and the reported device performance:

The document primarily demonstrates substantial equivalence through comparisons with predicate devices and adherence to relevant standards. It doesn't present a table of specific performance acceptance criteria in the way one would for an AI model's metrics (e.g., sensitivity, specificity).

Instead, "performance" here refers to the physical and biological characteristics of the dental abutment and its components:

Regarding the other points you requested (2 through 9), they are not applicable as this document discusses a physical medical device, not an AI/algorithm:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of device. The "tests" mentioned are non-clinical (e.g., sterilization, biocompatibility, packaging), not an evaluation of an algorithm on a dataset.
• 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. Ground truth, in the context of expert review, is not relevant to the non-clinical testing performed for dental abutments.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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. This document explicitly states, "No clinical data was included in this submission."
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a physical device's performance relies on adherence to material specifications, engineering standards, and biological compatibility.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for a physical medical device, not an AI or algorithm. Therefore, the specific details you requested regarding AI model evaluation are not present.

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