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The Highness Implant System is designed to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (crowns, bridges, and overdentures) in partially or fully edentulous individuals. It is used to the restore the patient's chewing function. Implants with diameter less than ø5.5mm are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated to the molar region and are indicated for delayed loading.

The Multi-Unit Abutments are intended for multi-unit restorations only and can be used up to 25 degrees when connecting cylinder.

The Highness Implant System is a titanium-metal dental implant designed to be surgically placed in the bone of the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

The Highness Implant System consists of fixtures and abutments.

The fixture is made of pure titanium metal and is supplied sterile (gamma irradiated). The surface is SLA, sandblasted (using 425-180-micron MCD apatitic abrasive, which is a granular, multi-phase calcium phosphate composed primarily of hydroxyapatite and tricalcium phosphate), large grit, acid-etched (solution of hydrochloric acid and nitric acid), treated.

The abutments are made of Ti-6Al-4V ELI titanium alloy (ASTM F136). It consists of a Cemented Abutment, Angled Abutment, Solid Abutment, Temporary Abutment, and Multi-Unit Abutment Screw & Abutment Screw, which are intended for use as an aid in single- or multiple-unit prosthetic restorations, and the Multi-Unit Abutment and Multi-Angled Abutment, which are intended for use only as aids in multiple-unit prosthetic restorations. In addition, Cover Screws and Healing Abutments are prefabricated prosthetic components that connect directly to endosseous dental implants and are indicated as temporary components to allow for soft tissue healing. All abutments are supplied non-sterile and individually packaged in FDA cleared wraps and/or pouches. The abutments should be sterilized prior to use by the end-user. And temporary abutments are intended to be used 6 months.

The abutments are compatible with both HS - I and HS - VII implant bodies.

This document, K240383, is a 510(k) Premarket Notification for the Highness Implant System. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving the device meets specific acceptance criteria related to clinical performance or AI/software.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets such criteria in the context of clinical effectiveness, AI performance, or human reader improvement. This document is a regulatory submission for a medical device (dental implants) and, as explicitly stated in Section X, it does not include data from clinical tests.

Therefore, I cannot provide answers to most of your requested points as they pertain to clinical studies, AI performance, or multi-reader multi-case studies, which are not present in this regulatory submission.

However, I can extract information related to non-clinical testing which demonstrates the device meets certain performance standards (acceptance criteria) for the device itself, not for an AI component or clinical outcomes.

Here's what can be extracted from the document regarding non-clinical performance:

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

The document provides performance data in relation to industry standards and guidance, which serve as the acceptance criteria for these non-clinical tests.

Points that cannot be addressed from the document:

• 2. Sample sized used for the test set and the data provenance: Not applicable for non-clinical tests in the context of user evaluation or clinical effectiveness. The numbers of devices tested for fatigue, biocompatibility, and sterilization validation are not specified, only that the tests were performed "in accordance with" standards. Data provenance (country, retrospective/prospective) is typically for clinical data, which is absent.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this refers to establishing ground truth for perception/interpretation tasks, or clinical endpoints, neither of which are part of this 510(k) submission.
• 4. Adjudication method: 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, as there's no AI component or clinical study.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for non-clinical material and mechanical tests. The "ground truth" here is the physical and material properties meeting specified engineering and biological standards.
• 8. The sample size for the training set: Not applicable, no AI/training set.
• 9. How the ground truth for the training set was established: Not applicable, no AI/training set.

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Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
• Link Abutment for CEREC
The Link Abutment for CEREC is titanium alloy abutments placed onto OSSTEM dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.

Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Osstem Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.
Osstem Abutment System is substantially equivalent in design, function and intended use to the predicate devices as above.
The document then lists various components of the system including Transfer Abutment, Angled Abutment, Link Abutment for Cerec, Temporary Abutment, Multi Angled Abutment, Multi NP-Cast Cylinder, Multi Combination Cylinder, Convertible Angled Cylinder, Stud Abutment, O-ring, O-ring Retainer Cap, Port Abutment, Port Angled Abutment, Port Angled Abutment Head, Port Male, Port Extended Male, Port Male Cap, Port Male Kit, Abutment Screw, Cylinder Screw, Esthetic-low Temporary Cylinder, and Temporary Cap (Narrow Ridge), along with their descriptions, materials, and dimensions.

The provided document is a 510(k) premarket notification for the Osstem Abutment System. It outlines how the device is considered substantially equivalent to already marketed predicate devices, rather than providing a performance study against specific acceptance criteria for a new AI/software device.

Therefore, many of the requested details, such as those related to AI/algorithm performance (e.g., test set sample size, expert ground truth establishment, MRMC studies, standalone performance), are not applicable to this type of submission. The document focuses on material properties, design, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, here's what can be extracted and what cannot:

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

The document does not present explicit acceptance criteria in the typical sense of performance metrics for an AI/software device (e.g., accuracy, sensitivity, specificity). Instead, substantial equivalence is claimed based on similarities in:

• Intended Use
• Technology (design principles)
• Material Composition
• Performance Characteristics (mechanical properties, biocompatibility, sterilization)

The performance is "reported" by demonstrating that the device is equivalent to known predicate devices through non-clinical testing (biocompatibility, sterilization validation, mechanical properties, specifically fatigue testing and retention testing). The document states: "Non-clinical testing data are submitted, referenced, or relied upon to demonstrate substantial equivalence."

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 applicable and not provided. The submission relies on non-clinical (laboratory) testing for mechanical properties and biocompatibility, as well as comparison to predicate devices, not on a clinical test set with patient data.

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. No clinical test set or human expert review of "truth" data for diagnostic performance is described.

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 is not an AI/software device that assists human readers.

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)

For mechanical testing, the "ground truth" would be established by the physical and mechanical properties of the materials and designs as measured in laboratory tests, and compared against established industry standards (ISO 14801) and FDA guidance for dental abutments. For biocompatibility, it's adherence to ISO 10993 standards. No clinical ground truth from patients is established or used for this 510(k) submission.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of device submission.

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

Not applicable.

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The TruBase S is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for serew-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:

• · Zimmer TSV 3.7, 4.1. 4.7. 6.0 mm (3.5. 4.5, 5.7mm platform sizes)
  All digitally designed abutments and/or coping for use with the TruBase S are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MCX or MC XL milling unit.

TruBase S consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment.
TruBase S abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters (4.3, 5.3, 6.5 mm) and four gingival heights (0.8, 1.8, 2.8, 3.8mm), all having a 4.7mm prosthetic post height. They also feature:

• cylindrical shape
• hexagonal indexing at the apical end of the connection
• indexing guide in the cementable portion for coping fitting
  The CAD/CAM patient-specific superstructure that composes the final abutment must be designed and milled through the Sirona Dental CAD/CAM System, according to the prosthetic planning and patient clinical situation.
  TruBase S is provided non-sterile therefore must be sterilized after the cementation of the patient-specific superstructure on the TruBase S.

The provided text describes a 510(k) premarket notification for a dental implant abutment, TruBase S, and details the non-clinical testing performed to establish its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the context of a clinical trial or a full performance study with human subjects, AI systems, or ground truth established by experts as would be typical for an AI/ML medical device.

The information primarily focuses on mechanical testing, material equivalence, and compatibility, which are acceptance criteria for this type of medical device's safety and effectiveness.

Here's a breakdown of the available information based on your request, with an emphasis on what is not present in the document.

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

The document doesn't present a table of acceptance criteria with specific numerical performance metrics in the way you might expect for an AI/ML device (e.g., sensitivity, specificity). Instead, it states that tests met "the criteria of the standard" or "demonstrated substantial equivalence."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "non-clinical testing" for the TruBase S and leverages results from predicate devices for other tests. These are likely laboratory or bench tests on physical samples rather than patient data.

• Sample size for test set: Not explicitly stated as "test set" in the context of patient data. For mechanical fatigue testing, "worst-case scenario (smallest diameter with maximum angulation)" implies a specific configuration of a few physical samples, but the exact number isn't provided.
• Data provenance: Not applicable in the context of patient data. The tests are non-clinical, likely conducted in a lab environment.

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 device is a passive dental component, and its evaluation relies on engineering standards and mechanical testing, not a clinical interpretation by human experts establishing ground truth from patient data.

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

Not applicable. There's no clinical imaging or diagnostic data 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

No. This document does not pertain to an AI/ML device that assists human readers.

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

No. This is not an AI/ML algorithm. The "software" mentioned is CAD/CAM software used for design and manufacturing, not an AI for diagnosis or treatment planning. The device itself is a physical dental abutment.

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

The "ground truth" for this type of device is established by adherence to recognized engineering standards (e.g., ISO 14801:2016 for fatigue, ISO 10993 for biocompatibility) and dimensional compatibility with existing implant systems. There is no biological or expert consensus "ground truth" as you would find for diagnostic devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that uses a training set.

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

Not applicable. This is not an AI/ML device.

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