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URIS OMNI Narrow System is indicated for use in the treatment of missing maxillary lateral incisors or the mandbular central and lateral incisors, in support of single or multiple-unit restorations including: cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

The URIS OMNI Prosthetic abutments are intended for use with URIS OMNI dental implants to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

All digitally designed abutments and/or coping for use with URIS OMNI Prosthetic abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

URIS OMNI Narrow System fixtures are dental implants made of Unalloyed Titanium, grade 4 (ASTM F67) intended for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors. The surface is SLA (Sandblasted, Large grit and Acid etched) treated and is provided sterile. It consists of two implant lines, the OMNI Straight and the OMNI Tapered, with corresponding cover screws, healing abutments and prosthetic abutments. The OMNI Tapered implant has a tapered wall with a single thread design. The OMNI Straight implant has straight wall with smaller threading at the coronal end, and bigger threading at the apical end. Both implant lines have Narrow (Ø 3.15 mm) platform sizes. Both implant lines share the following diameters and lengths.

Ø 3.15 x 10, 11.5, 13, 14.5mm (L)

URIS Prosthetic System is made of titanium alloy (Ti-6Al-4V ELI) intended for use as an aid in prosthetic restoration. It consists of Ball Abutment, Retainer, T LOC Straight Abutment, T Loc Titanium Cap, Multi-Unit Straight Abutment, Multi-Unit Angled Abutment, Multi-Unit Healing Cap, Multi-Unit Ti Cylinder, Multi-unit temporary cylinder, Multi-Unit Cylinder screw, URIS DS, URIS Base. No additional angulation is to be included in the when using a coping or cylinder (i.e., Multi-unit Ti Cylinder, Multi-unit Temporary Cylinder, Multi-unit Base) with any of the Multi-unit Abutments.

URIS Base 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. URIS Base is made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

URIS DS abutment as a patient matched titanium abutment compatible with both URIS OMNI System (K172100) and URIS OMNI Narrow System (subject).

The provided document is a 510(k) Summary for a dental implant system. It discusses the substantial equivalence of the "URIS OMNI Narrow System & Prosthetic" to predicate devices based on non-clinical testing. The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of human reader performance or a standalone algorithm performance for AI/ML-driven devices.

The document states: "No clinical data were included in this submission." and focuses on demonstrating substantial equivalence through comparisons of technological characteristics and non-clinical test data.

Therefore, I cannot provide the requested information for an AI/ML device related to acceptance criteria, detailed study design, sample sizes, expert ground truth, adjudication methods, or MRMC comparative effectiveness studies, as these types of studies are not discussed in this 510(k) summary for this device.

The "acceptance criteria" presented in this document are primarily related to the successful completion and results of non-clinical tests to demonstrate equivalence to predicate devices. These are not performance metrics for an AI/ML algorithm.

Here's an analysis of what is provided regarding acceptance criteria in the context of this traditional medical device:

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

The document implicitly defines acceptance criteria by listing the standards to which tests were performed and stating that "the results have met the criteria of the standards." The "reported device performance" is that it successfully met these standards, thereby demonstrating substantial equivalence.

2. Sample size used for the test set and the data provenance:
Not applicable for this type of non-clinical, non-AI device study. The document refers to testing on the device itself (e.g., fatigue testing, sterilization testing, biocompatibility).

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 as typically understood for AI/ML performance is not relevant here. The "ground truth" for these tests would be the accepted parameters and methods defined by the referenced ISO/ASTM standards and FDA guidance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a human reader or AI performance study.

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 is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable in the context of AI/ML device performance. For the described non-clinical tests, the "ground truth" is defined by the specific parameters and requirements of the referenced ISO/ASTM standards. For example, for biocompatibility, the ground truth is whether the materials meet the criteria specified in ISO 10993-1.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.

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"BoniPlus" Dental G-Mesh System is the non-absorbable membrane that is made of titanium metal to stabilize and support bone grafts in dento-alveolar bony defect sites.

The "BoniPlus" Dental G-Mesh System is a non-absorbable titanium screen made of pure Titanium (ASTM F-67), that helps in bone neoformation. They come in many different lengths, widths and thicknesses.

This document describes the "BoniPlus" Dental G-Mesh System, a non-absorbable titanium membrane designed to stabilize and support bone grafts in dento-alveolar bony defect sites. A 510(k) submission was made to the FDA to demonstrate its substantial equivalence to previously cleared predicate and reference devices.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are established through a series of non-clinical tests, and the device's performance is reported to meet these requirements, thus affirming its substantial equivalence to existing devices. The table below summarizes these criteria and the reported performance.

| Test Category | Acceptance Criteria/Requirement Description of Device Performance |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization | Compliance with ISO 11137-1, ISO 11137-2, ISO 11737-1, and ISO 11737-2 for gamma sterilization. | Sterilization verification successfully conducted according to the specified ISO standards for gamma sterilization. |
| Shelf Life | Compliance with ASTM F1980, ASTM F1929, ASTM F88/F88M, ASTM D882, BS EN 868-5, and ASTM F1140/F1140M for tensile, dye penetration, burst, and creep tests. | Shelf life determined to be 3 years based on successful completion of tensile test, dye penetration test, burst test, and creep test conforming to the listed ASTM and BS EN standards. |
| Biocompatibility | Compliance with ISO 10993-1, ANSI/AAMI/ISO 10993-5, ISO 10993-10, ISO 10993-2, ANSI/AAMI/ISO 10993-12, USP , and USP for in vitro cytotoxicity, sensitization, intracutaneous reactivity, and pyrogenicity. Pyrogen limit specification for endotoxin level set at 0.01 EU/device. | Biocompatibility tests (in vitro cytotoxicity, sensitization, intracutaneous reactivity, and pyrogenicity) were performed successfully according to the specified ISO, ANSI/AAMI/ISO, and USP standards. Endotoxin levels reported as:

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Healing abutments, healing caps and closure screws are intended for use with the implants of the Straumann Dental Implant System to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Fixation caps are used to stabilize bone grafts in cases where bone augmentation is being performed in conjunction with implant placement.

The Straumann Healing Abutments, Healing Caps, and Closure Screws are intended for use with the implants of the Straumann Dental Implant System (SDIS) to protect the inner features of the implant and to maintain, stabilize and form the soft tissue during the healing process. The devices are available in various diameters and heights. They are also not intended for use in immediate loading protocols; none of the devices of the Straumann Sterile Healing Solution are indicated for use in immediate loading protocols as they are intended to protect the internal features of the implant during the healing phase. When the implant has sufficient primary stability, the closure caps and fixation caps are used as a means to retain a bone graft used to augment the bone in the vicinity of the implant. These devices are not intended to be used with granular bone substitute materials or dental membranes.

The document provided is a 510(k) premarket notification for a medical device called "Straumann Sterile Healing Solution." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria based on studies involving AI or complex performance metrics typically associated with diagnostic algorithms.

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study that proves a device meets these criteria in the context of AI/ML or a complex diagnostic system. The document focuses on material, design, and intended use comparison to an existing predicate device for dental implants and associated healing components.

Specifically, the following points from your request cannot be addressed from the given text:

• A table of acceptance criteria and the reported device performance: This document doesn't provide such data. The performance data section refers to sterilization, biocompatibility, and shelf-life validation, not performance metrics for an AI-enabled device.
• Sample sized used for the test set and the data provenance: Not applicable. No test set for an AI model is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There's no AI model or ground truth establishment process described.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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: The document explicitly states "No animal or human clinical studies were conducted."
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The document is primarily a regulatory submission demonstrating substantial equivalence based on material, construction, and intended use, rather than performance validation data of an AI-driven or complex diagnostic device.

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