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Aria Bio's Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The Aria Bio Dental Implant System consists of two stage endosseous form dental implants, hexagonal and conical implants and hexagonal and conical abutments; cover screws and healing caps; abutment systems and superstructures and surgical instruments.

The provided document describes a 510(k) premarket notification for Aria Bio's Dental Implant System, asserting its substantial equivalence to predicate devices. The document does not describe acceptance criteria for particular performance metrics nor does it present detailed study results proving a device meets specific acceptance criteria in the format requested.

Instead, the document focuses on demonstrating substantial equivalence through:

• Comparison of indications for use and technological characteristics with predicate devices.
• Reporting that a series of performance tests (fatigue, surface analysis, biocompatibility, sterilization, shelf life) were performed and that "All results are supporting Aria Bio's labeling claims in order to establish substantial equivalency." However, it does not provide the specific acceptance criteria for these tests, nor the detailed results.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details regarding sample sizes for training/test sets, ground truth establishment, or specific study types like MRMC, as this information is not present in the provided text.

The document states:

• "A series of performance tests and evaluations were performed to demonstrate that Aria Bio's Dental Implant System does not raise any new issues that may affect its substantial equivalency with its predicate devices. These evaluations include fatigue (ISO 14801), surface analysis by SEM/EDS and XPS, biocompatibility in accordance with ISO 10993-1, sterilization validation (ISO 11137-2, AAMI TIR 33, ISO 17665-1) and shelf life validation (ISO 11607-1) in order to assure maintaining of SAL 10° along the shelf life."
• "All results are supporting Aria Bio's labeling claims in order to establish substantial equivalency."

This indicates that these tests were conducted, and their outcomes were deemed acceptable based on established industry standards (e.g., ISO 14801 for fatigue testing, ISO 10993-1 for biocompatibility). However, the specific quantitative acceptance criteria or the actual performance results (e.g., specific fatigue limits, exact sterilization validation parameters, detailed surface analysis findings) are not provided in the document beyond stating that they were performed and supported substantial equivalence.

Without these specific details, I cannot construct the requested table or answer most of the specific questions about the study design and results.

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Dental implant systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient's chewing function. Dental implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.

The proposed devices, Dental Implant Systems, are integrated systems of endosseous dental implants, which are intended to support prosthetic devices.

The systems are mainly available in two models which are Tissue Level (TL) and Bone Level (BL), each model consists of the following components: (1) Dental Implants, (2) Abutments, (3) Occlusal Screws and (4) Healing Caps. Each component is available in various configuration. In addition, the systems also consist of various specific surgical instruments.

Abutment models for TL dental implants include: Coping, Solid abutment, Retentive anchor abutment, Screw-retained abutment, Cementable abutment, Angled abutment.

Abutment models for BL dental implants include: Healing Abutment, Anatomic abutment, Meso abutment, Cementable abutment, Multi-base abutment.

The provided text is a 510(k) premarket notification for a Medical Device, specifically a "Dental Implant System." This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a study of device performance against pre-defined acceptance criteria in the context of clinical or AI-based performance metrics.

Therefore, the document does not contain the information requested for acceptance criteria and a study that proves the device meets those criteria, especially in relation to AI/algorithm performance. It is a regulatory submission demonstrating mechanical, material, and safety equivalence.

Here's a breakdown of why the requested information cannot be extracted from this document:

• No AI/Algorithm Component: There is no mention of any AI, machine learning, or algorithm being part of this "Dental Implant System." The device is a physical dental implant.
• Focus on Substantial Equivalence: The entire document is geared towards proving that the proposed device is "substantially equivalent" to a legally marketed predicate device (STRAUMANN DENTAL IMPLANT SYSTEM). This is a regulatory pathway, not a clinical trial to demonstrate new performance metrics against acceptance criteria for a novel AI.
• No Clinical Study: Section 7 explicitly states: "No clinical study is included in this submission." This means there is no data from human subjects or a clinical setting to evaluate performance.
• Non-Clinical Test Conclusion: Section 6 details non-clinical tests. These tests are primarily for material properties, sterility, biocompatibility, and mechanical durability (e.g., dynamic fatigue test). These are engineering and material science tests, not performance studies for a diagnostic or AI-driven medical device.

Therefore, it is impossible to complete the requested table or answer the specific questions about acceptance criteria, ground truth, expert adjudication, or MRMC studies, as these concepts are not applicable to the content of this 510(k) submission for a physical dental implant.

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Ask a specific question about this device