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The Guided Bone Regeneration (GBR) System is used to stabilize and fix bone filling materials and/or barrier membranes used for bone regeneration in the oral cavity.

The Guided Bone Regeneration (GBR) System is used to stabilize and fix bone filling materials and/or barrier membranes used for bone regeneration in the oral cavity.
MATERIALS: Only materials approved for medical purposes are used in the manufacture of products: Pure Titanium Grade 4 according to standard ISO 5832-2 and ASTM F67-13.

I am sorry, but the provided text is a 510(k) K233419 FDA clearance letter and related summary for a dental device called "GBR System". This document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through non-clinical testing and comparison of technological characteristics.

It does not contain information about acceptance criteria for a study proving device performance, nor details about a study that would meet such criteria. Therefore, I cannot extract the requested information from this document.

The document discusses:

• Non-clinical tests: Biocompatibility, Insertion Torque, Fracture Torque, Pull-out tests, sterilization validation, and MRI compatibility. These are primarily engineering and material characterization tests, not clinical studies with acceptance criteria for device performance in patients.
• Comparison to predicate devices: This is done to establish substantial equivalence, not to prove that the device meets specific performance acceptance criteria from a clinical study.

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The Orthodontic Screw is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only. The orthodontic screw is intended in patients aged 12 years and older.

The Mini Screws system has been designed to provide a firm anchorage point in the oral cavity for orthodontic treatment. Mini screws are manufactured with CP Ti Gr 4 and are SLA treated. The Mini Screw system is designed to be applied with different orthodontic solutions and is versatile enough to satisfy different clinical cases. Titanium orthodontic mini screws are intended to provide fixed anchorage for orthodontic treatment used by implanting in the maxillary and mandibular bone. These mini screws used for anchoring purposes can be divided into 3 parts as head, neck and body.

The provided text is an FDA 510(k) clearance letter and summary for a medical device called "Proimtech Mini Screw". This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets strict performance acceptance criteria through the kind of study typically associated with AI/ML software.

Therefore, the information required to answer the prompt regarding acceptance criteria and a study proving a device meets these criteria (especially sections related to AI/ML software performance like sample size, experts, MRMC, standalone performance, and ground truth establishment) is not present in the provided document.

The document discusses the physical characteristics, materials, and intended use of a dental mini-screw, and compares it to similar existing devices to show it is substantially equivalent, thus not requiring a new PMA (Premarket Approval Application). It does not involve an AI/ML component or a study with performance metrics in the way the prompt implies.

Here's how to interpret the available information in the context of the prompt:

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

• Acceptance Criteria (Implicit for Substantial Equivalence): The implicit acceptance criterion for a 510(k) clearance is that the new device is substantially equivalent to a legally marketed predicate device. This means it has the same intended use, and the same technological characteristics, or if it has different technological characteristics, these differences do not raise new questions of safety and effectiveness.
• Reported Device Performance: The document states: "However, testing data such as mechanical testing provided in the submission show that these differences do not raise issues in performance." This very generally indicates that the device met certain mechanical performance benchmarks, but no specific quantitative acceptance criteria or results are provided in the public summary.
  • The document also mentions: "The biocompatibility of our finished products has been carried out in accordance with EN 10993-1 Standard." and "Tests for the mechanical strength of our products have been carried out in accordance with TS EN ISO 19023 and ASTM F543 Standard." This indicates the types of tests performed for this physical device, but not the specific criteria or results.

2. Sample size used for the test set and the data provenance:

• Not applicable (N/A) / Not provided. The summary mentions "testing data" but does not detail sample sizes, data provenance (e.g., country of origin, retrospective/prospective), as it's a physical device, not an AI/ML software tested on a dataset of images/cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• N/A / Not provided. This is relevant for AI/ML software that requires expert annotation for ground truth. For a physical medical device like a mini-screw, ground truth is established through material standards, mechanical testing protocols, and biocompatibility assessments, not human expert interpretation of data.

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

• N/A / Not provided. This concept applies to human reader studies or data annotation for AI/ML, not a physical device's mechanical or material testing.

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:

• N/A / Not provided. This is specific to AI/ML software. The device is a surgical implant.

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

• N/A / Not provided. This is specific to AI/ML software.

7. The type of ground truth used:

• For a physical device, "ground truth" would be established through engineering standards, material specifications (e.g., ISO 5832-2, ASTM F67-13 for material composition), mechanical testing protocols (e.g., TS EN ISO 19023, ASTM F543 for mechanical strength), and biocompatibility assessments (e.g., EN 10993-1). The document indicates these standards were followed.

8. The sample size for the training set:

• N/A / Not provided. There is no "training set" in the context of a physical device. This refers to AI/ML model development.

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

• N/A / Not provided. As above, no training set for a physical device.

In summary, the provided document details the regulatory clearance of a physical medical device (dental mini-screw) based on substantial equivalence, and therefore does not contain the information typically associated with acceptance criteria and studies for AI/ML software performance.

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Indications for use Bilimplant® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

Bilimplant Abutments and Prosthetic parts are intended for use with Implants in the maxillary and / or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

The Bilimplant® dental implants and abutments, which are models within the Proimtech Implant and Abutment system, are intended for oral implantation to provide a support structure for connected prosthetic devices.

Bone Level Implant: Thanks to its design features, it is placed completely at the bone level. It is produced to be applied in different bone types and different regions (anterior and posterior) in the lower and upper jaw. Since it is at the bone level, it can be used for more aesthetic results, especially in the front areas of the jaws (in the areas on the smile line).

Tissue Level Implant: The Tissue Level Implant has a 2.3 mm machined collar. It can be used in posterior applications in the upper and lower jaw where there are no aesthetic concerns, in different bone types and especially in cases with high gingival amount in order to facilitate prosthetic stages.

Straight Abutments: It is the superstructure part that supports fixed partial dentures manufacture on a straight implant. It is used in single member or bridge cemented restorations. Cement retained abutments have a different gingival height of 1-5 mm, diameters of 3.5, 4.5, 6 mm depending on the platform diameters.

Healing Caps: Following the second surgery of the gingiva in two-stage surgical procedures, and after the placement of the implant in single-stage surgeries, it is screwed into the implant body and protects the internal structure of the implant. It is not used to support a prosthetic superstructure. It is used for transgingival healing and shaping of soft tissue during the healing process of soft tissue. There are two different designs for healing caps in dental implant systems. These are manufactured to be compatible with tissue level and bone level implants.

Abutment Screws: Connects and fixes the abutment and implant body.

This is a 510(k) premarket notification for a medical device family consisting of Proimtech Dental Body Implants, Abutments, Healing Caps, and Abutment Screws. The provided document is an FDA clearance letter and a 510(k) Summary, which details the device's characteristics and its substantial equivalence to previously cleared devices.

The document does not describe a study proving the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity, as it is a medical device clearance for physical devices, not a diagnostic or AI-powered device.

Therefore, I cannot provide information on acceptance criteria and a study proving the device meets them in the context of diagnostic performance. The studies mentioned are related to material properties, sterilization, biocompatibility, and packaging, which are standard for dental implants.

However, I can extract the information provided regarding the testing and characterization of the device components, which serve as evidence for their safety and effectiveness in achieving substantial equivalence.

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

Since this is a physical medical device (dental implants and associated components) and not an AI/diagnostic device, the concept of "acceptance criteria" and "reported device performance" typically refers to engineering performance (e.g., strength, durability, biocompatibility) rather than diagnostic metrics. The document describes several tests conducted to ensure the device's fundamental characteristics are met:

2. Sample size used for the test set and the data provenance

The document does not specify sample sizes for these tests (e.g., how many implants were tested for sterilization or biocompatibility). This level of detail is typically found in the full test reports, not the 510(k) summary.

• Data provenance: The testing was conducted as part of the regulatory submission process for a manufacturer in Turkey (Proimtech Saglik Urunleri Anonim Sirketi, Istanbul, Turkey). The studies are non-clinical (laboratory-based) as explicitly stated: "No clinical data were included in this submission." The testing would be considered prospective in the sense that it was performed specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to the type of device and studies described. "Ground truth" and "experts" in this context typically refer to diagnostic interpretation in AI or clinical studies. For physical device testing (material, sterilization, biocompatibility), the "ground truth" is established by adherence to international standards (e.g., ISO, ASTM, USP) and the results are interpreted by qualified laboratory personnel, not by a panel of medical experts establishing a "ground truth" for a diagnosis.

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

This is not applicable for non-clinical, laboratory-based testing of physical medical device properties. Adjudication methods are typically used in clinical trials or diagnostic performance studies to resolve discrepancies in expert opinions or outcomes.

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

This is not applicable. MRMC studies are used to evaluate the interpretive performance of readers (e.g., radiologists) with and without assistance from an AI device for diagnostic tasks. The Proimtech Dental Body Implant system is a physical dental implant and prosthetic components, not a diagnostic AI system.

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

This is not applicable. The device is a physical medical implant, not an algorithm or AI.

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

As explained in point 3, the concept of "ground truth" in the context of diagnostic devices is not applicable here. For the non-clinical tests conducted, the "ground truth" is defined by the objective measurement criteria and specifications outlined in the referenced international standards (e.g., ISO 11137 for sterilization, ISO 10993 for biocompatibility) and scientific analytical methods (e.g., SEM/EDS for surface characterization). Compliance with these standards is the "ground truth" for the device's physical and biological properties.

8. The sample size for the training set

This is not applicable. This device is a physical medical implant, not an AI or machine learning model that requires a training set.

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

This is not applicable, as there is no training set for a machine learning model.

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