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An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Patients must be subject for dental treatment with endosseous implants.

The Biomate Dental Implant System consists of Bone Type Implant Plus, Shaping Abutment and Healing Abutment. The Biomate Dental Implant System is made of commercial pure titanium (ASTM F67, Grade 4). Threaded dental implants are with Precision Dimension Laser (PDLTM) surface treatment, while Shaping Abutment and Healing Abutment are with TiN coated surface treatment. The device is designed for conventional two-stage and single stage procedures for single and multiple unit prosthetics. It is intended to replace missing teeth.

The provided text is a 510(k) premarket notification for a medical device (Biomate Dental Implant System). This type of document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing. It does not describe a study involving an AI algorithm or human reader performance. Therefore, I cannot provide information on acceptance criteria and studies related to AI performance from this document.

The document discusses traditional medical device validation through non-clinical performance tests, and states that "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

To answer your request, I would need a document describing a study for an AI-powered medical device.

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An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Patients must be subject for dental treatment with endosseous implants.

The BIOMATE Dental Implant System consists of threaded dental implants in 3.3, 4.1, 4.8, 5.5 mm diameters with 8, 10, 12, 14 mm lengths. The implants are made of commercial pure titanium and coated with the laser-modified Surface. BIOMATE Dental Implant System is comprised of Bone Type Implant, Solid Abutment, Simple Abutment, Angled Abutment, Temporary Abutment, Ball Abutment, Screw, Cover Screw, Healing Abutment. The system is designed for conventional two-stage and single stage procedures for single and multiple unit prosthetics. It is intended to be used to replace missing teeth.

This document is a 510(k) premarket notification for the Biomate Dental Implant System. It primarily demonstrates substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for an AI/ML device. Therefore, much of the requested information regarding AI/ML study design, such as sample sizes for test/training sets, expert qualifications, and adjudication methods, is not applicable or available in this document.

However, I can extract information related to the device's non-clinical performance and acceptance criteria as demonstrated through testing for regulatory approval.

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

The document states that "Design Verification activities were performed on Biomate Dental Implant System and all tests were verified to meet the required acceptance criteria." It then lists the standards followed for various non-clinical tests. While specific numerical acceptance criteria (e.g., minimum tensile strength of X N) and exact reported performance values are not detailed in this summary, the document explicitly states that the device met these criteria as per the standards.

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

The document does not specify exact sample sizes for each non-clinical test (e.g., number of implant samples for fatigue testing). It refers to the standards (e.g., ISO 14801, ISO 10993 series) which would typically dictate appropriate sample sizes for testing to achieve statistical significance or meet regulatory requirements.

The data provenance is for a device manufactured by Biomate Medical Devices Technology Co., Ltd. in Kaohsiung City, Taiwan. The tests are non-clinical bench tests, not clinical studies involving patient data. Therefore, "country of origin of the data" would refer to where the tests were performed (presumably conducted or overseen by Biomate or accredited labs on their behalf), and it is not retrospective or prospective clinical data.

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 as the document describes non-clinical bench testing for a physical medical device, not an AI/ML algorithm requiring expert ground truth for interpretation of medical images or other data. The "ground truth" for these tests are objective measurements against established engineering and biological standards.

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

This question is not applicable as the document describes non-clinical bench testing, which does not involve human adjudication for interpretative tasks. Test results are typically objective measurements against preset pass/fail criteria from the standards.

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 question is not applicable as no clinical studies are mentioned, and the device is a physical dental implant, not an AI/ML diagnostic or assistive tool.

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

This question is not applicable as the device is a physical dental implant, not an AI/ML algorithm.

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

For the non-clinical tests described:

• Biocompatibility: Ground truth is established by the specified biological effects or lack thereof, as defined by the ISO 10993 series, often involving cellular assays, animal studies, or chemical analyses.
• Sterilization: Ground truth is the demonstration of sterility to a defined sterility assurance level (SAL), measured through biological indicator inactivation and physical/chemical validation as per ISO 11137 and ISO 11737.
• Fatigue Testing: Ground truth is based on the material's ability to withstand a specified number of load cycles at a given force without mechanical failure, as defined by ISO 14801.
• General Device Performance: Ground truth is the objective measurement of mechanical properties, dimensional accuracy, and material composition against engineering specifications and the "Class II Special Controls Guidance Document."

8. The sample size for the training set

This question is not applicable as the document is about a physical dental implant and does not involve a training set for an AI/ML algorithm.

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

This question is not applicable for the same reason as above.

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