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SimpleLine II is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetics devices, such as artificial teeth, and to restore the patient's chewing function. SimpleLine II is for single stage surgery

The SimpleLine II is a dental fixture made of pure titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.

This document describes a 510(k) submission for the SimpleLine II endosseous dental implant, seeking clearance based on substantial equivalence to a predicate device. The information provided focuses on the physical characteristics and performance testing of the device, rather than a clinical study evaluating an AI algorithm's performance. Therefore, many of the requested categories related to AI study design, ground truth, and expert evaluation are not applicable to this document.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Device Performance (Dental Implant)

Explanation: The acceptance criteria for this dental implant are based on a direct comparison to a legally marketed predicate device (Implantium II) for fatigue characteristics and general design parameters. The primary performance test is a fatigue test.

Study Details (Based on the Provided Text)

Given the nature of the document (510(k) summary for a physical medical device, not an AI algorithm), the following information is either not applicable or can only be inferred in the context of device testing (not a clinical or AI study).

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

   • Sample Size: Not explicitly stated for the fatigue test. It is implied that at least one specimen was tested, as it refers to "specimen" in the singular ("Tilting angles of specimen is 30"). However, standard engineering tests typically involve multiple samples to ensure statistical validity. The exact number of implants tested isn't provided.
   • Data Provenance: The device company, Dentium Co., Ltd., is located in Suwon-si, Gyeonggi-do, Korea. The testing was presumably conducted there or at a contracted facility. The fatigue testing is prospective, as it's a test performed on the device itself.

2. 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)

   • N/A. This is not an AI or diagnostic study requiring expert ground truth for interpretation of images or patient outcomes. The "ground truth" for a fatigue test is the physical outcome of the test (fracture, deformation, cycles to failure).

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

   • N/A. Adjudication methods are typically used in clinical trials or diagnostic studies involving human interpretation or uncertain outcomes. The fatigue test results are objective mechanical measurements.

4. 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. This is not a study involving human readers or AI assistance.

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

   • N/A. This is a physical device undergoing mechanical testing, not an algorithm.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   • Mechanical Test Results: The "ground truth" is the objective physical state of the implant after the fatigue test: whether fracture, cracks, or severe distortion occurred, and the applied load at which it was still intact. This is based on direct observation and measurement, not expert consensus or pathology in a medical sense.

7. The sample size for the training set

   • N/A. This is not an AI algorithm, so there is no training set.

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

   • N/A. This is not an AI algorithm, so there is no training set ground truth.

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