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Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid to prosthetic rehabilitation.

Inclusive® Titanium Abutments for Hiossen HG Implant System are made of Titanium Alloy (Ti-6Al-4V) and are premanufactured prosthetic components connected directly to the endosseous dental implant and intended as an aid in prosthetic rehabilitation. They are compatible with Hiossen HG Implant System (Mini and Standard). The anti-rotational feature for Inclusive® Titanium Abutment is a hexagon. The numerical value which defines the across flats of the hexagon is 2.10 mm for the Mini, and 2.50 mm for Standard. Both have a tolerance range of ±0.05 mm.

This is a 510(k) summary for a dental device, not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, ground truth establishment, expert adjudication, and MRMC studies, are not applicable to this document.

However, I can extract the acceptance criteria and the study that proves the device meets those criteria based on this document.

Here's the information regarding the non-clinical testing and acceptance criteria for the Inclusive® Titanium Abutments compatible with Hiossen HG Implant System:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets and then "reported device performance." Instead, it states that non-clinical testing was performed based on FDA Guidance and relevant ISO/ASTM standards to demonstrate "implant to abutment compatibility" and "substantial equivalence" to predicate devices. The "reported device performance" is a general statement that the testing results and evaluations demonstrate this compatibility.

However, we can infer the acceptance criteria from the mentioned tests and standards:

Study Details (Not applicable for AI/ML, but details for this medical device are provided):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document does not specify the exact sample sizes (e.g., number of abutments tested) for the fatigue and static load failure tests. It refers to "finished assembled implant/abutment systems." The data provenance is not explicitly mentioned, but it would be from internal testing conducted by Prismatik Dentalcraft, Inc. (Irvine, CA, USA). These are non-clinical bench tests (prospective under controlled lab conditions).

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):
   Not applicable, as this is a physical medical device and its performance is evaluated through engineering bench tests, not expert interpretation of data.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. Device performance is determined by meeting engineering specifications and test outcomes, not by expert adjudication.

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:
   Not applicable, as this is a physical medical device, not an AI/ML system.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable, as this is a physical medical device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The "ground truth" for this device's performance is based on established engineering principles, material science, and performance standards as outlined in ASTM F136-12a, ISO14801:2007, and the FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." For biocompatibility, it's based on prior successful predicate devices with identical materials and processes.

7. The sample size for the training set:
   Not applicable, as this is a physical medical device, not an AI/ML system.

8. How the ground truth for the training set was established:
   Not applicable, as this is a physical medical device.

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