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MU System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

MU Ti Cylinder is manufactured by titanium alloy conforming to ASTM F136 and is used with s-Clean MU Angled Abutment and s-Clean MU Straight Abutment to provide support for multiple unit prosthetic restoration such as bridges, or overdentures. The subject abutments are indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations and supplied non-sterile.

s-Clean MU Healing Cap is manufactured by titanium alloy conforming to ASTM F136 and used with our cleared device, K210134 such as s-Clean MU Angled Abutment and s-Clean MU Straight Abutment and used for protecting inner hole of fixture and adjusting the appropriate height during the healing period.

This document, K222976, is a 510(k) premarket notification for the "MU System," an endosseous dental implant abutment. The review provided focuses on establishing substantial equivalence to predicate devices, rather than detailing a study that proves the device meets specific acceptance criteria in the context of diagnostic or treatment efficacy.

This submission is for a dental implant abutment, which is a physical component, not a device that makes diagnostic or treatment decisions based on data. Therefore, the questions related to clinical performance, such as diagnostic accuracy, human reader improvement, and ground truth establishment, are not applicable in the typical sense for this type of device.

Instead, acceptance criteria for this device are related to its physical properties, biocompatibility, and mechanical performance, which are assessed through non-clinical testing and comparison to predicate devices. The "study" here refers to the non-clinical testing performed to demonstrate that the device is safe and effective and performs as intended.

Here's an attempt to answer your questions based on the provided text, reinterpreting where necessary due to the nature of the device:

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

The document doesn't explicitly list "acceptance criteria" in a numerical format that would be typical for a diagnostic algorithm. Instead, the acceptance criteria for a dental implant abutment are implicitly met by demonstrating:

• Substantial equivalence to predicate devices regarding design, material, sterile method, and indications for use.
• Compliance with relevant international and FDA standards for non-clinical testing (biocompatibility, fatigue, sterilization).

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

This device is a physical component, not a data-driven diagnostic or AI system. Therefore, there isn't a "test set" in the context of images or patient data. The "testing" involves physical and material tests.

• Sample Size for Physical Tests: Not explicitly stated in terms of number of units for each test (e.g., number of abutments fatigued). Regulatory documents often refer to "representative test articles" without specifying the exact quantity for each test.
• Data Provenance: The "data" comes from non-clinical laboratory testing performed to international and US standards (ISO, ASTM, ANSI/AAMI, FDA guidance). It is not patient or clinical data. The manufacturer is Dentis Co., Ltd. in Korea.

3. 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. Ground truth, in the context of clinical expert consensus, is not relevant for the physical testing of an implant abutment. The "ground truth" here is established by the validated methods of material science, mechanical engineering, and biocompatibility testing standards.

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

Not applicable. This is not a study involving expert adjudication of clinical findings.

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

Not applicable. This is a dental implant abutment, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for this medical device approval is based on:

• Material Standards: Adherence to ASTM F136 for Ti-6Al-4V ELI.
• Biocompatibility Standards: Compliance with ISO 10993 series.
• Sterilization Standards: Compliance with ISO 17665 series and ANSI/AAMI ST79.
• Mechanical Testing Standards: Compliance with ISO 14801 for fatigue.
• MRI Safety Considerations: Compliance with FDA guidance on MR environment testing.
• Substantial Equivalence: Demonstrated comparison to already legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. See point 8.

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