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The OneQ-SL s-Clean Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

The OneQ-SL s-Clean Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. This implant system has internal hex connection, tapered with straight body, bone level and submerged type that are similar to other commercial available products based on the intended use, technology used, the claims, the material composition employed and performance characteristics. This implant system is supplied sterile. The OneQ-SL s-Clean Implant system is substantially equivalent in connection structure, similar design, function and intended use to the predicate device, OneQ-SL s-Clean Implant System (K153639). This subject device is compatible with the abutments of K073486, K082843, K111364 and K150344. The fixture is made of Ti-6A1-4V ELI and Pure Titanium Grade 4. The Cover screw was cleared in K073486. The surface is treated by Sand -blasting (Large grit) and acid etching method (SLA). This system only contains the implant bodies with cover screw and are provided as set-packing. The purpose of this submission is to add new fixtures.

This appears to be a 510(k) premarket notification for a medical device, specifically an endosseous dental implant system. The document states that the device, "OneQ-SL s-Clean Implant System," is substantially equivalent to legally marketed predicate devices, and therefore no new clinical studies are presented within this document to prove acceptance criteria through device performance.

The document does not describe acceptance criteria for a new device's performance through a clinical or non-clinical study directly comparing it to defined metrics. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices based on technological features, materials, and existing non-clinical test data.

Therefore, many of the requested elements about acceptance criteria and device performance based on a new study (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment for a new training set) are not applicable or available in this kind of regulatory submission. The "acceptance criteria" here is primarily about meeting the requirements for substantial equivalence to a predicate device.

Let's break down what can be extracted and what cannot:

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

This document doesn't provide a table of acceptance criteria and reported device performance for the new device that would typically come from a specific study designed to show such performance. Instead, it leverages test results from predicate devices and applies them to the current device to demonstrate substantial equivalence.

The acceptance criteria here would implicitly be that the subject device's performance in mechanical properties, sterilization, biocompatibility, and shelf life is equivalent to or better than the predicate devices, as demonstrated by meeting established standards.

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

• Sample Size: Not explicitly stated for each test (e.g., number of implants tested for fatigue). The document indicates that "Below tests were performed for predicate devices and leveraged for the subject device."
• Data Provenance: The tests were performed for predicate devices (K153639, K161244, K150344). No information regarding the country of origin of the data is provided, nor whether it was retrospective or prospective. It is non-clinical lab testing data.

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

This is not applicable as the document relies on non-clinical testing against recognized standards (ISO, ASTM, USP) for demonstrating substantial equivalence, not expert ground truth for a clinical dataset.

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

This is not applicable as there is no clinical test set requiring adjudication in this submission.

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. This is a submission for an endosseous dental implant, which is a physical medical device, not an AI-assisted diagnostic tool.

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

This is not applicable. This refers to AI/algorithm performance, which is not relevant for this device.

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

For the non-clinical tests, the "ground truth" or reference for acceptance is the specified performance criteria within the referenced international standards (ISO, ASTM, USP) which determine if the device (or its predicate) performed adequately.

8. The sample size for the training set:

This is not applicable as this is not a submission for an AI/machine learning device that would require 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 an AI/machine learning device.

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The OneQ-SL s-Clean Implant System is in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

The OneO-SL s-Clean Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. This implant system has internal hex connection, tapered with straight body, bone level and submerged type that are similar to other commercial available products based on the intended use, technology used, the claims, the material composition employed and performance characteristics. This implant system is supplied by gamma sterilized that is same with almost all dental implant. The OneQ-SL s-Clean Implant system is substantially equivalent in connection structure, similar design, function and intended use to the Dentis dental implant system (K073486) of DENTIS Co., Ltd., and Dentis dental implant system(K150344) of DENTIS Co., Ltd. The difference between the subject and the predicate device are slightly different shape and surface treatment. This subject device is compatible with the abutments of K073486, K082843, K111364 and K150344.

This document describes the OneQ-SL s-Clean Implant System, an endosseous dental implant. The purpose of the submission is to demonstrate its substantial equivalence to predicate devices, thus no clinical testing was performed.

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

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

Since this is a 510(k) submission demonstrating substantial equivalence rather than a clinical trial with specific performance metrics defined by acceptance criteria for a novel device, the concept of "acceptance criteria" and "reported device performance" are framed differently. The acceptance criteria here are adherence to relevant standards and demonstration of equivalence to legally marketed predicate devices. The "reported device performance" is the successful completion of non-clinical tests meeting these standards and showing similarity to predicates.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. The "test set" here refers to the non-clinical tests performed on the device itself and its components. These tests typically involve a specific number of samples required by the particular testing standard (e.g., a certain number of parts for fatigue testing). The document does not specify these exact numbers for each test but indicates tests were "performed to evaluate its substantial equivalence."
• Data Provenance: The document does not explicitly state the country of origin for the non-clinical test data. However, the manufacturer is Dentis Co., Ltd. located in Daegu, South Korea. It's highly probable the non-clinical testing was conducted there or arranged by them, adhering to international standards. The tests were prospective in the sense that they were performed specifically to support this regulatory submission, but they are non-clinical tests on the device materials and design, not human subject data.

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. This is a 510(k) submission for a physical medical device (dental implant), not an AI algorithm or diagnostic tool that requires expert human interpretation to establish ground truth for a test set. The "ground truth" for this device's performance is established by its adherence to engineering and material strength standards and biocompatibility tests.

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

Not applicable. This type of adjudication method (common in clinical trials or AI studies with expert review) is not relevant for the non-clinical, bench-top integrity and performance tests described for this dental implant.

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 not an AI-assisted diagnostic or treatment planning tool. It is a dental implant (physical device). No MRMC studies were conducted.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the non-clinical tests, the "ground truth" is defined by the established international and ASTM standards (e.g., ISO 10993 series for biocompatibility, ISO 11137-1 for sterilization, ISO 11607-1/-2 and ASTM F1980-07 for shelf life, and the FDA's Class II special controls guidance for fatigue testing). The device's performance is compared against the pass/fail criteria specified within these standards.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable. As noted above, this involves no AI model or training set.

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