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TRINON Titanium QZA and RS Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacement to restore patient esthetics and chewing function.

TRINON Titanium QZA and RS Dental Implants are indicated for single or multiple unit restorations in non-splinted applications. This can be achieved by a 2-stage surgical technique in combination with delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

TRINON Titanium QZA Dental Implants with a diameter of 3.3 mm may only be used in the upper jaw as a single tooth replacement of the lateral incisors and in the lower jaw as a single tooth replacement of the lateral and central incisors.

TRINON QZA and RS abutments are used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients.

QZA abutment models with an angulation of 30° are indicated for multi-unit loading, such as bridges or overdentures.

TRINON Titanium QZA Dental Implants are made of titanium grade 5. These are two-stage implants. They have a hexagonal internal cone connection and a spiralock internal thread design. Furthermore, QZA Dental Implants have micro threads in cortical part.

TRINON Titanium QZA Dental Abutments are also called prosthetic implant abutments. The connection part of the abutment is color-coded for identification with the correct QZA Dental Implant. All abutments are delivered in unsterile conditions and have to be sterilized before use according the validated procedures in the IFU.

The RS Implants are made of titanium Grade 5. The RS Dental Implants are two-stage implants and are available in 4 diameters for ideal implant selection and four easily identifiable platforms for efficient prosthetic restoration (color-coding). All diameters are available in lengths of 8.5 mm, 10 mm, 11.5 mm, 14.5 mm and 16 mm.

The RS Dental Implants have a conical hexagonal interlock. The RS Dental Implants are selftapping high torque arrow-shaped implants with counterclockwise self-tapping function. RS Dental implants have micro threads in cortical part of the implant feature.

The RS Abutments are made of titanium Grade 5. These are usually called prosthetic implant abutments. The connection part of the abutment is color-coded for identification with the correct RS dental implant. All abutments are delivered in unsterile conditions and have to be sterilized before use according the validated procedure descripted in the IFU.

The provided text describes a 510(k) premarket notification for the TRINON Titanium QZA and RS Dental Implant Systems. This document aims to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, rather than proving its effectiveness through clinical trials with specific performance metrics.

Therefore, the acceptance criteria and study information, as commonly sought for AI/ML device performance, are not explicitly present in the provided text. The document focuses on demonstrating substantial equivalence through comparisons with predicate devices and performance bench testing rather than clinical study outcomes.

However, I can extract information related to the performance data presented (bench tests and biocompatibility).

Here's an interpretation based on the provided text, addressing the points where information is available or noting its absence:

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

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., success rates, complication rates) for a study proving effectiveness. Instead, it relies on demonstrating substantial equivalence to predicate devices and acceptable results from specific bench tests and biocompatibility studies.

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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 s-Clean OneQ-SL Narrow Implant System (3.0, 3.3mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

The implants may be restored immediately

1. with a temporary prosthesis that is not in functional occlusion,
2. when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
3. for denture stabilization using multiple implants in the anterior mandible and maxilla.

The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

The s-Clean OneQ-SL Narrow Implant System is used to replace missing teeth in various situations ranging from a single tooth loss to the complete loss of incisors teeth. This system is restricted to substitute the maxillary lateral incisors and mandibular incisors. It is one and two stage endosseous screw type implant with internal double hexagonal connection, intended for single use. The s-Clean OneQ-SL Narrow Implant System is a suitable treatment option when the possibility of placing a standard implants is limited due to physical conditions, where the horizontal space is limited by adjacent teeth and roots, or in situations with a narrow alveola ridge.

This system consists of the fixture, cover screw, various abutments and prostheses. Only the subject abutments can be used with the subject fixtures.

This document describes the regulatory submission for the s-Clean OneQ-SL Narrow Implant System by Dentis Co., Ltd. The document is primarily a 510(k) summary demonstrating substantial equivalence to predicate devices, rather than a standalone study documenting acceptance criteria and performance. Therefore, detailed information on acceptance criteria and specific study results proving the device meets those criteria, particularly for clinical outcomes, is limited.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with quantified performance targets and corresponding device performance for direct comparison in the way a clinical study report would. Instead, it relies on non-clinical testing against recognized standards to demonstrate equivalence.

The "acceptance criteria" are implied by adherence to these standards and the demonstration of "substantial equivalence" to predicate devices. The "reported device performance" is essentially that the device met the criteria of these standards and demonstrated substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of human clinical data. All reported tests are non-clinical (biocompatibility, fatigue, endotoxin, sterilization, shelf life, surface characterization).

For non-clinical tests, sample sizes would typically be determined by the specific standards (e.g., ISO 14801 for fatigue testing might specify a minimum number of samples). The document states the tests were performed "for predicate devices and leveraged for the subject device" or "for the subject device." No specific sample numbers for these non-clinical tests are provided.

The "data provenance" for non-clinical tests is from the manufacturer's own testing (Dentis Co., Ltd.) or testing supporting their predicate devices. There is no mention of country of origin for non-clinical test data, but the manufacturer is based in South Korea.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a non-clinical submission demonstrating substantial equivalence through engineering and material testing, not human clinical trials requiring expert ground truth establishment for a test set.

4. Adjudication Method for the Test Set

Not applicable for a non-clinical 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

Not applicable. This device is a dental implant system, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was performed or is relevant.

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

Not applicable. This is a physical medical device (dental implant system), not an algorithm or software. Its performance is evaluated through material and mechanical testing, not algorithm performance.

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

For the non-clinical tests, the "ground truth" is established by the specifications and pass/fail criteria defined in the referenced international standards (e.g., ISO 10993, ISO 14801, USP ), and by demonstrating material/design equivalence to legally marketed predicate devices. There is no biological "ground truth" from pathology or outcomes data generated by this submission directly for the subject device.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable. There is no "training set" for this device.

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The s-Clean Tapered II RBM Implant System is 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-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible based on four splinted Interforaminal placed implants.

The s-Clean Tapered II RBM Implant System is a dental implant made of titanium metal (Titanium grade 4) intended to be surgically placed in the bone of the upper or lower jaw arches. This implant system has internal hex connection, 1.5° tapered 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. The fixture has been treated with RBM (Resorbable Blasted media).

The s-Clean Tapered II RBM Implant System diameter and lengths are below:

• Diameter Ø 3.7 with lengths of 7mm, 8mm, 10mm, 12mm and 14 mm -
• Diameter 0 4.1 with lengths of 7mm, 8mm, 10mm, 12mm and 14 mm -
• Diameter Ø 4.3 with lengths of 7mm, 8mm, 10mm, 12mm and 14 mm -
• -Diameter Ø 4.8 with lengths of 7mm, 8mm, 10mm, 12mm and 14 mm

The packaging has composed of fixture with cover screw. The fixtures are supplied sterile by gamma sterilization. The fixtures are provided as set-packing with the cover screw. The purpose of this submission is to add new fixtures.

The provided text describes a 510(k) premarket notification for a dental implant system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive standalone studies and acceptance criteria for performance metrics.

Therefore, the information requested (acceptance criteria, specific study design for meeting these criteria, sample sizes, ground truth establishment, expert roles, MRMC studies, and standalone performance) is largely not applicable in the context of this 510(k) submission as it is presented.

Here's why and what information can be extracted:

• No specific acceptance criteria listed for device performance: The document does not define numerical performance targets (e.g., specific accuracy, sensitivity, specificity values) for the "s-Clean Tapered II RBM Implant System." Instead, it aims to demonstrate that its characteristics are "substantially equivalent" to predicate devices.
• No standalone study to "prove" device meets acceptance criteria: The submission relies on comparison to predicate devices and existing test data from those predicates.
• No sample sizes, data provenance, expert ground truth, adjudication, or MRMC studies for "device performance" in the AI sense: These concepts are typically relevant for AI/ML device submissions where classification, detection, or other diagnostic performance metrics are being evaluated. This document concerns a physical medical device (dental implant).

However, I can extract information related to the non-clinical testing that was performed to support substantial equivalence. While these are not performance metrics in the AI sense, they serve as the "proof" that the device is equivalent to its predicate.

Here's a summary of the relevant information from the document, tailored as much as possible to your request, but highlighting the differences in context:

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

As mentioned, there are no acceptance criteria for "performance" as one might expect for a diagnostic AI device. Instead, the "performance" demonstrated is substantial equivalence to predicate devices, supported by adherence to manufacturing standards and existing test data.

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 specified in terms of clinical subjects. The non-clinical tests (fatigue, sterilization, shelf-life) would have involved specific numbers of implant units or samples, but these are not disclosed in this summary. The submission references data from predicate devices, implying those predicate devices underwent testing.
• Data Provenance: Not explicitly stated as "country of origin for data." However, the device manufacturer (Dentis Co., Ltd.) is from South Korea. The predicate devices are also manufactured by Dentis Co., Ltd. The testing referenced aligns with FDA guidance documents, suggesting it would meet U.S. regulatory expectations. The type of data is non-clinical testing data rather than patient data (e.g., 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 (e.g. radiologist with 10 years of experience)

• Not Applicable: This pertains to clinical ground truth, often for diagnostic devices. For a physical implant, "ground truth" is established by manufacturing specifications, material properties, and engineering standards. There is no mention of human experts establishing "ground truth" in this context; instead, the evaluation is based on engineering tests and comparison to established, legally marketed devices.

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

• Not Applicable: This is relevant for subjective assessments, particularly in clinical or imaging studies where multiple readers' opinions need to be reconciled. For a physical device undergoing non-clinical engineering tests (like fatigue or sterilization), the "adjudication" is based on objective measurements against predetermined 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

• Not Applicable: MRMC studies are specific to evaluating diagnostic performance, especially for AI-assisted systems, and typically involve human readers interpreting cases. This submission is for a physical dental implant and does not involve AI or human interpretation of medical images/data.

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

• Not Applicable: This refers to the performance of an AI algorithm. This device is a physical dental implant.

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

• For Non-Clinical Testing: The "ground truth" for non-clinical tests like fatigue, sterilization, and shelf-life is defined by established engineering standards, material specifications, and regulatory guidance documents. For instance, a fatigue test determines if the implant can withstand a certain number of stress cycles without fracture, as dictated by standards like ASTM or ISO. The "truth" is the device's physical response measured against a quantitative standard, not expert consensus on a diagnosis.
• For Substantial Equivalence: The ultimate "ground truth" for this 510(k) submission is that the device is as safe and effective as a legally marketed predicate device. This is established through the detailed comparison of design, materials, indications for use, and existing testing data.

8. The sample size for the training set

• Not Applicable: This refers to training data for AI/ML algorithms. This submission is for a physical device and involves no "training set."

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

• Not Applicable: As above, no training set or AI involved.

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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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The HAPTITE Coating 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 and not dedicated for immediate loading. This system is intended for delayed loading.

This product is the operating, dental material as placed dental implant to inner part of maxillary to sustain, maintain prosthetic repair tooth or denture, mainbody (structure of subpart) is made by Titanium (Grade 4), is treated as blasting powder, and RBM at room temperature of CaP type to reduce Bone loss to bottom 1mm of the Machine Collar. Also, screw part of below 1 mm is treated as SHS (Super High Speed) RBM HA (Hydroxyapatite) Coating at room temperature. It is connected to structure of upper part as the type of the internal. HA Thin film coating achieved through the process in which the HA particles impact on the surface of implant with high speed. By passing carrier gas, which comes from nitrogen tank, through the hopper containing HA particles, the HA particle and carrier gas can flow to the vacuum chamber. The vacuum chamber maintaining low pressure thanks to the vacuum pump, enable to spray the HA particles with carrier gas out in high speed(more than 500m/sec) through spray nozzle. As HA particles impact on the surface of implant, it reduced to fragment and those fragment make up thin film coating layer. The implant diameters are 3.7, 4.1, 4.3, 4.8, 5.5, 6.0, 6.5, and 7.0 mm and the implant lengths are 7, 8, 9, 10, 12, 14, and 16mm in this system. The system consists of 2 fixture systems, i-clean fixture and s-clean fixture, and 2 abutment systems i-clean and s-clean abutment. The i-clean abutment system is composed of healing cap, various abutments (solid, excellent solid, octa, synocta, inocta, temporary, healing, o-ring and free), screws (cover screw, closing screw, abutment screw, cvlinder screw), gold UCLA, gold cylinder. The s-clean abutment system is composed of healing cap, various abutments (sole, couple, hex, temporary, o-ring, free, octa, zero margin, freemill, and MOA), and gold cylinder, and various screws (abutment, cylinder). i-Clean Fixture is Non-submerged type, once surgery and safe structure as having 8° from center of connection part. s-Clean Fixture is Submerged type, twice surgery and safe structure as having 11° from center of connection part. The abutment lengths are 7, 8, 9, 10, 11, 12mm, and cuff lengths 0.5, 1, 1.5, 2, 2.5, 3, 3.5. 4. 4.5. 5.5. 7mm. The i-Clean fixture is available with either tapered, straight, or SAVE body designs. The i-Clean tapered fixture is available in diameters of 3.7, 4.1, 4.3, and 4.7mm and each diameter is available in lengths of 8, 10, 12, or 14mm. The i-Clean straight fixture is available in diameters of 4.05, 4.25, and 4.75mm and each diameter is available in lengths of 8, 10, 12, 14, and 16mm. The i-Clean SAVE fixture is available in diameters of 5.5, 6.0, 6.5, and 7.0mm and each diameter is available in lengths of 7, 8, 9, 10, and 12mm. The i-Clean Tapered II design contains a thread design with differs from the i-Clean Tapered fixture design. The i-Clean Tapered II has no 'micro thread' design. The s-Clean fixture is available with either tapered, straight, or SAVE body designs. The s-Clean tapered fixture is available in diameters of 3.7, 4.1, 4.3, and 4.8mm and each diameter is available in lengths of 8, 10, 12, or 14mm. The s-Clean straight fixture is available in diameters of 4.1, 4.3, and 4.75mm and each diameter is available in lengths of 8, 10, 12, 14, and 16mm. The s-Clean SAVE fixture is available in diameters of 5.5. 6.0. 6.5. and 7.0mm and each diameter is available in lengths of 7, 8, 9, 10, and 12mm. The s-Clean Tapered II design contains a thread design with differs from the s-Clean Tapered fixture design. The s-Clean Tapered II has no 'micro thread' design.

Here's an analysis of the provided text regarding the acceptance criteria and study for the HAPTITE Coating Implant System, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than setting novel acceptance criteria for a new device type. Therefore, direct "acceptance criteria" for performance are not explicitly stated as they would be for a truly novel device. Instead, the document compares the subject device's performance against the established performance of its predicate devices to demonstrate equivalence. The "acceptance criteria" are implied to be achieving performance comparable to or exceeding the predicate devices in the listed tests.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size:
  • The document does not explicitly state the sample sizes used for each test (e.g., how many implants were tested for shear strength, how many pig bones were used, etc.). This information is typically found in the full test reports, not always in the 510(k) summary.
• Data Provenance:
  • The tests were described as "Non-clinical Testing data" and performed by Dentis Co., Ltd. (the manufacturer).
  • Country of Origin: South Korea (where Dentis Co., Ltd. is located).
  • Retrospective or Prospective: These are laboratory tests and animal models, which are inherently prospective in their design to evaluate specific device properties.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• This information is not applicable to the type of non-clinical, laboratory, and animal model testing described. These tests rely on standardized methods (e.g., ASTM standards) and direct measurements, not expert consensus for "ground truth" in the way clinical studies or diagnostic AI algorithms do. Therefore, no experts were used to establish ground truth in this context.

4. Adjudication Method for the Test Set

• Not applicable. As these are objective, non-clinical tests (e.g., measuring shear strength, evaluating coating uniformity), there is no "adjudication" in the sense of reconciling differing expert opinions. The results are quantitative measurements or direct observations against a standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. The device in question is an endosseous dental implant, which is a physical medical device, not a diagnostic imaging AI algorithm that would typically be evaluated with MRMC studies or human-in-the-loop performance studies. The evaluation focuses on the physical and material properties of the implant itself.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. As stated above, this is a physical medical device, not an algorithm. Therefore, "standalone" performance for an algorithm is not relevant here.

7. Type of Ground Truth Used

• The "ground truth" for the non-clinical tests was based on objective measurements, adherence to ASTM standards, and direct observation of physical and material properties. For example:
  • Shear and tensile strength: Measured values against established ASTM standards (ASTM F1147, 1044).
  • Coating stability: Evaluation of the coating layer after an in-vivo graft test in pig bone.
  • Surface characteristics: Objective measurements and analyses of roughness, crystallinity, porosity, etc.

8. Sample Size for the Training Set

• Not applicable. Again, this is a physical medical device, not an AI algorithm 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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