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Indications for Use for Eco Abutment

The Eco Abutment is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation.

Indications for Use for Multiunit Abutment

The Multiunit Abutment is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation.

The Eco Abutment is a two-piece abutment. It consists of a base abutment which is used with temporary post, cemented post, angled post and healing cap. The base abutment is first secured to the dental implant with a base screw and the post is secured to the base abutment with post screw. The Eco Abutment has 4.5, 4.8, 5.5 and 6.5 of diameter and consists of 0, 6, 12 and 18 degree.

The Multiunit Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of single unit loading (i.e., crown) or multi-unit loaded restorations (i.e., bridge, bars, overdentures). It is consists of Multiunit Straight Abutment, Multiunit Angled Abutment and Temporary Cylinder. The Multiunit Abutment has 4.8mm of diameter and consists of two kind of design that has three angles. The Multiunit Straight abutment has 0 degree and the Multiunit Angled abutment has 20 or 30 degree

The Eco Abutment and Multiunit Abutment are made from titanium alloy conforming to ASTM F136. It is provided non-sterile and is steam sterilized before use.

Non-Hex connection abutments are intended for multi-unit restorations only.

The provided text is a 510(k) summary for dental implant abutments, focusing on regulatory approval based on substantial equivalence to predicate devices. It does not contain information about a clinical study with acceptance criteria for device performance relevant to AI/ML devices or studies involving human readers.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size for the test set or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, effect size, or improvement with AI assistance.
• Standalone performance (algorithm only).
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on non-clinical testing (sterilization validation, biocompatibility, mechanical properties, MR environment condition) to demonstrate substantial equivalence to existing predicate devices, which is a common pathway for medical device clearances that do not involve AI/ML components or comparative effectiveness studies with human readers. The document explicitly states "No clinical studies are submitted."

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DIOnavi-Denture02 is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with DIOnavi-Denture02 requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on a digital impression, a digital light processing (DLP) printer, and curing light equipment.

DIOnavi-Denture02 is a photo-cured resin intended to fabricate full and partial removable dentures in a CAD/CAM additive printing process. The material is an alternative to traditional heat cured and auto polymerization resins. It is denture base resins, Photo-cured product family comprises a family of dimethacrylate resins. The dimethacrylate resin is polymerized via photo initiators in a 3D printer. The color of the denture is determined by the addition of pigments. The material is used in a 3D printer, which prints the shape determined by a 3D drawing. After printed product is placed in a UVlight curing box for final polymerization. 3D printer and UV-light curing box is not included with the device.

The denture fabrication process begins with a traditional impression or optical impression of the oral region in the dentist office. This impression is sent to a dental lab. The denture base is then made layer-bylayer in a DLP (digital light processing) printer. After attachment of preformed plastic teeth, the denture is cured in a light chamber, and, lastly, sent back to the dentist for try-in and final adjustment.

The provided text is related to a 510(k) submission for a dental device (DIOnavi-Denture02), which is a light-curable resin for fabricating and repairing dentures. The document details the regulatory review process and the basis for the FDA's substantial equivalence determination.

However, the provided text does not describe a study that uses AI/ML or performs human reader improvement studies (MRMC study) or standalone AI performance. The studies mentioned are non-clinical performance tests (e.g., flexural strength, water sorption) and biocompatibility tests (e.g., cytotoxicity, sensitization) to demonstrate that the new device is substantially equivalent to a predicate device based on material properties and performance characteristics relevant to dental resins.

Therefore, many of the requested points regarding acceptance criteria and studies for AI/ML devices, such as sample size for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone AI performance, cannot be extracted from this document as they are not relevant to the type of device and study described.

The document specifically states: "No clinical testing was performed for this submission." This further reinforces that the type of study typically associated with AI/ML device approval (which often involves clinical data and human reader performance analysis) was not conducted or required for this dental resin.

Based on the provided text, here is what can be extracted regarding the "acceptance criteria" and "study" as applicable to this type of medical device submission:

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

The document lists performance tests in accordance with ISO 20795-1 and states that the "results have met the criteria of the standards." It does not provide a table with specific acceptance values and corresponding device performance values.

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: Not specified for non-clinical or biocompatibility tests. These are typically material property tests, not patient data tests.
• Data Provenance: Not applicable in the context of patient data, as the tests relate to the physical and chemical properties of the resin itself, not clinical outcomes from human subjects. The manufacturer is based in Republic of 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 this context refers to the defined standards (e.g., ISO 20795-1, ISO 10993 series) for material properties and biocompatibility, not expert consensus on medical images or clinical diagnoses.

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

• Not applicable. This is not a study involving human readers or clinical interpretation.

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:

• No. The document explicitly states: "No clinical testing was performed for this submission." This type of study is not relevant to the approval of a dental resin as a material.

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

• No. This is not an AI/ML device.

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

• The "ground truth" or reference standards are the international standards for dental materials (ISO 20795-1) for physical and mechanical properties and biocompatibility standards (ISO 10993 series) for biological safety. This is a material science and biocompatibility assessment, not a diagnostic accuracy assessment.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, and no training set was involved.

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

• Not applicable. No training set was used.

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DIOnavi-Denture is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with DIOnavi-Denture requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture based on a digital impression, a digital light processing (DLP) printer, and curing light equipment.

DIOnavi-Denture is a photo-cured resin intended to fabricate full and partial removable dentures in a CAD/CAM additive printing process. The material is an alternative to traditional heat cured and auto polymerization resins. It is denture base resins, Photo-cured product family comprises a family of dimethacrylate resins. The dimethacrylate resin is polymerized via photo initiators in a 3D printer. The color of the denture is determined by the addition of pigments. The material is used in a 3D printer. which prints the shape determined by a 3D drawing. After printed product is placed in a UVlight curing box for final polymerization. 3D printer and UV-light curing box is not included with the device.

The denture fabrication process begins with a traditional impression or optical impression of the oral region in the dentist office. This impression is sent to a dental lab. The denture base is then made layer-bylayer in a DLP (digital light processing) printer. After attachment of preformed plastic teeth, the denture is cured in a light chamber, and, lastly, sent back to the dentist for try-in and final adjustment.

The provided text is a 510(k) summary for the DIOnavi-Denture, a light-curable resin used for fabricating and repairing dentures. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria through a clinical study. Therefore, several of the requested categories for acceptance criteria and study details are not directly applicable or available in this M.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document refers to adherence to international standards and internal testing to demonstrate substantial equivalence, rather than defining specific clinical acceptance criteria for performance measures like diagnostic accuracy. The "acceptance criteria" are implied by meeting the requirements of the standards for similar devices.

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

The document does not detail specific sample sizes for non-clinical performance tests. The testing was laboratory-based, not clinical, so direct provenance like "country of origin" or "retrospective/prospective" data in a clinical sense is not applicable. The tests performed were outlined to meet ISO standards.

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

Not applicable. This was a non-clinical, bench-testing study of material properties, not a study involving expert assessment or ground truth establishment based on human interpretation.

4. Adjudication Method for the Test Set

Not applicable. There was no element of human judgment or interpretation requiring adjudication.

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. The DIOnavi-Denture is a tangible dental material and not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or software device. The product is a resin for dental fabrication.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical testing was defined by the established criteria and physical/chemical measurement techniques specified in the relevant ISO standards (ISO 20795-1 for dental base polymers and ISO 10993 for biocompatibility). For example, flexural strength is measured directly rather than requiring expert consensus.

8. The Sample Size for the Training Set

Not applicable. This is a physical material, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

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The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with the fixture in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients.

UF(II) Bar holder abutment and set screw is used for prosthetic restoration. Bar holder abutment is intended to be used in conjunction with the fixture in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients. UF(II) Bar holder abutments are made from Ti-6Al-4V ELI (ASTM F136). The UF(II) Bar holder abutment has two type shape which are Single body type and Cap type.

The UF(II) Bar holder abutment of single body type consists of abutment screw and set screw. The UF(II) Bar holder abutment of cap type consists of abutment screw, set screw and abutment cap. Both type Bar holder abutment has Hex, Non-Hex connection. Subject abutments are only intended for multi-unit restorations. It is provided non-sterile, this should be user steam sterilized before use. It is used for overdentures with clip for bar retention. The clip is fixed to the overdenture and used to supplement the retention of the bar and denture. The bar is used to fix the abutment and overdenture. It is held in place with the set screw. The cap is used to cover the bar holder abutment Cap Type. The components-clip, bar, and cap--are included in the device system.

Here's an analysis of the provided text regarding the acceptance criteria and study for the UF(II) Bar holder abutment:

This document is a 510(k) summary for a medical device (UF(II) Bar holder abutment). It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through clinical or standalone studies for a new type of AI/diagnostic device.

Therefore, the requested information elements related to AI algorithm performance (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable in this context. This is a traditional medical device submission for an implant component, where the focus is on mechanical integrity, materials, and intended use comparison to existing devices.

However, I can extract the relevant information regarding the non-clinical testing performed to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are derived from established international standards for dental implants and abutments. Since no specific performance metrics like sensitivity/specificity are reported for this type of device, the "reported device performance" is successful completion of the specified tests, thereby demonstrating substantial equivalence.

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

• Sample Size for Fatigue Test: Not explicitly stated as a number of devices, but the test was performed on "finished assembled implant/abutment systems of the worst-case scenario (smallest diameter with maximum angulation)." This implies a representative number of units for the specific configurations tested, as per the ISO standard.
• Data Provenance: The standard (ISO 14801:2007) is international. The testing itself would have been conducted by the manufacturer or a contracted lab. The document does not specify country of origin for the test results, but the submitter (DIO Corporation) is from the Republic of Korea. It is a prospective test, newly performed or leveraged for this submission.

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

• Not Applicable. This is a mechanical/material performance test, not a diagnostic or AI-driven assessment requiring expert ground truth for interpretation. The "ground truth" is determined by the physical outcome of the tests (e.g., whether the device fractured at a certain load, whether the sterilization parameters were met).

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

• Not Applicable. See point 3.

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 physical dental implant abutment, not an AI diagnostic tool.

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

• Not Applicable. See point 5.

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

• For the fatigue test: The "ground truth" is the physical failure or non-failure of the device under specific, controlled dynamic loading conditions, as defined by the ISO standard.
• For sterilization: The "ground truth" is the measurable Sterilization Assurance Level (SAL), typically confirmed by biological indicators or other validated methods.
• For biocompatibility: The "ground truth" is the established safety profile of the material based on chemical composition and previous testing (ISO 10993).

8. The sample size for the training set

• Not Applicable. There is no training set as this is not an AI/machine learning device.

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

• Not Applicable. There is no training set.

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UCLA CCM Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

UCLA CCM Abutment is used for prosthetic restoration. It is used for cases with path and aesthetic and spatial constrainsts. After customization, be sure to use only dental non-precious metal for casting to make the prosthesis. When cast a prosthesis with UCLA CCM Abutment, the post height above the transmucosal collar of UCLA CCM Abutment has to be taller than 4mm. The subject device is not to be used with any angulation and are straight only. UCLA CCM Abutment has Hex, Non Hex connection. Hex-type abutment should be used for single unit restorations and is not recommended for multiple tooth restorations. Non Hex-type abutment is for multiunit restorations only. Both abutments types are compatible implant bodies (K182194, K161987, K122519, K170608 and K173975). UCLA CCM Abutments are made from CCM Alloy. UCLA CCM Abutment consists of UCLA CCM Abutment and abutment screw. It is provided non-sterile, this should be user steam sterilized before use.

This document is a 510(k) Premarket Notification for a dental device, specifically an endosseous dental implant abutment. It does not pertain to an AI/ML medical device, and therefore does not contain the information required to answer the questions about acceptance criteria and a study proving device performance in the context of AI/ML.

The document discusses:

• Device Name: UCLA CCM Abutment
• Regulation Number: 21 CFR 872.3630 (Endosseous Dental Implant Abutment)
• Regulatory Class: Class II
• Indications for Use: Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
• Predicate Devices: NP-Cast Abutment System (K121843), UV Active Implant System, CCM Cylinder (K182194), DIO CAD/CAM Abutment (K181037), and various UF implant systems.
• Non-clinical Testing: Refers to in-vitro testing for fatigue (though none was done as the design does not include angulation), sterilization validation, and biocompatibility, leveraging data from predicate devices.
• Clinical Testing: Explicitly states, "No clinical testing was performed for this submission."

Therefore, I cannot provide details on acceptance criteria and study data related to an AI/ML device's performance, as outlined in your request, because this document describes a physical medical device (dental abutment) and not an AI/ML algorithm.

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The UF(II) Anatomic abutment is intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The abutment can be used in single tooth replacements and multiple tooth restorations.

The UF(II) Anatomic abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation. The anatomic abutment has scalloped margins to follow the gingival contour to provide better esthetic results with the final prosthesis. It consist of straight abutment and angled of 5°, 18°, and are made from titanium alloy conforming to ASTM F136. The anatomic abutments are pre-manufactured (stock) abutments is provided non-sterile, this should be user steam sterilized before use.

The provided text describes the 510(k) summary for the UF(II) Anatomic abutment, focusing on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study design for device performance. Medical devices like this, classified as Class II, typically undergo performance testing to ensure safety and effectiveness.

Based on the information provided, here's a breakdown of the acceptance criteria and the studies conducted:

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

The document mentions several tests performed according to specific ISO standards and FDA guidance. The "acceptance criteria" are implied by adherence to these standards and demonstration of "substantial equivalence." The "reported device performance" is framed as successful completion of these tests, indicating the device meets the requirements of the standards.

2. 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 explicitly state the sample sizes used for the non-clinical tests (sterilization, fatigue). It refers to standard testing protocols outlined in the cited ISO standards and FDA guidance documents. These standards typically specify the number of samples required for robust testing.

• Sterilization Validation: Sample size not specified, but implied to be sufficient for achieving SAL of 10^-6 according to ISO 17665-1 and ISO 17665-2.
• Fatigue Test: Sample size not specified, but implied to be sufficient for testing according to ISO 14801:2007, often involving multiple samples tested to failure or a specified number of cycles. The test was conducted on "the subject device."
• Biocompatibility: No new samples were tested for biocompatibility; it was leveraged from a previous submission (K122519).

Data Provenance: The document does not specify the country of origin of the data for the non-clinical tests, nor whether the studies were retrospective or prospective. These are lab-based tests, not clinical studies involving human patients. The submitter is DIO Corporation, located in the Republic of Korea, so the testing was likely conducted in that region or by a contract lab.

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)

This question is not applicable in the context of this 510(k) submission. The "ground truth" for non-clinical performance tests like sterilization and fatigue are objective measurements against established engineering and biological standards (e.g., microbial kill rate, force sustained before failure). These tests do not typically involve human expert interpretation or consensus for establishing "ground truth" in the way a clinical diagnostic accuracy study would.

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

This question is not applicable. Adjudication methods are used in clinical studies where human interpretation or a "gold standard" reference is subject to variability or requires reconciliation among multiple experts. The non-clinical tests described are objective, laboratory-based physical and biological assessments.

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 question is not applicable. The device described, the UF(II) Anatomic abutment, is a dental implant component (an abutment). It is a passive mechanical device and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.

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

This question is not applicable, as the device is mechanical and not an algorithm or AI system.

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

As discussed in point 3, the concept of "ground truth" derived from expert consensus, pathology, or outcomes data is not directly applicable to the non-clinical performance tests mentioned in the document.

For:

• Sterilization Validation: The "ground truth" is an objective measurement of microbial reduction (e.g., spore log reduction) or sterility against a defined standard.
• Fatigue Test: The "ground truth" is the objective mechanical performance (e.g., cycles to failure, maximum load sustained) measured by engineering equipment against the requirements of ISO 14801.
• Biocompatibility: The "ground truth" is derived from established biological responses to materials as per ISO 10993-1 (e.g., cytotoxicity, sensitization, irritation).

8. The sample size for the training set

This question is not applicable, as this is a mechanical device, not a machine learning model requiring a training set.

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

This question is not applicable for the same reason as point 8.

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DIO CAD/CAM Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Patient specific abutment is intended for use with the UF Implant Systems provided in the chart. All digitally designed abutments for use with DIO CAD/CAM Abutments are intended to be manufactured at a DIO Corporation validated milling center.

The DIO CAD/CAM Abutment includes two CAD/CAM abutment designs, Hybrid Link Abutment and Patient-Specific Abutment.

1. Hybrid Link abutment: Hybrid Link abutment is intended to provide support for customized prosthetic restorations such as crowns and bridges. The hybrid link abutment is composed of two-piece abutment that is a hybrid link at the bottom and a coping (CAD/CAM patient specific superstructure) at the top. The hybrid link abutments are pre-manufactured (stock) abutments, made from a titanium alloy conforming to ASTM F136. The diameters of Hybrid Link Abutment are 4.0/4.5/5.5mm. Hybrid Link abutment is provided non-sterile therefore must be sterilized after the cementation of the patient-specific superstructure on the Hybrid Link Abutment.

2. Patient-Specific Abutment: Patient-specific abutment is made from titanium alloy conforming to ASTM F136 titanium abutment to be used in fabricating patient-specific abutments. The subject abutments are indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations. Each patient-specific abutment is individually prescribed by the clinician. The diameters of patient-specific Abutment are 3.0/3.3/3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0 and two connection designs (Hex, Non-hex). Patient-specific abutments are supplied with an abutment screw previous cleared device as K122519 and K161987 and provided non-sterile.

The document provided is a 510(k) Premarket Notification from the FDA for a dental implant abutment. It does not describe a study involving an AI/ML device, nor does it provide acceptance criteria or performance metrics in the format requested. The document focuses on demonstrating substantial equivalence to predicate devices through material properties, design specifications, and non-clinical testing for dental implant abutments.

Therefore, I cannot provide the requested information regarding acceptance criteria and device performance from this document. The sections you asked for, such as sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment, are not applicable to the content of this 510(k) summary for a physical medical device.

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The UV Active Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function.

The narrow (Ø3.0, Ø3.3) implant is limited to the replacement of maxillary lateral incisors and mandibular incisors. It is intended for delayed loading.

The Regular (Ø3.8 ~ Ø5.5) 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 when good primary stability is achieved with appropriate occlusal loading.

The Wide (Ø5.9 ~ Ø6.4) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.

The UV Active Implant System includes UV Active Fixture, Abutments (Multi- unit abutment, Cemented abutment, Angled abutment, Solid abutment and Mill abutment), Cylinders (Temporary cylinder, Cemented cylinder, CCM Cylinder) and screws (Abutment screw, Cylinder screw). The UV Active Implant System is specially designed for using in dental implant surgery. A successfully osseointegrated fixtures will achieve a firm implant when the fixture is operated under the controlled conditions per well-known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.

The UV Active Fixture is made of pure titanium grade 4(ASTM F67) and surface treatment is done with SLA (Sand-blasted, Large grit, Acid-atched). The fixtures have the diameter (3.06.4mm) and length (7.013.0mm).

The multi-unit abutment have the diameter of 4.8mm and the angle has straight, 20° and 30°. It is made from titanium alloy conforming to ASTM F136.

The Cemented abutment, Angled abutment, Solid abutment and Mill abutment has same diameter when comparing to each primary predicate device. The subject device and the predicate device are the same except for surface treatment change from machined surface to TiN Coated surface. The Cemented abutment, Solid abutment and Mill abutment made from titanium alloy confirming to ASTM F67. The Abutment screw and Cylinder screw are made of titanium alloy confirming to ASTM F136 and no surface treatment for these components.

The Fixtures are supplied gamma sterilization. The abutments, screws and cylinders are provided nonsterile, these should be user steam sterilized before use.

The provided text describes a 510(k) submission for the UV Active Implant System, which is an endosseous dental implant system. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study design for acceptance criteria based on performance metrics such as sensitivity, specificity, and AUC. The "acceptance criteria" discussed are related to meeting standards for medical devices and demonstrating substantial equivalence.

Based on the provided information, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not in the format of sensitivity/specificity/AUC, but rather conformance to established medical device standards and demonstrated substantial equivalence to predicate devices.

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

The document does not describe a "test set" in the context of a clinical performance study with human subjects, nor does it refer to data provenance in terms of country of origin or retrospective/prospective collection for an AI/CAD-like device. The testing described is non-clinical testing on the device itself (e.g., sterilization, fatigue, biocompatibility). Therefore, there is no mention of sample size for human subjects or data provenance.

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

Not applicable. This device is not an AI/CAD system evaluated by experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable.

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. No AI/CAD functionality is described in this submission.

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

Not applicable. No AI/CAD functionality is described in this submission.

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

The "ground truth" in this context is the fulfillment of established engineering, material, and biological standards through laboratory testing. For example:

• Sterilization: Measured sterility assurance level (SAL).
• Fatigue: Measured force resistance and cycles to failure against ISO 14801:2007.
• Biocompatibility: In vitro cytotoxicity assays and general biological evaluation against ISO 10993 series.
• Dimensional/Material: Conformance to specified dimensions and material properties (e.g., CP Ti Gr4 (ASTM F67), Ti-6Al-4V ELI (ASTM F136)).

8. The Sample size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/CAD device.

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

Not applicable.

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The UF(II) Wide Fixture is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment's chewing function. The larger (Ø5.9 – Ø6.9mm) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.

UF(II) Wide Fixture is especially designed for use in dental implant surgery. It is intended to be surgically placed in the bone of the upper or lower jaw arches. It consists of titanium, screw-form, root-form endosseous dental implant.

This document is a 510(k) summary for a dental implant device, not a study report for a medical AI device. Therefore, it does not contain the information required to answer your prompt about acceptance criteria and a study proving the device meets those criteria for an AI device.

The document discusses the substantial equivalence of the UF(II) Wide Fixture dental implant to predicate devices based on non-clinical tests like sterilization validation, shelf-life testing, fatigue testing, biocompatibility, and mechanical testing. It does not mention any AI component or studies related to AI performance.

Therefore, I cannot provide the requested information.

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The UF(II) Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The UF(II) Implant System(Ø3.8 ~ Ø5.5) 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 when good primary stability is achieved with appropriate occlusal loading.

UF(II) Fixture is made of pure titanium grade 4 (ASTM F67) and the surface treatment is done with SLA (Sand-blasted, Large grit, Acid-etched). The diameters of fixture are 3.8, 4.0, 4.5, 5.0, 5.5mmand the lengths of fixture are 7.0, 8.5, 10.0, 11.5, 13.0, 15.0,16.0mm in this system. All fixture lengths are available in all diameters, except for the 7.0mm length, which is not available in 3.8 or 4.0mm diameters. The abutments and superstructures consist of Healing Abutment, Cemented Abutment Screw, Cover Screw, Solid Abutment, Cemented Cylinder, Cylinder Screw and Conical Abutment.

The provided text describes a 510(k) summary for the UF(II) Implant System, which relies on demonstrating substantial equivalence to predicate devices rather than proving a specific performance metric against acceptance criteria in the way a clinical study for a novel device would. Therefore, much of the requested information regarding clinical study design, sample size, expert adjudication, MRMC studies, effect sizes, training sets, and ground truth establishment is not directly applicable or available in this document.

The document focuses on non-clinical testing to demonstrate that the device meets criteria of established standards and is substantially equivalent to predicate devices.

Here's an attempt to extract the closest available information based on your request, highlighting what is implicitly or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are meeting the criteria of the referenced standards and demonstrating substantial equivalence to predicate devices. The "reported device performance" is the outcome of non-clinical tests that conclude these criteria are met.

Non-Clinical Test Acceptance Criteria and Reported Performance for UF(II) Implant System

• Accelerated aging shelf life testing was conducted according to ASTM F1980 for devices provided sterile (real-time testing ongoing to support results). |
  | Fatigue Test | Compliance with ISO 14801:2007 (Dentistry-Implants-Dynamic fatigue test for Endosseous Dental Implants) and ISO 14801:2016. Testing performed on worst-case scenario as per FDA guidance. | - The subject device was tested and met the criteria of ISO 14801:2007 and ISO 14801:2016.
• The worst-case scenario was chosen for testing. |
  | Biocompatibility | Compliance with ISO 10993-1:2009 ("Biological evaluation of medical devices-Part 1: Evaluation and testing within risk management process") and FDA Guidance document "Use of International Standard ISO 10993-1..." for relevant tests (Sensitization, Acute systemic toxicity, Cytotoxicity, Intracutaneous Reactivity Test, Pyrogen Test, Implantation Test). Abutment and superstructure must raise no new biocompatibility issues compared to predicates. | Fixture:
• Sensitization: Conducted according to ISO10993-10.
• Acute systemic toxicity: Conducted according to ISO 10993-11.
• Cytotoxicity: Conducted according to ISO10993-5.
• Intracutaneous Reactivity Test: Conducted according to ISO 10993-10.
• Pyrogen Test: Conducted according to USP.
• Implantation Test: Conducted according to ISO 10993-6.
  Abutment and Superstructure:
• No new biocompatibility issues raised due to identical nature of body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to predicate devices. No additional testing required. |
  | Mechanical Testing | Confirm external appearance (smooth, no cracks/damage), dimensional analysis, measurement of fixture-to-abutment gap, rotational angle (no significant rotation), maximum/removal torque for screws, static shear strength (equivalent to ISO 14801), and adequate packaging. | - Appearance Test: Confirmed smooth external appearance without cracks or damage.
• Dimension Test: Confirmed same fundamental technology through dimensional analysis.
• Measurement of the gap between Fixture and abutment: Confirmed same fundamental technology through dimensions.
• Rotational Angle Test: Confirmed no significant rotation for the subject device.
• Maximum Torque for dental implant screw Test: Confirmed equivalent rotational torque.
• Removal Torque for dental implant screw Test: Confirmed equivalent removal torque.
• Static Shear Strength Test: Conducted according to ISO 14801, confirming equivalent static shear strength.
• Packaging Test: Confirmed adequate and equivalent packaging. |
  | Substantial Equivalence | The device is similar in design, dimensions, material, intended use, surface treatment, and technological characteristics to identified predicate devices (K122519, K161987, K060501, K070569), raising no new questions of substantial equivalence. | Documentation provided shows comparison tables demonstrating similarity to predicates. Differences (e.g., fixture diameter range, surface treatment for abutments) are addressed and stated not to raise new questions of substantial equivalence. |

Specific Information on Study Design (Not Applicable to this 510(k) submission)

As this is a 510(k) premarket notification primarily relying on substantial equivalence through non-clinical testing, there are no clinical studies of the type you describe (e.g., involving human readers, ground truth consensus for image interpretation, effect sizes of AI assistance). The document focuses on demonstrating that the device meets established engineering and biological safety standards, and is equivalent to previously cleared devices.

Therefore, the following points are not applicable to the provided document:

2. Sample size used for the test set and the data provenance: Not applicable, as this refers to clinical test data. Non-clinical tests would use physical samples of the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical assessment is not established in this type of submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as it pertains to clinical performance assessment. Ground truth for non-clinical tests would be established through reference standards, metrology, and validated test methods.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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