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Geo Abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit cement-retained prosthesis in the mandible or maxilla. Geo Abutments are compatible with the following implants. All digitally designed custom abutments for use with Geo Abutments are to be sent to a GeoMedi Co. Ltd. validated milling center for manufacture.

The purpose of this submission is to obtain marketing clearance for Geo Abutment from GeoMedi Co., Ltd. a line of titanium base abutments (identified as Multibase) and machinable blank abutments (identified as CMFit) to interface with compatible dental implants from four (4) manufacturers, and a total of seven (7) implant-abutment connections. The compatible implant body diameters range from 3.0 mm to 8.0 mm. The subject device prosthetic platform diameters range from 4.0 mm to 4.6 mm. All patient-specific abutments prepared from subject device Geo Abutment are to be manufactured at a GeoMedi validated milling center.

Geo Multibase abutments are two-piece abutments in which the Geo Multibase Abutment comprises the first part of the two-piece abutment and a patient-specific zirconia superstructure comprises the second part; the assembly becoming a final finished medical device after cementation of the superstructure on the subject device abutment. They are provided in straight designs, and two (2) connection types: for single unit prostheses (engaging connection) and for bridge or multi-unit prostheses (non-engaging connection). They are not intended for angulation correction, as the design parameters for the superstructure are restricted to straight abutments only.

These abutments are made of titanium alloy (Ti-6Al-4V) with a titanium nitride (TiN) coating on the coronal portion of the external surface, not including the implant-abutment interface.

The Geo Multibase abutment and corresponding zirconia superstructure are provided to the clinician either with the superstructure cemented to the abutment by the dental laboratory or separately, for the clinician to bond together chairside, using the cement required in the labeling (3M ESPE RelyX Unicem bonding cement, cleared in K022476 as RelyX RMGIP).

All patient-specific custom zirconia superstructure fabrication is by prescription on the order of the clinician.

The design parameters for zirconia superstructures to be used with Geo Multibase abutments are:

• Minimum wall thickness – 0.5 mm
• Minimum cementable post height for single-unit restoration – 4.0 mm (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
• Minimum gingival height of the superstructure – 0 mm (Geo Multibase abutments have minimum gingival height of 1.0 mm)
• Maximum gingival height – 5.0 mm
• Maximum angle – 0° (straight only)

All zirconia copings (superstructures) for use with the subject device Geo Multibase abutment will be made at a GeoMedi Co., Ltd. validated milling center under FDA quality system regulations, and the material will conform to ISO 13356, Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).

Geo CMFit abutments are cylindrical titanium alloy abutments designed to be used for fabrication of a one-piece, all titanium patient-specific abutment by a CAD/CAM process. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in length or 13.9 mm in diameter by 20 mm in length. Geo CMFit abutments are available in engaging and non-engaging connections.

All patient-specific abutment fabrication is by prescription on the order of the clinician. The design parameters for all CMFit patient-specific abutments are:

• Minimum wall thickness – 0.65 mm
• Minimum cementable post height for single-unit restoration – 4.0 mm (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
• Minimum gingival height – 0.5 mm
• Maximum gingival height – 5.0 mm
• Maximum angle – 30°

Manufacture of the Geo Abutment CMFIT patient-specific abutment is to be performed at an GeoMedi Co., Ltd. validated milling center.

The provided text is a 510(k) clearance letter for a dental implant abutment, not an AI/ML medical device where performance characteristics like sensitivity, specificity, or reader studies are typically discussed.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through:

• Indications for Use (IFU) comparison: Showing that the intended use of the Geo Abutment is the same as already cleared devices (supporting prosthetic devices in edentulous patients, compatible with various implants).
• Technological characteristics comparison: Detailing similarities in design, materials (titanium alloy, TiN coating, zirconia for superstructures), manufacturing processes (CAD/CAM, milling center), mechanical properties, and sterilization methods.
• Non-clinical performance data: This section lists types of tests conducted (e.g., mechanical testing per ISO 14801, shear/tension testing per ASTM F1044/F1147, sterilization validation per ISO 17665-1/2, biocompatibility per ISO 10993-5/12) to ensure the device meets safety and performance standards equivalent to the predicate. However, it does not provide acceptance criteria or specific numerical results from these tests. It only states that these tests were done to "demonstrate that the subject devices... have sufficient strength for the intended use" and "characterize the mechanical properties."

Therefore, based on the provided document, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This detailed information is typically part of the test reports submitted to the FDA, but not usually summarized in the publicly available 510(k) clearance letter or summary in this level of detail (i.e., the specific pass/fail thresholds and the measured values for each test). The document only states what was tested and the conclusion that it demonstrated "sufficient strength."
2. Sample sizes used for the test set and the data provenance: This information is not present in the 510(k) summary. These details would be in the specific test protocols and reports.
3. Number of experts used to establish the ground truth... and their qualifications: This is not applicable as this is a physical device, not an AI/ML diagnostic aid requiring human expert annotation for ground truth.
4. Adjudication method for the test set: Not applicable for this type of device.
5. MRMC comparative effectiveness study: Not applicable for a physical dental abutment. This is typically for AI/ML diagnostic devices.
6. Standalone (algorithm only without human-in-the-loop performance): Not applicable for a physical device.
7. The type of ground truth used: For a physical device like a dental abutment, "ground truth" relates to material properties, mechanical strength, dimensional accuracy, and biocompatibility, as demonstrated through engineering tests and material characterization, not clinical outcomes or expert consensus in an AI sense. The document refers to ISO and ASTM standards, which define the test methods and what constitutes acceptable performance (the "ground truth" for material and mechanical properties).
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document demonstrates substantial equivalence for a physical dental device through comparison to predicate devices and adherence to established engineering and material standards, rather than through clinical study formats typically seen for AI/ML diagnostic tools.

To answer your question, if this were an AI/ML device document, the "acceptance criteria" and "reported device performance" would typically be found in sections describing performance metrics like:

• Sensitivity, Specificity, Accuracy
• Area Under the Receiver Operating Characteristic (ROC) Curve (AUC)
• Positive Predictive Value (PPV), Negative Predictive Value (NPV)
• F-score or Dice coefficient (for segmentation tasks)
• Comparison to a "clinical standard of care" or "expert performance."

And the "study that proves the device meets the acceptance criteria" would be a clinical validation study (often a retrospective or prospective reader study or a standalone algorithm performance study) with clearly defined ground truth, reader qualifications, and statistical analysis. None of these elements are present because the device is a physical dental abutment.

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TruAbutment DS is a patient-specific CAD/CAM abutment, which is directly connected to endosseous dental implants and is intended to be used as an aid in prosthetic rehabilitation. It is compatible with the following systems: Astra OsseoSpeed EV (K130999, K120414), Biomet 3i Full OSSEOTITE Tapered Certain (K130949), DIO UF (II) Internal Submerged (K161987, K170608, K173975), Neoss ProActive® (K083561), Osstem TS (K161604), Camlog Screw-Line (K083496), Conelog Screw-Line (K113779), Implant Direct Legacy2 (K192221), BioHorizons Internal Implant System (K093321, K143022, K071638), MegaGen AnyRidge Internal Implant (K140091). All digitally designed abutments and/or copings for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruBase is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for a screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems: Astra OsseoSpeed EV (K130999), Biomet 3i Full OSSEOTITE Tapered Certain (K130949), DIO UF(II) Internal Submerged (K161987, K170608, K173975), Neoss ProActive® (K083561), Camlog Screw-Line (K083496), Conelog Screw-Line (K113779), Implant Direct Legacy2 (K192221). All digitally designed abutments and/or copings for use with the TruAbutment are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruAbutment DS, TruBase and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F136). TruAbutment DS, TruBase are supplied with two identical screws which are used: (1) For fixing the abutment into the endosseous implant. (2) For dental laboratory use during construction of related restoration. TruAbutment DS, TruBase are provided non-sterile. Therefore, it must be sterilized before use. TruAbutment DS, TruBase are devices that can only be sold, distributed, or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices.

TruAbutment DS system includes patient-specific abutments that are placed into the dental implant to provide support for the prosthetic restoration. The subject abutments are indicated for serew-retained restorations. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center.

TruBase is a two-piece abutment. The base component is premanufactured and is used to support a cemented CAD/CAM zirconia superstructure. The base and the zirconia superstructure together form the final abutment. CAD/CAM customized superstructure that composes the final abutment is intended to be sent to a TruAbutment-validated milling center to be designed and milled, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect.

The provided text is a 510(k) summary for the TruAbutment DS and TruBase devices. It primarily focuses on demonstrating substantial equivalence to a predicate device (TruAbutment DS, K203649) and does not detail an acceptance criteria table with reported device performance in the manner of a clinical study. The text describes non-clinical testing performed, but not a study designed to prove the device meets acceptance criteria related to a specific clinical outcome or diagnostic accuracy.

Therefore, many of the requested items (acceptance criteria table, sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, type of ground truth) are not applicable based on the content of this 510(k) summary, which is a premarket notification for a medical device primarily based on demonstrating substantial equivalence through engineering and mechanical testing, not clinical performance or AI algorithm validation studies.

However, I can extract the information provided regarding non-clinical testing for the devices.

Acceptance Criteria and Study for TruAbutment DS & TruBase

Based on the provided 510(k) summary, the "acceptance criteria" and "study" described are focused on non-clinical mechanical performance testing and demonstration of substantial equivalence to a predicate device, rather than a clinical study proving performance against specific clinical or diagnostic accuracy metrics with human or AI components.

Here's the relevant information extracted and presented based on the document:

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

The document does not provide a table with specific quantitative acceptance criteria alongside actual reported numerical performance results for the new devices in the context of a comparative study proving their performance against such criteria. Instead, it states that "The results of the above tests have met the criteria of the standard and demonstrated substantial equivalence with the reference devices." This implies a qualitative "met standard" outcome rather than specific numerical performance data.

The tables provided describe the design limits of the devices and compare them to the predicate device, not performance data from a test:

TruAbutment DS Design Parameters (Acceptance Criteria are implied by meeting these limits)

TruBase Design Parameters (Acceptance Criteria are implied by meeting these limits)

For mechanical performance, the document states:
"Mechanical performance testing was performed according to ISO 14801. For compatible OEM implant line, worst-case constructs were subjected to static compression and compression fatigue testing. The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use."

This confirms that the acceptance criteria for mechanical performance were "sufficient for their intended use" as defined by ISO 14801 and worst-case testing, but quantitative results are not provided.

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: The document mentions "worst-case constructs" were tested for mechanical performance, and "the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws)" was evaluated for MRI environment conditions. However, specific numerical sample sizes for these tests are not provided.
• Data Provenance: The data comes from non-clinical laboratory testing following international standards (ISO 14801, ISO 17665-1/2, ISO 10993 series). The country of origin and retrospective/prospective nature are not applicable as it's not a clinical data study.

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 is not applicable. The "ground truth" for this type of device (dental abutments) is established through adherence to engineering design specifications, material standards (ASTM F136), and performance under mechanical stress tests (ISO 14801), as well as compliance with sterilization and biocompatibility standards. It does not involve expert interpretation of images or clinical outcomes in the same way an AI diagnostic device would.

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

• This is not applicable as there is no human interpretation or subjective assessment of data requiring adjudication. Testing is based on objective measurements against engineering 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

• This is not applicable. The device is an endosseous dental implant abutment, not an AI diagnostic tool.

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

• This is not applicable. The device is a physical dental component, not an algorithm.

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

• The "ground truth" for validating these devices is adherence to engineering specifications, material properties, and performance standards (e.g., passing specific load-bearing and fatigue tests per ISO 14801, meeting biocompatibility requirements, maintaining dimensional accuracy). "Dimensional analysis and reverse engineering" were used to confirm compatibility.

8. The sample size for the training set

• This is not applicable. There is no "training set" as this is a physical medical device, not an AI/machine learning algorithm.

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

• This is not applicable for the reason above.

Summary of the Study Proving Device Meets Criteria (Based on Provided Text):

The "study" conducted was primarily non-clinical laboratory testing to demonstrate the mechanical performance, sterilization efficacy, and biocompatibility of the TruAbutment DS and TruBase devices. The objective was to show substantial equivalence to an existing legally marketed device (TruAbutment DS, K203649) by proving that the new devices meet established design limits and performance standards relevant to dental implant abutments.

• Mechanical Testing: Performed on "worst-case constructs" according to ISO 14801 for static compression and compression fatigue. The outcome was that "construct strengths [were] sufficient for their intended use."
• Sterilization Testing: Performed per ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
• Biocompatibility Testing: Performed per ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
• MRI Environment Evaluation: A non-clinical worst-case MRI review was done using scientific rationale and published literature to assess magnetically induced displacement force and torque.
• Dimensional Analysis and Reverse Engineering: Conducted on the implant-to-abutment connection platform to assess critical design aspects and tolerances, confirming compatibility.

The overall conclusion was that the devices "met the criteria of the standard and demonstrated substantial equivalence with the reference devices," thus indicating they met their implied acceptance criteria for safety and performance as medical devices. Clinical testing was explicitly stated as "not necessary."

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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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The TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.

It is compatible with the following systems:

• · Biomet 3i Certain® (K130949) 3.25, 4.0, 5.0, 6.0 mm
• · DIO UF(II) Internal Submerged (K161987, K170608, K173975) 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm
• Megagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 mm
• · Neoss ProActive® (K083561) 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm

All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

The TruAbutment DS system includes custom abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for screwretained restorations. The custom abutment and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for:

• (1) For fixing into the endosseous implant
• (2) For dental laboratory use during construction of related restoration.

The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the custom abutments take into consideration the shape of final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.

The proposed abutments are available in internal hex connection, and are compatible with Biomet 3i Certain® Implant/DIO UF(II) Internal Submerged Implant/Megagen AnyRidge® Implant/Neoss ProActive® Implant.

The device being discussed is "TruAbutment DS", a patient-specific CAD/CAM abutment for dental implants.

The acceptance criteria for this device are established by demonstrating substantial equivalence to a predicate device (TruAbutment DS K170259) through non-clinical testing, primarily mechanical performance (fatigue) testing, and biocompatibility assessments. The study described focuses on non-clinical testing to meet these acceptance criteria rather than a clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not explicitly state the exact sample size (number of abutments or implants) used for the non-clinical mechanical and dimensional tests. It mentions "worst-case constructs" for fatigue testing.
Data provenance: The testing was conducted by the manufacturer (TruAbutment Inc.) as part of their 510(k) submission to the FDA, presumably in the USA (where the company is based). The data is retrospective as it was generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" for this device's performance is established by meeting recognized international and national standards (ISO, FDA guidance) through non-clinical laboratory testing, not by expert consensus on clinical cases.

4. Adjudication method for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation of medical images. The studies performed for this device were non-clinical laboratory tests.

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, an MRMC comparative effectiveness study was not done. This device is a physical dental implant abutment, not an AI or imaging diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a physical medical device, not an algorithm. The "standalone" performance is assessed by its mechanical integrity and biocompatibility when used as intended.

7. The type of ground truth used
The "ground truth" used for this device is based on established engineering and materials science principles and validated standards:

• Mechanical Performance: Defined by the specified fatigue limits and static load capabilities as per ISO 14801 and FDA guidance thresholds for dental implant abutments.
• Biocompatibility: Defined by the absence of adverse biological reactions as per ISO 10993 series standards.
• Dimensional Accuracy: Defined by precise measurements confirming compatibility with target implant systems.

8. The sample size for the training set
This is not applicable. This device is not an AI model that requires a training set. The CAD/CAM design process for patient-specific abutments involves individual patient data rather than a large training dataset for device development in the AI sense.

9. How the ground truth for the training set was established
This is not applicable as there is no "training set" in the context of an AI device. The design principles for the TruAbutment DS are based on established dental implantology, engineering design, and manufacturing standards for patient-specific CAD/CAM abutments.

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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 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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