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BioHorizons conical dental prosthetic components connected to the endosseous dental implants are intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed abutments for use with Conical Ti Base abutments are to be sent to a BioHorizons validated milling center for manufacture or to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

The BioHorizons Conical Ti Base abutments are prosthetic components and are intended for the restoration of BioHorizons dental implants within the specific indications of each implant system. All Conical Ti Base abutments are two-piece titanium-base type abutments with a pre-manufactured titanium base component cemented to a zirconia superstructure to create the final finished dental abutment. All the titanium bases are manufactured from Ti-6Al-4V titanium alloy per ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications and are for single patient use. The prosthetics are provided non-sterile as indicated on the label. The subject devices are permanent or long-term, tissue/bone implant devices intended for more than 30 days of patient contact. BioHorizons dental prosthetics are invasive and / or surgically invasive devices placed in healed or compromised oral sites in direct contact with bone and soft tissue.

The Conical Ti-Base abutments are provided in engaging and non-engaging designs and are designed for single-unit or multi-unit restoration with a CAD/CAM zirconia superstructure attached to the abutment. The titanium base components are available for narrow and regular platforms and with gingival heights of 0.8 mm and 2.0 mm. The titanium base component post has been manufactured with matte finish creating a roughened surface to accommodate cementing. All patient-specific custom abutment fabrication for Conical Ti Base abutments are by prescription on the order of the clinician. All zirconia superstructures for use with the subject device Conical Ti Base abutments are made at a BioHorizons validated milling center under FDA quality system regulations, as cleared in K240187, or according to a digital dentistry workflow (subject of this submission described in the section below). As cleared in K240187, zirconia material, sagemax NexxZr® zirconia (K130991) is used to fabricate the patient-specific zirconia superstructure or direct crown. The cement for bonding of superstructures or crowns is a dual cure cement, 3M™ RelyX™ Unicem 2 Automix (K022476). These cleared materials are identical to the proposed digital dentistry workflow. The pre-manufactured titanium base component are not to be modified and are only intended to permit a customized zirconia restoration.

The design and fabrication of the zirconia superstructure will be conducted using a digital dentistry workflow requiring the use of the following equipment:

• Scanner: 3Shape Trios 5 intra-oral scanner.
• Design Software: 3Shape Abutment Designer Software, K151455.
• Zirconia Material: sagemax® NexxZr zirconia, K130991.
• CAM software: hyperDENT® Classic
• Milling machine: imes-icore® CORiTEC 150i Pro milling machine
• Cement: 3M™ RelyX™ Unicem 2 Automix Self-Adhesive Resin Cement, K022476.

The designed superstructure is attached to the titanium base component by the use of an FDA-cleared cement, 3M™ RelyX™Unicem 2 Automix Self-Adhesive Resin Cement, K022476. The resulting final prosthetic restoration is screwed to the dental implant. All subject abutments are single-use and provided non-sterile. Final restoration (which includes the corresponding screw) is intended to be sterilized at the dental clinic before it is placed in the patient. The final abutment is equivalent to the final abutment cleared in K240187.

The provided document is an FDA 510(k) clearance letter for the Conical Ti Base abutments.

*Crucially, this document does not contain information about acceptance criteria or a study proving that the device meets those criteria, nor does it provide details about any clinical studies, sample sizes, expert ground truth establishment, or AI effectiveness studies.

The letter focuses on establishing substantial equivalence to previously cleared predicate devices based on:

• Identical intended use: Both the subject device and the primary predicate (K240187) are "intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations." The subject device adds the "digital dentistry workflow" aspect, which is equivalent to the secondary predicate (K231307).
• Similar or identical design and technological characteristics: This includes material composition (Ti-6Al-4V alloy for the titanium base, sagemax NexxZr zirconia for the superstructure), manufacturing methods, digital design software and hardware (for the zirconia superstructure), design limitations, usage, sterility, and biocompatibility.

The "Performance Data" section discusses:

• Reliance on predicate submission data for non-clinical aspects like mechanical testing, biological safety, steam sterilization, and magnetic resonance testing, as there were no changes since the previous clearance (K240187).
• New testing was conducted to support the CAD/CAM design and use within a digital dentistry workflow, demonstrating controls of this workflow and that the final abutment is equivalent to those produced by the validated milling center cleared in K240187. This involved assessing abutment angulation, diameter, height, wall thickness, tolerances, and part quality.
• Surface characterization (SEM and EDX) was done on the titanium base component to ensure no residual blast media.
• No clinical data were included in this submission.

Therefore, I cannot provide the requested information regarding acceptance criteria, specific study details, sample sizes, expert involvement, or AI effectiveness. The clearance is based on non-clinical data and substantial equivalence to existing devices.

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The Ti-Base & Master Fix are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally-designed Ti-Base and Master Fix are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.

The Ti-Base & Master Fix consist of a two-piece abutment, where the titanium base is premanufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that compose the final abutment.
Device Components:

1. Abutment

• Ti-Base
• Master Fix
• Abutment Screw
  The Ti-Base and Master Fix are provided non-sterilized. Ti-Base is enclosed with Abutment Screw in a packing. Master Fix is enclosed with Master Fix Screw in a packing. These devices are intended for single use only. All digitally designed custom abutments for use with Ti-Base or Master Fix are to be sent to ARUM DENTISTRY validated milling center for manufacture. All superstructures are to be manufactured from zirconia (cleared K190112). Digitally designed CAD/CAM abutments must have a 0.5 mm minimum gingival height dimension. The Titanium Base abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction.

The provided document is a 510(k) premarket notification for the "Ti-Base & Master Fix" dental implant abutments. It includes a summary of technology characteristics and performance data but does not contain specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth, expert opinions, or MRMC studies. The document focuses on demonstrating substantial equivalence to a predicate device (DESS Dental Smart Solutions, K191986) primarily through material composition, intended use, and mechanical testing that mitigates minor design differences.

Therefore, many of the requested details cannot be extracted from this document.

However, based on the information provided, here's what can be answered:

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

• The document does not explicitly state quantitative acceptance criteria for device performance (e.g., minimum fracture strength, fatigue life thresholds) or report specific numerical performance outcomes against such criteria for the "Ti-Base & Master Fix" directly.
• It references mechanical performance testing as a method to mitigate differences in design and ensure safety and effectiveness, implying that such tests were conducted and their results were deemed acceptable, but the actual data/criteria are not provided in this summary.
• It also mentions biocompatibility testing according to ISO 10993-5 and ISO 10993-12, and moist heat sterilization validation according to ISO 17665 -1 and ISO 17665-2. These standards implicitly contain acceptance criteria, but the specific results or criteria are not detailed in this submission summary.

Table of Acceptance Criteria and Reported Device Performance (Based only on what's implicitly mentioned as having been met)

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 provide details on sample sizes for mechanical performance testing, biocompatibility, or sterilization validation.
• No information on the country of origin of the data or whether the studies were retrospective or prospective can be extracted.

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 information is not applicable and not provided. The submission is for a medical device (dental implant abutment), and the performance data primarily relates to physical and material properties, not diagnostic imaging or clinical interpretation requiring expert ground truth establishment in that typical sense.

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

• Not applicable and not provided. This typically applies to clinical or imaging studies where expert consensus is formed, which is not the type of study described here.

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 and not provided. This is a medical device (dental implant abutment) submission, not an AI-assisted diagnostic device.

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

• Not applicable and not provided. This is a physical medical device.

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

• Not applicable. For physical device testing, ground truth would typically refer to established engineering standards, material properties, and validated test methods (e.g., ISO standards for mechanical testing, biocompatibility).

8. The sample size for the training set

• Not applicable and not provided. There is no machine learning or AI component described that would require a training set.

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

• Not applicable and not provided.

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INNO SLA Submerged Hybrid Ti-Base System is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations. All digitally designed zirconia superstructures for use with the INNO SLA Submerged Hybrid Ti-Base System are intended to be sent to a Cowellmedi validated milling center for manufacture.

INNO SLA Submerged Hybrid Ti-Base System consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment). These two pieces together form the final abutment. Ti-base Abutment System is made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The zirconia material is InCoris Zi, cleared under K123664, and the cement is RelyX Unicem 2Automiz, cleared under K100756. Zirconia CAD/CAM abutment or superstructure that composes the final prosthetics is intended to be designed and milled, according to the prosthetic planning and patient clinical situation. It is compatible with the following systems: INNO SLA Submerged Implant System(K132242) by Cowellmedi Co., Ltd. The system offers the following three types of Ti-Base with a screw that fix the abutment into the fixture. Hybrid S Ti-Base, Hybrid L Ti-Base, Hybrid A Ti-Base.

The provided text is a 510(k) Summary for the INNO SLA Submerged Hybrid Ti-Base System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data from a clinical or extensive non-clinical study that would typically be conducted for a de novo device or a device requiring premarket approval (PMA).

Therefore, the information required to fully answer your request (acceptance criteria, specific study results proving the device meets criteria, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in this 510(k) summary.

A 510(k) submission primarily relies on demonstrating that the new device has the same intended use and similar technological characteristics to a legally marketed predicate device, or if there are differences, that these differences do not raise new questions of safety and effectiveness. The "Performance Data (Non-Clinical)" section lists the types of tests performed (sterilization, biocompatibility, fatigue, MR environment review) and states that the "test results support that the subject device is substantially equivalent to the predicate devices." However, it does not provide the actual acceptance criteria or the specific numerical performance results against those criteria.

Here's what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in terms of pass/fail thresholds for each test. The implicit acceptance criterion for a 510(k) is that the device is "substantially equivalent" to the predicate.
• Reported Device Performance: Only general statements are made:
  • "Sterilization validating testing has been performed in accordance with ISO 17665-1 and ISO 17665-2 for steam sterilization." (Result: Implied adequate sterilization)
  • "Biocompatibility testing has been performed in accordance with ISO 10993-3, 5, 6, 10, 11, and 23." (Result: Implied biocompatible)
  • "Fatigue test in accordance with ISO 14801" (Result: "the result supports that the [subject device is] substantially equivalent to the predicate device in the market.")
  • "MR Environment Condition... Non-clinical worst-case MRI review was performed... based on the entire system including all variations... Rationale addressed parameters per the FDA Guidance... including magnetically induced displacement force and torque." (Result: Implied suitable for MR environment, likely "MR Conditional" or "MR Safe" based on the referenced guidance, though not explicitly stated.)

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

• Not specified. This document describes non-clinical engineering and materials testing, not a clinical study involving human patient data.

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

• Not applicable. This pertains to an AI/ML device where expert review establishes ground truth for image interpretation or diagnosis. This document is about a dental implant abutment system.

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

• Not applicable. This applies to expert review of data for AI/ML performance evaluation.

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. This is not an AI/ML device for diagnostic assistance.

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

• Not applicable. This is not an AI/ML diagnostic software.

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

• Not applicable in the AI/ML sense. For the engineering tests, the "ground truth" would be established by the specifications of the relevant ISO standards (e.g., ISO 14801 for dental implant fatigue, ISO 10993 for biocompatibility) and comparison to the predicate device's performance (though the specific predicate's performance is not numerated here).

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. This is not an AI/ML device.

In summary: The provided 510(k) summary for the INNO SLA Submerged Hybrid Ti-Base System details the types of non-clinical tests performed to demonstrate substantial equivalence to predicate devices (URIS Base, Preat Abutment, BioHorizons CAD/CAM Abutments). It does not provide the specific numerical acceptance criteria or quantitative performance results, as is typical for a 510(k) submission which relies heavily on comparison to existing legally marketed devices rather than requiring de novo clinical performance validation against novel acceptance criteria. The questions posed align more with the evaluation of AI/ML or diagnostic software devices, which this dental hardware device is not.

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DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw.
DD Ti-Base 2CUT abutments, for the Altatech Camlog Screw-Line 3.3mm implant bodies, Dentsply Implants Astra Tech OsseoSpeed 3.5mm implant bodies, Dentsply Implants Xive 3.4mm implant bodies, Straumann Bone Level 3.3mm implant bodies, Zimmer Biomet 31 Certain 3.4mm implant bodies and Zimmer Dental Tapered Screw-Vent 3.5mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
All digitally designed custom abutments for use with DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) are to be sent to a Dental Direkt validated milling center for manufacture.
Compatible Implant Systems:

• Altatech: Camlog (3.3, 3.8, 4.3, 5.0)
• Nobel Biocare: Nobel Active (3.5, 4.3/5.0)
• Nobel Biocare: Replace Select Tapered (3.5, 4.3, 5.0)
• Dentsply Implants: Xive (3.4, 3.8, 4.5, 5.5)
• Straumann: Bone Level (3.3, 4.1/4.8)
• Straumann: SynOcta (4.8, 6.5)
• Zimmer Dental: Tapered Screw-Vent (3.5, 4.5, 5.7)
• Dentsply Implants: Astra Tech OsseoSpeed (3.5/4.0, 4.5/5.0)
• Dentsply Implants: Astra EV (3.6, 4.2, 4.8, 5.4)
• Zimmer Biomet 3i: Certain (3.4, 4.1/5.0)

The DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) consist of the following parts: DD Ti-Base 2CUT and DD Ti-Base 2CUT noLock. The DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) are designed and made to individually fit the individual requirements for each patient.
DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock attach directly to the following dental implants:

• Altatech: Camlog (3.3, 3.8, 4.3, 5.0)
• Nobel Biocare: Nobel Active (3.5 NP, 4.3/5.0 RP)
• Nobel Biocare: Replace Select Tapered (3.5, 4.3, 5.0)
• Dentsply Implants: Astra Tech OsseoSpeed (3.5/4.0, 4.5/5.0)
• Straumann: Bone Level (3.3, 4.1/4.8)
• Straumann: SynOcta (4.8, 6.5)
• Zimmer Dental: Tapered Screw-Vent (3.5, 4.5, 5.7)
• Dentsply Implants: Xive (3.4, 3.8, 4.5, 5.5)
• Dentsply Implants: Astra EV (3.6, 4.2, 4.8, 5.4)
• Zimmer Biomet 3i: Certain (3.4, 4.1/5.0)
  The Ti-Bases (DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock) are used as part of a two piece abutment, where the base is premanufactured from titanium alloy (Ti-6Al-4V ELI) and the top half is a CAD-CAM zirconia superstructure, milled at a validated milling center. These pieces are cemented together to form the final abutment.
  All two implant components, the DD Ti-Base 2CUT and the DD Ti-Base 2CUT noLock are delivered each with an implant screw (DD Implant screw).

The provided text describes Dental Direkt GmbH's K230218 510(k) submission for "DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)." This submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K191111).

The document does not describe a study that uses a test set, expert readers, or AI performance metrics. Instead, it focuses on demonstrating substantial equivalence through a comparison of the subject device with a predicate device, relying on material, manufacturing, and general design similarities, along with performance testing according to established standards for dental implants.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document as it pertains to a different type of device evaluation (substantial equivalence based on physical and functional comparison to a predicate, rather than an AI/software performance study).

The "Performance data" section (Page 4, last entry of the large table) explicitly states:

• "Fatigue testing according to ISO 14801 [FDA Recognition #4-195] and FDA guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments dated May 12, 2004."
• "No new biocompatibility testing: Biocompatibilty testing for cytotoxicity according to ISO 10993-5 [FDA Recognition #2-245] leveraged from Predicate Device K191111 (worst case series)."
• "No new sterilization validation: Sterilization validation according to ISO 17665-1 [FDA Recognition #14-333], ISO 11737-1 [FDA Recognition #14-577] and ISO 11737-2 [FDA Recognition #14-540] leveraged from Predicate Device K191111 (worst case series)."
• "Reverse engineering dimensional analysis was conducted using OEM implant bodies, OEM abutments, and OEM abutment screws."

This indicates that the performance evaluation relies on bench testing (fatigue), leveraging existing biocompatibility and sterilization data from the predicate device, and dimensional analysis, not on clinical studies involving test sets, human readers, or AI.

In summary, the provided document does not contain the information required to answer the prompt as it pertains to AI/software performance studies. The device is a physical dental abutment, and its clearance is based on substantial equivalence to a predicate device through engineering and material comparisons and standardized physical testing.

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MIS Ti-base abutment is a titanium base placed onto MIS dental implants to provide support for customized cement-retained or screw retained single or multiple-unit restorations. It is used with a digitally designed mesostructure. MIS Ti-base and the mesostructure make up a two- piece abutment used in conjunction with MIS dental implants, to be placed in the upper or lower jaw arches, in order to restore masticatory function.

Narrow platform Ti-bases are indicated for use only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws.

MIS short implants are to be used only with straight abutments. Mesostructures for use with the MIS Tibase abutment are to be made from inCoris ZI, IPS e.max® CAD Abutment or VITA ENAMIC® (IS), designed and manufactured using Sirona CEREC SW version 4.6.1 software.

MIS Ti-base abutments are intended for use with the following MIS implants:

• C1 conical connection implant system
• V3 conical connection implant system
• SEVEN internal hex implant system
• M4 internal hex implant system
• Lance+ internal hex implant system

The subject MIS Ti-base abutments are endosseous dental implant abutments intended to be connected to MIS dental implants and used to support CAD/CAM customized cement-retained or screw retained single or multiple-unit restorations.

MIS Ti-base abutments consist of a titanium base and a prosthetic screw, both made of TI-6AI-4V ELI complying with ASTM F136. The prosthetic screw tightens the finished CAD/CAM abutment to the dental implant.

MIS Ti-base abutments are the bottom-half/base of a two-piece custom ceramic-titanium abutment consisting of a ceramic coping/mesostructure and a titanium base.

The top-half custom ceramic coping/mesostructure or crown is intended to be fabricated from Sirona inCoris ZI zirconium oxide ceramic block, IPS e.max® CAD ceramic block, or from IPS e.max® CAD ceramic block or VITA ENAMIC® (IS) ceramic block and designed and milled using Sirona chairside Dental CAD/CAM System, with software version: CEREC SW version 4.6.1. The mesostructure design will be subject to the Sirona system controls, such as: A maximum angulation of 20° and minimum wall thickness of 0.5mm for inCoris ZI and e.max materials and 0.8mm for VITA ENAMIC material.

It is not permitted to reduce the Ti-base's diameter, shorten the Ti-base or modify its implant-abutment connection and emergence profile in any way.

The subject, pre-fabricated titanium base abutment is designed with interface compatibility to specific MIS dental implant systems. The subject MIS Ti-base abutments are MIS connection and internal hex connection Ti-base abutments, and their connection is compatible with MIS conical connection C1 and V3 implants, and MIS SEVEN, M4 and Lance+ internal hex implants, which are not subject to this submission and were previously cleared.

This document describes a 510(k) premarket notification for the MIS Ti-base abutment. This is an FDA submission for devices that are "substantially equivalent" to predicate devices, meaning they have the same intended use and similar technological characteristics. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically demonstrating this substantial equivalence through non-clinical performance data, rather than a clinical trial with specific performance metrics like sensitivity or specificity for an AI algorithm.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a physical medical device (dental abutment) and not an AI algorithm, the "acceptance criteria" are related to demonstrating that the device performs as safely and effectively as a legally marketed predicate device. The performance is assessed through non-clinical testing against established standards.

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

• Sample Size for Test Set: The document does not specify a "test set" in the context of clinical data for AI. For the non-clinical fatigue testing, "worst case abutments" were chosen. The exact number of samples tested for each worst-case configuration (e.g., number of narrowest abutments, number of specific mesostructures) is not explicitly stated but implied to be sufficient for ISO 14801:2016 compliance.
• Data Provenance: Not applicable in the context of clinical or retrospective data for an AI algorithm. The performance data comes from laboratory non-clinical tests.

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

• This is not applicable as this is a non-clinical device submission for a physical component, not an AI algorithm requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

• Not applicable for a non-clinical device 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 is not an AI-assisted diagnostic device.

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

• Not applicable. This device is a physical dental abutment. The software mentioned (CEREC SW version 4.6.1) is for design and milling, not a standalone AI diagnostic algorithm.

7. The Type of Ground Truth Used

• For fatigue testing, the "ground truth" is defined by the mechanical strength and durability requirements of the ISO 14801:2016 standard, ensuring the device can withstand chewing forces.
• For biocompatibility, the "ground truth" is adherence to ISO 10993-1 and prior clearances of materials used.
• For sterilization, the "ground truth" is effective sterilization as demonstrated by ANSI/AAMI/ISO 17665 standards.
• For software verification, the "ground truth" is the established design limitations and the software's ability to enforce them.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI algorithm that requires a training set. The software mentioned (CEREC SW) is a CAD/CAM design software, not a machine learning model developed with a training set.

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

• Not applicable as there is no training set for an AI algorithm.

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MIS Ti-base abutment is a titanium base placed onto MIS dental implants to provide support for customized cement-retained or screw retained single or multiple-unit restorations.

It is used with a digitally designed mesostructure. MIS Ti-base and the mesostructure make up a two-piece abutment used in conjunction with MIS dental implants, to be placed in the upper or lower jaw arches, in order to restore masticatory function.

Narrow platform Ti-bases are indicated for use only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws.

MIS short implants are to be used only with straight abutments.

Mesostructures for use with the MIS Ti-base abutment are to be made from inCoris ZI, designed and manufactured using Sirona CEREC SW version 4.6.1 Software.

MIS Ti-base abutments are intended for use with the following MIS implants:

C1 conical connection implant system. V3 conical connection implant system. SEVEN internal hex implant system. M4 internal hex implant system and Lance+ internal hex implant system.

The subject MIS Ti-base abutments are endosseous dental implant abutments intended to be connected to MIS dental implants and used to support CAD/CAM customized cement-retained or screw retained single or multiple-unit restorations.

MIS Ti-base abutments consist of a titanium base and a prosthetic screw, both made of TI-6AI-4V ELI complying with ASTM F136. The prosthetic screw tightens the finished CAD/CAM abutment to the dental implant.

MIS Ti-base abutments are the bottom-half/base of a two-piece custom zirconia-titanium abutment consisting of a zirconium coping/mesostructure and a titanium base.

The top-half custom zirconia coping/mesostructure or crown is intended to be fabricated from Sirona inCoris ZI zirconium oxide ceramic block and designed and milled using Sirona chairside Dental CAD/CAM System, with software version: CEREC SW version 4.6.1. The mesostructure design will be subject to the Sirona system controls, such as: A maximum angulation of 20° and minimum wall thickness of 0.5mm. The InCoris Zi mesostructure is to be cemented to the subject MIS Ti-base abutments using PANAVIA F 2.0 dental cement in order to complete the two-piece, CAD/CAM abutment.

lt is not permitted to reduce the Ti-base's diameter, shorten the Ti-base or modify its implant-abutment connection and emergence profile in any way.

The subject pre-fabricated titanium base abutment is designed with interface compatibility to specific MIS dental implant systems. The subject MIS Ti-base abutments are MIS conical connection and internal hex connection Ti-base abutments, and their connection is compatible with MIS conical connection C1 and V3 implants, and MIS SEVEN, M4 and Lance+ internal hex implants, which are not subject to this submission and were previously cleared.

Here's a breakdown of the requested information based on the provided FDA 510(k) document for the MIS Ti-base Abutment.

Important Note: This document describes a dental abutment, not an AI/ML device. Therefore, many of the requested fields regarding AI/ML-specific study aspects (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to this type of medical device submission. The FDA 510(k) process for a device like this focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance testing.

Device Name: MIS Ti-base Abutment
Regulation Number: 21 CFR 872.3630
Regulation Name: Endosseous Dental Implant Abutment
Regulatory Class: Class II
Product Code: NHA

1. Table of Acceptance Criteria and Reported Device Performance

For non-AI/ML medical devices like this, "acceptance criteria" are tied to demonstrating substantial equivalence to a predicate device, often through mechanical and material testing against established standards. The performance is assessed against these standards and comparative data from the predicate.

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

• Sample Size for Test Set:
  • For Fatigue Testing (ISO 14801:2016), samples were tested. While a specific number isn't explicitly stated on the provided pages, ISO 14801 typically requires a sufficient number of samples (often 5-10 per test group) to achieve statistically meaningful results for fatigue curves. The document refers to testing "worst case abutments" from both narrow and standard platforms.
  • For Sterilization Testing, an unspecified number of representative samples would have been used for validation.
  • For Software Verification & Validation, the "test set" would be various design scenarios and inputs used to confirm software functionality and adherence to design constraints. The specific "sample size" of test cases is not quantified here.
• Data Provenance: The studies were non-clinical performance tests conducted by MIS Implants Technologies (manufacturer). The location of testing is not specified, but the manufacturer (Dentsply Sirona / MIS Implants Technologies Ltd.) is located in the USA (York, Pennsylvania) and Israel, respectively. These are prospective tests performed specifically for this 510(k) submission.

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

• N/A (Not Applicable for this device type). Ground truth based on expert consensus is typically relevant for AI/ML diagnostic or prognostic devices. For a dental implant abutment, "ground truth" is established by adherence to engineering standards, material specifications, and mechanical performance limits. The "experts" involved would be engineers and quality control personnel responsible for developing and conducting the tests, interpreting standard requirements, and designing robust products. Their qualifications would be in relevant engineering, materials science, and quality assurance fields.

4. Adjudication Method for the Test Set

• N/A (Not Applicable for this device type). Adjudication methods like 2+1 or 3+1 are used in clinical studies, especially for AI/ML devices, where human readers (often physicians) independently evaluate medical images or data, and a tie-breaking or consensus process is needed. For mechanical and software performance testing, adjudication is based on objective measurements and established pass/fail criteria from international 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

• No. This is not an AI/ML device, so an MRMC study comparing human reader performance with and without AI assistance was not conducted and is not relevant.

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

• N/A. This is not an AI/ML algorithm. Its "performance" is mechanical and procedural, not algorithmic. The software component (CEREC SW) is for design and manufacturing, not for automatic diagnosis or interpretation.

7. The Type of Ground Truth Used

• For this device, the "ground truth" is established by:
  • Engineering Standards: Adherence to established international voluntary consensus standards (e.g., ISO 14801:2016 for fatigue, ANSI/AAMI/ISO 17665 for sterilization).
  • Material Specifications: Compliance with material standards (e.g., ASTM F136 for TI-6Al-4V ELI).
  • Validated Design & Manufacturing Parameters: Verification that the CAD/CAM software maintains design limitations and that the manufacturing process yields correct physical properties.
  • Predicate Device Performance: Comparative performance data against the legally marketed predicate devices serves as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

• N/A. This is not an AI/ML device, so there is no "training set." The development process relies on engineering design, material science, and established manufacturing practices, not machine learning.

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

• N/A. As there is no training set for an AI/ML model, this question is not applicable.

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Dentium Ti-Base abutments are intended for use on Dentium endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.

All digitally designed abutments for use with Dentium Ti-Base abutments are intended to be sent to a Dentium-validated milling center for manufacture.

Dentium Ti-Base is a patient specific abutment fabricated by Dentium and composed of unalloyed titanium and zirconia ceramic. The Ti-Base has a titanium pre-manufactured precision abutment/implant interface and ceramic superstructure bonded to the post of the titanium base. Ti-Base is used for support of CAD/CAM fabricated zirconia superstructures or for support of hybrid crowns or bridges. Hybrid crowns or bridges and zirconia superstructures are manufactured by a Dentium validated milling center.

Ti-Base Abutments are available in two prosthetic diameters (4.5 and 5.5 mm) and four gingival heights (0.5, 1.0, 1.5, and 2.0 mm). Each of the abutments is available indexed and non-indexed. All subject device abutments are compatible with Dentium and Dentium Superline dental implants.

The provided text describes a 510(k) premarket notification for the Dentium Ti-Base dental abutment, establishing its substantial equivalence to previously marketed predicate devices. This type of submission relies on non-clinical performance data rather than extensive clinical studies with specific acceptance criteria as might be seen for novel devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size: Not explicitly stated for any of the non-clinical tests. For ISO 14801, typical sample sizes are small (e.g., n=5 or n=10 per test condition), but this is not specified.
• Data Provenance: The studies are non-clinical (laboratory/mechanical testing). The manufacturer is Dentium Co., Ltd. in the Republic of Korea. Therefore, the data originates from the manufacturer's testing or a contracted testing facility. All data is presumably prospective as it was generated to support the 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

• This information is not applicable as the studies are non-clinical performance tests for a device seeking substantial equivalence, not a diagnostic algorithm requiring expert-established ground truth. The "ground truth" for these tests is defined by the standards (ISO 17665-2, ISO 10993-5, ISO 14801).

4. Adjudication Method for the Test Set

• This information is not applicable as the studies are non-clinical performance tests and do not involve human adjudication for a "test set" in the context of diagnostic assessment.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical dental abutment, not a diagnostic AI system that would assist human readers.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study was not done. The device is a physical medical device. The "digitally designed abutments" mentioned refer to CAD/CAM processes used in manufacturing, but this is a manufacturing method, not an AI algorithm requiring standalone performance evaluation in the medical sense.

7. Type of Ground Truth Used

• The "ground truth" applied here is primarily established international standards for medical device testing (e.g., ISO 17665-2 for sterilization, ISO 10993-5 for cytotoxicity, ISO 14801 for mechanical strength). For substantial equivalence, the performance is compared against the characteristics of legally marketed predicate devices.

8. Sample Size for the Training Set

• This information is not applicable. The device is a physical product, not an AI/ML algorithm that is "trained" on a dataset. The manufacturing process might involve CAD/CAM software, but this is distinct from an AI training set.

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

• This information is not applicable as there is no "training set" in the context of an AI/ML algorithm.

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Ti-Base for individual Zirconium Abutments: The devices covered by this submission are abultments which are placed into a dental implant to provide support for a prosthetic restoration.

The Ti-Base for individual Zirconium Abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The Ti-Base abutments are indicated for use with the following implant systems:

• Nobel Biocare® Replace Select® .
• Nobel Biocare NobelActive TM .
• Biomet 3i® Osseotite® .
• Biomet 3i® Osseotite® Certain® .
• Nobel Biocare Branemark® ●
• Straumann® synOcta® .
• Straumann® Bone Level® .
• Zimmer® Tapered Screw-vent® .
• Astra Tech OsseoSpeed® .
• Dentsply-Friadent® Frialit® .

2-CONnect Abutment for Bridges and Bars: 2-CONnect for Bridges and Bars is indicated for use to provide support for prosthetic restorations such as bars and bridges. The 2-CONnect abutments can be used in multiple tooth restorations. The 2-CONnect abulment can be used together with cemented bridges and bar constructions for functional and aesthetical reconstruction. The 2-CONnect abutments are indicated for use with the following implant systems:

• Nobel Biocare® Replace Select® .
• Straumann® synOcta® .
• Straumann® BoneLevel® .

The Ti-Base Abutment is a premanufactured prosthetic component supplied in two parts, the abutment and screw, for fixation onto dedicated endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.

The 2-CONnect Abutment consists of 1 Abutment with screw (for fixation of abutment to the implant) and 1 titanium cap with 1 tiny screw (fixed into the hollow Abutment screw). The cap on top fits exactly to the abutment-geometry and does not have a rotation fixation, so it is easier to work with (not indicated for single crowns but strictly for bridges). The 2-CONnect is intended for use as an aid in prosthetic rehabilitation.

The NT-Trading Ti-Base and 2-CONnect is compatible, with commercially available dental CAD/CAM systems, such as 3Shape, Exocad, Dental Wings. Such systems must be validated by the user.

This K111935 510(k) submission describes the acceptance criteria and study for the NT-Trading Ti-Base Abutment and 2-CONnect Abutment, which are dental abutments.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states: "Testing was performed on the abutments in this submission with the implants that they are intended to fit." However, the exact sample size (number of abutments/implants tested) and the data provenance (e.g., country of origin of the data, retrospective or prospective) are not specified in the provided 510(k) summary.

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

This submission pertains to a medical device (dental abutments) and relies on engineering and performance testing (fatigue testing) rather than a clinical study with a "ground truth" established by human experts in the context of diagnostic performance. Therefore, the concept of "experts establishing ground truth" as it applies to diagnostic studies is not applicable here. The "ground truth" for this device is its physical performance under specified standards.

4. Adjudication Method for the Test Set

As this is a performance study based on engineering standards (fatigue testing), an adjudication method in the context of human expert disagreement is not applicable. The results are based on objective measurements and predefined pass/fail criteria according to ISO 14801.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This is a performance study for a physical device, not a diagnostic or AI-assisted interpretation study. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

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

No, a standalone "algorithm only" performance study was not done. This device is a physical dental abutment, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for this study is based on engineering standards and objective physical measurements in a laboratory setting, specifically fatigue testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous implants.

8. The Sample Size for the Training Set

The provided document describes a device subject to performance testing, not a machine learning model. Therefore, the concept of a "training set" and its sample size is not applicable.

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

As there is no training set for this device, the question of how its ground truth was established is not applicable.

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