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The LOCATOR Angled Abutment is indicated for the attachment of full or partial, fixed and removable restorations retained by endosseous implants to restore masticatory function for the patient.

The purpose of this submission is to expand the Indications for Use of the LOCATOR® Angled Abutment product line (K243272 & K233587) by adding compatibility of existing abutments with various new dental implant systems from Implant Direct and Biohorizons. Additionally, the submission expands the Indications for Use of the product line with a modified version of the predicate device shown to be compatible with the Implant Logistics Implant-One Series 300 and Series 400 Implant Systems. The LOCATOR Angled Abutment is designed and intended for the attachment of full or partial, fixed and removable, restorations retained by endosseous implants in the mandible or maxilla, as cleared to be used with LOCATOR FIXED (K213391) and LOCATOR Attachment Systems (K072878).

The LOCATOR Angled Abutments are manufactured from titanium (Ti-6Al-4V) and are titanium nitride (TiN) coated in various abutment heights, identical to the predicate device. The LOCATOR Angled Abutment interfacing features are provided at a 15 degree angle to allow for angle correction, substantially equivalent to the predicate device of K233587 and K243272. The abutments will be used with the accessories of the LOCATOR Implant Attachment System (retention inserts, denture attachment housing, and ancillary processing parts) and LOCATOR FIXED Attachment System (fixed inserts, denture attachment housing) for the attachment of a restoration, identical to the predicate device.

The provided document is an FDA 510(k) clearance letter for the LOCATOR® Angled Abutment, K250721. This document primarily focuses on demonstrating substantial equivalence to a predicate device and expanding indications for use, rather than detailing a study that proves the device meets specific performance acceptance criteria for a new clinical application.

Therefore, much of the requested information regarding study design, sample sizes, expert involvement, and ground truth establishment (which are typical for AI/ML device clearances or those requiring extensive clinical performance data) is not present in this type of regulatory submission for a dental implant abutment.

However, based on the information provided, I can construct a table for the acceptance criteria and reported "performance" in the context of this 510(k) submission, which is primarily a demonstration of mechanical compatibility and safety rather than a clinical efficacy study.

Here's an interpretation based on the provided text:

Overview of Device Performance and Acceptance Criteria (as per the 510(k) Submission)

The LOCATOR® Angled Abutment (K250721) is a dental implant abutment. The "study" proving it meets acceptance criteria in this context is a series of non-clinical tests and engineering analyses demonstrating its compatibility with various dental implant systems and confirming its mechanical properties and biocompatibility are substantially equivalent to previously cleared devices. The acceptance criteria are implicitly met by showing conformance to established standards and similarity to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as "sample size" in the conventional sense for a clinical trial. For physical testing (fatigue, packaging), standard engineering test specimen numbers would have been used, but these are not detailed. For material and biocompatibility, existing data was leveraged. Functional compatibility was primarily through engineering analysis.
• Data Provenance: The data comes from in-vitro non-clinical testing and engineering analyses conducted by the manufacturer, Zest Anchors, LLC, or leveraged from previous submissions (K243272, K233587, K213391, K072878, K173701, K102822). The origin is the manufacturer's internal testing and regulatory submissions. The nature of these tests is "retrospective" in the sense that results from previous validated tests (e.g., K233587 for TiN coating, K072878 for biocompatibility) are being applied ("leveraged") to demonstrate equivalence for the current device, implying these tests were performed in the past.

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

• Number of Experts: Not applicable. For this type of device (dental abutment) and submission (510(k) for expanded compatibility), "ground truth" is established through engineering specifications, material standards, and validated physical/mechanical testing protocols (e.g., ISO, ASTM). It does not involve human expert consensus on clinical images or patient outcomes.
• Qualifications of Experts: N/A, as the "ground truth" is based on objective, standardized physical and material properties, confirmed by engineering analysis.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is not a study requiring human adjudication of results. Engineering and laboratory tests have objective pass/fail criteria or conformance to standards.

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

• MRMC Study Done? No. MRMC studies are typically for AI/ML devices where human readers interpret diagnostic images. This device is a physical dental implant component.
• Effect Size of Human Readers Improvement: Not applicable.

6. Standalone Performance Study (Algorithm Only)

• Standalone Performance Study Done? No. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device's "performance" and "acceptance" is based on:
  • Engineering specifications and drawings: Ensuring physical compatibility (e.g., fit with implants).
  • International Standards: Conformance to mechanical testing standards (ISO 14801:2016 for fatigue), material standards (ASTM F136), and biocompatibility standards (ISO 10993 series).
  • Predicate device performance: Demonstrating that the subject device's design, materials, and performance characteristics are "identical" or "substantially equivalent" to previously cleared devices.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

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

• How Ground Truth Established: Not applicable.

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BioHorizons Tapered Pro Conical dental implants are intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

BioHorizons Tapered Short Conical dental implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or fixed bridgework and dental retention. These dental implants must be restored using delayed loading, for single tooth replacement, or may be used with a terminal or intermediate abutment for fixed or removable bridgework or for overdentures. Tapered Short Conical implants should be used only when there is not enough space for a longer implant. If the ratio of crown length is unfavorable, the biomechanical risk factors have to be considered and appropriate measures have to be taken by the dental professional.

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 CAD/CAM Ti Blanks and Ti Bases are to be sent to a BioHorizons validated milling center for manufacture.

The purpose of this submission is to obtain marketing clearance for an endosseous dental implant and abutment system, Tapered Pro Conical Implant System, from BioHorizons Implant Systems Inc. The Tapered Pro Conical Implant System includes a range of ental implants and prosthetic components, BioHorizons Tapered Pro Conical implants feature a tapered screw-shaped design with a reverse buttress thread. Cutting flutes are incorporated into the thread to be self-tapping when placed into the prepared surgical site. The outer surface of the implant has been roughened with resorbable blast texturing (RBT) using a hydroxyapatite blast media. Internally, the implant features a deep conical prosthetic connection between implants and abutments with six anti-rotation cams at the base of the connection, intended to interface with the three cams of the prosthetic components. It is available with or without Laser-Lok treatment applied to the collar of the implant.

Tapered Pro Conical Implants are available in a range of implant diameters and lengths with two prosthetic platform (implant/abutment connection) sizes, as shown below. Internal surfaces of the Tapered Pro Conical Regular platform implants are anodized yellow to distinguish them from Narrow platform implants.

Abutments are available in multiple designs, including straight and angled abutments intended for single tooth and multi-unit restorations. The Conical Ti-Base abutments are a two-piece abutment composed of a pre-manufactured Ti Base component and a CAD/CAM patient-matched mesostructure (superstructure) composed of sagemax® NexxZr zirconia (K130991).

The provided text is a 510(k) premarket notification summary for a dental implant system. It does not describe a study to prove the device meets acceptance criteria related to an AI/ML-driven medical device, nor does it contain information on the performance data, sample sizes, expert ground truth establishment, or multi-reader multi-case studies typically associated with such devices.

The document focuses on demonstrating substantial equivalence to predicate dental implants and their components. The "PERFORMANCE DATA" section (page 7 of the PDF, starting on page 8 of the transcription) lists non-clinical data such as validation of sterilization, bacterial endotoxin testing, shelf-life testing, biocompatibility, MRI compatibility, and mechanical testing, which are standard for dental implants.

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information about acceptance criteria and a study proving the device meets those criteria, specifically for an AI/ML medical device.

To be explicit, the document states:

• "No clinical data were included in this submission." (Page 7)
• The performance data discussed are entirely non-clinical and relate to the physical and material properties of the dental implants, not an AI or software component assessing images or providing diagnostic assistance.

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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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The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using the included prosthetic screw and attached to the zirconia superstructure by cementing.

The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in Table 1.

All digitally designed zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are only intended to be sent and manufactured at an FDA registered Elos Medtech approved milling facility.

The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and to support a patient-specific ceramic superstructure or a multi-unit direct restoration cemented to the base. The base and the superstructure form a patient-specific abutment that will support a definitive restoration, either a single crown or a multi-unit restoration. The Elos Accurate Hybrid Base Engaging is intended for single-unit restorations and Elos Accurate Hybrid Base Nonengaging is intended for multi-unit restorations. Alternatively, a definitive multi-unit restoration may be cemented directly to the Elos Accurate Hybrid Base.

Manufacture of the final finished device will be at an Elos Medtech-approved milling facility that is registered with FDA as a medical device manufacturer and is qualified as a contract manufacturer to Elos Medtech.

This submission includes a two-piece abutment (titanium base and zirconia superstructure) and abutment screws compatible with OEM implants from Dentsply Implants (Astra Tech TX, Astra Tech EV), Nobel Biocare (Nobel Active/Conical Connection and Nobel Replace) and Institut Straumann (Straumann Bone Level NC and RC).

Abutments compatible with Astra Tech implants are available in engaging (anti-rotational) designs, and all others are available in both engaging and non-engaging designs.

This document is a 510(k) Premarket Notification from the FDA regarding the "Elos Accurate® Hybrid Base" dental implant device. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study with acceptance criteria.

Therefore, the information required to directly answer some of your questions, particularly those related to the performance study design for an AI/ML-based medical device (e.g., sample size for test/training sets, expert consensus, MRMC studies, ground truth establishment for AI models), is not present in this document. This is because the device in question is a physical dental implant component, not an AI/ML algorithm.

However, I can extract the relevant information regarding the performance data provided for this physical device.

Here's a breakdown based on the provided document:

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

The document does not present a formal table of acceptance criteria and reported device performance in the way an AI/ML device submission would. Instead, it states that substantial equivalence is demonstrated through:

• Biocompatibility evaluation and confirmatory cytotoxicity testing: According to ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity).
• Dynamic compression-bending testing: According to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants).
• Engineering and dimensional analysis: To confirm compatibility with OEM implant bodies, OEM abutments, and OEM abutment fixation screws.
• Sterilization validation: In accordance with ISO 17665-1 and ISO 17665-2.

Reported Performance/Demonstration:

• "Substantial equivalence with regard to compatibility with OEM components is supported by engineering and dimensional analysis of OEM implant bodies, OEM abutments and OEM abutment fixation screws to confirm compatibility."
• "Substantial equivalence with regard to mechanical performance is supported by dynamic testing according to ISO 14801 Dentistry – Implants – Dynamic fatigue test for endosseous dental implants."
• "The coatings used on selected screws are identical to coatings on previously cleared devices."
• "Sterilization validation of the reprocessing instructions were conducted in accordance to ISO 17665-1 and ISO 17665-2."
• "Minor differences in the designs, dimensions, sizes, or compatible OEM implant lines... do not affect substantial equivalence. These minor differences... are related to the compatible OEM implant designs or are mitigated by the mechanical performance testing."

2. Sample sized 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 any of the non-clinical tests (biocompatibility, dynamic fatigue, engineering analysis, sterilization). The document indicates "No clinical data were included in this submission," further confirming that there wasn't a "test set" in the context of patient data for AI performance evaluation.
• Data Provenance: Not applicable as it's not clinical data. The tests are laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This device is a physical component, not an AI/ML diagnostic tool requiring expert ground truth for image interpretation.

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

• Not applicable. As above, this is not a diagnostic study 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. No clinical or human-in-the-loop study was conducted or required for this physical device.

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

• Not applicable. This is not an algorithm. The "performance data" refers to the physical and mechanical properties of the dental abutment.

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

• For the non-clinical performance data, the "ground truth" or reference standards are the ISO standards themselves (ISO 10993-5, ISO 14801, ISO 17665-1, ISO 17665-2), and the engineering specifications/dimensions of OEM implant components for compatibility analysis. This is a technical ground truth based on established material science and mechanical engineering principles, rather than medical expert consensus or patient outcomes.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of an AI/ML model for this physical device.

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

• Not applicable. As above, no training set for an AI/ML model.

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MIST IC 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. MIST IC abutments are compatible for use with the following implants:

Keystone Dental Implant Line Platform Diameter (mm) Body Diameter (mm) Genesis 3.8, 4.5, 5.5, 6.5 3.8, 4.5, 5.5, 6.5 PrimaConnex® 1.0 (Straight) 3.5, 4.1, 5.0 3.3, 4.0, 5.0 PrimaConnex® 1.0 (Tapered) 3.5, 4.1, 5.0 3.5, 4.1, 5.0

All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture.

MIST IC abutments include three abutment designs, MIST IC S-LINK, and MIST IC S-LINK, and MIST IC PREFIT, having connections compatible with three Keystone Dental implant systems. Subject device are provided in three interface connection diameters (SD (3.5 mm), RD (4.1 mm) and WD (5.0 mm)). All subject device abutments have the same connection type to the compatible Keystone Dental implants cleared in K101545 and K051614. Corresponding compatible implant platform diameters range from 3.5 mm to 6.5 mm. Corresponding compatible implant body diameters range from 3.3 mm. All sizes of the compatible Keystone Dental implants have one of the three interface connection sizes (SD, RD, and WD).

All subject device L-LINK and S-LINK abutments are two-piece abutments to be used as a base when fabricating a CAD/CAM customized restoration where the superstructure produced will compose the second part of the twopiece abutment; the assembly becoming a final finished medical device after cementation on the subject device abutment. The zirconia superstructure will be fabricated using a CAD/CAM process. MIST IC S-LINK has a cut out in the post to accommodate a restoration with an angled screw channel when clinically necessary. MIST IC PREFTT abutments are titanium cylindrical abutments designed for patient specific abutment fabrication using a CAD/CAM process. All patient-specific abutment fabrication on the order of the clinician.

Design parameters for the L-LINK zirconia superstructure are: minimum wall thickness -0.5 mm; minimum post height for single-unit restoration - 4.0 mm; maximum gingival height - 5.0 mm; and maximum angle - 20°.

Design parameters for the S-LINK zirconia superstructure are: minimum wall thickness - 0.7 mm; minimum post height for single-unit restoration - 4.0 mm; maximum gingival height - 5.0 mm; and maximum angle - 20°.

Design parameters for the PREFIT patient specific abutment are: minimum wall thickness - 0.5 mm; minimum post height for single-unit restoration - 4.0 mm; maximum gingival height - 5.0 mm; and maximum angle - 30°.

All subject device components (abutments and abutment screws) are made of titanium alloy conforming to ASTM F136. Zirconia superstructures for subject device abutments are made of Y-TZP conforming to ISO 13356.

All subject device components are provided non-sterile, and are intended to be end-user sterilized.

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Preat Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. The Titanium Base abutments consists of two major parts. Specifically, the titanium base and mesostructured components make up a two-piece abutment.

All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Blank are to be sent to a Preat validated milling center for manufacture.

Preat Abutments is a dental implant abutment system that includes ten (10) abutment designs compatible with twelve (12) OEM implant systems. The subject device abutment platform diameters range from 3.0 mm to 6.5 mm, and the corresponding compatible implant body diameters also range from 3.0 mm to 6.5 mm. The subject device includes the following abutment designs: temporary, esthetic angled 15°, multi unit straight, multi-unit angled 17°, ball (Clix Ball and O-Ring), titanium base, and titanium blank. The system also includes corresponding abutment screws.

All abutments and screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and are provided non-sterile to the end user. All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Base or Titanium Blank are to be sent to a Preat validated milling center for manufacture. All superstructures are to be manufactured from zirconia conforming to ISO 13356.

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.

For the Titanium Base abutment, the design parameters for the CAD/CAM zirconia superstructure are: Minimum wall thickness - 0.5 mm; Minimum post height for single-unit restorations - 4.0 mm; Maximum gingival height - 5.0 mm; and All zirconia superstructures are for straight abutments only.

The design parameters for the CAD/CAM Titanium Blank custom abutment are: Minimum wall thickness - 0.5 mm; Minimum post height for single-unit restoration - 4.0 mm; Maximum Angle - 30°; and Maximum gingival height - 1.5 mm to 2.65 mm (varies by implant line).

The provided document is a 510(k) Premarket Notification for dental implant abutments. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance data from a clinical or standalone study. Therefore, most of the requested information regarding acceptance criteria for an AI/device performance study, sample sizes for test/training sets, expert qualifications, and ground truth establishment is not available in this document.

The document details the technical and material characteristics of the Preat Abutments and compares them to predicate devices to argue for their equivalence. It includes non-clinical performance data related to mechanical testing, sterilization, and biocompatibility, but not data related to an AI's diagnostic performance or human reader improvement with AI assistance.

Here's an attempt to answer the questions based on the provided text, indicating when the information is not present:

Analysis of Device Performance and Acceptance Criteria (Based on Substantial Equivalence)

This 510(k) submission for Preat Abutments relies on demonstrating substantial equivalence to existing legally marketed predicate devices. The "acceptance criteria" here are implicitly related to meeting the performance characteristics and safety profiles of these predicates, rather than specific statistical thresholds for a new diagnostic algorithm's accuracy or efficacy. The "study" proving acceptance is primarily the non-clinical testing performed and the comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the context of an AI/diagnostic performance study. For the mechanical testing, the document states "worst-case constructs were subjected to static compression fatigue testing," but does not specify the number of samples or "test set" size.
• Data Provenance: Not applicable for location (country of origin), as this is a physical device testing submission. The data is from laboratory testing (mechanical, biocompatibility, sterilization validation). The testing is prospective in nature, as it was conducted specifically for this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. There is no "ground truth" established by experts in the context of a diagnostic performance study. The ground truth for mechanical and material properties is based on established engineering standards and test methods (e.g., ISO 14801, ISO 10993, ISO 17665).

4. Adjudication Method for the Test Set

• Not applicable. No human-based adjudication was performed for a diagnostic test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No. This is not a submission for a diagnostic AI device, so an MRMC comparative effectiveness study was not performed.
• Effect Size: Not applicable.

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

• No. This is not an AI algorithm submission. The "standalone" performance here relates to the physical device's mechanical and material properties, which were tested in a laboratory setting as described under "Performance Data."

7. The Type of Ground Truth Used

• For physical device performance: The "ground truth" is defined by international standards (e.g., ISO 14801 for mechanical testing, ISO 10993 for biocompatibility, ISO 17665 for sterilization) and engineering specifications derived from predicate device performance and design. It's not clinical outcomes data or expert consensus in the diagnostic sense.

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." The understanding of predicate device performance and design parameters, which inform the design and testing of the subject device, is derived from existing regulatory clearances and documented technical specifications of those predicate devices.

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BioHorizons Tapered IM Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

The BioHorizons Tapered IM Implants are machined titanium, screw-form endosseous dental implants supplied in 7.0mm and 8.0mm diameters. Both implants include a 5.7mm prosthetic platform. The implants are provided in 7.5mm, 9.0mm and 10.5mm lengths across both diameters. Implant material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surqical Implant Applications. The devices are further processed by roughening the threaded surface with Resorbable Blast Texture (RBT) media (hydroxylapatite) and by micro-machining grooves, known as Laser-Loke microchannels, on the implant collar. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10°, validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

The provided document is a 510(k) Premarket Notification from the FDA for a dental implant device. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a performance study with acceptance criteria in the typical sense of a human-in-the-loop or standalone AI/software study.

Therefore, many of the requested points regarding acceptance criteria and performance study details (like sample size, number of experts, adjudication, MRMC, standalone performance, training data, etc.) are not applicable to this type of submission. This document describes a medical device (a dental implant), not a diagnostic AI or imaging device that would typically involve such performance metrics and studies.

However, I can extract the relevant information pertaining to the "acceptance criteria" and "study" as presented in the context of this 510(k) submission, which are focused on physical and mechanical properties of the implant and demonstrating its safety and effectiveness through substantial equivalence.

Here's a breakdown based on the provided document:

Relevance of the Document to the Request:

This document is a 510(k) Premarket Notification for a dental implant (a physical medical device). The primary objective of a 510(k) submission is to demonstrate that the new device is substantially equivalent (SE) to a legally marketed predicate device, meaning it is as safe and effective as the predicate. This is different from a clinical trial or performance study typically conducted for AI/software-as-a-medical-device (SaMD) where metrics like sensitivity, specificity, or reader accuracy are paramount.

Therefore, many of the questions asked in the prompt, which are highly relevant to SaMD performance studies, are not directly addressed or applicable in this document about a physical dental implant.

Acceptance Criteria and Study for BioHorizons Tapered IM Implants (based on provided text):

The "acceptance criteria" and "study" in this context refer to the engineering and quality control measures to demonstrate the new implant's mechanical integrity, material compatibility, and manufacturing consistency, primarily by comparing it to already cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set (for dimensional assessment): Not explicitly stated as a numerical sample size. It refers to "the worst-case subject Tapered IM implant device (smallest implant body diameter combined with the shortest implant length)." This implies a single representative sample was chosen for a comparative dimensional analysis, demonstrating a specific design characteristic rather than a statistical test on a batch.
• Test Set (for mechanical fatigue): Not explicitly stated for the subject device. For the predicate devices, which were used to establish equivalence, the test involved the "worst-case 3.8mm x 15mm Tapered Internal Plus implant assembled with a 3.0mm Angled Esthetic Abutment" and "the worst-case 3.8mm x 15mm Tapered Internal implant assembled with a 3.5mm Angled Custom Abutment." The phrase "three consecutive fatigue runouts" suggests at least three samples of the predicate devices were tested to 5 million cycles.
• Data Provenance: The data are from BioHorizons Implant Systems, Inc., a U.S.-based company. The studies referenced (dimensional assessment, retrospective mechanical testing, sterilization validation, endotoxin testing, material conformity) are internal or industry-standard tests; the document implies typical
  • Retrospective for the mechanical testing of the predicate devices (data was already available from previous 510(k)s).
  • Prospective/Current Quality Control for endotoxin testing, sterilization validation, and the dimensional assessment of the subject device.

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

• Not Applicable. This document pertains to the physical and mechanical properties of a dental implant, not a diagnostic task requiring expert human interpretation of data/images to establish ground truth for a test set. Ground truth for these tests is based on engineering measurements, physical endurance testing, chemical analysis, and microbiological validation, conforming to industry standards (e.g., ISO, ASTM, USP).

4. Adjudication Method for the Test Set:

• Not Applicable. As above, no human "adjudication" in the sense of reconciling clinical interpretations is required for physical and mechanical testing of a device. The results are from quantifiable measurements and standard methods.

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 a 510(k) for a physical dental implant, not an AI/software 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 "standalone performance" here refers to the device's physical performance (e.g., strength, material properties) as demonstrated through engineering tests.

7. The Type of Ground Truth Used:

• The "ground truth" for the device's performance is established through:
  • Engineering Specifications and Measurements: For dimensional assessment (wall thickness).
  • Mechanical Testing Standards: For fatigue testing (meeting ISO 14801 standards and surviving specified cycles).
  • Material Standards and Chemical Analysis: For material composition (ASTM F136).
  • Sterilization Standards and Validation: For sterility (ANSI/AAMI/ISO 11137-1).
  • Microbiological Standards: For endotoxin levels (USP ).
  • Established Predicate Device Performance: The primary "ground truth" for substantial equivalence is the safety and effectiveness of the legally marketed predicate devices, which the new device is demonstrated to be similar to in design, materials, and function, with comparable or superior performance in key engineering metrics.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device that requires a "training set" in the context of machine learning.

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

• Not Applicable. (See #8)

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