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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 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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BioHorizons CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer® Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm, 4.5mm and 5.7mm internal hex-connection mating platform diameters.

All digitally designed abutments and/or copings for use with BioHorizons CAD/CAM Abutments are intended to be sent to a BioHorizons-validated milling center for manufacture. BioHorizons abutments designed using CAD/CAM techniques must fulfill the BioHorizons allowable range of design parameters.

BioHorizons CAD/CAM Abutments are dental implant final restorative abutments supplied in platform diameters of 3.0mm, 3.5mm, 4.5mm and 5.7mm. The abutments are intended to provide support for dental prosthetic restorations. Each abutment includes an abutment screw for fixation to the underlying implant. Abutment material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

Select abutments are further processed by applying patterns of micro-machined grooves or channels, known as Laser-Lok, to a specified region of the abutment margin. The abutments are provided non-sterile, and they are packaged using materials known in the industry to be appropriate for medical device packaging.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the BioHorizons CAD/CAM Abutments:

The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval (510(k)). This means the "acceptance criteria" are largely based on showing the device performs comparably to existing, legally marketed devices, rather than establishing de novo performance targets. The "studies" are tests conducted to support this claim of equivalence.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list numerical acceptance criteria in a typical pass/fail format with specific thresholds. Instead, the acceptance criteria are implicitly defined by the performance of the predicate devices and relevant industry standards. The reported device performance is demonstrated through various tests designed to show that the BioHorizons CAD/CAM Abutments perform in accordance with their intended use and are substantially equivalent to predicate devices.

Further Details on the Study:

Given the nature of this 510(k) submission for a dental abutment, it's highly unlikely that components like "test sets," "ground truth experts," "adjudication methods," or "MRMC comparative effectiveness studies" were part of the presented data. These concepts are more typically associated with diagnostic imaging AI/ML devices or clinical trials involving complex human interpretation.

Therefore, many of the requested items below will be marked as "Not Applicable" or "Not Provided" based on the document's content and the typical scope of device approval for implant components.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size (Test Set): Not explicitly stated for each test, but implied to be sufficient for compliance with the respective standards (e.g., ISO 14801 typically requires 12 samples per group for fatigue testing). The document mentions "worst-case 30° angled configurations" and "representative subset" for compatibility testing.
   • Data Provenance: Not specified, but generally assumed to be internal laboratory testing by the manufacturer or contracted labs. The document does not indicate data from human subjects or clinical sites.
   • Retrospective or Prospective: Not applicable as these are laboratory and validation tests, not clinical studies involving patient data.

2. 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. The "ground truth" for mechanical and sterilization testing is defined by the physical properties measured against engineering standards (e.g., fracture strength, SAL level). For software validation, it's the correct implementation of defined design parameters. No human expert "ground truthing" in the sense of clinical interpretation is relevant here.

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

   • None. Adjudication methods are relevant for ambiguous human interpretations, which is not the case for material property or mechanical performance testing.

4. 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 a diagnostic device involving human readers or AI assistance.

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

   • Not Directly Applicable. While software validation for the CAD/CAM milling process was performed (an "algorithm only" component), this isn't a standalone diagnostic AI. Its "performance" is about correctly enforcing design parameters, not making a diagnosis or prediction. The core device is a physical product, not a software algorithm presented for standalone performance evaluation in a clinical context.

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

   • Engineering Standards / Defined Specifications:
     • For Dynamic Mechanical Fatigue: ISO 14801 standards and BioHorizons' internal performance specifications for expected strength and durability.
     • For Compatibility: Physical fit and function with the specified implant systems.
     • For Sterilization: AAMI/ANSVISO 17665-1:2006, specifically achieving a Sterility Assurance Level (SAL) of 10⁻⁶.
     • For Software: BioHorizons' allowable range of design parameters and criteria.

7. The sample size for the training set

   • Not Applicable. As a physical medical device submission, there is no "training set" in the context of machine learning algorithms. The design process for the abutments is based on engineering principles and existing product lines, not data training.

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

   • Not Applicable. (See above, no training set for this type of device submission).

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