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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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Implant-One™ System Abutments are intended for use as an aid in prosthetic rehabilitation in the mandible or maxilla for support of single-unit or multi-unit restorations.

The Implant-One Ti-Base Abutment consists of the titanium base and a mesostructure component, making up a two-piece abutment, and will be attached to the implant using an abutment screw. The mesostructure for use with the Implant-One Ti-Base is intended only to be designed and manufactured according to digital dentistry workflow that integrates scan files from lab scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

The subject devices comprise abutments designed for the 300, 400, and 500 Series of the Implant-One" system. All subject device abutments incorporate a Morse taper at the implant/abutment interface, have a hexagonal male end for alignment purposes and are screw retained. The series is grouped according to the implant/abutment interface size and each series is color coded for ease of identification. The subject devices are Titanium Base Abutments.

The Implant-One™ Titanium Base Abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. The Implant-One" Titanium Base Abutments consist of two major components. Specifically, the titanium base and the mesostructured component make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling.

The standard Ti Base Abutments are offered in cuff heights of 0.5mm, 1.5mm and have a Ø4.0mm profile for the 300 series and a Ø4.5mm profile for the 400 & 500 series.

The following components are intended to be used for scanning, designing and manufacturing of ceramic mesostructures for the Implant-One™ Titanium Base Abutment:

• Lab scanner: Medit/Identica T500 3D Scanner (Medit Corp) ●
• CAD software (PNP): 3Shape Abutment Designer & Abutment Design (3Shape A/S -● K151455 & K200100) and exocad AbutmentCAD (exocad GmbH - K193352)
• Ceramic material: Katana™ Zirconia (Kuraray Noritake Dental, Inc. K143439) ●
• . Milling machine: Ceramill Motion 2 (Amann-Girrbach AG)
• Milling software: Ceramill Match 2 CAM Software (Amann Girrbach AG)
• Cement: RelyX™ Luting Plus Automix Cement (3M ESPE Dental Products K11185) ●

The provided document is a 510(k) Premarket Notification for a dental implant abutment system (Implant-One™ System). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting an AI/ML-based device performance study.

Therefore, the document does not contain the information requested regarding acceptance criteria and performance data for an AI/ML device, as it describes a traditional medical device submission.

Specifically, the following points from your request cannot be addressed based on the provided text:

• A table of acceptance criteria and the reported device performance: This document does not describe acceptance criteria for an AI/ML system or statistical performance metrics. Instead, it describes mechanical testing (ISO 14801) and sterilization validation (ISO 17665-1 and ISO 17665-2) for a physical medical device.
• Sample size used for the test set and the data provenance: There is no "test set" in the context of AI/ML evaluation. The performance data refers to mechanical and sterilization tests, not data for an algorithm.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is irrelevant in this context, as there is no AI/ML algorithm being evaluated.
• Adjudication method: Not applicable due to the absence of an AI/ML performance study.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: The document explicitly states "No clinical data were used in support of this submission," meaning no MRMC study was performed.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable, as this is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

The document primarily focuses on demonstrating that the Implant-One™ System is substantially equivalent to a legally marketed predicate device (NobelActive™ Universal Base Abutments) by comparing their indications for use, technological characteristics, materials, dimensions, and sterilization methods. It mentions "Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the mesostructure component outside of design limitations," which refers to CAD/CAM software used in the manufacturing process, not an AI/ML diagnostic or prognostic algorithm.

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The Implant-One™ Multi-Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for prosthetic rehabilitation of the mandible or maxilla with a multi-unit restoration.

The subject devices comprise abutments designed for the 300, 400, and 500 Series of the Implant-One™ system. All subject device abutments incorporate a Morse taper at the implant/abutment interface, have a hexagonal male end for alignment purposes and are screw retained. The series is grouped according to the implant/abutment interface size and each series is color coded for ease of identification. The subject devices are Angled Multi-Unit Abutments.

The Implant-One Multi-Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. The Implant-One Multi-Use Abutments are indicated for multiple-tooth restorations.

Angled Multi-Unit Abutments are available for the 300, 400, and 500 series and used for multiple implant restorations such as screw retained dentures. These abutments are offered in cuff heights of 2.5 mm and 3.5 mm for all series.

The provided text K212394 is a 510(k) premarket notification for an dental implant abutment. The document describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical performance data.

From the text, there is no information provided regarding acceptance criteria for a study proving device performance in a clinical setting, nor any details of a study involving human subjects or AI algorithms. The submission explicitly states: "No clinical data were used in support of this submission."

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided document does not contain this information.

Specifically, the following points of your request cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: No such clinical performance study or its acceptance criteria are mentioned. The "performance data" section refers to mechanical testing (ISO 14801), sterilization (ISO 17665), biocompatibility (leveraged from K173701), and MRI review (scientific evidence/published literature). These are non-clinical and do not involve "reported device performance" in a clinical sense.
2. Sample sizes used for the test set and the data provenance: Not applicable as no clinical test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as there is no mention of AI assistance or human reader studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as the device is a physical dental abutment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for the reasons mentioned above. For the non-clinical tests, the "ground truth" would be the standard test methods (e.g., ISO standards), but this is not clinical ground truth.
8. The sample size for the training set: Not applicable as this is not an AI/ML clinical study.
9. How the ground truth for the training set was established: Not applicable.

The submission focuses on demonstrating substantial equivalence based on non-clinical performance data (mechanical, sterilization, biocompatibility, MRI safety) and comparison of indications for use and technological characteristics with predicate devices.

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