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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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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 LOCATOR Angled Abutment consists of various height abutments with identical attachment features compared to LOCATOR Abutments of the LOCATOR Implant Attachment System, cleared in K072878. The LOCATOR Angled Abutment 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. 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. The LOCATOR Angled Abutments are manufactured from titanium (Ti-6Al-4V) and are titanium nitride (TiN) coated, identical to the predicate device.

This document (K243272) is a 510(k) premarket notification for a dental device, the LOCATOR Angled Abutment. It is important to note that this document does not describe the performance of software or an AI device. Instead, it describes a mechanical dental implant component and its substantial equivalence to previously cleared predicates.

Therefore, many of the requested categories related to AI/software performance criteria, expert adjudication, MRMC studies, ground truth establishment for AI/ML, and training set information are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the acceptance criteria (in terms of performance testing for a mechanical device) and how the device meets them:

1. Table of Acceptance Criteria (for a mechanical device) and Reported Device Performance:

Study Details (for a mechanical device):

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

   • Specific quantitative sample sizes for each mechanical test (e.g., number of abutments fatigued, number of coatings tested) are not detailed in this summary.
   • The data provenance is from non-clinical performance testing conducted by the manufacturer, Zest Anchors, LLC. This is typically internal laboratory testing.
   • The nature of the tests (fatigue, coating, packaging, functional fit) indicates this is prospective testing performed specifically to support this regulatory submission. Country of origin for data is not specified but is implicitly from the manufacturer's testing facilities (likely USA, given the submission location).

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

   • This question is not applicable as the "ground truth" for a mechanical device is established through objective engineering measurements and standardized performance tests (e.g., ISO, ASTM standards), not by human expert consensus on interpretations. The "experts" involved would be qualified engineers and technicians performing the tests.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth from multiple human readers/experts in AI/medical image analysis. For mechanical device testing, the results are objectively measured and compared against predefined performance specifications.

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 device is a mechanical dental abutment, not an AI or software product. Therefore, no MRMC study involving human readers and AI assistance was conducted or is relevant.

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

   • Not applicable. This device is a mechanical abutment, not an algorithm.

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

   • The "ground truth" for this device's performance is based on established engineering principles, material science specifications, and adherence to international standards (e.g., ISO 14801, ASTM F1044, ASTM F1147, ISO 10993). Functional fit was verified against OEM implant specifications through direct testing.

8. The sample size for the training set:

   • Not applicable. This is a mechanical device, not a machine learning model. There is no "training set."

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

   • Not applicable. As above, no training set exists for this type of device.

In summary, the provided document explicitly states that the submission aims to demonstrate substantial equivalence of the new LOCATOR Angled Abutment variations to existing predicate devices. This is achieved by showing that the new abutments share the same intended use, principles of operation, materials, manufacturing processes, and fundamental design, and they meet the same functional and performance characteristics through non-clinical testing. The "acceptance criteria" here refer to the successful completion and passing of these engineering and material performance tests against established standards.

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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 LOCATOR Angled Abutment is designed to be used with LOCATOR FIXED and LOCATOR Attachment Systems for the attachment of full or partial, fixed and removable, restorations retained by endosseous implants in the mandible or maxilla. The LOCATOR Angled Abutment consists of various height abutment bodies with an integrated abutment screw. The attachment features are identical compared to LOCATOR Abutments of the LOCATOR High Retention Attachment System (LOCATOR FIXED), cleared in K213391. The LOCATOR Angled Abutment is compatible with Straumann BLX Implant System cleared in K173961. The LOCATOR Angled Abutment 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. The LOCATOR Angled Abutment uses identical attachment features as the LOCATOR Abutments, but instead of the attachment features being aligned coaxially, the interfacing features are provided at a 15 degree angle to allow for angle correction, substantially equivalent to the device of K190040. The LOCATOR Angled Abutments and integrated abutment screw are manufactured from titanium (Ti-6Al-4V). The LOCATOR Angled Abutment body is titanium nitride (TiN) coated, identical to LOCATOR Abutments.

The provided FDA 510(k) summary for the "LOCATOR Angled Abutment" does not describe a study involving an AI/Machine Learning (ML) device or any specific performance metrics for such a device like sensitivity, specificity, or AUC, or a comparative effectiveness study involving human readers.

This submission is for a medical device (dental implant abutment) and focuses on demonstrating substantial equivalence to a predicate device through physical and mechanical testing, material compatibility, and intended use.

Therefore, I cannot provide a detailed answer to your request based on the provided text, as the information required (acceptance criteria for an AI/ML device, details of an AI/ML study, ground truth establishment, expert adjudication, MRMC studies, etc.) is not present.

In summary, the document does not contain the information needed to answer your questions regarding acceptance criteria and performance of an AI/ML device.

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MegaGen Dental Implant Abutment is intended to be surgically placed in the maxillary or mandibular areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patients chewing function. All digitally designed abutments for use with ZrGEN Abutment are intended to be sent to a MegaGen validated milling center for manufacture.

The submission includes descriptions for the following devices: Scan Healing Abutment, Temporary Abutment, Temporary Cylinder, Comfort Cap, Healing Cap, Healing Cap Screw, Milling Abutment, EZ Post Abutment/Extra EZ Post Abutment, EZ Post Cylinder, ZrGEN Abutment, Multi-unit Abutment, Multi-unit Angled Abutment, AXA Abutment (Straight), AXA Abutment (Angled), Abutment Screw, Cylinder Screw, and Crown Screw. Each description details the intended use, material, surface treatment, sterilization, single use status, dimensions, and compatible implant systems.

The provided document, a 510(k) premarket notification from MegaGen Implant Co., Ltd. for their "MegaGen Dental Implant Abutment" device, focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving that the device meets specific acceptance criteria through a standalone study.

For medical devices, especially those going through the 510(k) pathway, acceptance criteria are typically based on showing that the new device performs as safely and effectively as a legally marketed predicate device. The "study" proving this is primarily a non-clinical performance testing (bench testing) and a comparison to predicate devices. Clinical studies are often not required for 510(k) submissions, as explicitly stated in this document ("No clinical studies are submitted.").

Therefore, the acceptance criteria are implicitly defined by the performance characteristics of the predicate devices and general standards (like ISO 14801 for dental implants) as outlined in the "Summary of Non-Clinical Testing" section. The device performance is demonstrated through a comparative analysis to these predicates and the results of the bench testing.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission, the "acceptance criteria" for the subject device are fundamentally its demonstration of substantial equivalence to predicate devices, meaning it performs as safely and effectively. The "reported device performance" is a direct comparison to the predicate devices and adherence to relevant standards.

The document provides extensive comparison tables for each component of the MegaGen Dental Implant Abutment system against its predicate and reference devices. Below is a representative excerpt from these tables, focusing on a few key components to illustrate the comparison:

Example: Scan Healing Abutment

Summary of Device Performance (Based on "Substantial Equivalence Discussion" sections for all components):

The subject device is deemed substantially equivalent to its predicate/reference devices across all listed components (Scan Healing Abutment, Temporary Abutment, Temporary Cylinder, Comfort Cap, Healing Cap, Healing Cap Screw, Milling Abutment, EZ Post Abutment/Extra EZ Post Abutment, EZ Post Cylinder, ZrGEN Abutment, Multi-unit Abutment, Multi-unit Angled Abutment, AXA Abutment (Straight), AXA Abutment (Angled), Abutment Screw, Cylinder Screw, Crown Screw).

Any identified differences in characteristics (e.g., specific dimensions like diameter, gingival height, post height, total length, or surface treatment for some components) are explicitly discussed and concluded not to affect substantial equivalence. This is often supported by arguing that the differences are minor, fall within the range of cleared devices, allow for more precise treatment, or are supported by bench testing (e.g., fatigue tests for worst-case scenarios).

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

The document does not detail specific sample sizes for test sets in the context of clinical data, as no clinical studies were submitted.

For non-clinical testing (bench tests), the document states:

• "The bench tests have been performed in accordance with 'ISO 14801' and the recommendations of 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment' to evaluate the performance of the subject devices and the test results met the pre-set criteria."
• For ZrGEN Abutment, AXA Abutment (Angled type), and other potentially "worst-case" scenarios, fatigue tests were conducted to demonstrate performance and stability.

The data provenance is pre-market non-clinical testing data generated by the manufacturer. The country of origin for the manufacturing and testing is Republic of Korea (MegaGen Implant Co., Ltd. is based in Daegu, Republic of Korea). The data is prospective in the sense that it was specifically generated for this 510(k) submission to demonstrate equivalence.

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

This information is not applicable (N/A) as no clinical studies were conducted or submitted. For non-clinical bench testing, "ground truth" is established by adherence to recognized standards (like ISO 14801) and established testing methodologies, not typically by expert consensus of medical professionals on a test set.

4. Adjudication Method for the Test Set

This information is N/A as no clinical studies with human readers or image interpretation were conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement

This information is N/A as no clinical studies were conducted, and certainly no MRMC studies involving human readers, as this is a physical dental implant component, not an AI or imaging device that would typically involve human-in-the-loop performance evaluation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is N/A as the device is a physical dental implant abutment, not a software algorithm.

7. The Type of Ground Truth Used

For the purpose of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is:

• Performance specifications derived from legally marketed predicate devices.
• Adherence to recognized international standards (e.g., ISO 14801 for mechanical properties, ISO 10993-1 for biocompatibility, ISO 11137 for sterilization) for manufacturing and material properties.
• Results of non-clinical bench testing to confirm physical and mechanical performance characteristics.

There is no "expert consensus," "pathology," or "outcomes data" in the typical sense of a clinical study since none were performed.

8. The Sample Size for the Training Set

This information is N/A. The device is a physical product, not an AI/ML model that requires a "training set."

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

This information is N/A as there is no training set for a physical device.

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Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crown, bridges, or over-dentures.

The Angled Abutment is made from Ti-6Al-4V Eli (conforming to ASTM F136). Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crown, bridges, or over-dentures. The Angled Abutment has two types of connection (HEX and Non-HEX). The Angled Abutment connections compatible with NB 1 SA Implant System and NB Implant System. The Angled Abutment surfaces are partially TiN coated. Angled Abutments are supplied with an abutment screw previous cleared device as K213506.

The dimension ranges of the subject device are below:

Angled Abutment and Abutment Screw (Cleared in K213506) are provided non-sterile. The abutment should be sterilized before use by end user sterilization. These devices are intended for single use only.

The Angled Abutment is compatible with the following implant systems.

The provided text is an FDA 510(k) summary for a dental device called an "Angled Abutment." It does not contain any information about an AI/ML powered device, a study involving human readers, or any other data that would allow for the detailed description requested in the prompt regarding acceptance criteria and a study to prove performance for an AI/ML product.

The document primarily focuses on demonstrating the substantial equivalence of the "Angled Abutment" to previously cleared predicate devices based on its materials, design, intended use, and mechanical performance testing (specifically static and fatigue testing according to ISO 14801).

Therefore, I cannot fulfill your request for information related to:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size and data provenance for an AI/ML test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods for a test set.
• MRMC comparative effectiveness study or effect size.
• Standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
• Sample size for training set or how its ground truth was established for an AI/ML device.

The document is solely about a physical dental implant component and its mechanical and material properties. The 'Performance Data' section only mentions biocompatibility, sterilization validation, mechanical performance testing (ISO 14801), and MR environment condition assessment – none of which involve AI/ML.

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The Multi-unit Abutment, Multi-unit Angled Abutment is intended to the maxillary or mandbular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals.

The Multi-unit Abutment, Multi-unit Angled Abutment of a dental implant system to provide support for prosthetic restorations. It is attached to the implants and intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore patient's chewing function. The Multi-unit Abutment, Multi-unit Angled Abutment consists of straight & angled abutments and prosthetic components in varying sizes for single & multiple unit screw retained restorations.

Here's an analysis of the provided text regarding the acceptance criteria and study for the dental device:

Acceptance Criteria and Device Performance for MegaGen Implant Co. Ltd.'s Multi-unit Abutment, Multi-unit Angled Abutment (K203808)

This submission is a 510(k) premarket notification for dental implant abutments. The primary method of demonstrating acceptance and substantial equivalence is through comparison to predicate devices and performance testing according to established international standards (ISO 14801) and FDA guidance documents. There is no AI component or related acceptance criteria described in this document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical thresholds within the document, as the submission focuses on demonstrating substantial equivalence to existing predicate devices. The performance is assessed by confirming that the subject device meets the requirements of relevant standards, implying that its performance is comparable to or better than the predicate devices.

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

The document does not explicitly state the sample sizes used for the non-clinical performance (bench) testing. Similarly, the data provenance (e.g., country of origin, retrospective/prospective) for these tests is not specified beyond indicating they were performed in accordance with international standards. Given it's a Korean manufacturer, the testing likely occurred in Korea or at facilities that adhere to these international standards.

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

This section is not applicable as the device is a dental implant abutment, and the document describes a 510(k) submission based on substantial equivalence and non-clinical bench testing. There is no mention of a "ground truth" derived from expert consensus on patient cases for evaluation in the context of diagnostic or interpretive performance.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert readers independently assess cases and discrepancies are resolved. The submission relies on bench testing and comparison to predicates, not clinical interpretation studies.

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

No, an MRMC comparative effectiveness study was not done. This type of study involves human readers interpreting cases, often with and without AI assistance, to measure diagnostic performance. The submission pertains to a physical dental device (abutments) and does not involve AI or human-in-the-loop performance evaluation.

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 concept is specific to AI/CADe (Computer-Assisted Detection/Diagnosis) devices. The submitted device is a mechanical component, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically defined for diagnostic or AI studies (expert consensus, pathology, outcomes data) does not apply here. For this device, the "ground truth" for demonstrating acceptance is adherence to engineering specifications, material standards, and performance benchmarks established by international standards (ISO 14801) and FDA guidance documents. The acceptable performance of the predicate devices acts as the benchmark.

8. The Sample Size for the Training Set

Not applicable. The device is a physical product (dental implant abutment). There is no "training set" in the context of machine learning or AI algorithms for this type of submission.

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

Not applicable. As there is no training set for an AI algorithm, there is no ground truth to be established for it.

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Transfer & Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

The Transfer & Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment Screws. Surfaces are partially TiN coated.

The Transfer & Angled Abutment has mini connection structure that is consist two types of connection structure (Non-HEX and HEX (including A type hex)

Non-HEX connection of Transfer & Angled Abutment has a 11° Morse taper structure Hex Mini connection of Transfer & Angled Abutment has a 11° Morse taper structure and 2.08mm Hex connection structure.

Angled Abutment two types of Hex connection (A type hex, B type hex) to set direction (Double hex function)

Hex connection structure has function for anti-rotation

The provided document is a 510(k) premarket notification for a medical device called "Transfer & Angled Abutment." This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study proving that the device meets specific acceptance criteria based on its performance characteristics.

Therefore, many of the requested categories for the description of "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context.

Here's an analysis based on the information provided:

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

This document does not establish specific performance acceptance criteria for the "Transfer & Angled Abutment" as it would for a novel device requiring efficacy or safety trials. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to existing predicate devices (K130662 and K120847). The "reported device performance" is not explicitly quantified in terms of clinical outcomes, but rather inferred from the fact that its material, function, and intended use are highly similar to the predicate devices, and that it passed non-clinical fatigue testing.

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

• Sample Size for Test Set: Not applicable. This submission relies on substantial equivalence to predicate devices and non-clinical fatigue testing, not a clinical test set with human or patient data.
• Data Provenance: The fatigue testing would be laboratory-based (non-clinical). The origin of the device manufacturer is Republic of Korea.

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. No ground truth establishment by experts for a test set is described in this 510(k) summary, as it is not a clinical study.

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

• Not applicable. No adjudication method is described.

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 dental implant abutment, not an AI-powered diagnostic device. No MRMC study was conducted or is relevant.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Non-clinical testing: The "ground truth" for the fatigue testing would be the established engineering standards and guidelines for dental implant abutments (e.g., ISO 14801 or similar, as referenced by the "Guidance for industry and FDA staff Class II Special Controls Guidance Document").
• Substantial Equivalence: The "ground truth" for demonstrating substantial equivalence is the existing performance and safety profile of the predicate devices.

8. The sample size for the training set

• Not applicable. This is not a machine learning model.

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

• Not applicable. This is not a machine learning model.

In summary:

This 510(k) submission successfully argues for substantial equivalence primarily based on:

• Identical materials, coating, manufacturing processes, and packaging to the predicate devices.
• Identical intended use to the predicate devices.
• Dimensional changes (addition of a 4.0mm diameter) which were not deemed to alter the fundamental function or safety.
• Non-clinical fatigue testing performed according to relevant guidance, confirming the mechanical integrity of the device, particularly focusing on a "worst-case scenario."

The FDA's review and clearance indicate that the provided evidence was sufficient to demonstrate that the new device is as safe and effective as the predicate devices, without requiring a detailed clinical performance study with human subjects.

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GPS® Angled Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. These abutments are designed to only receive a fabricated multi-unit bridge or overdenture. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

GPS® Angled Abutments are designed to be used in conjunction with dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. The proposed GPS® Angled Abutments are intended to provide extra prosthetic options currently unavailable to the clinician. The proposed abutments are intended to complement the cleared systems listed in Table 2 below. The proposed abutments have the same compatible implant interface specific to each implant system and platform size. The GPS® Angled abutments have the same coronal GPS Angled Top for all proposed GPS® Angled abutments. The GPS top has a superior outer radius at its coronal region that is identical to the primary predicate GoDirect implants (K090234 - Spectra System Dental Implants 2008). The proposed GPS® Angled abutments are a two-piece design having an identical lower piece with same interface features and angles as the reference predicate InterActive screw receiving angled abutments with a ball top (K130572 - InterActive/SwishPlus2 Implant System).

The provided text describes the 510(k) summary for the GPS® Angled Abutments, detailing their substantial equivalence to predicate devices. Here's a breakdown of the requested information:

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

The document does not explicitly state acceptance criteria in a quantitative format for specific performance metrics (e.g., "Must pass X N of force"). Instead, it confirms that the device meets the "equivalent or higher load" than the primary predicate device when tested according to FDA and ISO standards. The general acceptance criteria are:

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

• Sample Size: The document indicates that testing was performed on "the worst case abutment testing" (InterActive® /SwishActive GPS® Angled Abutment, 3.0 mm Platform) and "the proposed Angled GPS Abutments, primary predicate GoDirect implant and compatible comfort caps." However, it does not provide specific numerical sample sizes (e.g., how many abutments were tested for fatigue).
• Data Provenance: The studies are non-clinical performance data, likely conducted by Implant Direct Sybron Manufacturing, LLC which is located in Thousand Oaks, California, USA. The data is retrospective in the sense that it's generated for a regulatory submission rather than a prospective clinical trial. There's no mention of country of origin of data beyond the company's location.

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 section is not applicable as the document describes non-clinical performance data (mechanical, sterilization, biocompatibility testing) rather than a study requiring expert-established ground truth like image analysis or disease diagnosis.

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

This section is not applicable for the same reason as point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The document describes a medical device (dental abutment), not an AI diagnostic tool that would involve human readers or AI assistance.

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

This section is not applicable for the same reason as point 5.

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

As mentioned in point 3, the studies are non-clinical performance evaluations. The "ground truth" for these tests are universally accepted scientific and engineering standards:

• Mechanical Testing: ISO 14801 standards for fatigue, and static compression tests. The ground truth is the physical failure or endurance limit of the material under applied forces.
• Sterilization: Sterility assurance level (SAL) of 10-6, as per AAMI/ANSI/ISO 17665-1 and ANSVAAMI ST79. The ground truth is the measurable absence of viable microorganisms.
• Biocompatibility: ISO 10993-5 standards for biological evaluation of medical devices. The ground truth is the measurable absence of toxic reaction from the devices.

8. The sample size for the training set

This section is not applicable. The device is a physical medical implant, not an algorithm that requires a training set.

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

This section is not applicable for the same reason as point 8.

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Zimmer 3.1mmD Dental Implants are designed for use in the anterior maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Zimmer 3.1mmD Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical). The Zimmer 3.1mmD Dental Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.

The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are used for attachment of restorations requiring off-axis correction. The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are designed to be used in edentulous or partially edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement.

The 2.9mm Contour Abutment and the 2.9mm Contour Abutment, Straight Hex are used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a singleor multiple-unit restoration. The 2.9mm Angled Contour Abutment and the 2.9mm Angled Contour Abutment, Straight Hex are designed to be used as a terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 17°. Abutment can be used for a single- or multiple-unit restoration.

The 2.9mm Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The 2.9mm Temporary Abutment can be used for cementretained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations.

The Ball Abutment is used for retaining overdentures or partial dentures when resilience and facilitated oral hygiene are desired.

The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only.

The Healing Screw is used to seal the implant internal connection and separate it from the soft tissue which is sutured over the implant during healing.

The Retaining Screws are intended to be used for securing the temporary abutments, final abutments and impression transfers to the implant or implant analog. The long Retaining Screw is intended to be used with Temporary Abutments for fabrication of screw-retained provisional restorations and with Impression Transfers for direct impressions.

The Zimmer 3.1mmD Dental Implant System consists of 3.1mm threaded endosseous dental implants, as well as prosthetic components, and ancillary components for placement and restoration of these implants. The prosthetic components include 2.9mm Angled Abutment, 2.9mm Angled Abutment, Straight Hex, 2.9mm Contour Abutment, 2.9mm Contour Abutment, Straight Hex , 2.9mm Temporary Abutment, and 2.9mm Ball Abutment. The 2.9mm Angled, 2.9mm Contour, and 2.9mm Temporary Abutments are made to support single or multiple unit restorations. The 2.9mm Ball Abutments are made to support overdentures. The ancillary components for the Zimmer 3.1mmD Dental Implant System include 2.9mm Healing Collars and 2.9mm Healing Screws which are used during the healing process.

Zimmer 3.1mmD Dental Implant is an endosseous dental implant composed of titanium alloy. The implant body is designed for ease of implantation and with greater surface area for osseointegration. The implant surface is treated to facilitate osseointegration. In addition, the implant body is tapered with triple-lead threads. The Zimmer Dental 3.1mmD Dental Implant is currently offered in 3.1mm diameter in lengths of 8, 10, 11.5, 13, and 16mm. They include two different texturing configurations: full texture to the top of the implant and texture to 0.5mm from the top of the implant. In addition, both texturing configurations of the implant have coronal grooves on the collar to within 0.64mm of the top of the implant similar to the predicate #1: Tapered Screw-Vent Implant Dental Implant. The implant-abutment interface platform diameter will be offered in a size of 2.9mm. The new device will feature MTX surface equivalent to existing Zimmer Dental implants.

The Abutments, Healing Collars, and Healing Screw are titanium alloy devices that are made to mate with the Zimmer 3.1mmD Dental Implant, which is also made of titanium alloy. The abutments are designed for use as a terminal or intermediate abutment prostheses.

The provided text is a 510(k) Premarket Notification for the Zimmer 3.1mmD Dental Implant System. It describes a medical device, not a diagnostic AI system, therefore most of the requested information regarding AI study design and performance metrics is not applicable.

However, I can extract the relevant information about the non-clinical testing performed to establish substantial equivalence.

Acceptance Criteria and Device Performance for Zimmer 3.1mmD Dental Implant System

The Zimmer 3.1mmD Dental Implant System is evaluated based on non-clinical testing to demonstrate substantial equivalence to predicate devices, focusing on mechanical performance and MRI compatibility.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that non-clinical testing indicates the new devices are "strong enough to withstand the anticipated forces and demonstrated improvements over the predicate device(s)." It also confirms that the device "poses no additional restrictions on MRI beyond those that would otherwise occur for the patient."

While specific numerical acceptance criteria (e.g., minimum fatigue strength in MPa or compression load in N) and exact reported device performance values are not explicitly provided in this summary, the general acceptance criteria can be inferred from the nature of the tests and the conclusions drawn:

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set: The document does not specify the sample size used for the fatigue, compression, or MRI compatibility tests. It only states "Non-clinical test data was used."
• Data Provenance: The tests were non-clinical, meaning they were likely conducted in a laboratory setting by Zimmer Dental Inc. The country of origin for the data is not specified, but the applicant information is for Zimmer Dental Inc. in Carlsbad, CA, USA. The data is prospective, as it involves testing of the new device.

3. Number of Experts and Qualifications for Ground Truth

• This is not applicable as the device is a dental implant system being evaluated through non-clinical mechanical and physical property testing, not an AI diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

• This is not applicable, as the evaluation is based on objective measurements from mechanical and physical testing, not subjective expert judgment, which would require adjudication.

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

• This is not applicable. The document describes a medical device (dental implant and associated components), not a diagnostic AI system. Therefore, no MRMC study testing human reader improvement with or without AI assistance was performed.

6. Standalone (Algorithm Only) Performance Study

• This is not applicable. The device is a physical dental implant system, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device is based on objective measurements derived from standardized non-clinical performance tests conforming to FDA guidance and ASTM standards. Specifically:

• Mechanical Integrity: Measured by fatigue and compression testing results.
• MRI Compatibility: Measured by interactions with magnetic fields during MRI.

8. Sample Size for the Training Set

• This is not applicable. The product is a physical device, not an AI model, and therefore does not have a "training set" in the context of machine learning.

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

• This is not applicable, as there is no training set for an AI model.

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Multi Angled Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures.

The Multi Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. The Multi Angled Abutment is used with Esthetic -low Cylinders (only Non-Hex) in the US System, K62030 and connected to HTIII SA Fixture in the HTIII SA Fixture System, K101096. The Multi Angled Abutment system consists of Abutment combined carrier that is tool to carry Multi angled abutment. and Abutment Screw. The Multi Angled Abutment system is exactly same with Multi Angled Abutment (K123755) except combined carrier. Carrier is just to carry the Multi Angled Abutment to implanted Fixture.

The provided document is a 510(k) summary for the OSSTEM Multi Angled Abutment system. This submission does not describe a study to prove a device meets acceptance criteria related to its performance in terms of accuracy, sensitivity, specificity, or other similar metrics.

Instead, this 510(k) summary is for a medical device (dental abutment). The "study" described herein is a comparison to a legally marketed predicate device to establish substantial equivalence for market clearance. This is a common regulatory pathway for medical devices and does not involve the types of performance studies or acceptance criteria typically associated with artificial intelligence or diagnostic software.

Therefore, many of the requested sections (Table of acceptance criteria, sample sizes, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission and device.

Here's a breakdown of the relevant information from the document in response to your request:

1. Table of acceptance criteria and the reported device performance

Not applicable. This is a 510(k) submission for a mechanical dental device, not a diagnostic or AI-driven aid with performance metrics like sensitivity or specificity. The "performance" assessment here is focused on mechanical and material equivalence to a predicate device.

Instead, the submission states:
"The Multi Angled Abutment system is merely improved for movement convenience of abutment by combination of carrier therefore, The Multi Angled Abutment is nothing changed from predicated Multi Angled Abutment (K123755) except combined carrier"

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

Not applicable. No "test set" in the context of performance metrics was used. The evaluation centered on design and material comparison to a predicate device.

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. No a "ground truth" or expert review of performance data was conducted for this type of device submission. The assessment was done by the manufacturer's engineers and subsequently by the FDA reviewers.

4. Adjudication method (e.g. 2+1, 3+1, none) 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. This device is not an AI-assisted diagnostic tool.

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

Not applicable. This device is not an algorithm.

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

Not applicable. The "ground truth" equivalent in this context is the design specifications, material properties, and intended use of the legally marketed predicate device (K123755). The new device is compared against these established characteristics to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable. No training set was used.

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

Not applicable.

Summary of the Study/Evaluation for Substantial Equivalence:

The "study" or evaluation performed for the K132067 submission was a comparison of the Multi Angled Abutment system to a legally marketed predicate device (Multi Angled Abutment, K123755).

• Acceptance Criteria (Implicit for Substantial Equivalence): The primary "acceptance criterion" was to demonstrate that the new device is as safe and effective as the predicate device, or is substantially equivalent. This means:
  • Same intended use.
  • Same or similar technological characteristics.
  • If there are differences in technological characteristics, those differences do not raise different questions of safety and effectiveness.
• Reported Device Performance (in context of substantial equivalence): The document reports that the Multi Angled Abutment system is "exactly same with Multi Angled Abutment (K123755) except combined carrier." The carrier is described as "just to carry the Multi Angled Abutment to implanted Fixture." This modification is stated to be "merely improved for movement convenience of abutment."
  • Intended Use: Identical for both new and predicate device: "intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures."
  • Abutment Angle (°): 17, 30 (same for both)
  • Platform (Ø): 4.8 (same for both)
  • Connection: The core abutment components are identical to the predicate (K123755). The only difference is the addition of a combined carrier.
• Nonclinical Testing: "The risks associated with the modification were evaluated via a DCAS table and it was determined that no performance testing is needed. However, minor modifications were made to the labeling." This indicates that the manufacturer determined the change (addition of a carrier) did not warrant new mechanical or material testing as the core functional components of the abutment remained unchanged from the predicate.
• Clinical Testing: "No clinical studies are submitted."

In essence, the entire argument for meeting the "acceptance criteria" for market clearance (substantial equivalence) is built on the claim that the device is fundamentally the same as its predicate, with a minor, non-performance-affecting addition.

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