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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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Simply Iconic™ dental implants are two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and termediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when stability has been achieved and with appropriate occlusal loading.

Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants are two-piece implants for one-stage or twostage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. The Legacy 2, Legacy3, and Legacy4 fixture-mounts are intended for use with the corresponding dental implants (Legacy3, and Legacy4, respectively). The fixture-mounts can function as an abutment, fixture-mounts are intended for use with dental implants in the maxillary and/or mandbular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

Custom Titanium Abutments are customizable devices intended for use with dental implants in the maxillary and or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

The Legacy™ SMARTBase Abutment system is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially edentulous patient. Legacy SMARTBase engaging abutments are intended for use in the mandible or maxilla in support of single unit restorations.

InterActive/SwishActive Implant System consists of two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or internediate SMARTBase support for fixed bridgework.

Implant Direct Custom Bars are patient specific devices indicated for attachment to dental implants in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function.

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.

InterActive/SwishActive Implant System consists of two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multipleunit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Legacy3 6mm Length consists of two-piece implants for one-stage or two-stage surgical procedures. There implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or internediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

InterActive/SwishPlus2 Implant System consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework: Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Spectra-System Dental Implants 2008 are comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. The implants are intended for use in the mandible and maxilla, in support of single unit or multiple unit cement or screw-receiving restorations and for the retention and support of overdentures. The implants are intended for immediate placement and function for the support of single-tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

The SwissPlant Dental Implant system consists of two-piece implants for one or two-stage surgical procedures that are intended for use in partially or fully edentulous maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained or overdenture restorations and in terminal or immediate abutment support for fixed bridgework. The SwissPlant dental implants are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing initial implant stability and appropriate occlusal loading, to restore normal masticatory function.

Spectra-System Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations such as crowns, bridges, overdentures or custom prosthetic fabrications in a partially or completely edentulous patient. Spectra-System Abutments are intended for use in the mandble or maxilla. Prostheses can be screw or cement retained to the abutment.

The ReActive Dental Implant System are dental implant fixtures that are a part of a two-piece implant system. The ReActive implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

ScrewIndirect Narrow Dental Implants for single-stage surgical procedures intended for use in partially or fully edentulous mandibles and maxillae, in support of complete or partial denture prostheses or as a terminal or intermediary attachment for fixed or removable bridgework via interface with copings. These implants are intended for for support of splinted multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met.

The RePlus Dental Implants with HA coating are dental implant fixtures that are a part of a two-piece implant system. The RePlus implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The immediate loading for support of single tooth and/or multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met.

The ScrewPlus Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system that is to be used for single-stage or two-stage surgical procedures. The ScrewPlus implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restoration and support of overdentures. The implants are intended for immediate placement and function for multiple tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

The Legacy Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system. The Legacy implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

The Spectra Dental Implant System consists of one-piece implants for single-stage or two- stage surgical procedures that are intended for use in partially or fully edentulous mandillae, in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. They may be placed in immediate function if initial implant stability can be established.

The Legacy Abutment System is intended for use with dental implants in the maxillary and/or mandbular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients.

Not Found

The provided text is a compilation of Indications for Use statements for various dental implant systems and components, all under the umbrella of "Implant Direct Dental Implant Systems Portfolio - MR Conditional." Each section describes the intended use for a specific product or family of products, often referencing previous 510(k) clearances.

Crucially, this document does not contain any information about acceptance criteria or studies that prove the device meets these criteria. It is a regulatory filing for the Indications for Use for a medical device which has already been cleared by the FDA to be "substantially equivalent" to predicate devices.

Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets the acceptance criteria based solely on the provided text. The document is for describing what the device is for, not how its performance was tested or validated.

To provide the requested information, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a validation plan for a specific performance characteristic.

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The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented, or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. CreoDent Solidex Customized Abutments and Screws to be compatible with the Implant Direct InterActive/Swish Active 3.0mm implants are only indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

The Solidex® Customized Abutment and Screw is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 standard and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutment and Screw are compatible with:

| Manufacturer | Implant Line | Platform
Diameter
(mm) | Implant
Body
Diameter
(mm) | Max
Diameter | Wall
Thickness
(mm) | Height
Min/Max
(mm) | Post
Height
Min/Max
(mm) | Collar
Height
Min/Max
(mm) | Angulation
Min/Max
(Degress) |
|-------------------------------|--------------|------------------------------|-------------------------------------|--------------------------------|---------------------------|---------------------------|-----------------------------------|-------------------------------------|------------------------------------|
| Neodent
Implant
Systems | GM Line | 3.5/3.75 | 3.5/3.75 | 5mm
from
Implant
Axis | .68 | 5 - 10 | 4 - 9 | 1 - 5 | 0 - 20 |
| Manufacturer | Implant Line | Platform
Diameter
(mm) | Implant
Body
Diameter
(mm) | Max
Diameter | Wall
Thickness
(mm) | Height
Min/Max
(mm) | Post
Height
Min/Max
(mm) | Collar
Height
Min/Max
(mm) | Angulation
Min/Max
(Degress) |
| Implant Direct
Sybron
Manufacturing
LLC | 2014
InterActive/SwishActive
System | 3.0 | 3.0 | 5mm
from
Implant
Axis | .68 | 5 - 10 | 4 - 9 | 1 - 5 | 0 - 20 |

The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, height, collar height and angulation.

This document, K220390, is a 510(k) Premarket Notification of intent to market the CreoDent Solidex® Customized Abutment and Screw. The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than detailing a study that proves the device meets specific acceptance criteria for a novel AI/software component.

Therefore, many of the requested elements for an AI/software study (e.g., sample size for test/training sets, ground truth establishment for AI, MRMC studies, effect size, etc.) are not applicable to this specific document as it is for a physical medical device (dental abutment and screw) and not an AI-powered device.

However, I can extract the information relevant to the device's performance demonstration for its intended function (mechanical strength and biocompatibility), which serves as its "acceptance criteria" for safety and effectiveness in the context of this 510(k) submission.

Here's a breakdown based on the provided document and the non-applicability of AI/software-specific questions:

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

For a physical device like a dental abutment, acceptance criteria primarily revolve around meeting established mechanical and biological safety standards for its intended use.

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated for each test, but standard for mechanical and biocompatibility testing of medical devices involves a sufficient number of samples to ensure statistical validity and representativeness (e.g., typically N=5 or N=10 for fatigue testing, multiple test specimens for biocompatibility). The document refers to "worst-case scenario" which implies targeted testing.
• Data Provenance: The testing was non-clinical (laboratory-based). "T.Strong INC obtains titanium alloy and c.p. titanium from US suppliers." CreoDent Prosthetics finalizes the abutment device at their manufacturing facility in New York. The testing would have been conducted by or for the manufacturer or a contracted lab.

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

• Not Applicable. This is a physical device, and the "ground truth" is established by adherence to recognized international standards (ISO, ASTM) for mechanical and biological properties, which are defined by material specifications and test methods, not expert consensus readouts.

4. Adjudication method for the test set

• Not Applicable. See point 3. Mechanical and biocompatibility tests are pass/fail based on objective measurements against predefined limits in standards.

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

• No. This is a physical device, not an AI-powered diagnostic or assistive tool. MRMC studies are for evaluating human performance (e.g., clinicians reading images) with and without AI assistance.

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

• No. This is a physical device, not an algorithm.

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

• The "ground truth" for this physical device is defined by established international standards (ISO, ASTM) and material specifications for mechanical properties (e.g., fatigue life, strength) and biocompatibility (e.g., absence of cytotoxicity). It's objective measurement against these standards, not a subjective interpretation.

8. The sample size for the training set

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

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

• Not Applicable. See point 8.

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The Zuga™ Dental Implant System is indicated for immediate or delayed implant placement for surgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges, and overdentures. The Zuga™ Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The Zuga™ Dental Implant System includes endosseous dental implants, sealing caps, healing caps, dental implant abutments, and fixation screws in a variety of sizes to accommodate differing patient anatomy. Implantation is suitable for one-or two-stage procedures. Endosseous implants are bone level, self-tapping, root-form, threaded. The threaded surface is blasted, then passivated. Sizematched anterior and posterior abutments are offered. Thes are fastened to the implant using a fixation screw. Sealing caps and healing caps provide protection to the abutment connection threads during endosseous and gingival healing. The implants are provided sterile, the remaining components must be sterilized prior to use.

The provided text describes a 510(k) premarket notification for the Zuga™ Dental Implant System. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving that the device meets a set of specific acceptance criteria through clinical performance metrics like sensitivity, specificity, or accuracy, as would be common for AI-driven diagnostic devices.

Therefore, the document does not contain the information requested regarding acceptance criteria in terms of performance metrics for an AI/ML device, nor does it detail a study proving the device meets such criteria with respect to AI performance.

Instead, the "Performance Data" section ([15]) focuses on biological and mechanical compatibility/safety testing, which is standard for medical devices like dental implants. These tests are designed to show that the physical device itself is safe and performs as intended, not to evaluate an AI algorithm's diagnostic or predictive capabilities.

Here's an breakdown of the information present and what's missing, based on the prompt's requirements:

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

• Present: The document lists various tests performed and their outcomes which act as "acceptance criteria" for a physical medical device. These are:
  • Static fatigue tests and dynamic fatigue tests (per ISO 14801 and FDA Guidance): "The results show that the Zuga™ Dental Implant System has sufficient mechanical strength for the intended clinical application."
  • Cytotoxicity testing (per ISO 10993-5 and USP ): "The results showed that the Zuga™ Dental Implant System received a passing score and is thus acceptable for clinical application."
  • Sterility tests (per ISO 10993, ISO 11137-1, 11137-2, ISO 17665-1, 17665-2): "yielded no difference in performance between the Zuga™ Dental Implant System and the predicate device."
  • LAL (Limulus Amebocyte Lysate) bacterial endotoxin tests (per ISO 10993 and USP , ): "yielded a EU/Device value that was less than the established acceptance criteria of 20 EU/Device".
  • Shelf life tests (per ISO 11607): "established the shelf life to be five years provided the sterile seal is not breached."
• Missing (for an AI/ML device context): Specific performance metrics like sensitivity, specificity, accuracy, AUC, FROC, etc., and their corresponding acceptance thresholds.

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

• Present: For LAL tests, it states: "The sampling plan consists of selecting 3% of the batch up to a maximum of 10 samples to be pooled for testing."
• Missing (for an AI/ML device context): Sample size for a "test set" of patient data (e.g., medical images, clinical records) for an AI algorithm. Data provenance (country of origin, retrospective/prospective) is not applicable or mentioned for these physical/biological tests.

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

• Missing: This information is not relevant to the mechanical/biological testing of a physical implant. It would be crucial for an AI/ML device based on clinical data.

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

• Missing: Not applicable to the presented data.

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:

• Missing: Not applicable. This device is a physical dental implant, not an AI-assisted diagnostic tool.

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

• Missing: Not applicable.

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

• Present (for physical device tests): The "ground truth" here is adherence to international standards (ISO, ASTM) and USP guidelines for mechanical strength, biocompatibility, sterilization, and endotoxin levels.
• Missing (for an AI/ML device context): Clinical ground truth established by experts or pathology for diagnostic purposes.

8. The sample size for the training set:

• Missing: Not applicable, as this is not an AI/ML device.

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

• Missing: Not applicable.

In summary: The provided document is an FDA 510(k) clearance letter for a physical dental implant system. Its "acceptance criteria" and "performance data" relate to the mechanical, chemical, and biological safety and efficacy of the implant itself, demonstrated through adherence to various international and US standards. It contains no information relevant to the development, testing, or performance of an AI/ML device.

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TAV Medical Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth and in order to restore the patient chewing function. The Implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

TAV Medical Dental Implant System is a two piece dental implant system for one stage or two stage surgical implantation of dental implant provided with cover screw and supported by a compatible abutment systems and surgical instruments. The implant is fabricated from a medical grade titanium alloy 6Al 4V ELI, according to ASTM F136. TAV Medical implant includes a body portion and a collar. The body portion is configured to extend into and Osseo integrate with the alveolar bone. The top surface of the collar lies flush with the crest of the jawbone bone. TAV Medical abutment lies on the top surface and extends through the soft tissue, which lies above the alveolar bone. The abutment supports the final prostheses. TAV Medical implants include the following brands: Silhouette, Sirius, and iCone. TAV Medical Abutments are intended for used as an adapter between the implant and the crown. The abutments are characterized by four distinct geometrically features: Height/length, angle, diameter and internal/external hex lock or conical connection. Anodized Color coding is used for categorical consideration only. TAV Medical abutments, as other available in the market of dental prosthetics are dental components composed either of titanium (Ti 6AL 4V ELI), PEEK and Yttrium Stabilized Zirconia (ZrO2). All the abutments fixation screws are composed of Ti 6AL 4V ELI. The abutments are supplied non-sterile to be sterilized by the physician before use according to the accompanied instruction for use. Abutment device refers to the fixture that is assembled on the implant. The crown is then built on the abutment. The prosthetic parts are divided into 3 main categories: Cemented retained restorations, Screw retained restorations, and Overdenture retained. Various abutment types are available: Titanium Abutments, Temporary Esthetic PEEK Abutments, Ball attachment, Locker overdenture, and Healing caps.

Here's an analysis of the provided text regarding the acceptance criteria and study for the TAV Medical Dental Implant System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" in the format typically used for AI/ML device performance. Instead, it details that the device underwent various non-clinical tests to demonstrate equivalence to predicate devices and adherence to established standards. The acceptance criteria for each test (e.g., biocompatibility according to ISO 10993-1, SAL of 10^-6 for sterilization, satisfactory results for mechanical and biological tests where material differences exist) are implicitly linked to the relevant standards or the statement of "satisfactory results" or "meets design specifications."

Here's a summary of the non-clinical testing performed and the reported performance, as extracted from the text:

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

• Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of patient cases or imaging data, as this is a medical device (dental implant system) and not an AI/ML diagnostic software. The "test set" refers to the physical devices and materials undergoing various engineering, biological, and material tests. The specific number of implants, abutments, or material samples used for each test is not detailed.
• Data Provenance: Not applicable in the context of clinical/imaging data provenance, as no such data was used. All testing appears to be non-clinical (bench testing, biocompatibility, sterilization validation).

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

Not applicable. Ground truth in this context refers to the defined parameters and expected outcomes of the physical and chemical tests performed on the dental implants. This is established by engineering standards, material specifications, and regulatory guidelines, rather than expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations (e.g., radiological reads). Here, the performance is measured against objective, measurable criteria from established scientific and engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers with vs. without AI Assistance

Not applicable. This is not an AI/ML medical device, so no MRMC studies involving human readers or AI assistance were performed or are relevant.

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

Not applicable. This is not an AI/ML medical device.

7. The Type of Ground Truth Used

The "ground truth" for the TAV Medical Dental Implant System is based on:

• Mechanical and Material Standards: Compliance with ISO (e.g., ISO 14801 for fatigue testing, ISO 13356 for Zirconia materials) and ASTM (e.g., ASTM F746 for corrosion) standards.
• Biocompatibility Standards: Conformance to ISO 10993 series and FDA guidance on biocompatibility.
• Sterilization and Packaging Standards: Compliance with ANSI/AAMI/ISO 11137 and ISO 11607-2.
• Design Specifications: The device met its own established design specifications, which are implicitly derived from the intended use and comparison to predicate devices.
• Predicate Device Equivalence: The performance results were considered "satisfactory" if they demonstrated equivalence to the safely and effectively marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML medical device.

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

Not applicable. This is not an AI/ML medical device.

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The Anatotemp Anatomic Dental Implant Healing Abutment is a pre-manufactured healing abutment intended for use with endosseous root-form dental implants to aid in prosthetic rehabilitation. The abutment is a temporary device that aids in creating an esthetic emergence through the gingiva during the healing period. The single use, sterilized device is used by dental professionals during the dental implant healing process and is removed prior to permanent prosthetic placement.

Anatotemp Anatomic Dental Implant Healing Abutments are compatible with the following implant systems:

The Anatotemp Anatomic Dental Implant Healing Abutment product line includes anatomically shaped temporary dental implant healing abutments that aid in creating an esthetic emergence through the gingiva during the healing period. Anatotemp Anatomic Dental Implant Healing Abutments are made of a polymethylmethacrylate biocompatible plastic and are held securely to an endosseous implant with a titanium abutment screw. Anatotemp Anatomic Dental Implant Healing Abutments are positioned well below the occlusal plane and are non-load bearing components that guide healing tissue.

Anatotemp Anatomic Dental Implant Healing Abutments are designed not to be in occlusion or sustain occlusal forces. Anatotemp Anatomic Dental Implant Healing Abutments come in six shapes that mimic original tooth shape at the gingival level and also exhibit a mild, biconcave shape interproximally that aids in creating an esthetic emergence through the gingiva during the healing period. Anatotemp Anatomic Dental Implant Healing Abutments exhibit anti-rotational connections that are compatible with many dental implant connections. Anatotemp Anatomic Dental Implant Healing Abutments are provided sterile, are single use, and are recommended for temporary placement of no longer than 180 days. Anatotemp Anatomic Dental Implant Healing Abutments are removed after dental implant healing (approximately 90-180 days) and replaced by the permanent abutment and crown.

The provided text describes a 510(k) premarket notification for the "Anatotemp Anatomic Dental Implant Healing Abutment." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria through a clinical study with a specific test set, ground truth, and expert adjudication as one would find for a novel AI/imaging device.

Therefore, many of the requested criteria cannot be directly extracted from this document, as the regulatory pathway for this device (a dental implant healing abutment) does not involve the same type of performance evaluation as, for instance, an AI-powered diagnostic imaging system.

This document primarily relies on non-clinical testing (biocompatibility, chemical characterization, packaging, sterilization, shelf-life, and reverse engineering analysis) and comparison to a predicate device to establish substantial equivalence. It explicitly states that "Formal clinical studies were not conducted to support the claim for substantial equivalence to the predicate device."

Here's an attempt to address your points based on the provided text, highlighting where information is not applicable or not present for this type of device submission:

Acceptance Criteria and Device Performance for the Anatotemp Anatomic Dental Implant Healing Abutment

Since this is a 510(k) submission for a physical medical device (dental implant healing abutment) demonstrating substantial equivalence to a predicate, the "acceptance criteria" and "device performance" are typically related to material properties, biocompatibility, sterility, and functional equivalence, rather than diagnostic accuracy metrics as would be seen for an AI system. The study described is a series of non-clinical tests and a comparison.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the standards and characteristics required for demonstrating substantial equivalence to the predicate device, as well as the successful completion of the non-clinical tests. Performance is reported as meeting these standards.

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

• Test Set Sample Size: For the non-clinical testing, specific sample sizes are not explicitly stated for each test (e.g., number of animals for biocompatibility, number of packages/devices for sterilization/packaging). The document mentions "sample of the OEM implants were measured" for reverse engineering. This is not a "test set" in the context of an AI study.
• Data Provenance: Not applicable for this type of submission. The data is generated from internal company testing and contract lab testing, not patient data from a specific country or collected retrospectively/prospectively in a clinical setting.

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

• Not applicable. This device does not use human "experts" to establish a ground truth for performance evaluation in the way an AI diagnostic imaging system would. The "ground truth" for the non-clinical tests is established by adherence to recognized international standards (ISO, ASTM, USP) and laboratory protocols.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" in the context of human interpretation or diagnostic accuracy for this device.

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

• No. The document explicitly states: "Formal clinical studies were not conducted to support the claim for substantial equivalence to the predicate device..." An MRMC study is a type of clinical study, typically for diagnostic devices or AI assistance in interpretation.

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

• The "ground truth" for this submission type is based on:
  • Regulatory Standards: Compliance with ISO, ASTM, and USP standards for biocompatibility, sterility, packaging, etc.
  • Engineering Specifications: Data derived from reverse engineering analysis of OEM implant systems to ensure compatibility.
  • Predicate Device Equivalence: The characteristics and performance of the legally marketed predicate device (Contour Healer).

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device. There is no "training set."

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

• Not applicable. There is no "training set."

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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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