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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 Omnibut is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

The Omnibut™ is a transmucosal abutment used to support screw-retained prostheses on four or more implants. The subject device has a premanufactured connection for the platforms listed in Table 1 Compatible Implant Systems.

The system involves a ball abutment attached to an implant. A retention attachment allows for angle corrections of up to 30° off the implant axis. The ball abutment is inserted into the attachment is adjusted to the desired angle using an orientation screw. The abutment supports prostheses that connect via titanium cylinders, which are incorporated into resin or ceramic prostheses. Finally, the prostheses are retained to the abutment by prosthetic screws.

The subject device abutments and system components are manufactured from Ti-6Al-4V alloy conforming to ASTM F136. The subject device is a single use device is provided nonsterile and intended to be sterilized by the user prior to placement in the patient.

Here's a breakdown of the acceptance criteria and study information for the Omni-Directional Multi-unit Abutment System (Omnibut™), based on the provided FDA 510(k) summary:

Description of the Device

The Omnibut™ is a pre-manufactured prosthetic component directly connected to endosseous dental implants. It is intended for use as an aid in prosthetic rehabilitation, specifically for supporting screw-retained prostheses on four or more implants. The system includes a ball abutment attached to an implant, with a retention attachment allowing for angle corrections of up to 30° off the implant axis. It supports prostheses that connect via titanium cylinders, which are incorporated into resin or ceramic prostheses. The device is made from Ti-6Al-4V alloy and is provided non-sterile, requiring user sterilization.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the exact sample sizes for each individual non-clinical test (e.g., number of abutments tested for dynamic fatigue, retention force, simulated use, or cleaning). It refers to the testing as "non-clinical" bench testing.

• Test Set Provenance: The data is generated from bench testing (laboratory studies), not from clinical data involving human patients. Therefore, information like "country of origin of the data" or "retrospective/prospective" is not applicable in the typical sense of clinical trials. The testing was performed in vitro.

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

This information is not applicable as the studies are non-clinical bench tests. The "ground truth" for these tests is based on established engineering standards (e.g., ISO 14801), biological evaluation standards (ISO 10993), and internal company protocols for mechanical and cleaning validation, not on expert clinical interpretation of patient data.

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

This information is not applicable as the studies are non-clinical bench tests. Adjudication methods are typically employed in studies involving human interpretation or clinical endpoints to resolve discrepancies in assessment.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human readers/interpreters, which is not the case for this dental implant abutment. The device is a physical component, not a diagnostic AI tool.

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

A standalone performance study was not done in the context of an algorithm. This question is relevant for AI/software devices; this device is a physical medical device. The "standalone" performance here refers to the device's mechanical and biological performance on its own, which is what the bench tests evaluate.

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

The "ground truth" for the non-clinical performance evaluations relies on:

• Established engineering and biological standards: e.g., ISO 14801:2016 for dynamic fatigue, ISO 10993 for biocompatibility, ANSI/AAMI/ISO for sterilization.
• Predetermined acceptance criteria: For retention force, simulated use, and cleaning efficacy, the "ground truth" is defined by specific pass/fail criteria established during the test design based on expected clinical performance and safety.
• Dimensional accuracy and compatibility models: For compatibility testing, the "ground truth" is established by the dimensions and specifications of OEM implant bodies and abutments.

8. The Sample Size for the Training Set

This information is not applicable because the device is a physical medical component, not a machine learning model or AI algorithm that requires a training set.

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

This information is not applicable for the same reason as above (not a machine learning model).

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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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DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed custom abutments for use with DESS Ti Base abutments or Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.

The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes dental implants, abutments, and prosthetic components cleared previously in various submissions. The previously cleared abutments and prosthetic components are compatible with a variety of original equipment manufacturer (OEM) dental implants as well as DESS Dental Smart Solutions dental implants.

This submission adds various abutments to the DESS and OEM implant lines as summarized on the following pages in Table 1 Summary of Subject Device Abutment Designs, and Table 2 Summary of Subject Device Abutment Sizes.

The subject device abutment designs include Cover Screws, Healing Abutments, Temporary Abutments, Ti Base Abutments, AURUM Base Abutments (Ti Base abutments with a screw channel design that allows easier instrument access to the abutment screw), CoCr Base Abutments, Pre-Milled Blank Abutments, Multi-Unit Abutments (straight and angled), DESSLoc Abutments (Locator-type abutments), and abutment screws.

This document is a 510(k) summary for the DESS Dental Smart Solutions, a line of endosseous dental implant abutments. It details the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, the device itself is a physical medical device (dental implant abutments and associated components), not a software or AI-driven system. Therefore, the questions related to AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, and ground truth establishment for AI would not be directly applicable to this product as described.

The document focuses on establishing substantial equivalence to previously cleared predicate devices through:

• Identical Intended Use: The device is intended for "functional and esthetic rehabilitation of the edentulous mandible or maxilla" by providing support for prosthetic restorations, which is the same as the predicate devices.
• Similar Technological Characteristics: The device utilizes similar designs, materials (Ti-6Al-4V, Co-Cr-Mo alloy), manufacturing processes, and sterilization methods as its predicates.
• Performance Data: Non-clinical testing (mechanical testing per ISO 14801, MR environment assessment) and comparison to existing data from predicate devices are used to demonstrate safety and effectiveness.

Therefore, many of the requested elements for describing AI acceptance criteria and studies are not present or applicable in this document.

However, I can extract information relevant to the device's performance assessment and criteria for its type of submission.

Here's an attempt to answer the questions based solely on the provided text, acknowledging that the nature of the device (a physical implant component) means many AI-specific questions will be answered as "Not Applicable" (N/A):

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

The document does not explicitly state quantifiable "acceptance criteria" in a table format with corresponding "reported device performance" metrics for this specific 510(k) submission. Instead, it relies on demonstrating substantial equivalence to existing predicate devices.

The underlying "acceptance criteria" for demonstrating substantial equivalence for this device type are primarily through:

• Mechanical Testing (ISO 14801): This is a critical performance standard for dental implants and abutments. The document states that mechanical testing was "conducted according to ISO 14801 to support the performance." The acceptance criteria would be successful completion of these tests, demonstrating the device's mechanical strength and fatigue resistance are comparable to or better than predicate devices. The reported performance is simply that the tests supported the performance.
• Material Conformance: Materials must conform to specific ASTM standards (e.g., ASTM F136 for Ti-6Al-4V, ASTM F1537 for Co-Cr-Mo). The reported performance is that the materials conform to these standards.
• Biocompatibility: While not detailed in this excerpt, the mention of "biocompatibility" in relation to predicates implies conformance to relevant biocompatibility standards (e.g., ISO 10993 series). The reported performance is that it is compatible.
• Sterilization Validation: Demonstrated sterility assurance level (SAL) of 10⁻⁶ via validated methods (moist heat or gamma irradiation). The reported performance is that validation was performed and met this SAL.
• Dimensional Compatibility: The abutments must fit the corresponding OEM implants correctly. The reported performance is that reverse engineering dimensional analysis confirmed compatibility.

Due to the nature of the document being a 510(k) summary focusing on substantial equivalence rather than a full study report, specific numerical performance results for the device tests are not provided in this text.

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

• Sample Size for Mechanical Testing: The document states "mechanical testing conducted according to ISO 14801." For such tests, ISO 14801 typically specifies minimum sample sizes (e.g., 10-11 samples for static strength, typically more for fatigue). The exact number of samples used for this specific submission is not explicitly stated, but it would have followed the standard's requirements.
• Data Provenance: The mechanical testing and material analyses are assumed to be "non-clinical data submitted or referenced" by the manufacturer, Terrats Medical SL, based in Barcelona, Spain. The "reverse engineering dimensional analysis" was done by Terrats Medical SL or through contractual agreement. This is prospective testing performed to support the 510(k). The document itself does not specify the country of origin for the underlying OEM implant data used for reverse engineering, although the OEM companies are listed (e.g., Astra Tech AB, BioHorizons).

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

N/A. This is a physical device. Ground truth, in the context of AI, refers to validated labels for data used to train and test an algorithm. For a physical device, performance is evaluated through engineering and biocompatibility testing against defined standards. There are no "experts" establishing ground truth in the AI sense. Testing would be performed by qualified engineers and technicians.

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

N/A. Adjudication methods are typically used in clinical studies involving interpretation (e.g., by radiologists) to resolve discrepancies. This document describes non-clinical performance testing of a physical device.

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

N/A. This product is a dental implant abutment, not an AI software intended to assist human readers.

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

N/A. This is a physical device, not an algorithm.

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

N/A. For engineering tests of physical devices, the "ground truth" is typically derived from established engineering principles, international standards (e.g., ISO 14801 for mechanical properties, ASTM for materials), and the physical properties of the materials and designs themselves. There isn't "expert consensus" or "pathology" in the AI or clinical trials sense.

8. The sample size for the training set

N/A. This is a physical device; there's no "training set" in the machine learning sense. The device is manufactured based on established engineering designs and material specifications.

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

N/A. No training set for AI. For device manufacturing, the "ground truth" for design and production parameters comes from established engineering best practices, prior successful device designs (predicate devices), and adherence to quality systems regulations (21 CFR Part 820).

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DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system by a change in sterilization status to provide products sterile to the end user that were previously cleared to be provided non-sterile. The subject device abutments and abutment screws were cleared previously to be provided non-sterile to the end user in K170588, K191986, K212628, and K22288. All subject device components will now be provided sterile.

The subject device components include Healing Abutments, Multi-Unit Abutments (0, 17°, and 30°), and abutment screws.

The provided text is a 510(k) summary for the DESS Dental Smart Solutions, an endosseous dental implant abutment. It details the device, its intended use, and its substantial equivalence to previously cleared predicate and reference devices. However, this document does not contain the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The 510(k) submission for this dental abutment focuses on establishing substantial equivalence based on:

• Design and Material: The subject device components are identical in design, material (Ti-6Al-4V alloy, DLC coating), and technological characteristics to previously cleared devices.
• Manufacturing: The manufacturing process is consistent with previously cleared devices.
• Biocompatibility: Referenced from previous K-clearances.
• Sterilization: The main change in this submission is expanding the system to provide products sterile to the end-user via gamma irradiation, which was validated by referencing a previous K-clearance (K212538).
• MR Environment Testing: Non-clinical analysis was performed to evaluate the subject devices in the MR environment, referencing published literature and FDA guidance.
• Shelf Life Testing: Referenced from a previous K-clearance (K212538) for samples after accelerated aging.

Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving an AI/ML device meets them based on the provided text, as this document is not about an AI/ML medical device. It's about dental implant abutments and establishes substantial equivalence through non-clinical performance data and comparison to predicate devices, not through AI/ML performance metrics.

To provide the information you requested, I would need a document detailing the validation of an AI/ML medical device, which would include definitions of acceptance criteria (e.g., accuracy, sensitivity, specificity), details of training and test datasets, ground truth establishment, and potentially clinical effectiveness studies if applicable.

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Multi-Unit DAS System abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.

Multi-Unit DAS System abutments are designed for retention of single-unit and multi-unit restorations. The multi-unit abutments are provided in a straight design (no angulation in the base portion) that threads directly to the OEM implant. For each of the compatible OEM implant lines, the multi-unit abutments are provided with gingival heights ranging from 1 mm to 5 mm, a prosthetic platform diameter of 4 mm, and a prosthetic post height of 1.4 mm. The multi-unit abutments are the base of a two-piece abutment. The second piece is a metal coping, called a Ti-Base in this submission, that attaches to the multi-unit abutment (not directly to an implant). For permanent restorations a zirconia superstructure is attached to the Ti-Base, and additional gingival height and angulation may be provided in the zirconia superstructure.

The subject device metal copings (Ti-Bases) include: a straight, prepable design with an additional gingival height of 1.5 mm and a prepable 9 mm prosthetic post; and Dynamic Ti-Bases in three (3) designs, each with an additional gingival height of 0.5 mm and a cut-out in the prosthetic post to accommodate a restoration with an angled screw channel when clinically necessary. The Dynamic Ti-Base prosthetic post heights are 4.5 mm (maximum height) / 3.0 mm (cut-out height), and 9.0 mm/3.5 mm. Multi-Unit DAS System Ti-Bases with a 9.0 mm post height may be shortened to no less than 4 mm for a single-unit restoration. The prepable Ti-Base has a platform diameter of 4 mm (platform to the multi-unit abutment) and a prosthetic platform diameter of 4 mm. The Dynamic Ti-Bases have a platform diameter of 4 mm (platform to the multi-unit abutment) and a prosthetic platform diameter of 4.15 mm.

The compatibility between the subject device abutments and the OEM implants listed in the Indication for Use Statement was established by reverse engineering analysis of the OEM implants, OEM abutments, and OEM abutment screws.

All subject device abutments and abutment screws are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136 and ISO 5832-3.

All zirconia copings (superstructures) for use with the subject device Dynamic Ti-Base will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.

The design parameters for the CAD-CAM zirconia superstructure for the Multi-Unit DAS System are:

Minimum wall thickness - 0.25 mm

Minimum post height for single-unit restorations - 4.0 mm

Maximum gingival height in the zirconia superstructure - 5.24 mm for compatible Biomet 31 OSSEOTITE® Certain®, MegaGen AnyRidge, NobelActive®, and Zimmer Tapered Screw-Vent® implants; 5.76 mm for compatible Astra Tech OsseoSpeed TX implants

Minimum gingival height - 0.5 mm (in the Ti-Base)

Maximum angulation - 30° for compatible Biomet 3i OSSEOTITE® Certain®, MegaGen AnyRidge, NobelActive®, and Zimmer Tapered Screw-Vent® implants; 25° for compatible Astra Tech OsseoSpeed TX implants

The recommended cement for bonding the zirconia superstructure to the Dynamic TiBases to create the final two-piece abutment is G-CEM LinkAce™, cleared as GAM-200 in K120243.

Here's a breakdown of the acceptance criteria and study information for the Multi-Unit DAS System:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Mechanical Testing (ISO 14801) & Sterilization Validation: The document does not explicitly state the sample sizes used for these tests. For ISO 14801, typically a statistically significant number of samples are tested to demonstrate fatigue resistance, but the exact number isn't provided. For sterilization, typically multiple runs with biological indicators are performed.
• Data Provenance: The document does not specify the country of origin for the data for specific tests, but the manufacturer, Talladium España, SL, is located in Lleida, Spain. The data is non-clinical.

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

• This information is not applicable (N/A) as the submission details non-clinical data (mechanical testing, material specifications, biocompatibility, sterilization, MR safety analysis) rather than studies involving human expert assessment of images or clinical outcomes.

4. Adjudication method for the test set

• N/A, as no expert adjudication for medical diagnoses/interpretations was conducted due to the non-clinical nature of the studies.

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 MRMC comparative effectiveness study was done. This is a medical device for dental implants, not an AI software intended for diagnostic assistance. The document explicitly states: "No clinical data were included in this submission."

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

• No standalone algorithm performance study was done. This is a physical medical device, not an algorithm.

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

• Mechanical Testing: Ground truth is defined by the ISO 14801 standard and the manufacturer's performance specifications.
• Biocompatibility: Ground truth is established by the cellular responses and lack of toxicity as defined by ISO 10993-5.
• Material Composition: Ground truth is defined by the ASTM F136 and ISO 5832-3 standards.
• Sterilization: Ground truth is defined by the Sterility Assurance Level (SAL) of 10^-5, validated against microbiological indicators as per ANSI/AAMI/ISO 17665.
• MR Safety: Ground truth is established by scientific rationale and published literature, determining the device's behavior in an MR environment.
• Compatibility with OEM Implants: Ground truth is established by the precise measurements and design characteristics obtained through reverse engineering analysis of the OEM implants and their components.

8. The sample size for the training set

• N/A. There is no AI component or machine learning model that requires a training set for this device.

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

• N/A. There is no AI component or machine learning model that requires a training set for this device.

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Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.

Dynamic TiBase abutments are designed for retention of a CAD-CAM fabricated zirconia superstructure where the final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration. Dynamic TiBase abutments are provided in engaging and non-engaging designs for single-unit and multi-unit restorations, respectively. For each of the compatible OEM implant lines, the Dynamic TiBase abutments are provided with a gingival height (in the titanium base) ranging from 0.3 mm to 5 mm, and a prosthetic platform diameter ranging from 4.3 mm to 5.9 mm. Additional gingival height and angulation may be provided in the zirconia superstructure. All Dynamic TiBase abutments have a prosthetic post with a cut-out to accommodate a restoration with an angled channel for screw access when clinically necessary. The prosthetic post heights range from 3.8 mm to 4.5 mm (maximum height), and from 2.3 mm to 2.7 mm (cut-out height). Dynamic TiBase abutments with a 4.5 mm maximum post height may be shortened to no less than 4 mm for a single-unit restoration. All subject device abutments and abutment screws are made of titanium alloy (Ti-6A1-4V) conforming to ASTM F136 and ISO 5832-3. All zirconia copings (superstructures) for use with the subject device Dynamic TiBase will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.

The provided text is a 510(k) Summary for a medical device (Dynamic TiBase dental abutments). It describes the device, its intended use, and its substantial equivalence to previously cleared devices. However, it does not contain any information about acceptance criteria, the study design, or performance metrics typically associated with AI/ML-based medical devices.

The document explicitly states: "No clinical data were included in this submission." and focuses on non-clinical data to demonstrate substantial equivalence, primarily through:

• Mechanical testing: "mechanical testing conducted according to ISO 14801 to support the performance of the subject device abutments in conjunction with the compatible OEM implants."
• Reverse engineering analysis: "reverse engineering analysis (of OEM implants, OEM abutments, and OEM abutment screws) demonstrating compatibility between the subject device abutments and the OEM implants listed in the Indication for Use Statement."
• Material compatibility and sterilization: referencing previous 510(k) submissions for biocompatibility and sterilization validation.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance in the context of an AI/ML-based device (e.g., sample size, ground truth, expert adjudication, MRMC studies), as this information is not present in the provided text. The device described is a physical dental abutment, not an AI/ML diagnostic or assistive tool.

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DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes abutments compatible with a variety of original equipment manufacturers (OEM) of dental implants. This submission adds abutments, designated DESS Multi-Unit Abutments, for implant lines from Zimmer Dental and Biomet 31 (now collectively, ZimVie Dental). The subject device abutments include Multi-Unit Abutments in straight, 17° angled, and 30° angled designs, which are compatible with implants having internal hex connections. This submission is also to change how previously cleared devices are provided; the change is from previously provided nonsterile to now provided sterile. All abutments are provided with the appropriate abutment screw (if applicable) for attachment to the corresponding implant. The subject device is only intended for multi-unit restorations such as bridges and bars.

It appears there might be a misunderstanding of the provided text. The document is a 510(k) premarket notification for a dental implant abutment, not an AI/ML medical device. Therefore, the information typically required for describing an AI/ML device's acceptance criteria and study data (like sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance) is not present.

The document discusses the substantial equivalence of the DESS Dental Smart Solutions abutment to legally marketed predicate devices. The "performance data" section refers to non-clinical testing to demonstrate the device's physical properties and compatibility, not a study evaluating an AI algorithm's diagnostic or predictive performance.

Let's break down what can be extracted from the provided text relevant to the device's acceptance, and then explain why the AI/ML specific questions cannot be answered.

Understanding the Device and its "Acceptance":

The "acceptance" in this context refers to the FDA's determination that the new DESS Dental Smart Solutions abutments are "substantially equivalent" to predicate devices already on the market. This determination is based on the device having the same intended use and similar technological characteristics (design, materials, performance via non-clinical testing).

Here's a summary of the information available in the document:

1. Table of Acceptance Criteria (or rather, Equivalence Criteria) and Reported Device Performance:

The document doesn't present acceptance criteria in a quantitative table with performance metrics like sensitivity, specificity, or accuracy, as would be common for an AI/ML device. Instead, "acceptance" is based on demonstrating substantial equivalence to predicate devices across several characteristics. The performance is shown through non-clinical testing to ensure safety and functionality.

Important Note: The "acceptance criteria" here are qualitative statements of substantial equivalence, backed by quantitative non-clinical engineering and materials testing, not performance metrics from a clinical study or an AI model's accuracy.

Regarding the AI/ML Specific Questions:

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

• Not applicable. This document is for a physical medical device (dental implant abutment), not an AI/ML algorithm. There is no "test set" in the context of data for an AI/ML model. The "testing" refers to mechanical, material, and sterilization validation.

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

• Not applicable. Ground truth establishment by experts is relevant for AI/ML diagnostic devices. This device's performance is assessed through engineering standards and material properties. Compatibility with implant systems is established through design agreements and reverse engineering data (referenced from K170588).

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

• Not applicable. Adjudication methods are used in clinical studies or for establishing ground truth labels for AI/ML datasets.

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. MRMC studies are for evaluating diagnostic efficacy, particularly with AI assistance. This device is a passive prosthetic component.

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

• Not applicable. There is no algorithm.

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

• Not applicable. The "ground truth" for this device's performance is its adherence to engineering standards (e.g., ISO 14801 for mechanical properties, ASTM for materials/MR safety) and its demonstrated compatibility with specified implant systems, rather than a clinical ground truth like disease presence.

8. The sample size for the training set:

• Not applicable. There is no AI model or training set.

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

• Not applicable. As above, no AI model or training set.

Conclusion from the document:

The provided document describes a 510(k) submission for a Class II medical device, DESS Dental Smart Solutions abutments. The "acceptance criteria" revolve around demonstrating substantial equivalence to existing legally marketed predicate devices. This is achieved through:

• Identical intended use.
• Similar technological characteristics: This includes materials (Titanium alloy), design (multi-unit, screw-retained), and geometric parameters (diameters, gingival heights).
• Performance via non-clinical testing: This includes mechanical testing (ISO 14801), MR safety testing (ASTM standards), sterilization validation (ANSI/AAMI/ISO standards), bacterial endotoxin testing (ANSI/AAMI ST72), shelf-life testing (ASTM F1980), and biocompatibility testing (ISO 10993-5).
• Compatibility with specified implant systems: This is supported by contractual agreements with OEMs (ZimVie/Terrats Medical SL) and referenced reverse engineering data.

The document explicitly states: "No clinical data were included in this submission." This further confirms that the evaluation framework is entirely non-clinical and does not involve AI/ML performance metrics, studies with human readers, or expert ground truthing as one would see for an AI-powered diagnostic tool.

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MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit, cement retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants:

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

MIST IC abutments for Biomet 3i Certain 3.25 mm implant bodies are indicated for maxillary lateral and mandbular central/lateral incisors only.

MIST IC from Imagine Milling Technologies, LLC is a line of Ti-base and machinable blank abutments to interface with compatible dental implants from 3 manufacturers, a total of 14 implant-abutment interface compatibilities. The compatible implant body diameters range from 3.25 mm to 6.0 mm and the corresponding implant platform diameters range from 3.4 mm. The subject device prosthetic platform diameters range from 3.8 mm. All stock subject device components (abutments and abutment screws) are made of titanium alloy conforming to ASTM F136. The subject device MIST IC L-LINK abutments have a TiN coating achieved through a physical vapor deposition (PVD) process that is identical to the process used for TiN coating of Imagine Milling Technologies, LLC devices cleared in K 182246. The PVD cathodic arc evaporation process is a high current, low voltage process in which material evaporated from the cathode (Ti) is ionized, transported through the vacuum chamber with reactive gas (N2) and deposited as a non-porous, thin film on the titanium substrate.

Each abutment is supplied with the non-sterile abutment screw designed for attachment to the corresponding compatible OEM implant.

All patient-specific abutment fabrication for all MIST IC abutments is by prescription on the order of the clinician. All MIST IC abutments are intended to be milled at an Imagine Milling Technologies, LLC validated milling center under FDA quality system regulations.

MIST IC L-LINK abutments are two-piece abutments to be used as a base when fabricating a CAD-CAM customized restoration where the superstructure produced will compose the second part of the two-piece abutment; the assembly becoming a final finished medical device after cementation on the subject device abutment. They are provided in straight designs, with engaging and non-engaging connections. The L-LNK abutments and corresponding zirconia superstructure are provided to the clinician either with the superstructure cemented to the abutment by the dental laboratory, or separately for the clinician to bond together chairside using the cement recommended in the labeling (RelyX RMGIP bonding cement, cleared in K022476).

Design parameters for the L-LINK zirconia superstructure are: Minimum wall thickness - 0.5 mm Minimum post height for single-unit restoration - 4.0 mm Minimum gingival height of the coping - 0 mm (all L-LINK bases have minimum gingival height of 0.5 mm) Maximum gingival height – 5.0 mm Maximum angle - 20°

All zirconia copings (superstructures) for use with the subject device MIST IC L-LINK abutments will conform to ISO 13356.

MIST IC PREFIT abutments are cylindrical abutments designed for patient-specific abutment fabrication by a CAD-CAM process and machined into a one-piece, all titanium abutment. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in diameter by 20 mm in diameter by 20 mm in length. MIST IC PREFIT abutments have an engaging connection.

Design parameters for the PREFIT patient specific abutment are: Minimum wall thickness - 0.5 mm Minimum post height for single-unit restoration - 4.0 mm Minimum gingival height - 0.5 mm Maximum gingival height - 5.0 mm Maximum angle - 30°

The provided text describes the regulatory clearance of a dental device, "MIST IC." It outlines the device's intended use and compares it to a predicate device. However, it does not contain explicit information about acceptance criteria or a specific study proving the device meets those criteria, especially in the context of AI performance.

This document focuses on establishing substantial equivalence for regulatory purposes, relying heavily on non-clinical testing and comparison to an existing predicate device. The information provided is primarily relevant to the safety and mechanical performance of the dental implant abutments, not AI/algorithm performance.

Therefore, many of the requested fields cannot be directly answered from the provided text.

Here's a breakdown of what can and cannot be extracted from the document based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of numerical thresholds or performance metrics for an AI algorithm. Instead, it lists non-clinical tests performed to demonstrate substantial equivalence to the predicate device and ensure safety and efficacy.

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

This information is not provided in the document. The document refers to "non-clinical testing data" but does not detail the sample sizes for these tests or the provenance of any data beyond indicating it's for dental implant abutment compatibility and mechanical strength. There is no mention of an "AI test set."

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

This information is not provided. The document describes mechanical performance and material compatibility testing, not a study requiring expert-established ground truth for an AI algorithm.

4. Adjudication Method for the Test Set

This information is not provided. As no "test set" for AI or expert review is mentioned, adjudication methods are not applicable here.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical data were included in this submission." This type of study typically involves human readers and is clinical in nature.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document describes a physical medical device (dental implant abutments) and its mechanical and material properties. There is no mention of an AI algorithm or standalone algorithm performance.

7. The Type of Ground Truth Used

For the non-clinical tests mentioned, the "ground truth" is established by objective engineering standards and validated testing protocols (e.g., ISO 14801 for mechanical testing, ISO 10993 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" as ground truth for an AI in this context.

8. The Sample Size for the Training Set

This information is not provided. There is no mention of a training set as the document does not concern an AI algorithm.

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

This information is not provided as there is no mention of a training set or AI algorithm in the provided text.

Summary of what the document IS about:

The document is an FDA 510(k) clearance letter for the MIST IC dental abutment. It establishes substantial equivalence to a predicate device (K182246) based on:

• Non-clinical testing: Biocompatibility, sterilization, MR compatibility, reverse engineering for compatibility, and static/dynamic compression-bending.
• Material properties: Both subject and predicate devices are made of Titanium Alloy (ASTM F136), with TiN coating for L-LINK abutments, and use zirconia copings (ISO 13356) and the same bonding cement (RelyX RMGIP).
• Design similarities: Similar CAD-CAM fabrication process, restoration types (single/multi-unit, cement-retained), and design parameters (minimum wall thickness, post height, gingival height, angulation).
• Intended Use: Supports a prosthetic device in partially or completely edentulous patients, compatible with various specified implant systems.

The text does not discuss, describe, or evaluate any AI component of the device.

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The CORE 3D abutment system for digital prosthetic solutions are dental abutments placed into a dental implant to provide support for dental prosthetic restorations. The abutments include:

• Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abulment;
• Titanium Abutment Blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques;
• Abutment Screws to permanently fix the abutments to the Implant.
  Core 3D abutments are intended for use to support single-tooth (unit) and multiple-tooth (bridges and bars) prostheses, in the mandible or maxilla for functional and aesthetic restorations.
  Core 3D abutments designed using CAD/CAM techniques must fulfill the Core 3D allowable range of design specifications and be provided as straight abutments only.
  Core 3D abutments and are compatible for use with the following dental implants:
• Nobel Biocare Branemark System (K022562, K934825)
• Zimmer Tapered Screwvent (K013227, K061410, K072589)

The proposed devices are dental implant abutments intended to be placed into dental implants and to provide support for dental prosthetic restorations.
The system is composed of the following principal components:

• Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutment;
• Titanium Abutment Blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques
• Abutment Screws: to fix abutments to the underlying dental implant.
  The final form of the device including superstructures to titanium bases and patientspecific designs for abutment blanks may be designed using CAD CAM techniques under Core3D design specifications and limitations using the following system:
• CAD/CAM Software: 3Shape Dental System including 3Shape Dental Designer
• Scanner: 3Shape D810 model
• Milling machine: SAUER HSC-20 DMG.
  Mechanical resistance of the implant-abutment connection is essential to ensure correct long-term functional performance of the complete dental restoration. Dimensional compatibility and mechanical performance of bases and screws together with the underlying implant are of primary importance. These concepts are the basis upon which the system design characteristics and functional performance are established.
  The proposed Titanium Bases and Titanium Abutment Blanks are available with either an internal conical connection or external connection, depending on the underlying dental implant. The internal conical types are available in diameters of 3.4, 4.5, and 5.7mm for bases and in diameters of 3.5, 4.5 and 5.7mm for blanks. The external connection types are available in diameters of 3.5, 4.1 and 5.1mm.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CORE 3D Abutment System for Digital Prosthetic Solutions:

Important Note: The provided document is a 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing entirely new safety and efficacy data through clinical trials. As such, the information you've requested regarding detailed acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and MRMC studies might not be explicitly present in the way it would be for a novel device. The document primarily highlights bench testing results proving compatibility and mechanical performance.

Acceptance Criteria and Device Performance

The document does not explicitly present a table of numerical acceptance criteria alongside reported device performance in the format of a clinical study. Instead, it states that bench testing was performed to determine conformance to performance specifications and requirements.

Table of Acceptance Criteria (Inferred) and Reported Device Performance:

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

• Sample Size for Test Set: The document does not specify the sample size used for the bench tests (e.g., number of abutments tested for mechanical properties).
• Data Provenance: The study was non-clinical bench testing. The document does not specify the country of origin for the data itself, but the submitter is based in Spain. It is retrospective in the sense that the testing was completed before the submission.

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

• Number of Experts: This information is not provided in the document. For non-clinical bench testing, "ground truth" is typically established by engineering specifications and standards, not by human experts adjudicating clinical outcomes.
• Qualifications of Experts: Not applicable in the context of this type of non-clinical testing.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable for non-clinical bench testing. The results are typically compared directly against engineering specifications and industry 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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted.
• Effect Size: Not applicable. This device is a dental implant abutment, not an AI-assisted diagnostic tool.

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

• Standalone Performance Study: The document does not describe a standalone performance study in the way it might for an AI algorithm. However, standalone bench testing of the physical abutments and an evaluation of the CAD/CAM software (which operates without human intervention in determining design limits once programmed) effectively represent the "algorithm only" performance for the relevant aspects of this device. The software validation aimed to ensure the software's inherent design limitations correctly prevent non-compliant abutment milling.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the mechanical and dimensional aspects of the abutments and their mating, the ground truth was based on engineering specifications, industry standards, and perhaps predicate device performance data. For the CAD/CAM software, the ground truth for software validation was the Core3D design specifications and limitations.

8. The Sample Size for the Training Set

• Sample Size for Training Set: This information is not provided and is generally not applicable in a traditional sense for a physical medical device. The CAD/CAM software is likely developed based on engineering rules and algorithms, not "trained" on a data set in the machine learning sense.

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

• How Ground Truth for Training Set was Established: Not applicable in the context of this device. The "ground truth" for the software's design rules would have been established by engineering design principles, material properties, and regulatory requirements specific to dental abutments.

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