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The Customized Abutments are intended use for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screw-retained single restorations or cement- retained single or multi-unit restorations. The Customized Abutment will be attached to a dental implant using the included abutment screw.

Patient-Specific Abutment is compatible with following Implant System:

1. Neodent Implant System -GM Line / Implant Diameter (mm): 3.5, 3.75, 4.0, 4.3, 5.0, 6.0/ Restorative Platform Diameter: 3.0
2. BioHorizons Tapered Internal Implant System / Implant Diameter (mm): 3.8, 4.6, 5.8/ Restorative Platform Diameter: 3.5, 4.5, 5.7
3. Astra Tech Implant System / Implant Diameter (mm): 3.5, 4.0, 4.5, 5.0/ Restorative Platform Diameter: 3.5, 4.0, 4.5, 5.0
4. 3i OSSEOTITE® Certain® Dental Implants / Implant Diameter (mm): 4.1, 5.0, 6.0/ Restorative Platform Diameter: 4.1, 5.0, 6.0

All digitally designed abutments for use with Customized Abutment are intended to be manufactured at an ARUM DENTISTRY validated milling center.

Patient-specific abutment is made from Ti-6Al-4V Eli conforming to ASTM F136 to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screwand cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician.

The diameters of patient-specific abutment are 3.5, 3.75, 3.8, 4.0, 4.3, 4.5, 4.6, 5.0, 6.0 mm and Hex connection design.

Customized abutments are supplied with an abutment and provided non-sterile.

This document is a 510(k) Premarket Notification from ARUM DENTISTRY Co., Ltd. for a dental device called "Customized Abutment." This notification aims to demonstrate the substantial equivalence of their device to legally marketed predicate devices, as required by the U.S. Food and Drug Administration (FDA).

Based on the provided information, the 510(k) summary (pages 4-12) details the device, its intended use, materials, and substantial equivalence comparison to a predicate device. The information is focused on a medical device clearance and does not describe an AI/ML-driven medical device, nor does it contain information typically associated with studies proving device performance against acceptance criteria in the context of AI/ML.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details, because the provided document does not pertain to an AI/ML device.

The document describes a physical medical device (Customized Abutment for dental implants) and its non-clinical testing to demonstrate substantial equivalence, primarily through:

• Reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility.
• Static and fatigue testing according to ISO 14801.

The closest information provided to "acceptance criteria" relates to the design parameters of the abutment, such as post height, angle, wall thickness, diameter, and gingival height, which are likely evaluated against engineering specifications and performance standards like ISO 14801.

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Elos Accurate Hybrid Base
The Elos Accurate® Hybrid Base The intended for attaching to dental inplants in order to provide basis for dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing.
The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1:
Table 1.
Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm]
Straumann BLX RB/WB | Ø3.4/Ø3.5/Ø4.5 | Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5
The zirconia superstructures for use with the Elos Accurate® Hybrid Base "" are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, ceramic material, milling machine and associated tooling and accessories.

Elos Accurate Customized Abutment
The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw.
The Elos Accurate® Customized Abutment is compatible with the implant systems listed in table 1: Table 1.
Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm]
Straumann BLX RB/WB | Ø3.4/Ø3.5/Ø4.5 | Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5
Astra Tech 3.0 | Ø3. | Ø3
Astra Tech EV 3.0 | Ø3 | Ø3
All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

The Elos Accurate® Customized Abutment and Elos Accurate® Hybrid Base™ are both patient-specific components designed for attaching to dental implants, providing a basis for single or multiple tooth prosthetic restorations.
The Elos Accurate® Customized Abutment and Elos Accurate® Hybrid Base™ will be attached to the implant using the included Elos Prosthetic Screw.
The Elos Accurate® Hybrid Base™ is a two-piece abutment composed of the pre-manufactured prosthetic component, the Hybrid Base in Titanium alloy per ASTM F136, as the bottom-half, and the zirconia superstructure as the top-half, which the laboratory/clinic is designing by use of the 510(k) cleared design software (3Shape Abutment Designer™ Software, K151455), which when assembled comprises the finished medical device. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Multilink Hybrid Abutment, K130436 or Panavia V5, K150704) While the Elos Accurate® Customized Abutment is a one-piece abutment which consists of an Abutment Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The same applies to the Elos Accurate® Hybrid Base™ which fits directly to an endosseous dental implant. The customized shape of the abutment is intended to be manufactured according to a digital dentistry workflow or intended to be manufactured at an FDA registered Elos Medtech approved milling facility.
The Elos Accurate library files for both Elos Accurate® Customized Abutment and Elos Accurate® Hybrid Base™ have built-in design limitations, and the user isn't allowed to exceed these limitations as follows:
Customized Abutments: | Hybrid Base abutments (zirconia part):
Min. wall thickness 0.4 mm | Min. wall thickness 0.5 mm
Gingival height min. 0.5mm or max. 5 mm | Gingival height min. 0.5mm or max. 5 mm
Max. angulation 20° or 30°. | Max. angulation 20°.
Min. post height* 4 mm | Min. post height* 4 mm
*The post height is defined as the cementable height of the abutment.
The Elos Accurate® Customized Abutment and the Elos Accurate® Hybrid Base™ are both delivered non-sterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient.

The provided text describes the submission of a 510(k) premarket notification for the "Elos Accurate® Hybrid Base™" and "Elos Accurate® Customized Abutment" dental devices. The purpose of this submission is to demonstrate that these devices are substantially equivalent to previously marketed predicate devices. The document details the indications for use, product descriptions, a comparison of technological characteristics with predicate devices, and a summary of non-clinical testing.

Here's an analysis of the acceptance criteria and the study proving device conformity:

1. Table of Acceptance Criteria & Reported Device Performance

The acceptance criteria are not explicitly stated with numerical targets in the document. Instead, the document focuses on demonstrating substantial equivalence to predicate devices. The "reported device performance" is primarily presented as the devices meeting the same or similar functional and safety standards as the predicate devices, with specific validations for expanded compatibility and design workflows.

The "Element of Comparison" table acts as a de facto set of acceptance criteria, where the subject device's characteristics are compared against the predicate devices, and "Substantial equivalent" is the reported "performance."

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

The document does not specify a "test set" in the context of an AI/human performance study. Instead, the testing described is primarily engineering and material characterization:

• Fatigue testing per ISO 14801: This testing involves multiple samples to assess mechanical durability. While the exact number of samples isn't given, standard ISO 14801 typically requires a significant number of samples tested to failure or for a specified number of cycles.
• Biocompatibility testing for cytotoxicity (ISO 10993-5): This testing would use biological samples or cell lines. The document states it's leveraged from previously cleared products (K230317/K231317) on "identically manufactured abutments and prosthetic screws manufactured from the same material."
• Sterilization validation (ISO 17665-1 & ISO 17665-2): Involves using Biological Indicators (BIs) or other validation methods, typically multiple cycles and samples. Leveraged from K230317/K231317.
• MRI Conditional Safety Evaluations (ASTM F2052, ASTM F2119, ASTM F2213, ASTM F2182): A "worst-case assembly" was tested, implying at least one, but possibly multiple, physical assemblies to cover various MRI conditions. Leveraged from K230317/K231317.
• Digital dentistry workflow validation: Conducted on "selected model of subject product lines," implying a representative set of designs.

Data Provenance: The data comes from non-clinical testing performed by the manufacturer (or leveraged from prior submissions by the same manufacturer, Elos Medtech Pinol A/S). The origin is Denmark (company location). The testing is prospective for the current submission but leverages retrospective data from previous clearances.

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

This information is not applicable to this submission. The device is a physical dental abutment, not an AI/diagnostic device that generates an output requiring expert interpretation for ground truth establishment. The "ground truth" for this device relates to its physical, mechanical, and biological properties, which are established through standardized engineering and laboratory tests, not expert consensus on diagnostic images.

4. Adjudication method for the test set

This is not applicable as there is no test set involving expert interpretation or a diagnostic outcome that would require adjudication.

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 is not applicable as the device is a physical dental abutment, not an AI-assisted diagnostic tool or software.

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

This is not applicable as the device is a physical dental abutment. The "digital dentistry workflow" involves software (3Shape Abutment Designer Software) but this is used for design and manufacturing, not for standalone diagnostic performance assessment.

7. The type of ground truth used

The "ground truth" for this engineering-focused submission is established through:

• Engineering and dimensional analysis: Measurements and specifications of various components (abutments, implants, screws).
• Mechanical testing: Fatigue testing per ISO 14801 to assess durability and strength under simulated physiological loading.
• Biocompatibility testing: Standardized testing (ISO 10993-5) to confirm non-cytotoxicity.
• Sterilization validation: Standardized testing (ISO 17665-1 & ISO 17665-2) to confirm sterility.
• MRI compatibility testing: Standardized testing (ASTM F2052, ASTM F2119, ASTM F2213, ASTM F2182) to confirm MR conditional status.
• Design software validation: Testing that the software (3Shape Abutment Designer) adheres to "built-in design limitations" and prevents users from exceeding them.

8. The sample size for the training set

This is not applicable. The submission is not for an AI/machine learning device that requires a training set. The descriptions of "design limitations" and "digital dentistry workflow validation" refer to the validation of software and manufacturing processes, not the training of an algorithm in the machine learning sense.

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

This is not applicable as there is no training set for the reasons outlined above. The "design limits" mentioned for the digital dentistry workflow are predefined by Elos Medtech based on engineering principles and safety considerations for dental prosthetics.

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The Customized Abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screwretained single restorations or cement-retained single or multi-unit restorations. The Customized Abutment will be attached to a dental implant using the included abutment screw.

Patient-Specific Abutment is compatible with following Implant Systems:

1. Zimmer Tapered Screw-Vent®
   / Implant diameter size (mm): 3.7, 4.1, 4.7, 6.0/ Restorative Platform diameter (mm): 3.5, 4.5, 5.7
2. Straumann® Bone Level Tapered Implant
   / Implant diameter size (mm): 3.3, 4.1, 4.8/ Restorative Platform diameter (mm): 3.1, 3.7, 4.4

All digitally-designed Customized abutments are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.

Patient-specific abutment is made from Ti-6Al-4V Eli conforming to ASTM F136 to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screwand cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician.

The diameters of patient-specific abutment are 3.3, 3.7, 4.1, 4.7, 4.8, 6.0 mm and Hex and square connection design.

Customized abutments are supplied with an abutment screw and provided non-sterile.

The provided text describes the regulatory clearance (K234112) for the ARUM DENTISTRY Co., Ltd. Customized Abutment, particularly focusing on its substantial equivalence to a predicate device (K223634). The information provided does not outline acceptance criteria for an AI/ML powered device, nor does it detail a study proving the device meets AI/ML specific acceptance criteria.

The information provided pertains to a traditional medical device (dental abutments) and focuses on engineering and material performance rather than AI/ML algorithm performance.

Therefore, many of the requested fields regarding AI/ML specific criteria cannot be extracted from the given text.

However, I can provide information on the non-clinical tests conducted for the Customized Abutment device, which are analogous to acceptance criteria and performance data for this type of medical device.

1. Table of Acceptance Criteria and the Reported Device Performance (Non-AI/ML):

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

• Mechanical Testing (Static and Fatigue): The document mentions "The worst-case construct was tested" for sterilization and that "static and fatigue testing according to ISO 14801" was conducted. Specific sample sizes are not provided.
• Data Provenance: The non-clinical tests were conducted internally or by contractors to ARUM DENTISTRY. The document does not specify a country of origin for the data beyond ARUM DENTISTRY Co., Ltd. being in the Republic of Korea. These are most likely prospective tests conducted specifically for this submission.

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 information is not applicable and not provided as the approval is for a physical dental abutment, not an AI/ML algorithm requiring expert interpretation for ground truth.

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

This information is not applicable and not provided. "Adjudication" typically refers to resolving discrepancies in expert labeling or diagnoses for AI/ML ground truth, which is not relevant here.

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 is not applicable. No MRMC study was conducted as the device is a physical dental abutment, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is a physical product, not an algorithm.

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

For the non-clinical tests, the "ground truth" is defined by the standards and specifications used (e.g., ASTM F136 for material, ISO 14801 for mechanical testing, ISO 17655-1 for sterilization, FDA guidance for MRI safety). The device's performance is compared against the requirements of these established standards.

8. The sample size for the training set:

This is not applicable. The device is a physical product, not an AI/ML model that requires a training set. The device design parameters are "trained" through engineering design principles and verified through physical testing.

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

This is not applicable. There is no training set as it's not an AI/ML algorithm. The design of the abutment relies on established engineering principles, material science, and compatibility specifications with existing implant systems.

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The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw. The Elos Accurate® Customized Abutments are compatible with the implant systems listed in Table 1.

The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an Abuttnent Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The customized shape of the abutument is intended to be manufactured according to a digital dentistry workflow or intended to be manufactured at an FDA registered Elos Medtech approved milling facility. The Elos Accurate® Customized Abutment is delivered non-sterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.

The provided document, K231307 for Elos Accurate® Customized Abutment, is an FDA 510(k) premarket notification. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a standalone study with defined acceptance criteria and performance metrics in the way a clinical trial or a performance study for an AI/ML powered medical device would.

The "acceptance criteria" discussed in this document pertain to the device meeting the requirements for FDA 510(k) clearance by demonstrating substantial equivalence to predicate devices, primarily through engineering, dimensional, and non-clinical testing. There is no mention of a human-in-the-loop study, a multi-reader multi-case (MRMC) study, or an AI/ML algorithm-only standalone performance study.

Therefore, many of the requested fields regarding expert adjudication, MRMC studies, and ground truth establishment for AI/ML models are not applicable to the information contained within this 510(k) submission.

Here's an interpretation of the document's contents in relation to your request, with a focus on non-clinical testing and substantial equivalence:

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

The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to its predicates and meeting established material and dental implant abutment standards. The document doesn't present a table with numerical acceptance criteria and performance for a diagnostic AI algorithm. Instead, it lists various non-clinical tests and their successful outcomes as evidence of substantial equivalence and safety/effectiveness.

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

• Test Set Sample Size: The document does not specify exact "sample sizes" in terms of number of abutments or implants tested for each reported non-clinical test. The tests are general performance validations (e.g., fatigue, cytotoxicity, sterilization efficacy) and dimensional analyses that demonstrate compliance with relevant standards or a worst-case scenario. For example, fatigue testing often involves a small number of samples (e.g., 6 minimum per ISO 14801, though more are often used for statistical power) under specific loading conditions. Similarly, biocompatibility is performed on representative samples.
• Data Provenance: The data comes from the manufacturer's (Elos Medtech Pinol A/S) internal testing and leverages data from previously cleared devices where material, size, and geometry are substantially equivalent. The provenance is therefore the manufacturer's testing facilities and associated regulatory submissions. There is no indication of different countries of origin for the data concerning these non-clinical tests. The tests are prospective in nature, as they are part of the premarket submission process.

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. The "ground truth" for this medical device (dental abutment) is established by engineering specifications, material properties, performance standards (e.g., ISO, ASTM), and clinical safety and effectiveness data from the predicates. There is no AI/ML component described that would require expert human review or "ground truth" establishment in the context of diagnostic interpretation.

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

This question is not applicable as there is no human interpretation or diagnostic "test set" that would require adjudication.

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 question is not applicable. The device is a physical dental abutment and its associated digital design workflow, not an AI-powered diagnostic tool requiring human reader studies.

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

This question is not applicable. The device is not a standalone AI algorithm. The digital dentistry workflow involves CAD software and CAM software, but these are tools for designing and manufacturing the physical abutment, not for automated diagnostic interpretation or decision-making in the clinical sense of an AI/ML algorithm.

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

The "ground truth" for this device's performance, as demonstrated in the submission, is based on:

• Compliance with international standards (e.g., ISO 14801 for fatigue, ISO 10993-5 for biocompatibility, ISO 17665 for sterilization).
• Engineering and dimensional analysis against established dental implant system specifications.
• Physical testing results (e.g., torque, heating, displacement) for MR compatibility.
• Validation of the digital workflow ensuring design constraints and manufacturing accuracy.
• The fundamental demonstration is substantial equivalence to existing legally marketed predicate devices, implying that their established safety and effectiveness forms the basis of the "ground truth" for this device's intended use.

8. The sample size for the training set

This question is not applicable. This is not an AI/ML device that requires a training set for model development. The design software has built-in constraints ("design limitations" and "design limits in the library file"), which are more akin to pre-programmed rules and geometric parameters rather than a learned model from data.

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

This question is not applicable. No AI/ML training set is mentioned or implied. The "ground truth" for the design limitations within the software (e.g., minimum material thickness) would be established by engineering principles, biomechanical studies (often in labs, not clinical trials), and clinical experience with dental prosthetics, which define safe and effective design parameters.

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ARUM Dentistry's Customized Abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. The Customized Abutment will be attached to a dental implant using the included ARUM Dentistry prosthetic screw.

Customized Abutments are compatible with the implant systems listed in the Compatibility Table:

| Implant Platform
compatibility | Restorative Platform
diameter (mm) | Implant Body diameter (mm) |
|-----------------------------------|---------------------------------------|--------------------------------|
| NB 1 SA Implant
System | 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 | 3.8, 4.0, 4.15, 4.25, 4.5, 5.0 |

All digitally-designed Customized Abutments are intended to be sent to an ARUM Dentistry-validated milling center for manufacture.

Patient-specific abutment is made from Ti-6Al-4V Eli conforming to ASTM F136 to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screwand cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician.

The diameters of patient-specific abutment are 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 mm and two connection designs (Hex, Non-hex).

Patient-Specific Abutment is compatible with following Implant Systems:

Patient-specific abutments are supplied with an abutment screw previous cleared device as K222131 and 7 newly designed screws and provided non-sterile.

Patient-specific abutment design parameters:

The provided text describes the 510(k) submission for ARUM DENTISTRY Co., Ltd.'s "Customized Abutment." This is a Class II medical device (dental implant abutment). The document focuses on demonstrating substantial equivalence to a predicate device, which is a common pathway for FDA clearance.

Here's a breakdown of the requested information, based on the provided text. It's important to note that many of the typical "acceptance criteria" and "study proves that the device meets the acceptance criteria" details for AI/ML devices, such as those related to accuracy, sensitivity, specificity, or reader studies, are not applicable to this type of device. This is a physical, custom-fabricated medical device (dental abutment), not an AI/ML-driven diagnostic or treatment planning system. Therefore, the "acceptance criteria" here refer to performance testing (mechanical, biocompatibility, sterilization) to ensure the device is safe and effective and substantially equivalent to a predicate. The study that proves it meets criteria is the testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not specify a numerical "sample size" in terms of number of abutments tested for mechanical performance. It refers to "worst-case constructs" for each compatible implant line. This is typical for mechanical testing where a representative "worst-case" configuration is tested to demonstrate the device's limits.
• Data Provenance: The testing data is derived from non-clinical performance tests (mechanical testing, sterilization validation, biocompatibility) of the device and its predicate. The origin of the raw data (e.g., specific lab, country) is not detailed, but it is implied to be internal or from a contract testing lab as part of the manufacturer's quality system. It is prospective for the specific tests performed to support this submission.

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

• This is not applicable to this type of medical device submission. Ground truth (in the AI/ML sense) is not established by human experts for mechanical/biocompatibility testing. The "ground truth" for proving the device meets acceptance criteria relies on the results of standardized engineering and biological tests conducted according to recognized standards (e.g., ISO, ASTM).

4. Adjudication method for the test set

• Not applicable. There is no human adjudication process involved in interpreting the results of mechanical, biocompatibility, or sterilization tests for this device. The results are compared directly to pre-defined criteria in the standards.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

• No, an MRMC study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This is a physical, custom-fabricated dental device, so such a study is not applicable.

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

• Not applicable. This device is not an algorithm. Performance evaluation for this device is based on physical and material properties, not algorithmic output.

7. The type of ground truth used

• The "ground truth" for this device's performance is established by objective, standardized test methods (e.g., stress-strain measurements for mechanical testing, biological assays for biocompatibility, sterility indicator results for sterilization). It is based on engineering and scientific standards rather than expert consensus on medical images or pathology.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML or software device that undergoes "training." Its design and manufacturing are based on established engineering principles for dental abutments.

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

• Not applicable, as there is no "training set" for this type of device. The "ground truth" for its development and validation relies on adherence to design specifications, material standards, and validated manufacturing processes.

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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 Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw.

The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an Abuttnent Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The customized shape of the abutment is intended to be manufactured according to a digital dentistry workflow. The Elos Accurate® Customized Abutment is delivered non-sterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.

The provided text describes the regulatory clearance of a dental abutment, not an AI/ML medical device. Therefore, it does not contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria.

The 510(k) summary focuses on demonstrating "substantial equivalence" of the Elos Accurate® Customized Abutment to previously cleared predicate devices. The non-clinical testing described is for the physical dental device itself (e.g., fatigue testing, biocompatibility, sterilization validation) and validation of the digital dentistry workflow for designing and manufacturing the abutment.

There is no mention of:

• Acceptance criteria in terms of AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
• A test set, training set, or data provenance for an AI/ML algorithm.
• Experts establishing ground truth for AI/ML performance.
• Adjudication methods for AI/ML.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Ground truth types related to AI/ML (e.g., pathology for image classification).

The "digital dentistry workflow validation" mentioned refers to the software (3Shape Abutment Designer Software) that provides design limits for the abutment, not an AI/ML algorithm that performs a diagnostic or predictive task. It essentially ensures the software's constraints prevent users from designing abutments outside safe parameters.

Therefore, I cannot extract the requested information about AI/ML device acceptance criteria and study details from the provided document. The document is for a traditional medical device (dental abutment) and its manufacturing workflow, not an AI/ML enabled device.

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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 restorations. The prosthesis can be cemented or screw retained to the abutment screw is used to secure the abutment to the endosseous implant. The CreoDent Solidex® Customized Abutment is compatible with the following dental implants:

| Manufacturer | Implant Line | Platform
Diameter (mm) | Implant Body
Diameter (mm) |
|------------------------------------------|-----------------------------------------------|---------------------------|-------------------------------|
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 3.3 | 3.3 |
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 3.8 | 3.8 |
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 4.3 | 4.3 |
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 5.0 | 5.0 |
| Astra Tech, Inc | Osseospeed TX Implants | 3.5 | 3.5 |
| Astra Tech, Inc | Osseospeed TX Implants | 4.5 | 4.5 |
| Biomet | 3i Osseotite Certain Dental Implants | 3.4 | 3.25 |
| Biomet | 3i Osseotite Certain Dental Implants | 4.1 | 4.0 |
| Biomet | 3i Osseotite Certain Dental Implants | 5.0 | 5.0 |
| Biomet | 3i Osseotite Certain Dental Implants | 6.0 | 6.0 |
| Dentium CO., Ltd | Dentium 3.6mm Implantium | 3.6 | 3.4 |
| Hiossen | Hiossen TS Implants | 3.5 (Mini) | 3.5 |
| Hiossen | Hiossen TS Implants | 4.0 (Regular) | 4.0 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 3.5 | 2.4 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 4.1 | 2.7 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 5.0 | 3.3 |
| Nobel Biocare | NobelActive™ Internal Connection Implant | 3.5 (NP) | 3.5 |
| Nobel Biocare | NobelActive™ Internal Connection Implant | 3.9 (RP) | 4.3 |
| Nobel Biocare | NobelReplace™ TiUnite Endosseous Implant | 3.5 (NP) | 3.5 |
| Nobel Biocare | NobelReplace™ TiUnite Endosseous Implant | 4.3, 5.0 (RP) | 4.3, 5.0 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 3.5 | 3.5 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.0 | 4.0 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.5 | 4.2 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 5.0 | 5.0 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 6.0 | 6.0 |
| Straumann | Straumann Bone Level (BL) Implants | 3.3 (NC) | 3.3 |
| Straumann | Straumann Bone Level (BL) Implants | 4.1, 4.8 (RC) | 4.1, 4.8 |
| Zimmer | Zimmer Screw-Vent, Tapered Screw-Vent Implant | 3.5 | 3.7 |
| Zimmer | Zimmer Screw-Vent, Tapered Screw-Vent Implant | 4.5 | 4.7 |
| Zimmer | Zimmer Tapered Screw-Vent Implant | 5.7 | 6.0 |

All digitally designed files for CreoDent Solidex® Customized Abutment are to be sent back to a CreoDent-validated manufacturing facility for manufacture.

The CreoDent Solidex® Customized Abutment is fabricated of Ti-6AL-4V ELI titanium alloy meeting the requirements of ASTM F136 or Commercially Pure (CP Ti) titanium meeting the requirements of ASTM F67 (Grade 04-06). The CreoDent Solidex® Customized Abutment retention screws are fabricated of Ti-6AL-4V ELI titanium alloy meeting the requirements of ASTM F136 or Commercially Pure (CP Ti) titanium meeting the requirements of ASTM F67 (Grade 04-06). The CreoDent Solidex® Customized Abutment is 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. CreoDent Solidex® Customized Abutments are compatible with the following implant systems and the listed implant and restorative platform diameters:

| Manufacturer | Implant Line | Platform
Diameter
(mm) | Implant Body
Diameter (mm) |
|------------------------------------------|-----------------------------------------------|------------------------------|-------------------------------|
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 3.3 | 3.3 |
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 3.8 | 3.8 |
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 4.3 | 4.3 |
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 5.0 | 5.0 |
| Astra Tech, Inc | Osseospeed TX Implants | 3.5 | 3.5 |
| Astra Tech, Inc | Osseospeed TX Implants | 4.5 | 4.5 |
| Biomet | 3i Osseotite Certain Dental Implants | 3.4 | 3.25 |
| Biomet | 3i Osseotite Certain Dental Implants | 4.1 | 4.0 |
| Biomet | 3i Osseotite Certain Dental Implants | 5.0 | 5.0 |
| Biomet | 3i Osseotite Certain Dental Implants | 6.0 | 6.0 |
| Dentium CO., Ltd | Dentium 3.6mm Implantium | 3.6 | 3.4 |
| Hiossen | Hiossen TS Implants | 3.5 (Mini) | 3.5 |
| Hiossen | Hiossen TS Implants | 4.0 (Regular) | 4.0 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 3.5 | 2.4 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 4.1 | 2.7 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 5.0 | 3.3 |
| Nobel Biocare | NobelActive™ Internal Connection Implant | 3.5 (NP) | 3.5 |
| Nobel Biocare | NobelActive™ Internal Connection Implant | 3.9 (RP) | 4.3 |
| Nobel Biocare | NobelReplace™ TiUnite Endosseous Implant | 3.5 (NP) | 3.5 |
| Nobel Biocare | NobelReplace™ TiUnite Endosseous Implant | 4.3, 5.0 (RP) | 4.3, 5.0 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 3.5 | 3.5 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.0 | 4.0 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.2 | 4.5 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 5.0 | 5.0 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 6.0 | 6.0 |
| Straumann | Straumann Bone Level (BL) Implants | 3.3 (NC) | 3.3 |
| Straumann | Straumann Bone Level (BL) Implants | 4.1, 4.8 (RC) | 4.1, 4.8 |
| Zimmer | Zimmer Screw-Vent, Tapered Screw-Vent Implant | 3.5 | 3.7 |
| Zimmer | Zimmer Screw-Vent, Tapered Screw-Vent Implant | 4.5 | 4.7 |
| Zimmer | Zimmer Tapered Screw-Vent Implant | 5.7 | 6.0 |

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, post height, collar height and angulation. All digitally designed files for CreoDent Solidex® Customized Abutment are to be sent back to a CreoDent-validated manufacturing facility for manufacture.

The provided text describes the CreoDent Solidex® Customized Abutment, a dental implant abutment and screw designed to support prosthetic devices in partially or completely edentulous patients.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

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

The document does not explicitly state acceptance criteria in a quantifiable manner (e.g., specific thresholds for fatigue cycles or sterilization effectiveness). Instead, it states that "Test results and Biological Evaluation performed for the sponsor's Predicate and Reference devices demonstrate suitable biocompatibility of the Subject device" and that the testing demonstrated "sufficient mechanical strength for their intended clinical application."

The acceptance criteria seem to be implicitly tied to:

• Mechanical Strength: Sufficient to withstand dynamic fatigue loads as per ISO 14801:2007.
• Biocompatibility: Suitable for its intended use based on previous evaluations of predicate/reference devices.
• Sterilization: Effective sterilization according to ISO 17665-1.
• Dimensional Accuracy: Compatibility with various dental implant systems.

Given the information, a table would look like this:

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

The document does not specify the sample size for any of the non-clinical tests (static/fatigue testing, reverse engineering, sterilization, biocompatibility). It also does not explicitly state the country of origin or whether the data was retrospective or prospective.

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 information is not provided. The testing described is non-clinical performance testing rather than studies involving expert interpretation of data.

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

This information is not applicable and not provided, as the studies are non-clinical performance tests, not studies requiring human expert adjudication for ground truth.

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 such study was conducted or mentioned in the document. The device is a physical dental abutment, not an AI-assisted diagnostic tool.

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

This is not applicable to a physical dental device.

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

For the non-clinical performance tests:

• Mechanical Strength: The ground truth would be established by the physical testing results against the requirements of ISO 14801:2007.
• Biocompatibility: The ground truth would be established by the results of biological evaluation (e.g., cytotoxicity, sensitization, irritation tests) against relevant standards (e.g., ISO 10993).
• Sterilization: The ground truth would be established by successful validation of the sterilization process according to ISO 17665-1.
• Dimensional Accuracy/Compatibility: The ground truth would be established by physical measurements and fit testing using OEM compatible components.

8. The sample size for the training set

This is not applicable. The device is a physical product, not an AI/machine learning algorithm.

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

This is not applicable. The device is a physical product, not an AI/machine learning algorithm.

Study Summaries:

The document states that "No new testing was performed as a part of this submission. Fatigue testing, reverse engineering, sterilization, and biocompatibility testing are all leveraged from previous submissions." This means the testing was conducted for earlier versions or similar devices (Predicate and Reference devices: K162734, K113738, K150012, K160436) and the results are considered applicable to the current submission due to substantial equivalence in design and materials.

• Static/Fatigue Testing:

  • Methodology: Conducted in accordance with ISO 14801:2007 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants) focusing on a "worst-case scenario" for the abutment connection platform.
  • Purpose: To demonstrate sufficient mechanical strength for the intended clinical application.

• Reverse Engineering Dimensional Analysis:

  • Methodology: Used OEM compatible implant bodies, abutments, and abutment fixation screws.
  • Purpose: To confirm the dimensional accuracy and compatibility of the CreoDent Solidex® Customized Abutment with various specified dental implant systems.

• Sterilization:

  • Methodology: Performed according to ISO 17665-1 (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices).
  • Purpose: To ensure the device can be effectively sterilized for safe clinical use.

• Biological Evaluation:

  • Methodology: Performed for the sponsor's Predicate and Reference devices. (Specific tests are not detailed, but typically involve ISO 10993 series for medical devices).
  • Purpose: To ensure the materials used are biocompatible and do not pose unacceptable biological risks to patients.

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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.

The CreoDent Solidex® Customized Abutment and Screw are compatible with the following:

• Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5

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:

• . Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5
  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 and maximum dimensions for wall thickness, diameter, height, collar height and angulation.

The provided text describes a 510(k) premarket notification for a medical device, the "CreoDent Solidex® Customized Abutment and Screw." This document focuses on demonstrating substantial equivalence to already legally marketed devices, rather than presenting a de novo clinical study with specific acceptance criteria, comprehensive performance data from a test set, or details about training sets, expert adjudication, or MRMC studies typical for AI/ML device submissions.

Therefore, the requested information cannot be fully extracted from the provided text in the manner typically asked for AI/ML device descriptions. The document does not include:

• A table of acceptance criteria and reported device performance in the context of an AI/ML algorithm.
• Details about sample sizes for a test set, data provenance, ground truth establishment for a test or training set.
• Information about expert numbers, qualifications, or adjudication methods for ground truth because the safety and effectiveness are established through physical performance testing and comparison to predicate devices, not through diagnostic performance in an AI/ML context.
• Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.

The study described is primarily a non-clinical, in-vitro performance study focusing on mechanical strength and material compatibility to demonstrate equivalence.

Here's what can be extracted and inferred based on the provided text, while acknowledging the limitations for an AI/ML context:

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

The document doesn't present "acceptance criteria" and "reported device performance" in the way one would for diagnostic accuracy of an AI/ML device. Instead, it details technical specifications and performance characteristics that demonstrate the device's functional integrity and equivalence to predicate devices. The study's "acceptance" is implicitly that the device performs mechanically at least as well as, or comparably to, the predicate devices, particularly under "worst-case scenario" conditions.

Result: "These results demonstrated that the Solidex® Customized Abutment and Screw have sufficient mechanical strength for their intended clinical application." This implies that the device met the performance requirements or thresholds defined by the ISO standard for dental implants. |
| Dimensional Compatibility | Reverse Engineering Dimensional Analysis: Conducted using OEM implant bodies, OEM abutments, and OEM abutment screws.

Result: Demonstrated the device's "compatibility with Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5 for which they are intended." The document also notes that safeguards and limitations in the design software will be imposed according to specified design limitations built into the abutment designer (e.g., minimum/maximum dimensions for wall thickness, diameter, height, collar height, and angulation). The less extreme maximum angulation compared to a reference predicate was "mitigated by fatigue testing and reverse engineering dimensional analysis." |
| Sterilization Efficacy | Sterilization Testing: Conducted according to ISO 17665-1.

Result: Sterilization was performed, implying that the protocol was effective and the device can be sterilized as intended. |
| Biocompatibility | Biocompatibility information is "leveraged from our previous 510k (K150012)," indicating that the material properties for biocompatibility are previously established and accepted for the predicate device, and the current device uses the same or an equivalent material (Ti-6Al-4V Eli titanium alloy). |

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

• Sample Size: Not explicitly stated as a number of "samples" for a "test set" in the context of an AI/ML study. For mechanical testing, the number of units tested per standard (ISO 14801:2007E) is typically small (e.g., 5-10 samples per test condition), but this specific number is not provided.
• Data Provenance: The testing is described as "Non-clinical Testing Data," which typically means in-vitro lab testing. The materials for the abutment blanks and screws are sourced from specific suppliers (T.Strong INC in Korea, who obtains materials from US suppliers). The final manufacturing occurs at CreoDent's facility in New York. This is not "clinical data" provenance in terms of patient data.

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

Not applicable. Ground truth in this context is established by engineering specifications, material standards (ASTM, ISO), and performance under mechanical stress tests, not by expert human interpretation of medical images or clinical outcomes.

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

Not applicable. There are no human adjudicators for the mechanical and material performance tests described.

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

Not applicable. This is a dental implant component, not an AI/ML diagnostic imaging device.

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

Not applicable. There is no AI algorithm involved. The device itself is a physical medical device. The "CAD/CAM Work Flow" is a manufacturing process using software to design the custom abutment, but this is not an AI/ML algorithm for making clinical decisions or performing diagnostics.

7. The type of ground truth used:

The "ground truth" for this device's performance validation is based on:

• Engineering Standards: Adherence to ISO 14801:2007E for dynamic fatigue testing, ISO 17665-1 for sterilization, and ASTM F-136/F-67 for material (titanium alloy) specifications.
• Predicate Device Performance: Demonstrating that the subject device's performance is equivalent to or better than that of the listed predicate devices (CreoDent Solidex Customized Abutments K150012, Straumann Tissue Level Standard Plus K171784) in terms of mechanical strength and compatibility for its intended use.
• Design Specifications: Meeting internal design limitations (Min/Max dimensions for wall thickness, diameter, height, collar height, angulation).

8. The sample size for the training set:

Not applicable. No AI/ML training set is mentioned or relevant for this device.

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

Not applicable.

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