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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 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.

Ask a specific question about this device

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 endentulous. 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:

• Sweden & Martina Premium Implant System 3.3mm and 3.8mm

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:

• Sweden & Martina Premium Implant System 3.3mm and 3.8mm
  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.

The CreoDent Solidex® Customized Abutment and Screw is a dental device intended for use with endosseous implants to support prosthetic devices. The information provided outlines the acceptance criteria and the study that proves the device meets these criteria as part of a 510(k) premarket notification.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "test set" in terms of a patient population size for clinical data. The testing described is primarily non-clinical:

• Non-clinical Testing Data: Static/Fatigue testing in accordance with ISO 14801:2007E. The sample sizes for these mechanical tests are not specified (e.g., number of abutments and screws tested).
• Dimensional Analysis: Conducted using OEM implant bodies, OEM abutments, and OEM abutment screws. The number of samples for this analysis is not specified.

The data provenance is from non-clinical laboratory testing and reverse engineering dimensional analysis, rather than patient-derived data from a specific country, and is therefore not retrospective or prospective in the clinical sense.

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

This section is not applicable as the studies described are non-clinical (mechanical and dimensional testing) and do not involve human expert interpretation or ground truth establishment in the traditional sense of clinical imaging or diagnostic studies. The "ground truth" for these tests would be the established engineering standards (e.g., ISO 14801:2007E), and the manufacturing specifications for the device and compatible implants.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above. There was no "test set" requiring adjudication by experts.

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 submission focuses on the mechanical and material equivalence of a dental abutment and screw to an existing predicate device using non-clinical testing. It does not involve human readers or AI assistance.

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

No, a standalone performance study in the context of an algorithm or AI was not done. This device is a physical medical device (dental abutment and screw), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was based on:

• Industry Standards: ISO 14801:2007E for dynamic fatigue testing.
• Manufacturer Specifications: OEM implant bodies, OEM abutments, and OEM abutment screws for reverse engineering dimensional analysis.
• Regulatory Standards: ASTM F-136 for material composition (Ti-6A1-4V Eli titanium alloy).
• Previous Biocompatibility Data: Leveraged from their previous 510(k) (K150012).

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical dental implant component, not an AI or machine learning model that requires a training set.

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

This section is not applicable for the reasons stated above.

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