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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.

Ask a specific question about this device

The CREOKORREKT Aligner is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The aligner positions teeth by way of continuous gentle force.

CREOKORREKT Aligners consist of a series of dentist-prescribed, thin, clear, thermoformed polyurethane and copolyester orthodontic appliances. The aligners provide gentle continuous force to move the patient's teeth in small increments from their original positions to planned positions. CREOKORREKT Aligners are intended as an alternative to conventional wire and bracket orthodontic technology and fixed appliances for the treatment of patients with tooth malocclusion.

A dentist determines a treatment plan based on the assessment of the patient's teeth and prescribes the CREOKORREKT. To obtain the dimensions and details of a patient's dentition, a dentist takes intraoral scanning or a physical impression (PVS Impression) and sends them with a prescription to CreoDent Prosthetics LTD.

With PVS impressions, physical models are fabricated and scanned. Scanned data are directly imported into dental design software for planning. CreoDent Prosthetics LTD designs the process of treatment by creating a series of the sequential model intended to gradually move the patient's teeth to the desired position in accordance with the dentist's prescription utilizing the dental design software. The doctor reviews and approves the treatment scheme. CreoDent Prosthetics LTD fabricates a series of models for thermoforming.

The provided document describes a 510(k) premarket notification for the CREOKORREKT Aligners. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with detailed acceptance criteria and performance metrics against a defined ground truth as would be common for novel high-risk devices.

Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available within this 510(k) summary.

Here's why and what information can be extracted:

• 510(k) Submissions: These primarily rely on non-clinical testing (e.g., material properties, biocompatibility) and comparison to predicate devices to demonstrate that the new device is as safe and effective as a device already on the market. They typically do not involve the kind of comparative effectiveness studies (e.g., MRMC studies with human readers and AI assistance) or standalone algorithm performance studies with detailed ground truth analysis that would be needed to answer your specific questions.
• "Acceptance Criteria" in this context: The "acceptance criteria" mentioned in the document relate to the manufacturing process validation test, which assesses if the manufactured aligner matches the software treatment design and achieves its intended use. This is a different type of acceptance criterion than, for example, a diagnostic device's sensitivity/specificity targets against a clinical ground truth.

Extracted Information (based on the document's content):

1. Table of Acceptance Criteria and Reported Device Performance:

   Test Type	Acceptance Criteria (as implied/stated)	Reported Device Performance
   Physical Properties Testing	Meets requirements of ASTM D6387, ASTM D790, ASTM D570, and ASTM D5420.	Demonstrated substantial equivalence (implicit passed).
   Biocompatibility Testing	Meets requirements of ISO 10993-3, 5, 10, and 11.	Demonstrated substantial equivalence (implicit passed).
   Manufacturing Process Validation Testing	"Evaluated the fit, form, and function of the final product by a trained physician as compared to software treatment design."	"Met the pre-established acceptance criteria." "Achieves its intended use, and it is substantially equivalent to the predicate devices."

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

   • The document does not specify the sample size for the manufacturing process validation test or any other "test set" in the context of clinical performance.
   • Data provenance for clinical outcomes is not mentioned, as this was not a clinical study to prove effectiveness.

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

   • The document mentions evaluation "by a trained physician" for the manufacturing process validation. It does not specify the number of physicians or their detailed qualifications beyond "trained."
   • No "ground truth" in a clinical sense (e.g., pathology, outcomes data) was established for an efficacy study. The ground truth for the manufacturing validation was the software treatment design.

4. Adjudication method for the test set:

   • Not applicable as a formal adjudication method for a clinical test set is not described. The document only mentions evaluation by a "trained physician" against the software design.

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. The device is a physical aligner, not an AI diagnostic or assistance tool for human readers.

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

   • Not applicable. This is a physical medical device. The "algorithm" here refers to the dental design software which guides the manufacturing, not a standalone AI for diagnosis or treatment decision.

7. The type of ground truth used:

   • For the manufacturing process validation, the "ground truth" was the software treatment design. For other non-clinical tests (material properties, biocompatibility), the ground truth generally refers to the standards/specifications that the material must meet.

8. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" in the context of machine learning or AI algorithm development for clinical performance. The manufacturing process uses software for design, but it's not described as an AI system requiring a training set in the clinical performance sense.

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

   • Not applicable, as no training set (in the context of AI/ML) is mentioned or implied for clinical performance evaluation.

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 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.

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 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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The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patents 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. An abutment screw is used to secure the abutment to the endosseous implant.

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. 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.

The CreoDent Solidex® Customized Abutment is a dental device intended to support prosthetic devices with endosseous implants in partially or completely edentulous patients. The study aimed to demonstrate substantial equivalence to previously cleared predicate devices through non-clinical testing.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The information provided does not explicitly state numerical "acceptance criteria" for performance metrics in a pass/fail format typical of many medical device studies. Instead, substantial equivalence is established by demonstrating that the device has the same intended use, fundamental scientific technology, and comparable technological characteristics and performance to predicate devices, with any differences being "mitigated" or demonstrated to be safe and effective.

The provided document details comparisons between the CreoDent Solidex® Customized Abutment and several predicate devices across various technological characteristics. The "reported device performance" is primarily qualitative, asserting mechanical strength and compatibility, and is supported by specific non-clinical tests.

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

The provided document describes non-clinical testing rather than a clinical study with a "test set" of patient data.

• Sample Size for Non-clinical Testing: The document does not specify the exact number of physical samples (e.g., abutments, screws, implants) used for static/fatigue testing or reverse engineering dimensional analysis. It refers to "worst-case scenario" testing for the abutment connection platform.
• Data Provenance: The data is from non-clinical bench testing rather than human patient data. Therefore, there is no country of origin or retrospective/prospective classification in the typical sense.

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

Not applicable. This device's clearance is based on non-clinical testing and demonstration of substantial equivalence, not a clinical study requiring expert-established ground truth from patient data. The "ground truth" here is the adherence to mechanical performance standards and dimensional compatibility, verified by engineering and material science evaluations.

4. Adjudication Method for the Test Set

Not applicable, as there is no test set in the context of clinical images or data 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. This type of study is relevant for diagnostic imaging or AI-assisted interpretation, which is not the nature of this dental abutment device.

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

Not applicable. This is a physical dental device (abutment) and not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Mechanical Standards: Adherence to established international standards for dental implants and abutments (e.g., ISO 14801:2007E for dynamic fatigue).
• Material Specifications: Compliance with material standards (ASTM F-136 for Ti-6Al-4V Eli titanium alloy).
• Dimensional Compatibility: Verification through reverse engineering dimensional analysis against original equipment manufacturer (OEM) compatible implant bodies, abutments, and fixation screws.
• Sterilization Standards: Compliance with ISO 17665-1.

8. The Sample Size for the Training Set

Not applicable. This is a physical dental device; there is no "training set" in the machine learning sense. The design and manufacturing processes are likely informed by extensive engineering knowledge and design principles accumulated over time for similar devices.

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

Not applicable, as there is no training set for an AI/algorithm. For a physical device, the "ground truth" for design and manufacturing is established through engineering principles, material science, and adherence to accepted industry standards and regulatory requirements.

Ask a specific question about this device

The CreoDent Solidex® Customized Abutment 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 is compatible with the following:

• Astra Tech Osseospeed TX Implants 3.5mm, 4.5mm
• Hiossen TS Implants 3.5mm, 4.0mm

The Solidex® Customized Abutment is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard and Screw is CP TI Gr4 meets ASTM F67 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 Abutments are compatible with:

• Astra Tech Osseospeed TX Implants 3.5mm, 4.5mm (K024111)
• Hiossen TS Implants 3.5mm, 4.0mm (K151858)

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 medical device under consideration is the CreoDent Solidex® Customized Abutment. The provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving a device meets specific acceptance criteria through a standalone clinical study. Therefore, some of the requested information, such as sample sizes for test/training sets, number/qualifications of experts for ground truthing, adjudication methods, and MRMC studies, is not typically part of a 510(k) submission for this type of device and is not present in the provided text.

Based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the CreoDent Solidex® Customized Abutment are implicitly derived from its substantial equivalence to predicate devices in material, indications for use, performance characteristics, and dimensions/angulations, backed by non-clinical testing. The performance is assessed against the established standards and the characteristics of the predicate devices.

Study Proving Acceptance Criteria:

The study proving the device meets its acceptance criteria is a non-clinical testing study focused on mechanical performance and compatibility.

• Study Type: Non-clinical testing, specifically static/fatigue testing, reverse engineering dimensional analysis, and sterilization validation.
• Standards Followed: ISO 14801:2007E (Dentistry-Implants-Dynamic fatigue test for endosseous dental implants) and ISO 17665-1 (Sterilization validation).
• Purpose: To demonstrate that the CreoDent Solidex® Customized Abutment has sufficient mechanical strength for its intended clinical application and is compatible with the specified Astra Tech Osseospeed TX and Hiossen TS implant systems. This testing specifically addressed the differences identified when comparing to predicate devices (compatible implant bodies and angulation).

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

• Sample Size for Test Set: Not specified in the document. Non-clinical mechanical testing typically involves a sufficient number of samples to ensure statistical significance for the specific test (e.g., number of abutment-implant assemblies tested for fatigue) but this exact number is not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). As a non-clinical, in-vitro mechanical testing study, the data is generated in a laboratory setting.

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

• This is a mechanical testing study, not one requiring expert human interpretation of medical images or patient data to establish ground truth. Therefore, this information is not applicable and not provided. The "ground truth" here is the physical performance of the device under defined test conditions per international standards.

4. Adjudication Method for the Test Set

• Not applicable. As a mechanical testing study, adjudication of human interpretations is not involved.

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

• No, a MRMC comparative effectiveness study was not done. This type of study is for evaluating diagnostic or prognostic algorithms read by human experts, which is not relevant for this dental implant abutment.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study

• Not applicable. This device is a physical medical device (an abutment for dental implants), not a software algorithm.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance evaluation is established through physical measurements and adherence to international mechanical testing standards (ISO 14801:2007E). The benchmarks are defined by these standards, the performance of the legally marketed predicate devices, and the physical properties of the materials and design.

8. Sample Size for the Training Set

• Not applicable. This is a physical device, and the validation process described is for its mechanical integrity and compatibility, not for an algorithm that requires a training set.

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

• Not applicable as there is no training set for a physical device like this.

Ask a specific question about this device

The CreoDent Solidex® Customized Abutment 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 sinqle 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 is compatible with the following:

• . Biomet 3i Osseotite Certain Dental Implants 3.25mm, 4.0mm, 5.0mm, 6.0mm
• o Straumann Bone Level Implants 3.3mm. 4.1mm. 4.8mm

The Solidex® Customized Abutment is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard and Screw is CP TI Gr4 meets ASTM F67 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 Abutments are compatibe with:

• Biomet 3i Osseotite Certain 3.25mm, 4.0mm, 6.0mm diameter implants K063341 .
• Straumann Bone Level implants 3.3mm, 4.1mm, 4.8mm K083550 K121131 .

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.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CreoDent Solidex® Customized Abutment:

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a traditional clinical trial report with specific acceptance criteria as might be found for a novel device. The "acceptance criteria" here are implicitly related to demonstrating performance equivalence to the predicate devices through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) summary, the "acceptance criteria" are the demonstration of equivalent or superior performance to the predicate devices through specific non-clinical tests. The reported device performance is that these tests showed sufficient strength and compatibility.

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

The document describes non-clinical laboratory testing, not human or animal clinical trials. Therefore, the concept of a "test set" in the context of clinical data or AI systems does not directly apply.

• Sample Size for Testing: The document does not specify the exact number of abutments or implants tested in the static/fatigue testing, dimensional analysis, or sterilization validation. It refers to these as "testing" or "analysis" without numerical details on the quantity of items used.
• Data Provenance: The data comes from non-clinical laboratory testing conducted by the manufacturer, CreoDent Prosthetics, Ltd. There is no information regarding country of origin of data beyond the manufacturer's location in New York, USA, or whether it's retrospective or prospective, as it's not a clinical study.

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

This section is not applicable. The "ground truth" for this device's performance is established through internationally recognized engineering standards (ISO 14801:2007E, ISO 17665-1) and direct physical/mechanical testing, not through expert clinical consensus or interpretation of images/data by human experts.

4. Adjudication Method for the Test Set

This section is not applicable. As the testing is non-clinical and based on objective engineering measurements and standards, there is no need for an adjudication method involving human 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. This type of study is relevant for diagnostic imaging devices or AI algorithms that rely on human interpretation of outputs. The CreoDent Solidex® Customized Abutment is a physical medical device (dental implant abutment), not a diagnostic or AI software.

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

No, a standalone algorithm performance study was not done. This device is a physical product, not an algorithm or AI software.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the safety and effectiveness of the CreoDent Solidex® Customized Abutment is based on:

• Engineering Standards and Specifications: Adherence to ISO standards (ISO 14801:2007E for fatigue, ISO 17665-1 for sterilization) and ASTM material standards (ASTM F-136, ASTM F67).
• Objective Mechanical and Physical Measurements: Results from static/fatigue testing and reverse engineering dimensional analysis.
• Comparison to Predicate Devices: Demonstrating that the subject device's performance, materials, and indications for use are substantially equivalent to legally marketed predicate devices.

8. The Sample Size for the Training Set

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

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

This section is not applicable for the same reason as above; there is no training set for a physical medical device.

Ask a specific question about this device

The CreoDent Solidex® Customized Abutment 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 is compatible with the following:

• Nobel Replace™ TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants .
• Nobel Active™ Internal Connection 3.5mm and 4.3mm diameter Implants .
• Zimmer Screw-Vent 3.7mm, 4.7mm ; Zimmer Tapered Screw-Vent , 3.7mm, 4.7mm and . 6.0mm diameter implants

The Solidex® Customized Abutment is made of CP TI Gr4 grade unalloyed titanium for surgical implants applications (meets ASTM Standard F67/Gr 04-06) 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 Abutments are compatible with:

• . Nobel Replace™ TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants (510K#023113)
• . Nobel Active™ Internal Connection 3.5mm and 4.3mm diameter Implants (510K#071370)
• Zimmer Screw-Vent 3.7mm, 4.7mm; Zimmer Tapered Screw-Vent 3.7mm, 4.7mm and 6.0mm diameter Implants (510K#013227)

The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist.

Here's an analysis of the provided text regarding the CreoDent Solidex® Customized Abutment, focusing on acceptance criteria and study details:

Preamble:
This document describes a 510(k) premarket notification for a medical device, the CreoDent Solidex® Customized Abutment. As such, the purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to establish novel clinical efficacy or safety standards through extensive clinical trials. The "acceptance criteria" here refer to demonstrating that the new device performs comparably to the predicate device, particularly in terms of mechanical strength and compatibility, and is therefore deemed safe and effective for its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

The core of the "acceptance criteria" and "reported device performance" for this 510(k) submission is the demonstration of similar mechanical properties to predicate devices and compatibility with specific implant systems. The study cited is non-clinical static/fatigue testing in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants.

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly met if the test results demonstrate comparable or superior performance to the predicate under the defined standard. The text doesn't provide numerical acceptance thresholds or specific performance metrics from the predicate devices with which to compare. Instead, it makes a qualitative statement that the device has "sufficient mechanical strength."

Study Details

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

   • Sample Size: The document does not specify the exact number of units tested. ISO 14801 typically defines sample sizes (e.g., n=5 or n=10 per group). The phrase "worst case scenario for the Solidex® Customized Abutment connection platform" suggests that specific configurations were selected for testing. Without the full test report, the precise sample size is unknown.
   • Data Provenance: Not explicitly stated, but as a premarket notification to the US FDA, the testing was likely conducted in an accredited lab, potentially within the US or a country with recognized testing standards. This would be a prospective set of tests designed specifically for this submission.

2. 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 question is not applicable to the type of study performed. The study was a non-clinical mechanical engineering test (static/fatigue testing) following an international standard (ISO 14801:2007E). The "ground truth" is established by the standardized test methodology and objective measurements, not by expert consensus on clinical data.

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

   • This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving human interpretation or subjective assessments. This was a non-clinical mechanical test with objective measurements guided by a standard.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a dental implant abutment, a physical component, and does not involve AI or human "readers" in its primary function or assessment for this submission.

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

   • No, this question is not applicable. This device is a physical medical device, not an algorithm or AI system.

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

   • The "ground truth" for this non-clinical study is defined by the ISO 14801:2007E standard itself, which provides a scientifically validated methodology for dynamic fatigue testing of dental implants. The "truth" is the objective measurement of load cycles to failure, maximum force, stiffness, etc., as determined by the specified test method. It's an engineering ground truth, not a biological or clinical one based on consensus or pathology.

7. The sample size for the training set:

   • This question is not applicable. There is no "training set" in the context of this non-clinical mechanical testing for demonstrating substantial equivalence. The device design and manufacturing processes are established based on engineering principles and materials science, not machine learning or AI training.

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

   • This question is not applicable as there is no training set.

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