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510(k) Data Aggregation
(139 days)
CEREC Cercon 4D™ Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.
The system comprises three parts:
- CEREC Cercon 4D™ Abutment Block
- TiBase
- CAD/CAM system
The CEREC Cercon 4D™ ceramic structure cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.
The CEREC Cercon 4D Abutment Blocks, which are used for fabrication of a ceramic structure, two-piece hybrid abutments (meso-structure and crown) and abutment crowns, that are cemented to a TiBase (titanium base) used with dental implant systems. The CEREC Cercon 4D Abutment Blocks are not provided as the finished, fully assembled dental implant medical devices. The abutment blocks are materials supplied to dental professionals that must be further processed/manufactured using CAD/CAM technology and they are not intended to be reused as in the context of direct patient-applied devices and materials.
CEREC Cercon 4D™ Abutment Block are Yttria-doped zirconia blocks suitable for chairside and lab side use in fabrication of single cement-retained restorations. CEREC Ceron 4D™ Abutment Block are designed with a pre-drilled screw access channel and anti-rotation feature. The design allows for fabrication of a ceramic structure, two-piece hybrid abutments (mesostructure and crown) and abutment crowns, that are cemented to theBase (Titanium base) used with dental implant systems.
The provided document describes the substantial equivalence of the CEREC Cercon 4D™ Abutment Blocks and System, primarily focusing on non-clinical performance and material characteristics, rather than an AI/ML-based device. Therefore, many of the requested elements pertaining to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document.
However, I can extract information related to the acceptance criteria and study that proves the device meets those criteria from the perspective of a medical device (specifically, a dental abutment system), even without AI elements.
Here's the information based on the provided text, with Not Applicable (N/A) for fields that relate to AI/ML studies and are not covered in this document.
Acceptance Criteria and Device Performance for CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System
The device under review is primarily a dental abutment system, and its performance is evaluated based on material properties, mechanical strength, and software integration, not on diagnostic accuracy or AI assistance.
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Performed | Test Method/Applicable Standards | Acceptance Criteria | Reported Performance (Results) |
|---|---|---|---|
| Flexural Strength | ISO 6872:2015 Amd 1. 2018 Dentistry-Ceramic Materials | >1,100 MPa | Pass |
| Fatigue Testing | ISO 14801:2016 Dentistry-Implants-Dynamic loading test for endosseous dental implants | (Implied: Meets requirements) | Pass |
| Sterilization Validation | 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 | Achieve a Sterility Assurance Level (SAL) of 10⁻⁶ | Validated |
| Biocompatibility | ISO 10993 standard series (specifically ISO 10993-5, -10, -23) | Meets ISO 10993 requirements | Meets requirements |
| Software Validation (Angulation) | Internal software integration requirements for the addition of the proposed device | Max angulation of 20° (User cannot proceed if outside) | Meets requirements |
| Software Validation (Wall Thickness) | Internal software integration requirements for the addition of the proposed device | Minimal wall thickness of 0.5 mm (User cannot proceed if outside) | Meets requirements |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set:
- For Flexural Strength (Table 8.1): Not explicitly stated, but typically involves a certain number of samples to ensure statistical significance as per ISO 6872.
- For Fatigue Testing (Table 8.2): "New fatigue testing was conducted on the worst-case combinations relating to the greatest angulation, the platform size and the gingival height for the proposed Dentsply Sirona TiBase/Dentsply Sirona Implant Systems and Third Party TiBase/Third Party Implant Systems (Camlog) combinations." The exact number of samples per test condition is not specified in the document, but standardized tests like ISO 14801 would stipulate a minimum.
- For Sterilization Validation, Biocompatibility, and Software Validation: Not explicitly specified in terms of sample count in this summary.
- Data Provenance: The document does not specify the country of origin of the data. The tests are described as "non-clinical tests" and "performance bench testing," indicating laboratory-based studies. The document does not mention if the data is retrospective or prospective, as this distinction is more relevant for clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI/ML diagnostic tool requiring expert ground truth for image interpretation or similar. The "ground truth" (or more accurately, established performance standards) for this device is based on mechanical properties and ISO standards, which are objective and do not require expert human interpretation in the way an AI diagnostic system would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no human expert interpretation or consensus review is involved in the performance testing of this device (e.g., physical strength, material composition).
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 not an AI-assisted diagnostic device; therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device. Its "system" aspect refers to the combination of the abutment block, TiBase, and CAD/CAM system for fabrication, not an AI algorithm. The performance described is of the physical components and the software's ability to constrain design parameters.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by international consensus standards (e.g., ISO 6872, ISO 14801, ISO 10993, ISO 17665-1) for dental materials and implants, along with internal software integration requirements. These are objective, quantitative measures rather than subjective human interpretations or clinical outcomes data in the context of diagnostic accuracy.
8. The sample size for the training set
Not applicable. This device does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. This device does not have a "training set" in the context of machine learning.
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(83 days)
The Straumann® TLX Variobase® C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® TLX Variobase® C abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
All digitally designed copings and/or crowns for use with the Straumann® TLX Variobase® C abutments are to be designed using Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
The Straumann® TLX Variobase® C abutments are two-piece abutments composed of the following components:
- . Straumann® TLX Variobase® C (Ti-base)
- Prosthetic Restoration (patient specific coping or crown) .
- . Basal Screw
The Straumann® TLX Variobase® C abutments provide the interface for copings or crowns designed and milled using a Sirona Dental CAD/CAM System with the Straumann dental implant platform: NT (Narrow TorcFit), RT (Regular TorcFit), and WT (Wide TorcFit). The Straumann® TLX Variobase® C abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases," made from a titanium-aluminum-niobium (TAN) alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona MC XL prosthetic milling systems, and the base portion is available to fit the Straumann® dental implant platforms listed above. The top half material that is compatible with the Straumann® TLX Variobase® C abutments is IPS e.max CAD.
The provided document is a 510(k) Summary for a dental device, the "Straumann® TLX Variobase® C". This document describes the device, its intended use, and how it compares to predicate devices. It does not describe a study involving an AI/ML algorithm or its performance characteristics.
Therefore, I cannot provide the information requested in your prompt because the document does not contain details about:
- Acceptance criteria for an AI/ML device.
- A study proving an AI/ML device meets acceptance criteria.
- Sample sizes for test or training sets for an AI/ML model.
- Ground truth establishment methods for AI/ML data.
- Expert consensus or adjudication for AI/ML performance evaluation.
- MRMC studies for AI/ML or human-in-the-loop performance.
- Standalone AI algorithm performance.
The "Performance Testing" section (Page 10, section {10}) refers to mechanical and software validation testing for a dental abutment, not an AI/ML algorithm. Specifically, it mentions:
- Dynamic fatigue and static strength tests (mechanical performance).
- Biocompatibility (material safety).
- Sterilization process validation.
- Software verification and validation for the abutment design library to ensure it operates within specified design limitations.
The software validation mentioned is to ensure the design software for the dental abutment (Sirona Dental CAD/CAM System) correctly applies design restrictions, not to evaluate an AI's diagnostic or predictive performance.
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(170 days)
The Straumann n!ce Glass Ceramic A14 Blocks are intended to be ceramic mesostructures cemented to the Ti-base for a two-piece hybrid abutment for single tooth restorations or hybrid abutment crowns, used in conjunction with endosseous dental implant to restore chewing function. The following compatibilities apply:
| Ti-Base | Block | ||
|---|---|---|---|
| manufacturer | system | Reference | interface size |
| Straumann | RC Variobase® for CEREC | 022.0024 | L |
| NC Variobase® for CEREC | 022.0025 | L | |
| RN Variobase® for CEREC | 022.0019 | L | |
| WN Variobase® for CEREC | 022.0020 | L |
Straumann® n!ce® glass ceramic is a proprietary lithium disilicate (Li2O-SiO2) dental glass ceramic material. The n!ce® glass-ceramic A14 blocks feature a pre milled interface that fits the Straumann® Variobase® for CEREC®. The blocks are further processed by the trained professional to make individually designed mesostructure that are milled into the desired shape of a hybrid abutment or hybrid abutment crown using the Sirona inLab (Version3.65) and CEREC® software (Version 4.2). n!ce® mesostructures can be additional crystallization firing. Stain & glaze techniques can be applied.
n!ce® A14 blocks are available in two levels of translucency: HT (High Translucency) and LT (Low Translucency). Both translucencies are available in shades , A1, A2, A3, B2, B4 and C2 for flexibility and application variety to meet individual patient needs. n!ce®A14 blocks are available with one interface size large (L)
The provided text describes the submission for a 510(k) premarket notification for the "Straumann® n!ce Glass Ceramic A14 Blocks," a dental device. It focuses on demonstrating substantial equivalence to a predicate device, rather than outlining acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device.
Therefore, many of the requested items (Acceptance Criteria Table, Sample Size for Test Set, Data Provenance, Number of Experts, Adjudication method, MRMC study, Standalone performance, Training set size, Training set GT establishment) are not applicable to this type of regulatory submission, as it is for a physical dental material block, not an AI/ML algorithm.
However, I can extract the "Performance Data" section which describes the types of tests conducted to support the device's safety and effectiveness and its substantial equivalence.
Here's the information that can be extracted from the document, focusing on what is relevant to "acceptance criteria" and "study."
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" paired with "reported device performance" in the way one might expect for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, it lists the types of performance tests that were conducted and implied their results supported substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| ISO 6872 compliance | Test data submitted or referenced to support the evaluation of the subject n!ce® Glass-Ceramic A14 Blocks, indicating compliance with ISO 6872 (Dentistry-Ceramic materials). |
| ISO 14801 compliance | Test data submitted or referenced, indicating compliance with ISO 14801 (Dentistry-Implants-Dynamic fatigue test for endosseous dental implants). |
| FDA guidance compliance | Test data submitted or referenced, indicating compliance with FDA guidance "Root-form endosseous dental implants and endosseous dental implant abutments." |
| ISO 7991 compliance | Test data submitted or referenced, indicating compliance with ISO 7991 (Glass—Determination of coefficient of mean linear thermal expansion). |
| ISTA 2A compliance | Transport and package testing per ISTA 2A and the standards referenced therein was submitted or referenced. |
| Sterilization effects | Effects of steam sterilization on product performance consistent with FDA guidance "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling, Guidance for Industry and Food and Drug Administration Staff, Appendix C" were evaluated. |
| Steam sterilization | Steam sterilization validation per ISO 17665 series standards was conducted. |
| Biocompatibility | Biocompatibility assessment per the ISO 10993 series of standards was conducted. |
| Chemical characterization | Chemical characterization per ISO 10993-18 (Biological evaluation of medical devices—Part 18: Chemical characterization of materials) was conducted. |
| Shelf life | Evaluation of shelf life per ASTM F1980 (Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices) was conducted. |
| Processing/Machinability | Laboratory processing including Workflow validation, and Machinability of blocks were performed. "The compatibility of the n!ce glass blocks with the existing IPS e.max CAD milling program is validated as part of this submission." (Implies successful milling and processing according to existing dental CAD/CAM systems). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to various standards and guidances but does not detail the specific sample sizes or the provenance of the data for each test.
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 is not applicable as the document describes a physical dental material, not an AI/ML device requiring expert-established ground truth for a diagnostic task.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the document describes a physical dental material.
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 document describes a physical dental material.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the document describes a physical dental material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the context of an AI/ML diagnostic device. For the dental material, "ground truth" would relate to its physical, chemical, and mechanical properties as defined by relevant ISO and ASTM standards and confirmed through laboratory testing.
8. The sample size for the training set
This is not applicable as the document describes a physical dental material, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as the document describes a physical dental material.
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(121 days)
The Straumann® Variobase Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® Abutments are indicated for screwretained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
The purpose of the subject submission is to add the zerion® ML and zerion® UTML Zirconia ceramic materials as a material suitable for fabrication of the coping, crown or bridge that, when bonded to the previously cleared Variobase abutment base (K120822, K142890), forms a finished dental prosthesis. The Straumann Variobase Abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases". Straumann Variobase Abutments are available to fit Straumann dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit), and RC (Regular CrossFit). A dental laboratory technician would design the corresponding coping and/or crown (the second component of the Variobase two-piece abutment) and/or prosthetic restoration in the dental laboratory via their preferred workflow. The restoration will be manufactured via validated Straumann milling.
The provided document is a 510(k) summary for the Straumann® Variobase® Abutments, an endosseous dental implant abutment. The primary purpose of this submission is to add new Zirconia ceramic materials (zerion® ML and zerion® UTML Zirconia) as suitable materials for fabricating the coping, crown, or bridge that attach to the Variobase abutment base.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines performance data related to the physical and biological characteristics of the device rather than traditional clinical performance (e.g., diagnostic accuracy metrics like sensitivity, specificity, AUC). The acceptance criteria are based on compliance with established standards and guidance documents.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Material Composition | Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb, TAN) meets ISO 5832-11. |
| Dynamic Fatigue Performance | Bench tested according to FDA guidance for Class II Endosseous Dental Implants and Abutments. (Implied successful completion to claim substantial equivalence) |
| Steam Sterilization Validation | Validated per FDA guidance "Reprocessing Medical Devices in Health Care Settings" (March 17, 2015) and ISO 17665 series standards. (Implied successful completion) |
| Cytotoxicity | Tested per ISO 10993-5. (Implied successful completion) |
| Inorganic Extractables/Leachables | Tested per ISO 10993-18. (Implied successful completion) |
| Software Validation | Validated per FDA guidance "General Principles of Software Validation" (January 11, 2002) and IEC 62304. (Implied successful completion) |
| Coping/Crown Material Equivalence (New Zirconia) | zerion® ML & UTML zirconia ceramics are substantially equivalent to previously cleared zerion® HT zirconia ceramics. (Determined through bench testing and material comparison) |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of abutments for fatigue testing, number of samples for cytotoxicity). It only states that "Bench testing was performed."
- Data Provenance: All testing appears to be retrospective bench testing conducted in vitro (laboratory setting) and pre-clinical. There is no indication of human or animal studies. The country of origin of the data is not explicitly stated but is implied to be conducted by or for Institut Straumann AG, a Swiss company with a US subsidiary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not applicable in the context of this submission. The "ground truth" for the acceptance criteria mentioned (e.g., material compliance, fatigue limits, sterility, biocompatibility) is established by international standards (ISO) and FDA guidance documents, not by individual experts establishing a "ground truth" on a test set in the same way an expert would for a diagnostic AI device. The tests themselves are designed to measure against these established benchmarks.
4. Adjudication Method for the Test Set:
- This information is not applicable. Since the "ground truth" is based on objective standards and measurement rather than expert interpretation of complex data (like medical images), there is no need for an adjudication method among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study assesses reader performance with and without AI assistance for diagnostic tasks. The Straumann® Variobase® Abutments are a physical implant component, not a diagnostic AI device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. The device is a physical medical component, not an AI algorithm. While software validation was performed, it relates to the design and manufacturing software, not a standalone AI diagnostic tool.
7. The Type of Ground Truth Used:
- The "ground truth" for the acceptance criteria is based on established regulatory standards, consensus standards (ISO), and FDA guidance quantitative limits and requirements. For example:
- Material: ISO 5832-11 for titanium alloys.
- Dynamic Fatigue: FDA guidance document for Class II Endosseous Dental Implants and Abutments, which sets performance thresholds.
- Biocompatibility (Cytotoxicity, Extractables): ISO 10993 series standards.
- Sterilization: ISO 17665 series standards and FDA guidance.
- Software: FDA guidance and IEC 62304.
8. The Sample Size for the Training Set:
- This information is not applicable. This submission is for a physical medical device, not a machine learning model that requires a training set. The term "training set" is relevant for AI/ML device development.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable for the same reasons as point 8.
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(246 days)
The Link Abutment for CEREC is titanium alloy abutments placed onto HIOSSEN dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
• Link abutment for CEREC
All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.
The Link Abutment for CEREC provide the interface for mesostructure designed and milled using the Sirona CEREC system with HIOSSEN Implant System (K140934) The Link Abutment for CEREC is pre-manufactured (stock) abutment made from a titanium alloy (ASTM F 136). The Link Abutment for Cerec is a Ti-base abutment design consisting of the Link Abutment and Sirona ceramic mesostructure. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona CEREC MC X and MC XL prosthetic milling systems.
This document is a 510(k) premarket notification for a dental device, the "Link Abutment for CEREC." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study for acceptance criteria of an AI/ML device. Therefore, much of the requested information regarding AI/ML device performance and ground truth establishment is not available in this document.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present "acceptance criteria" in the typical sense of metrics for an AI/ML device. Instead, it demonstrates substantial equivalence through comparisons of design, materials, indications for use, and non-clinical testing. The "reported device performance" is primarily in the context of mechanical properties and safety.
| Aspect | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Summary of Non-clinical Testing) |
|---|---|---|
| Material | Titanium Alloy comparable to predicates | Titanium Alloy (Ti-6Al-4V) |
| Gingival Heights | Comparable to predicate abutment designs | 0.5mm |
| Connection Type | Compatible with HIOSSEN dental implants | 11° Morse taper internal connection, Mini/Regular (Hex/non-Hex) |
| Diameter | Ranges comparable to predicate abutments | Ø 4.5mm |
| Post Height | Ranges comparable to predicate abutments | 4.7mm |
| Indications for Use | Similar to predicate devices | Screw-retained single tooth or cement-retained single tooth and bridge restorations. Uses Sirona CEREC AC/AF/AI, inLab software (v3.65)/CEREC Software (v4.2), and Sirona CEREC/inLab MC X/MC XL milling unit. |
| Fatigue Resistance | Demonstrated by substantial equivalence to K120847 | Fatigue testing conducted according to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with worst-case scenario. |
| Sterilization | Validated per recognized standards | Sterilization conducted according to ISO 17665-1:2006. |
| Biocompatibility | Demonstrated by substantial equivalence to K120847 | Demonstrated by reference to K120847. |
| Superstructure Design Limitation | Within specified ranges for Diameter, Height, Wall thickness, Angle, comparable to Sirona CEREC design limitations. | Diameter: 4.2 |
2. Sample size used for the test set and the data provenance
- This document describes non-clinical performance testing (fatigue, sterilization) of a physical dental device, not an AI/ML algorithm. Therefore, there isn't a "test set" of data in the AI/ML sense. The "sample size" would refer to the number of physical abutment samples tested. This specific number is not provided in the document, but it states "fatigue testing was considered... with the worst case scenario."
- Data provenance: Not applicable in the AI/ML context. The document refers to testing of the physical medical device and reference to predicate devices. The manufacturer is OSSTEM Implant Co., Ltd. from Busan, Republic of Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as this is not an AI/ML device study. Ground truth, in this context, would relate to the established engineering standards and specifications for dental abutments.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable as this is not an AI/ML device study. Adjudication methods are relevant for resolving discrepancies in expert labeling or diagnoses for AI/ML 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done because this is a physical dental abutment, not an AI/ML diagnostic or assistive device.
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 because this is a physical dental abutment, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's safety and effectiveness relies on established engineering principles, material science standards (e.g., ASTM F 136 for titanium alloy, ISO 17665-1:2006 for sterilization), and comparison to predicate devices that have already demonstrated safety and effectiveness through their prior clearances (K120847, K151324). It's essentially a demonstration of conformance to pre-defined physical and mechanical properties and established clinical use for dental abutments.
8. The sample size for the training set
- Not applicable as this is not an AI/ML device and therefore does not have a training set.
9. How the ground truth for the training set was established
- Not applicable as this is not an AI/ML device and therefore does not have a training set.
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