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510(k) Data Aggregation
(80 days)
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with DESS Bases or Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture, or to be designed and manufactured according to the digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine, and associated tooling and accessories.
The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K221301 and K240982 to allow additional options of zirconia material, scanners, CAM software, and milling machines to the digital dentistry workflow. The subject devices are to be sent to Terrats Medical validated milling centers for manufacture, or to be designed and manufactured via a digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, titanium and ceramic material, milling machine, and associated tooling and accessories. There are no changes to the abutment design, implant compatibilities, or design parameters. All part numbers have been cleared for manufacturing via a validated milling center and digital dentistry workflows (also referred to as point of care) under K221301 and K240982.
The subject device DESS Dental Smart Solutions abutments provide a range of prosthetic solutions for dental implant restoration. DESS abutments are offered in a variety of connection types to enable compatibility with currently marketed dental implants. All abutments are provided non-sterile, and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant.
Subject device Base Abutments are designed for fabrication of a patient-specific CAD/CAM zirconia superstructure on which a crown may be placed. They are two-piece abutments for which the second part (or top half) is the ceramic superstructure. They also may be used for support of a crown directly on the abutment.
All patient-specific custom abutment fabrication for Base Abutments and Pre-milled (Blank) Abutments is by prescription on the order of the clinician. The subject device Pre-milled (Blank) Abutments and all zirconia superstructures for use with the subject device Ti Base Interface, DESS Aurum Base, ELLIPTIBase, and DESS C-Base will be manufactured using a validated milling center or a digital dentistry workflow. A validated milling center will be under FDA quality system regulations. The digital dentistry workflow scans files from intra-oral and lab (desktop) scanners, CAD software, CAM software, titanium and ceramic material, milling machine and associated tooling and accessories.
The digital dentistry workflow uses scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
The provided 510(k) summary for DESS Dental Smart Solutions focuses on demonstrating substantial equivalence to predicate devices for dental implant abutments. It primarily addresses the expansion of compatible materials, scanners, CAM software, and milling machines within an existing digital dentistry workflow. The document does not describe an AI/ML-based device that would typically have acceptance criteria related to diagnostic performance.
Therefore, many of the requested items related to AI/ML device performance (like acceptance criteria for diagnostic metrics, sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this submission.
The acceptance criteria and supporting "study" (non-clinical data) for this device are related to its mechanical performance, biocompatibility, and integration within the digital workflow, demonstrating that the expanded components maintain the safety and effectiveness of the previously cleared predicate devices.
Here's a breakdown based on the information provided and the non-applicability of AI/ML-specific questions:
1. A table of acceptance criteria and the reported device performance
Since this is not an AI/ML diagnostic device, the acceptance criteria are not in terms of traditional diagnostic metrics (sensitivity, specificity, AUC). Instead, they are related to material properties, mechanical integrity, and the digital workflow's accuracy.
| Acceptance Criteria Category | Reported Device Performance (Summary from Submission) |
|---|---|
| Mechanical Integrity / Compatibility | - Fatigue testing of OEM implant bodies with patient-specific abutments made at worst-case angled conditions. (Implies successful completion to similar or better standards than predicate.) |
| Biocompatibility | - Biocompatibility testing according to ISO 10993-5 and ISO 10993-12. (Implies successful demonstration of biocompatibility.) |
| Sterilization | - Sterilization validation according to ISO 17665-1, ISO 17665-2, and ISO 14937. (Implies successful validation for sterilization.) |
| CAD Design Restrictions | - Software verification included testing of restrictions that prevent design of components outside of the stated design parameters. |
- Abutment design library validated to demonstrate established design limitations are locked and cannot be modified by the user. (Implies successful implementation and verification of design constraints.) |
| CAM Restriction Zones / Manufacturing Accuracy | - Validation testing of CAM restriction zones conducted, including verification to show avoidance of damage or modifications of the connection geometry, and locking of restriction zones from user editing in CAM software. (Implies successful validation to ensure manufacturing precision and prevent damage.) |
| Material Conformance | - Zirconia materials conform to ISO 6872. - Titanium alloy conforms to ASTM F136.
- Co-Cr-Mo alloy conforms to ASTM F15337. (Implies materials meet standards.) |
| Physical Dimensions | - Device encompasses the same range of physical dimensions as the predicate device. (Implies dimensional equivalence.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated in terms of a "test set" for diagnostic performance. The validation involved physical testing of components (e.g., fatigue testing) and software verification. The specific number of abutments or digital design instances used for these non-clinical tests is not detailed in this summary.
- Data Provenance: Not applicable in the context of patient data for an AI/ML device. The "data" here refers to engineering and material testing results, likely conducted in controlled lab environments (implied to be in accordance with international standards like ISO and ASTM). The manufacturer is Terrats Medical SL, in Spain, so testing would likely originate from their facilities or contracted labs.
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)
Not applicable. This is not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for this device relates to engineering specifications and material science.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a diagnostic device involving expert review adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" is based on:
- Engineering Specifications: Defined design parameters (e.g., minimum wall thickness, post height, angulation limits).
- Material Standards: Conformance to international standards such as ASTM F136, ISO 6872.
- Benchmarking/Predicate Equivalence: Performance is assessed against established performance of the predicate devices and OEM implant systems.
- Software Validation Logic: Verification that software correctly enforces design rules and CAD/CAM restrictions.
8. The sample size for the training set
Not applicable. This device does not involve a machine learning training set.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a machine learning training set.
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(138 days)
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K221301 to add the ability for the subject device Base Abutments and Pre-milled (Blank) Abutments to be designed using AbutmentCAD software in the digital dentistry workflow, as well as add angulation to some of the Pre-Milled (Blank) Abutments. The subject devices are to Terrats Medical validated milling centers for manufacture, or to be designed and manufactured via a digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, titanium and ceramic material, milling machine, and associated tooling and accessories. The proposed change is to allow the subject devices to be designed using AbutmentCAD by exocad GmbH, the current workflow allows only the use of 3Shape by 3Shape A/S for the design software. Another purpose of this submission is to expand the design parameters to allow angulation (up to 30°) on Pre-milled (Blank) Abutments that are compatible with Neodent Grand Morse, Nobel Active/Nobel Parallel Conical 3.0 mm, and Straumann BLX implants. There are no changes to the abutment design or implant compatibilities. All part numbers have been cleared for manufacturing via a validated milling center and digital dentistry workflows in under K221301.
The subject device DESS Dental Solutions abutments provide a range of prosthetic solutions for dental implant restoration. DESS abutments are offered in a variety of connection types to enable compatibility with currently marketed dental implants. All abutments are provided non-sterile, and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant.
Subject device Base Abutments are designed for fabrication of a patient-specific CAD/CAM zirconia superstructure on which a crown may be placed. They are two-piece abutments for which the second part (or top half) is the ceramic superstructure. They also may be used for support of a crown directly on the abutment.
All patient-specific custom abutment fabrication for Base Abutments and Pre-milled (Blank) Abutments is by prescription on the order of the clinician. The subject device Pre-milled (Blank) Abutments and all zirconia superstructures for use with the subject device Ti Base Interface, DESS Aurum Base, ELLIPTIBase, and DESS C-Base will be manufactured using a validated milling center or a digital dentistry workflow. A validated milling center will be under FDA quality system regulations. The digital dentistry workflow scans files from intra-oral and lab (desktop) scanners, CAD software, titanium and ceramic material, milling machine and associated tooling and accessories.
The digital dentistry workflow uses scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The digital workflow includes the following products (not subject devices of this submission):
- Ceramic material: VITA YZ ST and VITA YZ XT (K180703)
- . Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436)
- . Intraoral Scanner: 3Shape TRIOS A/S Series Intraoral Scanner (510(k) exempt under 21 CFR 872.3661)
- Desktop scanner: 3Shape D900 Dental Lab Scanner (510(k) exempt under 21 CFR 872.3661)
- Abutment design software: 3Shape Abutment Designer Software (K151455) and AbutmentCAD ● (K193352)
- . Milling machine: VHF R5 by vhf camfacture AG with DentalCAM and DentalCNC 7 software
The provided text describes a 510(k) premarket notification for DESS Dental Smart Solutions, which are dental implant abutments. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's effectiveness through clinical performance studies with specific statistical acceptance criteria for accuracy, sensitivity, or specificity.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance (in terms of clinical metrics like accuracy, sensitivity, specificity).
- Sample size used for the test set or its provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study or its effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How the ground truth for the training set was established.
The study described in this document focuses on non-clinical performance data to demonstrate substantial equivalence, specifically:
- Sterilization validation: According to ISO 17665-1, ISO 17665-2, and ISO 14937.
- Biocompatibility testing: According to ISO 10993-5 and ISO 10993-12.
- Fatigue testing and reverse engineering analysis: Of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility. This includes fatigue testing of OEM implant bodies with patient-specific abutments made at worst-case angled conditions.
- MR Conditional labeling.
- Validation testing of CAM restriction zones: Including verification to show avoidance of damage or modifications of the connection geometry, and locking of restriction zones from user editing in the CAM software.
- Software verification: Included testing of restrictions that prevent design of components outside of the stated design parameters. The abutment design library was validated to demonstrate that established design limitations and specifications are locked and cannot be modified by the user.
The acceptance criteria and reported "performance" for this submission are based on these engineering and design validations, ensuring the device meets safety and performance standards equivalent to the predicate device, K221301. The key "performance" metrics are about maintaining physical and material integrity and compatibility.
The core of the submission is to expand the DESS Dental Smart Solutions abutment system to:
- Allow design using AbutmentCAD software (in addition to 3Shape software).
- Add angulation (up to 30°) to some Pre-milled (Blank) Abutments for specific implant systems.
The document explicitly states: "No clinical data were included in this submission." and "The subject device, the predicate device, and reference devices have the same intended use, technological characteristics, and are materials. The subject device, the predicate device, and reference devices encompass the same range of physical dimensions, manufactured by similar methods, are packaged in similar materials, and are to be sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above."
Therefore, this FDA submission is for a physical medical device (dental implant abutment) and its manufacturing/design software modifications, not an AI or diagnostic device that would involve clinical performance metrics like sensitivity or specificity.
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(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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(79 days)
NobelProcera Zirconia Implant Bridge (previously cleared per K202452) The NobelProcera® Zirconia Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially edentulous jaws for the purpose of restoring chewing function.
TiUltra Implants and Xeal Abutments (previously cleared per K202344) NobelActive TiUltra NobelActive TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. Nobel Active Tilltra implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. NobelActive TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible. Nobel Active TiUltra 3.0 implants are indicated for single-unit restorations only. NobelReplace CC TiUltra NobelReplace CC TiUltra implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations. The NobelReplace CC Tilltra implants can be used in splinted or non-splications. The NobelReplace CC TiUltra implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied. NobelParallel CC TiUltra NobelParallel CC TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function. NobelParallel CC TiUltra implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early of delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants with
Not Found
This document is a 510(k) premarket notification decision letter from the FDA to Nobel Biocare AG regarding their Dental Implant Systems Portfolio - MR Conditional. It explicitly states that the letter covers indications for use and general controls, but does not contain information about acceptance criteria or performance studies for the device itself.
Therefore, I cannot provide the requested information for the following reasons:
- Acceptance Criteria and Performance Data: The document is a regulatory clearance letter, not a clinical study report. It does not contain acceptance criteria for device performance, nor does it present any data from studies proving the device meets particular criteria. The letter confirms substantial equivalence to legally marketed predicate devices, which means the FDA has determined the device is as safe and effective as a previously cleared device, not that specific performance metrics were tested and met in a new study.
- Study Details (Sample size, data provenance, experts, adjudication, MRMC, Standalone, Ground Truth, Training Set): Since no performance study data is included in this FDA 510(k) clearance letter, none of these details can be extracted. The document refers to various previously cleared predicate devices (e.g., K202452, K202344, K181869), but it doesn't describe the studies that led to their clearance.
In summary, the provided text does not contain the information necessary to describe acceptance criteria or a study proving the device meets those criteria.
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(247 days)
The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient for purpose of restoring chewing function. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.
The Panthera Dental Milled Bars are indicated for compatibility with:
- · NobelActive: NP Ø3.5; RP Ø4.3 / Ø5.0; WP Ø5.5
- NobelParallel CC: NP Ø3.75: RP Ø4.3 / Ø5.0: WP Ø5.5
- NobelReplace: NP Ø3.5; RP Ø4.0 / Ø4.3 / Ø5.0; WP Ø5.0; 6 Ø6.0
- NobelSpeedy: RP Ø4.0 / Ø5.0; WP Ø5.0 / Ø6.0
- Brånemark: NP Ø3.3; RP Ø3.75 / Ø4.0; WP Ø5.0
The Panthera Dental Milled Bar is a metallic dental restorative device that is intended for attaching by screw retention to dental implants to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function.
The Panthera Dental milled bars for which clearance is requested, are included in one of the following bar types, which have distinct design specifications.
The Type I bars are specific for removable overdenture and include:
- . Panthera Dental Dolder Bar, Hader Bar, Milled Bar, REBourke Bar and Paris Bar.
The Type II bars are specific for fixed prostheses and include:
- Panthera Dental Wrap-around Bar, Montreal Bar, Montreal Bar with metallic lingual, Pin Lingual Bar and Pin Wrap-Around Bar.
The Panthera Dental Milled Bar is designed to match an individual patient. Panthera Dental designs the bar from a three-dimensional optical and/or digital scanner system that scans the patient's impression; the dental professional prepares the model cast beforehand. The designed bar is then machined using a computer-aided design/ computer-aided manufacturing (CAD/CAM) software system. The bar is milled from titanium (Ti-6AI-4V grade 5). CAD/CAM fabrication is only performed by Panthera Dental, within our manufacturing control and not by the dental laboratory.
The Panthera Dental Milled Bar is packaged as non-sterile, and delivered to a dental laboratory for completion. Once received at the laboratory, the Panthera Dental Milled Bar is matched to a denture for final placement. The Panthera Dental Milled Bar provides retention and support for a removable or fixed denture made of standard laboratory dental materials such as resin composite.
Here's a breakdown of the acceptance criteria and the study information for the Panthera Dental Milled Bars, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present acceptance criteria in a tabular format with specific numerical targets. Instead, it describes performance through compliance with recognized standards and successful testing outcomes. The "performance" is primarily demonstrated through meeting mechanical strength requirements and biocompatibility standards, and by showing substantial equivalence to a predicate device.
| Acceptance Criteria Category | Description of Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Meets the requirements for dynamic fatigue testing for endosseous dental implants. | The device (bar and cylinders) has the mechanical strength for its intended clinical application, as demonstrated by fatigue testing according to ISO 14801 and FDA guidance. |
| Biocompatibility | Biocompatible with tissue/bone/dentin for long-term contact. | Made from Titanium Ti-6Al-4V, a material used in the predicate. Cytotoxicity, extractable/leachable, toxicological risk assessment, and bacterial endotoxin testing compliant with ISO 10993-1, ISO 10993-5, ISO 10993-12, ANSI/AAMI ST72, and USP . |
| Sterilization | Can be effectively sterilized to a Sterility Assurance Level (SAL) of 10^-6. | Sterilization validation (Pre-vacuum steam sterilization) for the primary predicate was successful, demonstrating an SAL of at least 10^-6. The proposed device uses the same materials and sterilization cycle, therefore no additional testing was required. |
| Design Accuracy/Fit | Ensures a perfect fit and proper seating with compatible implant systems, with no possible interference. | Reverse engineering (RE) confirmed that the critical parameters of the design for interface connection, including tolerance limits, fall within the measured sizes of the Nobel Biocare counterparts. |
| Manufacturing Reliability | Manufacturing process is reliable and produces consistent results. | A process capability study conducted for the primary predicate (K173466) is valid for the proposed device, as the manufacturing process is identical. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size for each test (e.g., how many bars were subjected to fatigue testing). It refers to "the bar itself" and "the bar cylinders" for fatigue testing. For reverse engineering, it mentions "each interface connection" and "each components per size and type" which implies multiple samples were analyzed to determine critical parameters and tolerance limits.
- Data Provenance: The document does not specify country of origin for data. The non-clinical testing was conducted by Panthera Dental Inc., a Canadian company. The tests are framed within the context of a 510(k) submission to the U.S. FDA. The testing conducted was for the primary predicate device (K173466) and determined to be applicable to the proposed device due to identical materials and manufacturing processes. The tests were retrospective in the sense that they were done on manufactured devices/components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: This information is not explicitly stated. The document refers to compliance with ISO and FDA guidance documents for testing, which implies a standard methodology rather than expert consensus on a subjective test set.
- Qualifications of Experts: Not specified. Testing was performed by Panthera Dental Inc. or their designated testing facilities to meet recognized standards.
4. Adjudication Method for the Test Set
Not applicable. The tests mentioned (fatigue, biocompatibility, sterilization, reverse engineering, process capability) are objective physical, chemical, and mechanical tests, not subjective evaluations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The Panthera Dental Milled Bars are a physical dental device, not an AI or imaging diagnostic tool that would typically involve a reader study.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device, not an algorithm or software. The mention of CAD/CAM refers to the design and manufacturing process, not an independent algorithm performance.
7. Type of Ground Truth Used
The "ground truth" for the device's performance is established through:
- Compliance with recognized standards: ISO 14801 for fatigue testing, ISO 10993 series and USP for biocompatibility, and ANSI/AAMI-ST8 for sterilization.
- Measurement and verification: Reverse engineering to ensure precise fit with implant systems.
- Predicate device equivalence: Performance data for the predicate device (K173466) is directly applied due to identical materials, design principles, and manufacturing processes.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI. The design and manufacturing processes are established based on engineering principles and validated through testing.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the context of this device. The design specifications and manufacturing parameters are established through engineering design, material science, and testing against industry standards, not via a machine learning training process.
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(120 days)
Atlantis® suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
Atlantis® suprastructures are intended for attachment to a minimum of two (2) implants. Atlantis® suprastructures are compatible with following implants and abutments: (list of compatible implants and abutments follows in the document)
Atlantis suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The subject Atlantis suprastructures include new compatible interfaces of the currently marketed Atlantis suprastructures made by milling (K163350) or additive manufacturing techniques (K163398) for the following abutments and implants: (list of compatible implants and abutments follows in the document). The design of the subject device is derived from patient dental models and completed by Dentsply Sirona technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of the Atlantis suprastructures are fabricated using additive manufacturing (AM) to produce a customized, patient-specific device. The Atlantis suprastructures subject of this bundled premarket notification are fabricated by milling or by additive manufacturing techniques.
The milled Atlantis suprastructures are composed of commercially pure titanium (CPTi) or cobalt chrome alloy and are available in following design types: Bar, Bridge, Hybrid and 2 in 1. Additional design limitations regarding minimum required segment cross-section, maximum span between implants and maximum cantilever extension, have been introduced for Atlantis suprastructures made by milling.
Atlantis suprastructures made by additive manufacturing are provided as Bridge and Hybrid types with optional mechanical retention (pin or cell retention) on the surface. The manufacturing of the Bridges and Hybrids of the Atlantis suprastructures by an additive manufacturing technique start from a titanium alloy and a cobalt-chrome alloy in powder form.
Milled variants of the subject Atlantis® suprastructures are offered in versions composed of unalloyed titanium conforming to ASTM F67 (Standard Specification for Unalloyed Titanium for Surgical Implant Applications) and cobalt chromium alloy (CoCr) conforming to ISO 22674 (Dentistry – Metallic materials for fixed and removable restorations and appliances). Variants of the subject Atlantis® suprastructures which are fabricated utilizing additive manufacturing are manufactured using titanium alloy powder or cobalt chromium alloy powder conforming to ISO 22674 (Dentistrv – Metallic materials for fixed and removable restorations and appliances).
Fixation screws for use with the subject Atlantis® suprastructures are composed of titanium alloy confirming to ASTM F136 (Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications).
Screws are available for all compatible implants and abutments to screw the Atlantis suprastructures into the implant or onto the abutment.
Labeling is modified by providing a separate compatibility chart which lists all implants and abutments compatible with the Atlantis suprastructures.
This FDA 510(k) summary for the Dentsply Sirona Atlantis® suprastructures does not describe a clinical study for acceptance criteria. Instead, it argues for substantial equivalence to existing predicate devices based on non-clinical performance data and a comparison of indications for use, design, manufacturing techniques, and materials.
Here's an analysis of the provided information, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily relies on the equivalency to previously cleared devices. Therefore, explicit "acceptance criteria" in the sense of predefined thresholds for a new study are not presented. Instead, the performance is demonstrated through comparisons to the predicate devices and by referencing a previous fatigue test.
| Feature/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Indications for Use | Identical clinical indications to predicate devices (K1633350, K163398) | Met by comparison: The clinical indications for use are identical to the predicate devices, differing only in the expanded list of compatible implants and abutments. (Text on page 9 "The indications for use of the subject and predicate Atlantis suprastructures (K163350, K163398) are identical with respect to the clinical indications.") |
| Compatible Interfaces (New) | Maintain structural integrity and performance when attached to new compatible implants/abutments. | Met by non-clinical testing and comparison: Cross-sectional material analysis of interfaces, geometric measurement data, and statistical compatibility analysis of OEM components support compatibility. Reference to results of fatigue testing (K160207) conducted according to ISO 14801. (Text on page 10 "Cross-sectional material analysis of the subject Atlantis suprastructure interfaces with the compatible implants and abutments, comparison to existing worst case interface geometry and reference to results of fatigue testing (K160207) conducted according to test methods of ISO 14801...") |
| Manufacturing Process (Additive Manufacturing) | Additive manufacturing process must be validated and ensure comparable device characteristics. | Met by reference to previous validation: Reference to process validation testing (K163398) for Atlantis suprastructures made by additive manufacturing. (Text on page 10) |
| Sterilization Parameters | Sterilization process must be validated according to relevant international standards. | Met by reference to previous validation: Reference by equivalence to validation of moist heat sterilization parameters conducted according to ISO 17665-1 and ISO 17665-2. (Text on page 10) |
| Biocompatibility | Device materials must be biocompatible. | Met by reference to previous data: Reference by equivalence to biocompatibility data of predicate devices (K163350, K163398). (Text on page 10) |
| Design Parameters (Milled) | Adherence to established design limitations for segment cross-section, span, and cantilever. | Met by comparison: Additional design limitations for some types of milled Atlantis suprastructures are within the design parameters cleared for the predicate device (K163350). (Text on page 10) |
| Design Parameters (Additive Manufacturing) | Adherence to established design parameters. | Met by comparison: The design parameters cleared for the predicate Atlantis suprastructures made by additive manufacturing (K163398) remain unchanged. (Text on page 10) |
| Materials | Conformity to specified ASTM and ISO standards for unalloyed titanium, titanium alloy, and cobalt-chrome alloy. | Met by specification: Milled variants composed of CPTi (ASTM F67) or CoCr (ISO 22674). Additive manufactured variants use titanium alloy powder or CoCr alloy powder (ISO 22674). Fixation screws are titanium alloy (ASTM F136). (Text on page 7) |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "cross-sectional material analysis" and "geometric measurement data and statistical compatibility analysis." However, it does not provide specific sample sizes for these analyses. The data provenance is implied to be internal testing conducted by Dentsply Sirona or its subsidiaries, and it's non-clinical. There is no mention of country of origin for this testing data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device's clearance is based on non-clinical engineering and material testing, and substantial equivalence to existing devices, not a clinical study requiring expert ground truth for interpretation of outcomes.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication by experts is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is a dental implant suprastructure, not an imaging AI device where MRMC studies are typically performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, this is a physical medical device. The "algorithm" aspect refers to the CAD design process, but the testing focuses on the resulting physical product's performance and compatibility, not an AI algorithm's diagnostic performance.
7. The Type of Ground Truth Used:
For the evaluation of the new compatible interfaces and materials, the "ground truth" is defined by:
- Engineering specifications and dimensional accuracy.
- Material property standards (ASTM F67, F136, ISO 22674).
- Performance standards, particularly ISO 14801 for fatigue testing.
- Comparison to the established performance of the predicate devices.
8. The Sample Size for the Training Set:
Not applicable. There is no mention of a training set for an AI algorithm. The CAD design uses pre-programmed libraries and patient-specific scans, but "training set" in the context of machine learning is not relevant here.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the machine learning sense described for this device. The design process is CAD-based, utilizing established engineering principles and material science.
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(175 days)
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with Aurum™ Abutment or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture.
DESS Dental Smart Solutions subject devices include four abutment design types (Aurum Base, Pre-milled Blank, CoCr Pre-milled Blank, CoCr Abutment) and one screw type (Aurum Base Screw). Abutments are provided in ten abutment connections compatible with eleven implant platform diameters range from 3.3 mm to 6.5 mm. Corresponding implant body diameters range from 3.25 mm to 6.0 mm. All abutments are provided non-sterile.
The document describes the DESS Dental Smart Solutions, which are dental implant abutments. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a typical tabular format with specific numerical targets. Instead, it relies on demonstrating equivalence to predicate devices through various performance tests and comparisons. The "acceptance criteria" are implied by the successful completion of these tests and the determination that the device is "substantially equivalent" to already marketed devices.
However, some design parameters are mentioned as remaining the same or being comparable to the predicate devices, which can be seen as implicit performance criteria:
| Feature / Performance Metric | Acceptance Criteria (Implied by Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Sterilization | SAL of 10^-6 according to ISO 17665-1 and ISO 17665-2 | "Sterilization to an SAL of 10^-6 according to ISO 17665-1 and ISO 17665-2 to ensure sterilization of the final finished device" (Successful) |
| Biocompatibility | Non-cytotoxic according to ISO 10993-1 and ISO 10993-5 | "Biological evaluation according to ISO 10993-1 and cytotoxicity testing to ISO 10993-5 to demonstrate that all devices are non-cytotoxic" (Successful) |
| Minimum Wall Thickness | Aurum Abutment: 0.4 mm | |
| Pre-milled Blank: 0.45 mm | ||
| CoCr Abutment: 0.4 mm (Same as primary predicate K170588) | Aurum Abutment: 0.4 mm | |
| Pre-milled Blank: 0.45 mm | ||
| CoCr Abutment: 0.4 mm (Stated to remain the same as primary predicate K170588, implying conformity to existing successful designs) | ||
| Minimum Post Height (single-unit) | Aurum Abutment: 4.0 mm | |
| Pre-milled Blank: 4.0 mm | ||
| CoCr Abutment: 4.0 mm (Increased from previous version, but deemed substantially equivalent to K092341 at 4mm) | Aurum Abutment: 4.0 mm (Stated as the new minimum for single-unit restorations, deemed substantially equivalent to K092341's titanium post height which also requires additional castable component to create 4mm) | |
| Pre-milled Blank: 4.0 mm | ||
| CoCr Abutment: 4.0 mm (Stated to remain the same as primary predicate K170588) | ||
| Maximum Gingival Height | Aurum Abutment: 6.0 mm | |
| Pre-milled Blank: 6.0 mm | ||
| CoCr Abutment: 6.0 mm (Same as primary predicate K170588) | Aurum Abutment: 6.0 mm | |
| Pre-milled Blank: 6.0 mm | ||
| CoCr Abutment: 6.0 mm (Stated to remain the same as primary predicate K170588) | ||
| Maximum Total Abutment Height | Pre-milled Blank: 19 mm | Pre-milled Blank: 19 mm |
| Angulation Correction | No angulation correction (Same as primary predicate K170588) | All abutments are for straight abutments only (implies no angulation correction, same as primary predicate K170588) |
| Chemical Composition | Materials used are comparable to predicate devices (Titanium Alloy, CoCr, Zirconia) | Aurum Base (Titanium Alloy ASTM F136), CoCr Pre-milled Blank (CoCr ASTM 1537), Ti Pre-milled Blank (Titanium Alloy ASTM E136), CoCr Abutment (CoCr ASTM 1537). Screws are Titanium Alloy. (Found to be substantially equivalent to predicates) |
| Physical Dimensions | Encompasses the same range of physical dimensions including diameter and design of abutments as predicate devices. | "The subject device and predicate devices encompass the same range of physical dimensions, including diameter and design of the abutments." (Stated as a conclusion of equivalence) |
| Packaging/Sterilization Methods | Similar to predicate devices. | "The subject and predicate devices are packaged in similar materials and are to be sterilized using similar methods." (Stated as a conclusion of equivalence) |
2. Sample Size Used for the Test Set and the Data Provenance
The document states: "Non-clinical testing data submitted to demonstrate substantial equivalence included: sterilization... biological evaluation... and compatibility analysis by reference to K170588."
- The report does not specify sample sizes for the sterilization or biocompatibility tests.
- The data provenance is implied to be from the manufacturer's (Terrats Medical SL) internal testing as part of their submission for regulatory clearance. It's not explicitly stated whether the data is retrospective or prospective, or the country of origin of the raw data, beyond the manufacturer being from Spain. The "compatibility analysis by reference" means using existing data/information from the predicate device (K170588).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information – number and qualifications of experts for ground truth – is typically relevant for studies involving subjective assessments, like image interpretation in AI/ML medical devices. This document is for a physical dental implant abutment, and the tests performed are objective, non-clinical tests (sterilization, biocompatibility, mechanical properties based on design parameters). Therefore, this information is not applicable and not provided in the submission.
4. Adjudication Method for the Test Set
As the tests are objective non-clinical tests, an adjudication method for a "test set" (in the context of expert review) is not applicable and not mentioned. The results of the non-clinical tests would either meet or not meet the specified standards (e.g., SAL, non-cytotoxicity).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. This type of study is specifically relevant for AI/ML-driven diagnostic or interpretative devices involving human readers. The device described here is a physical dental implant abutment, not an AI/ML diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This is not an AI/ML device. The "CAD/CAM process" mentioned refers to computer-aided design and manufacturing for custom abutments, which is a manufacturing process, not an analytical algorithm for diagnosis or interpretation.
7. The Type of Ground Truth Used
For the non-clinical tests conducted:
- Sterilization: The ground truth is the scientific standard for sterility, defined as a Sterility Assurance Level (SAL) of $10^{-6}$ based on ISO 17665-1 and ISO 17665-2.
- Biocompatibility: The ground truth is the absence of cytotoxicity, determined by adherence to ISO 10993-1 and ISO 10993-5.
- Design Parameters/Mechanical Equivalence: The "ground truth" for design parameters (e.g., wall thickness, post height) is derived from engineering specifications and comparison to the proven safety and effectiveness of the legally marketed predicate devices (K170588 and other reference devices). The ultimate ground truth effectively is that the device performs equivalently to previously approved devices.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process in that context.
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(213 days)
The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw.
The Elos Accurate® Customized Abutments are compatible with the following implant systems:
Ref. No. Platform compatibility Implant diameter
AB-BRA411213-US Nobel Biocare® / Brånemark® RP 3.75 mm & 4 mm
AB-BRA351213-US Nobel Biocare® / Brånemark® NP 3.3 mm
AB-BRA511213-US Nobel Biocare® / Brånemark® WP 5 mm
All digitally designed Elos Accurate® Customized Abutments are intended to be manufactured at an Elos Medtech approved milling facility.
The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an abutment blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a Brånemark® endosseous dental implant. The customized shape of the abutment is intended to be manufactured by an Elos Medtech approved milling facility. The Elos Accurate® customized abutment is delivered non-sterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.
The provided document is a 510(k) summary for a medical device (Elos Accurate® Customized Abutment). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way a clinical trial or algorithm validation study would.
Therefore, the requested information, particularly regarding acceptance criteria and the study that proves the device meets the acceptance criteria with specific performance metrics, sample sizes of test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, is not fully available in this type of regulatory document.
However, I can extract the information related to the non-clinical testing performed to support substantial equivalence, which serves a similar function in demonstrating device safety and effectiveness.
Here's an organized breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantitative table with specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the non-clinical testing aims to demonstrate that the subject device's mechanical, material, and biological properties are equivalent to or better than the predicate device and comply with relevant international standards and FDA guidance.
| Test Performed | Acceptance Criteria Implied (Based on Standards/Guidance) | Reported Device Performance / Conclusion |
|---|---|---|
| Fatigue Testing | Compliance with ISO 14801 and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004) to demonstrate mechanical strength and ability to withstand 20° angulation. | Test substantiates an angulation of 20° and the mechanical strength for the subject device. |
| Biocompatibility | Compliance with ISO 10993-5 (cytotoxicity). | Biocompatibility testing for cytotoxicity was conducted. (Implied successful completion and compliance, as no issues are reported and substantial equivalence is claimed). |
| Sterilization Validation | Compliance with ISO 17665-1 & ISO 17665-2, demonstrating a Sterility Assurance Level (SAL) of 10^-6. | Sterilization validation demonstrated a SAL of 10^-6. |
| Engineering and Dimensional Analysis | Compatibility with original manufacturers' components (abutments, implants & abutment screws) and determination of nominal dimensions and tolerances. | Data demonstrated engineering- and dimensional analysis for compatibility. (Implied successful fit and function with specified implant systems). The subject device has the same intended use, operating principle, basic design, similar materials, and sterilization processes as the predicate. |
| Abutment Screw DLC Coating Evaluation | Compliance with FDA "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004) to support substantial equivalence to the DLC coated abutment screw reference device. | Evaluation of the abutment screw DLC coating supported substantial equivalence to the DLC coated abutment screw reference device. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. For engineering and biocompatibility tests, sample sizes are typically determined by relevant standards (e.g., ISO, ASTM), but specific numbers are not disclosed here. The document describes tests on the device itself, not patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the document describes non-clinical testing of a physical medical device, not a diagnostic algorithm requiring expert-established ground truth from medical images or patient data.
4. Adjudication Method
This information is not applicable for the same reasons as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable as the document describes non-clinical testing of a physical medical device, not a diagnostic algorithm or AI assistance requiring human reader evaluation.
6. Standalone Performance (i.e., algorithm only without human-in-the-loop performance)
This information is not applicable as the document relates to a physical medical device (dental abutment), not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Compliance with international standards (e.g., ISO 14801 for fatigue, ISO 10993-5 for biocompatibility, ISO 17665-1 & -2 for sterilization).
- Compliance with FDA guidance documents (e.g., "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments").
- Physical measurements and engineering analysis compared against established specifications and predicate devices.
8. Sample Size for the Training Set
This information is not applicable as the document describes a physical medical device, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
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(247 days)
The LOCATOR® F-Tx Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restory function. It is used in fixed hybrid restorations that can be attached with a snap-in system.
The LOCATOR® F-Tx Attachment System is compatible with the following implants: Implant Manufacturer Connection Type / Platform
| Astra Tech | OsseoSpeed Plus EV: 3.6, 4.2, 4.8 mm |
|---|---|
| BioHorizons | Internal Hex: 3.0, 3.5, 4.5, 5.7 mm |
| Biomet 3i | Osseotite ® Certain ® : 3.4, 4.1, 5.0, 6.0 mm |
| Camlog | Camlog, Conelog: 3.3, 3.8, 4.3, 5.0 mm |
| iSy: 3.8, 4.4, 5.0 mm | |
| Dentsply | Ankylos ® : 3.5, 4.5, 5.5, 7.0 mm |
| MIS Implants | Internal Hex: 3.75, 4.5 mm |
| Nobel Biocare | NobelActive ™ : 3.0, 3.5, 3.9 mm |
| Replace ™ Select: 3.5, 4.3, 5.0, 6.0 mm | |
| Brånemark: 3.5, 4.1, 5.1 mm | |
| Straumann | Bone Level: 3.3, 4.1, 4.8 mm |
| Standard: 4.8, 6.5 mm | |
| Zimmer | Tapered Screw-Vent ® : 3.5, 4.5, 5.7 mm |
The LOCATOR® F-Tx Attachment System is for rigid connection of fixed, partial and full arch restorations on endosseous dental implants using a snap-in or screw-retained attachment system. The system includes abutments and healing caps. LOCATOR F-Tx abutments are compatible with the implant systems, connection types, and platform sizes listed above, and are provided in various gingival cuff heights ranging from 1 to 6 mm. LOCATOR F-Tx System abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). LOCATOR F-Tx abutments may be provided with an optional coating of either TiCN (titanium carbon nitride) or TiN (titanium nitride). LOCATOR F-Tx System Healing Caps are made of PEEK.
The provided text describes a 510(k) premarket notification for a medical device, the LOCATOR® F-Tx Attachment System. It focuses on demonstrating substantial equivalence to pre-existing predicate devices, rather than presenting a study design with specific acceptance criteria and detailed performance data often seen for novel AI/ML devices. As such, many of the requested points regarding acceptance criteria, study types (MRMC, standalone), sample sizes for test/training sets, expert qualifications, and ground truth establishment are not applicable or cannot be extracted from this document, as it is not a performance study report for an AI/ML device.
This document outlines the device's intended use, design, materials, and provides a comparison to legally marketed predicate devices to establish substantial equivalence. The "Performance Data" section primarily details the non-clinical testing performed to meet various ISO standards related to sterilization, biocompatibility, and mechanical testing, which are typical for dental implant components.
Here's an attempt to address the request based only on the available information, noting where information is absent:
Acceptance Criteria and Device Performance for LOCATOR® F-Tx Attachment System
Based on the provided 510(k) summary, the "acceptance criteria" are primarily demonstrated through substantial equivalence to predicate devices and adherence to relevant non-clinical performance standards. The performance data presented focuses on material properties, sterilization, biocompatibility, and mechanical retention, rather than performance metrics for an AI/ML system.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence: | |
| - Similar Indications for Use | -"The LOCATOR® F-Tx Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory function. It is used in fixed hybrid restorations that can be attached with a snap-in system." |
- "Substantial equivalence in indications and design principles to legally marketed predicate devices." Comparing language: "The subject device and primary predicate have slightly different Indications for Use language. However, the difference in language does not change the intended use of abutments." |
| - Similar Design Principles | - "LOCATOR F-Tx and Locator (K072878) are each provided with varving cuff heights. The abutment/implant interfaces of all LOCATOR F-Tx abutments are identical to those of the corresponding Locator (K072878) abutments." |
| - Similar Materials | - Abutment: Ti-6Al-4V ELI (same as predicate). - Abutment Coating: TiN (same as predicate), TiCN (same as reference predicate K150295).
- Prosthetic Retention Component: PEEK (predicate uses Nylon). This difference is noted but deemed acceptable. |
| Material Biocompatibility (ISO 10993-1, -5, -12) | - "Characterization and biocompatibility testing of the TiCN coating," - "Biocompatibility testing of the PEEK Healing Caps."
- (Specific results not detailed, but testing was performed and deemed acceptable for submission). |
| Sterilization (ISO 17665-1, -2) | - "Sterilization testing." - (Specific results not detailed, but testing was performed and deemed acceptable for submission). |
| Mechanical Performance (Specifically Retention Strength) | - "The mechanical testing demonstrated the retention strength of the LOCATOR F-Tx Attachment System when using the High Retention Balls was statistically greater than the tensile force created when masticating worst case sticky food (p
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(267 days)
Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Medentika PreFace CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
The subject device includes two CAD/CAM abutment designs, the Medentika TiBase and the Medentika PreFace. The TiBase is a two-piece abutment used as a base when fabricating a zirconia superstructure and the PreFace is an abutment used in fabricating a full patient-specific abutment in titanium alloy. Both abutment designs are provided non-sterile and are intended to be sterilized by the clinician. Medentika Preface Abutment is available in diameters 3.0 mm to 7.0 mm. Medentika TiBase Abutment is available in diameters 3.25 mm to 7.0 mm. The specific diameters for each Series coordinate with the compatible implant systems and sizes listed below.
TiBase is available in two post designs. TiBase Generation 1 has a conically shaped post that is 4.0 mm high and TiBase Generation 2 has a parallel walled post shape that is 5.5 mm high. PreFace is available in one cylinder height of 20 mm. The maximum angle for abutments fabricated using TiBase or PreFace is 30°, the maximum gingival height is 6 mm and the minimum post height is 4 mm.
Medentika CAD/CAM Abutments are compatible with eleven dental implant systems. Each Medentika abutment series has a precision implant/abutment interface corresponding to the implant system predicate for that series.
The provided document is a 510(k) premarket notification for Medentika CAD/CAM Abutments, asserting substantial equivalence to legally marketed predicate devices. It does not describe a study involving an AI/ML powered device, nor does it detail acceptance criteria related to such a device's performance. Instead, it focuses on non-clinical testing to demonstrate safety and effectiveness for a dental abutment. Therefore, I cannot extract the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, or human-in-the-loop studies from this document.
The "Performance Data" section (Page 6/7) explicitly states the types of non-clinical testing conducted:
- Engineering analysis and dimensional analysis: To determine compatibility with original manufacturers' components.
- Static and dynamic compression-bending testing: According to ISO 14801 (Dentistry – Implants – Dynamic fatigue test for endosseous dental implants).
- Sterilization testing: According to ISO 17665-1 and ISO 17665-2 to demonstrate an SAL of 10^-6.
- Biocompatibility testing: For cytotoxicity according to ISO 10993-5.
The acceptance criteria would be the successful completion of these tests in accordance with the specified ISO standards and demonstrating compatibility and performance comparable to the predicate devices. However, the document does not list the quantitative acceptance criteria or the specific numerical results obtained for each test (e.g., specific fatigue life, or precise dimensional tolerances met).
In summary, the document does not contain the information required to answer the prompt as it pertains to AI/ML device performance. The device is a physical medical device (dental abutments), and the review is for substantial equivalence based on physical and mechanical properties, not an AI/ML algorithm.
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