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510(k) Data Aggregation
(90 days)
The BellaTek Bars are indicated for attachments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The BellaTek Bars are intended for attachment to a minimum of two (2) abutments.
All digitally designed BellaTek Bars are intended to be sent to Biomet 3i for manufacture.
The BellaTek Bars are indicated for compatibility with the following abutment systems:
· Universal Multi-Unit Abutments manufactured by Terrats Medical SL., 2.9-5.7mm, Angled, max 30 degrees
- · ZimVie Eztetic Implant System
- · ZimVie TSX Implant System
- · ZimVie Tapered Screw-Vent System
- · ZimVie Low Profile Abutments, 3.4-6.0mm, Angled, max 30 degrees
- · ZimVie Osseotite Implant System
- ZimVie T3 and T3 PRO Implant System
- · ZimVie Tapered Abutments, 3.5-5.7mm, Angled, max 30 degrees
- · ZimVie TSX Implant System
- · ZimVie Tapered Screw-Vent Implant System .
The BellaTek Bars are intended to disperse the load of a prosthesis across dental implant-abutment assemblies. They also provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The subject devices are identical to the reference predicate device CAM StructSURE Precision Milled Bars cleared in K080864 (SE 07/21/2008) with the only addition of the new connection geometry. The subject device has a new bar-to-abutment connection tailored to the multi-unit restorative abutment component(s) with which the device is intended to be used. Similar to the primary predicate device (K233083), the BellaTek Bars are manufactured out of commercially pure titanium per ASTM F67 or Titanium Alloy per ASTM F136. The BellaTek Bars are placed in a nylon bag and sealed in same manner as the reference predicate device (K080864). A label is applied to the bag.
Like the primary predicate device (K233083), the BellaTek Bars are offered in two types. A Type I Bar is a Titanium Alloy bar designed for use with removable overdentures. A Type II Bar is a Pure Titanium or Titanium Alloy bar designed for fixed prosthesis. All BellaTek Bars (Dolder, Primary, Hader, Hybrid, Freeform, Canada, Wraparound and Copy Milled) are designed to match an individual patient. The bars are designed from a three-dimensional optical and/or digital scanner system that scans the casting of a patient's impression and then is machined using a CAD/CAM software system in accordance with customer specifications, within the limits of design defined in tables below. The subject devices are provided non-sterile in same manner as the predicate devices.
The BellaTek Bars are dental implant abutments intended to restore chewing function in partially or fully edentulous jaws by attaching to a minimum of two abutments.
Here's an analysis of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are primarily aligned with demonstrating substantial equivalence to a predicate device through materials, design specifications, and performance bench testing. Specific quantitative performance targets are not explicitly listed in an "acceptance criteria" table format in the provided document, but rather implied through comparison to existing standards and predicate devices.
| Acceptance Criteria Category | Description and Reported Device Performance |
|---|---|
| Intended Use | Substantially equivalent to the primary predicate device (K233083). |
| – BellaTek Bars: Indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for restoring chewing function. Intended for attachment to a minimum of two (2) abutments and manufactured by Biomet 3i. | |
| – Predicate Device (Osteon Precision Milled Suprastructure K233083): Indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for restoring chewing function. Intended for attachment to a minimum of two (2) abutments and manufactured by Osteon. | |
| Design Principles & Technological Characteristics | Substantially equivalent to the primary predicate device (K233083) and reference predicate device (K080864). |
| - Similar features: bar base material, bar-to-abutment connection, prosthetic platform sizes, mode of prosthetic retention. | |
| - Differences in prosthetic platform connection geometry are supported by identified predicate devices. | |
| Material and Manufacturing | Bar Material: Ti-6Al-4V ELI (ASTM F136) or Grade 4 CP Titanium (ASTM F67). |
| - Meets chemical and mechanical requirements of ASTM F136 and ASTM F67. | |
| - Packaging: Nylon pouch. | |
| - Sterilization Process: Moist heat, validated according to EN ISO 17665-1:2006 to achieve a sterility assurance level (SAL) of 10-6. | |
| Biocompatibility | Testing performed according to ISO 10993-1:2018 and ISO 10993-5:2009 on representative Biomet 3i patient-specific bar devices using the same ASTM F136 titanium alloy and ASTM F67 unalloyed titanium materials. |
| - Concluded that the material, chemical testing, and literature provide sufficient basis for demonstrating biocompatibility. | |
| MRI Safety | Non-clinical worst-case MRI review performed using scientific rationale and published literature (e.g., Woods et al., 2019). |
| - Addressed parameters per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque. | |
| - Reported Performance: BellaTek Bars have been labeled as MR conditional. | |
| Performance Bench Testing | Worst-case design validated in accordance with Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004. |
| - Demonstrates that differences from the predicate are accounted for and do not render the device not substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices or cases. The document refers to "worst case design" being validated. For sterilization, the validation process implies testing units to demonstrate SAL. For biocompatibility, "representative Biomet 3i patient-specific bar devices" were used. For MRI review, it was a "non-clinical worst-case MRI review... based on the entire system including all variations." This suggests a methodology of evaluating design limits and material properties rather than a large clinical test set.
- Data Provenance: The studies are non-clinical (bench testing, material analysis, literature review, MRI rationale). No specific country of origin for non-clinical data is mentioned, but the standards followed (e.g., ASTM, ISO, EN ISO) are international. The studies are by nature prospective as they are conducted to support the specific device submission, but they leverage established scientific literature and standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that the studies are non-clinical bench tests, material characterizations, and literature reviews, the concept of "experts establishing ground truth for a test set" in a clinical diagnostic sense does not directly apply. The "ground truth" for these types of studies is established by:
- Regulatory Standards: Adherence to recognized standards like ASTM F136, ASTM F67, ISO 10993-1, ISO 10993-5, EN ISO 17665-1, and FDA guidance documents.
- Engineering and Scientific Expertise: The performance of bench tests, material analysis, and MRI safety assessments would be conducted by engineers, material scientists, and physicists with expertise in these areas. While individual names or specific numbers aren't listed, this expertise is inherent in conducting such tests.
- Literature: The MRI safety assessment explicitly mentions using "published literature" as part of its scientific rationale, implying leveraging the consensus of experts in that field.
No specific number of experts or their detailed qualifications (e.g., "radiologist with 10 years of experience") are provided in the context of establishing ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies among multiple human readers in clinical studies where subjective interpretation is involved (e.g., image reading). The studies described here are non-clinical, objective evaluations (bench testing, material analysis).
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. The provided document states: "No clinical data were included in this submission." Therefore, no MRMC study or AI assistance evaluation was conducted or reported.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical dental implant bar, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for these studies is based on:
- Regulatory Standards and Specifications: Adherence to performance parameters detailed in FDA guidance documents (e.g., "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments"), and international standards (ASTM, ISO, EN ISO).
- Material Properties: Data derived from chemical and mechanical testing of the materials (ASTM F136, ASTM F67).
- Biocompatibility Endpoints: Established biological safety endpoints defined by ISO 10993 standards.
- MRI Safety Rationale: Scientific principles and published literature related to magnetic fields and medical devices.
- Demonstration of Substantial Equivalence: Direct comparison of technological characteristics and performance to legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing processes are developed through traditional engineering methods and validated through the testing described.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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(165 days)
The Osteon Precision Milled Suprastructure is indicated for attachments in the treatment of partially or fully edentulous jaws for the purpose of restoring function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.
The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:
- · Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
- · BioHorizons Multi Unit Abutment, 4.8mm, max 30°
- · CONELOG® Implant System
- · Biomet 3 i Multi Unit Abutments, 4.8mm, max 30°
- · TSXTM Implants
- · Tapered Screw-Vent Implant
- · DESS Dental Multi Unit Abutments, 3.4-5.7 mm, 0°
- · 3i OSSEOTITE®
- · Astra Tech OsseoSpeed™
- · Neodent Grand Morse
- NobelReplace® Trilobe
- · NobelReplace® Conical
- · Nobel Brånemark System®
- · Straumann BLX Implants
- · DESS Dental Multi Unit Abutments. Angled. 3.4-6.5 mm, max 30°
- · NobelActive® NobelParallel Conical
- Straumann® Bone Level
- · Zimmer Screw Vent® and Tapered Screw-Vent®
- · Dentium SuperLine® Abutments, 4.5-5.5 mm, max30°
- · Genesis ACTIVE™ Multi-Unit Abutments, 4.8mm, max 30°
- · Implant Direct GPS® Angled Abutment, 5.0mm, max 30°
- KDG Abutments, 4.8mm, max 30°
- · Keystone Multi Unit Abutment, 4.8mm, 0°
- · Medentika Multi Unit Abutments, 4.8mm, max 30°
- · EV Series Dentsply® Implants Astratech Osseospeed®
- · F Series Nobel Biocare NobelActive® NobelReplace® Conical
- · H Series Biomet 3i Certain®
- L Series Straumann Bone Level
- · N Series Straumann Soft tissue Level
- · R Series Zimmer Dental Tapered Screwvent®
- Medentika Multi Unit Abutments, 4.8mm, 0°
- E Series Nobel Biocare Replace™ Select
- · I Series Biomet 3i Osseotite®
- K Series Nobel Biocare™ Branemark
- · S Series Astra Tech OsseoSpeedTM
- · T Series Dentsply Friadent® Frialit/Xive®
- · MegaGen Multi Unit Abutments, 4.8mm, max 30°
- · Xpeed® AnyRidge® Internal Implant System
- AnyOne® Internal Implant System
- AnyRidge® Octa 1 Implant System
- AnyOne® External Implant System
- AnyRidge® Octa 1 Implant System
- AnyOne® Internal Implant System
- Rescue Internal Implant System
- MIS Multi-unit Abutments, 4.8mm
- · C1 Conical Connection Implant System, max 30°
- · V3 Conical Connection Implant System, max 30°
- · Internal Hex Implant System, max 30°
- · Conical Connection, max 30°
- · Neodent GM Mini Conical Abutment, 4.8 mm, max 30°
- · Nobel Biocare™ Brånemark Multi Unit Abutment, 4.8 mm, max 17°
- · Nobel Biocare™ Multi Unit Abutment Plus, 4.8 mm, max 30°
- · Nobel Biocare™ Multi Unit Abutment, 4.8 mm, max 30°
- Nobel Biocare™ Multi Unit Abutments for Straumann and Astra Tech System, 4.8 mm, max 30°
- Nobel Biocare™ Multi Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems, 4.8 mm, max 30°
- · Nobel Biocare Xeal Abutments, 4.8 mm, max 30°
- · OSSTEM Multi Unit Abutment, 4.8mm, max 30°
- SS SA Fixture Implants
- SA Implant System
- · ET US SSS Prosthetic System
- · Paltop Multi Unit Abutment, 5.0 mm, max 17°
- · Southern Compact Conical Abutments, 4.8 mm
- MAX Implant System, 0°
- · Provata Implant System, max 30°
- · Deep Conical (DC) Implants, 0°
- · Piccolo Implants, 0°
- · External Hex Implants, max 30°
- Straumann® BLX Screw Retained Abutment, 4.6 mm, max 30°
- · Straumann® Screw Retained Abutment, 4.6 mm, max 30°
- · Zimmer Angled Tapered Abutments, 4.5 mm, max 30°
The Osteon Precision Milled Suprastructures (also referred to as superstructures) are metallic dental restorative devices that are intended to be attached by screw retention to dental implant abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function. These suprastructures attach to dental implant abutments using the prosthetic screws from the original equipment manufacturers (OEM) and are used to support the final multi-unit restoration.
The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's dental impression. The suprastructure is manufactured with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical.
Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence are categorized as Type A and Type B.
- Type A: Intended to act as a supporting structure to facilitate the attachment of a removable dental prosthesis and include Primary Bar and Nexus Removable Bar.
- . Type B: Intended to act as a supporting structure to facilitate the attachment of a fixed dental prosthesis and include Melbourne Bar and Nexus Fixed Bar (including Nexus Hybrid, Nexus Bridge, Micro Nexus, and Nexus Wraparound).
The provided FDA 510(k) summary (K233083) describes the acceptance criteria and study for the Osteon Precision Milled Suprastructure.
1. Table of Acceptance Criteria and Reported Device Performance
This submission is a 510(k) for an expansion of an existing device (K221019) to add compatibility with new OEM abutment systems and introduce three new Type B Nexus Fixed Bars. The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate devices in terms of intended use, technological characteristics, and material composition.
The tables below synthesize the design specifications (acceptance criteria) and the device's performance (reported as meeting these specifications) by demonstrating substantial equivalence to predicate devices.
Table 1: Comparison of General Characteristics and Materials (summarized for clarity)
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Intended Use | Dental implant abutment for restoring chewing function in partially or fully edentulous jaws, attached to a minimum of two abutments. Specific compatible OEM abutment systems listed. | Substantially Equivalent. The subject device shares the same intended use. The primary difference is an expanded list of compatible OEM abutment systems. |
| Device Material | Titanium alloy Ti-6Al-4V (ASTM F136) | Meets/Substantially Equivalent. Manufactured from titanium alloy conforming to ASTM F136. |
| Design/Technology | CAD/CAM milling from single milling blanks | Meets/Substantially Equivalent. CAD/CAM milling from single milling blanks. |
| Design/Construction | Patient specific/machined | Meets/Substantially Equivalent. Patient specific/machined. |
| Sterility | Supplied Nonsterile | Meets/Substantially Equivalent. Supplied Nonsterile (to be sterilized by end-user). |
| Prescription/OTC | Prescription only | Meets/Substantially Equivalent. Prescription only. |
| Recommended Cleaning & Maintenance | Proper oral hygiene | Meets/Substantially Equivalent. Proper oral hygiene. |
Table 2: Design Specifications (Acceptance Criteria vs. Reported Performance)
| Design Parameters | Type A (Removable Prosthesis) Acceptance Criteria (Predicate) | Type B (Fixed Prosthesis) Acceptance Criteria (Predicate) | Type A (Removable Prosthesis) Reported Performance (Subject Device) | Type B (Fixed Prosthesis) Reported Performance (Subject Device) |
|---|---|---|---|---|
| Total Cylinders | 2-10 | 2-10 | 2-10 | 2-10 |
| Suprastructure Span Between Cylinders (mm) | 1-30 mm | 1-30 mm | 1-30 mm | 1-30 mm |
| Suprastructure Height (mm) | 3-12 mm | 3*-22 mm | 3-12 mm | 3*-22 mm |
| Suprastructure Width (mm) | 3.4-12 mm | 3.4**-12 mm | 3.4-12 mm | 3.4**-12 mm |
| Distal Cantilever Section (mm) | 0-15 mm | 0-15 mm | 0-15 mm | 0-15 mm |
| Cylinder Height (mm) | 0-4.6 mm | 0-4.6 mm | 0-4.6 mm | 0-4.6 mm |
| Cylinder Diameter (mm) | 4.5-8 mm | 4.5-8 mm | 4.5-8 mm | 4.5-8 mm |
*Note for Suprastructure Height: The Minimum Suprastructure Height for the Micro Nexus Bar (a new Type B bar in the subject device) is 2.5 mm, which is within the stated range of 3*-22 mm, where * indicates variability for this new bar.
**Note for Suprastructure Width: The Minimum Suprastructure Width for the Micro Nexus Bar (a new Type B bar in the subject device) is 2.5 mm, which is within the stated range of 3.4**-12 mm, where ** indicates variability for this new bar.
2. Sample size used for the test set and the data provenance
The submission is a 510(k) for an expansion of an existing device (K221019). The "study" proving the device meets acceptance criteria primarily relies on non-clinical data and demonstration of substantial equivalence to predicate devices.
- Test set/Sample size: The document does not describe a "test set" in the traditional sense of a clinical or imaging study with a defined sample size for statistical analysis. Instead, it relies on:
- Reverse engineering analysis of OEM abutments and OEM abutment screws: This was done to confirm compatibility. The sample size for this analysis is not explicitly stated but would involve the specific OEM abutments listed for compatibility with the subject device.
- Fatigue testing: The document states, "Fatigue testing was not performed since the Subject devices are abutment-borne and are not intended to compensate for angulation in excess of the maximum angulation of OEM angled abutments..." This indicates that engineering analysis and design specifications, rather than physical fatigue testing, were used to demonstrate performance in this regard.
- Data provenance: Not directly applicable as there isn't a "test set" from patients. The data relies on engineering analysis, existing predicate device data, and compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert readers to establish ground truth. Substantial equivalence claims are based on engineering, material, and design comparisons to legally marketed devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" or diagnostic performance study that would require an adjudication method.
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 a physical dental suprastructure, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical dental suprastructure, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" equivalent for this submission is the established safety and effectiveness of the primary predicate device (K221019) and various reference devices, supported by:
- Compliance with recognized standards: Biocompatibility (ISO 10993-5, ISO 10993-12), sterilization validation (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, ANSI/AAMI/ISO 14937).
- Material specifications: Conformance to ASTM F136 for titanium alloy.
- Engineering analysis and design specifications: Comparison of design features to predicate devices and confirmation of compatibility through reverse engineering.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this device.
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(246 days)
The Zfx Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandbular arch to provide support for prosthetic restorations.
All digitally designed custom abutments or superstructures and/or hybrid abutment crowns for use with Zfx TiBase or Pre-Milled Blank Abutments are intended to be sent to a Zfx validated milling center for manufacture.
The Zfx TiBase abutments for the 03.25 mm Certain implant bodies, and 03.1 mm Eztetic implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
The subject device, Zfx Abutments, consists of two abutment types, a TiBase and a Pre-milled Abutment Blank, with corresponding retaining screws. Zfx Abutments are offered in a variety of connections compatible with ZimVie dental implants. All abutments and screws are provided non-sterile.
TiBase Abutments: Subject device TiBases are two-piece abutments. The pre-manufactured titanium base component is the apical part. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. The subject device TiBase abutments are available in hexed/engaging and non-hexed/nonengaging configurations. The engaging TiBase abutments are intended for single and multi-unit restorations and the non-engaging TiBases are intended for multi-unit restorations. The superstructure is intended to be manufactured at a Zfx validated milling center.
Pre-milled Abutment Blanks: The Pre-milled Abutment Blank is a cylindrical titanium alloy abutment designed for patient-specific abutment fabrication with CAD/CAM technology. The patient-specific abutment milled from a Pre-milled Abutment Blank is secured directly to the implant using a retaining screw. Pre-milled Abutment Blanks are available in an engaging/hexed design only for single-unit and multi-unit restorations.
Retaining Screws: Corresponding retaining screws are packaged with the abutment and replacement screws are available individually. All screws are compatible with the corresponding ZimVie dental implants.
Material Composition: All subject device abutments are made of titanium alloy Ti-6Al-4V ELI conforming to ASTM F136. Screws are made of either titanium alloy Ti-6A1-4V ELI conforming to ASTM F136, or Gold-Tite® screws with stainless steel conforming to ASTM F138. Gold-Tite screws have a gold-plating conforming to ASTM B488 and ASTM B571. Zirconia superstructures for use with the TiBase Abutments are made of zirconia conforming to ISO 13356.
The provided text is an FDA 510(k) clearance letter for Zfx Abutments, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and supporting data in the way a clinical study report or a formal performance evaluation report would.
Therefore, the information required to answer many of the questions regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not present in this document. The document primarily outlines the device's technical specifications, indications for use, and a comparison to predicate devices, supported by non-clinical testing data (mechanical testing, biocompatibility, sterilization, etc.).
However, I can extract the information that is available and explain why other requested details are missing.
Acceptance Criteria and Device Performance (Based on "Equivalence to Marketed Devices" and "Performance Data" sections):
This document describes a substantial equivalence submission, meaning the acceptance criteria are primarily demonstrated by showing the device is as safe and effective as a legally marketed predicate device. The performance is assessed through non-clinical testing to ensure it meets established standards comparable to the predicate.
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (Non-Clinical/Design) |
|---|---|
| Indications for Use Equivalence | "Zfx Abutments (subject device) are substantially equivalent in design, function, material, and Indications for Use to the Primary Predicate, DESS Dental Smart Solutions abutments cleared in K222288. All are intended for use with endosseous dental implants in the maxilla and mandible to provide support for single and multi-unit restorations." |
| Material Equivalence | "All subject device abutments are made of titanium alloy Ti-6Al-4V ELI conforming to ASTM F136." "Screws are made of either titanium alloy Ti-6A1-4V ELI conforming to ASTM F136, or Gold-Tite® screws with stainless steel conforming to ASTM F138." "Zirconia superstructures for use with the TiBase Abutments are made of zirconia conforming to ISO 13356." This is compared to comparable materials in the predicate. |
| Product Design and Manufacturing Process Equivalence | "All digitally designed subject device abutments and primary predicate abutments are to a validated milling center for manufacture. Subject device abutments are similar in range of sizes, connections, and technological characteristics to the DESS Dental Smart Solutions, K22288." "Design parameters for the TiBase CAD/CAM zirconia superstructure are listed in the following tables (Tables 2-5)." "Design parameters for the CAD/CAM patient-specific abutment using a Pre-milled Abutment Blank are included in Table 6." |
| Sterilization Efficacy (Non-clinical) | "sterilization validation according to ISO 17665-1" |
| Biocompatibility (Non-clinical) | "biocompatibility testing according to ISO 10993-1 Table A-1, ISO 10993-5, and ISO 10993-10" |
| Reprocessing Validation (Non-clinical) | "reprocessing validation according to ISO 17665-2" |
| Mechanical Strength/Fatigue (Non-clinical) | "mechanical testing according to ISO 14801 to determine that the subject device has sufficient strength for its intended use." |
| MR Safety (Non-clinical) | "MR Safety testing was conducted according to ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119 for a determination of MR Conditional." |
| Compatibility with Existing Systems | "reverse engineering analysis to confirm compatibility with the Sirona inCoris Meso Blocks" (for TiBase). |
Missing Information and Explanations:
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. This document details a 510(k) submission based on non-clinical testing for substantial equivalence, not a clinical trial or performance study with human data. The "Performance Data" section explicitly states: "No clinical data were included in this submission." Therefore, there is no "test set" in the context of clinical images or patient data to analyze. The "samples" used were physical samples for mechanical, sterilization, and biocompatibility testing. The data provenance would be from laboratory tests.
-
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/Not provided. As no clinical data or clinical "test set" was used, there was no need for expert adjudication to establish ground truth from patient data. The ground truth for mechanical and material properties is established by engineering specifications and industry standards.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/None. No clinical test set to adjudicate.
-
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 (Zfx Abutments) is a physical dental implant component, not an AI software/device. Therefore, an MRMC study or AI assistance is not relevant to its performance evaluation for this submission.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As above, this is a physical medical device, not an algorithm or AI.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for demonstrating substantial equivalence for this device relies on engineering specifications, material standards (e.g., ASTM, ISO), mechanical test results (e.g., forces to fracture), and comparative analysis with the predicate device's established safe and effective performance. There is no clinical outcomes ground truth cited here.
-
The sample size for the training set:
- Not applicable. This refers to a dataset for training an AI model. This device is not an AI/software.
-
How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI model.
In summary, this document is a regulatory clearance letter focused on substantial equivalence for a physical dental device. The "study" proving it meets acceptance criteria consists of various non-clinical bench tests and a comparison to a predicate device's specifications and performance, rather than a clinical study with patients or an AI model's performance evaluation.
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(142 days)
Kontact™ Dental Implant System is indicated for use in partially or fully edentulous patients to support maxillary or mandibular single unit, multiple-unit, or overdenture dental restorations. Kontact Dental Implant System is indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate. Kontact 3 mm diameter implants and prosthetics components are indicated for use in surgical and restorative applications in the maxillary lateral incisor or mandibular incisor regions.
The Kontact™ Dental Implant System comprises endosseous root-form dental implants, abutments, abutment screws, and other associated components for single-unit, multi-unit, and overdenture restorations. Kontact dental implants are provided in five body diameters: 3.0 mm, 3.6 mm, 4.2 mm, 4.8 mm, and 5.4 mm. The platform diameter for each size is the same as the (maximum) body diameter. The implants are provided in lengths ranging from 8 mm to 16 mm. The implants have a recessed internal section for abutment indexing, and an internal threaded section for mating to the corresponding subject device cover screw, or abutment screw. All implants are manufactured from titanium alloy conforming to ASTM F136 and ISO 5832-3. The endosseous threaded surface of the subject device implants is grit-blasted with non-resorbable aluminum oxide (Al2O3) particles. Kontact conventional and prosthetic components include cover screws, abutment screws, temporary abutments, straight abutments, angled abutments, prepable abutments, multi-unit abutments, healing caps, and overdenture abutments. Most device screws and all subject device abutments are manufactured from titanium alloy conforming to ASTM F136 and ISO 5832-3. Select subject device abutments and screws manufactured from titanium alloy are anodized using standard electrolytic passivation processing to impart a distinctive surface color. The subject device abutment screw intended for 3 mm diameter implants and the prosthesis screw intended for conical abutments are manufactured from cobalt alloy, conforming to ASTM F1058 and ISO 5832-7. The abutment screw is coated with titanium nitride (TiN); the prosthesis screw is coated with chromium nitride (CrN). Subject device healing caps intended for use with UniPost abutments, and IsoPost abutments are manufactured from polyetheretherketone (PEEK). Subject device healing caps intended for NanoPost abutments and IsoPost abutments are manufactured from polymethyl methacrylate (PMMA).
The product, Kontact™ Dental Implant System, has not reported any clinical studies. The only data provided is non-clinical performance data.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Evaluation Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Conformance to ISO 10993-5 and ISO 10993-12 | Device demonstrates biocompatibility according to ISO 10993-5 (tests for in vitro cytotoxicity) and ISO 10993-12 (sample preparation and reference materials). Specific results are not detailed but compliance with these standards indicates meeting requirements for biological safety. |
| Gamma Sterilization | Conformance to ISO 11137-1 and ISO 11137-2 | Validation performed for subject device implants and cover screws. Specific Sterility Assurance Levels (SAL) are not stated, but conformance to these standards implies achieving a validated sterile state (e.g., SAL of 10^-6). |
| Bacterial Endotoxin Testing (BET) | ≤ 20 EU/device | Limulus amebocyte lysate (LAL) test performed according to ANSI/AAMI ST72 and USP 43-NF38:2020 . Ongoing monitoring and control ensure BET levels meet or are below ≤ 20 EU/device. This indicates the devices are free from pyrogenic contamination within accepted limits. |
| Shelf Life Validation | Conformance to ASTM F1980 and ISO 11607-1 | Packaging stability validated. Conformance to ASTM F1980 (standard guide for accelerated aging of sterile medical device packages) and ISO 11607-1 (packaging for terminally sterilized medical devices) indicates the device maintains its integrity and sterility over its claimed shelf life. Specific shelf life duration is not provided. |
| Moist Heat Sterilization (End-user) | Conformance to ISO 17665-1 and ISO TS 17665-2 | Instructions and validation for end-user moist heat sterilization provided. Conformance to ISO 17665-1 (sterilization of health care products - moist heat - requirements for the development, validation and routine control of a sterilization process for medical devices) and ISO TS 17665-2 (guidance on the application of ISO 17665-1) ensures proper sterilization by the end-user. Specific parameters are not detailed. |
| Static Compression & Compression Fatigue Testing | Conformance to ISO 14801 | Mechanical performance testing performed on the subject device according to ISO 14801 (dentistry - implants - dynamic fatigue test for endosseous dental implants). The fatigue limit data for abutments compatible with 3.0 mm diameter implants was supported by reference device K183518, and "constructs of all other subject device abutments in combination with all other subject device implants have sufficient strength for their intended use." This indicates the devices meet mechanical strength requirements for their intended application. The specific criteria for "sufficient strength" are not explicitly quantified (e.g., number of cycles survived, load at failure) but implied by conformance to the standard. |
| Endosseous Surface Characterization | Demonstrated by SEM and EDS | The grit-blasted surface (with non-resorbable aluminum oxide) was validated by scanning electron microscope (SEM) and energy dispersive X-ray spectroscopy (EDS) characterization. This confirms the presence and composition of the surface modification intended to facilitate osseointegration. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for any of the non-clinical tests.
- Data Provenance: All data is non-clinical and derived from laboratory testing of the device and its components, primarily referencing international and industry standards (ISO, ASTM, ANSI/AAMI, USP). Information on the country of origin of the test data is not provided, but the manufacturer is Biotech Dental, SAS, based in France. The data is retrospective in the sense that it's generated as part of a premarket submission, not from a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This device relies on pre-defined engineering and sterility standards, not expert-established ground truth from clinical cases. There were no clinical studies.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Not applicable. There was no test set for clinical performance requiring 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. No clinical studies were conducted, and this product does not involve AI or human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This product is a physical dental implant system, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
- Not applicable. Ground truth, in the clinical sense, was not used as there were no clinical studies. The "ground truth" for non-clinical testing is adherence to established international and industrial standards (e.g., ISO, ASTM) for material properties, mechanical performance, and sterility.
8. The Sample Size for the Training Set
- Not applicable. There was no training set, as this is a physical medical device and not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There was no training set.
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(274 days)
Ziacom Dental Implant Systems are intended to be surgically placed in the bone of the mandibular or maxillary jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function and to aid in prosthetic rehabilitation. Ziacom Dental Implant Abutments are intended to be used with Ziacom Dental Implants to aid in prosthetic rehabilitation.
The intended use for Ziacom Dental Implant Zinic® NP 3.30mm diameter is limited to replacement of mandibular incisors.
Zinic® and Zinic MT implants are threaded, self-tapping, root-form dental implants manufactured from CP titanium Grade 4 conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700). The implants have apical flutes, an internal hexagonal abutment interface and a conical bevel at the abutment interface. They are threaded internally for attachment of mating abutments, cover screws, healing abutments or temporary abutments. The coronal portion of the implant has a microthread design. The Zinic design is a straight implant, while Zinic MT implants are tapered in the apical 40% of the implant length. All implants have a grit blasted and acid etched surface, designated Osseonova Surface.
Implants and abutments with the same platform connection are compatible. Zinic and ZinicMT implants are available with following sizes: (Table of sizes provided in the document).
Zinic and ZinicMT implants are provided sterile to the end-user in a single-unit package, and are for single-patient, single-use only. They are provided in ZPlus packaging or Z2Plus packaging, attached to the ZPlus or Z2Plus Mount, respectively, or in NoMount packaging, without an implant mount. Packaging facilitates the aseptic handling and placement of the implant, with the mounts also capable of serving either as a provisional abutment or a definitive abutment. Z2Plus also can serve as a transfer for a Snap-On impression technique.
Subject device abutments include cover screws, healing abutments, provisional abutments, sculptable (prepable) abutments, conical abutments in straight and angled (15°, 25° and 30°) designs, castable abutments (CoCr base plus burn-out sleeve) in straight and angled (15°, 20°) designs, Basic and Unitary Basic abutments to serve as intermediate abutments between the implant and the prosthesis. XDrive multi-unit abutments in straight and angled (17°, 30°) designs.
All subject device abutments have the universal internal implant connection and are compatible with both implant lines, except that NP abutments are compatible only with Zinic NP implants (there are no ZinicMT NP implants). Abutments are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), polyetheretherketone (PEEK) conforming to ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications or cobalt-chromium-molybdenum alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539).
Subject device abutments include two overdenture abutments (Kirator,ZM-Equator). Kirator overdenture abutments are straight prosthetic abutments that are used for the retention of preexisting or newly fabricated full dentures (classified as implant-retained mucosupported overdentures). ZM-Equator abutments are straight prosthetic abutments used for the retention of tissue-supported implantretained prostheses. Its is indicated in rehabilitation of narrow ridges and/or reduced vertical dimension Each overdenture abutment is the "male" part of a removable prosthesis retention which contains a metal housing cap that incorporate plastic retention with different degrees of elastic retention. Abutments and housing caps are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The different plastic retentions are manufacture from Kepital, Rilsan bmno and Pebax.
All abutments are provided non-sterile to the end-user in a single-unit package, and are for singlepatient, single-use only.
Clinical screws used to attach abutments and prosthetic components to implants are available with an M1.6 thread and 8 mm length to fit NP abutments and implants and with an M1.8 thread and 7.85 mm length to fit RP and WP abutments and implants. They are available in a machined Ti-6AI-4V design and in a design that is hard anodized to provide anti-loosening characteristics, designated Kiran®. Machined titanium alloy screws are anodized for identification, with the M1.6 thread screw that fits NP abutments and implants colored yellow and the M1.8 thread screws that fit RP and WP abutments and implants colored blue. Kiran screws are dark grey.
A TX30 Torx screw is available for retention of the TX30 Mechanized Abutment. It incorporates a 6-lobed internal feature mating with a 6 lobed spherical tip screwdriver to permit driving the screw with the driver inserted through the angled portion of the restoration. It is provided with the Kiran hard anodizing treatment.
Additional screws are available to attach prosthetic components to Basic abutments and to XDrive abutments. Basic screws have an M1.8 thread and are 4.3 mm long, while XDrive screws have an M1.4 thread and are 3.5 mm long. Each is available as an anodized titanium alloy screw or as a Kiran screw with the hard anodizing treatment.
The provided text describes the Ziacom Dental Implant Systems and its substantial equivalence to predicate devices, but it does not contain information about an AI/ML-enabled medical device study or acceptance criteria for such a device.
The document is a traditional 510(k) premarket notification for a Class II medical device (endosseous dental implant). The performance data presented focuses on mechanical strength testing, material characterization (surface roughness, chemistry), biocompatibility (cytotoxicity), and sterilization validation, which are standard for dental implants.
Therefore, I cannot fulfill your request for the following sections as the necessary information is not present in the provided document:
- A table of acceptance criteria and the reported device performance (for an AI/ML device)
- Sample sizes used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method for the test set
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study details
- Standalone (algorithm-only) performance
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
The document describes the device's technical specifications and how it is demonstrated to be substantially equivalent to existing predicate devices based on non-clinical performance data (mechanical and biological testing), rather than clinical or AI/ML performance.
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(432 days)
The Zuga™ Dental Implant System is indicated for immediate or delayed implant placement for surgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges, and overdentures. The Zuga™ Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The Zuga™ Dental Implant System includes endosseous dental implants, sealing caps, healing caps, dental implant abutments, and fixation screws in a variety of sizes to accommodate differing patient anatomy. Implantation is suitable for one-or two-stage procedures. Endosseous implants are bone level, self-tapping, root-form, threaded. The threaded surface is blasted, then passivated. Sizematched anterior and posterior abutments are offered. Thes are fastened to the implant using a fixation screw. Sealing caps and healing caps provide protection to the abutment connection threads during endosseous and gingival healing. The implants are provided sterile, the remaining components must be sterilized prior to use.
The provided text describes a 510(k) premarket notification for the Zuga™ Dental Implant System. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving that the device meets a set of specific acceptance criteria through clinical performance metrics like sensitivity, specificity, or accuracy, as would be common for AI-driven diagnostic devices.
Therefore, the document does not contain the information requested regarding acceptance criteria in terms of performance metrics for an AI/ML device, nor does it detail a study proving the device meets such criteria with respect to AI performance.
Instead, the "Performance Data" section ([15]) focuses on biological and mechanical compatibility/safety testing, which is standard for medical devices like dental implants. These tests are designed to show that the physical device itself is safe and performs as intended, not to evaluate an AI algorithm's diagnostic or predictive capabilities.
Here's an breakdown of the information present and what's missing, based on the prompt's requirements:
1. A table of acceptance criteria and the reported device performance:
- Present: The document lists various tests performed and their outcomes which act as "acceptance criteria" for a physical medical device. These are:
- Static fatigue tests and dynamic fatigue tests (per ISO 14801 and FDA Guidance): "The results show that the Zuga™ Dental Implant System has sufficient mechanical strength for the intended clinical application."
- Cytotoxicity testing (per ISO 10993-5 and USP ): "The results showed that the Zuga™ Dental Implant System received a passing score and is thus acceptable for clinical application."
- Sterility tests (per ISO 10993, ISO 11137-1, 11137-2, ISO 17665-1, 17665-2): "yielded no difference in performance between the Zuga™ Dental Implant System and the predicate device."
- LAL (Limulus Amebocyte Lysate) bacterial endotoxin tests (per ISO 10993 and USP , ): "yielded a EU/Device value that was less than the established acceptance criteria of 20 EU/Device".
- Shelf life tests (per ISO 11607): "established the shelf life to be five years provided the sterile seal is not breached."
- Missing (for an AI/ML device context): Specific performance metrics like sensitivity, specificity, accuracy, AUC, FROC, etc., and their corresponding acceptance thresholds.
2. Sample sized used for the test set and the data provenance:
- Present: For LAL tests, it states: "The sampling plan consists of selecting 3% of the batch up to a maximum of 10 samples to be pooled for testing."
- Missing (for an AI/ML device context): Sample size for a "test set" of patient data (e.g., medical images, clinical records) for an AI algorithm. Data provenance (country of origin, retrospective/prospective) is not applicable or mentioned for these physical/biological tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Missing: This information is not relevant to the mechanical/biological testing of a physical implant. It would be crucial for an AI/ML device based on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Missing: Not applicable to the presented data.
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:
- Missing: Not applicable. This device is a physical dental implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Missing: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Present (for physical device tests): The "ground truth" here is adherence to international standards (ISO, ASTM) and USP guidelines for mechanical strength, biocompatibility, sterilization, and endotoxin levels.
- Missing (for an AI/ML device context): Clinical ground truth established by experts or pathology for diagnostic purposes.
8. The sample size for the training set:
- Missing: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Missing: Not applicable.
In summary: The provided document is an FDA 510(k) clearance letter for a physical dental implant system. Its "acceptance criteria" and "performance data" relate to the mechanical, chemical, and biological safety and efficacy of the implant itself, demonstrated through adherence to various international and US standards. It contains no information relevant to the development, testing, or performance of an AI/ML device.
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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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(161 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 TiBase or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture.
DESS Dental Smart Solutions is a dental implant abutment system that includes seven abutment design types (Healing, Temporary, Straight, TiBase, Pre-milled Blank, DESS LOC, Multi-Unit), and ten abutment connections compatible with eleven implant systems. Platform diameters range from 3.3 mm to 5.7 mm. Corresponding implant body diameters range from 3.25 mm to 6.0 mm. Abutments are offered in a variety of connection types to enable compatibility with a large number of currently marketed implants. Straight, Temporary and TiBase abutments have a SelectGrip® surface. DESS LOC Abutments have a ZrN coating. Selected DESS screws include DLC coating. DESS Dental Smart Solutions abutments are straight abutments. All abutments are provided non-sterile.
This document describes the premarket notification for the DESS Dental Smart Solutions, an endosseous dental implant abutment. The information provided is for regulatory clearance based on substantial equivalence, not a standalone performance study of the device. Consequently, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based medical device are not applicable or find direct answers within this document.
However, I can extract the relevant information from this regulatory document concerning the device's performance evaluation to demonstrate its substantial equivalence to predicate devices, which serves as its "acceptance criteria" for market clearance.
Here's an analysis of the provided text in relation to your questions, focusing on the available "performance data":
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for this device are based on demonstrating substantial equivalence to legally marketed predicate devices, rather than meeting specific performance metrics of an AI algorithm like sensitivity, specificity, or accuracy. The "performance" is shown through engineering and dimensional analysis, and material compatibility, to ensure it functions similarly to the predicate devices.
| Acceptance Criteria (based on Substantial Equivalence) | Reported Device Performance (as demonstrated by non-clinical testing) |
|---|---|
| Sterilization: Ensure sterilization of the final finished device. | Sterilization validation to an SAL of 10^-6 according to ISO 17665-2. |
| Biocompatibility: Demonstrate devices are non-cytotoxic. | Biological evaluation according to ISO 10993-1 and cytotoxicity testing according to ISO 10993-5 for all surfaces. |
| Surface Suitability: Demonstrate suitability of specialized surfaces (ZrN and SelectGrip). | SEM evaluation and measurement of the ZrN and SelectGrip surfaces. |
| Compatibility with OEM Implant Systems: Confirm compatibility with various OEM implant bodies, abutments, and abutment fixation screws. | Engineering and dimensional analysis of OEM implant bodies, OEM abutments, and OEM abutment fixation screws. |
| Design, Function, Material, Size, and Indications for Use: Be substantially equivalent to predicate devices. | Detailed comparison tables demonstrating similarity in Indications for Use and Technological Characteristics (Prosthesis Attachment, Restoration, Abutment Platform Diameter, Abutment Angle, Abutment/Implant Interface, Material for Abutment and Screw). |
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 for Test Set: Not explicitly stated in terms of a "test set" as one would define it for an AI/algorithm study. The "test set" here refers to the actual physical devices (parts, materials) subjected to engineering, dimensional, and biological evaluations. The document does not specify the number of individual abutments or components tested for each non-clinical evaluation.
- Data Provenance: The document states that Terrats Medical SL is located in Montcada i Reixac, Spain. The testing was non-clinical. No information is provided regarding the country of origin of testing data beyond the manufacturer's location.
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 type of expertise for establishing ground truth is relevant for AI/algorithm studies involving image interpretation or clinical diagnosis. For a dental implant abutment, "ground truth" is based on established engineering and material science standards (e.g., ISO standards, dimensional specifications, material composition), which do not typically involve human expert consensus in the same way as an AI diagnostic study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers interpret data (e.g., medical images) and their discrepancies need to be resolved. This document pertains to the physical and material properties of a medical device, which are evaluated against defined engineering and biological standards, not subjective interpretations requiring 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: No MRMC study was performed. This document concerns the regulatory clearance of a physical medical device (dental abutment), not an AI-assisted diagnostic tool. The document explicitly states: "No clinical data were included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an AI algorithm. The device "DESS Dental Smart Solutions" refers to a system of dental implant abutments, which are physical components. The document indicates that "All digitally designed custom abutments... are to be sent to a Terrats Medical validated milling center for manufacture," implying a digital design process, but the device itself is a physical product, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance relies on established engineering standards, material specifications, and biological safety standards (e.g., ISO 17665-2 for sterilization, ISO 10993-1/5 for biocompatibility), and dimensional compatibility with OEM implant systems. It is a physical and material "ground truth" rather than a clinical or diagnostic "ground truth."
8. The sample size for the training set
- Not Applicable: This device is a physical product, not an AI model that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable: As there is no training set for an AI model, this question is not relevant.
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(178 days)
Dentium abutments are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.
All digitally designed abutments for use with Dentium CAD/CAM Abutments are intended to be sent to a Dentium-validated milling center for manufacture.
Dentium CAD/CAM Abutments are titanium abutments to be used in fabricating patient-specific abutments. Each patient-specific abutment is individually prescribed by the clinician. Dentium CAD/CAM Ti-Blank Abutments are abutments with a pre-manufactured precision interface and are used by a validated milling center to fabricate patient-specific abutments. Ti-Blanks are available in three cylinder diameters (10 mm, 14 mm, and 15.8 mm) and three connection designs (Hex, Long Hex). Dentium CAD/CAM Custom Abutments are patient-specific abutments fabricated by Dentium. Custom Abutments are available for fabrication in three connection designs (Hex, Long Hex, and Non-hex). Dentium CAD/CAM Abutments are available for four corresponding implant platform diameters (3.6 mm. 4.0 mm, 4.5 mm, 5.0 mm). Each abutment is supplied with a corresponding abutment screw, cleared previously in K141457. All subject device abutments are compatible with Implantium dental implants.
I am sorry, but the provided text from the FDA 510(k) Pre-Market Notification for Dentium CAD/CAM Abutments does not contain any information about acceptance criteria or a study proving that an AI/device meets acceptance criteria related to diagnostic performance.
The document is a clearance letter for a dental device (CAD/CAM abutments), not an AI or diagnostic imaging device. It focuses on demonstrating substantial equivalence to predicate devices based on:
- Non-clinical performance data: steam sterilization validation, biocompatibility, and dynamic compression-bending testing.
- Design similarities: material, size, and interface.
- Intended use.
Therefore, I cannot extract the information required by your request, such as a table of acceptance criteria for diagnostic performance, sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, or training set details, because this document is for a medical device that does not involve such diagnostic performance evaluations.
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(176 days)
CAM Titanium Blanks are intended for the fabrication of abutments and healing caps on CAMLOG® SCREW-LINE and CAMLOG® ROOT-LINE implants in the maxilla and mandible for the purpose of supporting single or multiple tooth prostheses of a partially or fully edentulous patient. Digitally designed abutments fabricated with CAD/CAM techniques for use with CAMLOG® CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for manufacture.
CAM Titanium Blanks are intended for the fabrication of abutments and healing caps on CONELOG® SCREW-LINE implants in the maxilla and mandible for the purpose of supporting single ooth prostheses of a partially or fully edentulous patient. Digitally designed abutments fabricated with CAD/CAM techniques for use with CONELOG® CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for manufacture.
CAM Titanium Blanks are intended for the fabrication of abutments and healing caps/gingiva former on iSy® implants in the maxilla and mandible for the purpose of supporting single or multiple tooth prostheses of a partially or fully edentulous patient. Digitally designed abutments fabricated with CAD/CAM techniques for use with iSy CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for manufacture.
CAM Titanium Blanks are abutments with a prefabricated, precision interface (implant/abutment connection) and a screw channel suitable for the respective implant system. CAM Titanium Blanks are to be used by a CAMLOG validated milling center with CAD/CAM technology to fabricate a final finished customized abutment made of titanium alloy. Each patient-specific abutment is individually prescribed by the clinician as a temporary, permanent, single, or multi-unit abutment. Computer-aided manufacturing (CAM) techniques are used to process the cylinder portion above the implant connection into an individual abutment or healing cap/gingiva former design. The healing cap/gingival former is temporary and used during healing. Permanent abutments have straight and angled designs that can be used for crowns, bridges or overdentures.
CAM Titanium Blanks are available for CAMLOG SCREW-LINE and ROOT-LINE implants fitting five implant diameters (3.3. 3.8. 4.3. 5.0. 6.0 mm), for CONELOG SCREW-LINE implants fitting four implant diameters (3.3. 3.8, 4.3, 5.0 mm), and for the iSy implants with one connection fitting three implant diameters (3.8, 4.4, 5.0 mm).
This document is a 510(k) summary for the "CAM Titanium Blanks" dental device, which is related to endosseous dental implant abutments. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting a performance study with specific acceptance criteria and detailed quantitative results.
Therefore, much of the requested information regarding acceptance criteria and performance study specifics for an AI/ML device (like sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not applicable or present in this regulatory submission.
However, I can extract the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide specific quantitative acceptance criteria or corresponding reported device performance values in the way one might see for an AI/ML diagnostic or predictive device (e.g., sensitivity, specificity, AUC thresholds). Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence through:
- Non-clinical testing: This includes sterilization validation, biological evaluation, and mechanical testing. The acceptance here is successful completion according to the referenced standards.
- Comparison of Indications for Use: The claim is that the indications are "substantially equivalent."
- Comparison of Technological Characteristics: The claim is that the characteristics are "similar" or "substantially equivalent."
| Acceptance Criteria (Implied from Substantial Equivalence Determination) | Reported Device Performance (as demonstrated by comparison/testing) |
|---|---|
| Sterilization validated per ISO 17665-1 and ISO 17665-2 | Sterilization validated (by reference to standards) |
| Biological evaluation per ISO 10993-1 | Biological evaluation complete (by reference to K083496, K113779, K133991) |
| MR testing per ASTM F2052, F2213, F2182, F2119 | MR testing complete (by reference to standards) |
| Static and dynamic compression-bending testing per ISO 14801 | Static and dynamic compression-bending testing complete (by reference to standard) |
| Indications for Use are substantially equivalent to predicates | Indications for Use are "substantially equivalent" |
| Technological Characteristics are similar to predicates | Design, material (Ti-6Al-4V ELI), and intended use are "substantially equivalent" or "similar" to predicates. Similar range of physical dimensions (diameter 3.3-6.0 mm, angle up to 30°). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This document is for a mechanical dental device (titanium blanks for abutments), not an AI/ML-driven device that typically uses test sets of data.
- The "test set" here refers to the actual physical devices subjected to non-clinical tests. The sample sizes for these specific non-clinical tests (sterilization, biological, MR, mechanical) are not explicitly stated in this summary, but would be defined by the relevant ISO/ASTM standards referenced.
- Data provenance (country of origin, retrospective/prospective) is not applicable in the context of this summary for a mechanical device.
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 as this is a mechanical device, not an AI/ML device relying on expert-labeled ground truth data. The "ground truth" for mechanical properties would be derived from standard test methods and measurements, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is a mechanical device.
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. This type of study is relevant for AI/ML diagnostic tools that assist human readers, which this device is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for demonstrating the safety and effectiveness of this mechanical dental device is based on established engineering standards and material properties testing. For example, the "ground truth" for mechanical strength is whether the device withstands specified forces according to ISO 14801. The "ground truth" for biocompatibility is conformance to ISO 10993-1.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not an AI/ML device trained on data.
9. How the ground truth for the training set was established
- Not applicable.
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