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510(k) Data Aggregation
(89 days)
NeoConvert Solution: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. The NeoConvert Solution may be used with single-stage or two-stage procedures, for temporary multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Direct Screw to MUA: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. The Direct Screw to MUA may be used with single-stage or two-stage procedures, for screw-retained multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. All digitally designed personalized copings to be used with the Direct to Multi Unit Abutment Screw are intended to be sent to Straumann for manufacture at a validated milling center.
GM Attachment TiN 30°: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. The GM Attachment TiN 30° may be used with single-stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
This premarket notification includes the following additions to the Neodent Implant System: NeoConvert Solution, Direct Screw to MUA, GM Attachment TiN 30°. The Neodent Multi-Unit Abutments proposed on this submission are similar to devices already cleared in previous submissions of Neodent Implant System, according to predicate devices described above. This submission intends to expand the portfolio of Neodent Abutments with these new solutions for multi-unit restorations, to provide more treatment options to customers. The NeoConvert Solution is a technique comprised by some abutments (not subject of this submission) used for converting removable temporary prosthesis into a screw-retained fixed temporary prosthesis. The Direct Screw to MUA is a prosthetic component designed to fix planned and digitally designed multi-unit milled restorations directly onto mini or micro abutments, eliminating the need for using the passive seating cylinder to restore chewing function. The GM Attachment TiN 30° is a prosthetic component used to stabilize implant-mucosa-supported removable full prosthesis (retained on the implant and supported on the mucosa), on implants installed in the maxilla or mandible. Although all these three new solutions are compatible with the same implants and components of Neodent Implant System and used for multiple unit rehabilitation, they are not used in conjunction with each other.
The provided text describes a 510(k) premarket notification for the "Neodent Implant System," focusing on the NeoConvert Solution, Direct Screw to MUA, and GM Attachment TiN 30°. This document details the device's technical characteristics, intended use, and its substantial equivalence to previously cleared predicate devices.
However, the provided text does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device submission. The document is a traditional 510(k) submission for dental implants and abutments, which are physical medical devices, not AI/ML software. Therefore, the specific requirements for an AI/ML device study (such as sample sizes for test and training sets, expert qualifications for ground truth, MRMC studies, or standalone performance) are not applicable or present in this document.
The "Performance Testing" section (pages 15-16) describes bench testing (dynamic fatigue, torsion, SEM images), MRI compatibility testing, biocompatibility testing, sterilization validation, and shelf-life testing for the physical dental implant components. These are standard performance tests for this type of physical device, not AI/ML algorithm validation.
Therefore, I cannot provide a table of acceptance criteria and a study proving the device meets acceptance criteria as typically outlined for an AI/ML medical device, as this information is not present in the provided document. The document focuses on demonstrating substantial equivalence of a physical dental device to predicate devices through engineering and material testing.
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Indications for Use for Helix Short Implant:
The Neodent Implant System is recommended for surgical procedures on maxilla or mandible bones. It provides support for prosthetic components such as artificial teeth, thus restoring the chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Indications for Use for Mini Straight, Angled Abutment and screws:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Indications for Use for Helix Short Attachment:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Indications for Use for Helix Short Healing Abutment:
This product is used for the maintenance of soft tissue, during the bone integration stage of Neodent implants to be rehabilitated with the late loading technique. The Healing Abutment may be used in the implant installation surgery or the reopening surgery (second surgical stage).
Indications for Use for Helix Short Cover Screw:
This product is used for the maintenance of soft tissue, during the bone integration stage of Neodent implants to be rehabilitated with the late loading technique. The Cover Screw must remain intragingival, preventing the growth of tissue over the implant platform. The Cover Screw takes place in the conical region of the implant interface.
Indications for Use for Temporary Abutment for Helix Short Implant
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Temporary Abutments are installed over Helix Short Implants and to provide support for prosthetic structures for up to 6 months.
Indications for Use for Helix Short Titanium Base:
The Helix Short Implant Titanium base that is placed over Neodent dental implants to provide support for customized prosthetic restorations, such as copings and crowns. It is indicated for single- and multiple-structure restorations, screw- or cement-retained on implants installed in the maxilla or mandible. All digitally-designed copings and/or crowns to be used with the Neodent Titanium Base System must be sent to Straumann for manufacture at a validated milling center.
- All the subject devices are intended for single use;
- The subject implants are provided sterile via gamma irradiation and the subject abutments are provided sterile via Ethylene Oxide to an SAL of 1x10-9;
- The subject implants are manufactured of Commercially Pure Titanium (Grade 4), the subject abutments, prosthetic screws and abutment screws are manufactured of Titanium alloy Ti-6Al-4V ELI (ASTM F136) and the restorations placed onto Helix Short Titanium Bases are made of various top half materials.
- The subject implants have a wide cone prosthetic interface with an internal hexagon for short implants lengths available from 4.0 to 7.0; cylindrical shape with double threads and conical apex with three helical flutes for diameters from 3.75 to 7.0mm.
- The implants are provided in two different surfaces: Neoporos: Sand blasted and acid etched, and Acqua: Hydrophilic surface aggregated to the rough surface obtained by double treatment: abrasive blasting and acid subtraction.
- The Helix Short Implant Titanium Base abutments is used as two-piece abutment, where the base is premanufactured from titanium alloy and the top half is created via burn out coping or a digital workflow with CAD/CAM at a validated milling center. The final top half can be created from Ticon, Coron, Zerion LT, IPS e.max, or PMMA. The top half and base pieces are cemented together to form the final abutment.
Here's an analysis of the acceptance criteria and supporting studies for the Neodent Implant System - Helix Short Implant System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly present a table of specific numerical acceptance criteria alongside reported performance for each test. Instead, it describes what was tested and states that the results "met the acceptance criteria" or demonstrated "equivalent performance." We can infer the general acceptance criterion from the study descriptions.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Mechanical Testing: | |
| Dynamic Fatigue Test (per ISO 14801): Equivalent fatigue strength to predicate devices. | The tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices. |
| Torsion Test (static torsional loading): Meet acceptance criteria. | The results met the acceptance criteria. |
| Insertion Test: Evaluate insertion torque in various bone types. | Performed to evaluate the insertion torque of the Helix Short System when it is inserted in bones type I, II, III, and IV. (No explicit "met criteria" statement, but implied by successful evaluation). |
| Implant Surface Area Simulation and Pull Out Test: Demonstrate acceptable BIC rate and pull out resistance. | Results demonstrated that the subject devices, despite having a slightly smaller surface area than the reference devices, presented a higher BIC rate and pull out resistance upon placement. Thus, the subject devices exhibit a level of benchtop performance equivalent to that reviewed for the reference device. |
| MR Compatibility Testing: | |
| Not configure a new worst case compared to reference devices, allow safe scanning under established parameters. | An assessment was made to demonstrate that the subject devices do not configure a new worst case and can be represented by the previously conducted studies reviewed for reference devices, since both have the same raw material and similar dimensions. The subject devices are therefore MR conditional devices and a patient treated with the subject devices can be safely scanned observing the parameters previously established per reference devices. |
| Surface Treatment: | |
| Identical or similar chemical processes to predicate/reference devices to achieve roughness. | The surface treatments applied to subject devices are identical to these applied and previously evaluated for primary predicate devices. Although some reference devices have a surface with different nomenclature, the chemical processes applied to the surface are similar to create the roughness surface. Acqua implants are submitted to an additional step in order to increase their hydrophilicity, as already cleared for primary predicate device. |
| Sterilization Validation: | |
| Implants (Gamma Irradiation): Minimum Sterility Assurance Level (SAL) of 1 x 10^-6. | A minimum Sterility Assurance Level (SAL) of 1 x 10^-6 has been validated based on ISO 11137-1 and ISO 11137-2. |
| Abutments (Ethylene Oxide): Minimum Sterility Assurance Level (SAL) of 1 x 10^-6. | A minimum Sterility Assurance Level (SAL) of 1 x 10^-6 has been validated based on ISO 11135-1. |
| Endotoxin Testing (LAL): | |
| Meet pyrogen limit specifications (acceptance criteria for endotoxin levels). | Subject devices meet the acceptance criteria for endotoxin levels as well as the primary predicate and reference devices. |
| Shelf Life Validation: | |
| Packaging integrity maintained; established expiration date. | The shelf life for devices provided sterile is 5 years, except Helix Short Acqua Implants that have a shelf life of 4 years. The expiration date was determined considering product integrity and packaging tests. |
| Biocompatibility: | |
| No new issues compared to predicate/reference devices. | No new issues of biocompatibility are raised for the subject devices when compared to primary predicate and reference devices. Therefore, no additional biocompatibility testing was required. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the test sets in the mechanical, MR compatibility, or other in-vitro studies. It refers to "tested subject devices" or "representative samples."
- Data Provenance: The studies described (mechanical testing, MR compatibility, surface treatment, sterilization, endotoxin, shelf life, biocompatibility) are all benchtop/laboratory studies (in vitro). There is no mention of human subject data, animal data, or clinical retrospective/prospective data for these specific performance criteria. The manufacturer is JJGC Indústria e Comércio de Materiais Dentários S.A. (dba Neodent) based in Curitiba, Paraná, Brazil.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As these are benchtop/laboratory performance studies, "ground truth" is established by adherence to recognized standards (e.g., ISO 14801, ISO 11137, ISO 11135, ISO 10993) and scientific methods, not by expert consensus in the typical sense for clinical data.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for interpreting clinical images or patient outcomes, not for objective benchtop performance data against engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is an endosseous dental implant system, which is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims is based on:
- Adherence to International Standards: Performance measured against specifications outlined in standards like ISO 14801 (dynamic fatigue), ISO 11137 and ISO 11135 (sterilization), ISO 10993 series (biocompatibility).
- Benchtop Test Results: Direct measurements and observations from the mechanical, physical, chemical, and biological laboratory tests performed on the device.
- Comparison to Predicate Devices: Performance is frequently established by demonstrating equivalence or superiority to already legally marketed predicate devices, which serve as a benchmark.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device. The concepts of "training set" and "validation set" are primarily used for machine learning and AI, not for the regulatory approval of physical implants based on benchtop testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as point 8.
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The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage procedures, for single- or multiple-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Implant Narrow GM is indicated to replace upper lateral incisors, lower incisors or for retaining overdenture prostheses.
Prosthetic component to be installed in the Narrow GM Implant, providing support for prosthetic structures. Indicated for temporary restorations with unitary structures, screwed, on implants installa or mandible. Temporary Abutments Narrow GM have a maximum duration of usage of 180 days.
Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations as copings and crowns. It is indicated for cemented or screw mounted single-cemented applications on implants installed on the maxilla or mandible. All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
All the subject devices are intended for single use;
The subject implants are provided sterile via gamma irradiation and the subject abutments are provided sterile via Ethylene Oxide to an SAL of 1x10 -;
The subject implants are manufactured of Commercially Pure Titanium (Grade 4) and the subject abutments are manufactured of Titanium alloy Ti-6Al-4V ELI (ASTM F136),
The subject implants present a Grand Morse prosthetic interface with internal indexer; cylindrical shape with double threads; cervical diameter equal to the implant body diameter (2.9 mm)
The implants are provided in two different surfaces: Neoporos: Sand blasted and acid etched, and Acqua: Hydrophilic surface aggregated to the rough surface obtained by double treatment: abrasive blasting and acid subtraction.
The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device. Instead, it is a 510(k) summary for a "Neodent Implant System - GM Narrow Implant System," which is a dental implant system, not an AI/ML device.
The information provided pertains to demonstrating substantial equivalence of a new dental implant system to legally marketed predicate devices, focusing on:
- Indications for Use: Comparing the intended purposes of the new implant system and its components (implants, conventional abutments, temporary abutments, titanium bases) to existing predicate devices.
- Technological Characteristics: Comparing material, design (e.g., interface, shape, threads, gingival height), sterilization methods, and reusability.
- Performance Data: Mentioning biocompatibility testing (ISO 10993 standards), mechanical testing (Dynamic fatigue per ISO 14801), and sterilization validation (ISO 11137 for gamma irradiation, ISO 11135 for Ethylene Oxide).
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML device based on the provided text. The text is relevant for a traditional medical device (dental implant system) and its substantial equivalence determination.
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