(162 days)
Not Found
No
The summary describes software for importing medical images, creating 3D representations, and planning implant placement. It mentions "expert clinical judgment" and "knowledge of the locations and orientations of the implants prior to surgery," but there is no mention of AI, ML, or any related terms or concepts that would indicate the use of such technology for tasks like image analysis, automated planning, or prediction. The performance studies focus on software validation, bench testing, and clinical evaluation of the system's usability and effectiveness, not on the performance of an AI/ML model.
No.
The SimPlant Immediate Smile System is a treatment planning and guidance system for dental implant placement, and serves as a tool enabling the restoration of masticatory function. It does not directly provide therapy.
No
The device is intended for treatment planning and placement of dental implants to restore masticatory function, rather than for diagnosing a condition or disease. While it imports medical imaging information from diagnostic tools (CT/MRI) and uses it in conjunction with other diagnostic tools and expert clinical judgment for assessment, its primary function is planning and guiding treatment, not diagnosis itself.
No
The device description explicitly states that the system includes "patient specific SurgiGuide guides" which are physical tools produced from the software planning. This indicates the system is not solely software.
Based on the provided information, the SimPlant Immediate Smile System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- SimPlant's Function: The SimPlant Immediate Smile System is used for treatment planning and placement of dental implants. It utilizes medical imaging data (CT/MRI) to create a 3D model of the patient's jaw and plan the surgical procedure. It also facilitates the creation of surgical guides and a provisional prosthesis.
- No Specimen Analysis: The system does not analyze any biological specimens from the patient. Its function is based on processing and visualizing medical imaging data and facilitating a surgical procedure.
Therefore, the SimPlant Immediate Smile System falls under the category of a surgical planning and guidance system, not an IVD.
N/A
Intended Use / Indications for Use
The SimPlant Immediate Smile System is intended for use in treatment planning and placement of dental implants, in order to restore masticatory function.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, DZE, EBG
Device Description
The SimPlant Immediate Smile System is intended for use in treatment planning and placement of dental implants, in order to restore masticatory function. The SimPlant Immediate Smile System enables a predictable dental implant restoration procedure according to case planning done by the clinician.
The SimPlant Immediate Smile System enables a provisional prosthesis to be produced prior to and attached in the same session as implant installation.
The SimPlant Immediate Smile System includes SimPlant software that provides a method of importing medical imaging information from radiological imaging systems such as a Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) to a computer file that is usable in conjunction with other diagnostic tools and expert clinical judgment. Visual representations of the imaged anatomical structures (e.g. the jaw) are derived, allowing for a three-dimensional assessment of the patient without patient contact. SimPlant enables the clinician to plan the dental implant positions including orientations pre-operatively in a virtual, 3D environment. The case planning can be used to produce patient specific SurgiGuide guides, thus transferring the virtual case planning into physical tools enabling the intra-operative preparation of the implant sites for the installation of implants in accordance to the virtual case planning.
The SimPlant Immediate Smile System is based upon knowledge of the locations and orientations of the implants prior to surgery. This knowledge enables the production of a SurgiGuide surgical guide. Aided by the SurgiGuide surgical guide, the implant sites can be prepared and the dental implants placed in the predetermined locations, enabling the immediate installation of the custom-made prefabricated provisional Immediate Smile bridge.
Mentions image processing
Common/Usual Name: System, Image processing. The product uses images acquired from Computerized Tomography (CT) scanners
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computer Tomography (CT) or Magnetic Resonance Imaging (MRI)
Anatomical Site
jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The software is thoroughly tested in accordance with documented test plans and in accordance to internal software development and testing procedures. This test plan is derived from the specifications and ensures that all controls and features are functioning properly. The software is validated together with end-users. The subsequent testing to validate the mitigations was documented in software test reports.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Validation in addition to bench top performance testing was conducted to ensure the compatibility of all system components.
The SimPlant® Immediate Smile System was evaluated in a clinical setting by 11 doctors from different countries. The System was evaluated with 20 patients. 6 different implant brands were used during the evaluation. Case follow-up was done after 12 weeks. Clinical feedback was gathered for all cases relative to the usability, aesthetic result and adequacy of the material properties of the system components. Predefined acceptance thresholds were met for all criteria indicative for the system safety and effectiveness. The immediate smile bridge component of the System can be used as a temporary restoration for immediate loading up to 12 weeks. The results of the clinical validation confirmed safety and effectiveness of the System.
Several Engineering tests and evaluations were undertaken to demonstrate the conformity of the system:
The minimal dimension of the cylindrical connections of the immediate smile bridge where determined based on the maximal load that should be withstood without risk of fracture of the bridge.
In order to evaluation the potential micro-movement of the implants upon loading of the immediate smile bridge component a predictive (mass-spring/ finite element) model was used. Micro-movement is a risk factor for implant failure. With bite load (point load) of 400 N on bridges without distal extension, predicted movements were shown to be acceptable.
Evaluation of cement bonding was conducted via pull-out testing of cylindrical abutments fixed by means of the standard composite into a cylindrical hole corresponding in dimensions with the cylinders incorporated in the design of the provisional restoration. With a average maximal tensile force of 232N and a minimal measured tensile force of 190 N, the threshold of 150 N was exceeded.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
510(k) Premarket Notification -SimPlant® Immedia
510(k) Summary
MAY 3 0 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance
with the requirements of 21 CFR § 892.2050.
| Submitter: | Materialise Dental NV
Technologielaan 15
Leuven
Belgium |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Reg. Number: | 3006638827 |
| Contact: | Carl Van Lierde
QARA Management Representative
Materialise Dental NV
Technologielaan 15
Leuven
Belgium
Tel. +32 16 39 6620
Fax. +32 16 39 66 22
Email: Carl.VanLierde@materialise.be |
| Date Prepared: | November 29, 2011 |
| Trade/
Proprietary
Name: | SimPlant Immediate Smile System |
| Common/Usual
Name: | System, Image processing. The product uses images acquired from Computerized
Tomography (CT) scanners |
| Classification
Name/ FDA
Reviewing
Branch: | Picture Archiving and Communication system |
| Device
Classification/
Code: | Class II - 21 CFR §892.2050 LLZ |
| Predicate Device
Manufacturer: | SimPlant® 2011; (K110300)
Nobel Biocare Guided Surgery Concept; (K050393)
Ivoclar Vivadent - Telio CAD (K093708) |
| Purpose of the
510(k) notice: | The reason for this 510k submission is to request clearance for a device that has been
referred to herein as SimPlant Immediate Smile System (Image processing system)
referenced under 21 CFR §892.2050 and considered a Class II device. |
| Device
Description: | The SimPlant Immediate Smile System is intended for use in treatment planning and
placement of dental implants, in order to restore masticatory function. The SimPlant
Immediate Smile System enables a predictable dental implant restoration procedure
according to case planning done by the clinician.
The SimPlant Immediate Smile System enables a provisional prosthesis to be
produced prior to and attached in the same session as implant installation.
The SimPlant Immediate Smile System includes SimPlant software that provides a
method of importing medical imaging information from radiological imaging systems
such as a Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) to a
computer file that is usable in conjunction with other diagnostic tools and expert
clinical judgment. Visual representations of the imaged anatomical structures (e.g. the
jaw) are derived, allowing for a three-dimensional assessment of the patient without
patient contact. SimPlant enables the clinician to plan the dental implant positions
including orientations pre-operatively in a virtual, 3D environment. The case planning
can be used to produce patient specific SurgiGuide guides, thus transferring the virtual
case planning into physical tools enabling the intra-operative preparation of the implant
sites for the installation of implants in accordance to the virtual case planning.
The SimPlant Immediate Smile System is based upon knowledge of the locations and
orientations of the implants prior to surgery. This knowledge enables the production of
a SurgiGuide surgical guide. Aided by the SurgiGuide surgical guide, the implant sites
can be prepared and the dental implants placed in the predetermined locations, enabling
the immediate installation of the custom-made prefabricated provisional Immediate
Smile bridge. |
| Indications for
Use: | The SimPlant Immediate Smile System is intended for use in treatment planning and
placement of dental implants, in order to restore masticatory function. |
| Technological
Characteristics : | The predicate devices, SimPlant® 2011, Nobel Biocare Guided Surgery Concept and
Ivoclar - Telio CAD have a number of very similar and equivalent design
/technological characteristics, which are very similar and equivalent with the SimPlant
Immediate Smile System (see Substantial Equivalence comparison table in Section 14). |
| Performance.
Data: | Software Validation in addition to bench top performance testing was conducted to
ensure the compatibility of all system components. |
| Clinical Data: | The SimPlant® Immediate Smile System was evaluated in a clinical setting by 11
doctors from different countries. The System was evaluated with 20 patients. 6
different implant brands were used during the evaluation. Case follow-up was done
after 12 weeks.
Clinical feedback was gathered for all cases relative to the usability, aesthetic result
and adequacy of the material properties of the system components. Predefined
acceptance thresholds were met for all criteria indicative for the system safety and
effectiveness. The immediate smile bridge component of the System can be used as a
temporary restoration for immediate loading up to 12 weeks.
The results of the clinical validation confirmed safety and effectiveness of the System. |
| Non clinical
testing | Several Engineering tests and evaluations were undertaken to demonstrate the
conformity of the system:
The software is thoroughly tested in accordance with documented test plans and in accordance to internal software development and testing procedures. This test plan is derived from the specifications and ensures that all controls and features are functioning properly. The software is validated together with end-users. The subsequent testing to validate the mitigations was documented in software test reports. The minimal dimension of the cylindrical connections of the immediate smile bridge where determined based on the maximal load that should be withstood without risk of fracture of the bridge. In order to evaluation the potential micro-movement of the implants upon loading of the immediate smile bridge component a predictive (mass-spring/ finite element) model was used. Micro-movement is a risk factor for implant failure. With bite load (point load) of 400 N on bridges without distal extension, predicted movements were shown to be acceptable. Evaluation of cement bonding was conducted via pull-out testing of cylindrical abutments fixed by means of the standard composite into a cylindrical hole corresponding in dimensions with the cylinders incorporated in the design of the provisional restoration. With a average maximal tensile force of 232N and a minimal measured tensile force of 190 N, the threshold of 150 N was exceeded. |
16 .
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510(k) Premarket Notification -SimPlant® Immediate Smile System
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510(k) Premarket Notification -SimPlant® Immediate Smile System
| Based on the performance data the SimPlant Immediate Smile System was
demonstrated to be safe and effective, testing all pre-set criteria on component and
| System levels. | |||
|---|---|---|---|
| Performance | |||
| Standards: | DICOM NEMA PS 3.1-3.18: Digital imaging and communication in medicine: 2009 | ||
| ISO14971: Applications of risk management to medical devices: 2007 | |||
| ISO 13485: Medical devices Quality Management System: 2003 | |||
| ISO10993: Biological evaluations of medical devices: 1992 | |||
| Technological | |||
| Characteristics: | Materialise Dental NV's SimPlant Immediate Smile System included in this | ||
| submission uses the same fundamental scientific technology as the previously cleared | |||
| SimPlant® 2011; (K110300). | |||
| Device for premarket notification | K110300 | ||
| Material | Trade name | SimPlant® Immediate Smile System | SimPlant® 2011 |
| Software - Magnetic media | |||
| Hardware - | |||
| acrylic guides - biocompatible material stainless steel tubes/sleeves - medical grade PMMA provisional bridges - biocompatible | Software - Magnetic media |
4
$$\mathbf{\hat{r}} \mathbf{\hat{r}} \mathbf{\hat{r}} \mathbf{\hat{u}}$$
f
510(k) Premarket Notification -SimPlant® Immediate Sm
| Design | Software for use in pre-operative planning.
The SimPlant Immediate Smile System includes
SimPlant ® software, which provides a means for
the clinician for image segmentation and advanced
pre-operative planning. This enables the clinician to
view three-dimensional CT-scan data as well as to
plan the case in a virtual three-dimensional
environment.
This case planning can be used to produce a
Surgical Template, thus transferring the virtual case
planning into physical tools enabling the surgical
installation according to the virtual case planning.
The SimPlant Immediate Smile System is based
upon knowledge of the location and orientation of
the implant(s) prior to the surgery. This knowledge
enables the production of a SurgiGuide.
Aided by the SurgiGuide, the sites can be prepared
and the implants placed in the predetermined
locations enabling the immediate attachment of the
prefabricated temporary prosthesis, i.e. the
Immediate Smile bridge structure or final
prosthesis. | Software for use in pre-operative
planning.
SimPlant ® software provides a
means for image segmentation
and advanced pre-operative
planning. Surgical templates may
be fabricated based on the output
of the pre-operative planning. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| Function | The SimPlant® software component is used to
incorporate the images from either an MRI or CT
scan of the affected joint into the specialized
planning software.
The SimPlant® software is used by a qualified
surgeon to plan, inspect, fine-tune and approve the
pre-surgical plan. The software is used pre-
operatively.
SimPlant® software contains a library of dental
implants, and additional instruments for the
placement of implants.
A SurgiGuide® guide and/or Immediate Smile
Provisional bridge structures may be designed and
fabricated based on the output of the pre-operative
planning.
SurgiGuide® guides are patient specific templates
that are intended to transfer the pre-operatively
determined positioning of the dental implants to
the patient intra-operatively, assisting the surgeon
in placing dental implants by guiding and marking
drill locations.
The Immediate Smile bridge structure is a patient
specific temporary restoration, for partially or fully
edentulous cases either in lower or upper jaw, to be
used immediately after implant placement and this
for a short term, i.e. maximally 16 weeks. | SimPlant® software is used to
incorporate the images from either
an MRI or CT scan of the affected
joint into the specialized planning
software.
The SimPlant® software is used by
a qualified surgeon to plan,
inspect, fine-tune and approve the
pre-surgical plan. The software is
used pre-operatively.
SimPlant® software contains a
library of dental implants, and
additional instruments for the
placement of implants.
A SurgiGuide® guide may be
designed and fabricated based on
the output of the pre-operative
planning. |
| Programming
language | C++ | C++ |
| Operating
system | Windows | Windows |
.
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510(k) Premarket Notification --SimPlant* Immediate Smile System
| Device for premarket notification | K093708 | ||
|---|---|---|---|
| SimPlant® Immediate Smile Bridge resin | Ivoclar - Telio CAD | ||
| Trade | |||
| name | |||
| Material | |||
| Chemical | |||
| Characteri- | |||
| sitics | 100 % PMMA (Polymethylmethacrylat) | 99.5 % Polymethylmethacrylate | |
| (CAS-No. 9011-14-7), Pigments | |||
| Mechanical | |||
| Characterisitics | Flexural strength 97 MPaHardness | ||
| 145 MPa Water absorption | |||
| 1,1 µg/mm³ | Flexural strength 130 MPa | ||
| Hardness 180 MPa | |||
| Water absorption |