Search Results
Found 5 results
510(k) Data Aggregation
(66 days)
ArgenZ MTZ zirconia can be used for the production of full-contour and substructure restorations up to and including a full arch.
All blanks are processed by dental laboratories or by dental professionals.
The ArgenZ MTZ (referring to multi-translucent, multi-layer) zirconia consist of yttria-stabilized pre-shaded 4 mole and 5 mole percent zirconia.
They are manufactured (pressed and sintered) into disc forms and offered multiple thicknesses and multiple shades. They contain oxides of Hafnium and Aluminum and minute amounts of coloring oxides of iron, erbium, cobalt and manganese.
The discs are single use, non-sterile devices and used for fabricating dental restorations, using CAD/CAM systems that can accommodate the disc sizes.
The provided document is a 510(k) Premarket Notification for a dental device, ArgenZ MTZ, which is a dental zirconia ceramic. It outlines the device's characteristics and compares it to a legally marketed predicate device to establish substantial equivalence.
This document describes the device itself and its physical and chemical properties, but does not describe a study involving a human expert in the loop (e.g., radiologist) or an AI algorithm for diagnostic purposes. Therefore, many of the requested items related to AI/human performance studies are not applicable to the information contained in this document.
However, I can extract information related to the acceptance criteria for the device's physical and chemical properties and how those properties were tested.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document provides a "Substantial Equivalence Comparison Table" that lists various physical and chemical properties and the device's performance against specified criteria, which effectively serve as acceptance criteria to demonstrate equivalence to the predicate device and compliance with ISO standards.
| Acceptance Criteria (Property) | Acceptance Standard / Predicate Performance | Reported Device Performance (ArgenZ MTZ) |
|---|---|---|
| Classification (per ISO 6872:2015) | Class 5 (Predicate) | Class 5 |
| Composition | Yttria-stabilized zirconia (5Y on top of 4Y - Predicate) | Based on yttria-stabilized zirconia, 5Y zirconia on top of 4Y zirconia |
| Color | Color (Predicate) | Color |
| Intended User | Professional dental technicians (Predicate) | Professional dental technicians |
| Single Use | Yes (Predicate) | Yes |
| Sterile | Non-sterile (Predicate) | Non-sterile |
| Physical Properties | Conform to ISO 6872:2015 (Predicate) | Conform to ISO 6872:2015 |
| Uniformity | Uniform (Predicate) | Uniform |
| Freedom from extraneous materials | Free from extraneous materials (Predicate) | Free from extraneous materials |
| Radioactivity | ≤ 1.0 Bq·g⁻¹ (Predicate) | ≤ 1.0 Bq·g⁻¹ |
| Flexural strength | ≥ 800 MPa (Predicate: Multilayer-3Dpro) | ≥ 800 MPa |
| Chemical solubility | < 100 µg/cm² (Predicate) | < 100 µg/cm² |
| Linear thermal expansion coefficient | (10.4±0.5)×10⁻⁶ K⁻¹ (Predicate: Multilayer-3D pro) | (9.9)×10⁻⁶ K⁻¹ |
| Biocompatibility | Conforms to ISO 7405:2018 (Predicate) | Conforms to ISO 10993-1 |
| Labeling | Complies with 21 CFR 801 (Predicate) | Complies with 21 CFR 801 |
2. Sample size used for the test set and the data provenance
The document states, "Bench testing, performed according to ISO 6872:2015 Dentistry – Ceramic materials, showed the ArgenZ MTZ meets the requirements specified in the standard."
While it specifies the standard used for testing, it does not provide the specific sample size (e.g., number of discs or samples tested for each property) nor the data provenance (e.g., country of origin, retrospective/prospective). The testing would have been conducted on a representative sample of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a material, and the "ground truth" for its performance is established through standardized physical and chemical bench testing, not expert interpretation of outputs like in AI/imaging studies.
4. Adjudication method for the test set
Not applicable. This is not a study involving human readers or AI algorithms 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. This document pertains to a dental material, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No algorithm is being evaluated.
7. The type of ground truth used
The ground truth for the device's performance is established by objective measurements and adherence to recognized international standards for dental ceramic materials, specifically ISO 6872:2015 (for ceramic materials) and ISO 10993-1 (for biocompatibility). This is akin to "bench test results" against specified industry standards.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set. The device is a manufactured dental material.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/machine learning device.
Ask a specific question about this device
(130 days)
The Argen Clear Aligner and Argen Clear Aligner Premium are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The aligner positions teeth by way of continuous gentle force.
The Argen clear aligners are comprised of series of clear plastic removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. A dental health professional (e.g. orthodontist or dentist) prescribes the Argen Clear Aligner or the Argen Clear Aligner Premium based on an assessment of the patient's teeth. The dental health professional (dentist/orthodontist) takes intraoral scans or physical impressions of the patient's teeth, determines a course of treatment with the system, and completes a prescription form using a standard dental software used for tooth alignment. The series of plastic trays are designed in accordance with the physician's prescription using standard dental software for planning the tooth alignment. The software system used is Ortho Analyzer, 2019 ver 1.8.1.0 by 3Shape A/S (K180941). It is used for management of 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, and design of orthodontic appliances based on 3D scanned orthodontic models. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Argen produces trays, which are formed of clear, thin, thermoformed plastic. The trays are provided to the dental health care professional who provides them to the patient, confirming fit and design. The thermoplastic materials used in the manufacture of the Argen aligners are similar to the materials commonly used in many dental and orthodontic appliances including clear aligners. The Argen Clear Aligner is made of a thermoplastic polyurethane resin and the Argen Clear Aligner Premium is made of a thermoplastic polyurethane-polyester composite resin.
The provided text describes the "Argen Clear Aligner" and "Argen Clear Aligner Premium" devices. These are orthodontic devices, and the information is from an FDA 510(k) summary, which focuses on substantial equivalence to predicate devices rather than detailed performance studies for AI/software components as would be described for diagnostic AI tools.
Therefore, many of the requested details, such as specific acceptance criteria related to diagnostic performance metrics, sample sizes for test sets (in the context of AI models), number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for AI performance, are not applicable for this type of medical device submission.
This document describes a physical medical device (clear aligners) and its manufacturing process, incorporating a software system (Ortho Analyzer) for treatment planning and design. The "performance data" referred to in Section VII of the 510(k) summary (page 3) relates to physical properties and biocompatibility testing, and verification and validation activities to ensure consistency between the aligner series' design and manufactured aligners. This is distinct from the performance evaluation of a diagnostic AI algorithm.
Here's a breakdown of the requested information based on the provided text, indicating where information is not applicable or not provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) because it's not a diagnostic AI device. The "acceptance criteria" mentioned refer to the manufacturing and design consistency of the physical aligners.
| Acceptance Criteria (General) | Reported Device Performance (Summary) |
|---|---|
| Material Properties: | Thermoplastic polyurethane resin (Argen Clear Aligner) and thermoplastic polyurethane-polyester composite resin (Argen Clear Aligner Premium) are similar to materials commonly used in many dental and orthodontic appliances, including clear aligners. Biocompatibility shown to meet requirements (referenced from predicate device submissions). |
| Manufacturing Consistency: | Verification and validation activities were assessed on the proposed device to ensure consistency between the aligner series' design and manufactured aligners. The results show the proposed device met all pre-defined acceptance criteria (specific criteria are not detailed in this summary, but would typically relate to dimensional accuracy, fit, and material integrity as per design specifications). |
| Intended Use: | The device performs its intended use of treating tooth malocclusion in patients with permanent dentition by positioning teeth via continuous gentle force. This is affirmed through a substantial equivalence determination to predicates with established safe and effective use. The software system, Ortho Analyzer, is used for management of 3D scanned orthodontic models, orthodontic diagnosis by measuring/analyzing/inspecting/visualizing 3D scanned models, virtual planning of orthodontic treatments by simulating tooth movements, and design of orthodontic appliances. The prescribing physician reviews and approves the model scheme before production. |
| Safety: | A Risk Analysis was performed according to ISO 14971:2012, assessing the modification (material change) and its impact on performance and safety. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the device is a physical orthodontic aligner, and its 510(k) submission primarily relies on substantial equivalence and engineering/biological verification and validation, not a clinical study involving a "test set" of patient data for AI performance evaluation. The "software" mentioned (Ortho Analyzer) is a tool for design and planning, not a diagnostic AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable for the reasons stated above.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated above.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable for the reasons stated above.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. While there is software involved in the design and planning of the aligners (Ortho Analyzer), it is not described as a standalone diagnostic AI algorithm. The process explicitly involves a "dental health professional (dentist/orthodontist)" who "determines a course of treatment" and a "prescribing physician reviews and approves the model scheme." This indicates a human-in-the-loop design and prescription process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable in the context of diagnostic AI performance. For the aligners, the "ground truth" would relate to successful orthodontic treatment outcomes, which are assessed clinically by the treating dentist/orthodontist over time, not through a single reference standard for an AI algorithm.
8. The sample size for the training set
This information is not applicable. The device itself is a physical product. While the "Ortho Analyzer" software likely has an underlying model or algorithm for generating treatment plans, the document does not provide details of its training set, as this is not an AI diagnostic submission.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
Ask a specific question about this device
(199 days)
The Argen Clear Aligner is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The aligner positions teeth by way of continuous gentle force.
The Argen Clear Aligner is comprised of a series of clear plastic removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. A dental health professional (e.g. orthodontist or dentist) prescribes the Argen Clear Aligner based on an assessment of the patient's teeth, determines a course of treatment with the system, and completes a prescription form using a standard dental software used for tooth alignment. The series of plastic trays are designed in accordance with the physician's prescription using standard dental software for planning the tooth alignment. The software system used is Ortho Analyzer, 2019 ver 1.8.1.0 by 3Shape A/S (K180941). It is used for management of 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, and design of orthodontic appliances based on 3D scanned orthodontic models. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Argen produces trays, which are formed of clear, thin, thermoformed plastic. The trays are provided to the dental health care professional who provides them to the patient, confirming fit and design. The thermoplastic material used in the manufacture of the Argen aligners is similar to the material commonly used in many dental and orthodontic appliances including clear aligners.
This document is a 510(k) Premarket Notification for the Argen Clear Aligner. It primarily demonstrates substantial equivalence to a predicate device, rather than presenting a standalone study with specific acceptance criteria and performance metrics for the Argen Clear Aligner itself. As such, no specific acceptance criteria or a dedicated study proving the device meets those criteria are directly provided for the Argen Clear Aligner's efficacy in tooth alignment.
Instead, the submission relies on the established safety and efficacy of its predicate device and the similarity of its design and materials.
Here's an analysis of what is and isn't available based on your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria for the Argen Clear Aligner: Not explicitly stated as performance metrics for tooth alignment. The submission focuses on demonstrating substantial equivalence to a predicate device (The Align System, K981095). Therefore, the "acceptance criteria" are implicitly that the Argen Clear Aligner is as safe and effective as the predicate.
- Reported Device Performance of Argen Clear Aligner: No specific performance metrics (e.g., accuracy of tooth movement, treatment success rates) are reported for the Argen Clear Aligner. The document states that "Animal and human performance testing are not required for this product type," indicating clinical efficacy trials were not performed for this 510(k) submission.
The comparison table (Page 5) highlights similarities between the Argen Clear Aligner and the predicate device, which serves as the basis for substantial equivalence:
| Feature/Criterion | Argen Clear Aligner | The Align System (Predicate) | Result/Similarity |
|---|---|---|---|
| Intended Use | Similar | Similar | Met |
| Mode of Action | Similar | Similar | Met |
| Method of Use | Similar | Similar | Met |
| Polymer Materials | Similar | Similar | Met |
| Mechanical Testing | Referenced Dentsply: K062828 | Referenced Dentsply: K062828 | Assumed Met |
| Biocompatibility | Yes | Yes | Met |
| OTC or Rx | Rx | Rx | Met |
| Software Use | Yes | Yes | Met |
| Sterile | No | No | Met |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. No dedicated performance study with a test set was conducted for the Argen Clear Aligner for its 510(k) submission. The submission relies on non-clinical performance and biocompatibility testing referencing another device (Dentsply's K062828), which is not detailed here.
- Data Provenance: Not applicable for a performance study of the Argen Clear Aligner. The data presented is for the predicate device comparison and general device description.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth establishment by experts for a test set is described for the Argen Clear Aligner's 510(k) submission.
4. Adjudication method for the test set
- Not applicable. As no test set performance study was conducted, no adjudication method is mentioned.
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. This device is a physical medical device (clear aligners), not an AI-assisted diagnostic or therapeutic tool. Therefore, a multi-reader multi-case comparative effectiveness study with AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a physical medical device. While software is used in its design (Ortho Analyzer by 3Shape A/S), the submission does not detail a standalone algorithm performance study for tooth movement prediction or clear aligner design, as this is typically handled by the software manufacturer's own submissions. The Argen Clear Aligner is the manufactured product based on the software's output.
7. The type of ground truth used
- Not applicable for a performance study of the Argen Clear Aligner. The "ground truth" implicitly referenced across the entire 510(k) process for substantial equivalence is the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that would require a training set in the context of its 510(k) submission. The "designs" of the aligners are based on physician prescriptions and standard dental software, not a learned model from a training set in the way AI algorithms are trained.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
In summary, the provided document is a 510(k) premarket notification primarily demonstrating substantial equivalence due to physical and functional similarities to an existing predicate device. It does not contain a study of the Argen Clear Aligner's clinical performance against specific acceptance criteria, nor does it detail AI algorithm performance metrics.
Ask a specific question about this device
(280 days)
ArgenIS Titanium Abutments are intended to be single use available by prescription only in the construction of dental restorations supported by the endosseous dental implant. The Argents Titanium Abutments are designed to specifically fit an individual patient's needs of the final restoration. All digitally designed abutments files are intended to be sent to Argen manufacturer for milling.
The ArgenIS Titanium Abutments are compatible with the following implant systems:
| Implant Brand Name | Platform | Manufacturer | Implant Trade Name | ImplantLine/Connection | Implant Diameter |
|---|---|---|---|---|---|
| Hiossen ET III SA | 3.5mm | Hiossen | Hiossen Implant System | Internal Hex | 3.75, 3.77mm |
| Hiossen ET III SA | 4.0/4.5/5.0mm | Hiossen | Hiossen Implant System | Internal Hex | 4.25, 4.65, 4.63,4.6, 5.1, 5.08,5.05mm |
| Nobel Active WidePlatform (WP) | 5.5mm | Nobel Biocare AB | Nobel Active WidePlatform (WP) | Internal Hex | 5.5mm |
The ArgenIS Titanium Abutments are designed specifically for an individual patient and then milled from a titanium blank with a pre-milled interface correlating to a specific implant system. The titanium abutment may be designed with a maximum angulation of 30°. The abutment is then fixed with the use of a lab screw to a model containing the implant analog for final construction of the related prosthetic restoration. The ArgenIS Titanium Abutments are then intended to be fixed in the mouth with the prosthetic final screw. The ArgenIS Titanium Abutments are supplied with two package configurations. One includes two final screws and the abutment and another includes one final screw and one lab screw and the abutment. The final screw is used for fixing abutment to the endosseous implant body, and the lab screw is used for laboratory use during construction of related restoration to avoid any damage to the final prosthetic screw. The final prosthetic screw will be marked "final Screw". The final screw must be torqued on the endosseous implant body with the specific torque setting provided. The device is finalized at the Argen facility and provided to the dental laboratory in a final patient specific form. There are no accessories associated with the subject devices.
Minimum and Maximum Gingival Height is 0.5mm - 6mm Minimum diameter at abutment/implant interface is 3.5mm to interface base Maximum length of abutment from abutment/implant interface is 12.5mm Minimum length of abutment post (length above abutment collar/gingival height) is 4.0mm Minimum wall thickness at abutment/implant interface is 0.65mm Maximal angle in relationship to the long axis of implant is 30°
All digitally designed abutment files are intended to be sent to Argen manufacturer for milling. Argen is a registered contract manufacturer with a quality system under FDA QSR regulation.
The document primarily focuses on establishing "substantial equivalence" of the ArgenIS Titanium Abutments to legally marketed predicate devices, rather than defining specific acceptance criteria for a new device and proving its performance against those criteria in a typical clinical study.
However, based on the non-clinical performance testing summarized in section 14 and the comparison table in section 13, we can infer some "acceptance criteria" related to the device's physical and mechanical properties, and how it was evaluated.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Strength/Fatigue Life: The device must withstand fatigue forces representative of oral use. | "Fatigue testing was performed on worst case scenario samples in accordance with the Class II Special Controls Guidance Document and ISO 14801. Performance testing demonstrated conformance to design input and indications for use." |
| Dimensional Accuracy/Compatibility: The abutments must accurately fit specified implant systems. | "Non-Clinical testing consisted of reverse engineering of the OEM implant body, abutment and abutment screw and tolerance analysis of platforms to ensure implant/abutment compatibility, dimensional verification and implant/abutment connection checks." |
| Sterility Assurance Level (SAL): The sterilization process must achieve an SAL of 10^-6. | "Moist Heat sterilization validation testing was performed in accordance with ANSI/AAMI/ISO 17665-1: 2006 and ISO ANSI/AAMI/ISO 17665-2: 2009. Test results demonstrate a sterility assurance level of 10-6." |
| Biocompatibility: The materials must be biocompatible. | "The Argen IS Titanium Abutments have the same sterilization process and biocompatibility as previously cleared Argen and Sterngold devices. Therefore sterility and bio-compatibility testing performed on cleared Argen devices is applicable to the proposed devices." |
2. Sample sized 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: The document does not specify exact sample sizes for the fatigue or dimensional testing. It mentions "worst case scenario samples" for fatigue testing.
- Data Provenance: The data is from non-clinical testing (laboratory testing) and not a clinical study involving human subjects. Therefore, "country of origin of data" or "retrospective/prospective" are not applicable in the typical sense of a human clinical trial. This is manufacturer-led testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable. The evaluations described are technical and engineering-based (fatigue, dimensional analysis, sterilization validation), not subjective assessments requiring expert interpretation of clinical data or images to establish a "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable as the testing involves objective measurements against engineering standards and material properties, not subjective assessments 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
- No MRMC or human-in-the-loop study was conducted. This device is a dental implant abutment, a physical component, and does not involve AI or human "readers" in the context of interpretation of data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone (algorithm only) performance study was done as this is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical testing was based on engineering standards and specifications (e.g., ISO 14801 for fatigue testing, ANSI/AAMI/ISO 17665-1/2 for sterilization), and the design input/specifications for the abutment and its compatibility with implant systems. For biocompatibility, it relied on the "ground truth" established for previously cleared Argen and Sterngold devices with similar materials.
8. The sample size for the training set
- This question is not applicable. There is no software algorithm or AI model being "trained" for this physical device.
9. How the ground truth for the training set was established
- This question is not applicable as there is no training set for this physical device.
Ask a specific question about this device
(186 days)
ArgenIS Titanium Abutments are intended to be single use available by prescription only in the construction of dental restorations supported by the endosseous dental implant. The ArgenIs Titanium Abutments are designed to specifically fit an individual patient's needs of the final restoration. All digitally designed abutments files are intended to be sent to Argen manufacturer for milling. The ArgenIS Titanium Abutments are compatible with the following implant systems:
| IMPLANT BRANDNAME | PLATFORM | Manufacturer | Implant TradeName | ImplantLine/Connection | ImplantDiameter |
|---|---|---|---|---|---|
| Nobel Biocare ReplaceSelect | 6.0mm | Nobel Biocare USA | Nobel ReplaceTaperedConicalConnection | Nobel ReplaceInternal ConicalConnection WP | 6.0mm |
| Nobel Biocare Active | 3.5mm | Nobel Biocare AB | NobelActiveInternalConnectionImplant | Nobel ActiveInternal Conn.RP and NP | 3.0, 3.5, 4.3,5.0mm |
| Nobel Biocare Active | 4.3/5.0mm | Nobel Biocare AB | NobelActiveInternalConnectionImplant | Nobel ActiveInternal Conn.RP and NP | 3.0, 3.5, 4.3,5.0mm |
| Straumann Bone Level | 3.3mm | Straumann USA | StraumannBone LevelTaperedImplants | Bone LevelInternal Conn.NC | 3.3mm |
| Straumann Bone Level | 4.1/4.8mm | Straumann USA | StraumannBone LevelTaperedImplants | Bone LevelInternal Conn.RC | 4.1, 4.8mm |
| Straumann Synocta | 4.8mm | Institut StraumannAG | StraumannDental Implant | Synocta ImplantInternal Conn.4.8mm RN (Reg.Neck) | 4.8, 6.5mm |
| Straumann Synocta | 6.5mm | Institut StraumannAG | StraumannDental Implant | Synocta ImplantInternal Conn.6.5mm (WideNeck) | 4.8, 6.5mm |
| Astra Tech OsseoSpeed | 3.5/4.0mm | Astra Tech AB | AstraTechImplantOsseoSpeed | OsseoSpeedInternal ConicalConnection RP | 3.6, 4.2, 4.8mm |
| Astra Tech OsseoSpeed | 4.5/5.0mm | Astra Tech AB | AstraTechImplantOsseoSpeedPlus | OsseoSpeed PlusInternal ConicalConnection RP | 3.0, 3.5, 4.0, 4.5,5.0mm |
Argen IS Titanium Abutments are designed specifically for an Individual patient and then milled from a Titanium blank with a pre-milled interface correlating to a specific implant system. This abutment can be fixed in the laboratory model work containing the implant analog for final construction of the related prosthetic restoration. The Argen IS Titanium Abutments are then intended to be fixed in the mouth with the included prosthetic screw. The Argen IS Titanium Abutments are supplied with 2 screws (1) A Final Screw for fixing to the endosseuos Implant. (2) A lab screw for Laboratory use during construction of related restoration to avoid any damage to the final prosthetic screw will be marked "final Screw". The final screw must be torqued on the endosseuos Implant with the specific torque setting provided. The device is finalized at the Argen facility and provided to the dental laboratory in a final patient specific form.
Minimum and Maximum Gingival Height is 0-6mm
Minimum diameter at abutment/implant interface is 3.5mm to interface base
Maximum length of abutment from abutment/implant interface is 12.5mm
Minimum length of abutment post (length above the abutment collar/gingival height) is 4.0mm.
Minimum wall thickness at abutment/implant interface is 0.65mm
Maximal angle in relationship to the long axis of implant is 30°
The available range of diameters and connection type is summarized on the table below:
This document describes a 510(k) premarket notification for the "ArgenIS Titanium Abutments" by Argen Corporation. This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a clinical study or performance goals with clinical outcomes. Therefore, much of the requested information (like expert ground truth, adjudication methods, MRMC studies, training set details, or effect size of human readers with AI assistance) is not applicable to this type of device and submission.
Here's an analysis of the provided text in relation to your request, highlighting what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of a clinical trial or performance study with numerical targets and achieved results. Instead, it demonstrates substantial equivalence by comparing the device's technical characteristics and performance to predicate devices. The "performance" in this context refers to bench testing to ensure functional compatibility and mechanical integrity, not clinical outcomes.
| Feature | Acceptance Criteria (Implied / Predicate Comparison) | Reported Device Performance |
|---|---|---|
| Material | Predicate devices use Titanium-6AL-4 Vanadium ELI Alloy or CP Titanium. | ArgenIS Titanium Abutments use Titanium-6AL-4 Vanadium ELI Alloy. (Consistent with predicate K143051 and functionally equivalent to CP Titanium for this application). |
| Intended Use | Similar to predicate devices: construction of dental restorations supported by endosseous dental implants, single use, prescription only, designed to fit individual patient needs. | ArgenIS Titanium Abutments share the same intended use: single-use, prescription-only for dental restorations supported by endosseous dental implants, designed for individual patient needs. "Minor changes in descriptive terms used in the indications for use do not change the intended use of the proposed device." |
| Prosthetic Connection | Compatibility with specific implant systems (Nobel Biocare, Straumann, Astra Tech) as listed for predicate devices and the new device. | ArgenIS Titanium Abutments are compatible with a range of Nobel Biocare, Straumann, and Astra Tech implant systems, similar to the scope covered by the various predicate devices. |
| Implant Diameters/Lengths | Within the range of existing predicate devices. | ArgenIS supports diameters 3.3mm, 3.5mm, 4.0mm, 4.1mm, 4.3mm, 4.5mm, 4.8mm, 6.0mm, 6.5mm, which are covered by the collective range of the predicate devices. |
| Type of Retention | Screw-retained to the implant; prosthesis cement-retained to the abutment, consistent with predicate devices. | ArgenIS Titanium Abutments are screw-retained to the implant, with the prosthesis cement-retained to the abutment. (Identical to all predicates shown). |
| Manufacturing Process | Machining, consistent with predicate devices. | ArgenIS Titanium Abutments are manufactured via machining. (Identical to all predicates shown). |
| Abutment Sterilization | Moist Heat (Steam), consistent with predicate devices. | ArgenIS Titanium Abutments use Moist Heat (Steam) for sterilization. (Identical to all predicates shown). |
| Abutment Angulation | Within the range of predicate devices (0°-30°). | ArgenIS Titanium Abutments have an angulation range of 0° - 30°. (Consistent with primary predicate K143051, and overlaps with/encompasses other predicates' ranges). |
| Dimensional Compatibility | Demonstrated through tolerance analysis and functional fit checks. | "Testing included tolerance analysis to ensure abutment/implant interface compatibility. Functional fit checks of abutment blank to compatible implant and prosthetic screw. Testing showed correct functionality of the device as per its intended use, including dimensional compatibility, and mechanical performance." |
| Mechanical Performance (Fatigue) | Conformance to ISO 14801 for worst-case scenarios (smallest diameter, shortest length from each platform). This implicitly means meeting at least the performance levels of predicate devices that would also conform to ISO 14801. | "Fatigue testing was conducted on worst case scenario samples. Worst case scenario was defined as the smallest diameter and shortest length from each platform. The worst case scenarios from each of the proposed platforms were tested per ISO 14801." (The document asserts conformance to performance specifications, implying successful completion of these tests in line with relevant standards and predicate performance). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions "worst case scenario samples" for fatigue testing but does not specify the exact number of samples. This is typical for bench testing where the focus is often on specific critical configurations rather than a large statistical sample of all possible configurations.
- Data Provenance: This was "Non-clinical test data" from "Bench testing." As such, there is no country of origin for patients or retrospective/prospective classification. It's laboratory data.
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 device is an implant abutment, and the testing involved engineering/mechanical validation (bench testing), not clinical diagnosis or interpretation requiring expert human judgment for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no human expert adjudication of test results in the clinical sense. Performance was determined by objective measurements during bench testing against engineering specifications and 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 a dental implant abutment, not an AI 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 medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on engineering specifications, material properties, and relevant international standards (e.g., ISO 14801). For compatibility and fit, it's about precise dimensional measurements and physical mating tests against the actual or specified dimensions of compatible implant systems.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
Ask a specific question about this device
Page 1 of 1