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510(k) Data Aggregation
(27 days)
Implantswiss Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implantswiss Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implants.
Implantswiss Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa and Multi-Unit Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture. All digitally designed Premill abutments for use with the Implantswiss Dental Abutment System are intended to be sent to a Novodent validated milling center for manufacture.
The Implantswiss Dental Implantswiss Dental Abutment Systems are compatible titanium/titanium alloy dental implants and abutments. This submission provides additional models to the existing family of implants and abutments.
The Implantswiss Dental Implants are provided as bone level type implants and their surface is modified by a Sandblasted Rough Acid-etched (SRA) process. The additional devices added in this submission are all bone level implants, manufactured of pure titanium. The subject implant bodies have the same surface modification as the existing/cleared devices.
The Implantswiss Bone Level Implants have diameters of 3.3 mm, 4.3 mm 4.8 mm, and 5.5mm with lengths of 8 mm. 10 mm. 12 mm. Additional implant models are 3.3 mm diameter implants with straight design and 3.7 mm diameter implants with hybrid design (tapered apex).
The Implantswiss Dental Abutment System is used in combination with Implantswiss dental implants to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. The Implantswiss Dental Abutment System consists of provisional (temporary) and final type abutments, abutment screws, and the Healing Cap, a protective cover. The dental abutment provides the link between the dental implant and the prosthetic restoration that restores the chewing function.
The Implantswiss Dental Abutment System consists of Healing, Solid, Couple, Angled, Multi, O-ring, Multi-Unit. Premill, and Locator abutments with diameters 0 5.5 mm. 0 6.5 mm. 0 6.5 mm have lengths of 8.9 mm, 9.9 mm, 11.9 mm, 12.9 mm and 10.4 mm, 11.4 mm, 12.4 mm, 13.4 mm, 14.4 mm. Non-hex Couple abutments with diameters Ø 5.5 mm, Ø 6.5 mm have lengths of 8.7 mm, 9.7 mm, 10.7 mm, 11.7 mm and 12.7 mm.
Bone Level Angled Abutments with 15° angles have diameters Ø 5.5 mm with lengths varying from 10.57 mm to 12.57 mm. Bone Level Angled Abutments with 25° angles have diameters Ø 5.5 mm, Ø 6.5 mm with lengths varying from 11.06 mm to 13.13 mm. Non-hex Bone Level Angled Abutments with 15° angles have diameters Ø 5.5 mm, Ø 6.5 mm with lengths varying from 10.37 mm to 12.38 mm. Nonhex Bone Level Angled Abutments with 25° angles have diameters Ø 5.5 mm, Ø 6.5 mm with lengths varying from 10.86 mm to 12.93 mm. Tissue Level Angled Abutments have 15° angles with diameter Ø 3.5 mm with length 9.8 mm.
Bone Level Solid Abutments have diameters of Ø 5.5 mm and Ø 6.5 mm with lengths between 12.4 mm to 16.4 mm.
Bone Level O-ring Abutments have diameters of Ø 3.42 mm and Ø 3.7 mm with lengths between 10.1 mm to 13.1 mm. Tissue Level O-ring Abutments have a diameter of 3.5 mm with lengths 9.1 mm, 11.1mm and 13.1 mm.
Bone Level Multi Abutments have diameter of Ø 5.5 mm with length 15.63 mm. Non-Hex Bone Level Multi Abutments have a diameter of Ø 5.5 mm with length 15.63 mm.
Bone Level Healing Abutments have diameters of Ø 5.5 mm with lengths 9.5 to 13.5 mm. Tissue Level Healing Abutments have diameter of Ø 6.4 mm with lengths 7.4 mm, 8.4 mm and 9.9 mm.
Bone Level Locator Abutments have diameter of Ø3.86 mm with length 13.95 mm.
Bone Level Multi-Unit Abutments have a diameter Ø 4.8 mm with lengths 8.45 mm and 12.65 mm. Bone Level Multi-Unit Abutments with 17° angle have a diameter Ø 4.8 mm with length 7.2 mm. Bone Level Multi-Unit Abutments with 25° angle have a diameter Ø 4.8 mm with lengths 7.5 mm, 8.5 mm and 9.5 mm.
Bone Level Premill Abutments have pre-mill diameters of Ø 10 mm, Ø 14 mm and Ø 16 mm with length 33.75 mm. Tissue Level Premill Abutments have pre-mill diameters of Ø 10 mm, Ø 14 mm and Ø 16 mm with length 30.08 mm. The finished premill custom abutment diameter is Ø 4.0 mm.
The provided document describes a 510(k) premarket notification for the Implantswiss Dental Implant System and Implantswiss Dental Abutment System. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify explicit "acceptance criteria" in terms of quantitative thresholds for device performance. Instead, it relies on demonstrating that the new models are "the same or similar" to previously cleared predicate and reference devices, and that relevant testing (biocompatibility, sterilization, shelf life, mechanical fatigue) leveraging existing data for the predicate device supports their continued safety and effectiveness.
However, based on the non-clinical testing section, the implicit acceptance criteria are that the device performance should be equivalent to the predicate devices and meet relevant ISO standards for dental implants and abutments.
| Acceptance Criterion (Implicit) | Reported Device Performance and Basis of Acceptance |
|---|---|
| Biocompatibility: Device materials are biocompatible and do not elicit adverse biological responses. | Biocompatibility testing was conducted on the predicate Implantswiss Dental Implant and Implantswiss Dental Abutment Systems per the ISO 10993 series of standards. This testing was leveraged for the subject devices due to identical materials and manufacturing as the predicate. |
| Sterilization: Sterilization process achieves a Sterility Assurance Level (SAL) of 10^-6. | Implants: Sterilized using a gamma ray sterilization process (ISO 11137-1 and ISO 11737-2) validated to ensure a SAL of 10^-6. LAL testing conducted per USP . Validation from the primary predicate leveraged due to identical materials, manufacturing, and worst-case analysis. |
| Abutments: Provided non-sterile. Recommended end-user steam gravity sterilization method and parameters validated to achieve an SAL of 10^-6 according to ISO 17665-1, ISO 17665-2, and ISO 11737-2. Validation from the primary predicate leveraged due to identical materials, manufacturing, and worst-case analysis. | |
| Shelf Life: Device maintains sterility and integrity over its intended shelf life. | Shelf life of the Implantswiss Dental Implant System remains at 2-years. Packaging testing of accelerated aged and real-time aged product previously demonstrated that the sterility of the Implantswiss Dental Implant System is maintained over the 2-year shelf life period. These tests (Visual Inspection ASTM F1886, Dye Penetration ASTM F1929-15, Seal Peel Strength Test BS EN 868-5:2009, Sterility test) were performed on the predicate devices and leveraged for the subject due to worst-case analysis. |
| Mechanical Integrity (Fatigue Resistance): Dental implant and abutment combinations can withstand dynamic fatigue forces consistent with the oral environment and relevant standards. This includes worst-case scenarios. | Fatigue testing, in accordance with ISO 14801 Dentistry- Implants-Dynamic fatigue test for Endosseous Dental Implants, was performed on the worst-case bone level Implant mated with the worst-case Implantswiss Dental Abutment. Results of the fatigue testing presented in the predicate submission found that the worst-case dental implant/abutment combinations were consistent with FDA Class II Special Controls guidance and ISO 14801. The additional models do not introduce a new worst-case and are covered by this prior testing. |
| Functional Equivalence: The additional models of implants and abutments are functionally equivalent to the predicate devices and compatible with their intended use (e.g., provide root form for prosthetic attachment, support prosthetic restorations). This includes similarity in design, size, dimensions, and material composition to existing cleared devices. | Implants: New implant models have the same intended use. Bench testing on worst-case dental implant found acceptable fatigue resistance properties. Minimum/maximum implant lengths match the predicate. Same surface treatment as predicate. Additional models are all bone level (original had both bone and tissue level). Manufactured from Commercially Pure Titanium Grade 4 (predicate used both pure titanium and titanium alloy). |
| Abutments: Similar in design, material, and basic features to predicate and reference devices. Enlarged diameter size ranges are covered by existing testing. Specific abutment types (Locator, Premill, Multi-Unit) compared to relevant predicate/reference devices, showing equivalence in design, dimensions, and manufacturing process (e.g., validated milling center for Premill). Bench testing on worst-case implant-abutment combinations for larger diameters found acceptable fatigue resistance. |
Study Proving Device Meets Acceptance Criteria:
The document describes a reliance on non-clinical bench testing and leveraging data from previously cleared predicate devices rather than a new standalone clinical study for the current submission.
2. Sample size used for the test set and data provenance:
- Test Set Sample Size: The document does not specify a distinct "test set sample size" in terms of cases or patients, as it's a bench study leveraging prior data for substantial equivalence. For the fatigue testing, it states that "fatigue testing... was performed on the worst-case bone level Implant mated with the worst case Implantswiss Dental Abutment." This implies a limited number of physical devices representing the "worst-case" scenario were tested as per ISO 14801. However, the exact number of samples tested for fatigue is not explicitly stated in this summary.
- Data Provenance: The data primarily comes from non-clinical bench testing (biocompatibility, sterilization, shelf life, mechanical fatigue) performed on the predicate device (K181266) and other reference devices (K160221, K150295, K161416, K181037). These studies were presumably conducted by the manufacturer, Novodent SA, or its affiliates and contracted labs. The country of origin of this specific testing data is not explicitly mentioned but is likely from the region where Novodent SA (Switzerland) and its partners operate. The studies are retrospective in the context of this 510(k) submission, as they were conducted for prior device clearances and are now being leveraged.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
Not applicable. This is a non-clinical device submission demonstrating substantial equivalence through bench testing, not a study involving human subjects or expert assessment for ground truth on disease detection.
4. Adjudication method for the test set:
Not applicable, for the same reasons as point 3.
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, 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 is a physical medical device, not an algorithm.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by established scientific and engineering principles, international performance standards (e.g., ISO 10993, ISO 11137-1, ISO 11737-2, ISO 17665-1, ISO 17665-2, USP , ISO 14801, ASTM F1886, ASTM F1929-15, BS EN 868-5:2009), and material specifications (e.g., ASTM F-67, ASTM F-136). Compliance with these standards and material properties, validated by bench testing results, serves as the basis for "ground truth" for device performance.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable. This is a physical medical device, not a machine learning model.
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(343 days)
Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
• Link Abutment for CEREC
The Link Abutment for CEREC is titanium alloy abutments placed onto OSSTEM dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.
Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Osstem Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.
Osstem Abutment System is substantially equivalent in design, function and intended use to the predicate devices as above.
The document then lists various components of the system including Transfer Abutment, Angled Abutment, Link Abutment for Cerec, Temporary Abutment, Multi Angled Abutment, Multi NP-Cast Cylinder, Multi Combination Cylinder, Convertible Angled Cylinder, Stud Abutment, O-ring, O-ring Retainer Cap, Port Abutment, Port Angled Abutment, Port Angled Abutment Head, Port Male, Port Extended Male, Port Male Cap, Port Male Kit, Abutment Screw, Cylinder Screw, Esthetic-low Temporary Cylinder, and Temporary Cap (Narrow Ridge), along with their descriptions, materials, and dimensions.
The provided document is a 510(k) premarket notification for the Osstem Abutment System. It outlines how the device is considered substantially equivalent to already marketed predicate devices, rather than providing a performance study against specific acceptance criteria for a new AI/software device.
Therefore, many of the requested details, such as those related to AI/algorithm performance (e.g., test set sample size, expert ground truth establishment, MRMC studies, standalone performance), are not applicable to this type of submission. The document focuses on material properties, design, indications for use, and a comparison to predicate devices to establish substantial equivalence.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not present explicit acceptance criteria in the typical sense of performance metrics for an AI/software device (e.g., accuracy, sensitivity, specificity). Instead, substantial equivalence is claimed based on similarities in:
- Intended Use
- Technology (design principles)
- Material Composition
- Performance Characteristics (mechanical properties, biocompatibility, sterilization)
The performance is "reported" by demonstrating that the device is equivalent to known predicate devices through non-clinical testing (biocompatibility, sterilization validation, mechanical properties, specifically fatigue testing and retention testing). The document states: "Non-clinical testing data are submitted, referenced, or relied upon to demonstrate substantial equivalence."
| Acceptance Criteria (Demonstration of Substantial Equivalence to Predicates) | Reported Device Performance (as described in the 510(k)) |
|---|---|
| Biocompatibility | Evaluted following FDA Guidance Document ISO 10993-1 and ISO 10993 suite of standards. (Implies compliance, but no specific numerical results or pass/fail thresholds are provided in this summary.) |
| Sterilization Validation | Considered according to ISO 17665-1 (for non-sterile delivery). (Implies validation, but no specific numerical results or pass/fail thresholds are provided. Products are provided non-sterile, so this refers to validation of sterilization methods for the end-user.) |
| Mechanical Properties (Fatigue Testing) | Considered according to FDA Guidance Document "Guidance for Industry and FDA Staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801 standard with worst-case scenario. (Implies testing was performed and passed, but no specific numerical results or pass/fail thresholds are provided.) |
| Mechanical Properties (Retention Testing for Dental Attachments) | Conducted. (Implies testing was performed and passed, but no specific numerical results or pass/fail thresholds are provided.) |
| Indications for Use | "Identical, with the exception of the addition to the Subject Indications for Use Statements language regarding the Link Abutment for CEREC. This language is identical to the Indications for Use Statement of the Reference Device being used for the Substantial Equivalence comparison for the Link Abutment for CEREC." (Demonstrated through comparison tables in Section 6). |
| Material Composition | "Identical" or "Within the range of the predicates" for most components. (Demonstrated through comparison tables in Section 6). |
| Design/Dimensions | "Identical" or "Similar" or "Within the range of the predicates" with explanations for minor differences and why they don't affect safety/effectiveness. (Demonstrated through comparison tables in Section 6). |
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 and not provided. The submission relies on non-clinical (laboratory) testing for mechanical properties and biocompatibility, as well as comparison to predicate devices, not on a clinical test set with patient 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. No clinical test set or human expert review of "truth" data for diagnostic performance is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/software device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical testing, the "ground truth" would be established by the physical and mechanical properties of the materials and designs as measured in laboratory tests, and compared against established industry standards (ISO 14801) and FDA guidance for dental abutments. For biocompatibility, it's adherence to ISO 10993 standards. No clinical ground truth from patients is established or used for this 510(k) submission.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of device submission.
9. How the ground truth for the training set was established
Not applicable.
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(360 days)
The Implant-One™ System is indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The Implant-One™ system is indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.
Endosseous implants are self-tapping and threaded, and offered having root-form or wide thread forms. Root-form implant diameters range from 3.25mm to 5.5mm having lengths from 8mm to 14mm. Wide thread implant diameters are available in 4.1 and 4.5mm (8mm to 14mm lengths), 5.5mm (8mm to 12mm lengths) and 6.5mm (8mm to 10mm lengths). Cover screws and healing caps provide protection to the threads of the abutment connection during endosseous and gingival healing. Cover screws are pre- packaged with each implant. Healing caps are provided as an alternative to the cover screw and are packaged separately. The Implant-One™ dental implants and cover screws are provided sterile. Not all abutments can be used for single-unit restorations. The conical, angled conical, ball, locator and glueless abutments are intended only for multi-unit loaded restorations. The ball, locator and glueless abutments are to be used in fully removable dentures. The conical and angled conical abutments are to be used in screw retained dentures and with the titanium sleeve for screw retention. The final design parameters for the custom blank abutment are as follows: maximum total height, 12.5mm; minimum/maximum gingival height, 0.5mm/6mm; minimum post height, 4mm; maximum angulation, 30°; minimum wall thickness, 0.78 (at 1.5mm above the proximal end); minimum diameter, 3.75 mm for the 300 Series, 4.25 mm for the 300 Series and 4.75 mm for the 500 Series.
The provided text is a 510(k) summary for the Implant-One™ System, a dental implant device. It demonstrates the device's substantial equivalence to existing legally marketed predicate devices through non-clinical performance data.
However, the document does not describe a study involving an algorithm, AI assistance, human readers, or any form of "acceptance criteria" related to diagnostic performance or accuracy as one would expect for an AI/ML medical device.
Instead, the "acceptance criteria" and "study" described in this document pertain to engineering and biocompatibility performance of a physical medical device (dental implants and abutments), not a software or AI-driven system.
Therefore, for each of the requested points, the answer is that the information is not applicable (N/A) in the context of this document, as it describes a physical dental implant system and not an AI/ML device that would have such performance criteria.
Here's how to address each point based on the provided text:
Acceptance Criteria and Device Performance (Based on Device Type - Dental Implants)
Since this is for a physical dental implant system, the "acceptance criteria" are related to mechanical integrity, biocompatibility, sterilization, and packaging/shelf-life, rather than diagnostic accuracy. The "device performance" indicates that the device met these criteria by demonstrating substantial equivalence to predicates.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Demonstrated Equivalence To) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ISO 14801 (for worst-case construct performance) | "Non-clinical mechanical testing of the worst case Implant-One™ System construct was performed according to ISO 14801 and demonstrated that the Implant-One™ system performs as well as or better than the predicate devices." |
| Biocompatibility | ISO 10993-5 | "Biocompatibility testing was performed according to ISO 10993-5 and demonstrated substantial equivalence." |
| Sterilization | ISO 11137 and ISO 17665 | "Sterilization validations were performed according to ISO 11137 and 17665 and demonstrated substantial equivalence." |
| Packaging & Shelf-life | ASTM D4169 (including ASTM F1886, ASTM F88, and ASTM F1929) | "Packaging and shelf-life validations were performed according to ASTM D4169 including ASTM F1886, ASTM F88 and ASTM F1929 and demonstrated substantial equivalence." |
| Endotoxin Limit |
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(171 days)
Implantswiss Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implantswiss Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implantswiss Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa and Multi-Unit Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture.
The Implantswiss Dental Implant and Implantswiss Dental Abutment Systems are compatible titanium/titanium alloy dental implants and abutments. The Implantswiss Dental Implants are provided as bone level or tissue level type implants and their surface is modified by a Sandblasted Rough Acid-etched (SRA) process. The Implantswiss Bone Level Implants have diameters of 3.3mm, 3.7mm, 4.3mm and 4.8mm with lengths of 8mm, 12mm and 14mm; and diameter of 5.5mm with lengths of 8mm, 10mm and 12mm. The 3.3mm and 3.7mm diameter Bone Level Implants are composed of Titanium Ti6Al4V ELI – ASTM F136-13. The 4.3mm, 4.8mm and 5.5mm diameter Bone Level Implants are composed of Titanium Grade 4 – ASTM F67-13. The Implantswiss Tissue Level Implants have diameters of 3.7mm, 4.3mm and 4.8mm with lengths of 8mm, 10mm, 12mm and 14mm; and diameter of 5.5mm with lengths of 8mm, 10mm and 12mm. The Tissue Level Implants are composed of Titanium Grade 4 – ASTM F67-13. The Implantswiss Dental Abutment System consists of Couple, Angled, Solid, O-ring, Multi, Octa, Synocta, Healing, Locator and Multi-Unit Abutments.
The provided text is a 510(k) summary for the Implantswiss Dental Implant System and Implantswiss Dental Abutment System. It outlines the regulatory clearance process, device description, indications for use, and a comparison to predicate devices, including performance testing.
However, it does not contain information about acceptance criteria or a study that uses a machine learning or AI model. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical performance testing (biocompatibility, sterilization, mechanical testing) for dental implants and abutments, which are physical medical devices, not AI-driven software.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of medical device submission.
I will provide the information that is applicable based on the text provided, highlighting where the requested AI/ML specific details are not relevant.
Acceptance Criteria and Study for Implantswiss Dental Implant System & Abutment System
This device clearance (K181266) is for physical dental implants and abutments, not a software or AI/ML device. Therefore, the "acceptance criteria" and "study" refer to non-clinical performance evaluations relevant to the material properties, design, and intended use of these dental devices.
1. A table of acceptance criteria and the reported device performance
The document does not present specific quantitative "acceptance criteria" in a table format for each test. Instead, it refers to compliance with established international standards and FDA guidance documents. The "reported device performance" is a statement of consistency with these standards.
| Acceptance Criteria (Reference to Standard/Guidance) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| ISO 10993-1:2009 (Evaluation and testing within risk management process) | Conducted according to ISO 10993-1:2009 and FDA Guidance document "Use of International Standard ISO 10993-1..." for each subject device fixture. |
| Cytotoxicity (in vitro) ISO 10993-5:2009 | Tests conducted: Cytotoxicity, Sensitization, Irritation/Intracutaneous Toxicity, Implantation test, Chemical Analysis (SVOC, VOC). (Explicit "performance" results not detailed, but implied as compliant for clearance.) |
| Sensitization ISO 10993-10:2010 | |
| Irritation/Intracutaneous Toxicity ISO 10993-10:2010 | |
| Implantation test ISO 10993-6:2016 | |
| Chemical Analysis (IS0 10993-12, Method 8270D, 8260C) | |
| Sterilization & Shelf Life: | |
| Gamma Ray Sterilization ISO 11137-1 & ISO 11737-2 | Validated to ensure SAL of 10^-6. |
| LAL testing (USP ) | Conducted in accordance with USP . |
| Steam Gravity Sterilization (ISO 17665-1, ISO 17665-2, ISO 11737-2) for non-sterile abutments | Validated to achieve an SAL of 10^-6. |
| Packaging integrity (ASTM F1886, ASTM F1929-15, BS EN 868-5:2009) | Demonstrated that sterility is maintained over 2-year shelf life period for implants. Tests performed: Visual Inspection, Dye Penetration, Seal Peel Strength Test, Sterility Test. |
| Mechanical Testing: | |
| ISO 14801 Dentistry - Dynamic fatigue test | Results consistent with FDA Class II Special Controls guidance and ISO 14801 for worst-case bone level implant/abutment combinations. |
| Surface analysis (SEM, EDS) | SEM found that the implant surface had a homogeneous structure after the SRA process. |
| Consistency with FDA Class II Special Controls guidance document | Non-clinical performance testing supports substantial equivalence. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: This information is not explicitly provided in the summary. For mechanical and biocompatibility testing, it is generally conducted on a sample of devices (e.g., a specific number of implants/abutments) to demonstrate compliance with standards. The summary states "worst-case" testing was performed.
- Data Provenance: Not applicable in the context of device performance testing for physical implants. These are lab-based tests of the physical product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in this context refers to standard-compliant test methods and material properties, not expert-curated clinical data for an AI/ML model.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is relevant to expert panel consensus for clinical data, not materials and mechanical testing.
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 implant and abutment system, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This 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 type of device clearance is established by internationally recognized standards (ISO standards), FDA guidance documents, and validated test methods (e.g., for biocompatibility, mechanical fatigue, sterilization parameters). Material specifications (e.g., ASTM F-67, ASTM F-136) also serve as a form of "ground truth" for material composition.
8. The sample size for the training set
Not applicable. There is no AI/ML training set for this physical device.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML training set for this physical device.
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(247 days)
The LOCATOR® F-Tx Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restory function. It is used in fixed hybrid restorations that can be attached with a snap-in system.
The LOCATOR® F-Tx Attachment System is compatible with the following implants: Implant Manufacturer Connection Type / Platform
| Astra Tech | OsseoSpeed Plus EV: 3.6, 4.2, 4.8 mm |
|---|---|
| BioHorizons | Internal Hex: 3.0, 3.5, 4.5, 5.7 mm |
| Biomet 3i | Osseotite ® Certain ® : 3.4, 4.1, 5.0, 6.0 mm |
| Camlog | Camlog, Conelog: 3.3, 3.8, 4.3, 5.0 mm |
| iSy: 3.8, 4.4, 5.0 mm | |
| Dentsply | Ankylos ® : 3.5, 4.5, 5.5, 7.0 mm |
| MIS Implants | Internal Hex: 3.75, 4.5 mm |
| Nobel Biocare | NobelActive ™ : 3.0, 3.5, 3.9 mm |
| Replace ™ Select: 3.5, 4.3, 5.0, 6.0 mm | |
| Brånemark: 3.5, 4.1, 5.1 mm | |
| Straumann | Bone Level: 3.3, 4.1, 4.8 mm |
| Standard: 4.8, 6.5 mm | |
| Zimmer | Tapered Screw-Vent ® : 3.5, 4.5, 5.7 mm |
The LOCATOR® F-Tx Attachment System is for rigid connection of fixed, partial and full arch restorations on endosseous dental implants using a snap-in or screw-retained attachment system. The system includes abutments and healing caps. LOCATOR F-Tx abutments are compatible with the implant systems, connection types, and platform sizes listed above, and are provided in various gingival cuff heights ranging from 1 to 6 mm. LOCATOR F-Tx System abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). LOCATOR F-Tx abutments may be provided with an optional coating of either TiCN (titanium carbon nitride) or TiN (titanium nitride). LOCATOR F-Tx System Healing Caps are made of PEEK.
The provided text describes a 510(k) premarket notification for a medical device, the LOCATOR® F-Tx Attachment System. It focuses on demonstrating substantial equivalence to pre-existing predicate devices, rather than presenting a study design with specific acceptance criteria and detailed performance data often seen for novel AI/ML devices. As such, many of the requested points regarding acceptance criteria, study types (MRMC, standalone), sample sizes for test/training sets, expert qualifications, and ground truth establishment are not applicable or cannot be extracted from this document, as it is not a performance study report for an AI/ML device.
This document outlines the device's intended use, design, materials, and provides a comparison to legally marketed predicate devices to establish substantial equivalence. The "Performance Data" section primarily details the non-clinical testing performed to meet various ISO standards related to sterilization, biocompatibility, and mechanical testing, which are typical for dental implant components.
Here's an attempt to address the request based only on the available information, noting where information is absent:
Acceptance Criteria and Device Performance for LOCATOR® F-Tx Attachment System
Based on the provided 510(k) summary, the "acceptance criteria" are primarily demonstrated through substantial equivalence to predicate devices and adherence to relevant non-clinical performance standards. The performance data presented focuses on material properties, sterilization, biocompatibility, and mechanical retention, rather than performance metrics for an AI/ML system.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence: | |
| - Similar Indications for Use | -"The LOCATOR® F-Tx Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory function. It is used in fixed hybrid restorations that can be attached with a snap-in system." |
- "Substantial equivalence in indications and design principles to legally marketed predicate devices." Comparing language: "The subject device and primary predicate have slightly different Indications for Use language. However, the difference in language does not change the intended use of abutments." |
| - Similar Design Principles | - "LOCATOR F-Tx and Locator (K072878) are each provided with varving cuff heights. The abutment/implant interfaces of all LOCATOR F-Tx abutments are identical to those of the corresponding Locator (K072878) abutments." |
| - Similar Materials | - Abutment: Ti-6Al-4V ELI (same as predicate). - Abutment Coating: TiN (same as predicate), TiCN (same as reference predicate K150295).
- Prosthetic Retention Component: PEEK (predicate uses Nylon). This difference is noted but deemed acceptable. |
| Material Biocompatibility (ISO 10993-1, -5, -12) | - "Characterization and biocompatibility testing of the TiCN coating," - "Biocompatibility testing of the PEEK Healing Caps."
- (Specific results not detailed, but testing was performed and deemed acceptable for submission). |
| Sterilization (ISO 17665-1, -2) | - "Sterilization testing." - (Specific results not detailed, but testing was performed and deemed acceptable for submission). |
| Mechanical Performance (Specifically Retention Strength) | - "The mechanical testing demonstrated the retention strength of the LOCATOR F-Tx Attachment System when using the High Retention Balls was statistically greater than the tensile force created when masticating worst case sticky food (p
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