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510(k) Data Aggregation
(265 days)
Anthogyr FlexiBase® titanium bases for Axiom® BL are indicated for use as a support for singleunit customized prosthetic restorations. All digitally designed copings and / or crowns for use with the Anthogyr Flexibase® titanium bases for Axiom® BL are intended to be sent to Straumann for manufacturing by a validated milling center (Straumann CARES System).
Anthogyr FlexiBase® titanium bases for Axiom® BL are intended to be placed into Anthogyr dental implants to provide support for single-unit restorations. The second component of the two-piece abutment (coping or crown) must be cemented onto the titanium component of the FlexiBase® abutment to constitute the final two-piece abutment design, which is then screwed onto the implant.
The bottom portion of the FlexiBase® are made from Titanium alloy. They are provided in several dimensions, there is one chimney height, and two platform diameters of 4.0 mm and 5.0 mm, and for each of the platform diameters there are three gingival heights of 1.5 mm, 2.5 mm and 3.5 mm.
Anthogyr FlexiBase® titanium bases for Axiom® BL are very similar to the primary predicate device Medentika TiBase CAD/CAM Abutments cleared in K150203.
The FlexiBase® are fixed in the implant by means of a prosthetic screw which is manufactured in titanium alloy and DLC coated identical to K161177.
The FlexiBase® abutments are two-piece abutments used as a base when fabricating a CAD/CAM customized restoration. The design and milling of the customized restoration must be made using the Straumann CARES® Visual software.
The FlexiBase® is a two-piece abutment ultimately composed by three components:
- . FlexiBase® abutment titanium component
- Top-half component (coping and/or crown) .
- . Prosthetic screw
The FlexiBase® abutments will be marketed:
- through a validated Straumann Centralized milling center, in this case all digitally . designed copings and/or crowns are intended to be manufactured at a validated Straumann milling center (Straumann CARES® System).
The provided text describes a 510(k) premarket notification for "Anthogyr FlexiBase® titanium bases for Axiom® BL". This document focuses on demonstrating substantial equivalence to predicate devices, and therefore, the acceptance criteria and study detailed below relate to the performance of the device in comparison to these predicates, rather than proving a specific diagnostic accuracy or clinical outcome for a novel AI algorithm.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance (Anthogyr FlexiBase®) |
|---|---|---|---|
| Sterilization | ISO 17665-1, ISO 17665-2, FDA Guidance "Reprocessing Medical Devices..." | Validation of recommended sterilization method for end-user moist heat (steam) sterilization. | Sterilization method validated according to ISO 17665-1 and ISO 17665-2 and applicable FDA guidance. Parameters equivalent to predicate devices. |
| Biocompatibility | ISO 10993-1, ISO 10993-5, FDA Guidance "Use of International Standard ISO 10993-1..." | Biological assessment performed, cytotoxicity testing conducted. Equivalent materials to predicate devices. | Biological assessment performed. Cytotoxicity testing performed as per ISO 10993-5. No new issues raised due to material equivalence to predicate devices. |
| Electromagnetic Compatibility (EMC) | Not explicitly stated, referenced from prior testing/clearance (K180564) | MR Conditional status due to no significant material/dimension changes from marketed predicate devices. | Considered MR Conditional. No new issues of electromagnetic compatibility raised due to physical equivalence to predicate devices. |
| Dynamic Fatigue | FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments", ISO 14801 | Covered permanent restoration without failure for 2 million cycles (in saline, 2 Hz, 37°C); Covered temporary restoration without failure for 200,000 cycles (in saline, 2 Hz, 37°C). | Demonstrated equivalence to primary predicate and reference devices. Tested without failure for 2 million cycles (permanent restoration) and 200,000 cycles (temporary restoration) under specified conditions. |
2. Sample size used for the test set and the data provenance
The document does not detail specific "sample sizes" in the context of a statistical test set using patient data. The performance testing described relates to in-vitro bench testing of the devices themselves.
- Dynamic Fatigue Testing: The document states the test was conducted on the devices, but the specific number of units tested is not provided ("the subject devices").
- Data Provenance: Not applicable in the context of clinical patient data. The testing described is laboratory-based bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is a physical dental implant component, and the testing described is engineering performance testing (sterilization, biocompatibility, fatigue). There is no "ground truth" to be established by clinical experts in the context of this 510(k) submission.
4. Adjudication method for the test set
Not applicable, as this is laboratory bench testing, not a clinical study involving human judgment on a test set.
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. The device is a dental implant base, not an AI, imaging, or diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The performance criteria are based on engineering standards and regulatory guidance for device performance and safety (e.g., ability to withstand dynamic loading, biocompatibility, sterility) rather than clinical "ground truth" derived from patient data or expert consensus on clinical findings.
8. The sample size for the training set
Not applicable. This is not an AI algorithm or a device requiring a training set in that sense.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is detailed under "Performance Testing - Bench" and "Performance Testing 1.1 - Sterilization Validation and Shelf-life", as well as "Biocompatibility Testing" and "Electromagnetic Compatibility".
-
Study Design: The studies essentially comprised benchtop engineering tests performed according to recognized international standards and FDA guidance documents. This included:
- Sterilization Validation: Demonstrated the effectiveness of the recommended moist heat (steam) sterilization method for end-users, aligning with ISO 17665-1, ISO 17665-2, and FDA guidance.
- Biocompatibility Testing: Conducted biological assessment according to ISO 10993-1 and ISO 10993-5, including cytotoxicity testing. The materials were deemed equivalent to those in predicate devices, implying comparable biocompatibility.
- Electromagnetic Compatibility (EMC): Assessed by confirming no significant changes in materials and dimensions compared to previously cleared predicate devices, thus inferring MR Conditional status based on prior clearances (e.g., K180564).
- Dynamic Fatigue Testing: Conducted in accordance with FDA guidance for endosseous dental implants and ISO 14801. This involved cyclic loading tests in saline (2 Hz, 37°C) for:
- 2 million cycles for permanent restorations (without failure).
- 200,000 cycles for temporary restorations (without failure).
-
Proof of Meeting Acceptance Criteria: The outcome of these tests indicated that the "Anthogyr FlexiBase® titanium bases for Axiom® BL" devices successfully met the performance requirements outlined by the respective standards and guidance documents. The key finding was that the subject devices demonstrated equivalence to the primary predicate and reference devices in all these aspects of performance and safety. This equivalence is the primary basis for the 510(k) clearance.
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(316 days)
The Straumann PURE Ceramic Implant is indicated for the restoration of single-tooth gaps and in edentulous or partially edentulous jaws. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.
Closure and Healing caps are intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Closure and Healing caps should be used only with suitable implant connections. Do not use healing components for longer than 6 months.
The provisional components are intended to serve as a base for temporary crown or bridge restoration out of occlusion for the Straumann® PURE Ceramic Implant System. The Straumann® Temporary Abutment VITA CAD-Temp® for the Straumann® PURE Ceramic Implant is indicated for temporary usage of up to 180 days.
CI RD Straumann PUREbase abutment is a titanium base placed onto Straumann ceramic dental implants to provide support for customized prosthetic restorations and 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 Straumann® Variobase Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
The Straumann PURE Ceramic Implant is a dental implant made out of yttrium-stabilized zirconium dioxide (Y-TZP). The Straumann PURE Ceramic Implant is based on features of the Straumann PURE Ceramic implant Monotype. Straumann PURE Ceramic Implants can be placed using the existing instruments using the same osteotomy preparation protocol as for Bone Level implants. The subject implant is a two -piece implant and is available in Ø4.1 mm with lengths of 8, 10, 12, and 14 mm.
The Closure and Healing caps are screws machined as one piece and come in three gingival heights to accommodate individual gingival thickness. The material of the devices is titanium grade 4. The Closure caps are screwed into the implant to protect the inner configuration and shoulder of the implant during the healing phase in cases of submerged (submucosal) healing protocols and do not support a prosthetic restoration. Healing caps are screwed into the implant to protect the inner configuration in cases of transmucosal healing protocols and are placed out of occlusion and do not support a prosthetic restoration.
The Temporary Abutments are used to serve as a temporary crown or bridge restoration for the Straumann PURE Ceramic Implant System.
The CI RD Straumann PUREbase Abutment for Ceramic implant is a premanufactured (stock) abutment (the first piece of the two-piece abutment), sometimes referred to as "Tibase", and is used as a base when fabricating a CAD/CAM customized restoration (the second piece of the two-piece abutment). The assembly of the two-pieces becomes a finished medical device after cementation of the CAD/CAM customized restoration on the PURE base abutment.
The Straumann PURE Ceramic Implant System did not present specific, quantified acceptance criteria with corresponding performance data in the provided text. Instead, the document focuses on demonstrating substantial equivalence to predicate and reference devices through various tests.
However, based on the provided "Performance Data 5.7" section and the comparison tables, we can infer the types of acceptance criteria and the nature of the study that proves the device meets those criteria. The acceptance criteria generally revolve around demonstrating equivalence to legally marketed predicate and reference devices in terms of safety and effectiveness, as per FDA guidelines for 510(k) submissions.
Here's an attempt to structure the information based on the request, interpreting "acceptance criteria" as the performance standards expected for demonstrating substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit numerical acceptance criteria were not stated, this table describes the type of performance evaluated and the outcome in relation to the predicate/reference devices.
| Acceptance Criterion (Inferred from regulatory requirements and comparative studies) | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials are safe for biological contact and do not cause adverse reactions. (In accordance with ISO 10993-1:2009). | The subject device materials are identical to the predicate and reference device materials. Therefore, no new issues regarding biocompatibility were raised. |
| Sterilization Efficacy (for sterile components): Sterilization process reliably achieves a Sterility Assurance Level (SAL) of 10-6. (Per ISO 11135). | Sterilization validation was performed using the Half Cycle Overkill Approach, demonstrating the process can reliably and consistently sterilize to a minimum SAL of 10-6. |
| Pyrogenicity: Device does not contain pyrogens above acceptable limits. (Based on FDA Guidance, testing limit of 20 EU/device for blood contacting/implanted devices). | The device meets pyrogen limit specifications as determined by LAL Endotoxin Analysis, with a testing limit of 20 EU/device. |
| Reprocessing Validation (for non-sterile components to be reprocessed by end-user): Reprocessing methods (e.g., autoclaving) are effective. (Per ISO 17665-1:2006 and FDA guidance). | The sterilization process for the Straumann PURE temporary abutment and CI RD Straumann PUREbase abutments (as recommended in labeling) was validated according to applicable recommendations in FDA guidance and ISO 17665-1:2006. |
| Mechanical Strength/Fatigue: Device can withstand dynamic loading forces typical of oral function without failure. (Per ISO 14801:2016 and FDA guidance). | Dynamic fatigue tests demonstrated the Straumann PURE Ceramic Implant, Straumann PURE temporary abutments, and CI RD Straumann PUREbase abutments are equivalent to the predicate and reference devices. |
| Wear on Implant-to-Abutment Connection: Connection surfaces exhibit comparable wear behavior to predicate/reference devices. | Post-fatigue bench tests concluded comparable behavior of the subject device to the reference devices in terms of wear on the implant-to-abutment connection. |
| Screw Loosening: Risk of screw loosening is comparable to predicate/reference devices. | Post-fatigue bench tests concluded comparable behavior of the subject device to the reference devices in terms of screw loosening. A literature review was also provided to evaluate the risk of screw loosening with ceramic abutments. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes bench testing for mechanical performance, biocompatibility, and sterilization. It does not refer to a "test set" in the context of clinical data or data from human subjects.
- Sample Size: Not explicitly stated for each test, but typically, mechanical and sterilization validations involve a statistically representative number of units or replicates to demonstrate consistency and meet statistical confidence levels defined in the relevant ISO standards (e.g., ISO 11135, ISO 14801). Biocompatibility is based on material composition equivalency, not a specific sample size.
- Data Provenance: The studies are described as bench tests (laboratory studies), biocompatibility assessments based on material equivalency, and sterilization/reprocessing validations. There is no mention of country of origin of data in the context of test subjects, as these are not human studies for this specific assessment. The data is generated from laboratory testing and analytical comparisons.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is typically relevant for studies involving human interpretation (e.g., image analysis by radiologists). For this device, which involves material properties and mechanical performance, the "ground truth" is established by adherence to international standards (ISO) and FDA guidance documents, and the expertise lies in the validation engineers and materials scientists performing and interpreting these tests. There is no mention of "experts" in the sense of clinical adjudicators for a "test set" in the provided text.
4. Adjudication Method for the Test Set
Not applicable as this is not a study involving human interpretation of medical data (e.g., images) requiring adjudication of findings. Performance is evaluated against objective engineering and scientific standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an endosseous dental implant system, not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or software. It is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluations (mechanical, sterilization, biocompatibility) is defined by the International Organization for Standardization (ISO) standards and FDA guidance documents to which these tests were conducted.
- Biocompatibility: ISO 10993-1:2009.
- Sterilization: ISO 11135 and FDA Guidance on "Submission and Review of Sterility Information...".
- Reprocessing: ISO 17665-1:2006 and FDA guidance "Reprocessing Medical Devices in Health Care Settings...".
- Mechanical Testing (Dynamic Fatigue): ISO 14801:2016 and FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
- Wear and Screw Loosening: Bench tests demonstrating comparable behavior to reference devices, supported by a literature review for screw loosening risk.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device is not an AI/machine learning model.
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(159 days)
Straumann® BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX Implants can be placed with immediate function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components.
Straumann® Closure Caps and Healing Abutments are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and to shape, maintain and stabilize the soft tissue during the healing process. Closure caps and healing abutments should be used only with suitable implant connections. Straumann Closure Caps and Healing Abutments have a maximum duration of usage of 6 months.
Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. Final abutments may be placed into occlusion when the implant is fully osseointegrated. BLX Temporary Abutments have a maximum duration of usage of 180 days.
Straumann® Variobase® prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (crowns) can be cemented onto the Straumann® Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
The Straumann BLX Implants are fully tapered implants manufactured utilizing the Roxolid material and are finished with SLActive® surface. The connection is identified as conical fitting with Torx style engaging feature. The prosthetic platforms are identified as RB (Regular Base) and WB (Wide Base). The implants with a RB platform have a "small top/head", and implants with WB platform have a "large top/head", whereas the internal connection is identical for both platform and all the implant diameters and lengths.
The closure cap and healing abutments are manufactured from Titanium Grade 4, per ISO 5832-2 and ISO 5832-11, and are anodized signal violet for the parts compatible with the RB platform and brown for the parts compatible with the WB platform for identification purposes. Closure caps are screwed into the implant to protect the inner configuration and shoulder of the implant during the healing phase in cases of submerged (submucosal) healing. Healing abutments are screwed into the implant to protect the inner configuration in cases of transmucosal healing and are placed out of occlusion.
The temporary abutments are manufactured from TAN and are anodized signal violet (RB platform) and brown (WB platform) for identification purposes. The temporary abutments are fixed in the implant with a basal screw which is also manufactured from TAN. The basal screw will be delivered with the temporary abutment.
BLX Variobase abutments is a two-piece abutment ultimately composed by three components: Variobase™ Abutment (Ti-base), Prosthetic restoration (coping and/or crown), and Basal Screw. The BLX Variobase Abutments are manufactured and are delivered with the corresponding basal screw. The prosthetic restoration (crowns) can be cemented onto the Variobase prosthetic components.
Basal screws are used to seat the temporary abutments and the BLX Variobase Abutments to the dental implant, and can be also be used during lab procedures to fix lab prosthetic parts on implant analogs. There is one basal screw for the RB platform and one for the WB platform. They have identical designs and differ only in color-coding (signal violet and brown) to ease the handling. They are provided along the abutments but they are also provided as standalone screws. The BLX basal screws are manufactured from TAN.
This document describes the Straumann® BLX Implant System, a dental implant system, and its various components. The information provided is for a 510(k) premarket notification to the FDA. The goal is to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than setting and meeting specific, quantitative acceptance criteria for novel performance. Instead, the "acceptance criteria" are implied by successful comparative testing and adherence to existing standards and guidance documents. The "reported device performance" is the outcome of these tests.
| Test Type | Implied Acceptance Criteria (Demonstrated by Equivalence/Compliance) | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Achieves a Sterility Assurance Level (SAL) of 10⁻⁶ via gamma irradiation. Complies with ISO 11137-1:2006 and ISO 11137-2:2013. For end-user sterilized components, validation according to ISO 17665-1, ISO 17665-2, and FDA guidance "Reprocessing Medical Devices in Health Care Settings." | BLX implants, closure caps, and healing abutments are sterile via gamma irradiation (25 kGy minimum), validated to SAL 10⁻⁶ per ISO 11137-1:2006 and ISO 11137-2:2013 (overkill bioburden method). BLX Temporary Abutments and BLX Variobase Abutments are end-user sterilized by moist heat (steam), validated per ISO 17665-1, ISO 17665-2, and FDA reprocessing guidance. |
| Shelf Life | Packaging ensures maintaining sterility for a specified period and materials are not adversely affected. | Shelf life for sterile devices remains 5 years, as packaging is equivalent to predicate/reference devices and materials are not adversely affected by time. |
| Pyrogenicity | Meets pyrogen limit specifications based on LAL Endotoxin Analysis (e.g., |
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(151 days)
The Straumann® Variobase® for Crown AS is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for Crown AS are indicated for screw retained single tooth or cement-retained single tooth and bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. All digitally designed copings and/or crowns for use with the Straumann Variobase® for Crown AS are intended to be sent to Straumann for manufacture at a validated milling center.
The Straumann® Variobase® for Crown AS are pre-manufactured (stock) lower parts of two-piece abutments, sometimes referred to as "bonding bases" or "TiBases". The Straumann® Variobase® for Crown AS are available to fit to Straumann® dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit®), and RC (Regular CrossFit®).
There are two prosthetic heights to allow for treatment flexibility and for each of the bone level connections (NC, RC), there are gingiva heights of 1.00 mm, 2.00 mm and 3.00 mm. The Straumann® Variobase® for Crown AS provides the dental technician and patient with the possibility to have an "Angled Screw channel" in the crown.
The lower side of the Straumann® Variobase® for Crown AS and a small angulation of the innerwall allows the screw-channel exit to move from a position directly above the implant screw channel to a laterally displaced position. Thus the screw-channel exit can be moved a small distance from occlusal contact or esthetic regions where its potential impact to esthetics is smaller, in Figure 1 the screw-channel exit has been moved from the occlusal contact point of an incisor to behind the incisal edge. The patient-specific upper part of the two-piece abutment (referred to as coping or crown) is to be designed via a traditional workflow of casting/pressing or a digital workflow using the dental CAD software Straumann CARES Visual.
There are three components to the Straumann® Variobase® for Crown AS:
- . Straumann® Variobase® for Crown AS (Ti-base)
- o Prosthetic restoration (coping and/or crown)
- o Basal Screw
Here's an analysis of the provided text regarding the Straumann® Variobase® for Crown AS, focusing on acceptance criteria and the study proving it meets those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The provided FDA 510(k) summary does not explicitly state numerical acceptance criteria in the typical sense (e.g., "device must perform at X% accuracy"). Instead, it focuses on demonstrating substantial equivalence to predicate devices through various performance tests and material comparisons. The "acceptance criteria" can be inferred as successful completion of the listed tests and demonstrating comparable performance or safety profiles to the predicates.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (Summary from submission) |
|---|---|
| Dynamic Fatigue Performance (conforming to FDA guidance and ISO 14801) | Met: Dynamic fatigue testing was conducted, and the device (both subject and listed materials) demonstrated performance comparable to or exceeding predicate devices. The study results are deemed "satisfactorily addressed" via bench studies. |
| Software Validation (conforming to IEC 62304) | Met: Software validation was conducted. |
| Sterilization Validation (conforming to ISO 17665-1 and ISO/TS 17665-2) | Met: Sterilization validation was conducted for various materials, including those for the subject device and predicates. |
| Biocompatibility Testing | Met: Biocompatibility testing was conducted for various materials, including the subject device and predicates. |
| Material Equivalence (Ti-6Al-7Nb alloy for TiBase) | Met: Identical Ti-6Al-7Nb alloy used for both subject and predicate devices. |
| Dimensional Equivalence (Abutment Diameter) | Met: Identical abutment diameters (3.8 mm – 7.0 mm) for subject and predicate devices. |
| Functional Equivalence (Mode of Attachment) | Met: Identical screw-retained or cement-retained attachment for subject and predicate devices. |
| Manufacturing Workflow Equivalence | Met: Both traditional casting/pressing and Straumann Milling workflows are supported, identical to predicate where applicable. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the specific sample sizes for the test sets (e.g., number of units tested for fatigue, number of software test cases). It broadly states that "bench studies" were conducted.
- Sample Size: Not explicitly stated for performance tests.
- Data Provenance: The studies were internal "bench studies" conducted by Institut Straumann AG. The country of origin of the data is not specified, but the applicant is Institut Straumann AG (Switzerland), with a US contact address. The studies appear to be prospective as they were conducted to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in this context. The device is a physical dental implant component, not an AI/software device requiring expert interpretation for "ground truth" establishment of medical images or patient data. The "ground truth" for performance is based on established engineering standards (ISO, FDA guidance) and validated testing methods.
4. Adjudication Method for the Test Set
This is not applicable. As a physical device undergoing performance and material testing, there is no need for an adjudication method as would be relevant for clinical studies or AI diagnostic tools involving human interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not conducted and is not applicable for this type of device. An MRMC study is typically used for diagnostic devices (e.g., AI in radiology) where the performance of human readers with and without AI assistance is being evaluated. This device is a dental implant abutment, not a diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not conducted and is not applicable. This is a physical medical device, not a standalone algorithm. Its function is to be physically implanted and support dental restorations. While it supports digitally designed copings, the device itself is not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on established engineering standards, material science properties, and validated test methods. Specifically:
- Dynamic fatigue testing: Conformance to ISO 14801 and FDA guidance. This standard dictates how fatigue life is measured and evaluated.
- Software validation: Conformance to IEC 62304 for medical device software lifecycle processes.
- Sterilization validation: Conformance to ISO 17665-1 and ISO/TS 17665-2.
- Biocompatibility: Likely conformance to ISO 10993 series.
- Material specifications: Ti-6Al-7Nb alloy properties.
These standards and specifications define the "truth" against which the device's physical and functional performance is measured.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical component. It does not employ machine learning or AI that requires a "training set" of data in the conventional sense. The "training" for this device involves its design, engineering, and manufacturing process based on established dental implant principles.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8. There is no training set or ground truth in the context of machine learning for this device. The design and validation are based on engineering principles and regulatory standards.
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(262 days)
The Straumann CARES M-Series CAD/CAM System is indicated for the design and fabrication of single or multiple-unit implant-borne prosthetics for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners, CAD software, CAM software, restoration material blanks, milling machines and associated tooling and accessories. The system is used to design and fabricate CAD/CAM milled coping, crown and bridge restorations to be cemented onto Straumann® Variobase® Abutments, as well as milled abutments to be affixed to the endosseous dental implants of the Straumann® Dental Implant System using a basal screw.
The Straumann CARES M-Series CAD/CAM System is intended for the design and fabrication of dental restorations by dental laboratories by means of a digital workflow. The Straumann CARES M-Series CAD/CAM System employs optical impression files that document the topographical characteristics of teeth, traditional dental impressions, or stone models. The Straumann CARES Visual CAD software then allows the design of the desired restorations. The CAM software converts the digital restoration design into the tooling and tool path commands needed to fabricate the restoration. The CAM software also allows multiple restoration files to be combined (nested) in order to maximize the use of dental material blanks. The milling command file is encrypted prior to transfer to the M-Series mill; this encryption ensures that files generated using other CAD or CAM software cannot be used with the M-Series mill. The user will load the milling command file into the M-Series mill where it is decoded. The user loads the appropriate dental material blank and initiates the milling operation.
The provided document describes the acceptance criteria and the study that proves the Straumann CARES M-Series CAD/CAM System meets those criteria, primarily through a substantial equivalence comparison with predicate devices and various bench studies.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the document. Instead, performance is demonstrated through a claim of "equivalence" to predicate devices, which implicitly means meeting the performance standards of those legally marketed devices. The reported device performance is presented as "Equivalent" for various features when compared to predicate devices.
| Feature / Acceptance Criteria | Reported Device Performance (Equivalence Discussion) |
|---|---|
| Indications for Use (Straumann CARES M-SERIES CAD/CAM System vs. SIRONA DENTAL CAD/CAM SYSTEM) | Equivalent: The basic indication of providing support for prostheses scanning, design, and fabrication is the same. Support for TiBase-borne restorations is the same. The subject device indications refer to fabrication of coping, crowns, and bridges, including mesostructures (top-half of two-piece abutment), which are the same as referenced in the primary predicate indications. The crowns and bridges of the subject device are considered equivalent to hybrid abutments. The subject device also supports the fabrication of implant-connected solid abutments. This implies its performance meets the predicate for all these restoration types. |
| Source of Input Files | Equivalent: Capabilities of the subject device (Intra-Oral Scanner, Bench-top Scanners) include the scope of capabilities for the predicate device (Bench-top scanners). |
| Bench Scanner Control | Equivalent |
| Implant Detection | Equivalent: Both use Scanbodies. |
| Design Environment | Equivalent: Both are Closed CAD Systems facilitating the design of restorations, but for devices from different companies. Performance is considered equivalent in terms of design functionality. |
| Restoration Types Supported | Equivalent: Capabilities of the subject device (Copings/Crowns for Variobase, Copings/Crowns/Bridges for Screw-Retained Abutments, Bridges/Bars for Variobase for Bridge/Bar, Solid TAN Abutments) include the scope of capabilities for the predicate device (Copings/Crowns for TiBase, Copings/Crowns for Camlog Titanium Base). Both allow design and fabrication of the mesostructure for two-piece abutments (standard coping or hybrid crown/bridge). The subject device also allows design and fabrication of a one-piece titanium abutment. The areas of the abutment available for design are equivalent. |
| Supported Hardware Devices | Equivalent: Capabilities of the subject device (Straumann Variobase Abutments, Straumann Screw-Retained Abutments, Solid abutments) include the scope of capabilities for the predicate device (Sirona Ti-bases, Camlog Titanium Base). The subject devices provide support for implant-connected abutments. |
| Supported Restorative Materials | Equivalent: ZrO2 Ceramic material with indications according to ISO 6872 Classification are equivalent. The ZrO2 materials for use with the Straumann CARES M-Series CAD/CAM System have been previously cleared by FDA. The TAN material is identical to material used in CARES TAN Abutments (K150899). Straumann n!ce Blocks for Amann Girrbach were previously cleared (K170420). The use of the Ivoclar IPS e.max CAD material with Variobase Abutments has been cleared (K142890). The use of the n!ce material with Variobase Abutments has been cleared (K170354). This implies the milling performance and material properties for these materials meet prior predicate standards. |
| Restoration Sizes | Equivalent: Capabilities of the subject device (Single crown up to 16-Unit bridge) include the scope of capabilities for the predicate device (Single crown). Support of bridges through two or more implants is achieved through Variobase for Bridge/Bar abutments (K151157). Use of multiple implants in the bridge limit the force on the individual implant to be less or equivalent to that of the single crown. For a 16-unit bridge, the force is spread over 4 or more implants. |
| Interface to Ti-Base | Equivalent: The ability of the subject device to use solid blocks provides greater design flexibility to the user (compared to predicate's pre-milled blocks). |
| CAD to CAM Transfer | Equivalent: Seamless, same software interface. |
| CAM Capability | Equivalent: Capabilities of the subject device (Nesting, selection of tools/paths/speeds/feed rates, encryption) include the scope of capabilities for the predicate device (selection of tools/paths/speeds/feed rates). |
| CAM to Mill Transfer | Equivalent: Capabilities of the subject device (encrypted file format ensuring only Straumann CARES Visual and CAM Module files are accepted) include or exceed the scope of capabilities for the predicate device (expected transfer encryption). |
| Supported Mills | Equivalent: Capabilities of the subject device (Straumann CARES M-Series Mills) include the scope of capabilities for the predicate device (CEREC MCXL Mill, inLab MCXL Mill). |
| Fabrication Workflow | Equivalent: Capabilities of the subject device (Dry milling of partially crystallized ceramic, Wet milling of Ti-6Al-7Nb Pre-Milled Abutment Blanks, Ivoclar IPS e.max CAD, and n!ce Glass Ceramic) include the scope of capabilities for the predicate device (In-lab wet milling of pre-sintered ceramic blocks). |
| Variobase Abutments: Indications for Use | Identical to predicate Straumann Variobase Abutments (K142890, K120822). |
| Variobase Abutments: Ti-base Material | Identical: Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb). |
| Variobase Abutments: Abutment Diameter | Identical: 3.8 – 7.0 mm. |
| Variobase Abutments: Abutment Height | Identical: 3.5 – 4.5 mm. |
| Variobase Abutments: Coping/Crown Material | Equivalent/Identical: Digital workflow is expanded to add additional materials (Ceramill ZOLID series, Ivoclar IPS e.max CAD, Straumann n!ce). The Zi, ZOLID series are equivalent to predicate's zerion ZrO2 material. Use of n!ce and IPS e.max CAD is identical to previously cleared devices. |
| Variobase Abutments: Design Workflow | Equivalent: Subject employs a subset of predicate's techniques (CAD vs. Wax-up or CAD). |
| Variobase Abutments: Fabrication Workflow | Equivalent: Restorations milled by the dental laboratory are equivalent to those produced by the Straumann milling center. |
| Variobase Abutments: Mode of Attachment | Identical: Screw-retained or cement retained. |
| Variobase Abutments: Reusable | Identical: No. |
| Laboratory Milled CARES® TAN Abutments: Indications for Use | Identical to predicate Straumann® CARES® TAN Abutments (K150899). |
| Laboratory Milled CARES® TAN Abutments: Abutment Material | Identical: Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb, TAN). |
| Laboratory Milled CARES® TAN Abutments: Abutment Apical Design | Identical: Engaging, BoneLevel (NC, RC), Tissue Level (RN, WN). |
| Laboratory Milled CARES® TAN Abutments: Abutment Coronal Design | Identical: CADCAM design process, designs controlled by material-specific design limits in CARES Visual CAD software, model verification by CAM software, and milling blank dimensions. |
| Laboratory Milled CARES® TAN Abutments: CAD Design Limits | Identical: Max. Angulation 30°, Emergence Offset 0.1 mm, Emergence Angle 65°, Min. Thickness 0.4 mm, Smooth Distance 0.5 mm, Min post surface area 37 to 56mm². |
| Laboratory Milled CARES® TAN Abutments: Fabrication Method | Equivalent: Both methods use Straumann CARES Visual CAD software for design, applying the same validated limits. The difference is the manufacturing location (QSR controlled vs. dental laboratory). The milling accuracy of the Straumann CARES M-Series CAD/CAM System has been validated. Labeling has been revised and validated for milling unit installation, maintenance, and required tools/machine liquids/material blocks to ensure equivalence. |
| Laboratory Milled CARES® TAN Abutments: Directly Veneerable? | Identical: Yes. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" sample size in the context of clinical studies with patients. The studies conducted are primarily bench studies involving laboratory testing of materials and device components. The number of samples for each type of bench test (fatigue, biocompatibility, etc.) is not detailed in this summary, but these are typically standardized tests with a defined number of specimens as per the relevant ISO or FDA guidance.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective" clinical data, as it primarily refers to bench testing data. These tests would have been performed in a controlled laboratory environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable. The evaluations are based on engineering and material performance specifications (bench studies) and comparison to predicate devices, not on expert clinical review of a test set for establishing ground truth in a diagnostic sense.
4. Adjudication Method for the Test Set
This information is not applicable, as the evaluation is based on bench testing and comparison to technical specifications, not human adjudication of diagnostic data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is a CAD/CAM system for fabricating dental prosthetics, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to improving human reader performance with AI is not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document describes the Straumann CARES M-Series CAD/CAM System as an integrated system involving CAD software, CAM software, milling machines, and material blanks. The "algorithm" component is the CAD/CAM software. The system's performance is inherently "standalone" in its function of designing and fabricating prosthetics based on input scan files, but it is a tool used by human operators (dental technicians/laboratories). The bench studies performed evaluate the output of this system (e.g., strength of the milled prosthetics), which indirectly assesses the standalone performance of the algorithms and hardware in creating the physical restorations.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the bench studies, the "ground truth" refers to established engineering and material standards. Specifically:
- Dynamic fatigue testing: Conforming to FDA guidance and ISO 14801. The ground truth is the performance criteria defined by these standards.
- Software validation: Conforming to the requirements of IEC 62304. The ground truth is compliance with this software safety standard.
- Sterilization validation: Conforming to ISO 17665-1 and ISO/TS 17665-2. The ground truth is achieving sterility assurance levels defined by these standards.
- Biocompatibility testing: Conforming to ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, and ISO 10993-18. The ground truth is meeting the safety criteria for biological interaction.
- Electrical safety testing: Conforming to IEC 61010-1 and IEC 61010-2-010. The ground truth is compliance with electrical safety standards.
For the substantial equivalence comparison, the "ground truth" is the performance and characteristics of the legally marketed predicate devices.
8. The Sample Size for the Training Set
The document does not refer to a "training set" in the context of machine learning. The CAD/CAM software is likely based on computational design and manufacturing principles, not on a machine learning model that requires a labeled training set derived from large datasets of past cases. Therefore, this concept is not applicable here.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" in the machine learning sense, this question is not applicable. The underlying principles for the software's functionality would stem from dental anatomical knowledge, engineering mechanics, material science, and manufacturing tolerances, which form the basis of its deterministic operation.
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(170 days)
The Straumann n!ce Glass Ceramic A14 Blocks are intended to be ceramic mesostructures cemented to the Ti-base for a two-piece hybrid abutment for single tooth restorations or hybrid abutment crowns, used in conjunction with endosseous dental implant to restore chewing function. The following compatibilities apply:
| Ti-Base | Block | ||
|---|---|---|---|
| manufacturer | system | Reference | interface size |
| Straumann | RC Variobase® for CEREC | 022.0024 | L |
| NC Variobase® for CEREC | 022.0025 | L | |
| RN Variobase® for CEREC | 022.0019 | L | |
| WN Variobase® for CEREC | 022.0020 | L |
Straumann® n!ce® glass ceramic is a proprietary lithium disilicate (Li2O-SiO2) dental glass ceramic material. The n!ce® glass-ceramic A14 blocks feature a pre milled interface that fits the Straumann® Variobase® for CEREC®. The blocks are further processed by the trained professional to make individually designed mesostructure that are milled into the desired shape of a hybrid abutment or hybrid abutment crown using the Sirona inLab (Version3.65) and CEREC® software (Version 4.2). n!ce® mesostructures can be additional crystallization firing. Stain & glaze techniques can be applied.
n!ce® A14 blocks are available in two levels of translucency: HT (High Translucency) and LT (Low Translucency). Both translucencies are available in shades , A1, A2, A3, B2, B4 and C2 for flexibility and application variety to meet individual patient needs. n!ce®A14 blocks are available with one interface size large (L)
The provided text describes the submission for a 510(k) premarket notification for the "Straumann® n!ce Glass Ceramic A14 Blocks," a dental device. It focuses on demonstrating substantial equivalence to a predicate device, rather than outlining acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device.
Therefore, many of the requested items (Acceptance Criteria Table, Sample Size for Test Set, Data Provenance, Number of Experts, Adjudication method, MRMC study, Standalone performance, Training set size, Training set GT establishment) are not applicable to this type of regulatory submission, as it is for a physical dental material block, not an AI/ML algorithm.
However, I can extract the "Performance Data" section which describes the types of tests conducted to support the device's safety and effectiveness and its substantial equivalence.
Here's the information that can be extracted from the document, focusing on what is relevant to "acceptance criteria" and "study."
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" paired with "reported device performance" in the way one might expect for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, it lists the types of performance tests that were conducted and implied their results supported substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| ISO 6872 compliance | Test data submitted or referenced to support the evaluation of the subject n!ce® Glass-Ceramic A14 Blocks, indicating compliance with ISO 6872 (Dentistry-Ceramic materials). |
| ISO 14801 compliance | Test data submitted or referenced, indicating compliance with ISO 14801 (Dentistry-Implants-Dynamic fatigue test for endosseous dental implants). |
| FDA guidance compliance | Test data submitted or referenced, indicating compliance with FDA guidance "Root-form endosseous dental implants and endosseous dental implant abutments." |
| ISO 7991 compliance | Test data submitted or referenced, indicating compliance with ISO 7991 (Glass—Determination of coefficient of mean linear thermal expansion). |
| ISTA 2A compliance | Transport and package testing per ISTA 2A and the standards referenced therein was submitted or referenced. |
| Sterilization effects | Effects of steam sterilization on product performance consistent with FDA guidance "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling, Guidance for Industry and Food and Drug Administration Staff, Appendix C" were evaluated. |
| Steam sterilization | Steam sterilization validation per ISO 17665 series standards was conducted. |
| Biocompatibility | Biocompatibility assessment per the ISO 10993 series of standards was conducted. |
| Chemical characterization | Chemical characterization per ISO 10993-18 (Biological evaluation of medical devices—Part 18: Chemical characterization of materials) was conducted. |
| Shelf life | Evaluation of shelf life per ASTM F1980 (Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices) was conducted. |
| Processing/Machinability | Laboratory processing including Workflow validation, and Machinability of blocks were performed. "The compatibility of the n!ce glass blocks with the existing IPS e.max CAD milling program is validated as part of this submission." (Implies successful milling and processing according to existing dental CAD/CAM systems). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to various standards and guidances but does not detail the specific sample sizes or the provenance of the data for each test.
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 is not applicable as the document describes a physical dental material, not an AI/ML device requiring expert-established ground truth for a diagnostic task.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the document describes a physical dental material.
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 is not applicable as the document describes a physical dental material.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the document describes a physical dental material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the context of an AI/ML diagnostic device. For the dental material, "ground truth" would relate to its physical, chemical, and mechanical properties as defined by relevant ISO and ASTM standards and confirmed through laboratory testing.
8. The sample size for the training set
This is not applicable as the document describes a physical dental material, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as the document describes a physical dental material.
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