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510(k) Data Aggregation
(212 days)
Materials cleared by the FDA under 21 CFR
872.6660 or exempt materials as described
under 21 CFR 872.3060
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 workflow is unchanged from the primary predicate K171649. This premarket notification is introducing the Straumann Variobase Abutments for the BLX implant to abutment interface to the previously cleared 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.
This premarket notification includes restorations (copings, and bridges) manufactured from Zolid HT/Zolid SHT materials for cementation on Straumann Variobase Abutments for the BLX implant system. The BLX dental implant platforms include RB (Regular Base) and RB/WB (Regular Base/Wide Base). The combination of the coping, crown, or bridge and the Variobase Abutment component make up a two-piece abutment assembly, which is used in conjunction with endosseous dental implants for single or multiple tooth dental prostheses.
Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dynamic Fatigue Test (Straumann BLX Variobase with Zolid SHT and Zolid HT crowns) | Demonstrated equivalence to the primary predicate and reference devices 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 Abutments". | The tests demonstrated that the Straumann BLX Variobase with Zolid SHT and Zolid HT crowns are equivalent to the primary predicate and reference devices. |
| Milling System Validation | Confirmation that dimensions of milled restoration were the same as the intended CAD design from CARES Visual. | Leveraged from K171649, confirming the dimensions of the milled restoration were the same as the intended CAD design from CARES Visual. (Subject devices were not considered a new worst case, so existing validation was referenced). |
| Simulated Use Validation | Confirmation of scan, design, and production capability of the subject devices in CARES Visual. | Leveraged from K171649, confirming the scan, design, and production capability of the subject devices in CARES Visual. (Subject devices were not considered a new worst case, so existing validation was referenced). |
| Sterilization Process Validation | Validation according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". | The sterilization process for the Straumann Variobase as recommended in the labeling was validated. |
2. Sample Size Used for the Test Set and Data Provenance
Specific sample sizes for the test set of the dynamic fatigue tests, milling system validation, and simulated use validation are not explicitly stated in the provided document.
The document mentions that the studies were "leveraged from K171649" (the primary predicate device) and that "the subject devices were not considered a new worst case." This implies that the validation data was likely historical or previously collected for the predicate device.
Regarding data provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not explicitly stated, but "leveraged from K171649" suggests a retrospective application of existing data and validation reports.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The studies mentioned are primarily engineering and performance tests (dynamic fatigue, dimensional accuracy, sterilization efficacy) and do not involve human expert interpretation of device output in a diagnostic or clinical context to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as the studies described are performance and engineering validations, not studies involving human interpretation or clinical adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned in the document. The device described is a CAD/CAM system for fabricating dental prosthetics, which is a manufacturing process, not an AI-powered diagnostic or interpretive tool that would typically be evaluated with MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Milling System Validation" and "Simulated Use Validation" could be considered forms of standalone performance evaluation for the CAD/CAM system's components (software outputs, milling accuracy).
- Milling System Validation: Confirmed "the dimensions of the milled restoration were the same as the intended CAD design from CARES Visual." This evaluates the algorithm's (CAD/CAM software's) ability to translate digital design into physical form, without human intervention in the final output quality check for the purpose of this specific validation.
- Simulated Use Validation: Confirmed "the scan, design, and production capability of the subject devices in CARES Visual." This also assesses the system's performance in a simulated workflow.
The dynamic fatigue tests evaluate the physical product, not directly the algorithm's performance.
7. The Type of Ground Truth Used
- Dynamic Fatigue Test: Ground truth is established by the specified FDA guidance document regarding performance requirements for dental implants and abutments. This involves objective physical testing against performance standards.
- Milling System Validation: The "intended CAD design from CARES Visual" serves as the ground truth against which the milled restoration is compared for dimensional accuracy.
- Simulated Use Validation: The expected functional capability of the system (scan, design, production) serves as the ground truth.
- Sterilization Process Validation: The ground truth is adherence to the validated sterilization parameters and expected sterility assurance levels as defined by the FDA guidance document.
8. The Sample Size for the Training Set
This information is not provided in the document. The device is a CAD/CAM system, and while CAD/CAM software development might involve training (e.g., machine learning for design optimization or material properties), the submission focuses on validating the manufacturing process and the final product's performance, not the training of an AI model in the typical sense. The "training set" for the CAD/CAM system would implicitly be the engineering data and design principles embedded in the software.
9. How the Ground Truth for the Training Set Was Established
As above, this information is not provided. If there were any AI/ML components in the CAD/CAM software that involved "training," the method for establishing ground truth for that training is not discussed. For the broader CAD/CAM system's engineering and design, the ground truth would typically be established through established engineering principles, material science, and preclinical testing to ensure precise and functional designs.
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(90 days)
Materials cleared by the FDA under 21
CFR 872.6660 or exempt materials as
described under 21 CFR 872.3060
Materials cleared by the FDA under 21
CFR 872.6660 or exempt materials as
described under 21 CFR 872.3060
Straumann BLX Healing Abutments for Bars and Bridges: Straumann 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 form, maintain and stabilize the soft tissue during the healing process. Healing abutments should be used only with suitable implant connections. Healing components have a maximum duration of usage of 6 months.
Straumann BLX Temporary Abutments for Bars and Bridges: 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 BLX Variobase Abutments for Bar and Bridges: 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 (bridge or overdenture) can be cemented on the Straumann® Variobase® prosthetic components. 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. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.
Straumann BLX Variobase Abutments AS: 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.
Straumann BLX Novaloc Abutments: The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants.
Straumann BLX CARES Abutments: The Straumann CARES Abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.
BLX Healing Abutments for Bars and Bridges: Healing abutments are screwed into the implant in cases of transmucosal healing to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. They are placed out of occlusion and have a maximum duration of usage of 180 days. Unlike the predicate RB/WB healing abutments (K173961), the subject healing abutments are intended to shape the soft tissue for posterior placement of bridge restorations instead of single crowns. The subject healing abutments are manufactured from Titanium Grade 4 and are anodized in violet.
BLX Temporary Abutments for Bars and Bridges: Temporary Abutments are intended to be placed into Straumann dental implants to provide support for temporary restorations. 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, as well as provide a temporary esthetic solution. They support a temporary restoration and may not be placed into of occlusion. Straumann BLX Temporary Abutments have a maximum duration of usage of 180 days. Unlike the predicate RB/WB temporary abutments (K173961), the subject temporary abutments are intended to shape the soft tissue for posterior placement of bridge restorations instead of sinqle crowns. The subject temporary abutment cannot be shortened. The Temporary abutment for bar/bridge is a non-engaging device intended to support multiple-unit restoration. The subject temporary abutment is manufactured from TAN and is anodized in violet. The temporary abutments are fixed in the implant by means of a basal screw which is also manufactured from TAN.
BLX Variobase Abutments for Bars and Bridges: Variobase Abutments for Bars and Bridges are intended to be placed into Straumann implants to provide support for multi-unit restorations. The prosthetic restoration (bar/bridge) must be cemented onto the Variobase abutments, which is then screwed onto the implants. 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. Unlike the predicate Variobase abutments (K173968), the subject Variobase abutments present 3 retention features in the chimney instead of 4. The Variobase abutments for bar/bridges are non-engaging devices intended to support multiple-unit restorations. The subject Variobase abutments are manufactured from TAN and are anodized in violet. The Variobase abutments are fixed in the implant by means of a basal screw which is also manufactured from TAN.
BLX Variobase Abutments AS for Crowns: Variobase abutments AS for crowns are intended to be placed into Straumann implants to provide support for single-unit restorations. The prosthetic restoration (crown) must be cemented onto the Variobase abutment, which is then screwed onto the implant. 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. The Variobase abutments are manufactured from TAN and are anodized in violet or in brown according to the compatible BLX implant platform (RB/WB or RB). Unlike the predicate Variobase abutments (K173961/K173379), the subject Variobase abutments present 3 retention features in the chimney instead of 4. The chimney presents a cutout window to facilitate the handling of the screw driver in an angulated position. The Variobase abutments AS for crown are engaging devices intended to support single-unit restorations. The Variobase abutments are fixed in the implant by means of a basal screw which is also manufactured from TAN. The Variobase abutments for crown AS are titanium bases to be used as the lower part of two-piece abutments. The upper part of the two-piece abutment is a CAD/CAM designed and manufactured restoration. The planning and milling of the customized restoration must be made using the validated Straumann CARES Visual, Dental Wings software using the Straumann CARES Visual Plug-In. All digitally designed copings and/or crowns for use on the Variobase abutments are intended to be manufactured at a validated milling center.
BLX Novaloc Abutments: Novaloc Abutments are intended to be placed into Straumann dental implants to provide support for full arch detachable restorations (over-denture). The Novaloc abutments are manufactured from TAV (Ti-6Al-4V, Titanium-Aluminum-Vanadium) and are anodized in violet. The restoration is connected to the Novaloc abutment through a snap-on fixture provided by a negative shape of Novaloc snap-on fixture embedded into the final restoration. The snap-on feature is TiN coated. Unlike the reference Novaloc abutments (K173902), the subject Novaloc abutments are not only provided in a straight version but also angulated. The Novaloc abutments are provided non-sterile with instructions for end user sterilization. Angled models: are composed of an abutment body with a coupled basal screw. They are engaging devices. Straight models: both body and thread parts are machined in one piece. They are nonengaging devices.
BLX CARES Abutments: CARES Abutments are intended to be placed into Straumann implants to provide support for prosthetic reconstructions such as crowns and bridges. The final abutment, fabricated from a pre-milled blank, is designed to allow for individual customization regarding function and esthetics. The blank, manufactured from TAN and CoCr, is composed of a pre-milled implant-toabutment connection (TorcFit) and a cylindrical body with enough material volume to create a wide range of geometries for the final abutment. Inside the abutment, a screw channel provides access to the internal thread feature of the implant, such that the component can be firmly attached while providing fit between screw, abutment and implant. The planning and milling of the customized restoration must be made using the validated Straumann CARES Visual, Dental Wings software using the Straumann CARES Visual Plug-In. The maximum angulation allowed is 30° and the minimum wall thickness allowed is 0.4 mm. All digitally designed abutments are intended to be manufactured at a validated milling center.
BLX Basal Screws: Basal screws are used to fix abutments to dental implant, and can also be used during lab procedures to fix lab prosthetic parts on implant analogs. They are provided along the abutments and also provided as standalone screws. The subject Basal Screws are manufactured from TAN. The Basal Screw for Variobase AS is anodized in green since this color identifies Straumann devices pertaining to AS system.
The provided 510(k) summary for the Straumann® BLX Line Extension - New Abutments is a pre-market notification to the FDA. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than proving the device meets acceptance criteria through a traditional clinical study with defined performance targets.
Instead of "acceptance criteria," the focus here is on bench testing performance demonstrating fundamental material and structural integrity compared to predicate devices, and lack of significant differences in technological characteristics and indications for use.
Therefore, the requested information elements related to clinical studies, test sets, ground truth, and expert adjudication are not applicable in the context of this 510(k) summary, as no device-specific clinical data has been submitted to demonstrate substantial equivalence. The submission relies on performance data from bench testing and biocompatibility assessments to support the claim of substantial equivalence.
Here's the information that can be extracted from the provided text, re-interpreting "acceptance criteria" as the comparable characteristics to predicate devices and "reported device performance" as the results of the bench and biocompatibility tests.
Acceptance Criteria and Study Details for Straumann® BLX Line Extension - New Abutments
As this is a 510(k) submission primarily relying on substantial equivalence to predicate devices, the concept of "acceptance criteria" is less about meeting specific numerical performance targets in a clinical setting and more about demonstrating that the new devices do not raise new questions of safety or effectiveness. The study supporting this is primarily bench testing and biocompatibility assessments, rather than a clinical trial.
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for a 510(k) are implicitly that the new device's technological characteristics and performance are substantially equivalent to a predicate device, without raising new questions of safety or effectiveness. The "reported device performance" refers to the results of the bench tests and sterility/biocompatibility validations.
| Characteristic / "Acceptance Criteria" | Reported Device Performance (Summary) | Supporting Study/Method |
|---|---|---|
| Technological Characteristics | Equivalent or minor differences from predicate devices (e.g., material, connection type, dimensions). Differences found to be non-significant. | Comparison matrices (Tables 1-6) against predicate and reference devices. |
| Material Biocompatibility | Biologically safe. | Biocompatibility testing according to ISO 10993-1:2009 and FDA Guidance. |
| Sterilization Efficacy | Achieves SAL of 10^-6 (for sterile products). | Validation according to ISO 11137-1:2006 and ISO 11137-2:2013 (for healing abutments), and ISO 17665-1/2 for end-user sterilization. |
| Pyrogenicity | Meets pyrogen limit specifications ( |
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(200 days)
Materials cleared by the FDA under 21 CFR
872.6660 or exempt materials as described
under 21 CFR 872.3060
Materials cleared by the FDA under
21 CFR 872.6660 or exempt
materials as described under 21 CFR
872.3060
Straumann® Variobase™ for Bridge/Bar Cylindrical prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The patient-specific prosthetic restoration (bridge or over-denture) can be cemented on the Straumann® Variobase™ for Bridge/Bar Cylindrical prosthetic components. 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. Straumann® Variobase™ for Bridge/Bar Cylindrical and patient-specific restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed Straumann® Variobase® for Bridge/Bar Cylindrical prosthetic components are intended to be sent to Straumann for manufacture at a validated milling center.
The Straumann® Variobase™ for Bridge/Bar Cylindrical, see Figure 1 and Table 1, are non-engaging (without rotational lock) abutments made from Ti-6Al-7Nb (TAN) that support a bridge or bar reconstruction (framework or full contour) on two or more dental implants. The corresponding basal screw is delivered with the abutment for connecting the abutment to the implant. A dental laboratory technician designs and manufactures the bridge/bar reconstruction via their preferred workflow using traditional or CAD/CAM methods.
This document is a 510(k) premarket notification for a medical device called "Straumann® Variobase™ for Bridge/Bar Cylindrical". It does not describe a study that uses software, AI, or machine learning. Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies as these concepts are not applicable to the provided document.
The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and bench testing (dynamic fatigue, software validation, sterilization validation, and biocompatibility testing) for a dental implant abutment. The "Software validation conforming to the requirements of IEC 62304" mentioned in the Performance Data section refers to the validation of software used in the manufacture of the device (specifically, for digitally designed components intended to be sent to a validated milling center), not a clinical performance or diagnostic AI component of the device itself.
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(96 days)
Materials cleared by the FDA
under 21 CFR 872.6660 or
exempt materials as described
under 21 CFR 872.3060
Straumann® Variobase™ prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration (bridge or over-denture) can be cemented on the Straumann® Variobase™ prosthetic components. 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. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.
Straumann® Variobase® abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as bridges and over-dentures.
The Straumann Variobase Abutments for Bars & Bridges are non-engaging abutments made from Ti-6Al-7Nb (TAN) that support a bridge or bar reconstruction (framework or full contour) on two or more dental implants. The corresponding basal screw is delivered with the abutment for connecting the abutment to the implant. A dental laboratory technician designs and manufactures the bridge/bar reconstruction via their preferred workflow using traditional or CAD/CAM methods.
The provided text is a 510(k) Summary for the Straumann® Variobase® Abutment for Bridges/Bars. It outlines the characteristics of the device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the typical sense of a diagnostic or clinical performance study.
Instead, the "study" referred to is a bench study focused on mechanical performance and material characteristics to demonstrate substantial equivalence to legally marketed predicate devices, rather than a clinical study evaluating diagnostic accuracy or effectiveness.
Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
The document doesn't present explicit "acceptance criteria" in a quantitative, pass/fail table for clinical performance. Instead, it discusses "equivalence" based on various features and a dynamic fatigue test.
| Feature/Characteristic | Acceptance Criteria (Implied by Equivalence) | Reported Device Performance |
|---|---|---|
| Indications for Use | Within the scope of the predicate devices. | "The basic indication of providing support for prostheses is identical. Where the predicate is indicated for both single-unit and multi-unit restorations, the subject devices are only suitable for multi-unit restorations. This limited indication is within the scope of the indication of the predicate devices." (Equivalent) |
| Abutment Material | Identical to predicate device material (Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb)). | "Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb)" (Identical) |
| Abutment Diameter | Within the range of predicate device diameters. | "Subject device diameters are within the range of diameters for the predicate device." (Subject: 4.2 - 7.0 mm, Predicate: 3.8 - 7.0 mm) (Equivalent) |
| Abutment Height | Same minimum height as predicate; taller variants' performance addressed via bench testing. | "The subject devices have the same minimum height as the Variobase predicates. Performance of the taller subject device is addressed via bench testing." (Subject: 3.5 – 5.2 mm, Predicate: 3.5 – 4.5 mm) (Equivalent) |
| Abutment Apical Design | Morse taper portion identical to predicate; non-engaging feature for multi-unit restorations. | "The Morse taper portion of both the subject and Variobase predicate devices are identical. Non-engaging abutments are necessary so as not to introduce mechanical constraints in the framework that would affect fit." (Equivalent) |
| Abutment Coronal Design | Conic taper within the range established by reference predicates. | "The conic taper of the subject devices is within the range established by the synOcta and Multibase predicates." (Equivalent) |
| Restoration Material | Within the scope of materials indicated for the predicate devices. | "The range of materials cleared for use with the predicate devices is within the scope of materials indicated for the subject devices." (Equivalent) |
| Design/Manufacturing Workflow | Identical to predicate. | "Identical" |
| Mode of Attachment | Identical to predicate (Screw-retained or cement retained). | "Identical" |
| Reusable | Identical to predicate (No). | "Identical" |
| Dynamic Fatigue | Satisfactorily addressed via bench studies and consistent with FDA guidance and ISO 14801. (Implied: Device must meet or exceed performance of predicate or relevant standards.) | "Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced in support of this submission." This indicates the device passed these structural integrity tests relevant to dental implants and abutments. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily relies on bench testing for dynamic fatigue. It doesn't specify a sample size for this testing other than "data have been referenced." No information is provided about data provenance ( країни of origin or retrospective/prospective nature) as it's not a clinical data study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable here because the "test set" refers to physical samples for mechanical testing (dynamic fatigue), not a dataset for a diagnostic algorithm where expert ground truth would be established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies, not for mechanical bench 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
This is not applicable. The device is an endosseous dental implant abutment, a physical component, not an AI or diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the mechanical performance standards (e.g., ISO 14801 for dynamic fatigue) and the material properties of the device, which are evaluated through bench testing. There is no biological or diagnostic "ground truth" from human subjects involved in this 510(k) submission for mechanical equivalence.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not a machine learning or AI-based device.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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(36 days)
Silver Creek, New York 14136
Re: K052463
Trade/Device Name: Prometal HN86 Regulation Number: 21 CFR 872.3060
HIGH NOBLE DENTAL ALLOY FOR THE FABRICATION OF SINGLE CROWNS, BRIDGES, INLAYS AND ONLAYS.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a dental alloy named "PROMETAL HN86." This document grants market clearance based on substantial equivalence to a predicate device. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or clinical effectiveness studies (like MRMC or standalone performance).
Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them based on the given text. The document is primarily a regulatory clearance notification.
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(83 days)
Pineview Drive Amherst, New York 14228
Re: K041433
Trade/Device Name: Bright Gold xh Regulation Number: 872.3060
Brite Gold XH alloy intended to be used for onlays, % crowns, crowns and short span bridges PFM crowns
Bright Gold
I am sorry, but based on the provided text, I cannot provide a description of the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a dental alloy named "Bright Gold xh" (and later corrected to "Brite Gold XH").
The letter states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the device has been found to be as safe and effective as a device already on the market, but it does not include details about specific performance acceptance criteria or a study demonstrating that the device meets those criteria.
The document primarily focuses on:
- The device name and regulation details.
- The FDA's finding of substantial equivalence.
- Regulatory requirements and responsibilities for the manufacturer.
- The intended indications for use (onlays, ¾ crowns, crowns, short span bridges, PFM crowns).
It does not contain the specific information requested in your prompt regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance of a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for the training set was established.
These kinds of details would typically be found in the premarket notification submission itself (which is not provided here) or in a separate study report, not in the FDA's clearance letter.
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(70 days)
Suite 215 Anaheim, California 92804
Re: K041378
Trade/Device Name: BIO 60 Regulation Number: 21 CFR 872.3060
BIO 60 is intended for use in the fabrication of implant superstructures and gold cylinders for dental implants.
Gold cylinder for using UCLA Abutment
This K041378 submission for the BIO 60 device, a gold cylinder for UCLA Abutment, relies on a comparison to a legally marketed predicate device, the Southern Implants Cylinder, using established industry standards rather than a clinical study with acceptance criteria in the traditional sense. Therefore, many of the requested fields are not applicable (N/A) as this is a material comparison and not an AI/software device.
Here's an analysis of the provided information based on the requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Performance) | Reported Device Performance (BIO 60) |
|---|---|
| Composition (weight) | |
| Au (%): 60.00 | Au (%): 60.00 |
| Pt (%): 19.00 | Pt (%): 15.20 |
| Pd (%): 20.00 | Pd (%): 24.00 |
| In (%): 1.0 | In (%): 0.8 |
| Physical and Mechanical Properties | |
| Melting Point Range (°F): 1,475 | Melting Point Range (°F): 1,400-1,490 |
| Hardness (vickers): 265 | Hardness (vickers): 250 |
| Proof Strength (0.2%): 635 N/mm-2 | Proof Strength (0.2%): 645 N/mm-2 |
| CTE (x10-6/°C): 12.0 | CTE (x10-6/°C): 11.8 |
| Density (g/c x103m3): 18.5 | Density (g/c x103m3): 17.9 |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This submission is for a material comparison based on established test methods (ANSI/ADA 5 and ISO 9693) for dental alloys, not a clinical study on a "test set" in the context of image analysis or AI. The performance data presented are for the material itself.
- Data Provenance: The data provenance is derived from laboratory testing of the material's properties according to the specified standards. The country of origin of the data is not explicitly stated but would presumably be from the manufacturer's testing facilities or a contracted lab. This is retrospective data, as it reflects the properties of the manufactured material.
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 would refer to the accurate measurement of material properties, which are established through standardized laboratory tests, not by expert consensus or interpretation of images. The 'truth' is the measured physical and chemical properties.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically employed in studies where expert interpretation or consensus is required (e.g., medical imaging reads). This submission relies on objective, repeatable laboratory measurements of material properties.
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 submission is for a dental material (gold cylinder), not an AI or software device. Therefore, no MRMC study, human readers, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This submission is for a dental material, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the material comparison is the measured physical and chemical properties of the alloy, determined according to recognized industry standards (ANSI/ADA 5 and ISO 9693). This is objective, quantitative data from laboratory testing.
8. The sample size for the training set
- Not applicable. This submission is for a material comparison, not an AI or machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI device, this question is not relevant.
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(73 days)
Classification name: Product code: C.D.R section: Classification:
Alloy, gold based, for clinical use EJT 872.3060
Strabe 13 D-75 179 Pforzheim GERMANY
Re: K040672
Trade/Device Name: Porta Reflex Regulation Number: 872.3060
Porta Reflex is a gold-platinum alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Inlays/ Onlays, Partial crowns, Crowns, Short span bridges, Long span bridges, Removable partials and can be used for Telescopic and milling work. Porta Reflex can be veneered with suitable dental ceramics as well as with dental-composites.
Porta Reflex is an extra-hard gold-platinum ceramic alloy with high contents of noble metals (97,7%), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from inlays/onlays and crowns, up to long span bridges with two or more pontics and removable partials. It is free of copper and therefore suitable for telescopic and milling work. Porta Reflex is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. Porta Reflex can be veneered with suitable dental ceramics and with dental composites, in which the golden yellow color of the alloy provides an excellent basis for manufacturing aesthetically pleasing dental restorations.
Here's an analysis of the provided 510(k) summary for the Porta Reflex device, focusing on the acceptance criteria and study information:
This document, K040672 for "Porta Reflex," is a 510(k) Premarket Notification. For this type of device (a dental alloy), 510(k)s typically demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria that one might see for AI/ML-based diagnostic devices.
Therefore, the structure of the request for acceptance criteria and study data needs to be interpreted in the context of this specific device and filing type. The "study" here is primarily a demonstration of compliance with established standards and comparison to a predicate, not a clinical effectiveness trial in the way that an AI diagnostic would have.
Acceptance Criteria and Reported Device Performance
Given that this is a dental alloy and a 510(k) submission, the "acceptance criteria" are typically compliance with recognized standards and demonstration of properties comparable to a predicate device, rather than specific sensitivity/specificity targets.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with International Standard ISO 9693 | "Porta Reflex... fully complies to the international standard ISO 9693" |
| Compliance with European Directive 93/42/ECC | "Porta Reflex... fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." |
| High Corrosion Resistance | "Porta Reflex is highly corrosion resistant" |
| Excellent Biocompatibility | "Porta Reflex... has an excellent biocompatibility." |
| Suitable for Vennering with suitable dental ceramics | "Porta Reflex can be veneered with suitable dental ceramics..." |
| Suitable for Vennering with dental composites | "...and with dental composites" |
| Golden yellow color (aesthetic basis) | "...the golden yellow color of the alloy provides an excellent basis for manufacturing aesthetically pleasing dental restorations." |
| No copper (for telescopic/milling work) | "It is free of copper and therefore suitable for telescopic and milling work." |
| Legally Marketed Equivalent Device (Predicate) | Porta Geo Ti (K023389) -- The entire 510(k) aims to demonstrate equivalence to this predicate. |
Study Information
For this type of device, the "study" is more akin to engineering and materials testing, and a comparison to an existing predicate, rather than a clinical trial with human subjects testing AI performance.
-
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes or data provenance for any specific mechanical or material property tests. This information would typically be detailed in the full submission, which is not provided, but often isn't explicitly summarized in the 510(k) summary itself for materials devices. The "tests" here are standard material characterization tests, likely conducted in a lab setting, not on patient data.
-
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 as this is not a diagnostic device involving expert interpretation of medical images or patient data. The "ground truth" would be material properties established via standardized lab measurements.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a clinical study requiring adjudication of diagnoses.
-
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/ML device, nor a diagnostic device that would involve human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm/AI device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device would be established through laboratory material characterization tests conforming to ISO 9693 and other relevant engineering standards. These tests measure properties like tensile strength, corrosion resistance, biocompatibility, etc.
-
The sample size for the training set
- Not applicable. There is no AI/ML model for which to define a training set. If interpreted in a broader sense of "development data," it would refer to the materials used in R&D and optimization, but this is not specified.
-
How the ground truth for the training set was established
- Not applicable. There is no AI/ML model for which to define a training set. The "ground truth" for development would be the target material properties and performance characteristics defined by engineering specifications and industry standards.
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(80 days)
Classification name: Product code: C.D.R section: Classification:
Alloy, gold based, for clinical use EJT 872.3060
13 D-75179 Pforzheim GERMANY
Re: K040524
Trade/Device Name: Porta Solder 1090 W Regulation Number: 872.3060
Porta Solder 1090 W is intended for use as a solder before firing in operations in which dental ceramic alloy(s) parts are joined to form a dental restoration. It should be used only together with recommended dental alloys with suitable melting ranges and compositions
Porta Solder 1090 W is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a white alloy with high contents of precious metals (Gold, Palladium, Iridium and Silver: 95,5%). Porta Solder 1090 W is suitable for use as a filler material in operations in which dental alloy(s) parts are joined to form a dental restoration, e.g. bridges. It is intended as solder before firing for ceramic dental alloys with appropriate melting ranges and compositions, especially Euro 50, which is manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany. Porta Solder 1090 W is highly corrosion resistant. It fully complies to the international standard ISO 9333 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
The provided text describes a 510(k) premarket notification for a dental brazing alloy called "Porta Solder 1090 W." The submission focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or comparative effectiveness studies typically associated with AI/software-as-a-medical-device (SaMD) clearances.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics for an AI/SaMD device are not applicable to this document. The document describes a traditional medical device (a dental alloy).
Here's an analysis based on the information provided, highlighting the sections that are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category (Typical for SaMD) | Specific Criteria (N/A for this device) | Reported Performance (N/A for this device) |
|---|---|---|
| Mechanical Properties | (Not explicitly stated as "acceptance criteria" but implied benchmarks for dental alloys) | "fully complies to the international standard ISO 9333" |
| Corrosion Resistance | (No specific numeric criteria given, but general statement) | "highly corrosion resistant" |
| Biocompatibility | (Implied by regulatory compliance) | Fulfills essential requirements of European directive 93/42/ECC |
| Material Composition | (Not an "acceptance criteria" in the context of a performance study, but a characteristic) | High contents of precious metals (Gold, Palladium, Iridium and Silver: 95.5%) |
| Melting Range/Suitability | (Implicitly matched with ceramic dental alloys) | Suitable for use as filler material in operations where dental alloy parts are joined. Intended as solder before firing for ceramic dental alloys with appropriate melting ranges and compositions. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable as this is a dental alloy, not an AI/SaMD device that would typically have a "test set" in the context of algorithm performance. The "study" referenced in the document is the process of comparing the Porta Solder 1090 W to its predicate device, Argesol-WSF (K 942505), to establish substantial equivalence based on material properties and intended use. There is no mention of a "test set" of patients or data in the way an AI study would define it.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable. The "ground truth" for a dental alloy typically refers to its physical, chemical, and mechanical properties, as measured by standardized tests, and its compliance with industry standards (like ISO 9333) and regulatory requirements. It is not established by expert consensus on clinical findings in the same vein as an AI diagnostic device.
4. Adjudication Method for the Test Set
This information is not applicable. There is no "test set" of clinical cases requiring adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. An MRMC study is relevant for evaluating the impact of AI assistance on human readers for diagnostic tasks. This device is a dental alloy for fabrication, not a diagnostic tool where human readers interact with AI.
6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study
This information is not applicable. This device is a physical dental alloy, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device is based on:
- Material Science and Engineering Properties: Chemical composition, melting range, corrosion resistance, and mechanical properties determined through laboratory testing according to established international standards (e.g., ISO 9333).
- Regulatory Compliance: Meeting the essential requirements of the European directive 93/42/ECC and demonstrating substantial equivalence to a legally marketed predicate device (Argesol-WSF).
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" for a physical dental alloy in the context of an algorithmic device. The term "training set" is generally used for machine learning models.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
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(15 days)
name:
I'M A
WINNER
Alloy, precious metal, for clinical use Classification name: Product code: ETS 872.3060
75179 Pforzheim GERMANY
Re: K040436
Trade/Device Name: Simidur Superior Regulation Number: 21 CFR 872.3060
Simidur Superior is a palladium - silver ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients.
It is intended for manufacturing
- Crowns
- Short span bridges
- Long span bridges
- Removable partials
and can be used for
- Telescopic and milling work
Simidur Superior can be veneered with suitable dental ceramics as well as with dentalcomposites.
SIMIDUR SUPERIOR is a palladium-silver ceramic alloy with high contents of precious metals (87,0%), intended for dental technicians to fabricate dental restorations.
It has an indication for use which ranges from single crowns up to long span bridges with two or more pontics. In addition, it can be used for removable partials as well as for telescopic and milling work.
SIMIDUR SUPERIOR is highly corrosion resistant and has aan excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
SIMIDUR SUPERIOR can be veneered with suitable dental ceramics and with dental composites.
I am unable to extract specific acceptance criteria for the device performance from the provided text. The document is a 510(k) summary for a dental alloy, Simidur Superior, and primarily focuses on its substantial equivalence to a predicate device and its compliance with general regulations and standards.
The text states:
- "SIMIDUR SUPERIOR is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices."
However, it does not provide:
- A table of specific acceptance criteria (e.g., minimum tensile strength, maximum corrosion rate, specific biocompatibility test results with acceptance thresholds).
- Any details of a specific study or test results that "prove the device meets the acceptance criteria." The mention of compliance to ISO 9693 implies testing was done, but the results and methodologies are not described in this document.
Therefore, I cannot provide the requested table or details about a study, sample sizes, ground truth, experts, adjudication, or MRMC/standalone studies. This 510(k) summary is a declaration of compliance rather than a detailed report of performance testing.
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