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Indications for Use for Helix Short Implant:

The Neodent Implant System is recommended for surgical procedures on maxilla or mandible bones. It provides support for prosthetic components such as artificial teeth, thus restoring the chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Indications for Use for Mini Straight, Angled Abutment and screws:

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Indications for Use for Helix Short Attachment:

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Indications for Use for Helix Short Healing Abutment:

This product is used for the maintenance of soft tissue, during the bone integration stage of Neodent implants to be rehabilitated with the late loading technique. The Healing Abutment may be used in the implant installation surgery or the reopening surgery (second surgical stage).

Indications for Use for Helix Short Cover Screw:

This product is used for the maintenance of soft tissue, during the bone integration stage of Neodent implants to be rehabilitated with the late loading technique. The Cover Screw must remain intragingival, preventing the growth of tissue over the implant platform. The Cover Screw takes place in the conical region of the implant interface.

Indications for Use for Temporary Abutment for Helix Short Implant

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Temporary Abutments are installed over Helix Short Implants and to provide support for prosthetic structures for up to 6 months.

Indications for Use for Helix Short Titanium Base:

The Helix Short Implant Titanium base that is placed over Neodent dental implants to provide support for customized prosthetic restorations, such as copings and crowns. It is indicated for single- and multiple-structure restorations, screw- or cement-retained on implants installed in the maxilla or mandible. All digitally-designed copings and/or crowns to be used with the Neodent Titanium Base System must be sent to Straumann for manufacture at a validated milling center.

• All the subject devices are intended for single use;
• The subject implants are provided sterile via gamma irradiation and the subject abutments are provided sterile via Ethylene Oxide to an SAL of 1x10-9;
• The subject implants are manufactured of Commercially Pure Titanium (Grade 4), the subject abutments, prosthetic screws and abutment screws are manufactured of Titanium alloy Ti-6Al-4V ELI (ASTM F136) and the restorations placed onto Helix Short Titanium Bases are made of various top half materials.
• The subject implants have a wide cone prosthetic interface with an internal hexagon for short implants lengths available from 4.0 to 7.0; cylindrical shape with double threads and conical apex with three helical flutes for diameters from 3.75 to 7.0mm.
• The implants are provided in two different surfaces: Neoporos: Sand blasted and acid etched, and Acqua: Hydrophilic surface aggregated to the rough surface obtained by double treatment: abrasive blasting and acid subtraction.
• The Helix Short Implant Titanium Base abutments is used as two-piece abutment, where the base is premanufactured from titanium alloy and the top half is created via burn out coping or a digital workflow with CAD/CAM at a validated milling center. The final top half can be created from Ticon, Coron, Zerion LT, IPS e.max, or PMMA. The top half and base pieces are cemented together to form the final abutment.

Here's an analysis of the acceptance criteria and supporting studies for the Neodent Implant System - Helix Short Implant System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly present a table of specific numerical acceptance criteria alongside reported performance for each test. Instead, it describes what was tested and states that the results "met the acceptance criteria" or demonstrated "equivalent performance." We can infer the general acceptance criterion from the study descriptions.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for the test sets in the mechanical, MR compatibility, or other in-vitro studies. It refers to "tested subject devices" or "representative samples."

• Data Provenance: The studies described (mechanical testing, MR compatibility, surface treatment, sterilization, endotoxin, shelf life, biocompatibility) are all benchtop/laboratory studies (in vitro). There is no mention of human subject data, animal data, or clinical retrospective/prospective data for these specific performance criteria. The manufacturer is JJGC Indústria e Comércio de Materiais Dentários S.A. (dba Neodent) based in Curitiba, Paraná, Brazil.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As these are benchtop/laboratory performance studies, "ground truth" is established by adherence to recognized standards (e.g., ISO 14801, ISO 11137, ISO 11135, ISO 10993) and scientific methods, not by expert consensus in the typical sense for clinical data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for interpreting clinical images or patient outcomes, not for objective benchtop performance data against engineering 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, which is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims is based on:

• Adherence to International Standards: Performance measured against specifications outlined in standards like ISO 14801 (dynamic fatigue), ISO 11137 and ISO 11135 (sterilization), ISO 10993 series (biocompatibility).
• Benchtop Test Results: Direct measurements and observations from the mechanical, physical, chemical, and biological laboratory tests performed on the device.
• Comparison to Predicate Devices: Performance is frequently established by demonstrating equivalence or superiority to already legally marketed predicate devices, which serve as a benchmark.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. The concepts of "training set" and "validation set" are primarily used for machine learning and AI, not for the regulatory approval of physical implants based on benchtop testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reasons as point 8.

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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

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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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.

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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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The software is intended to be used at a dental laboratory. The software uses patient-specific data from scanners, e.g. a scanned geometry, and facilitates the CAD of individual restorative solutions based on these data, such as a supporting dental framework, dental abutments, copings, crowns, and bridges. The software also serves as a means of creating and managing of cases, and the ordering of products.

NobelDesign (also marketed as DTX Studio design) is an integrated CAD Software in a cockpit application that enables the user to design dental restorations. The software receives and reads scan data containing topographical characteristics of real teeth and dental impressions from extra and intra-oral scanners. The NobelDesign/DTX Studio design software uses the data and it integrates a third-party software used to perform the CAD design of the dental restorations. Using this software, the user can create and track cases, scan models and design prosthetics restorations (excluded implant/abutment interface). The output of the device is a computer file which contains the dental restoration design in a digital form. The dental restoration is manufactured in Nobel Biocare registered facilities using the digital format. Prosthetic restorations (excluding prosthetic restorations with implant/abutment interface or as part of a multi-piece or Ti-base abutment under 872.3630, NHA) can also be designed with the software but can be manufactured in the dental lab, using 510k cleared material for this purpose (872.3770, EBG).

This document does not contain the detailed information necessary to complete all sections of your request. It is a 510(k) summary for a medical device (NobelDesign/DTX Studio Design software) and focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed performance study with acceptance criteria and results.

Here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The document states that "Design Control Activities including risk management following the ISO 14971:2012 verification/validation testing, was conducted... This documentation includes testing which demonstrates that the requirements for the features have been met." However, it does not specify what those requirements (acceptance criteria) were or the quantitative results of the performance testing.

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 explicitly provided for a specific test set. The document mentions "an entire end-to-end validation (scan, design, and order) for multiple worst-case scenario scan and design requirements," but details about the sample size (number of scans, designs, or orders), the nature of the data, or its provenance are absent.

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 provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in this document. This software is a CAD design tool, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes the software as enabling "the user to design dental restorations" and facilitating "the CAD of individual restorative solutions." This implies human-in-the-loop operation, as it's a design tool. Therefore, a purely standalone algorithm evaluation would likely not be applicable or relevant to this device's function. The document does not describe a standalone performance study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document mentions "an entire end-to-end validation (scan, design, and order)." For CAD design software, "ground truth" would likely relate to the accuracy and precision of the digital designs compared to predefined specifications or validated physical models, and the fidelity of the manufacturing output to the digital design. However, the specific type of "ground truth" or how it was established is not detailed. It's implied that designs are evaluated against "design requirements" and "manufacturing specifications."

8. The sample size for the training set

This information is not applicable in the context of this document. The software described is a CAD design tool, not a machine learning model that undergoes "training." Its functionality is based on predefined algorithms for geometric design and integration, not on learning from a large dataset.

9. How the ground truth for the training set was established

This information is not applicable as the document does not describe a training set for machine learning.

Summary of what is available from the document:

• Device Name: NobelDesign / DTX Studio Design
• Device Type: CAD Software for dental restorations (abutments, copings, crowns, bridges)
• Purpose of Study (as described): Software verification and validation activities conducted under Design Control Activities, following ISO 14971:2012 and FDA Guidance General Principles of Software Validation. This demonstrated that "requirements for the features have been met."
• Validation Scope: "An entire end-to-end validation (scan, design, and order) for multiple worst-case scenario scan and design requirements."
• Regulatory Compliance: Conformance with IEC 62304:2006 standards. FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" (May 2005) guidance was also followed for documentation.

For a detailed answer to your request, the original 510(k) submission document, particularly the verification and validation reports, would need to be reviewed, as the summary provided here does not contain that level of detail.

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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.

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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BegoPal+ is a porcelain-fused-to-metal (PFM) noble alloy. It is suitable for fabrication of crown and bridge restorations. BegoPal+ is available as powder and is processed by selective laser melting.

BegoPal+ is a palladium containing cobalt-chromium alloy for fabrication of porcelain fused to metal dental restorations. BegoPal+ is available as powder and is processed by selective laser melting.

This appears to be a 510(k) premarket notification document for a dental alloy, BegoPal+. This document does not contain information about software, or a device that would require the kind of performance study details (acceptance criteria, training/test sets, expert adjudication, MRMC studies) you've requested.

The document discusses:

• Device Description: BegoPal+ is a palladium-containing cobalt-chromium alloy for dental restorations.
• Processing: It's processed by selective laser melting (SLM).
• Indications for Use: Porcelain-fused-to-metal (PFM) noble alloy for crown and bridge restorations.
• Predicate Devices: Lists similar alloys (Wirobond C, Wirobond C+, Callisto CP+).
• Comparison to Predicate Devices: States substantial equivalence based on indications, technical parameters, and biocompatibility, despite differences in product shape, processing, and material composition.
• Testing: Mentions test results according to ISO 22674, ISO 9693-1, ISO 10271, and ISO 10993 which demonstrate safety and effectiveness.

Therefore, it is impossible to extract the information you requested from this document as it pertains to a physical material, not a software or AI-driven medical device.

If you are looking for an example of a 510(k) submission for a software or AI device, you would need a different document.

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This device is a non precious, nickel-chromium-molybdenum-berylium based ceramic casing alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices.

This device is a non precious, nickel-chromium-molybdenum-berylium based ceramic casing alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices.

I am sorry, but the provided text does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a device. The document is an FDA 510(k) clearance letter for a dental alloy named "Continum™ V," confirming its substantial equivalence to a legally marketed predicate device. It addresses regulatory information, marketing authorization, and general compliance requirements, but it does not include performance studies or validation data.

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This device is a non precious, nickel-chromium-molybdenum-beryllium based alloy for use in the construction of cast ceramic bonded crown and bridge dental restorations.

This device is a non precious, nickel-chromium-molybdenum-beryllium based alloy.

I apologize, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to Aalba Dent, Incorporated for their Continum™ dental alloy. It primarily confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Details on sample sizes, data provenance, or retrospective/prospective study design.
3. Information on the number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with AI.
6. Data on standalone algorithm performance.
7. The type of ground truth used (e.g., pathology, outcomes).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The letter only states the device name (Continum™), its regulation name (Base Metal Alloy), regulatory class (Class II), and its intended use (a non-precious, nickel-chromium-molybdenum-beryllium based alloy for use in the construction of cast ceramic bonded crowns and bridges). It indicates that the FDA has determined the device to be substantially equivalent.

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This device is a non precious, nickel-chromium-copper-tin based crown and bridge ("Type III") alloy for use in the construction of cast crown and bridge prosthetic devices. According to 21 CFR Ch.1 (4-1-89 Ed.) Part 872, the classification name for this device is Base Metal Alloy, a Class II device.

This device is a non precious, nickel-chromium-copper-tin based crown and bridge ("Type III") alloy.

I am sorry, but based on the provided document, the information you are requesting about acceptance criteria and a study proving device adherence to such criteria is not available. This document is a 510(k) K033356 clearance letter from the FDA for Verasoft ES, a dental alloy.

The letter explicitly states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This indicates that the device was cleared based on its substantial equivalence to an already legally marketed predicate device, as per the 510(k) pathway. This pathway typically relies on demonstrating that a new device is as safe and effective as a predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria and studies demonstrating that the device meets those criteria in the same way a Premarket Approval (PMA) application would.

Therefore, the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

The "Indications For Use" section simply defines the device as a "non precious, nickel-chromium-copper-tin based crown and bridge ("Type III") alloy for use in the construction of cast crown and bridge prosthetic devices." This describes the intended use but does not provide specific performance metrics or acceptance criteria as you've outlined.

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