Search Results

The Straumann CARES Visual/Nova Implant-borne CAD software are indicated for the design of two-piece or one-piece abutment components for 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 and CAD software. The system is used to design two-piece abutment CAD/CAM milled copings, crown and bridge restorations to be cemented onto Ti-bases, customized one-piece abutments and bridges/bars to be affixed to the endosseous dental implants using a basal screw. The use of the software requires the user to have the necessary training and domain knowledge in the practice of prosthetic design, as well as training in the use of the software.

Straumann CARES Visual/Nova is a dental CAD software to create implant-borne restorations. The software employs optical impression files that represent the topographical characteristics of the patient's intraoral situation. The Straumann CARES Visual/Nova software then allows the desired restorations. All implant-borne restorations available in Straumann CARES Visual/Nova software require FDA review and 510(k) clearance. Design specifications ("design envelope"), selectable materials, mouth positions need to be described in these 510(k) submissions. Each restorative solution is defined in a secured design library that provides the CAD software with the design specifications and restrictions for instance, minimum wall thickness, maximum angulation, cementable abutment post height etc. Standard connecting geometries e.g., abutment to implant interface are also defined in the library which cannot be edited by a user. Any dental implantborne restoration can only be created within the 510(k)-cleared design envelope.

The output of the CAD software is a three-dimensional geometry file which is linked to meta data like material and patient identifier.

All designed implant-borne restorations are intended to be:

• sent to Straumann for manufacturing by a validated milling center, or .
• milled on a validated Straumann C series or M series milling machine (only . with the CARES Visual software, K171649 and K203456)
• 3D printed as a temporary crown, or temporary bridge (up to 180 days) using P pro . Crown & Bridge material on a validated Straumann P series printer (only with the CARES Visual software, K203750)

Straumann CARES Visual/Nova has no patient contact since it is software.

The provided text is a 510(k) summary for the Straumann CARES Visual and Nova Dental CAD software. This document outlines the device's indications for use, its technological characteristics, and a comparison to predicate devices, but lacks detailed performance study information with numerical acceptance criteria and measured performance.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Performance Testing - Bench" and "Software verification and validation testing," indicating that tests were performed to demonstrate that the software adheres to design specifications and restrictions. However, it does not provide specific numerical acceptance criteria (e.g., accuracy percentages, dimensional tolerances) or their corresponding numerical performance results.

Instead, the acceptance criteria are implicitly described as:

• The software effectively controls design specifications and material selections for compatible abutment design libraries that undergo separate 510(k) clearance.
• Restrictions prevent the design of patient-matched components outside of allowable design limitations.
• Design limitations and specifications of compatible implant-abutment design libraries are locked and cannot be modified by the end user.

The reported performance is a general statement that these tests were "provided to demonstrate" and "conducted to demonstrate" these aspects. No quantitative measurements are included.

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

The text does not specify the sample size used for the test set or the provenance of any data (e.g., country of origin, retrospective/prospective). It only refers to "representative screenshots under user verification testing," which suggests qualitative evaluation rather than quantitative statistical analysis on a defined dataset.

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

The document does not mention the use of experts to establish ground truth for a test set. The validation appears to be centered on the software's functionality and adherence to predefined design rules rather than a comparison to expert-derived ground truth on clinical cases.

4. Adjudication Method for the Test Set

As there's no mention of experts establishing ground truth or evaluating cases, there is no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study is mentioned. The device is CAD software for designing dental prosthetics, which is different from an AI-assisted diagnostic tool where human reader performance would typically be assessed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The performance testing described is inherently standalone from a human-in-the-loop perspective, as it verifies the software's ability to enforce design rules and generate valid geometry files. The software's output (geometry file) is then used for manufacturing. The device inherently functions "without human-in-the-loop performance" in terms of its core design rule enforcement, although a human user still operates the software to create the design.

7. The Type of Ground Truth Used

The ground truth for this device appears to be primarily predefined design specifications and limitations based on engineering rules, material properties, and anatomical considerations for dental prosthetics. The software's internal logic and libraries incorporate these rules. It's not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or predictive AI.

8. The Sample Size for the Training Set

The document does not mention a training set for the software. This suggests that the software is likely rule-based CAD software rather than a machine learning or AI model that requires a training set of data. Its functionality is based on programmed algorithms and predefined libraries ("design envelope").

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

Since no training set is mentioned, this point is not applicable.

Ask a specific question about this device

CloudPoint FastDesign Chairside is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. CloudPoint FastDesign Chairside is intended for use by a dental practitioner or dental laboratory staff for designing the patient-matched component of a two-piece hybrid dental implant abutment. The resulting abutment design is intended to be used by the manufacturer of an endosseous dental implant to create the final device.

CloudPoint FastDesign Chairside (also known as FastDesign), is a software suite intended to be used by trained dental practitioners or dental laboratory staff to design the patient-matched component of a two-piece hybrid dental implant abutment. A titanium base-type abutment and hybrid abutment-crown component are combined to make the two-piece hybrid dental implant abutment. The software allows a dental practitioner or dental laboratory staff to design the matching dental abutment based on imported scan data containing topographical characteristics of the patient's dentition. The resulting abutment design will be exported to a remote milling machine to make the final device.

CloudPoint FastDesign Chairside, is restricted to be used with 510(k) cleared abutment systems. The software includes design parameters from the 510(k) cleared abutment systems such as maximum and minimum dimensions (e.g., abutment post height, gingival height, angulation, gingival margin diameter, etc.). CloudPoint FastDesign Chairside designs the endosseous dental implant abutment under the directions of a clinical professional and maintaining accordance to the requirements of the compatible 510(k) cleared abutment systems with cleared design parameter size ranges.

The provided text describes the "CloudPoint FastDesign Chairside," a dental abutment design software. However, it does not contain the detailed acceptance criteria for device performance, nor the specifics of a study proving the device meets those criteria, as typically requested in your prompt.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Abutment Design K200100) based on intended use, indications for use, and technological characteristics. It mentions "Software verification and validation" and "Cybersecurity Analysis" as non-clinical data submitted, but does not provide a table of acceptance criteria with reported device performance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided document. The document states that software verification and validation were conducted to "verify that the software development output met the input requirements, and to validate that the software specifications confirm to user needs and its intended uses," but it does not list these specific requirements or their direct performance outcomes.
2. Sample sizes used for the test set and the data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
4. Adjudication method: Not specified.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned or conducted. The document states "No clinical data is included in this submission."
6. Standalone (algorithm only) performance study: Not explicitly detailed with performance metrics. The software verification and validation focused on confirming design limitations and specifications.
7. Type of ground truth used: Not specified.
8. Sample size for the training set: Not applicable as this is a design software, not an AI/ML diagnostic algorithm that typically relies on a training set in the same way. The document highlights "software design verification and validation."
9. How the ground truth for the training set was established: Not applicable.

What the document does state regarding performance data is:

• Non-clinical data submitted:
  • Software verification and validation, according to the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued on May 11, 2005.
  • Cybersecurity Analysis, according to the FDA Guidance Document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," issued on October 02, 2014.
• No clinical data is included in this submission.
• Software Verification and Validation details:
  • Conducted by Prismatik Dentalcraft, Inc. to verify that software development output met input requirements and validate that software specifications conform to user needs and intended uses.
  • Used to address questions related to substantial equivalence based on technical feature differences.
  • Provided for the compatible abutment design library to demonstrate use with the software suite.
  • Conducted to demonstrate that "restrictions prevent design of the patient-matched component of the two-piece hybrid dental abutment outside of the allowable design limitations, including screenshots under user verification testing."
  • Established that "the design limitations and specifications are locked and cannot be modified within the abutment design library."
• Cybersecurity Analysis details:
  • Risk assessment (hazard analysis, mitigation, design considerations for intentional and unintentional cybersecurity risks) was performed.
  • Concluded that benefits outweigh residual risk after mitigation, and all risks were mitigated as far as possible.

In summary, the provided text confirms the device underwent software verification and validation and cybersecurity analysis as non-clinical testing to support its substantial equivalence, but it does not offer the specific device performance acceptance criteria or detailed study results you've requested.

Ask a specific question about this device

TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxillae. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxilla. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

TRUST is restricted to be used with 510(k) cleared abutment systems, and the design output from TRUST (the patient specific part of the abutment) must be manufactured according to the instruction of the selected Implant system.

TRUST includes design parameters from the 510(k) cleared abutment systems such as implant type, maximum and minimum dimensions (e.g., abutment post height, angulation, gingival marqin diameter, wall thickness). The design parameters, provided by abutment system manufacturers(Truabutment), for an abutment system are available via a Trust server when documentation of the 510(k) clearance of said implant system is confirmed by Rgorithm.

TRUST has no patient contact being a software only device. (stand-alone software)

The provided text describes a 510(k) premarket notification for a dental abutment design software called TRUST. However, it does not contain any information regarding acceptance criteria, reported device performance, or any study details like sample size, ground truth establishment, or expert qualifications.

The document primarily focuses on establishing substantial equivalence to a predicate device (Abutment Design, K200100) by comparing intended use, technological characteristics, and hardware/software requirements.

Here's a breakdown of what is and is not present in the provided text:

What is present:

• Device Name: TRUST
• Indication for Use: "TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxillae. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device."
• Predicate Device: Abutment Design (K200100)
• Confirmation of Non-clinical Testing: "Software, hardware, and integration and validation testing was performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued on May 11, 2005. The validation suite includes validation of implemented mitigations related to device hazards identified in the risk management procedures."
• Cybersecurity Analysis: "The cybersecurity analysis was performed in accordance with the FDA Guidance Document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", issued on October 02, 2014."
• Clinical Testing Statement: "Clinical testing is not a requirement and has not been performed."

What is explicitly missing or not described in the provided text, and therefore cannot be filled in based on this input:

• A table of acceptance criteria and the reported device performance. The document states that "All test results have been reviewed and approved, showing the TRUST to be substantially equivalent to the primary predicate device," but it does not provide the specific criteria or the performance metrics themselves.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done. (While it mentions "software only device," it doesn't quantify its standalone performance or discuss specific studies.)
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

Conclusion:

The provided document describes a device (TRUST software) and its intended use, and states that non-clinical testing and cybersecurity analysis were performed to demonstrate substantial equivalence to a predicate device. However, it does not provide the specific details of acceptance criteria, device performance, or study methodology that would be required to complete the requested table and information points about test and training sets, ground truth, and expert evaluation.

Ask a specific question about this device

The AbutmentCAD module is intended as an aid to the restoration in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

AbutmentCAD is a software application for the purpose of designing patient-specific implant-based dental restorations, such as one-piece abutments, two-piece/hybrid abutments and single or multi-unit screw retained restorations. The AbutmentCAD software can be used with basic dental CAD systems such as exocad's ChairsideCAD. AbutmentCAD is used solely for the patient-specific components of abutments and screw retained crowns and bridges. The software application runs on "off-the-shelf" PC hardware with current Microsoft Windows operating system and standard peripheral components.

Here's an analysis of the provided text regarding the acceptance criteria and study for AbutmentCAD:

Note: The provided document is a 510(k) Summary, which is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device. It does not present a detailed clinical study with performance metrics in the way a typical AI-based diagnostic device FDA clearance would. Instead, it focuses on software verification and validation, ensuring the software performs its intended function within defined parameters and adheres to design limitations.

Acceptance Criteria and Reported Device Performance

The document primarily focuses on the software's ability to accurately enforce design limitations and correctly process data, rather than diagnostic accuracy metrics.

Details of the Study/Testing

Given that this is a 510(k) for a CAD software, the "study" described is primarily software verification and validation testing, not a clinical trial or large-scale comparative effectiveness study for diagnostic accuracy.

1. Sample sizes used for the test set and data provenance:

   • Test Set Sample Size: Not explicitly stated as a single number of cases. The testing involved "realistic and artificial data" for verifying design limitations.
   • Data Provenance: Not specified in terms of country of origin. The data includes "imported scan and the geometry information of objects in integrated implant libraries." The testing uses "realistic and artificial data." It is software validation, so likely a mix of simulated and real-world-representative data, potentially from internal sources. It's retrospective in the sense that it's testing a developed software against pre-existing data or simulated scenarios.

2. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. For verifying geometric and angular accuracy, the "ground truth" would likely be derived from engineering specifications, CAD standards, and the explicit instructions provided by the implant manufacturers (which form the basis of the "Implant Libraries"). "3rd party tools" were used to prove the correctness of the software.

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

   • Not applicable/Not mentioned. The verification tests involved checking if the software correctly enforced the predefined design limitations using precise measurements (0.01mm, 0.5° accuracy) and external tools, rather than human expert adjudication of subjective interpretations.

4. 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 study was not done. This device is a CAD software for design, not a diagnostic AI system intended to assist human readers in image interpretation or diagnosis. It aids in the design of dental prosthetics based on pre-established parameters.

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

   • Yes, in essence. The core verification for enforcing design limitations and maintaining library integrity is a standalone performance assessment of the algorithm's accuracy in following its programming rules. The software itself, without human intervention during the calculation/enforcement of constraints, needs to perform accurately. However, it's explicitly "intended to be used by trained professionals in dental practices or dental laboratories for the design." So, while standalone verification of programmatic rules occurred, the overall device is a human-in-the-loop tool for design.

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

   • The ground truth for design limitations is based on engineering specifications and explicit instructions provided by the original implant manufacturers. These are encoded into the "Implant Libraries." The accuracy of the software in adhering to these parameters (0.01mm for dimensions, 0.5° for angles) forms the primary ground truth for the verification testing.

7. The sample size for the training set:

   • Not applicable / Not mentioned. This device description does not indicate the use of machine learning that would typically involve a "training set." It appears to be a rule-based CAD software where design limitations are explicitly programmed rather than learned from data. The "Implant Libraries" are essentially predefined data sets of specifications, not training data in the ML sense.

8. How the ground truth for the training set was established:

   • Not applicable. As no machine learning training set is mentioned, this question is not relevant. The "ground truth" for the software's functionality relates to correctly implementing engineering and manufacturer specifications.

Ask a specific question about this device

Abutment Design is intended as an aid to the restoration in partially or fully edentulous mandibles and maxillae. Abutment Design is intended for use by a dental practitioner or dental laboratory staff for designing the patient specific component of a two-piece, or hybrid dental implant abutment. The resulting abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

The Abutment Design software receives scan data containing topographical characteristics of real teeth, dental impressions, or stone models. The software provides the user with the ability to create matching endosseous dental implant abutments using computer aided design.

The Abutment Design is restricted to be used with 510(k) cleared abutment systems, and the design output from Abutment Design (the patient specific part of the abutment) must be manufactured according to the instruction of the selected abutment system.

The Abutment Design software includes design parameters from the 510(k) cleared abutment systems such as implant type, maximum and minimum dimensions (e.g., abutment post height, gingival height, angulation, gingival margin diameter, etc.). The design parameters, provided by abutment system manufacturers, for an abutment system are available via a 3Shape server when documentation of the 510(k) clearance of said implant system is presented to 3Shape.

Abutment Design has no patient contact being a software only device.

I am sorry, but the provided text only discusses the comparability of "Abutment Design" software to a predicate device, and includes general statements about nonclinical testing for verification and validation without providing specific acceptance criteria or study details that would allow me to populate the requested table and answer the detailed questions about sample sizes, ground truth, expert qualifications, and specific study designs.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details.

Ask a specific question about this device

The Sirona Dental CAD/CAM System with InLab Software is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the BH 3.0 S, SSO 3.5 L and SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. The system consists of three major parts: TiBase, inCoris mesostructure, and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructures may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.xxxx) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems: (list of compatible implant systems and sizes follows).

The Sirona Dental CAD/CAM System with InLab Software is a modification to the Sirona Dental CAD/CAM System as previously cleared under K111421. The modifications represented in the subject device consist of the implementation of functionality for the control of critical CAD/CAM abutment dimensions. The subject Sirona Dental CAD/CAM System with InLab Software consists of: InLab SW version 18.5, "labside" CAD/CAM software, InEos X5 3D digital desktop scanner, InEos Blue 3D digital desktop scanner, InLab MC X5 milling unit, InLab MCXL milling unit, Sirona TiBase titanium base components, inCoris ZI zirconium mesostructure blocks. The system is utilized to digitally acquire and/or record the topographical characteristics of teeth, dental impressions, or physical stone models in order to facilitate the computer aided design (CAD) and computer aided manufacturing (CAM) of two-piece "CAD/CAM" abutments. The patient-specific two-piece abutments consist of pre-fabricated "TiBase" components and the zirconium ceramic mesostructure component which is designed using the InLab software and milled using the InLab milling equipment. The completed mesostructure is cemented to the TiBase component using PANAVIA F 2.0 dental cement.

The provided text is a 510(k) Premarket Notification from Dentsply Sirona for their Sirona Dental CAD/CAM System with InLab Software. This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than providing a detailed clinical study report with acceptance criteria and performance data for a novel artificial intelligence algorithm.

Therefore, many of the specific details requested in your prompt (e.g., sample size for test set, data provenance, number of experts, MRMC study, standalone performance, training set details) are not applicable or not present in this type of FDA submission.

This document indicates that the device is a modification to an already cleared system (K111421), and the current submission (K200191) focuses on bringing the "labside" variant (InLab software) into equivalency with a previously cleared "chairside" variant (CEREC software, K181520), which already incorporated the software design limitation controls.

Here's an analysis based on the provided text, addressing what information is available and what is not:

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

• Acceptance Criteria/Performance: The document does not provide a quantitative table of acceptance criteria and reported device performance in terms of clinical outcomes or diagnostic accuracy, which would be typical for an AI/algorithm-based diagnostic device.
• Instead, the "acceptance criteria" are implied by the regulatory standards and successful validation against those standards. The performance is assessed by showing conformity to these standards and the equivalence of its function and safety to the predicate device.
  • IEC 60601-1: Medical electrical equipment - General requirements for basic safety and essential performance.
  • IEC 60601-1-2: Medical electrical equipment - Electromagnetic compatibility.
  • IEC 62304: Medical device software - Software lifecycle processes.
  • Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions of Software Contained in Medical Devices (May, 2005).
  • "Software verification and validation testing was conducted to demonstrate that the software's design restrictions prevent design of the mesostructure component outside of design limitations, including screenshots under user verification testing." This indicates functional performance testing, where the "acceptance" is that the software correctly restricts design parameters.
  • "the encrypted abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified within the abutment design library." This confirms data integrity and adherence to design specifications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated in terms of patient data or case numbers. The testing appears to be on the device's functional and safety aspects (e.g., software function, electrical safety), not a clinical dataset of patient images or outcomes.
• Data Provenance: Not applicable in the context of device functional testing. There's no indication of patient data being used for "testing" in the sense of a clinical 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)

• Not applicable. This document describes a CAD/CAM system for designing dental abutments, not a diagnostic AI system requiring expert-derived ground truth from medical images. The "ground truth" here relates to the engineering specifications and design limitations of the dental abutment, which are inherent to the software's programming and validated through functional testing.

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

• Not applicable. No clinical image-based adjudication process is described as this is not a diagnostic imaging AI.

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 study is not mentioned. This is a CAD/CAM system for manufacturing dental prosthetics, not a system providing AI assistance to human readers for diagnostic interpretation.

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

• The document implies the software, as a component of the system, operates in a "standalone" fashion in terms of its internal logic for design limitations. However, the overall device (Sirona Dental CAD/CAM System) is inherently human-in-the-loop, as dentists and lab technicians use it for design and manufacturing. The focus of the validation is on the software's ability to enforce design restrictions automatically.

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

• The "ground truth" for the software's performance is based on engineering specifications and design limitations for dental abutments. These limitations are programmed into the software and verified to be unmodifiable and correctly enforced.
• This is not clinical ground truth derived from patient data or expert consensus on clinical findings.

8. The sample size for the training set

• Not applicable. This CAD/CAM system's software (InLab Software) is not described as utilizing a machine learning or deep learning algorithm that requires a "training set" in the conventional sense of AI. It's a design and manufacturing software, where "training" would refer to its development and programming against predefined dental design rules, not learning from data samples.

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

• Not applicable. As no training set is mentioned for an AI/ML algorithm, the concept of establishing ground truth for it does not apply. The software's functionality is based on established dental design principles and manufacturing parameters, which are encoded into its programming.

Ask a specific question about this device

DTX Studio design software is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. DTX Studio design software is intended to be used by dental laboratory staff or a dental practitioner for designing patient specific component of a two-piece, one-piece or hybrid dental implant abutment. The single or multiple patient specific abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

DTX Studio design is a stand-alone software platform that integrates CAD software to render a design of a dental abutment. The software receives surface scan data containing topographical characteristics of real teeth, position and orientation of implants and uses also an integrated third-party software to perform the CAD design of the dental abutment. Additional functions include creating and tracking cases. The output of the device is a computer file containing the dental abutment in a digital form.

I am sorry, but the provided text from the FDA 510(k) K181932 submission for "DTX Studio design" does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets those criteria.

The document primarily focuses on:

• The FDA's letter confirming substantial equivalence.
• The Indications for Use.
• A comparison table between the subject device (DTX Studio design), a primary predicate device (3Shape Abutment Designer Software), and a reference predicate device (previous DTX Studio design K171466).
• A brief discussion of the comparison.
• A general statement about performance data, noting that the device was designed under Quality System Regulations (21 CFR § 820, ISO 13485:2016), conforms to EN IEC 62304:2006, and underwent design control activities including risk management (ISO 14971:2012) and verification/validation testing per FDA guidance.

It explicitly states: "This documentation includes testing which demonstrates that the requirements for the features have been met." However, it does not provide the specifics of:

1. A table of acceptance criteria and the reported device performance: This is not present in the document.
2. Sample size, data provenance, number of experts, qualifications, and adjudication methods for the test set: These details are not mentioned.
3. Whether MRMC comparative effectiveness studies were done, or specific effect sizes: Not discussed. The device is CAD software, not an AI for diagnostic imaging interpretation in the traditional sense that would typically involve MRMC studies for reader performance improvement.
4. Whether standalone (algorithm only) performance was done: While it's software, the performance data section is very general and doesn't specify standalone performance metrics.
5. Type of ground truth used: Not specified.
6. Sample size for the training set: Not mentioned.
7. How ground truth for the training set was established: Not mentioned.

The information provided is typical for a 510(k) summary, which generally aims to demonstrate substantial equivalence to a predicate device rather than providing the granular detail of a comprehensive clinical study report or a detailed V&V report for software. For such detailed performance data, one would typically need access to the full 510(k) submission and supporting documentation, which is not usually made public in this summarized format.

Ask a specific question about this device

The 3Shape Abutment Designer Software is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. The 3Shape Abutment Designer is intended for use by a dental practitioner or dental laboratory staff for designing the patient specific component of a two-piece, or hybrid dental implant abutment. The single or multi-unit abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

The 3Shape Abutment Designer™ Software receives scan data containing topographical characteristics of real teeth, dental impressions, or stone models. The software provides the user with the ability to create matching endosseous dental implant abutments using computer aided design. The output of the device is a computer file containing the abutment(s) in digital form which can be used by manufacturers that hold an implant abutment 510(k) or are milling per the specific instructions provided by the holder of a 510(k) marketing clearance for a patient specific implant abutment. The 3Shape Abutment Designer Software output is restricted in the U.S. to be manufactured by a holder of an implant abutment 510(k) or milled per the specific instructions provided by the holder of a 510(k) marketing clearance for a patient specific implant abutment. The 3Shape Abutment Designer™ Software can be run on properly configured "off-the-shelf" PC hardware running Microsoft® Windows and using a standard keyboard and mouse. The 3Shape Abutment Designer™ Software requires the loading of implant libraries, which includes information such as implant type, maximum and minimum dimensional parameters for abutments, etc., created by separate abutment manufacturers and cleared by the FDA. In the US, the Implant Libraries are obtained via a 3Shape server after demonstration to 3Shape of the FDA clearance of the Implant Library.

The provided text describes the 3Shape Abutment Designer™ Software, its intended use, and the nonclinical testing performed for its 510(k) submission. However, it does not provide specific details on acceptance criteria or a detailed study proving the device meets those criteria, as typically found in a clinical study report.

The text focuses on the software's substantial equivalence to a predicate device (Sirona Dental CAD/CAM System) by comparing their intended use, technological characteristics, and software output. The "Nonclinical Testing" section broadly mentions "approved acceptance criteria" but without enumerating them or describing a specific study report that would contain the requested details.

Therefore, many of the requested elements cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or extracted, and what is missing:

1. Table of acceptance criteria and the reported device performance

Missing: Specific, quantifiable acceptance criteria (e.g., accuracy metrics, specific error rates, precision targets) are not detailed. The actual performance outcome against numerical targets for these acceptance criteria is also not provided.

2. Sample size used for the test set and the data provenance

Missing: The text does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data). "Test set" in this context refers to the data used for the "verification and validation testing" mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Missing: This information is not provided. The testing described is primarily software verification and validation, not a clinical study involving expert ground truth establishment for diagnostic or treatment efficacy.

4. Adjudication method for the test set

Missing: This information is not provided.

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

Missing: No MRMC comparative effectiveness study is mentioned. The device is software for designing abutments, not an AI for diagnosis or interpretation that would typically involve human readers.

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

The device is a standalone software component ("algorithm only" in the sense that it automates design based on input). The "Device Description" states it receives scan data and provides digital output. The "Nonclinical Testing" section confirms "Software, hardware, and integration verification and validation testing was performed." This implies standalone testing of the software's functionality.

However, specific performance metrics for this standalone functionality are not detailed.

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

Missing: The text does not explicitly state the type of "ground truth" used for its verification and validation. Given the nature of the software (CAD for dental abutments), the "ground truth" likely refers to established engineering specifications, design rules, and possibly simulated or physical models that conform to dental anatomical and functional requirements. It is not clinical "ground truth" in the diagnostic sense (like pathology or outcomes data).

8. The sample size for the training set

Missing: This is not applicable in the typical sense of a machine learning "training set." The 3Shape Abutment Designer™ Software appears to be a rule-based CAD software, not a machine learning algorithm that is "trained" on a dataset. It "requires the loading of implant libraries" which contain design information cleared by the FDA, but these are not "training sets."

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

Missing: As per point 8, a "training set" in the machine learning context is not applicable here. The "implant libraries" used by the software are based on information from actual implant manufacturers, cleared by the FDA, which function as pre-defined specifications and constraints rather than a statistical training dataset.

Ask a specific question about this device