(130 days)
The Zfx Dental CAD System is intended to allow the user to acquire patient specific data via a scan or digital file and define the shapes of dental prosthetic devices such as dental abutments, crowns, bridges, copings, in-lays, on-lays, and veneers through the use of a 3D-CAD tool. Zfx Dental CAD System creates an output file of the restorations designed by the user that can be manufactured using a CAM system.
The Zfx Dental CAD system is software that is used to design dental restorative prosthetic devices from digital optical impressions. The software receives topographical characteristics of dental impressions or stone models from a compatible scanning system. The design created in the software is complied into a format enabling manufacturing of a patient specific component at Zimmer Dental. The CAD software is pre-installed on a Windows compatible computer system.
Here's an analysis of the acceptance criteria and study information for the Zfx Dental CAD System, based on the provided text:
Important Note: The provided document is a 510(k) summary, which often focuses on substantial equivalence to predicate devices rather than formal acceptance criteria and detailed clinical study results for a new medical device claiming performance improvements. As such, some of the requested information (like specific quantifiable acceptance criteria, effect sizes, and detailed ground truth acquisition for training data) is not present in this type of submission.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Quantitative/Qualitative) | Reported Device Performance |
|---|---|
| Ability to accept digital scan files from a compatible dental scanner. | System demonstrated acceptance of digital scan files from a compatible dental scanner. |
| Ability to design a patient-specific restoration (e.g., abutment, crown, bridge). | System demonstrated the ability to design patient-specific restorations (abutments, crowns, bridges). |
| Ability for Zimmer to manufacture the patient-specific restoration to the required design specifications. | Verification testing conducted to confirm patient-specific restorations can be manufactured by Zimmer to required design specifications. |
| Software, hardware, and integration verification and validation in accordance with FDA guidance. | Verification and validation testing performed according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005). |
Study Information
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Sample size used for the test set and the data provenance:
- The document does not specify a distinct "test set" sample size in terms of number of patient cases or designs.
- The testing described is verification and validation, implying an internal product development and testing process, rather than a clinical trial with a patient-specific test set.
- Data provenance is not specified regarding country of origin or whether it was retrospective/prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. Since no clinical testing was performed, and the testing was focused on software and manufacturing capabilities, the concept of "ground truth" as established by medical experts for diagnostic accuracy doesn't directly apply in the way it would for an AI-diagnostic device. The "ground truth" for the device's function would be its adherence to design specifications and manufacturing capabilities.
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Adjudication method for the test set:
- Not applicable as this was not a clinical study involving human interpretation of medical images or data requiring adjudication. The verification and validation process would involve internal engineering and quality assurance checks against design requirements.
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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 MRMC comparative effectiveness study was done.
- This device is a CAD system for designing dental prosthetics, not an AI-powered diagnostic or interpretation tool for human readers. Its function is to facilitate design, not to assist in human diagnostic decisions.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, the "standalone" performance is the device's function. The Zfx Dental CAD System is software that takes digital input and allows a user to design restorations. The verification and validation testing assesses the software's ability to perform these functions accurately (i.e., accept files, allow design, output files for manufacturing). It does not involve a human in a diagnostic loop that would be compared to an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the verification and validation, the "ground truth" would be the design specifications and manufacturing requirements established by Zimmer Dental for patient-specific restorations. The system's output (digital designs) and the subsequent manufactured physical restorations would be compared against these established specifications for accuracy and adherence.
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The sample size for the training set:
- This information is not provided. The Zfx Dental CAD System is described as CAD software for design, not as a machine learning model that undergoes a training phase with a distinct training set of data. Its functionality likely relies on algorithms based on geometric principles and dental design rules, rather than statistical learning from a large training dataset.
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How the ground truth for the training set was established:
- Not applicable as the device is not described as a machine learning system requiring a labeled training set with established ground truth in the typical sense. The "ground truth" for developing such software would be established by engineering requirements, dental prosthetic design principles, and industry standards.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)