(459 days)
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.
§ 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.)