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DGA Abutment is a patient-specific prosthetic component directly connected to the endosseous dental implant (details as below) and is intended for use as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

DGA Abutment is endosseous implant abutment which is placed into a corresponding dental implant to provide support for a prosthetic restoration. DGA Abutment is made of titanium grade Ti-6Al-4V ELI (meets ASTM Standard F136). The DGA Abutment is mounted on the implant with a screw. Each abutment is supplied with two identical screws which are used for:
a. For fixing into the endosseous implant.
b. For dental laboratory use during fabrication of restoration.
The screw is also made of titanium grade Ti-6AI-4V ELI (meets ASTM Standard F136).

The provided text is a 510(k) summary for the DGA Abutment, a dental implant component. It addresses substantial equivalence rather than presenting an AI/ML device study with acceptance criteria and performance data. Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies for an AI/ML device.

The document discusses the mechanical properties and biocompatibility of the DGA Abutment, comparing it to predicate devices. It states that fatigue testing was conducted according to ISO 14801:2016 and FDA guidance, and biocompatibility testing was done as per ISO 10993 series. However, it does not provide specific acceptance criteria or reported performance data in a table format for these tests, nor does it refer to an AI/ML algorithm.

Therefore, I cannot directly answer your prompt using the provided text. The prompt's questions pertain to acceptance criteria and study methodologies for an AI/ML device, which are not found in this 510(k) submission for a physical dental abutment.

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The TRIOCLEAR System is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of increment, it sequentially positions teeth by way of continuous gentle force.

The TRIOCLEAR System is a removable, non-sterile device intended for single patient use. TRIOCLEAR is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing sets of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.

The provided text describes the TRIOCLEAR System, an orthodontic device. However, it does not include the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML-driven device.

The document is a 510(k) summary for the TRIOCLEAR System, which is a series of clear plastic aligners. The submission aims to establish substantial equivalence to a predicate device, primarily due to changes in raw material and thickness types. The performance testing section focuses on material properties of the thermoforming sheet, not the performance of an AI/ML component.

Therefore, I cannot provide the requested information from the given text. The text does not discuss:

• Acceptance criteria for an AI/ML device's performance.
• A study proving an AI/ML device meets acceptance criteria.
• Sample size for test sets or data provenance for AI/ML validation.
• Details about experts for ground truth establishment.
• Adjudication methods.
• MRMC studies or effect sizes for AI assistance.
• Standalone AI algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes) in the context of AI.
• Training set sample size or ground truth establishment for a training set for an AI/ML model.

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