(372 days)
eXceed Computerized Precision Bracket Placement Solution is a software system intended for use as an aid in orthodontic treatment planning to correct Malocclusions in Orthodontic Patients. For use by dental professionals trained in orthodontic treatment, including radiographic analyses and treatment planning. eXceed Computerized Precision Bracket Placement Solution is intended for use with commercially available brackets currently used in standard orthodontic treatment. The end product is an indirect bonding tray for use by the Dental professional to place multiple brackets at the same time.
The device consists of proprietary software that calculates the ideal position of the dental brackets based on the dental impressions and or 3D models supplied by the patients Orthodontist. Commercially available brackets are used as part of the system. Using the images provided by the Dental Professional, the software creates a 3D model and identifies the ideal placement of the brackets. The file is sent to the Dental Professional for review and approval. The Dental Professional may adjust the final position of the bracket if desired. A 3D model is printed, and the brackets are placed on the model in the prescribed location, approved by the Orthodontist. An indirect bonding tray is fabricated with the brackets in place. The tray and brackets are sent to the Dental professional. The Dental Professional places the indirect tray using their chosen commercially available bracket adhesive.
The provided text describes the "eXceed Computerized Precision Bracket Placement Solution" and its substantial equivalence to a predicate device, Ortho CADiQ. However, the document does not contain details about specific acceptance criteria, a detailed study that proves the device meets specific performance metrics, or the other requested information such as sample sizes, expert qualifications, or adjudication methods for performance studies.
The text focuses on demonstrating substantial equivalence based on intended use, technological characteristics, and principles of operation, rather than providing granular performance data from a specific study against predefined acceptance criteria.
The only mention of "Performance Data" is:
"The software is verified and validated by the digital model generated, matching the 3D model and bracket placement locations prescribed and approved by the Orthodontist."
This statement is very general and does not provide quantifiable acceptance criteria or detailed study results. The document notes: "As confirmed in comparative testing, the visual guidance system used by the subject device is accurate, in the sense that it corresponds exactly with the virtual coordinates dictated by the approved placement plan, thus enabling the technician to place the brackets on the working model precisely according to that plan." Again, this is a general statement without specific metrics or details of the comparative testing.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's an attempt to answer the questions based only on the available information:
-
A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in measurable terms in the provided document. The general criteria seem to be that the visual guidance system is "accurate" and "corresponds exactly with the virtual coordinates dictated by the approved placement plan."
- Reported Device Performance: "the visual guidance system used by the subject device is accurate, in the sense that it corresponds exactly with the virtual coordinates dictated by the approved placement plan, thus enabling the technician to place the brackets on the working model precisely according to that plan."
Acceptance Criteria (inferred) Reported Device Performance Visual guidance system for bracket placement is accurate and corresponds exactly with approved virtual placement plan coordinates. "the visual guidance system used by the subject device is accurate, in the sense that it corresponds exactly with the virtual coordinates dictated by the approved placement plan, thus enabling the technician to place the brackets on the working model precisely according to that plan." -
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 specified.
- Data Provenance: Not specified.
-
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 specified. The ground truth seems to be "the approved placement plan" from the orthodontist.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
-
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 study is mentioned. The document describes "comparative testing" of the visual guidance system's accuracy, but not a study of human readers’ improvement with AI assistance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The "performance data" describes the software generating a digital model and bracket placement, which is then verified against the orthodontist's prescription. This implies a standalone assessment of the software's output matching the desired plan. However, the exact methodology and metrics of this "verification and validation" are not detailed.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the device's accuracy appears to be the "approved placement plan" or "virtual coordinates dictated by the approved placement plan" supplied and approved by the "Dental Professional" or "Orthodontist."
-
The sample size for the training set
- Not specified. (This device is described as software that calculates ideal positions based on dental impressions/3D models and an orthodontist's plan, rather than a deep learning AI model that would typically have a specific training set size).
-
How the ground truth for the training set was established
- Not applicable/Not specified. The document does not describe a machine learning model that would require a ground-truthed training set in the conventional sense. The "ground truth" (the approved placement plan) is established by the dental professional for each case being processed by the system.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.