(210 days)
The Digital Impression System for Orthodontic Use is an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva, and/or palate. The Digital Impression System is intended for use in conjunction with the production of orthodontic appliances.
The Digital Impression System for Orthodontic Use (DIS) is a handheld intraoral 3D imager intended for use inside the human oral cavity to digitally capture the three-dimensional topography of teeth, gingiva, and/or palate in clinical settings. It is intended to replace traditional cast impressions which are the current standard for recording dental and orthodontic features of patients undergoing orthodontic treatment. The system is intended to be used by orthodontists and orthodontic assistants in an orthodontic office environment. The system consists of a handheld wand connected to a computer which is housed in a base unit. The computer contains proprietary software to acquire, process, and store the digital 3D image data. Patient information is entered into the software using a touch screen monitor connected to the computer. To capture a 3D image of the patient's dental arch and/or bite, the operator moves the wand over the surface of the teeth to be scanned. A video camera inside the wand captures images of the teeth surfaces. Algorithms in the software process these images into a 3D image and display the 3D image on the computer monitor in real time. The software also saves the 3D image data and identifying patient information to be used by orthodontic manufacturers to design and manufacture customized orthodontic appliances.
The provided document (K122065 510(k) Summary) describes the Digital Impression System for Orthodontic Use (DIS) and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format with corresponding numerical performance metrics for the device. Instead, the "acceptance criteria" are implied by the non-clinical test's conclusion of "substantial equivalence" to traditional methods (PVS impressions).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| 3D topographical files created by DIS are substantially equivalent to files derived from digitized polyvinylsiloxane (PVS) traditional impressions. | "Test results confirmed that digital impressions generated by the Digital Impression System for Orthodontic Use are substantially equivalent to PVS impressions made by traditional means." |
| Software performance is validated successfully. | "Additionally, the Digital Impression System for Orthodontic Use software has been successfully validated to confirm the performance of the device." |
| Biocompatibility of disposable wand tip meets standards. | "Biocompatibility studies (Cytotoxicity, Irritation and Sensitization) have been completed on the disposable wand tip included in the Digital Impression System for Orthodontic Use product." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size for the "3D topographical files" comparison study. It only states that "files were created" and "compared to files derived from, digitized polyvinylsiloxane (PVS) traditional impressions."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the comparison study. The ground truth appears to be based on "digitized polyvinylsiloxane (PVS) traditional impressions," which themselves are physical impressions. How the "ground truth" was established from these PVS impressions (e.g., by expert measurement, specific metrology tools) is not detailed.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing has not been conducted on this product." The comparison was between digital files from the DIS and digitized traditional impressions, not involving human readers comparing output from the DIS versus traditional methods.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the primary test described is a standalone performance assessment. The comparison was between the 3D topographical files generated solely by the Digital Impression System for Orthodontic Use (algorithm + hardware) and files derived from digitized traditional impressions. There is no mention of human interaction or interpretation as part of this comparison.
7. The Type of Ground Truth Used
The ground truth used was based on "digitized polyvinylsiloxane (PVS) traditional impressions." This implies that the PVS impressions served as the reference for accurate topographical representation of teeth, gingiva, and/or palate. It is a form of empirical ground truth based on an established, existing clinical method.
8. The Sample Size for the Training Set
The document does not mention a training set nor its sample size. This suggests the comparison was likely an evaluation of a fully developed system rather than an iterative model training and validation process often associated with machine learning.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, this information is not applicable/not provided.
§ 872.3661 Optical Impression Systems for CAD/CAM.
(a)
Identification. An optical impression system for computer assisted design and manufacturing (CAD/CAM) is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer-assisted design and manufacturing of dental restorative prosthetic devices. Such systems may consist of a camera, scanner, or equivalent type of sensor and a computer with software.(b)
Classification. Class II (Special Controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of the chapter subject to the limitations in § 872.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA.” For the availability of this guidance document, see § 872.1(e).