(48 days)
The SciCan Classic and accessories is to provide video images of the mouth and oral structures, dental cavities, dental pulps, dental canal morphology. It is used to perform various diagnostic procedures, to provide educational information to patients as well as to other clinical personnel and to provide documentation for patient records and for insurance companies.
SciCan Classic also is used for inspection of reliable diagonsis of border gaps when dealing with inlays. Additionally it acts as an effective caries detector during the examination of areas of the mouth which are normally difficult to approach. Further indications for use are extra-oral imaging of the whole face and of the mouth, outline imaging of the quadrants and macroscopic images of the dental enamel.
The SciCan Classic and accessories are indicated for use when video images are desired to provide visual information during dental examinations and procedures.
The SciCan Classic is a video camera system with a modular design due to a handpiece system with interchangeable optics. It uses a CCD ½" camera chip and provides fiber optic illumination by an integrated light source with automatic exposure control. It has removable and interchangeable probe options (90° probes, 0° probe). It supports NTSC / PAL video systems and has a power consumption of 150 Watt.
The provided 510(k) summary for the Ka84556 SciCan Classic device does not contain a study that proves the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML device would be analyzed.
Instead, this submission is for a video camera system, and its "effectiveness" is established based on its intended use for providing video images and adherence to general safety and quality standards, and comparison to a predicate device.
Here's an breakdown of the information as requested, highlighting what is present and what is absent given the nature of this submission:
1. A table of acceptance criteria and the reported device performance
Based on the provided document, specific quantitative "acceptance criteria" related to a performance study for image quality or diagnostic accuracy are not defined. The effectiveness is broadly stated:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Providing video images for dental examinations and procedures. | "The SciCan Classic is effective for its intended use of providing video images for the above described purposes and procedures." |
| Compliance with relevant safety standards. | "The device complies with IEC 601-1-2, and IEC 601-1-2, and IEC 601-2-18." |
| Substantial equivalence to predicate device. | The FDA's letter (K984556) affirms substantial equivalence to the Welch Allyn Reveal Intraoral Camera System (K981937). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. This submission does not describe a clinical performance study with a test set of data (e.g., images for diagnostic evaluation). Its effectiveness is based on technological characteristics and comparison to a predicate device, rather than a statistical analysis of a sample of cases.
3. 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 applicable. No such test set or ground truth establishment by experts is described for this device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring expert adjudication is described.
5. 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
- Not applicable. This device is a video camera system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The SciCan Classic is a hardware device (a camera system), not an algorithm. Standalone performance as typically described for AI/ML devices is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No explicit "ground truth" as would be used in a diagnostic performance study is mentioned. The device's "effectiveness" is tied to its ability to capture and display images, fulfilling its intended diagnostic and educational purposes, and its technical specifications compared to a predicate.
8. The sample size for the training set
- Not applicable. This is a hardware device (video camera system), not a machine learning algorithm. Therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is not relevant.
Summary Explanation:
The K984556 submission for the SciCan Classic is for a general-purpose video camera system intended for dental use. Its clearance is primarily based on:
- Substantial Equivalence: Demonstrated by comparing its design, power consumption, camera type, video system, illumination, light control, handpiece, probes, and standards met to the legally marketed predicate device, the Welch Allyn Reveal Intraoral Camera System (K981937).
- Compliance with Standards: Adherence to safety standards like IEC 601-1-2 and IEC 601-2-18.
- Stated Effectiveness: The device's ability to provide "video images of the mouth and oral structures, dental cavities, dental pulps, dental canal morphology" for diagnostic, educational, and documentation purposes.
The rigor of clinical performance studies with acceptance criteria, test sets, expert ground truth, and statistical analyses (like those for AI/ML or complex diagnostic devices) is not typically required for this type of device, especially given its 1998 submission date. The FDA determined it substantially equivalent to a predicate, allowing it to proceed to market under general controls.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.