(20 days)
Scanora 3D is a dental cone beam computed tomography x-ray system intended to image teeth, jaw and TMJ areas of the skull. A flat panel detector is used to acquire 3D images and an optional CCD sensor to acquire panoramic images. The device is operated and used by dentists and other qualified professionals.
Scanora 3D is a dental cone beam CT for imaging of teeth, jaw and TMJ areas of the skull. In CT mode it generates a pulsed conical x-ray beam during rotation around a patient's head and produces two dimensional images on a flat panel detector. Three dimensional images are then reconstructed and viewed with software. In panoramic mode panoramic and TMJ images can be taken in the classical way on a separate CCD detector.
The provided text is a 510(k) summary for the Scanora 3D dental cone beam CT system. It does not contain information about specific acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, expert qualifications, or details typically found in a clinical study report.
The document focuses on demonstrating substantial equivalence to predicate devices rather than an independent study with predefined acceptance criteria.
Here's a breakdown of what can be extracted and what information is missing:
Information from the document:
- Device Name: Scanora 3D
- Intended Use: "Scanora 3D is a dental cone beam computed tomography x-ray system intended to image teeth, jaw and TMJ areas of the skull. A flat panel detector is used to acquire 3D images and an optional CCD sensor to acquire panoramic images. The device is operated and used by dentists and other qualified professionals."
- Comparison Basis: Substantial equivalence to predicate devices (Planmeca Promax 3D (K060328) and i-CAT Scanner (K061284)).
- Assessment Method: "A non-clinical image quality comparison demonstrated Scanora 3D produces similar image quality to the predicate device."
- Compliance: "Scanora 3D complies with applicable FDA and FDA recognized performance standards."
Missing Information (not found in the provided text):
- A table of specific acceptance criteria (e.g., resolution, contrast, artifact levels) and reported device performance against those criteria.
- Details of any specific study designed to prove the device met acceptance criteria. The document describes a "non-clinical image quality comparison," but no specific study design, methodology, or results are provided.
- Sample size used for a test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study or related effect size.
- Results of a standalone algorithm performance study.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Summary Table (based on available information):
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Technological Characteristics | Similar to predicate devices (X-ray generation, detectors, imaging technique, system footprint). |
| Image Quality | "Similar image quality to the predicate device" demonstrated via non-clinical comparison. |
| Regulatory Compliance | Complies with applicable FDA and FDA recognized performance standards. |
Missing Study Details:
Since the document relies on substantial equivalence and a "non-clinical image quality comparison" rather than a detailed device performance study against specific acceptance criteria, most of the requested study details are not present.
The 510(k) summary states: "A non-clinical image quality comparison demonstrated Scanora 3D produces similar image quality to the predicate device." This indicates that some form of internal testing was performed to compare image quality, likely using phantom images or cadaveric specimens, but the specific metrics, methods, sample sizes, and expert interpretations (if any beyond internal engineers) are not disclosed in this summary.
Therefore, it's not possible to answer most of the specific questions about sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, or training set details from the provided text.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.