(114 days)
FinScan F350 is CBCT, panoramic and cephalometric x-ray imaging system. The device is intended to radiographic examination of the dento-maxillofacial and TMJ structure for diagnostic support for adult and pediatric patients. Cephalometric image also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment.
The device is to be operated and used by dentists or other legally qualified health care professionals.
Dental Cone-beam Computed Tomography (model: FinScan F350) uses cone-beam computed tomography (CBCT) technology through X-ray cone-beam, panoramic radiography, cephalometric radiography to produce images of the dento-maxillofacial and TMJ structure to provides diagnostic details for dental clinics and dental hospitals.
This product mainly consists of column, rotating unit, tube head assembly, CBCT/panoramic detector, cephalometric detector, the workstation and image processing software.
The provided text describes the 510(k) premarket notification for the Dental Cone-beam Computed Tomography (model: FinScan F350) and its substantial equivalence to a predicate device. However, the document does not contain explicit acceptance criteria or a comprehensive study demonstrating that the device meets specific performance criteria in a quantitative manner as typically expected for device performance studies.
The document focuses on regulatory compliance, outlining how the FinScan F350 is substantially equivalent to the predicate device RCT700 (K213226) based on technological characteristics and adherence to recognized standards. It mentions "Performance bench testing" and "Clinical images acquired using FinScan F350 were evaluated by two US board certified experienced dentists to be of acceptable clinical effectiveness," but it does not provide specific metrics or the study details requested.
Here's an analysis based on the available information, noting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions performance bench testing that measured spatial resolution, CNR (Contrast-to-Noise Ratio), and homogeneity for CT image quality. It states that "The results demonstrate that the subject device is as effective, and perform as well as the predicate device." However, specific numerical acceptance criteria or the reported performance values for these metrics are NOT provided in the text.
2. Sample Size Used for the Test Set and Data Provenance:
The document briefly mentions "Clinical images acquired using FinScan F350 were evaluated..." but does not specify the sample size (number of images or cases) used for this evaluation, nor does it provide information on the data provenance (e.g., country of origin, retrospective or prospective nature of the image acquisition).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
"Clinical images acquired using FinScan F350 were evaluated by two US board certified experienced dentists to be of acceptable clinical effectiveness for the proposed indications for use."
- Number of experts: 2
- Qualifications: US board certified experienced dentists. (Specific years of experience are not mentioned).
4. Adjudication Method for the Test Set:
The document states "evaluated by two US board certified experienced dentists," but it does not specify an adjudication method (e.g., whether consensus was required, if a third expert was used in case of disagreement, or if individual evaluations were aggregated).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study is NOT mentioned in the provided text. The document describes a substantial equivalence submission, which typically focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than quantifying performance improvements with AI assistance. The device is described as an imaging system, not an AI-based diagnostic tool that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The FinScan F350 is a medical imaging device (CBCT, panoramic, cephalometric x-ray system) that produces images for diagnostic support. It includes "image processing software." The performance evaluation mentioned (bench testing and clinical image evaluation by dentists) is about the general image quality and clinical effectiveness of the imaging system itself. The concept of "standalone algorithm performance" (without human-in-the-loop) as typically applied to AI/CADe systems is not directly applicable or discussed for this device based on the provided text, as it's an image acquisition system, not primarily a standalone diagnostic algorithm.
7. The Type of Ground Truth Used:
For the "clinical images evaluation report," the ground truth seems to be implicitly expert judgment/consensus of the two US board-certified experienced dentists, who deemed the image quality "acceptable clinical effectiveness." Pathology or outcomes data are not mentioned as ground truth sources for this evaluation.
8. The Sample Size for the Training Set:
The document does not mention any training set size. This is expected as the document describes a hardware imaging device with associated standard image processing software, not a machine learning or AI algorithm that requires a "training set" in the context of deep learning. The software mentioned (FinScan and FinScanFW) performs control, image acquisition, reconstruction, storage, browsing, and processing, which are typically deterministic software functions, not machine learning models.
9. How the Ground Truth for the Training Set was Established:
As no training set is mentioned as applicable to this type of device (traditional imaging system with processing software, not an AI/ML algorithm), this information is not applicable and not provided.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.