(65 days)
FineCube is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.
The FineCube consists of two main elements: (1) The X-Ray generation and acquisition system and (2) the image analysis software. The X-Ray generation/acquisition system creates a cone-shaped x-ray field which is acquired on a flat panel sensor with a resolution of 608 x 616 x 200 um. FineCube is an X-ray imaging device that constructs a three dimensional model from images taken during a rotational X-ray sequence. FineCube is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects
The provided 510(k) summary for the FineCube Dental CT System (K063622) does not contain detailed information about acceptance criteria and specific studies demonstrating the device meets those criteria. Instead, it focuses on establishing substantial equivalence to predicate devices based on indications for use and specification comparisons.
Here's a breakdown of the available information and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided document. The 510(k) summary only provides a table comparing the specifications of the FineCube with two predicate devices. It doesn't list defined "acceptance criteria" for performance metrics like image quality, diagnostic accuracy, or specific measurements, nor does it present the FineCube's performance against such criteria. The document states "The results of bench, test laboratory and clinical testing indicates that the new device is as safe and effective as the predicate devices," but no specific performance data or statistical analysis is provided to support this claim against defined criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not explicitly stated in the document. The document mentions "bench, test laboratory and clinical testing," but does not provide details on the sample sizes used for these tests or the provenance (country of origin, retrospective/prospective) of any clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not available in the provided document. There is no information regarding the establishment of ground truth by experts for any testing conducted.
4. Adjudication Method for the Test Set
Not available in the provided document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The FineCube is an imaging device (cone beam computed tomography) and not an AI-powered diagnostic algorithm designed to assist human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be relevant to this device's submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. It is a medical imaging device.
7. The Type of Ground Truth Used
Not available in the provided document.
8. The Sample Size for the Training Set
Not applicable. As a medical imaging device, the concept of a "training set" in the context of machine learning algorithms is not directly relevant. The device undergoes engineering and performance validation rather than algorithmic training.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the machine learning sense for this device.
Summary of what is available and what is missing:
The 510(k) summary for K063622 primarily relies on demonstrating substantial equivalence to predicate devices through a comparison of their indications for use and technical specifications. While it generally asserts that safety and effectiveness were demonstrated through "bench, test laboratory and clinical testing," it lacks the specific details requested regarding acceptance criteria, study methodologies, sample sizes, ground truth establishment, expert involvement, or any data related to AI performance metrics. This level of detail is often not included in the public 510(k) summary and would typically be found in the complete 510(k) submission that is reviewed by the FDA.
§ 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.