(448 days)
This 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. Not for mammographic use.
The Bel-Cat series is a set of arm type X-ray CT diagnostic devices which has exposure modes can be customized to meet a wide variety of diverse diagnostic imaging needs. The Bel-Cat series is a true all-in-one system capable of offering diverse acquisition modes that deliver the high-definition images demanded in dental fields.
The provided text describes a 510(k) summary for the Bel-Cat Dental Cone Beam CT device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics of the device itself. Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for test and training sets, how ground truth for the training set was established) are not explicitly present in the provided information.
However, based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) submission are implied to be "as safe and effective as the predicate device" and having "few technological differences, and no new indications for use." The device's performance is demonstrated through a comparison of its specifications to the predicate device.
| Feature | Acceptance Criteria (Implied: Equivalent to Predicate) | Reported Bel-Cat Device Performance |
|---|---|---|
| Indication for Use | 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. Operated by physicians, dentists, and x-ray technologists. | SAME (as predicate device) |
| Focal spot | 0.6mm x 0.6mm | 0.5mm x 0.5mm (Slight difference, but deemed substantially equivalent) |
| Tube voltage | 60-100 kV | 60-95 kV (Within predicate range for lower end, slightly lower max) |
| Tube current | 2-15 mA | 2-12 mA (Within predicate range for lower end, slightly lower max) |
| Exposure time | 17 sec maximum | 17 sec maximum |
| Input | 3 kVa | 2 kVa (Lower, indicates potentially less power consumption, not a safety concern for equivalence) |
| Power supply | AC 220 v, 50/60 Hz | AC 220 v, 50/60 Hz |
| Projection mode | CT, Panoramic | CT, Panoramic |
| Detector dimension | Varian 2520: 250mm x 200mm, 127µm x 127µm, 1536 x 1920 pixels; Varian 3030: 300mm x 300mm, 194µm x 194µm, 1536 x 1536 pixels | Varian 2520: 250mm x 200mm, 127µm x 127µm, 1536 x 1920 pixels; Varian 1313: 130mm x 130mm, 127µm x 127µm, 1024 x 1024 pixels (Offers a different, smaller detector option than one of the predicate's options, but also deemed substantially equivalent) |
2. Sample size used for the test set and the data provenance
The document states that "The results of bench, test laboratory and clinical testing indicates that the new device is as safe and effective as the predicate devices," and mentions "bench test data as well as external laboratory testing to applicable standards." However, no specific sample size or details about the data provenance (e.g., country of origin, retrospective/prospective) for any "test set" are provided. The submission focuses on technical specifications and equivalence, not a clinical trial with a defined test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not provided. This type of information is not typically included in a 510(k) summary for a device demonstrating substantial equivalence through technical specification comparison, especially if no specific clinical test set is detailed.
4. Adjudication method for the test set
Not provided. As no specific clinical test set with human assessments is described, no adjudication method would be presented.
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
No MRMC study was done or reported. This device is a diagnostic imaging system, not an AI-assisted interpretation device. The submission focuses on the safety and effectiveness of the imaging system itself, not the improvement of human readers with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable/Not provided. This is a hardware device (CT scanner). The concept of "standalone algorithm performance" does not apply directly to this type of medical device submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not explicitly detailed. The "ground truth" for demonstrating substantial equivalence appears to be established through engineering specifications, performance tests (bench and laboratory), and implied clinical consensus on the diagnostic utility of the images produced, as it is equivalent to an already marketed device. There's no mention of specific pathology or outcomes data from a new clinical study.
8. The sample size for the training set
Not applicable/Not provided. This device is a conventional CT scanner, not a machine learning or AI-based system that undergoes "training."
9. How the ground truth for the training set was established
Not applicable/Not provided. As there is no "training set" for this type of device, no ground truth establishment method for it is relevant.
§ 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.