(37 days)
The BELMAX CM dental panoramic and cephalometric X-ray system is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.
The BELMAX CM Model X168 X-Ray System is the next generation of the Takara Belmont digital dental X-ray systems. Similar to the prior Takara Belmont ANA-BEL, ANA-BEL CM equipped with the Takara Belmont ADR Plus SSXI, the BELMAX CM Model X168 X-Ray System offers digital imaging with panoramic and cephalometric imaging programs with the same exposure levels (KV/mA). Modifications resulting in the device include a new sized CCD sensor including three rather than two of the same sensor array grids mounted in a removable cartridge rather than bolted in place.
The provided document describes a 510(k) premarket notification for the BELMAX CM Model X168 X-Ray System. The study conducted for this device is a clinical trial comparing its performance to film images.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the clinical study in the form of a pre-defined threshold that the device needed to meet to be considered successful. Instead, it presents comparative performance metrics against film images, aiming to demonstrate that the BELMAX CM digital images are "better than" or "as good as" film.
| Acceptance Criteria (Implied) | Reported Device Performance (BELMAX CM Digital Images) | Comparator (Film Images) |
|---|---|---|
| Clear observation of skeletal hard tissue structures | 97% of subjects | 81% of subjects |
| Sufficient depiction of soft tissue structures | 87% of images | 43% of images |
| Overall image quality | Rated better than film images | - |
| Sufficient clarity for landmark identification | 93.6% average percentage | 81.6% average percentage |
2. Sample size used for the test set and the data provenance
- Sample Size: 30 patients
- Data Provenance: Retrospective, conducted in Japan at the Department of Oral Radiology, Asahi University School of Dentistry.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Five specialists
- Qualifications of Experts: Specialists in orthodontic dentistry. (Further details on experience level, e.g., years of experience, are not provided).
4. Adjudication method for the test set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It mentions that "Readings were performed by five specialists in orthodontic dentistry." It's implied that these experts performed the evaluations that led to the reported percentages, but the method for resolving discrepancies among their readings, if any, is not detailed.
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
- MRMC Comparative Effectiveness Study: A comparative study was done between digital images and film images, and human readers (specialists) were involved in reading both. However, this was not a study on AI assistance for human readers. It was a comparison between different imaging modalities (digital X-ray vs. film X-ray).
- Effect Size of Human Readers with AI vs. without AI assistance: Not applicable, as the device is an X-ray system, not an AI-powered assistant for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) performance study was not done. The study specifically involved human readers (specialists) evaluating both digital and film images. The device itself is an imaging system, not an independent diagnostic algorithm.
7. The type of ground truth used
- Expert Consensus/Expert Reading: The "ground truth" for evaluating image quality and clarity was established through the readings and ratings performed by five specialists in orthodontic dentistry. The document uses phrases like "rated as sufficient" and "rated better than," indicating subjective expert assessment. No objective pathology or outcomes data is mentioned as ground truth.
8. The sample size for the training set
The document does not mention a "training set" or any machine learning components for which a training set would be required. The BELMAX CM Model X168 is an X-ray imaging system, not an AI-driven diagnostic tool. Therefore, the concept of a training set as used in AI/ML is not directly applicable here. The focus of the study was on the image quality produced by the device for human interpretation, not on training an algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI/ML algorithm.
§ 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.