(71 days)
The ANA-BEL and ANA-BEL 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.
ANA-BEL and ANA-BEL CM, Takara X-Caliber and X-Caliber CM, and PLANMECA 2002 CC Proline Panoramic X-ray all employ X-ray tube with maximum rated peak tube potential of 90 kV.
The provided document describes a 510(k) submission for the ANA-BEL and ANA-BEL CM X-ray systems, seeking substantial equivalence to predicate devices (Takara X-Caliber and X-Caliber CM, and PLANMECA 2002 CC Proline Panoramic X-ray).
The document does not contain detailed information about specific acceptance criteria or a dedicated study report proving the device meets those criteria in a quantitative sense. Instead, the equivalence is established by comparing the new device's indications for use and technological characteristics to those of the predicate devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document uses the concept of "substantial equivalence" as its acceptance overarching criterion. The performance is assessed by confirming that the new device shares the same intended use and similar technological characteristics with existing legally marketed devices.
| Acceptance Criterion (Implicit) | Reported Device Performance (ANA-BEL and ANA-BEL CM) |
|---|---|
| Same Indications for Use | Yes, "Generation of radiographic images of the dento-maxilofacial region for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures." This matches the predicate devices. |
| Same Technological Characteristics (Design, Materials, etc.) | Yes, employs an X-ray tube with a maximum rated peak tube potential of 90 kV, similar to predicate devices. (A detailed comparison table is referenced but not provided in the excerpt). |
| New characteristics do not affect safety and effectiveness | No, asserted that new characteristics do not affect safety and effectiveness. |
| New characteristics do not raise new types of safety or effectiveness questions | No, asserted that new characteristics do not raise new questions. |
| Acceptable scientific methods exist for assessing effects of new characteristics | Yes, asserted. |
| Performance data available to assess effects of new characteristics | Yes, asserted. |
| Performance data demonstrate equivalence | Yes, asserted. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a separate "test set" or provide details on data provenance (e.g., country of origin, retrospective/prospective) for a performance study. The basis for clearance is demonstrating equivalence to predicate devices, not through a separate clinical performance study with a distinct test set in the traditional sense. The phrase "performance data available to assess effects of new characteristics" is generic and not further elaborated on to describe specific testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not mention the use of experts or the establishment of ground truth for a test set. The regulatory decision is based on a review of the device's specifications and comparison to predicates by the FDA, not on a human-readability study or expert consensus for image interpretation.
4. Adjudication Method for the Test Set:
Since there is no described test set or expert evaluation, there is no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done or at least not described in this document. The submission is for substantial equivalence, which often relies on technical specifications and functional comparisons rather than comparative clinical performance trials.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone performance study (e.g., for an AI algorithm) was not done. This document pertains to an X-ray imaging device, which is hardware, not an AI algorithm.
7. Type of Ground Truth Used:
The concept of "ground truth" as typically used in AI or diagnostic accuracy studies is not applicable or mentioned in this context. The basis for equivalence relies on comparing the device's functional and design characteristics to those of predicate devices, and its ability to "Generate radiographic images" for diagnosis, rather than the accuracy of image interpretation against a definitive ground truth.
8. Sample Size for the Training Set:
Not applicable. This document describes an X-ray imaging device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set mentioned, this information is not provided.
§ 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.