(90 days)
For Panoramic or Cephalometric diagnostic radiographic use in dental, oral surgery, and orthodontic practices.
The ENCOMPASS HF100-Eagle Panoramic X-Ray Machine with CCD sensor is a complete system for dental imaging capable of Digital Panoramic Profiles and Digital Cephalometric Profiles. The machines use a sensor CCD sensor technology with the traditional scintillator technologies and auto image processing that allow a speed up the diagnostic and improve the clinic workflow. The equipment has three movement axes (two in orthogonal directions and one rotational) making it possible to execute elaborate imaging profiles. It features a complex profile movement around the dental arch and radiographic emission compensation in the spinal region, when necessary reconstructing the dental arch into a plane image. Each individual profile prioritizes a set of characteristics improving diagnostic capabilities. For example, the standard panoramic prioritizes image layer width, constant vertical magnification and homogeneous exposure along the whole image. Likewise, the low dosage profile prioritizes the reduction of dosage (time and anodic current). ONLY THE SENSOR HAS CHANGED.
The provided text describes the ENCOMPASS HF100-Eagle Panoramic/Cephalometric X-Ray with CCD sensor. Based on the information, here's a description of the acceptance criteria and the study that proves the device meets them:
Acceptance Criteria and Device Performance
The device sought substantial equivalence to its predicate device (K110371, Encompass made for Panoramic Corp.). The acceptance criteria appear to be focused on achieving comparable diagnostic quality, sharpness, and overall image quality to the predicate device, as well as meeting relevant safety and performance standards.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Diagnostic quality comparable to predicate | "He found them to have comparable diagnostic quality" |
| Sharpness comparable to predicate | "He found them to have comparable...sharpness" | |
| Overall quality comparable to predicate | "He found them to have comparable...overall quality" | |
| Technical Performance | Resolution figures | "The resolution figures are as good as or better than our former sensors used in our predicate K110371." |
| Safety | Electrical, mechanical, environmental safety | "Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 was performed" |
| EMC | Electromagnetic Compatibility | "EMC testing was conducted in accordance with standard IEC 60601-1-2(2001)." |
| X-Ray Standards Compliance | Compliance with applicable X-Ray standards | "Compliance testing was performed for the applicable portions of the following X-Ray standards: IEC 60601-1-3/2001: 60601-2-28/2001; IEC 60601-2-32/2001." |
| Software Validation | Software functionality and reliability | "Software validation was performed." |
| Accuracy | Accuracy of testing | "Accuracy testing...was performed." |
Overall Result: "All test results were satisfactory." and the clinical summary states the images were found to have comparable diagnostic quality, sharpness, and overall quality.
Study Details:
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Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text only mentions "the predicate and new device pan and ceph images."
- Data Provenance: Not specified. It does not mention the country of origin of the data, nor whether the data was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "a licensed dentist" (singular).
- Qualifications of Experts: A "licensed dentist." No further details on experience level (e.g., years of experience, specialization) are provided.
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Adjudication method for the test set:
- Adjudication Method: Not specified. With only one expert reviewing, there was no adjudication process (like 2+1 or 3+1 consensus). The assessment was based on a single licensed dentist's review.
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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 Study: No, an MRMC study was not done. The evaluation involved a single licensed dentist comparing images from the new device and the predicate device, not assessing human reader performance with or without AI assistance. This device is an X-ray machine with a new sensor, not an AI-assisted diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable in the context of an X-ray imaging device itself. The device produces images for human interpretation. The "resolution figures" and technical performance tests (safety, EMC, X-ray standards) could be considered standalone performance metrics for the device's technical capabilities, but not a standalone diagnostic "algorithm" performance.
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The type of ground truth used:
- Ground Truth Type: Expert opinion/consensus. In this case, it was the opinion of a single "licensed dentist" who evaluated the diagnostic quality, sharpness, and overall quality of the images. There is no mention of pathology or outcomes data being used as ground truth.
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The sample size for the training set:
- Sample Size: Not applicable. The device is an X-ray machine with a new sensor, not a machine learning model that requires a "training set" in the conventional sense. The "auto image processing" mentioned is likely built-in firmware/software rather than a continually learning AI.
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How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable, as there is no mention of a training set for a machine learning model.
§ 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.