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The Bel-Cypher Pro dental panoramic X-ray system is indicated for use as generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the tooth, jaw, and oral structures.

The Bel-Cypher Pro is a user-friendly, digital panoramic X-ray system that features bitewing imaging capability, as well as diagnostic panoramic and TMJ imaging capabilities. The Bel-Cypher Pro utilizes a high frequency inverter and has a small focal spot to produce crisp, clear images.

The provided text is a 510(k) Premarket Notification for the Bel-Cypher Pro dental panoramic X-ray system. It describes the device, its indications for use, and compares it to a predicate device (Bel-Cypher N) to demonstrate substantial equivalence.

However, the document does not contain information about a study that proves the device meets specific acceptance criteria in the context of AI/ML performance, human reader improvement with AI assistance, or expert consensus ground truthing.

The 510(k) submission largely focuses on technical specifications, safety standards, and performance tests related to the X-ray system's hardware and basic imaging capabilities. It compares physical and operational characteristics (e.g., focal point, kV range, mA range, dimensions, weight, sensor type, resolution, noise) between the new device and the predicate.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance based on AI/ML validation, sample sizes for test/training sets for AI, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as this information is not present in the provided document.

The document does state the following general "acceptance criteria" through conformance to standards and testing:

• Safety and EMC Standards Compliance:
  • AAMI / ANSI ES60601-1:2005((R)2012 And A1:2012,, C1:2009(R)2012 And A2:2010/(R)2012 (Consolidated Text)
  • IEC 60601-1-2:2007/(R)2012
  • IEC 60601-1-3 Edition 2.1 2013-04
  • IEC 60601-2-28 Edition 2.0 2010-03
  • IEC 60601-2-63 Edition 1.0 2012-09
  • IEC 60601-2-65 Edition 1.0 2012-09
• Imaging Performance Testing: IEC 61223-3-4 First Edition 2000-03 (Evaluation And Routine Testing In Medical Imaging Departments - Part 3-4: Acceptance Tests - Imaging Performance Of Dental X-Ray)
• Risk Management: ISO 14971 Second Edition 2007-03-01
• X-Ray Tube Housing Conformity: IEC60601-1-3 and 21CFR 1020.30(k)
• Software Functionality: "Modifications of software were tested and confirmed based on applicable standards" and "Exe files and DLLs of Radiograph software and image reconstruction software were developed under Windows 10 environment."
• Image Equivalence: "We also tested all of the radiograph modes and conmfirmed images are equvalent to the ones taken by the predicate device."

Without the specific data on how "images are equivalent" was quantitatively measured against defined acceptance criteria (e.g., specific image quality metrics with thresholds), a detailed table cannot be created from this document in the way you requested for AI/ML performance.

The document describes the device as an "Extraoral source x-ray system" which generates "radiographic images," not a device that interprets images or uses AI/ML for diagnosis. The "study" mentioned here is the set of engineering tests and comparisons performed to demonstrate substantial equivalence to a predicate device under 510(k) regulations, not a clinical trial involving human readers or AI algorithms for diagnostic performance.

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