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The CDX Digital X-ray Imaging System is intended to be used with standard X-ray systems to collect dental x-rays photos and convert them into electronic data that may be stored, viewed, and manipulated by dentists for the diagnosis of diseases of the teeth, jaw, and oral structures.

Digital Dental intraoral Xray Sensor

The provided text is a 510(k) premarket notification for the CDX Digital X-ray Imaging System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria as you might see for a PMA device.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

Here's why and what we can infer based on the provided text:

• Acceptance Criteria and Reported Performance: Not explicitly stated. The core of a 510(k) submission is to demonstrate that the new device has "substantially equivalent" technological characteristics and indications for use to a predicate device. This is evaluated by comparing technical specifications rather than setting up performance targets for clinical outcomes.

• Study That Proves the Device Meets Acceptance Criteria: No such clinical study is described. The approval is based on a comparison to a predicate device (Dr. Suni Digital Radiography System K021718).

• Absence of Clinical Study Information:

  • Sample size (test set): Not applicable, as a clinical test set is not described.
  • Data provenance: Not applicable.
  • Number of experts and qualifications: Not applicable.
  • Adjudication method: Not applicable.
  • MRMC comparative effectiveness study: Not conducted or described.
  • Standalone performance: Not described in terms of a formal study with metrics like sensitivity/specificity.
  • Type of ground truth: Not applicable, as no ground truth for clinical performance is established or used for evaluation in this context.
  • Sample size for training set: Not applicable, as this is not an AI/ML device that undergoes a training phase as understood today.
  • How ground truth for training set was established: Not applicable.

What the document does provide in relation to your prompt (though it doesn't directly answer all questions):

• Device Name: CDX Digital X-ray Imaging System
• Intended Use: "to be used for dental radiographic examination for the diagnosis of diseases of the teeth, jaw, and oral structures."
• Indications for Use: "The CDX Digital X-ray Imaging System is intended to be used with standard X-ray systems to collect dental x-rays photos and convert them into electronic data that may be stored, viewed, and manipulated by dentists for the diagnosis of diseases of the teeth, jaw, and oral structures."
• Predicate Device: Dr. Suni Digital Radiography System K021718, manufactured by Suni Imaging Microsystems, Inc.
• Basis for Approval: The FDA determined that the CDX Digital X-ray Imaging System has "similar technological characteristics and to be equivalent" to the predicate device. This implies that the comparison of technical specifications (e.g., sensor type, resolution, image processing capabilities) to the predicate device would have served as the "proof" for substantial equivalence.

In summary, for a 510(k) submission like this, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device, and the "study" is a comparison report of technical characteristics rather than a clinical trial.

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