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K Number
K120106
Device Name
APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM
Manufacturer
APIXIA INC.
Date Cleared
2012-05-07

(115 days)

Product Code
MUH
Regulation Number
872.1800
Type
Traditional
Panel
Radiology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Apixia Digital Dental Radiography System replaces the traditional film approach to x-ray imaging. Phosphor plates and a scanner are the main components of the device. The device is used to capture x-rays from an external source and produce digital dental radiographs of a patient's mouth. The digital images can be used for analysis, archiving and electronic transmission.

Device Description

Phosphor plates and a scanner are the main components of the device.

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the Apixia Digirex Digital Dental Radiography System. It generally does not contain detailed information about acceptance criteria or specific study results that would typically be found in a clinical study report. The letter focuses on the FDA's "substantial equivalence" determination to a predicate device.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

  1. A table of acceptance criteria and the reported device performance

    • Not available in the provided text. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not specify performance acceptance criteria or report specific performance metrics for the Apixia Digirex system.

  2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Not available in the provided text. The letter does not describe any specific testing data or its source.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • Not available in the provided text.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Not available in the provided text.

  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

    • Not available in the provided text. The Apixia Digirex system is described as a "Digital Dental Radiography System" that replaces film, and it does not appear to involve AI assistance for human readers based on this document.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • Not available in the provided text. The device is a radiography system, not an algorithm for standalone performance evaluation in the typical sense of AI/CADe devices.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    • Not available in the provided text.

  8. The sample size for the training set

    • Not available in the provided text.

  9. How the ground truth for the training set was established

    • Not available in the provided text.

Summary based on the provided document:

The FDA 510(k) clearance document confirms that the Apixia Digirex Digital Dental Radiography System has been determined to be "substantially equivalent" to predicate devices for its stated "Indications for Use," which are: "The Apixia Digital Dental Radiography System replaces the traditional film approach to x-ray imaging. Phosphor plates and a scanner are the main components of the device. The device is used to capture x-rays from an external source and produce digital dental radiographs of a patient's mouth. The digital images can be used for analysis, archiving and electronic transmission." However, the document does not elaborate on the specific acceptance criteria, study design, or performance data that led to this determination.

§ 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.