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K Number
K192766
Device Name
Digital Intraoral Imaging Plate System
Manufacturer
Fsusen Technology Co., Ltd
Date Cleared
2019-12-05

(66 days)

Product Code
MUH
Regulation Number
872.1800
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
Predicate For
K214091
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Digital Intraoral Imaging Plate System is indicated for capturing, digitization and processing of intraoral x-ray images stored in imaging plate recording media.

And it is intended for uses in hospitals and clinics, and shall be operated and used by trained professionals with physician's guidance.

Device Description

Not Found

AI/ML Overview

The provided document (K192766) is a 510(k) clearance letter for a Digital Intraoral Imaging Plate System. It states the indications for use of the device: "Digital Intraoral Imaging Plate System is indicated for capturing, digitization and processing of intraoral x-ray images stored in imaging plate recording media." It also specifies that it is "intended for uses in hospitals and clinics, and shall be operated and used by trained professionals with physician's guidance."

However, this document does not contain any information about acceptance criteria or the study that proves the device meets acceptance criteria. 510(k) clearance letters primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies against specific acceptance criteria. These details would typically be found in the original 510(k) submission summary or a separate performance testing report, which is not included in the provided text.

Therefore, I cannot fulfill the request for:

  1. A table of acceptance criteria and the reported device performance
  2. Sample sized used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
  4. Adjudication method for the test set
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done
  6. If a standalone performance study was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

To obtain this information, you would need to consult the complete 510(k) submission for K192766, which is typically available through the FDA's medical device databases.

§ 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.