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K Number
K161188
Device Name
HEPATIQ 1.1
Manufacturer
HEPATIQ LLC
Date Cleared
2016-06-09

(43 days)

Product Code
LLZ
Regulation Number
892.2050
Type
Special
Panel
RA
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

HEPATIQ is a nuclear medicine software application used to display and process liver-spleen images. The results obtained may be used as a tool, by a nuclear physician, in quantifying liver-spleen images. The data processed may be derived from any nuclear medicine liver-spleen procedure. The HEPATIQ software should only be used by qualified nuclear medicine professionals.

Device Description

HEPATIQ is a nuclear medicine software application used to display and process liver-spleen images.

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) summary for HEPATIQ 1.1 does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The document is a letter from the FDA to HEPATIQ LLC confirming the substantial equivalence of their device to a predicate device, and includes the "Indications for Use" for HEPATIQ 1.1.

It does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes for test or training sets, nor data provenance.
  3. Information on experts used for ground truth (number or qualifications).
  4. Adjudication methods.
  5. Findings from an MRMC comparative effectiveness study or effect sizes.
  6. Details of a standalone algorithm performance study.
  7. The type of ground truth used (e.g., pathology, outcomes data).
  8. How ground truth for the training set was established.

Therefore, I cannot fulfill your request for this specific information based on the provided text.

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).