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K Number
K963980
Device Name
PHILIPS EASYVISION
Manufacturer
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
Date Cleared
1996-12-23

(81 days)

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

Not Found

Device Description

optional package: SPINE

AI/ML Overview

I apologize, but the provided text is a 510(k) summary (K963980) from Philips Medical Systems for an optional "SPINE" package for their Easy Vision X-Ray workstations, submitted in 1996.

This document does not contain the detailed technical study information, acceptance criteria, or performance data that you have requested. It is a very high-level summary stating that the device is safe and effective based on past experience with predicate devices.

Therefore, I cannot extract the following information from the provided text:

  1. A table of acceptance criteria and the reported device performance: Not present.
  2. Sample sized used for the test set and the data provenance: Not present.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
  4. Adjudication method: Not present.
  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 present. This document is from 1996, well before "AI assistance" in the modern sense was a standard clinical or regulatory consideration for X-ray workstations.
  6. If a standalone performance was done: Not present.
  7. The type of ground truth used: Not present.
  8. The sample size for the training set: Not present.
  9. How the ground truth for the training set was established: Not present.

The document is purely an administrative summary for a 510(k) submission, confirming the submission of information for safe and effective use, and referencing predicate devices. It does not go into the specifics of performance studies or ground truth establishment.

§ 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).