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K Number
K963980

Validate with FDA (Live)

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
Radiology
Age Range
All
Reference & Predicate Devices
N/A
Predicate For
K992925
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis 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.

{0}------------------------------------------------

Philips Medical Systems

P.O. Box 10000. 5680 DA Best. The Netherlands

Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section.

K963980
DEC 23 1996

QA Department XRD Best XBQ87-960792/HD/wp

1996.05.20

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

for the optional package:

SPINE

for use in PHILIPS Easy Vision X-Ray workstations

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

The undersigned certifies that the 510(k) Pre-Market notification for the above referenced products contains adequate information and data to enable CDRH to determine substantial equivalence.

This information and data is summarized as follows:

  • The information for Users contains comprehensive information to insure safe and 1. effective use;
  • Past experience with substantially equivalent predicate devices/methods has shown 2. our device to be safe and effective when used as directed in the Information for Users.

R.W. Rijntjes

Approbation Officer Quality Assurance dept. XSB / XCB Philips Medical Systems, Best The Netherlands.

lips Medical Systems Nederlar pluis 6, Best. The Netherla 31 40 27 911 11 Fax: +31 40 27 622 05 Commercial Register Eindhoven no. 17060498

N/A