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K Number
K992164
Device Name
TELEMEDICINE 2000
Manufacturer
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
Date Cleared
1999-08-30

(66 days)

Product Code
DXH
Regulation Number
870.2920
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Telemedicine 2000 is a Telemedicine Receiving Center intended for supporting transtelephonic monitoring of Electrocardiographic (ECG) and Spirometric parameters of cardiac patients.

Device Description

Not Found

AI/ML Overview

This FDA 510(k) clearance letter dated August 30, 1999, for the "Card Guard Telemedicine 2000" outlines the regulatory acceptance of the device but does not contain any information regarding specific acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot provide the requested information based on the provided document. The letter primarily focuses on the device's classification, substantial equivalence to a predicate device, and the general regulatory provisions it must comply with.

Here's a breakdown of why I cannot answer each point from the input based on the provided text:

  1. A table of acceptance criteria and the reported device performance: This information is not present. The letter states the device is "substantially equivalent" but provides no performance metrics or criteria.
  2. Sample sized used for the test set and the data provenance: Not mentioned.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
  4. Adjudication method for the test set: Not mentioned.
  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 mentioned. This device is a "Telemedicine Receiving Center" for ECG and spirometric parameters, not an AI-assisted diagnostic tool in the sense of image interpretation, so such a study would be unlikely to be applicable or discussed in this context.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. The device's description as a "Telemedicine Receiving Center intended for supporting transtelephonic monitoring" implies human involvement in interpreting the received parameters.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned.
  8. The sample size for the training set: Not mentioned.
  9. How the ground truth for the training set was established: Not mentioned.

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).