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K Number
K992696
Device Name
ECG MINIMONITOR, MODEL CG-5000
Manufacturer
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
Date Cleared
1999-10-07

(56 days)

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

CG-5000 ECG MiniMonitor is a medical device intended for recording, display, output to the electrocardiograph recorder, and, optionally, transtelephonic transmission of the ECG signal for the purpose of cardiac conditions analysis.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a device called "ECG Minimonitor, Model CG-5000." This type of document does not contain the detailed study information, acceptance criteria, or performance data that you are requesting.

510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not necessarily on new clinical trials or detailed performance studies that would be necessary to define acceptance criteria and prove adherence for an AI/ML medical device.

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

  1. A table of acceptance criteria and the reported device performance: This information is not present.
  2. Sample size used for the test set and the data provenance: Not available.
  3. Number of experts used to establish the ground truth for the test set and the qualifications: Not available.
  4. Adjudication method: Not available.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not available.
  6. If a standalone performance (algorithm only) study was done: Not available.
  7. The type of ground truth used: Not available.
  8. The sample size for the training set: Not available.
  9. How the ground truth for the training set was established: Not available.

The document primarily states that the device is "substantially equivalent" to legally marketed predicate devices and outlines its "Indications For Use": "CG-5000 ECG MiniMonitor is a medical device intended for recording, display, output to the electrocardiograph recorder, and, optionally, transtelephonic transmission of the ECG signal for the purpose of cardiac conditions analysis."

§ 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).