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K Number
K012686
Device Name
CAIRD TECHNOLOGY HOLTER 2000
Manufacturer
CAIRD TECHNOLOGY
Date Cleared
2001-12-13

(121 days)

Product Code
DPS
Regulation Number
870.2340
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Designed for Adult and Pediatric Patients.
  • For Hospital and Clinic use only.
  • For Prescription use only.
    Some of the conditions for use are as follows:
  • Evaluation of Symptoms suggesting arrhythmia or myocardial ischemia.
  • Evaluation of ECG documentation therapeutic intervention in individual or groups of patients.
  • Evaluation of patients for ST segment Changes
  • Evaluation of patients response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery).
  • Evaluation of clinical syndromes or situations where arrhythmia may increase the risk of sudden death.
  • Clinical and epidemiological research studies.
Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the Caird Technology Holter 2000, dated December 13, 2001. It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

Unfortunately, the provided document does not contain the specific information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods.

The letter focuses on the regulatory clearance of the device based on substantial equivalence and outlines general regulations. It mentions indications for use and a precaution about computerized ECG analysis not replacing a physician's diagnosis, but it does not delve into the performance study details.

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 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 for the test set: 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.
  6. If a standalone (i.e. algorithm only without human-in-the-loop 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.

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).