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K Number
K993616
Device Name
CARDIO-CARD INTERPRETATION SYSTEM I
Manufacturer
NASIFF ASSOC., INC.
Date Cleared
2000-04-10

(167 days)

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

The Cardio-Card interpretation program analyzes and reports abnormal and normal ECGs and possible classifications of what kind of abnormals may have been detected from ECG data sent to it. The ECG statements reported assist the user in knowing what problems may exist in the ECG. These statements are to be overread by a Physician trained in the art of ECG interpretation as no automated analysis is completely reliable.

It is intended to be used by or on the order of a physician or similarly qualified health care professional in any environmental setting that the ECG acquisition device is suitable for. These environments include hospitals, physician offices, and clinical settings.

It is intended to be used on the adult patient population.

Device Description

Cardio-Card Interpretive System I

AI/ML Overview

This is a 510(k) clearance letter from the FDA for a device called "Cardio-Card Interpretation System I". This type of letter generally does not contain detailed study information, acceptance criteria, or performance metrics. It primarily states that the device has been found substantially equivalent to a legally marketed predicate device.

Therefore, based on the provided text, I cannot extract the requested information. The document focuses on regulatory approval and provides indications for use, but no specific performance study data, acceptance criteria, sample sizes, expert qualifications, or ground truth details.

Here's a breakdown of why each point cannot be addressed:

  1. A table of acceptance criteria and the reported device performance: Not present in the document.
  2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not present in the document.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not present in the document.
  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present in the document.
  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 in the document.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document mentions "automated analysis" and states "These statements are to be overread by a Physician trained in the art of ECG interpretation as no automated analysis is completely reliable," implying it's not standalone or requires human oversight. However, no specific study proving this or measuring standalone performance is provided.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present in the document. It only states the system "analyzes and reports abnormal and normal ECGs and possible classifications."
  8. The sample size for the training set: Not present in the document.
  9. How the ground truth for the training set was established: Not present in the document.

To obtain this information, one would typically need to refer to the full 510(k) submission (if it's publicly available and unredacted), or scientific publications related to the device's validation.

N/A