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K Number
K960449
Device Name
PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)
Manufacturer
BIOSENSOR CORP.
Date Cleared
1996-05-30

(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

Not Found

Device Description

Stress and ECG systems contain digital and analog hardware, associated firmware and software, which must perform effectively, accurately, and reliably.

AI/ML Overview

The provided text is a summary of safety and effectiveness information for the "PC ECG 1200 ECG and Stress Electrocardiography System." It discusses various factors that can affect the effectiveness of the system, such as lead placement, line interference, EMG interference, baseline wander, and averaging. It also briefly mentions the importance of "Diagnostic Accuracy" for ST measurements, QRS detector, and VE detector.

However, the document does not provide acceptance criteria in a structured table, nor does it present the results of a specific study to prove the device meets those criteria. It references standards (ANSI/AAMI EC11-1982, IEC 601-1, 601-2, 601-3) that likely contain such criteria and test methodologies, but the criteria themselves and the device's performance against them are not detailed in this excerpt.

Therefore, for your specific questions, I can only extract limited information based on what is directly stated:

Here's a breakdown of what can and cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance

  • Cannot be provided. The document states that "Standards and test methods for the performance of these systems are compiled in detail in ANSVAAMI EC11-1982 and IEC 601-2 and 3" and that "Testing of the diagnostic accuracy of the ST measurements, QRS detector and VE detector are necessary to evaluate the value of the measurements and trends supplied to the physician for review." However, it does not actually list specific numerical acceptance criteria or the device's performance against them.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

  • Cannot be provided. This information is 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)

  • Cannot be provided. The document does not describe a clinical study with expert adjudication for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

  • Cannot be provided. The document does not describe a clinical study with an adjudication method.

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

  • Cannot be provided. The document does not describe a MRMC study, nor does it refer to AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

  • Cannot be provided. While the document refers to "algorithms used to make such measurements," it does not describe a standalone performance study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

  • Cannot be provided. The document mentions the need for "diagnostic accuracy testing" but does not specify how ground truth would be established for such testing.

8. The sample size for the training set

  • Cannot be provided. The document does not describe a training set for an algorithm.

9. How the ground truth for the training set was established

  • Cannot be provided. The document does not describe a training set.

In summary, the provided safety and effectiveness information focuses on general considerations for ECG and stress systems, potential issues (like interference), and a general statement about the need for diagnostic accuracy testing as per existing standards. It lacks the specific details of a study that would demonstrate the device's performance against defined acceptance criteria.

§ 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).