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The device is intended for use as a diagnostic device which retrieves, records, and produces a visual display the of electrical signal produced by the heart.

The device is a battery-operated, portable, 12 lead electrocardiograph which produces a 1, 3, 6, or 12 channel printout. Data can also be displayed on a the monitor, using computer personal application software package.

The provided text is a 510(k) summary for the Macquarie CT 200 Portable Electrocardiograph. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria, device performance studies, or the methodologies for establishing ground truth.

Therefore, I cannot provide the requested information in the format specified because the necessary details are not present in the provided text.

Based on the content, the document is primarily focused on:

• Device Identification: K961798, Macquarie CT 200 Portable Electrocardiograph.
• Classification: Class II (74 DSP).
• Intended Use: As a diagnostic device to receive, record, and produce a visual display of the electrical signal produced by the heart.
• Technological Similarity: To other standard electrocardiographs producing multipage printouts and utilizing application software.
• Regulatory Communication: FDA's letter granting market clearance based on substantial equivalence to predicate devices.

The text does not include sections typically found in a clinical study report or a performance validation document, such as:

• Specific performance metrics (e.g., sensitivity, specificity, accuracy).
• Details of a test set, its size, or its provenance.
• Information about expert review, adjudication, or ground truth establishment.
• Any mention of standalone algorithm performance or human-in-the-loop studies.

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The device is intended for use as a diagnostic device which retrieves, records, and produces a visual display of the electrical signal produced by the heart.

The device is a battery-operated, portable, 12 lead electrocardiograph which produces a single channel strip chart output.

The provided text describes a 510(k) summary for the Macquarie CT 100 Electrocardiograph. However, it does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The document primarily focuses on:

• Manufacturer and Contact Information: Macquarie Medical Systems.
• Device Classification and Names: Electrocardiograph, CT 100 Electrocardiograph.
• Substantial Equivalence: To Schiller Cardiovit AT-1 (K946205) and Burdick Elite II (K904032).
• Device Description: Battery-operated, portable, 12-lead electrocardiograph producing a single-channel strip chart output.
• Intended Use: Diagnostic device to retrieve, record, and visually display the heart's electrical signal.
• Technological Characteristics: Similar to other standard one-channel printout electrocardiographs.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: No such criteria or performance data are present.
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: Not mentioned.
5. MRMC comparative effectiveness study: Not mentioned.
6. Standalone performance study: Not mentioned.
7. Type of ground truth used: Not mentioned.
8. Sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

This document is a regulatory submission for substantial equivalence based on technological characteristics and intended use, not a clinical or performance study report that would detail the information you are seeking.

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