Search Results

CG-2100 is a personal single lead event ECG transtelephonic transmitter. The device is intended for self-testing by patients and records a limited period of heart activity. The recording is activated by patient, when symptom is experienced. CG-2100 enables transmission of the recorded data to a receiving station, where data is displayed for analysis and evaluation by physician. The transmission includes the time, when the event recording was activated by patient. CG-2100 is compatible and intended for use with Telemedicine 2000, the Card Guard's Transtelephonic Receiving Center in its LAN as well as its standalone configuration. The device is intended for self-testing by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device is not intended for simultaneous recording and transmitting of the patient ECG signals.

CG-2100 is a personal single lead event ECG transtelephonic transmitter. It has two control buttons: RECORD/SEND and RESET/CLEAR. It has a data storage capacity of 32 Kbyte, sufficient for one ECG event. Transmission is via acoustic transducer. It includes pacemaker detection and marking. The device is internally-powered with applied parts of type BF, suitable for continuous operation. It has low battery detection and audio warning. The user interface includes the control buttons, fluctuating recording sound, fluctuating transmission sound, and low battery warning.

The provided documentation describes the CG-2100 ECG Transmitter and its 510(k) submission, primarily focusing on its substantial equivalence to a predicate device and a list of design control tests. However, it does not contain specific acceptance criteria or a detailed study proving the device meets performance acceptance criteria.

The document outlines design controls and hazard analysis, which include various validation tests (Environmental Tests, Mechanical Vibration, Shock, Surface temperature, Leakage Current, Dielectric Strength, Common Mode Rejection, High and Low Temperature and Humidity, Frequency Response, Input Dynamic Range, Overall System Error, Step Response, Safe Current, System Noise, Ingress of Liquids, and EMC Test). It states that these tests were "conducted to verify and validate the CG-2100 compliance with all the design specifications."

It also mentions that "The conclusions drawn from clinical and laboratory testing of CG-2100 demonstrate that the device is as safe, as effective and performs as well as or better than the legally marketed predicate device, CG-2206 personal ECG transmitter (K963725)."

Without the specific results of these tests and defined acceptance thresholds, it's impossible to create the requested table and answer many of the questions. The document focuses on regulatory compliance through substantial equivalence, rather than a detailed performance study with explicit acceptance criteria.

Therefore, the requested information cannot be fully extracted or inferred from the provided text.

Here's a breakdown of what can be said based on the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: The document lists types of tests conducted (e.g., "Frequency Response Test," "Overall System Error Test"). However, it does not specify the acceptance criteria (quantitative thresholds or pass/fail conditions) for these tests, nor does it provide the actual reported device performance results against these criteria. It only states that the tests were conducted to "verify and validate the CG-2100 compliance with all the design specifications."

2. Sample Size Used for the Test Set and Data Provenance:

Missing Information: The document does not provide details on the sample size used for any specific performance testing (such as a test set for a clinical study or a technical validation). It mentions "clinical and laboratory testing" but no specifics on patient numbers, demographics, or data origin (country of origin, retrospective/prospective).

3. Number of Experts and their Qualifications for Ground Truth:

Missing Information: This information is not present in the document. The device is a "single lead event ECG transtelephonic transmitter" intended for physician analysis of recorded data, implying that a physician would interpret the ECG. However, there's no mention of experts establishing a ground truth for a test set.

4. Adjudication Method for the Test Set:

Missing Information: No adjudication method is mentioned as there is no described study involving multiple readers or complex diagnostic tasks requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Missing Information: There is no indication of an MRMC study being conducted, nor any quantification of human reader improvement with or without AI assistance. The device itself is an ECG transmitter, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

Missing Information: The device's function is to transmit ECG data for a physician to analyze. It is not an automated diagnostic algorithm that would have a "standalone" performance evaluation in the context of AI. The document describes laboratory tests for the transmitter's technical specifications, but these are not evaluating an algorithm's diagnostic performance.

7. Type of Ground Truth Used:

Missing Information: Since no specific performance study with a test set is detailed, the type of ground truth used is not described. For a device like this, the ground truth for performance might involve comparing transmitted ECGs to reference ECG recordings, or evaluating the accuracy of technical specifications against established standards. The document primarily refers to compliance with standards (e.g., ANSI/AAMI EC38-D) and design specifications.

8. Sample Size for the Training Set:

Missing Information: There is no mention of a "training set" as this device does not appear to utilize machine learning or AI that would require a training phase.

9. How the Ground Truth for the Training Set Was Established:

Missing Information: Not applicable, as there is no mentioned training set.

Ask a specific question about this device