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The Cambridge Heart Hi-Res TM ECG Electrode is intended for short term use to measure electrocardiogram signals at rest and during ECG stress testing with the CH 2000 Stress Test System and successor systems. This device is supplied non-sterile and is intended for one time use only.

The Cambridge Heart Hi-Res TM ECG Electrode is a pregelled, single use, multisegment Ag/AgCl electrode used in measuring electrocardiogram signals. It was designed specifically for use with the Cambridge Heart, Inc. CH 2000 Stress Test System and successor systems. The electrode comprises four closely spaced electrode segments, consisting of three equal sized segments equidistant around a center segment, each capable of receiving ECG signals. By itself, the center segment functions as a standard Ag/AgCl ECG electrode. The three ring segments are used to receive additional ECG signals and are used, along with the center segment, to obtain real time measures of electrode surface-to-skin impedance and trans-thoracic (respiratory) impedance. These additional ECG signals and impedance measurements are used by the noise reduction algorithms on the CH 2000 to reduce baseline wander and movement artifact from the ECG.

The provided text describes the Cambridge Heart Hi-Res™ ECG Electrode and its substantial equivalence to predicate devices, primarily focusing on regulatory aspects and comparisons based on design and adherence to standards. However, it does not include a study specifically designed to establish acceptance criteria with reported device performance in the format requested.

Here's an analysis of what information can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the Hi-Res™ ECG Electrode "met the performance requirements of ANSI/AAMI EC12-1991 and the biocompatibility requirements of ISO 10993-5." While these are the acceptance criteria (i.e., compliance with these standards), the document does not provide a table with specific performance metrics and their measured values from a study. It only states that the device "met" these requirements.

Similarly, it mentions that the CH 2000 Stress Test System's respiratory impedance measurement method "meets the AAMI Standard For Safe Current Limits for Electromedical Apparatus ES1, Section 3.5." Again, this indicates the acceptance criterion but does not report specific performance data.

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

The document mentions "testing" for performance and biocompatibility but does not specify the sample size used for these tests. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts and Their Qualifications for Ground Truth

The document does not describe a process for establishing ground truth using experts in the context of device performance testing. The evaluation of adherence to standards would typically involve laboratory testing and verification against the standard's specifications, rather than expert-derived ground truth.

4. Adjudication Method

As there is no mention of expert-established ground truth, an adjudication method is not applicable and therefore not mentioned.

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

The document does not describe a Multi Reader Multi Case (MRMC) comparative effectiveness study. The focus is on the substantial equivalence of the device itself, not on how human readers perform with or without AI assistance from the device. The "noise reduction algorithms" mentioned are part of the device's function, not a human-in-the-loop AI assistance system in the context of MRMC studies.

6. Standalone (Algorithm Only) Performance

The document describes the performance of the "Hi-Res™ ECG Electrode" and the "CH 2000 Stress Test System" which includes "noise reduction algorithms." This implies a standalone performance of the system as a whole against the standards. However, it does not provide specific metrics for the algorithm's performance in isolation (e.g., sensitivity, specificity for noise reduction, or specific error rates). It simply states the system "reduces baseline wander, movement artifact and muscle artifact from the ECG" and that the algorithm "creates an ECG signal that can then be processed by the CH 2000 like a standard ECG signal."

7. Type of Ground Truth Used

The ground truth used for assessing the device's performance is compliance with established voluntary industry standards: ANSI/AAMI EC12-1991 for electrode performance, ISO 10993-5 for biocompatibility, and AAMI Standard For Safe Current Limits for Electromedical Apparatus ES1, Section 3.5 for respiratory impedance measurement. These standards provide objective criteria and test methods. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these evaluations.

8. Sample Size for the Training Set

The document does not describe any training set or machine learning model development. The device is an ECG electrode with associated signal processing, and the evaluation focuses on its physical and electrical characteristics and adherence to existing medical device standards.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set, the establishment of its ground truth is not applicable.

In summary, the provided text is primarily a 510(k) summary aimed at demonstrating substantial equivalence. It confirms that the device meets relevant performance and biocompatibility standards but does not offer the detailed performance data, study design specifics, or expert-based ground truth information typically found in a clinical study report for an AI/ML powered device.

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