Search Results

The CardioSoft PC ECG is intended for use in acquiring, processing, recording, archiving and displaying electrocardiographic information. It can provide serial comparison of ECG information to facilitate review of current and previous records and is intended for use by trained operators. The system offers no diagnostic opinion to the user, but may be used by a physician to render his or her own medical opinion.

The CardioSoft PC ECG is an electrocardiograph that detects signals associated with cardiac activity and produces an ECG graphical record. The device operates on a personal computer through a USB hardware module. The device can acquire, process, record, archive and display 3-, 6-, or 12-lead ECG and vector cardiograms. The device provides portable ECG with important advantages compared to traditional machines.

The presented document is a 510(k) summary for the CardioSoft PC ECG device, a substantially equivalent submission to the predicate device CARDIAX (K924544). The document does not describe specific acceptance criteria or a dedicated study to prove the device meets performance criteria through clinical data or comparative effectiveness. Instead, it relies on demonstrating substantial equivalence to a predicate device and compliance with recognized standards.

Here's a breakdown of the requested information based on the provided text:

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

The document explicitly states: "The FDA has not established performance standards for this device." Therefore, there are no specific FDA-mandated acceptance criteria or direct reported device performance metrics (e.g., sensitivity, specificity, accuracy) derived from a clinical study for this 510(k) submission.

The "performance" section instead focuses on demonstrating equivalence through non-clinical testing and adherence to quality assurance measures.

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

The document does not describe a clinical "test set" with a specific sample size. The performance assessment relies on non-clinical testing and comparison to a predicate device. Therefore, no information on data provenance (country of origin, retrospective/prospective) for a clinical test set is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no clinical test set or ground truth establishment process for diagnostic performance is described, there's no mention of experts or their qualifications in this context.

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

Not applicable. There is no clinical test set described in the submission, therefore no adjudication method is mentioned.

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

No. The document makes no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The device, an electrocardiograph, "offers no diagnostic opinion to the user" and there is no AI component mentioned that would assist human readers in a diagnostic setting.

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

The device is an "electrocardiograph that detects signals associated with cardiac activity and produces an ECG graphical record." It is not an algorithm providing diagnostic output without human interpretation. It generates a record "that may be utilized only by a qualified healthcare professional for review and interpretation when based upon patient history, medical examination, and other clinical findings." Therefore, a standalone algorithm-only performance study as typically understood for AI-driven diagnostic tools was not conducted or described. The "performance" refers to the device's ability to accurately acquire, process, record, archive, and display ECG information.

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

Given the nature of the device (ECG acquisition and display) and the absence of a clinical diagnostic performance study, the concept of "ground truth" as typically applied to diagnostic algorithms (e.g., expert consensus for disease presence or absence, pathology results) is not relevant or mentioned in this submission. The "ground truth" for demonstrating performance would likely involve the accuracy of signal acquisition, processing, and display compared to known electrical signals or established ECG benchmarks.

8. The sample size for the training set

Not applicable. The CardioSoft PC ECG is described as an upgrade/modification of an existing device, preserving the "software processes of the predicate device." It's not a machine learning or AI-driven device that typically requires a 'training set' in the conventional sense for a 510(k). The focus is on hardware and interface improvements while maintaining functional equivalence.

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

Not applicable, as there is no mention of a training set for a machine learning model.

Ask a specific question about this device