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PocketView ECG software is a version of Cardioview™ 3000 software, a Windows-based program intended to interpret electrocardiograms. PocketView ECG software receives, displays and stores a single or standard 12 Lead Simultaneous ECG recording using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, and interpret the ECG signal. PocketView ECG Software allows the ECG information to be displayed on a commercially available personal digital assistant (PDA) running the Windows CE operating software.

The proposed device is modification to the Cardioview™ 3000 software that allows the 12 Lead Simultaneous Cable to be linked to commercially available personal digital assistants (PDA) running the Windows CE operating system.

The provided text describes a 510(k) submission for the "PocketView ECG software," which is a modification of the "Cardioview™ 3000 software." The key modification is the ability to display ECG information on commercially available personal digital assistants (PDAs) running Windows CE.

Based on the provided text, the following information can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly detailed in the provided text. The document states, "Nonclinical testing was performed to evaluate the modification to the predicate device. Testing verified that the modified device displayed acceptable performance." However, specific criteria (e.g., accuracy percentages, error rates) or how "acceptable performance" was quantified are not provided.

2. Sample Size Used for the Test Set and Data Provenance: This information is not provided in the text. The document only mentions "Nonclinical testing was performed."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts: This information is not provided in the text.

4. Adjudication Method for the Test Set: This information is not provided in the text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: An MRMC study is not mentioned. The focus of this 510(k) is the display capability on a PDA, not an AI interpretation improvement.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study: The document indicates that the device "contains proprietary software algorithms to receive, store, analyze, and interpret the ECG signal." This implies a standalone algorithm for interpretation. However, specific standalone performance metrics or a dedicated standalone study are not detailed in this submission. The "nonclinical testing" was performed to evaluate the modification (PDA display), not necessarily to re-evaluate the core interpretation algorithm's standalone performance, which is presumably a characteristic inherited from the predicate device.

7. Type of Ground Truth Used: This information is not explicitly provided. Since it's an ECG interpretation device, the ground truth would typically be established by expert cardiologists.

8. Sample Size for the Training Set: This information is not provided in the text.

9. How the Ground Truth for the Training Set Was Established: This information is not provided in the text.

In summary, the provided 510(k) submission focuses on the substantial equivalence of adding PDA display functionality to an existing ECG interpretation software. It does not detail specific performance studies, acceptance criteria, or ground truth methodologies for the interpretation algorithms themselves, as these would have been established for the predicate device. The "nonclinical testing" mentioned primarily verified the acceptable performance of the modification (PDA connectivity and display).

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