Search Results

This device is intended for use as a patient monitor for any patient undergoing ECG S-T Segment Analysis and/or ECG stress analysis during rest or exercise. Exercise can be performed treadmill or bicycle ergometer use. The intended use locations are either in a physician's office, hospital or rehabilitation facilities, or similar use areas. It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in a hospital environment, physician's office, or similar settings. This device is not intended for home use.

The QRS CARD™ S-T Segment Analysis Patient Monitoring System converts a commercially available personal computer (PC) into an ECG monitor with ST segment measurement capability. Physicians can initiate ST evaluations on patients and the data are transmitted, using Bluetooth wireless technology, to a computer screen. Test results can also be printed at any time during the testing, or saved in computer memory for future review or additional report generation. The QRS CARD™ S-T Segment Analysis Patient Monitoring System consists of the following components: The QRS CARD™ Office ECG Device, ECG Patient Cable and Lead Wires, Product Software on CD, User Manual.

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets these criteria. The document is a 510(k) Summary for a "Special 510(k)" modification, stating that the technological characteristics of the device are "safe and effective and substantially equivalent to the legally marketed predicate devices." This type of submission generally relies on demonstrating equivalence to existing devices rather than presenting new clinical study data against defined performance metrics.

However, based on the information provided, here's what can be extracted and what is missing:

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

This information is not provided in the document. The document primarily focuses on the device description, intended use, and substantial equivalence claim to predicate devices. It does not list specific numerical acceptance criteria or present performance data from a study.

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

This information is not provided. As no specific performance study is detailed, there is no mention of a test set, sample size, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. There is no mention of experts or ground truth establishment for a test set.

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

This information is not provided.

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

There is no indication that an MRMC comparative effectiveness study was done. The device is described as converting a PC into an ECG monitor with ST segment measurement capability, implying it's a diagnostic tool, not an AI-assisted reading system for human improvement.

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

The document does not detail any standalone algorithm performance study.

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

This information is not provided.

8. The sample size for the training set

This information is not provided. If the device uses algorithms that require training data, there is no mention of such a training set or its size.

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

This information is not provided.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance data from a new study against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the given text.

Ask a specific question about this device