(30 days)
The device is a PC based diagnostic tool intended to acquire, process, and store ECG data of patients undergoing stress exercise testing. The software records ECG, heart rate, and ST data, creates summary tables, trends and a final report regarding a variety of cardiac data indices. The cardiac data provided by X-Scribe II is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis of the electrocardiographic data reflecting the patient's physiological condition during stress exercise testing.
The device captures and presents electrocardiographic data reflecting a patient's physiological condition during physiologic stress testing that can be useful in determining a diagnosis when reviewed by a trained clinician or physician. The cardiac data provided by X-Scribe II is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis of adult patients with various rhythm patterns.
The device is not intended to be the sole basis of diagnosis.
The device is indicated for use in a clinical setting by a physician, or trained personnel who are acting on the orders of a licensed physician.
The device is indicated for use on adult populations, typically symptomatic. The device is not intended to be used as a vital signs physiological monitor.
The Mortara X-Scribe II is the latest evolution of the Mortara X-Scribe (K900720). It is a PC based diagnostic tool consisting of an ECG analysis software application running on a commercial PC using Windows operating system. Electrocardiographic data is obtained by means of a compatible device, such as the Mortara X-12 (K974149) or the Mortara direct connect patient cable, and sent to the CPU for processing. The user may generate reports for display or may opt to print results via a printer.
The device consists of a CPU, display, mouse, printer, keyboard, isolation power supply, and data collector. The device may interface with external devices, including a treadmill or erqometer for dynamic exercise evaluation, non-invasive blood pressure equipment, and computer communications equipment.
The provided text describes the Mortara X-Scribe II Stress Exercise Testing System but does not contain specific acceptance criteria or details of a study proving the device meets particular performance metrics. The document is a 510(k) summary and approval letter, which focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than a detailed performance study with acceptance criteria.
Therefore, many of the requested details cannot be extracted from the provided input. However, based on the information that is present, I can provide the following:
1. A table of acceptance criteria and the reported device performance
- This information is not available in the provided text. The document is a 510(k) summary, which typically focuses on describing the device and its intended use, and demonstrating substantial equivalence to a predicate device for regulatory clearance. It does not include a detailed performance study with specific acceptance criteria and reported device performance metrics in the way you might find in an academic paper or a more comprehensive validation report.
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 available in the provided text.
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 available in the provided text, as there is no description of a test set or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not available in the provided text.
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
- This information is not available in the provided text. The device is described as an "ECG analysis software application running on a commercial PC," and "The cardiac data provided by X-Scribe II is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis." This suggests human-in-the-loop operation, but the text does not detail any comparative effectiveness study with or without AI assistance, or any specific AI components that would typically be evaluated in such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not available in the provided text. The "Indications for use" explicitly state, "The cardiac data provided by X-Scribe II is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis," and "It is not intended as a sole means of diagnosis." This indicates the device is not intended for standalone use without human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This information is not available in the provided text, as no performance study or ground truth establishment is described.
8. The sample size for the training set
- This information is not available in the provided text.
9. How the ground truth for the training set was established
- This information is not available in the provided text.
In summary, the provided document is a regulatory submission for a medical device (a stress exercise testing system), focusing on showing substantial equivalence to existing devices for market clearance rather than detailing performance studies with specific statistical acceptance criteria. Therefore, the majority of the information requested, which pertains to rigorous performance evaluation and validation, is not present in this type of document.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).