Search Results

The Philips ST80i Stress Test System 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 produces a final report regarding a variety of cardiac data indices. The cardiac data provided by the Stress system is intended to be reviewed, confirmed, and used by trained medical personnel to assist in the evaluation of the patient's cardiovascular condition and the patient's physiological condition during stress exercise testing. The arrhythmia detection portion of the ST80i Stress Exercise System is provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms.

The Philips ST80i Stress Test System is indicated for use in exercise ECG testing where the clinician decides to evaluate the electrocardiogram of patients at 10 years or older, as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule out causes for symptoms of cardiovascular disease. The Philips ST80i Stress Test System is not intended to be used as a physiological monitor.

The ST80i Stress Test System is a PC-based diagnostic tool intended to acquire, process, and store ECG data (resting and physiologic) of patients undergoing stress exercise testing and acquire data from ancillary devices (such as SpO2 and Ambulatory Blood Pressure). The software records ECG, heart rate, and ST data, creates summary tables, trends, and produces a final report regarding a variety of cardiac data indices. The arrhythmia detection portion of ST80i Stress Testing System is provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms. The cardiac data provided by the stress system is intended to be reviewed, confirmed and used for diagnostic purposes by trained medical personnel to assist in the diagnosis of coronary artery disease (CAD) and the patient's physiological condition during stress exercise testing. The ST80i Stress Test System will be offered in two versions which are a complete turnkey system which includes an ECG data acquisition module, trolley with a PC loaded with the application software and optional thermal printer or a minimal system with the application software and data acquisition module only.

The Philips ST80i Stress Test System is a PC-based diagnostic tool designed to acquire, process, and store ECG data during stress exercise testing. It records ECG, heart rate, and ST data, generates summary tables, trends, and reports for cardiac data indices. The system's arrhythmia detection offers convenience but does not provide alarms. It is intended to assist trained medical personnel in evaluating cardiovascular conditions, diagnosing coronary artery disease (CAD), and assessing physiological conditions during stress exercise testing for patients 10 years or older. It is not intended as a physiological monitor.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ST80i Stress Test System are largely demonstrated through its equivalence to the predicate devices, CASE V6.6 and CS V6.6 Cardiac Testing Systems. The provided documentation presents a comparison of specifications and features rather than explicit acceptance criteria with numerical targets. The "Comparison" column indicates whether the ST80i's performance is "Same," "Similar," or "Different" to the predicate.

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

The provided summary does not explicitly detail a specific "test set" or its sample size for evaluating the ST80i Stress Test System's performance for this 510(k) submission. Instead, the document states: "The performance data demonstrated that the ST80i Stress Test System meets the design specifications of the system."

It further indicates that key algorithms incorporated into the ST80i Stress Test System—the Philips CAlg-STR Exercise ECG Analysis Algorithm and the Philips ECG Algorithm—were previously approved for market under separate 510(k) submissions (K112959 and K073376, respectively). The performance data related to these algorithms would have been established during their individual approval processes.

Therefore, for the ST80i system itself, the primary "test" was likely a verification against its own design specifications and a comparison to the predicate device, rather than a new clinical study with a distinct test set for de novo performance evaluation.

No information is provided regarding the country of origin of data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the given 510(k) summary for the ST80i Stress Test System. The document does not describe the establishment of a new ground truth for a test set for this specific submission, but rather relies on the performance of previously approved algorithms and substantial equivalence to a predicate device.

4. Adjudication Method for the Test Set

This information is not provided in the given 510(k) summary. Given the reliance on previously approved algorithms and substantial equivalence, a specific adjudication method for a new clinical test set is not described for the ST80i Stress Test System in this document.

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 mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study being performed for the ST80i Stress Test System in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device and notes the prior approval of its constituent algorithms.

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

While a standalone performance evaluation wasn't explicitly conducted for the entire ST80i system for this submission, the document states that the Philips CAlg-STR Exercise ECG Analysis Algorithm and the Philips ECG Algorithm have been previously approved for market under K112959 and K073376, respectively. This implies that these core algorithms would have undergone standalone performance evaluations during their individual 510(k) approval processes. The current submission leverages these prior approvals.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

The 510(k) submission for the ST80i Stress Test System mainly relies on demonstrating "substantial equivalence" to a predicate device (CASE V6.6 and CS V6.6 Cardiac Testing Systems) and the previous approvals of its incorporated algorithms (Philips CAlg-STR Exercise ECG Analysis Algorithm and Philips ECG Algorithm).

For the individual algorithms (K112959 and K073376), it is typical for ground truth in ECG analysis algorithms to be established by:

• Expert Consensus: Review by multiple cardiologists or electrophysiologists.
• Manual measurements: Detailed manual measurements of ECG waveforms by trained experts.
• Correlation with clinical diagnoses or outcomes: Although not explicitly stated, this is often a component in such evaluations.

However, the specific type of ground truth used for those previous approvals is not detailed within this particular 510(k) summary.

8. The Sample Size for the Training Set

The 510(k) summary does not provide information about the sample size used for the training set of the ST80i Stress Test System or its incorporated algorithms (Philips CAlg-STR Exercise ECG Analysis Algorithm and Philips ECG Algorithm). This level of detail regarding algorithm training data is typically found in the original 510(k) submissions for those algorithms (K112959 and K073376) rather than in a subsequent submission for a system integrating them.

9. How the Ground Truth for the Training Set Was Established

The 510(k) summary does not provide information on how the ground truth for the training set was established for the ST80i Stress Test System or its incorporated algorithms. Similar to the training set size, this information would generally be found in the details of the original 510(k) submissions (K112959 and K073376) for the algorithms themselves.

Ask a specific question about this device