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Intended Use:

The intended use of the QED2000 is to record 12-lead ECG signals from patient's heart activity through body surface ECG electrodes. This device can acquire, display, record, analyze, and store these ECG signals from adult patients for review by the user. Analysis of the ECG signals is accomplished with algorithms that provide data presentations, graphical presentations, and measurements. These are presented for review and interpretation by a trained physician or clinician in determining a diagnosis based upon knowledge of the result of physical examination, and other clinical findings.

The QED2000 is intended to be used in hospital and general physician's office by trained healthcare professionals.

Indications for Use:

The QED2000 is intended to be used to acquire, display, record, analyze, and store 12-lead ECG waveforms from adult patients through body surface ECG electrodes. Using algorithms to generate data presentations, graphical presentations, and measurements for review and interpretation by a trained physician in determining a diagnosis based upon knowledge of the patient, the result of physical examination, and other relevant clinical findings.

The QED2000 is intended to be used in hospital and general physician's office by trained healthcare professionals. The QED2000 is not intended to be used as a cardiac monitor.

The Quantitative Electrocardiographic Detector (QED2000) is a 12-lead resting electrocardiograph. It is a device for acquiring, displaying, analyzing and storing the 12-lead electrocardiogram.

The device can print the resting ECG report via the external printer including USB printer and network printer. The device has optional removable storage to store resting ECG records. The device also can export the resting ECG record to SD card/shared directory/FTP server as an optional function. An optional USB barcode reader and magnetic card scanner to enter patient information is also available.

Based on the provided text, the device in question is the Quantitative Electrocardiographic Detector (QED 2000), an electrocardiograph. The acceptance criteria and the study proving the device meets them are primarily described in Section 5, specifically in subsections 10 and 11, and further supported by Table 3.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

The document presents the device's performance against two types of ECGs: IEC calibration ECGs and Biological ECGs from the CSE Database. The acceptance criteria are "Standard" values provided in the "IEC 60601-2-25 Standard" column for IEC calibration ECGs and "Standard" column for Biological ECGs. The reported device performance is listed under "ACME QED2000".

Interpretation of Table:
For all measured parameters (PR-interval, QRS-duration, QT-interval), the Mean and Standard Deviation of the ACME QED2000's measurements fall within or are superior to the specified standard acceptance criteria for both IEC calibration ECGs and Biological ECGs. For instance, for IEC calibration ECGs, the PR-interval "Standard" mean is ±10 and SD is 8, while the QED2000 showed a mean of 4.5 and SD of 5.4, indicating better or equivalent performance. Similar observations can be made for other parameters. This demonstrates that the device meets the defined performance standards.

2. Sample size used for the test set and the data provenance

The text refers to the use of "IEC calibration ECGs" and "Biological ECGs: CSE Database" for testing the algorithm. However, the specific sample size (number of ECGs/patients) for these test sets is not explicitly stated in the provided document.

Regarding data provenance:

• IEC calibration ECGs: These are standardized synthetic waveforms, not from human subjects directly, used for calibrating devices according to the IEC 60601-2-25 standard.
• Biological ECGs: CSE Database: This refers to the Common Standards for Quantitative Electrocardiography (CSE) Database. While the document doesn't explicitly state the country of origin or if it's retrospective/prospective, the CSE Database is a well-known, established and publicly available database for ECG research, typically comprised of retrospective human ECG data collected over time from various sources for standardization purposes.

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

The document mentions that the QED2000's algorithm provides "data presentations, graphical presentations, and measurements" that are "presented for review and interpretation by a trained physician or clinician in determining a diagnosis..." However, the provided text does not specify the number of experts used to establish the ground truth for the test sets (IEC calibration ECGs or CSE Database), nor does it detail their qualifications. For the CSE database, ground truth is typically established by consensus of multiple cardiologists/electrophysiologists based on clinical findings, but this process is not described in this document for this specific study.

4. Adjudication method for the test set

The document does not explicitly state any adjudication method (e.g., 2+1, 3+1) used for establishing the ground truth for the test sets. The ground truth for the IEC calibration ECGs is inherent in their design as reference signals. For the CSE Database, the ground truth is pre-established within the database itself, usually via expert consensus during its creation.

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

The study described in this document is focused on the standalone performance of the QED2000's algorithm against established standards and predicate devices' algorithms. It does not mention or present any multi-reader multi-case (MRMC) comparative effectiveness study involving human readers with and without AI assistance. Therefore, no effect size of human improvement with AI assistance is provided.

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

Yes, a standalone study was done. The performance data presented in Table 3 directly compares the QED2000's algorithm (ACME 12-lead ECG measurement algorithm) measurements against standard criteria and the results obtained from predicate devices' algorithms (Marquette 12SL ECG analysis program and Philips 12-lead ECG algorithm) on IEC calibration ECGs and Biological ECGs from the CSE Database. This is a direct evaluation of the algorithm's performance without human interaction in the measurement process.

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

The types of ground truth used are:

• IEC calibration ECGs: These are synthetic reference standards, which act as a ground truth for measuring device accuracy.
• Biological ECGs: CSE Database: These are expert-annotated biological ECGs. The CSE database's ground truth annotations (measurements) were derived through a rigorous, often expert consensus-based, process during the database's creation. The document implies that the "Standard" values provided in Table 3 for the CSE database are considered the ground truth for comparison.

8. The sample size for the training set

The document does not provide any information regarding the sample size used for training the ACME 12-lead ECG measurement algorithm. This detail is not typically included in 510(k) summaries unless specific claims are made about the training process or dataset.

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

The document does not provide any information on how the ground truth for the training set (if any, as the algorithm's development process is not detailed) was established.

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