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ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in the following cases: Patients with suspected cardiac abnormalities Populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics is desired. Stress Testing Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemia, indicative of reduced blood supply to the cardiac muscle. The electrocardiogram may establish the diagnosis of ischemic heart disease if characteristic changes are present. Stress testing is the most widely used method to decide whether this chest pain is related to myocardial ischemia, and thus to coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients exercise by bioycle, treadmill, or other means, while the ECG is monitored continuously. Exercise body of treading, on one may of The ECG signals as well as the HF-QRS signals are recorded for the resting, exercise, andreasonals phase portions of the exercise protocol. The changes in both ECG waveforms are compared to the resting ECG records. In the HyperQ™ stress test, changes in the high frequency of the mid QRS complex, calculated as root-mean-square (RMS) values, are compared to the resting values. Most of the commercial stress test systems control the bicycle or treadmill automatically according to the requirements of the chosen protocol, although this is not essential. ST segment monitoring is intended as an aid in the evaluation of myocardial ischemia in patients with known or suspected coronary artery disease. The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician. HyperQ™ The HyperQ™ Software is intended to be used as an aid to the ECG stress test by means of analysis of high frequency components present within the central portion of the QRS complex. The significance of the HF-QRS changes must be determined by a physician.

The HyperQ™ AD-100 System is a compact monitor for measuring, processing, storing, and displaying information derived from an electrocardiogram (ECG). The device analyzes and records the high frequency components of the QRS complex of standard ECG.

Here's an analysis of the provided text regarding the acceptance criteria and study for the HyperQ™ AD-100 System, structured to address your specific points.

Important Note: The provided document is a 510(k) Summary of Safety & Effectiveness for a medical device. This type of document is a summary and often refers to detailed reports (e.g., validation results) not included in the summary itself. Therefore, some specific details you requested (like exact sample sizes for test/training, number/qualifications of experts, or specific effect sizes from MRMC studies) are often not explicitly stated in a 510(k) summary, as these are typically found in the full submission. I will extract what is explicitly available and note where information is not provided.

Acceptance Criteria and Device Performance Study for HyperQ™ AD-100 System

Based on the provided K102579 510(k) Summary, the device is largely presented as "substantially equivalent" to a predicate device (HyperQ™ System K082564). The primary difference is the ability to be an accessory. The summary states that "Based upon the validation results, BSP believes this change does not raise additional safety or efficacy concerns." This indicates that the new device is expected to perform at least as well as the predicate and that the validation study aimed to confirm this.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a specific table for "reported device performance" in the way one might expect for a new diagnostic accuracy claim (e.g., sensitivity, specificity thresholds). Instead, the performance is generally framed around its "substantial equivalence" to the predicate device and the continuation of its intended use.

The closest we get to performance criteria are the technical specifications, which are identical to the predicate device, implying that meeting these specifications is a form of acceptance criterion to maintain equivalence. The "performance" is then demonstrating that the modified device still adheres to these specifications and intended uses, particularly regarding the HyperQ™ analysis and ST segment monitoring.

The core "acceptance criterion" for this 510(k) appears to be demonstrating that the new device, despite being an accessory and having slight physical differences, performs the intended functions (ECG, stress testing, HyperQ analysis, ST segment monitoring) to the same standard as the predicate device, especially regarding safety and efficacy.

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

• Sample Size for Test Set: The document explicitly states "a database is used as a tool for performance testing" for the ST segment algorithm and refers to "validation results" for the device as a whole. However, the specific sample size (number of patients/cases) used for these test sets is not provided in this summary.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The manufacturer is based in Israel, so it's possible the data originated there, but this is not confirmed.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done?: Not explicitly mentioned. The focus is on the device's technical specifications and maintaining its intended functions, rather than a direct comparison of human readers with and without AI assistance. The HyperQ™ Software is "intended to be used as an aid," implying human-in-the-loop, but no study comparing human performance with and without this specific AI aid is described here.
• Effect Size of Human Reader Improvement: Not applicable, as no MRMC study details are provided.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done?: Yes, to an extent. The document states, "The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing." This implies an evaluation of the algorithm's output (ST segment data) against a reference, which is a standalone assessment. Similarly, the statement "In the HyperQ™ stress test, changes in the high frequency of the mid QRS complex, calculated as root, mean-square (RMS) values, are compared to the resting values" describes an algorithmic function. The summary itself does not provide quantitative results (e.g., sensitivity, specificity) of this standalone performance.

7. Type of Ground Truth Used

• Ground Truth Type:
  • For ST segment algorithm accuracy: "a database is used as a tool for performance testing." While not explicitly stated, clinical consensus from expert cardiologists or reference ECG analyses would be the most common ground truth for such assessments.
  • For HyperQ™ analysis: The ground truth is implicit in the comparison "changes in the high frequency of the mid QRS complex...are compared to the resting values." This suggests a comparative approach to a baseline, rather than an external "ground truth" for the HyperQ™ values themselves. The significance of these changes, however, "must be determined by a physician," implying that the ultimate clinical ground truth relies on expert interpretation in context.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not provided. The summary mentions "a database" for testing, but doesn't elaborate on specific training data. Given the context of a 510(k) for an accessory that builds on an existing predicate, there might have been a development database for the original HyperQ™ system, but details for the AD-100's specific training are not in this summary.

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

• Ground Truth for Training Set: Not provided. (See point 8).

In summary, this 510(k) document primarily asserts substantial equivalence based on technical specifications and the continued intended use of the device's analytical capabilities (HyperQ™ and ST segment monitoring). While it states that "validation results" confirm that changes do not raise new safety or efficacy concerns and that the ST segment algorithm has been "tested for accuracy," it does not provide granular details on the methodologies (sample sizes, expert qualifications, specific performance metrics, ground truth establishment) of these validation studies as would typically be found in a full scientific publication or the more extensive 510(k) submission itself.

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ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in the following cases: Patients with suspected cardiac abnormalities Populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics is desired. Stress Testing Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemia, indicative of reduced blood supply to the cardiac muscle. The electrocardiogram may establish the diagnosis of ischemic heart disease if characteristic changes are present. Stress testing is the most widely used method to decide whether this chest pain is related to myocardial ischemia, and thus to coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients exercise by bicvcle, treadmill, or other means, while the ECG is monitored continuously. Exercise loads are determined by predefined protocols. The ECG signals as well as the HF-QRS signals are recorded for the resting, exercise, and recovery phase portions of the exercise protocol. The changes in both ECG waveforms are compared to the resting ECG records. In the HyperQ™ stress test, changes in the high frequency of the mid QRS complex, calculated as root-mean-square (RMS) values, are compared to the resting values. Most of the commercial stress test systems control the bicycle or treadmill automatically according to the requirements of the chosen protocol, although this is not essential. ST segment monitoring is intended as an aid in the evaluation of myocardial ischemia in patients with known or suspected coronary artery disease. The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician. HyperQ™ The HyperQ™ Software is intended to be used as an aid to stress ECG test by means of analysis of high frequency components present within the central portion of the QRS complex. The significance of the HF-QRS changes must be determined by a physician.

The HyperQ™ System is a compact monitor for measuring, processing, storing, and displaying information derived from an electrocardiogram (ECG). The device analyzes and records the high frequency components of the QRS complex of standard ECG.

The provided document, K072389, is a 510(k) summary for the HyperQ™ System. It outlines the device's intended use and a comparison to a predicate device, but it does not contain information regarding detailed acceptance criteria, specific study designs (like sample sizes, data provenance, ground truth establishment, or expert qualifications), or performance metrics (sensitivity, specificity, accuracy, etc.) typically found in a clinical study report.

The document focuses on demonstrating substantial equivalence to a predicate device (HyperQ™ System K070624) based on technological characteristics and intended use. It states: "The primary difference is that the modified device provides a reformatted graphic interface unit (GIU) with additional enhancements, features, and user selectable options. Based upon the validation results, BSP believes these differences do not raise additional safety of efficacy concerns."

The only mention of performance testing is related to the ST segment algorithm: "The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing." However, no details about this testing (e.g., acceptance criteria, results, study design, sample size, or ground truth) are provided.

Therefore, many of the requested details cannot be extracted from this specific 510(k) summary.

Here's an attempt to answer the questions based only on the provided text, indicating where information is absent:

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

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

• Sample Size for Test Set: Not specified in the document.
• Data Provenance: Not specified in the document. It mentions "a database is used as a tool for performance testing" for the ST segment algorithm, but no details about this database are provided.

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)

• Number of Experts: Not specified in the document.
• Qualifications of Experts: Not specified in the document.

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

• Adjudication Method: Not specified in the 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

• MRMC Comparative Effectiveness Study: No evidence of an MRMC study is mentioned. The document primarily focuses on technological equivalence to a predicate device, not on human-AI comparative effectiveness.

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

• Standalone Performance Study: The document indirectly suggests some form of standalone testing for the ST segment algorithm, stating it "has been tested for accuracy of the ST segment data," and for the HyperQ™ stress test where it analyzes HF-QRS changes. However, no specific results or a clear "standalone performance study" section with metrics are provided. The device itself is described as a "compact monitor for measuring, processing, storing, and displaying information." The "HyperQ™ Software is intended to be used as an aid to stress ECG test," implying it complements rather than replaces physician interpretation.

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

• Type of Ground Truth: Not specified in the document for any testing.

8. The sample size for the training set

• Sample Size for Training Set: Not specified in the document.

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

• Ground Truth Establishment for Training Set: Not specified in the document.

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ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in the following cases: Patients with suspected cardiac abnormalities; Populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics is desired. Stress Testing: Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemia, indicative of reduced blood supply to the cardiac muscle. The electrocardiogram may establish the diagnosis of ischemic heart disease if characteristic changes are present. Stress testing is the most widely used method to decide whether this chest pain is related to myocardial ischemia, and thus to coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise by bicycle, treadmill, or other means, while the ECG is monitored continuously. Exercise loads are determined by predefined protocols. The ECG signals as well as the HF-QRS signals are recorded for the resting, exercise, and recovery phase portions of the exercise protocol. The changes in both ECG waveforms are compared to the resting ECG records. In the HyperQ™ stress test, changes in the high frequency of the mid QRS complex, calculated as root-mean-square (RMS) values, are compared to the resting values. Most of the commercial stress test systems control the bicycle or treadmill automatically according to the requirements of the chosen protocol, although this is not essential. ST segment monitoring is intended as an aid in the evaluation of myocardial ischemia in patients with known or suspected coronary artery disease. The ST segment algorithm has been tested for acuracy of the ST segment data, and a database is used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician. HyperQ™: The HyperQ™ Software is intended to be used as an aid to the ECG stress test by means of analysis of high frequency components present within the central portion of the QRS complex. The significance of the HF-QRS changes must be determined by a physician.

The HyperQ™ System is a compact monitor for measuring, processing, storing, and displaying information derived from an electrocardiogram (ECG). The device analyzes and records the high frequency components of the QRS complex of standard ECG.

The provided text is a 510(k) summary for the HyperQ™ System, which is an ECG monitoring device. It describes the device's intended use and compares it to a predicate device, but it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing. The document states that "The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing" and similar for "validation results" of enhancements, but it does not provide specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or reported performance values for these metrics.

2. Sample Size for the Test Set and Data Provenance

Missing specific details. The document mentions "a database is used as a tool for performance testing" for the ST segment algorithm and that "validation results" were obtained for the modified device. However, it does not specify the sample size of this database or the nature of the data (e.g., number of patients, number of ECGs, country of origin, retrospective or prospective). Given the manufacturer is based in Israel, it's possible the data originated there, but this is not explicitly stated.

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

Missing. The document indicates that "The significance of the ST segment changes must be determined by a physician" and "The significance of the HF-QRS changes must be determined by a physician." This implies physician involvement in interpreting results, which could be related to ground truth. However, it does not specify the number of experts used, their qualifications, or their role in establishing ground truth for the test set.

4. Adjudication Method for the Test Set

Missing. There is no information provided about any adjudication methods used (e.g., 2+1, 3+1 consensus) for establishing ground truth or evaluating the device's performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes the device itself and its equivalence to a predicate device. It does not mention any MRMC study or comparative effectiveness study involving human readers with or without AI assistance. The device is presented as an aid to the stress ECG test, assisting physicians, but not in the context of comparative performance against human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document heavily implies a standalone algorithm's performance was evaluated, as it states: "The ST segment algorithm has been tested for accuracy of the ST segment data..." and "changes in the high frequency of the mid QRS complex, calculated as root-mean-square (RMS) values, are compared to the resting values." These statements suggest the algorithm generates data and makes comparisons autonomously. However, no specific "standalone study" with detailed results is described. The context is that the output of the algorithm needs to be interpreted by a physician.

7. The Type of Ground Truth Used

The document states, "The significance of the ST segment changes must be determined by a physician" and similarly for HF-QRS changes. This suggests that expert physician interpretation or diagnosis serves as the ultimate ground truth for the clinical significance of the ECG changes detected by the device. It's not explicitly stated whether this ground truth was derived from pathology, outcomes data, or only expert consensus on ECG readings.

8. The Sample Size for the Training Set

Missing. The document does not provide any information about a training set or its sample size. This is typical for a 510(k) for a device like this, which focuses on substantial equivalence rather than a de novo marketing application requiring detailed algorithm development and validation data.

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

Missing. As no training set information is provided, there is no mention of how its ground truth was established.

In summary, the provided text serves as a regulatory submission focused on substantial equivalence to a predicate device, highlighting its intended use and technological characteristics rather than providing a detailed scientific study report with specific performance metrics and validation methodologies.

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ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in the following cases:

• Patients with suspected cardiac abnormalities
• Populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics is desired.

Stress testing is the most widely used method to decide whether this chest pain is related to myocardial ischemia, and thus to coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients exercise by bicycle, treadmill, or other means, while the ECG is monitored continuously. Exercise loads are determined by predefined protocols. The ECG signals as well as the HF-QRS signals are recorded for the resting, exercise, and recovery phase portions of the exercise protocol. The changes in both ECG waveform and, in the HyperQ™ stress test, changes in the high frequency of the mid QRS complex, calculated as Root Mean Square (RMS) values, are compared to the resting values.

ST segment monitoring is intended as an aid in the evaluation of myocardial ischemia in patients with known or suspected coronary artery disease. The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician.

The HyperQ™ Software is intended to be used as an aid to stress ECG test by means of analysis of high frequency components present within the central portion of the QRS complex. The significance of the HF-QRS changes must be determined by a physician.

The HyperQ™ System is a compact monitor for measuring, processing, storing, and displaying information derived from the following physiological measurements:

• Electrocardiogram (ECG). A twelve lead ECG is acquired and a waveform can be displayed real-time on the LCD screen, recorded or printed. The design of the ECG function is derived directly from the predicate device, the PC ECG 1200 device.
• Detection, analyzing and recording of the high frequency components of the QRS complex of standard ECG signals.

The provided text is a 510(k) summary for the HyperQ™ System, which is a physiological patient monitor primarily for ECG and stress testing, including analysis of high-frequency components of the QRS complex (HF-QRS). The document does not contain a dedicated section detailing specific acceptance criteria and a study proving the device meets them with quantitative performance metrics.

However, based on the information provided, we can infer some aspects related to its performance claim, which is primarily substantial equivalence to a predicate device.

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

The document does not explicitly state quantitative acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, etc.) nor does it present a table of reported device performance against such criteria. The primary performance claim is related to substantial equivalence to a predicate device and compliance with various voluntary and federal standards.

The document states:

• "The HyperQ™ System is substantially equivalent to the PC ECG 1200 device (NORAV MEDICAL LTD.) cleared under K000404 in terms of intended use, technological characteristics, performance and user interface."
• "The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing." (No specific accuracy values are provided).
• Compliance with various standards: U.S. Federal Performance Standard set forth in 21 CFR 898 for electrode lead wires and Patient Cables; IEC-601-1:1988 and amendments, IEC 60601-1-2:2001, IEC 60601-2-27:1994, IEC60601-2-25:1999 and amendment, IEC 60601-1-4:1996, EC53:1995, EC38:1998 and EC11:1991.

Since no specific performance metrics like sensitivity, specificity, or accuracy are provided for the HyperQ™ System itself, a performance table cannot be constructed with quantitative values for an "AI" component. The document focuses on the functional equivalence and safety aspects relative to the predicate device and established standards.

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

The document mentions: "The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing."

• Sample size for test set: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

For the HyperQ™ software module, it states: "The HyperQ™ System includes a new off-line software module that does not raise new issues of safety or effectiveness based on previous pre-clinical and clinical studies and software validation." This implies some form of testing or validation was performed, but details about the test set are missing.

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):

Not specified.

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

Not specified.

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:

Not mentioned or implied. The document states the HyperQ™ software is "intended to be used as an aid to stress ECG test" and that "The significance of the HF-QRS changes must be determined by a physician." This suggests a human-in-the-loop scenario, but no comparative effectiveness study with or without the AI aid is described, nor is an effect size reported.

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

The document mentions that "The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing." This implies a standalone evaluation of the algorithm's accuracy, but no specific results are provided. The broader HyperQ™ System, including the HF-QRS analysis, is framed as an "aid" to a physician.

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

For the ST segment algorithm, it states it was "tested for accuracy of the ST segment data." This implies the existence of a reference standard (ground truth) for ST segment changes, likely established by expert interpretation or a highly reliable measurement, but the specific method (e.g., expert consensus with explicit criteria) is not detailed.

8. The sample size for the training set:

Not specified.

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

Not specified.

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