Search Results

Assessment of symptoms that may be related to rhythm disturbances of the heart in patients . from pediatric to adult age. Patients with palpitations.
Assessment of risk in Patients With or Without Symptoms of Arrhythmia. Patients with . symptomatic or asymptomatic idiopathic hypertrophic cardiomyopathy and postmyocardial infarction patient with left ventricular dysfunction using arrhythmia e.g.: ventricular ectopy, as method of risk assessment.
Assessment of efficacy of Antiarrhythmia Therapy. Patients with baseline high frequency, . reproducible, sustained, symptomatic premature ventricular complexes supraventricular arrhythmia or ventricular tachycardia.
Assessment of Pacemaker Function. Evaluation of patients with paroxysmal symptoms, ● detection of myopotential inhibition, detection of pacemaker mediated tachycardia, evaluation of antitachycardia pacing device function, evaluation of rate-responsive physiological pacing function.
Detection of Myocardial Ischemia. Patients with chest pain suggestive of Prinzmetal's ● angina.
Assessment of EASI derived 12-lead ST measurements is recommended for patients that . meet the following parameters.
- 1. Ages: 33 to 82 years
- 1. Heights: 147 to 185 cm (58 to 73 in)
- 1. Weights: 53 to 118 kg (117 to 261 lb)
- 1. Height to Weight ratios: 1.41 to 2.99 cm/kg ( 0.25 to 0.54 in/lb.)
QT measurements can be used by the physician in risk assessment process indicated for . patients with and without symptoms of arrhythmia. OT measurement is intended to be used by competent health professionals in hospital or clinic environment. Composite QT measures the interval only and is not intended to produce any interpretation or diagnosis of those measurements.

Device Description

AI/ML Overview

Here's an analysis of the Agilent 2010 Plus Holter for Windows, outlining its acceptance criteria and the study that demonstrates its performance, based on the provided text.

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with acceptance criteria in the same way a PMA or a more recent 510(k) would. As such, some of the requested information (like specific numerical acceptance criteria for performance metrics) is inferred from the overall claim of substantial equivalence and the comparison to industry-standard databases, rather than explicitly stated as acceptance criteria in the document.

Description of the Device and its Purpose

The Agilent 2010 Plus Holter for Windows is a device that analyzes recorded cardiac ECG data to generate reports on various cardiac data, including individual ECG waveforms and patterns of consecutive waveforms. This information is used by trained medical personnel for diagnosing patients with various cardiac rhythm patterns. Its primary function is to provide clinical tools such as ECG report generation, review of patient cardiac performance, multi-channel automatic ST analysis, frequency domain Heart Rate Variability, multi-channel morphology analysis, QT analysis, and custom reports. The key addition in this "Plus" version compared to its predicate is QT analysis.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical terms (e.g., "sensitivity must be > X%"). Instead, the document frames the acceptance criteria as demonstrating "Substantial Equivalence" to predicate devices, particularly the Zymed Holter Scanner Model Holter 2000, and meeting expected performance against industry-accepted databases. The core assertion is that the performance data between the new system and previous systems were "nearly identical," supporting substantial equivalence.

Performance Metric/Feature	Acceptance Criteria (Inferred from Substantial Equivalence and Study Design)	Reported Device Performance
Overall Holter Performance (against standard databases)	Performance "typical for the Holter as targeted" when measured against industry-accepted databases. This implies meeting or exceeding general benchmarks for arrhythmia detection, ST analysis, and noise immunity that would be expected for a Holter system seeking market clearance.	- Results were "typical for the Holter as targeted."

Sensitivities (SE), Positive Predictivity (+P), and False Positive Rate (FPR) were examined for each arrhythmia product (PVCs, short runs, long runs) against AHA and MIT databases.
Duration Sensitivity (DSE), Duration Positive Predictivity (D+P) were examined for the European ST-T (EST) database for ST analysis. |
| Arrhythmia Analysis (PVCs, short runs, long runs) | Performance comparable to the predicate device and expected levels for specific arrhythmia detections when tested against standard databases (AHA, MIT). The implicit criterion is that SE, +P, and FPR are within acceptable ranges for clinical use and are not significantly worse than predicate. | Examined for each arrhythmia product (PVCs, short runs, long runs) against AHA and MIT databases. Performance was deemed "nearly identical" to the predicate. |
| ST Analysis | Performance comparable to the predicate device and expected levels for ST analysis when tested against standard databases (European ST-T). The implicit criterion is that DSE and D+P are within acceptable ranges. | Examined against European ST-T (EST) database. Performance was deemed "nearly identical" to the predicate. |
| High Heart Rate Performance | Demonstrated ability to handle high heart rates, including those seen in pediatric patients (> 300 bpm). | Demonstrated mediator of 31 million in excess of 300 bpm (this phrasing is ambiguous, likely means it could process data with heart rates up to 300bpm, or that it was tested on 31 million beats, with some exceeding 300bpm). The performance in this scenario was consistent with the old system (predicate). |
| Noise Immunity | Performance in the presence of noise (baseline, electrode, or muscle artifact) within recommended guidelines should be comparable to the predicate device. | Performance in the presence of noise (baseline, electrode, or muscle as the cause of noise) was consistent with the old system (predicate). |
| QT Analysis (New feature) | While "performance" of the QT analysis as a diagnostic tool isn't discussed (as it's specifically stated "not intended to produce any interpretation or diagnosis"), the system's ability to measure the interval must be robust and produce consistent, objectively verifiable measurements. The implicit criterion is that the QT measurements themselves are accurate and reliable for aggregation and review by a competent health professional, enabling their risk assessment process. Accuracy of the measurements would be assumed to be validated. | The major difference between the new system and the Zymed 2000 is the addition of QT analysis. No specific performance metrics for QT measurement accuracy are provided in this summary, but its inclusion implies that the measurement function itself was deemed acceptable for its stated use (interval measurement only). The document states "Composite QT measures the interval only." |
| Overall Equivalence | Performance data between the two systems (new and predicate) must be 'nearly identical' such that it supports a claim of Substantial Equivalence. | Performance data between the two systems were "nearly identical." |

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

Sample Size for Test Set: Not explicitly stated as a number of patients or ECG recordings. However, the study utilized "industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases." These databases contain standardized ECG recordings with known arrhythmias and ST changes.
Data Provenance: The data came from established, publicly available, and industry-accepted databases (AHA, MIT, European ST-T). These databases typically contain retrospective ECG recordings from a variety of patient populations. The countries of origin for these specific databases are generally North America and Europe.

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

Number of Experts: Not specified in the provided text.
Qualifications of Experts: The ground truth for the AHA, MIT, and European ST-T databases is established by expert cardiologists and technicians who have meticulously annotated the recordings. While the document doesn't detail their qualifications for this specific submission, the "industry accepted" nature of these databases implies that their ground truth was established by highly qualified and experienced professionals in the field of cardiac electrophysiology.

4. Adjudication Method for the Test Set

The document does not describe the specific adjudication method used for the pre-existing ground truth within the AHA, MIT, and European ST-T databases. However, for such widely recognized and "industry-accepted" databases, it is common that the ground truth has undergone rigorous review, often involving multiple experts and some form of consensus building or majority vote (e.g., 2+1 or 3+1 methods implicitly or explicitly during their creation). The 510(k) summary focuses on the device's performance against this established ground truth, rather than the methods used to create the ground truth itself.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, the document does not describe an MRMC comparative effectiveness study involving human readers. The study focuses purely on the standalone performance of the algorithm and compares it to a predicate device and established databases. There is no mention of comparing human reader performance with and without AI assistance.

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

Yes, a standalone study was done. The performance evaluation discussed in the document ("Overall Holter performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases") describes the algorithm's performance in analyzing ECG data independently. The output of the 2010 Plus Holter for Windows is then used by "trained medical personnel to diagnosis patients," indicating the algorithm's standalone analysis provides the foundation for subsequent human interpretation.

7. The Type of Ground Truth Used

The ground truth used was expert consensus / annotated data from industry-standard databases, specifically:

AHA (American Heart Association) database
MIT (Massachusetts Institute of Technology) database
European ST-T database

These databases are meticulously annotated by cardiologists/experts with confirmed cardiac events (arrhythmias, ST changes), serving as the gold standard for testing ECG analysis algorithms.

8. The Sample Size for the Training Set

The document does not explicitly specify the sample size for the training set. It describes the device as inheriting much of its core functionality from existing Zymed systems ("The only difference between the two Zymed systems is the addition of QT Analysis to the 2010 Plus for Windows System"). This suggests that much of the underlying algorithm was likely trained or developed using extensive datasets over time, prior to this specific iteration. The performance testing against the noted databases would likely be part of a validation or test phase, rather than a training phase for this specific 510(k) submission.

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

As the document does not explicitly detail a training set for this specific submission, it also does not describe how its ground truth was established. However, for a device relying on previously developed algorithms (as implied by the substantial equivalence claim to an older model), the ground truth for any initial training of those algorithms would have been established through methods similar to the test set: expert cardiologists annotating large volumes of diverse ECG data.

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Ask a specific question about this device

K Number

K003940

Device Name

2010 PLUS HOLTER FOR WINDOWS

Manufacturer

AGILENT TECHNOLOGIES

Date Cleared

2001-02-08

(49 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K974192,K990170,K895208

Intended Use

Assessment of symptoms that may be related to rhythm disturbances of the heart in patients . from pediatric to adult age. Patients with palpitations.
Assessment of risk in Patients With or Without Symptoms of Arrhythmia. Patients with . symptomatic or asymptomatic idiopathic hypertrophic cardiomyopathy and postmyocardial infarction patient with left ventricular dysfunction using arrhythmia e.g.: ventricular ectopy, as method of risk assessment.
Assessment of efficacy of Antiarrhythmia Therapy. Patients with baseline high frequency, . reproducible, sustained, symptomatic premature ventricular complexes supraventricular arrhythmia or ventricular tachycardia.
Assessment of Pacemaker Function. Evaluation of patients with paroxysmal symptoms, . detection of myopotential inhibition, detection of pacemaker mediated tachycardia, evaluation of antitachycardia pacing device function, evaluation of rate-responsive physiological pacing function.
Detection of Myocardial Ischemia. Patients with chest pain suggestive of Prinzmetal's . angina.

Device Description

The Zymed system presents the user with a number of clinical tools such as ECG report generation. The system also provides tools to review a patient's cardiac performance. Features such as individual ECG printouts, multi-channel automatic ST analysis, frequency domain Heart Rate Variability, multi-channel morphology analysis and Custom Reports further enhance the system's qualities as a valuable and practical clinical tool.

The system has the options available: Full Arrhythmia analysis to include multi-channel automatic ST Analysis 12 lead ECGD Data Acquisition on 2 or 3 Channels Choice of Cassette Tape or Digital Input Laser Printer

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Zymed 2010 Plus Holter for Windows, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numerical or target performance format. Instead, it frames the performance by comparing it to industry standards and the predicate device, aiming for "nearly identical" results. The table below summarizes the reported findings in relation to these implicit criteria.

Feature/Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Overall Holter Performance	Typical for Holter systems (compared to AHA and MIT databases)	"Results were typical for the Holter as targeted."
Ventricular Ectopic Beat Detection	Separate sensitivities (SE), positive predictivity (+P), and false positive rate (FPR) meeting standards (specific values not provided in document).	"Separate sensitivities (SE), positive predictivity (+P), and false positive rate (FPR) were examined for each type of beat...and measured for QRS, Ventricular, Couples, Short runs and Long runs." (Implies results were acceptable, as substantial equivalence was claimed).
ST Analysis Performance	Separate sensitivities (DSE) and positive predictivity (D+P) for ST events meeting standards.	"Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. 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Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. "Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs." The phrasing suggests both DSE and DPs were evaluated against the European ST-T (EST) database, implying acceptable performance.
High Heart Rate Performance	Within recommended guidelines in excess of 300 bpm (to include pediatric patients).	"High heart rates to include pediatric patients were demonstrated to be within recommended guidelines in excess of 300 bpm."
Performance in Presence of Noise	Equivalent to the predicate system (Holter 2000) for baseline, electrode, or muscle noise.	"Performance in the presence of noise was identical to the old system when looking at baseline, electrode or muscle as the cause of noise."

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

Sample Size: The document does not explicitly state the sample size (number of patients or recordings) used for the test set. It refers to "industry accepted AHA (AHA), MIT (MIT)" databases for overall Holter performance and the "European ST-T (EST) database" for ST analysis.
Data Provenance: The data provenance is implied by the use of "industry accepted AHA (AHA), MIT (MIT)" and "European ST-T (EST) database." These are well-known, publicly available databases, suggesting the data is likely retrospective and compiled from various sources. The country of origin for the AHA and MIT databases would primarily be the US, while EST would be Europe.

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

The document does not provide details on the number of experts or their qualifications used to establish the ground truth within the AHA, MIT, or EST databases. These databases typically have established ground truths generated by expert cardiologists or technicians following standardized protocols, but the specifics are not in this submission.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing or validating the ground truth in the test sets. It relies on the pre-established ground truths within the referenced industry-accepted databases.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on comparing the new device's algorithmic performance to industry standards and the predicate device, not on how human readers' performance is altered by using the device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The document states, "Overall Holter performance was measured against industry accepted AHA (AHA), MIT (MIT) databases" and "Separate sensitivities (SE), positive predictivity (+P), and false positive rate (FPR) were examined for each type of beat... and measured for QRS, Ventricular, Couples, Short runs and Long runs." This indicates the algorithm's performance was evaluated directly against the established ground truth in these databases, without human intervention in the analysis process itself.

7. The Type of Ground Truth Used

The ground truth used was based on established, "industry accepted" databases:

Expert Consensus: The AHA and MIT databases are widely known to have rhythm annotations verified by expert consensus.
Pathology/Clinical Outcomes: While the document doesn't explicitly link to pathology or outcomes for the ground truth, the "European ST-T (EST) database" is used for ST analysis, which implies ground truth related to ischemic events, likely from clinical annotations.

8. The Sample Size for the Training Set

The document does not provide any information about the sample size used for the training set. It only discusses the evaluation of the device's performance (i.e., the test set).

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 was established, as details about a training set are not included in this submission. This document focuses on demonstrating substantial equivalence through performance testing against established benchmarks.

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K Number

K003763

Device Name

2010 PLUS HOLTER FOR WINDOWS

Manufacturer

AGILENT TECHNOLOGIES

Date Cleared

2001-01-05

(30 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K984089,K990170

Intended Use

Assessment of symptoms that may be related to rhythm disturbances of the heart in patients from pediatric to adult age. Patients with palpitations.
Assessment of risk in Patients With or Without Symptoms of Arrhythmia. Patients with asymptomatic idiopathic hypertrophic cardiomyopathy and postmyocardial infarction patient with left ventricular dysfunction using arrhythmia e.g.: ventricular ectopy, as method of risk assessment.
Assessment of efficacy of Antiarrhythmia Therapy. Patients with baseline high frequency, reproducible, sustained, symptomatic premature ventricular complexes supraventricular arrhythmia or ventricular tachycardia.
Assessment of Pacemaker Function. Evaluation of patients with paroxysmal symptoms, detection of myopotential inhibition, detection of pacemaker mediated tachycardia, evaluation of antitachycardia pacing device function, evaluation of rate-responsive physiological pacing function.
Detection of Myocardial Ischemia. Patients with chest pain suggestive of Prinzmetal's angina.
Assessment of EASI derived 12-lead ST measurements is recommended for patients that meet the following parameters.
- 1. Ages: 33 to 82 years
- 1. Heights: 147 to 185 cm (58 to 73 in)
- 1. Weights: 53 to 118 kg (117 to 261 lb)
- 1. Height to Weight ratios: 1.41 to 2.99 cm/kg ( 0.25 to 0.54 in/lb.)

Device Description

The 2010 Plus Holter for Windows is a device that analyzes recorded cardiac ECG and creates reports from the recorded data. The ECG is pre-recorded onto one of several data storage mediums, which is fed into the Holter 2000. The 2010 Plus Holter for Windows software analyzes the ECG and provides reports on a variety of cardiac data. The cardiac data that is analyzed is individual ECG waveforms and patterns of consecutive waveforms. Cardiac data provided by 2010 Plus Holter for Windows is used by trained medical personnel to diagnosis patients with various cardiac rhythm patterns. The Zymed system presents the user with a number of clinical tools such as ECG report generation. The system also provides tools to review a patient's cardiac performance. Features such as individual ECG printouts, multi-channel automatic ST analysis, derived 12 lead ST analysis multi-channel morphology analysis and Custom Reports further enhance the system's qualities as a valuable and practical clinical tool. The system has the options available: Full Arrhythmia analysis to include multi-channel automatic ST Analysis 12 lead ECGD Data Acquisition on 2 or 3 Channels Choice of Cassette Tape or Digital Input Laser Printer

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Zymed 2010 Plus Holter for Windows, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The 510(k) summary claims substantial equivalence to a predicate device (Zymed Holter Scanner Model Holter 2000 - 510(k) K990170) and focuses on the performance of the Holter system in analyzing cardiac data. The acceptance criteria are implicitly tied to maintaining performance levels "typical for the Holter as targeted" and equivalence to the predicate device.

Acceptance Criteria Category	Specific Metric (Implicit)	Reported Device Performance and Notes
QRS Detection and Arrhythmia Analysis	Sensitivity (SE), Positive Predictivity (+P), False Positive Rate (FPR) for: QRS, Ventricular, Couplets, Short runs, Long runs	"Separate sensitivities (SE), positive predictivity (+P), and false positive rate (FPR) were examined for each database (AHA), (MIT), (EST) and results were typical for the Holter as targeted... High heart rates to include pediatric patients were demonstrated to be within recommended guidelines in excess of 300 bpm." No specific numerical values are provided for these metrics, only a qualitative assessment of "typical" performance.
ST Analysis	Episode Sensitivity (E+P), Episode Positive Predictivity (E+P), Duration Sensitivity (DSE), Duration Positive Predictivity (D+P)	"Separate Episode and measured for QRS, Ventricular, Couplets, Short runs and Long runs. Separate Episode Sensitivity (E+P), Duration Sensitivity (DSE) and Duration Positive Predictivity (D+P) were examined for the European ST-T (EST) database and measured for ST analysis." No specific numerical values are provided, only that these were examined.
Performance in Presence of Noise	Equivalence to old system with baseline, electrode, or muscle noise	"Performance in the presence of noise indicates the new system is equivalent to the old system when looking at baseline, electrode or muscle as the cause of noise."
High Heart Rate Performance (e.g., pediatric patients)	Within recommended guidelines (>300 bpm)	"High heart rates to include pediatric patients were demonstrated to be within recommended guidelines in excess of 300 bpm."
Overall Comparison to Predicate (Holter 2000)	Performance data nearly identical	"In summary, performance data between the two systems were nearly identical, and therefore, supports a claim of Substantial Equivalence."

Study Details from the 510(k) Summary:

Sample size used for the test set and the data provenance:
- Test Sets: The study utilized industry-accepted databases: AHA (American Heart Association), MIT (MIT-BIH Arrhythmia Database), and European ST-T (EST) database.
- Sample Size: The exact number of patients or recordings within each database is not specified in the provided text.
- Data Provenance: The databases used (AHA, MIT, EST) are generally international, publicly available, and represent retrospective collections of ECG data. The specific country of origin of the data within these databases is not detailed here, but they are widely recognized benchmarks. The study implicitly used this data retrospectively for evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts involved in establishing the ground truth for the AHA, MIT, and EST databases. These databases typically have ground truth established by expert cardiologists or electrophysiologists, but the details are not part of this 510(k) summary.
Adjudication method for the test set:
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the ground truth of the test set. Given the use of established public databases, the annotations within those databases are considered the ground truth.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this 510(k) summary. The study is focused on the standalone performance of the device's algorithms compared to established benchmarks and its predicate device. This is a very early 510(k) submission (2001), and MRMC studies were not standard practice for such devices at that time.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation was done. The summary states, "Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases..." This indicates the algorithm's performance was assessed independently against the pre-established ground truth of these databases.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the test sets (AHA, MIT, EST databases) would be based on expert consensus (manual annotations by cardiologists/electrophysiologists) of the ECG waveforms.
The sample size for the training set:
- The document does not provide any information regarding the sample size used for training the algorithms. It is common for 510(k) summaries from this era to focus on performance evaluation rather than detailed training methodologies.
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 was established.

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