(32 days)
The "Intended Use" of the Premier 11 software is the same as the predicate devices. The intended use is for evaluation of the recorded ECG for patients who are subject to physician ordered Holter ECG monitoring environments; such as, palpitations, dizziness, chest pains, shortness of breath, pacemaker function, and drug therapy follow-up. The evaluation includes the standard Holter software measurements and reporting of arrhythmia, ST changes, R-R Variability, QRS interval changes, and heart rate trends. The PC computer-generated results do not contain diagnostic interpretation. The data can be edited, and only the qualified physicians are intended to review the ECG data and to make a diagnosis.
The Premier 11 Holter is intended to be used only by physicians, or on the order and supervision of a physician.
Indications For Use:
The indications for use for 24-hour ambulatory ECG for this modified Premier ll software and the listed predicate devices are for ECG evaluation of, but limited, to typical symptoms of chest pains, palpitations, dizziness, shortness of breath, and pacemaker. More specifically, indications for use include the following:
- . Assessment of symptoms that may be related to rhythm disturbances of the heart in patients from pediatric to adult age; such as, palpitations.
- . Assessment of risk in patients with or without symptoms or arrhythmia; such as, patients with symptomatic or asymptomatic idiopathic hypertrophic cardiomyopathy and postmyocardial infarction patients with left ventricular dysfunction.
- . Assessment of efficacy of anti-arrhythmic therapy.
- . Assessment of pacemaker function.
- . Detection of transient ST Depression, as well as Prinzmetal ST Elevation.
The Premier 11 Holter is a software program that analyzes recorded ambulatory ECG (Holter), then creates ECG print-outs and numerical reports based on the analyzed data. The ambulatory ECG, as well as pacemaker pulse data, is prerecorded onto data storage mediums by Holter ECG recorders. The Premier 11 Holter software reads these raw data into standard PC computers, and then performs analysis to generate numerical reports.
The Premier 11 Holter software provides review and editing tools that allow trained medical personnel to review and edit the initial analysis of the recorded Holter ECG data. This data processing is performed on a standard PC computer, such as an XP Home or Professional operating platform.
The cardiac data that is processed by the Premier 11 Holter is both individual ECG waveforms and patterns of consecutive ECG waveforms. The Premier 11 Holter software does not provide diagnostic interpretation of the ECG data. Only the trained physician can provide such diagnosis. The cardiac data processed by the Premier 11 Holter is used by trained medical professionals to assist them to perform diagnosis on patients with various cardiac rhythm patterns.
The Premier 11 provides the standard Holter ECG processing features; such as individual ECG print-outs, Full Disclosure ECG print-outs, multi-channel morphology and ST analysis, heart rate analysis, manual markers for measuring the QRS width in both filtered and unfiltered modes, editing of arrhythmias, editing of ECG strips. editing of abnormal ECG events, selection of desired page prints for the Holter report, PageScanning of 100% of the 24-hour ECG, and storage of the Holter ECG file for future review of the data.
Here's a breakdown of the acceptance criteria and study information for the Premier 11 Holter, based on the provided text:
Acceptance Criteria and Device Performance
The provided document (a Special 510(k) Notification from 2006) doesn't explicitly state new, quantitative acceptance criteria for the Premier 11 Holter. Instead, it asserts substantial equivalence to existing predicate devices (K911615B Premier Holter system and K031466 IQmark Digital Holter). The primary acceptance criterion appears to be that the Premier 11 performs "essentially the same" and "function[s] in the same manner" as its predicates, particularly regarding the analysis algorithm and the analytical results. The key justification for substantial equivalence is that the core analysis algorithm remains unchanged from the K911615B Premier software, and the modifications are primarily in the operating system environment (DOS to Windows).
Therefore, the reported device performance is equivalent to the predicate devices, as the core analysis is identical.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence: The analysis algorithm and resulting data (Full Disclosure print-outs, printed ECG strips) are essentially the same and function in the same manner as the predicate devices. | The analysis algorithm is still in DOS and is essentially the same as the K911615B Premier software. The function and results of the Premier 11 Holter software versus the predicate cleared device are the same, except that the Premier 11 Holter software operates in the Windows environment. |
| Safety and Effectiveness Equivalence: Product modifications do not affect the safety or effectiveness of the device compared to the predicate device. | The product modifications of the Premier 11, as compared to the predicate Premier device (K911615B), do not affect the safety or effectiveness of the device. |
Study Information
The document describes a verification and validation process rather than a traditional clinical study with a detailed test set of patient data.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of patient cases or recordings but referred to as "the same testing data bases."
- Data Provenance: The data bases were used for verification and validation of the K911615B Premier Holter software from the mid-1990s and are now used for the Premier 11 software. This indicates retrospective usage of previously established internal testing data. No country of origin is specified, but given the submitter's location (Stateline, NV, USA), it's likely U.S.-centric or internal company data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The text focuses on the software's analytical output rather than external expert ground truth for specific diagnoses.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. The "ground truth" seems to be the expected analytical output from the established predicate algorithm.
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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 MRMC study was done. The device (Premier 11 Holter) is an analysis tool for recorded ECG data, which then supports a "trained physician" for diagnosis. It's not described as an AI-assisted diagnostic tool that directly improves human reader effectiveness in the way more modern AI/ML devices are. The "analysis algorithm" itself is the device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in effect. The core of the evaluation is a comparison of the Premier 11 (algorithm only) against the predicate Premier (algorithm only) using the "same testing data bases" to confirm "the analysis results are the same." The software generates numerical reports and supports the physician, but its own performance as an algorithm is what's being verified. The device does not provide diagnostic interpretation; that is left to the physician.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the verification and validation appears to be the established and expected analytical results produced by the predicate K911615B Premier software when run on "the same input data." This is an internal, computational ground truth rather than clinical ground truth (e.g., from pathology or expert consensus on patient outcomes).
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The sample size for the training set:
- Not applicable / not provided. As this is a modification of an existing, already-cleared algorithm rather than a de novo AI/ML model being developed, there's no mention of a separate "training set" in the context of contemporary machine learning. The algorithm itself was developed and validated earlier.
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How the ground truth for the training set was established:
- Not applicable / not provided. See above. The document describes verification that the pre-existing algorithm's output remains unchanged despite operating system migration.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).