(17 days)
The Impresario™ software is intended for the analysis, summary and reporting of prerecorded ambulatory ECG data. At the requirement of a clinician, ambulatory ECG data is recorded in analog or digital form for up to 48 hours in multiple channels. The resultant recordings are segregated into a series of reports presenting significant clinical events as defined by the system, and affirmed by the review and confirmation of a clinician. The system is employed as a screening tool to record ECG events and to present these events to a qualified clinician review, edit and assessment.
Impresario is an arrhythmia analysis software system that allows the customer to purchase software only and install it on his/her computer. It is compatible with all Del Mar ambulatory ECG (Holter) recorders. It provides 3-channel automated arrhythmia analysis with operator intervention and edit. Reports include summary, totals, trends, histograms, and full disclosure.
The provided text describes a 510(k) summary for the Del Mar Medical Impresario™ Holter Analysis Software. However, it does not contain a detailed study section with acceptance criteria and a comprehensive study that proves the device meets those criteria.
The document states that "The fundamental technology of Impresario is the same as the predicate device. The base arrhythmia algorithm remains unchanged." This implies that substantial equivalence is being claimed based on the existing performance of the predicate device (Del Mar Avionics Model 263 Spectrascan®).
Therefore, I cannot provide a table of acceptance criteria and reported performance, nor can I answer questions related to sample sizes, ground truth establishment for a new study, expert qualifications, or MRMC studies, as this information is not present in the provided text.
Based on the available information:
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A table of acceptance criteria and the reported device performance: This information is not provided in the document. The device claims substantial equivalence to its predicate.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.
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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 provided.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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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: Not provided. The device description mentions "operator intervention and edit" and analysis by a "licensed physician," indicating a human-in-the-loop system, but no MRMC study details are given.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly stated, but the "operator intervention and edit" suggests it's not purely standalone.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided for the Impresario software itself. The intended use states it is a "screening tool to record ECG events and to present these events to a qualified clinician review, edit and assessment," implying clinician review is the ultimate ground truth in clinical practice.
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The sample size for the training set: Not provided.
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How the ground truth for the training set was established: Not provided.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).