(260 days)
The Transonic HCM103 system is intended for diagnostic assessment of cardiovascular status and circulatory variables in patients aged 1 month and older. The measurements include continuous cardiac output and associated hemodynamic parameters (such as stroke volume variation; pulse pressure variation, systemic vascular resistance and related index parameters) by continuous arterial pressure waveform analysis. In this stand-alone system, cardiac output (CO) value is entered from such devices as COstatus (HCM101) system or equivalent to calibrate the pressure wave form for measurement of continuous cardiac output. In addition the system also provides heart rate, systolic, diastolic pressures, mean arterial pressure and indexed parameters.
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transonic Systems Inc. intends to introduce into interstate commerce the Transonic HCM103 system, which is an apparatus based on arterial pressure waveform analysis to provide diagnostic assessment of cardiovascular status including continuous cardiac output and associated hemodynamic parameters (such as stroke volume variation; pulse pressure variation). In this stand-alone system, calibration value is entered from such devices as COstatus (HCM101) system or equivalent. In addition the system also measures heart rate, systolic, and diastolic pressures and derives mean arterial pressure. These patients could be in the intensive care units (ICU), operating room (OR) or other such environments.
The provided document is a 510(k) summary for the Transonic HCM103 System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria or a detailed study proving the device meets those criteria, especially in terms of clinical performance metrics like sensitivity, specificity, accuracy, or diagnostic effectiveness.
Here's an analysis based on the information provided in the document, highlighting what is missing for a complete answer to your request:
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A table of acceptance criteria and the reported device performance
- Not provided. The document states: "Bench studies confirmed the accuracy of the HCM103 system based on arterial pressure waveform analysis to accurately measure continuous cardiac output, stroke volume variation, pulse pressure variation, systemic vascular resistance index and other related parameters." However, it does not provide specific numerical acceptance criteria (e.g., "accuracy of +/- 10%") or the reported device performance against such criteria.
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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. The document states "Bench studies confirmed the accuracy..." but does not mention any clinical test set, sample size, or data provenance. It explicitly states, "Animal and clinical testing was not required to support substantial equivalence."
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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 applicable / Not provided. Since clinical testing was not required and no clinical test set is described, there's no mention of experts establishing ground truth for such a set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. See point 3.
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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 applicable. The HCM103 system is a diagnostic computer for cardiovascular status and circulatory variables. It's not an AI-assisted diagnostic tool that human readers would use to interpret images or data in a comparative effectiveness study. The document describes it as a "stand-alone system" where a CO value is "entered from such devices as COstatus (HCM101) system or equivalent to calibrate the pressure wave form."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The document describes the HCM103 system as performing measurements "by continuous arterial pressure waveform analysis" and deriving parameters. This is a standalone algorithm. The "Performance Testing" section focuses on "Bench studies confirmed the accuracy" and "software testing and electrical safety testing." There's no human-in-the-loop performance described beyond the entering of a calibration CO value.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated for the "bench studies." For a device measuring physiological parameters, the "ground truth" in bench studies would typically come from highly accurate reference instruments or simulated physiological models with known parameters. The document only mentions "Bench studies confirmed the accuracy," implying comparison to some form of established "true" values within a bench setting.
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The sample size for the training set
- Not provided. The document does not describe the development or training of any machine learning model or algorithm. It refers to its analytic approach as "arterial pressure waveform analysis." If an algorithm was developed, details on its training data are not included.
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How the ground truth for the training set was established
- Not provided. See point 8.
In summary:
The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting detailed clinical performance data against specific acceptance criteria. For the Transonic HCM103 System, the FDA determined that "Animal and clinical testing was not required to support substantial equivalence." The performance testing mentioned ("Bench studies confirmed the accuracy...") is described broadly and without specific metrics or the methodology required to answer most of your detailed questions.
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).