(228 days)
Use of this device is indicated where a physician or healthcare professional requires information about the electrical events within the myocardium using waveforms recorded from the body's surface during depolarization and repolarization of the atrium and ventricles. The FCP-2155 is indicated where a clinician seeks advisory interpretive measurement, and diagnostic statements that would require confirmation by a physician. This device is indicated where the clinician seeks R to R timing measurements and trend information.
The basic EKG and recording features of this device are intended to be used on any patient; neonate, pediatric, or adult; where the placement of EKG electrodes does not interfere with or complicate the treatment of the patient. The interpretive feature of this device is intended to be used on any patient, at least one (1) year old, where the placement of EKG electrodes docs not interfere with or complicate the treatment of the patient. This device is not intended for home use.
The FCP-2155 may be operated from battery or AC power
The Fukuda Denshi model FCP-2155 Multi Channel Electrocardiograph is a portable, multi channel, interpretive, automatic or manual electrocardiograph. This electrocardiograph is designed to produce a thermally printed recording of the electrical signals produced by the heart. A digital value of the heart rate is also produced. If selected by the operator, the FCP-2155 is able to provide an interpretation of the EKG and to trend R-R interval. Numeric values of measurements made may also be printed.
The FCP-2155 incorporated the ability to store program settings that define the printout format and operating conditions of the device. These settings are maintained even when power has been turned OFF and the device has been unplugged from the wall. In its automatic mode, the FCP-2155 will produce a 12 lead standard or Carbrera formatted EKG without operator intervention. Interpretation of these waveforms may be included in the printout for review and final analysis by a trained physician.
This light weight unit is portable and may be operated from AC power or its internal, rechargeable battery.
The provided text describes the Fukuda Denshi model FCP-2155 Multi Channel Electrocardiograph and its substantial equivalence to a predicate device. However, it does not explicitly detail acceptance criteria in a structured table or provide specific performance metrics beyond stating that it "met all design specifications."
Here's an analysis of the available information based on your requested points:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with reported device performance. It generally states that the device "met all design specifications" and demonstrated "substantial equivalence" to the predicate device. The performance claims for the FCP-2155 focus on its ability to acquire and record EKG waveforms and data, provide EKG interpretation, and R-R interval measurements. The device is also designed to meet UL 601, CSA 22.2, and AAMI standards for electrical safety to prevent excessive electrical leakage current.
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 does not specify the sample size for any test set or the provenance of the data used for testing. It mentions "laboratory testing" and "clinical and laboratory testing" but does not provide details about patient cohorts or data origin.
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)
No information is provided regarding the number or qualifications of experts used to establish ground truth for any test set. The interpretive feature of the device is intended to provide "advisory interpretive measurement, and diagnostic statements that would require confirmation by a physician," implying that a physician would ultimately establish the ground truth for clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method used for a test set.
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
The document does not mention an MRMC study or any assessment of how human readers might improve with AI (or the device's interpretive features) assistance. The primary comparison is against a predicate device for substantial equivalence, not against human performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not explicitly state that a standalone algorithm-only performance study was conducted. The interpretive feature is described as providing "advisory" information that "would require confirmation by a physician," indicating that it's designed to be used with a human in the loop. The testing focused on validating design specifications and compliance with standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for testing the device's interpretive capabilities. Given that the device provides "advisory interpretive measurement, and diagnostic statements that would require confirmation by a physician," it implies that physician diagnosis would be the ultimate ground truth in clinical practice, but the method for establishing ground truth during initial testing is not detailed.
8. The sample size for the training set
The document does not provide any information about a training set or its sample size. This device pre-dates modern AI/machine learning paradigms where a distinct training set is a standard component of development and validation.
9. How the ground truth for the training set was established
Since no training set is mentioned, there is no information on how its ground truth might have been established.
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