(160 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 FX-4010 is indicated where a clinician seeks advisory interpretive measurement, and diagnostic statements that would require confirmation by a physician. Also, can provide measurement data, R to R timing measurements with trend information and interpretation of arrhythmia to the clinician.
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 does not interfere with or complicate the treatment of the patient. This device is not intended for home use.
The Fukuda Denshi model FX-4010 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. The size of the unit is 37.8(W) x 33.8(D) x 10.1(H) cm and weighs approximately 8 kg.
The provided text is a 510(k) summary for the Fukuda Denshi model FX-4010 Multi Channel Electrocardiograph. It describes the device, its intended use, and generally outlines the testing performed, but it does not contain detailed acceptance criteria or a specific study demonstrating performance against those criteria.
Instead, the submission primarily focuses on demonstrating substantial equivalence to a predicate device (FCP-2155) through general compliance with relevant standards and risk analysis. The text states that "Laboratory testing was conducted to validate and verify the Fukuda Denshi model FX-4010 Multi Channel Electrocardiograph met all design specifications and was substantially equivalent to the FUKUDA DENSHI model FCP-2155," but it doesn't provide the specifics of these "design specifications" as measurable acceptance criteria or the numerical results of those tests.
Therefore, I cannot populate the table or answer most of the questions based on the provided text alone.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria | Reported Performance |
|---|---|---|
| General | - Met all design specifications. |
- Substantially equivalent to FUKUDA DENSHI model FCP-2155. | "met all design specifications and was substantially equivalent" (No specific performance data provided to quantify "met" or "substantially equivalent" beyond general claims.) |
| Safety | - Compliance with ANSI/AAMI ES1-1993 for safe current limits. - Compliance with UL 2601, CSA 22.2, and AAMI standards for electrical safety to prevent excessive electrical leakage current. | "demonstrate compliance with ANSI/AAMI ES1-1993"
"device is designed to meet UL 2601, CSA 22.2 and AAMI standards for electrical safety" (No specific test results or values of leakage current provided.) |
| Efficacy (Diagnostic Accuracy) | - Inferred: Prevent misdiagnosis due to inadequate design of signal processing, measurement circuitry, or software. | "The design of the FX-4010 has taken into account all the above." (No direct performance metrics like sensitivity, specificity, or agreement rates for interpretive features are provided.) |
| Performance (Diagnostic Features) | - Compliance with ANSI/AAMI EC11-1991 for diagnostic electrocardiographic devices. | "demonstrate compliance with [...] ANSI/AAMI EC11-1991" (No specific test results related to ECG signal acquisition, measurement accuracy, or interpretive statement accuracy are provided.) |
2. 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 refers to "Laboratory testing" but does not specify sample sizes or data provenance for any performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not provided. The document does not describe any specific ground truth establishment processes involving experts for performance testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided.
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
- Not provided. The device is an "interpretive electrocardiograph," implying it provides automated interpretations, but there is no mention of a comparative effectiveness study involving human readers with and without its assistance. This type of study is more common for AI-driven diagnostic aids. This ECG device is a much older technology.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Implied, but no specific data presented. The device "can provide ECG interpretation" and "measurement and interpretive analysis." The "Laboratory testing" would have assessed the device's functional integrity as a standalone unit, but no specific performance metrics for the interpretive algorithm are given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not provided. For a device claiming interpretive capabilities, ground truth would typically be established by expert cardiologists. However, the document does not elaborate on how ground truth was determined for any internal testing related to its interpretive features.
8. The sample size for the training set
- Not applicable / Not provided. For older ECG devices with built-in interpretive algorithms, the algorithms are typically rule-based or derived from extensive analysis of ECG patterns, rather than "trained" in the modern machine learning sense. The document does not mention any training data or its size.
9. How the ground truth for the training set was established
- Not applicable / Not provided. See point 8.
N/A