(231 days)
This device is intended to be used for the evaluation of the cardiovascular system. It is intended to by used by or on the order of a physician or similarly qualified health care professional. The FX-2111 is intended to be used in a doctors office; all hospital environments; ER ICU, CCU, OR, etc .; or similar settings. This device is intended to be use on any patient; neonate, pediatric, or adult; 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 model FX-2111 Single Channel Electrocardiograph is a portable, single channel, automatic or manual electrocardiograph. This electrocardiograph (EKG) is designed to produce a thermally printed recording of the electrical signals produced by the heart. A digital value of the heart's rate is also displayed. The FX-2111 incorporates the ability to store fifteen programmable 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 unplugged from the wall. In its automatic mode, the FX-2111 will produce a 12 lead standard or Cabrera formatted EKG without operator intervention. This light weight unit is portable and may be operated from AC or an optional rechargeable battery.
This 510(k) summary for the FUKUDA DENSHI Model FX-2111 Single Channel Electrocardiograph provides limited information regarding the performance of the device and the associated studies. Based on the provided text, a comprehensive table of acceptance criteria and reported device performance, and several other requested details cannot be fully answered.
Here's an analysis of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document mentions compliance with "all design specifications" and voluntary standards (ANSI/AAMI EC11-1991 for "Diagnostic Electrocardiographic Devices" and ANSI/AAMI ES1-1993 for "Safe current limits for electromedical apparatus"). However, specific numerical acceptance criteria or performance metrics derived from these standards are not detailed in the provided text, nor are specific reported device performance values.
The document highlights the risk of "Misdiagnosis" due to "Inadequate design of the EKG signal processing circuitry or program" leading to "inaccurate diagnostic data." This implies accuracy in ECG signal processing is a key performance criterion, but no quantitative measures are given.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text.
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)
This information is not provided in the given text. The device's primary function is to record and display ECG signals, not to provide automated diagnoses that would typically require expert-established ground truth for validation in this context. The risk mentioned is about "inaccurate diagnostic data" which refers to the quality of the signal and its processing, rather than the accuracy of an automated diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given text.
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
This information is not provided in the given text. The FX-2111 is a single-channel electrocardiograph designed to record and display ECGs for physician interpretation, not to provide AI-assisted diagnostic interpretations directly to human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is unlikely to have been performed for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the given text. The device records and displays ECG signals for a human healthcare professional to interpret. While it processes signals, it doesn't appear to have a standalone diagnostic algorithm in the sense of modern AI systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document focuses on the technical performance of the device in recording and processing ECG signals accurately according to design specifications and recognized standards. It aims to prevent "inaccurate diagnostic data" from being generated. For such a device, the "ground truth" would primarily relate to:
- Physical signal accuracy: Comparing the recorded ECG signals to known, accurate electrical inputs or reference signals.
- Parameter accuracy: Validating the accuracy of derived parameters like heart rate displayed by the device.
- Compliance with standards: Demonstrating that the device's electrical characteristics, filtering, and printing capabilities meet the requirements specified in standards like ANSI/AAMI EC11-1991.
There is no mention of "expert consensus, pathology, or outcomes data" being used for ground truth, as the device doesn't claim to provide automated clinical diagnoses for which such ground truth would be relevant.
8. The sample size for the training set
This information is not provided in the given text. This device, being from 1996, predates the widespread use of machine learning algorithms that require large training sets as described in modern AI contexts. The "software controlled medical device" aspect likely refers to firmware and control logic, not a trainable AI model.
9. How the ground truth for the training set was established
This information is not applicable/not provided given the likely nature of the device's software (control logic rather than a trainable AI model). If there were any "training" in a broad sense (e.g., calibrating signal processing algorithms), the methods are not described.
Summary of the Study Mentioned:
The study described is a series of laboratory tests conducted to validate and verify that the FUKUDA DENSHI Model FX-2111 met "all design specifications" and demonstrated substantial equivalence to its predicate device, the FUKUDA DENSHI model FX-1201.
- Environmental Testing: Identified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document. (Details of specific environmental conditions or acceptance criteria are not provided).
- Compliance with Voluntary Standards:
- ANSI/AAMI EC11-1991, "Diagnostic Electrocardiographic Devices"
- ANSI/AAMI ES1-1993, "Safe current limits for electromedical apparatus"
- Hazard Analysis: Performed on the system and its software.
- System Validation: Conducted to validate the system's overall operation.
Conclusion of the Study:
"The conclusions drawn from the laboratory testing... demonstrate that the device is as safe as effective, and performs as well as or better than the legally marketed predicate device, the FUKUDA DENSHI model FX-1201."
Key Missing Information (based on your request):
The provided text is a 510(k) summary from 1996. It focuses on demonstrating substantial equivalence to a predicate device and adherence to basic safety and performance standards of the time. It does not contain the detailed clinical study information and metrics commonly expected for AI/ML-enabled devices today. Specifically, there is no mention of:
- Quantitative acceptance criteria for misdiagnosis risk.
- Specific performance metrics (e.g., sensitivity, specificity, accuracy) for signal processing or derived heart rate.
- Any details on sample sizes for testing.
- Expert involvement in establishing "ground truth" for diagnostic accuracy.
- MRMC studies or AI involvement.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).