Search Results

The Cardiofax V electrocardiograph is intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a patient record (monitor and recorder) and prepare a record and/or provide wireless transmission of data to a remote printer and/or computer.

For non-interpretive applications, the device is intended for use with a full range of patient populations as determined by a clinician.

The devices also provide an interpretive ECG program intended for use with patients age 3 years and older. The interpretation program is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis. Assessments provided by the interpretation program are not intended as the sole basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography.

Nihon Kohden's ECG-1500A series is intended for medical purposes to process the electrical signals produced by the heart through electrocardiograph electrodes and to produce a visual display, to produce a record and/or to transmit data to a remote computer. The product is a portable ECG acquisition terminal, which measures up to 15 lead ECG waveforms. The measured ECG waveforms are analyzed and a patient record is prepared for transfer to an ECG data filing system thru a wireless LAN or may be printed by integral printer with optional model available with recorder. Measurements and waveforms and diagnostic information are offered to physicians on an advisory basis.

The ECG-1500A series prepares a full page file with 3 to 15 channel selectable formats, waveform display and waveform analyses with measurements. The device includes keyboard data entry, battery with internal battery recharging circuit and AC power operation , all of which are features of the predicate devices. The new device offers an optional PC memory card, comparable to the predicate Nihon Kohden's ECGs. The new device does offer an external optional printer and uses a different type of battery. These changes have been made to address user preferences and do not affect the indication for use or safety and efficacy of the new device.

The provided text is a 510(k) summary for the Nihon Kohden ECG-1500A series electrocardiograph. It describes the device, its intended use, and states that it has undergone testing and is believed to be substantially equivalent to predicate devices. However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or details about performance metrics (sensitivity, specificity, accuracy, etc.) beyond a general statement that "The results confirmed that the device performed within specifications."

Therefore, I cannot provide the requested table or answer most of the questions, as the information is not present in the provided text.

Here's what I can infer or answer based on the given document:

• 1. A table of acceptance criteria and the reported device performance: Not provided in the document. The document only states, "The results confirmed that the device performed within specifications," but doesn't list the specifications or performance metrics.
• 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 in the document.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document. The document mentions an "interpretive ECG program" for diagnosis assistance, which states, "All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography." This refers to clinical use, not the establishment of ground truth for a test set.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the document.
• 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 in the document. The device offers an "interpretive ECG program" but no study details are given about its impact on human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly stated as a standalone performance study in the context of diagnostic accuracy. The document mentions "Software validation tested the operation of the software of the device," but this generally refers to functional and safety testing, not standalone diagnostic performance against a ground truth. The interpretive program is explicitly stated to assist the physician and not be the sole basis for diagnosis, implying it's not intended for standalone use.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided in the document.
• 8. The sample size for the training set: Not provided in the document.
• 9. How the ground truth for the training set was established: Not provided in the document.

Ask a specific question about this device