(21 days)
The QP-156E Exercise Test Option with its parent device, the Nihon Kohden ECG-1500A Series/Cardiofax V Electrocardiograph, is intended for medical purposes used to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and to prepare a record of the electrical signals produced by the heart. The QP-156E will develop a report based upon acquired data and subsequent calculations.
The ECG-1500A Series/Cardiofax V Electrocardiograph with QP-156E Exercise Test Option will be available for use by a physician within a hospital, laboratory, clinic or in a remote environment under the supervision of a physician.
The QP-156E Exercise Test Option is an optional accessory for the Nihon Kohden ECG-1500A Series or Cardiofax V Electrocardiograph. The QP-156E exercise test software is installed into an ECG-1500A Series or Cardiofax V Electrocardiograph, it can manage exercise testing, perform auto recording and automatically measure heart rate and ST level. After exercise testing, QP-156E can also print a final report and save the examination data in the memory, or in an optional memory card or diskette, or transfer it to other external instruments.
The provided text describes a 510(k) notification for the NIHON KOHDEN AMERICA, INC. QP-156E Exercise Test Software. However, it does not contain detailed information about specific acceptance criteria, a study proving device performance against those criteria, or most of the requested fields.
The document states that there are "no significant changes in function, performance or manufacturability compared to the predicate device that would affect the safety and effectiveness of the device as intended for use," and therefore, "Nihon Kohden believes that the device is substantially equivalent to the predicate device." This suggests that the performance expectations for the QP-156E are aligned with its predicate, the Nihon Kohden OP-932E ECG Exercise Test Option.
Here's a breakdown based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria or corresponding reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision, etc.) are explicitly stated in the provided text. The document focuses on performance testing related to environmental, EMC, and safety standards, rather than clinical performance or diagnostic accuracy.
The relevant section states: "There are no significant changes in function, performance or manufacturability compared to the predicate device that would affect the safety and effectiveness of the device as intended for use. Therefore, Nihon Kohden believes that the device is substantially equivalent to the predicate device."
This implies that the device is expected to perform at a level comparable to its predicate device, but no quantitative performance data is provided to demonstrate this.
2. Sample Size Used for the Test Set and Data Provenance
Not mentioned in the provided text. The document describes environmental, EMC, and safety testing but does not detail any clinical test set, sample size, or data provenance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not mentioned in the provided text. No information is given about experts or ground truth establishment for any clinical performance evaluation.
4. Adjudication Method for the Test Set
Not mentioned in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not mentioned in the provided text. There is no indication of an MRMC study or any assessment of human reader improvement with or without AI assistance.
6. Standalone Performance Study (Algorithm Only)
Not mentioned in the provided text. The document does not describe a standalone performance study for the algorithm's clinical capabilities. The "performance testing" mentioned refers to non-clinical aspects like environmental, EMC, and safety testing.
7. Type of Ground Truth Used
Not mentioned in the provided text. Due to the lack of clinical performance study details, the type of ground truth is not specified.
8. Sample Size for the Training Set
Not mentioned in the provided text. This device is an "Exercise Test Software" and likely relies on established algorithms for ECG analysis rather than recent machine learning models that require large training datasets in the conventional sense. The document does not provide details of any such training set.
9. How Ground Truth for the Training Set Was Established
Not mentioned in the provided text.
§ 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).