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The QP-932E Exercise Test Option with its parent device, the Nihon Kohden Cardiofax ECG-9320A 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-932E will develop a report based upon acquired data and subsequent calculations.

The QP-932E Exercise Test Option is an optional accessory for the Nihon Kohden Cardiofax, Model ECG-9320A Electrocardiograph. The QP-932E will develop a report based upon acquired data and subsequent calculations.

This document, a 510(k) submission for the Nihon Kohden QP-932E Exercise Test Option, does not provide the detailed information requested regarding specific acceptance criteria for performance, a formal study design with sample sizes, expert qualifications, or ground truth methodologies. It's a pre-market notification that asserts substantial equivalence to predicate devices, rather than a report detailing a dedicated performance study against quantitative acceptance criteria.

Therefore, many of the requested fields cannot be directly extracted from the provided text. However, based on the information available, the following can be inferred and stated:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified.
• Data Provenance: Not specified (likely internal testing by Nihon Kohden, but no details on country of origin or retrospective/prospective nature).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• Not specified. The document focuses on verification of device operation, not clinical ground truth establishment in a diagnostic sense.

4. Adjudication Method for the Test Set:

• Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC study was not mentioned. The document describes verification and validation of the device itself, not a comparative effectiveness study involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

• This document describes the "QP-932E Exercise Test Option," which is an accessory to an electrocardiograph that "will develop a report based upon acquired data and subsequent calculations." This implies standalone processing of ECG data to generate a report, but a formal standalone performance study with quantitative metrics and a clear ground truth comparison is not described. The software validation confirmed it performed "within specifications," which alludes to its standalone function.

7. The Type of Ground Truth Used:

• The ground truth for the "software validation" and "performance testing" was likely based on internal engineering specifications and reference data, ensuring the device outputs according to its design. It does not refer to clinical ground truth established by external clinical experts or pathology reports.

8. The Sample Size for the Training Set:

• Not applicable. This device is an accessory to an electrocardiograph, and the document describes its verification and validation, not a machine learning model that would require a "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no mention of a training set for a machine learning model.

Summary of Study Type:

The document describes verification and validation (V&V) activities for a medical device accessory and its software, rather than a clinical performance study with a test set, ground truth, and expert interpretations. The primary "study" reported is the demonstration of substantial equivalence to predicate devices, supported by:

• Electromagnetic, environmental, safety, and performance testing of the parent device (ECG-9320A).
• Software validation confirming the QP-932E's functions were "within specifications."

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