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GLS-700 e-Pulse Analysis Monitor is used to measure automatically human's Systolic, Diastolic blood pressure and pulse rate.

GOCANNING GLS-700 e-Pulse Analysis Monitor is designed to measure the systolic and diastolic blood pressure, and pulse rate(heart of an individual).

The provided text describes the GOCANNING GLS-700 e-Pulse Analysis Monitor, a non-invasive blood pressure monitor, and its 510(k) submission. However, the document does not contain the detailed acceptance criteria, the specific study conducted to prove the device meets these criteria, or most of the requested information regarding the study design.

The document primarily focuses on the device's substantial equivalence to a predicate device (Rossmax Automatic Blood Pressure Monitor K021225) based on intended use, technological characteristics, and conformance to applicable standards (EN-1060-1, EN-1060-3, ANSI/AAMI SP-10, IEC 60601-1 and IEC 60601-1-2). It mentions "bench testing" and "clinical testing" were supplied without providing any details about these studies.

Here's a breakdown of the available information and the requested details that are missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Detailed acceptance criteria, such as specific blood pressure measurement accuracy ranges (e.g., mean difference and standard deviation compared to a reference method), and the actual measured performance values from the clinical study are not present.

2. Sample size used for the test set and the data provenance:

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only mentions "clinical testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  (For blood pressure monitors, ground truth is typically established by trained technicians or clinicians using a reference measurement method, like auscultatory measurement with a mercury sphygmomanometer, not usually "experts" in the sense of radiologists, etc.)

4. Adjudication method for the test set:

• Adjudication Method: Not specified.

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 device is a non-invasive blood pressure monitor, not an AI-powered image analysis or diagnostic tool involving "human readers." Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• This directly relates to the device's function as an automatic blood pressure monitor. The device is standalone in its measurement capability, meaning its algorithm provides the blood pressure and pulse rate readings without human interpretation of raw data. The "clinical testing" mentioned would assess this standalone performance against a reference standard. However, the details of this testing are not provided.

7. The type of ground truth used:

• Type of Ground Truth: Not specified. For blood pressure monitors, the ground truth is typically established using a validated reference method (e.g., auscultatory method with a mercury sphygmomanometer) by trained observers.

8. The sample size for the training set:

• This device is not explicitly described as employing a machine learning or AI algorithm that requires a "training set" in the common sense for medical imaging or complex diagnostic tasks. While the internal algorithms for signal processing and blood pressure determination are developed, the document does not refer to a "training set" in the context of such algorithms. If it does use machine learning, the training set size is not specified.

9. How the ground truth for the training set was established:

• How Ground Truth was Established: Not applicable/Not specified, as a training set is not explicitly mentioned for this device type in the provided text.

Summary of what is known from the provided text:

• Device Name: GOCANNING GLS-700 e-Pulse Analysis Monitor
• Intended Use: Measures human's Systolic, Diastolic blood pressure, and pulse rate, and is intended for adult of age 18 and above for over-the-counter use.
• Predicate Device: Rossmax Automatic Blood Pressure Monitor (K021225)
• Performance Claim: The device conforms to EN-1060-1, EN-1060-3, ANSI/AAMI SP-10, IEC 60601-1, and IEC 60601-1-2 requirements.
• Proof: "Bench testing" and "clinical testing" were supplied to demonstrate substantial equivalence and that any technological differences do not raise new questions of safety or effectiveness.

Key Missing Information for a comprehensive answer: The specific details of the "clinical testing" and the "bench testing," including methodologies, acceptance criteria, raw performance data, sample sizes, and how ground truth was established, are entirely absent from this 510(k) summary. These details would typically be found in the full 510(k) submission and associated test reports.

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