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E-pulse is an electro-acupuncture device for use in the practice of Acupuncture by qualified practitioners of acupuncture as determined by the state.

Miniaturized, battery powered unit designed to administer auricular point stimulation treatment over a 96 hour period. The device is on for 3 hours, then off for 3 hours. It has a pre-programmed micro-processor as to frequency, pulse and duration for the stimulation of the auricular acupuncture points. The device itself is applied on the neck, below the ear with the integrated selfadhesive electrode patch. The voltage source is from the three batteries 1.4 volts (each). The device has different frequency modes and waveform modes. The wires from the device are connected to the acupuncture needles simply by positioning and snapping a plastic ring over the semi-permanent acupuncture needles.

The provided document describes the E-pulse model UH900, an electro-acupuncture device, and its substantial equivalence to a predicate device (P-Stim). The study design focuses on testing the device's technical specifications and safety rather than clinical efficacy with human subjects.

Here's a breakdown of the requested information based on the provided document:

1. Acceptance Criteria and Reported Device Performance

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

The document describes non-clinical performance and safety testing directly on the device itself, not on biological samples or patient data.

• Sample Size: Not explicitly stated as a number of devices, but the phrasing "the unit under test (UUT)" suggests individual units were tested for each performance characteristic.
• Data Provenance: Not applicable in the context of clinical data. The tests were performed in a lab setting, likely by the manufacturer or a contracted testing facility. The standards cited (IEC 60601 series, CISPR 11) are international standards for medical electrical equipment.

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

Not applicable. This was a technical performance and safety study conducted on the device hardware and software, not a study requiring expert clinical assessment for ground truth. The "ground truth" was the device's technical specifications and compliance with international standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or subjective assessments. This study involved objective measurements of electrical output and compliance with safety standards.

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

No, an MRMC comparative effectiveness study was not done. This device is an electro-acupuncture device, and the study presented in the 510(k) summary is focused on technical performance and safety, establishing substantial equivalence to a predicate device. There is no mention of human readers, AI, or comparative effectiveness in a clinical context.

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

While the device has software (firmware), the study described is not an "algorithm-only" performance study in the typical sense of AI/image analysis. It's a study of the device's overall hardware and embedded software functionality in meeting its design specifications. It evaluates the device's physical outputs (pulses, voltage, timing, cycles) and its electromagnetic compatibility/interference. There is no indication of a separate standalone performance evaluation of the "algorithm" in isolation from the hardware.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for this study was the pre-defined technical specifications and regulatory standards (e.g., pulse width 1.1ms +/- 10%, max. 4.2V output, 3-hour on/off cycle, compliance with IEC 60601 standards). These are objective, measurable parameters.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning study where a training set (or a "test set" in the context of clinical performance evaluation) is used. The "training set" concept is irrelevant here as it's an engineering verification and validation study.

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

Not applicable, as there was no training set in the context of this device's evaluation.

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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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