(167 days)
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
| Acceptance Criteria (Design Objective) | Reported Device Performance (Test Results) |
|---|---|
| Pulse Timing: Output pulse timing consistent with 1.1 ms +/- 10% wide positive and negative pulses, 1100ms +/- 10% impulse interval (1.1Hz). | PULSE TIMING: "Output pulse timing measurement of the unit under (UUT) test were taken with the oscilloscope and tabulated in output specifications." (Implies consistency with specified limits; no specific deviation reported, but "passes if within specified limits" is the design pass criterion.) The document also states: "Performance testing was performed and all tests show satisfactory results." |
| Pulse Level: Output pulse voltage level and waveform consistent with design objective (max. 4.2V, output amplitude diminishes with battery voltage). | PULSE LEVEL: "Load resistors as per table 2 have been attached to the output leads of the unit under (UUT) test, output pulse voltage readings taken with the oscilloscope." (Implies consistency with specified limits; no specific deviation reported, but "passes if within specified limits" is the design pass criterion.) The document also states: "Performance testing was performed and all tests show satisfactory results." |
| Pulse Cycle: Unit output pulse ON (3 hours) and OFF (3 hours) cycle, and end of life time interval (up to 96 hours). | PULSE CYCLE: "The unit operation was observed over the time period specified and output pulse ON and OFF cycle and end of life time interval results recorded in device wave forms." (Implies consistency with specified limits; no specific deviation reported, but "passes if within specified limits" is the design pass criterion.) The document also states: "Performance testing was performed and all tests show satisfactory results." |
| EMC (Immunity): Output pulse stability maintained independent of applied Rf-radiation according to IEC 60601-2-10 paragraph 36, Test 1 and paragraph 36.202 Amendment 1 IEC 60601-2-10 1987 Immunity. | EMC: "The methods applied were in accordance with IEC601-2-10 paragraph 36, Test 1 and paragraph 36.202 Amendment 1 IEC 60601-2-10 1987 Immunity." (Implies passing, as "Nonclinical testing... show satisfactory results" is stated.) |
| EMI (Emissions): Unit complies with paragraph 36.201 Amendment 1 IEC 60601-2-10 1987 Emissions and CISPR 11. | EMI: "The EMI test methods applied were in accordance with paragraph 36.201 Amendment 1 IEC 60601-2-10 1987 Emissions and CISPER 11." (Implies passing, as "Nonclinical testing... show satisfactory results" is stated.) |
| Watchdog Timer Functionality: Designed to shut down unit and return all outputs to zero if output pulse exceeds 2 ms; unit remains shut down. | Watchdog Timer: "A watchdog timer is employed to ensure proper code execution, It is designed to shut the unit down and return all outputs to zero if the output pulse exceeds 2 ms. The unit will remain in shut down mode as long as power is applied." (Described as incorporated functionality, implying it meets this criterion.) |
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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