(252 days)
TENS: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS: It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
The BH - 18 is a portable; battery powered (3.7VDC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device.
Two channels effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, there are 6 modes of operation.
The provided document, K132563, describes the Pinook Stimulator, Model BH-18, a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS). This 510(k) submission seeks to demonstrate substantial equivalence to a predicate device, the Hi-Dow Model JQ-5C (K102598).
The document details the device's technical specifications and intended uses, focusing on non-clinical testing and comparison to the predicate device to establish safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
For this specific 510(k) submission (K132563), the acceptance criteria are not explicitly stated as performance metrics in the typical sense (e.g., sensitivity, specificity, accuracy) for a diagnostic AI device. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device through comparison of technical specifications and compliance with relevant standards. The "device performance" is presented as a direct comparison of the new device's electrical output parameters against those of the predicate device.
| S.No | Description | Acceptance Criteria (Predicate Device K102598 - Hi-Dow JQ-5C) | Reported Device Performance (Pinook Stimulator BH-18) |
|---|---|---|---|
| 1. | Max Output Voltage over 10k, V | 84 V @ 10KΩ, 79.2 V @ 2.2KΩ, 62.4 V @ 500Ω | 84 V @ 10KΩ, 79 V @ 2.2KΩ, 61 V @ 500Ω |
| 2. | Max Current over 10k, mA | 8.4 mA @ 10KΩ, 39.6 mA @ 2.2KΩ, 124.8 mA @ 500Ω | 8.4 mA @ 10KΩ, 39.5 mA @ 2.2KΩ, 122 mA @ 500Ω |
| 3. | Pulse Width, micro seconds | 100 | 100 |
| 4. | Pulse Period, msec | 16.3-833mS | 16.3-833Ms |
| 5. | Max. Pulse Frequency, Hz | 61.3 | 62 |
| 6. | Net Charge µC per pulse | 0 | 0 |
| 7. | Max Phase Charge over 500Ω, µC | 12.48 | 12.2 |
| 8. | Max Current Density over 500Ω, mA/cm² | 12.04 | 11.77 |
| 9. | Max Power Density over 500 Ω, W/cm² | 0.747 W/cm² | 0.718 W/cm² |
| 10. | For multiphasic waveforms only: Symmetrical phases | YES | YES |
| Phase Duration† (include units) | 100μS | 100μS | |
| 11. | ON Time (seconds) | 5 Seconds (M2, M3 & M4) | 5 Seconds (M2, M3 & M4) |
| 12. | OFF Time (seconds) | 3 Sec. (M2), 2 Sec. (M3 & M4) | 3 Sec. (M2), 2 Sec. (M3 & M4) |
The study demonstrates that the Pinook Stimulator BH-18's reported performance for all listed electrical stimulation parameters is either identical or very similar to the predicate device, meeting the implicit acceptance criteria for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
This submission does not involve a "test set" in the context of evaluating an AI algorithm's performance on a dataset of patient images or clinical data. The study primarily relies on technical specifications comparison and non-clinical testing (e.g., electrical safety and EMC compliance to IEC standards). Therefore, there is no sample size for an external test set of patient data, nor is there data provenance in terms of country of origin or retrospective/prospective collection for an AI model evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As this is not an AI diagnostic device, there is no "ground truth" established by experts for a test set of medical cases. The ground truth for the device's performance is objective measurements against engineering specifications and industry standards.
4. Adjudication Method for the Test Set
Not applicable. There is no test set of medical cases where adjudication would be necessary.
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
Not applicable. This device is an electrical stimulator, not an AI-assisted diagnostic tool, so an MRMC study is not relevant to its demonstration of safety and effectiveness.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not employ an AI algorithm. Its performance is inherent in its hardware and firmware as an electrical stimulator.
7. The Type of Ground Truth Used
The "ground truth" for this submission is established through:
- Engineering specifications and measurements: The electrical output parameters (voltage, current, pulse width, frequency, charge, power, etc.) are objectively measured and compared against the predicate device's specifications.
- Compliance with voluntary standards: Adherence to standards like IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-2-10 (nerve and muscle stimulators), IEC 60601-1-11 (home healthcare), and ISO 14971 (risk management).
- Predicate device's established safety and effectiveness: The regulatory clearance of the predicate device (K102598) serves as the basis for the new device's substantial equivalence.
- Literature review: The submission states that "The effectiveness of the device for the proposed indications is supported by a number of articles in peer-reviewed publications, which demonstrates that electrical stimulation does improve muscle performance as well as pain reduction." This refers to existing scientific literature supporting the general efficacy of TENS and PMS technologies.
8. The Sample Size for the Training Set
Not applicable. This device does not utilize a "training set" for an AI algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device does not utilize a training set, so no ground truth for a training set was established.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).