(63 days)
TENS: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. PMS: It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. Heating: It is intended for temporary relief of minor aches and pains.
The Low-frequency stimulator is a portable device. It has 10 modes: 9 stimulation modes each has 99 levels of intensity and 1 heating mode has 3 levels of heating intensity, which can give certain stimulation to help the users relax their muscle and relief their pain. The Low-frequency stimulator has 7 buttons on the main unit: Press Power button to turn on/off the device. Press "Mode+" and "Mode-" buttons to select 9 stimulation modes; Press "Intensity+" and "Intensity-" to increase or decrease the stimulus intensity, there are a total of 99 intensities to choose from; Press "Heat" to adjust the heating temperature, there are three temperatures(38℃, 40℃ and 43℃) that can be adjusted. Press "Time" to adjust the treatment time, increasing by five minutes each time, up to 60 minutes. It will automatically shut down in 30 minutes by default when it is turned on. The LCD screen can show stimulation intensity, heating intensity, heating intensity and time remaining of an application mode. All the functions of the device can only be controlled by the button on the main unit. The device is equipped with an adapter, bandage, a pair of electrode wire. The electrode wire is used to connect the electrode pads to the main unit. There are four conductive heads on the main unit, which are mainly composed of stainless steel sheets and giving users stimulation and heating functions, and help users relieve knee pain. The stimulation and heating functions can happen simultaneously or independently by control the button on the main unit. When in use, the main unit is fixed with a bandage, and the electrode sheet is placed at the relevant treatment site according to the instructions. The electrode pads can be used on the guidance site for stimulation only when connected to the host. There are two models of the device, which differ only in appearance. The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
This document (K212989) is a 510(k) Premarket Notification for a Low-frequency Stimulator. The document details the product description, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence, rather than providing details of a clinical study assessing the device's performance against specific acceptance criteria.
Therefore, most of the information requested in your prompt related to clinical study design, performance metrics, ground truth establishment, and expert involvement is not available within the provided text. The document explicitly states: "No clinical study is included in this submission."
However, I can extract the following information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
Since no clinical study demonstrating performance against specific numerical acceptance criteria for clinical effectiveness (e.g., pain reduction percentage, muscle performance improvement metrics) was conducted or reported, such a table cannot be provided from this text. The acceptance criteria described are largely related to non-clinical testing and safety standards.
| Acceptance Criteria (from non-clinical testing) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Electrical safety (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10) | Met the requirements |
| Electromagnetic compatibility (IEC 60601-1-2) | Met the requirements |
| Biocompatibility (ISO 10993-5, ISO 10993-10) | Met the requirements; electrode pads are compliant |
| Usability (IEC 62366-1) | Met the requirements |
| Software verification and validation (FDA Guidance for Pre-Market Submissions and for Software Contained in Medical Devices) | Met the requirements |
| Waveform test (Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning) | Conducted to verify output specifications |
| Patient Leakage Current | AC: 54.5 μA, DC: 0.5 μA (met standards IEC 60601-1-2 and IEC 60601-2-10) |
| Maximum Skin Temperature | 43°C (as claimed and compared to predicate) |
| Net Charge (per pulse) | 0μC @ 500Ω (Balanced waveform) |
| Maximum Phase Charge | 10.56μC @ 500Ω |
| Maximum Current Density | 1.63mA @ 500Ω |
| Maximum Power Density | 0.0000266mW/cm² @ 500Ω |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not applicable as no clinical test set was used. The evaluation was based on non-clinical (bench) testing.
- Data Provenance: Not applicable for clinical data. For non-clinical testing, the tests were conducted by the manufacturer, Shenzhen OSTO Technology Company Limited, in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical test set requiring expert-established ground truth was reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set was reported.
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 a stimulator, not an AI-assisted diagnostic tool for image interpretation. No human reader study of this type was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is a physical medical device, not a software algorithm for diagnostic interpretation. Its "performance" is measured by its physical output and adherence to safety standards. The software aspect mentioned is for verification and validation of the device's internal software control, not for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical testing, the "ground truth" or reference points were established by international and FDA-recognized standards (e.g., IEC 60601-1, ISO 10993-5, FDA Guidance documents for TENS and PMS devices). Device specifications and safety limits are derived from these standards.
8. The sample size for the training set:
- Not applicable as no machine learning model requiring a training set was used for the device's clearance.
9. How the ground truth for the training set was established:
- Not applicable as no machine learning model was used.
In summary, this 510(k) submission relies on non-clinical bench testing and comparison to legally marketed predicate devices to demonstrate safety and effectiveness for substantial equivalence, rather than de novo clinical study data.
§ 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).