(352 days)
PMS (Mode 1) It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (Mode 2) 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.
Low-frequency Multi-function Physiotherapy Instrument is a household multifunctional device. it can stimulate healthy muscles in order to improve and facilitate muscle performance, and to relief the pain associated with sore and aching muscles in the waist, upper and lower back, back of the neck, upper extremities (shoulder, arm and hand), lower extremities (hip, knee, ankle, leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. Low-frequency Multi-function Physiotherapy Instrument has 2 operation modes and two channels, which can give certain electrical pulse through 2 pairs of electrode pads on the skin to help users to enjoy body massage and sole massage. The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key, Intensity Modification keys and time selection keys. The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode. The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device.
The provided document is a 510(k) summary for a Low Frequency Multi-Function Physiotherapy Instrument. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study with an AI device. Therefore, much of the requested information (like sample sizes for test/training sets, data provenance, ground truth establishment, expert qualifications, and MRMC studies) is not applicable or not detailed in this document.
However, I can extract information regarding the device's technical specifications and how its performance was evaluated against standards for safety and effectiveness.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not present "acceptance criteria" in the typical sense of a clinical performance study with thresholds for metrics like sensitivity or specificity. Instead, it demonstrates compliance with recognized medical device standards and compares the technical specifications of the new device (Subject Device) with a legally marketed predicate device. The "Verdict" column in the comparison table essentially serves as the "reported device performance" against the implicitly accepted performance of the predicate and compliance with standards.
| Elements of Comparison | Subject Device Performance | Predicate Device Performance | Verdict |
|---|---|---|---|
| Company | Shenzhen OSTO Technology Co., Ltd | Shenzhen OSTO Technology Co., Ltd | -- |
| Trade Name | Low-frequency Multi-functional physiotherapy instrument | Health Expert Electronic Stimulator | -- |
| Classification Name | Stimulator, Nerve, Transcutaneous, Over-The-Counter; Stimulator, Muscle, Powered, For Muscle Conditioning | Stimulator, Nerve, Transcutaneous, Over-The-Counter; Stimulator, Muscle, Powered, For Muscle Conditioning | -- |
| 510(k) Number | K172834 | K133929 | -- |
| Product Code | NUH, NGX | NUH, NGX | SE |
| Intended Use / Indications for Use | PMS (Mode 1): Stimulate healthy muscles to improve/facilitate muscle performance. TENS (Mode 2): Temporary relief of pain due to strain from exercise or normal household activities by stimulating nerves. | PMS (Mode 1 | SE |
| Power Source | Adaptor Input: 100-240Vac, 50-60Hz, 0.1A; Output: 5Vdc, 1A; Unit Input: 5Vdc, 1A | Adaptor Input: 100-240Vac, 50-60Hz, 0.1A; Output: 5Vdc, 1A; Unit Input: 5Vdc, 1A | SE |
| Method of Line Current Isolation | Type BF Applied Part |
| Type BF Applied Part | SE |
| Patient Leakage Current | NC: AC: 54.5µA, DC: 0.5µA; SFC: AC:120.0µA, DC: 0.6µA | NC: AC: 54.5µA, DC: 0.5µA; SFC: AC:120.0µA, DC: 0.6µA | SE |
| Main Unit Weight | 115 g | 2 kg | SE (Note 1) |
| Main Unit Dimension | 128.6 x 69.8 x 25 mm | 428 x 428.8 x 185mm | SE (Note 1) |
| Number of Output Channels | 2 | 2 | SE |
| Number of Output Modes | 2 | 25 | SE (Note 2) |
| Output Intensity Level | 99 | 99 | SE |
| Synchronous or Alternating? | Synchronous | Synchronous | SE |
| Regulated Current or Regulated Voltage? | Yes | Yes | SE |
| Software/Firmware/Microprocessor Control? | Yes | Yes | SE |
| Automatic Shut Off | Yes | Yes | SE |
| Indicator Display | On/Off Status, Voltage/Current Level | Yes (On/Off Status, Voltage/Current Level) | SE |
| Indicator Display (Low Battery) | Yes | No | SE |
| Timer Range | 5-60 min | 25 min | SE (Note 2) |
| Waveform | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic | SE |
| Shape | Rectangular, with interphase interval | Rectangular, with interphase interval | SE |
| Maximum Output Voltage | 44V±10% @ 500Ω; 80V±10% @ 2KΩ; 112V±10% @ 10KΩ | 44V±10% @ 500Ω; 80V±10% @ 2KΩ; 112V±10% @ 10KΩ | SE |
| Maximum Output Current | 88mA±10% @ 500Ω; 40mA±10% @ 2KΩ; 11.2mA±10% @ 10KΩ | 88mA±10% @ 500Ω; 40mA±10% @ 2KΩ; 11.2mA±10% @ 10KΩ | SE |
| Pulse Duration | 120μs | 120μs | SE |
| Pulse frequency | 77.3Hz | 77.3Hz | SE |
| Charge density | 0.21µC/ cm² @ 500Ω | 0.21µC/ cm² @ 500Ω | SE |
| Power density | 16.37μW/cm² @ 500Ω | 16.37μW/cm² @ 500Ω | SE |
| Active surface area | 50.04cm² | 50.04cm² | SE |
| Environment for operation | Temperature: 5 ~ 45°C; Humidity: 15% - 90%; Atmospheric pressure range of 700 hPa to 1 060 hPa | Temperature: 5 ~ 45° C; Humidity: 20 ~ 65% RH | SE |
| Environment for storage | Device: -25 - +70°C, up to 90% humidity, 700-1060 hPa; Pads: 10-20°C, up to 90% humidity, 700-1060 hPa | Device: 0 ~ 45° C, 10 ~ 90% RH; Electrode Pad: 10~20° C | SE |
Note 1 (Weight, Dimension): The differences in weight and dimensions are deemed substantially equivalent as they "won't affect the safety and effectiveness of the device."
Note 2 (Number of Output Modes, Time Range): The differences are justified as the design meets requirements in the energy aspect due to adjustable levels and default treatment time.
The study that proves the device meets the acceptance criteria:
The "study" here refers to a series of laboratory bench tests and comparisons against a predicate device, rather than a clinical trial for an AI algorithm. The device demonstrated substantial equivalence through:
- Electrical safety test: According to IEC 60601-1-11 and IEC 60601-2-10 standards.
- Electromagnetic compatibility test: According to IEC 60601-1-2 standard.
- Biocompatibility test: According to ISO 10993-5 and ISO 10993-10.
- Usability test: According to IEC 62366 standard.
- Software verification and validation test: According to the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Waveform test: Conducted to verify output specifications according to "Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over The Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning."
- Comparison to a predicate device (K133929): The detailed comparison table shows that the subject device shares technological characteristics, features, specifications, materials, mode of operation, and intended use with the predicate, with differences not raising new questions of safety or effectiveness.
Regarding the specific questions about AI/Software-as-a-Medical-Device (SaMD) studies:
This device is a physical medical instrument (Transcutaneous Electrical Nerve Stimulator/Powered Muscle Stimulator) and not an AI/SaMD. Therefore, many of the questions related to AI device evaluation are not applicable.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable (N/A): This is a hardware device, and the evaluation involved bench testing and comparison to technical specifications, not a clinical test set for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A: No expert-established ground truth for a test set in the context of diagnostic or interpretive AI performance was required or provided. The "ground truth" for this device's evaluation was based on engineering standards and the established performance of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A: No adjudication method was used as there was no test set requiring interpretation by multiple experts.
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
- N/A: Not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in concept: The "standalone" performance of the device was evaluated through the bench tests mentioned above (electrical safety, EMC, biocompatibility, usability, software verification, waveform tests) and direct comparison of its technical specifications to the predicate device. This is the device's inherent performance without human interpretation "in-the-loop" in a diagnostic sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Technical Specifications and Regulatory Standards: The "ground truth" for this submission refers to the established safety limits and performance parameters defined by international medical device standards (e.g., IEC 60601 series, ISO 10993) and the documented performance of the legally marketed predicate device (K133929).
8. The sample size for the training set
- N/A: Not an AI device; no training set in the context of machine learning.
9. How the ground truth for the training set was established
- N/A: Not an AI device; no training set.
§ 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).