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510(k) Data Aggregation
(197 days)
This home used device is designed to be used for adult and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. In addition, it also provides a heat function intended to temporarily relieve minor aches and pains.
The FT-810R with a remote controller is a self-adhesive TENS device with 15 adjustable intensity level for pain relief. Moreover, it also provides a heat function which can be used in conjunction with the TENS function. TENS, Transcutaneous Electrical Nerve Stimulation, refers to the electrical stimulation of nerves through the skin which is an effective non-pharmacological method of pain relief. It can be used for self-treatment. Any symptoms that could be relieved using TENS must be checked by your general practitioner who will also give you instruction on how to carry out a TENS self-treatment regime.
TENS device works by passing electrical currents over the skin via a set of gel pads. As a transfer medium, the gel pads are subject to natural wear and tear and must be replaced when they stop providing sufficient contact or the main device no longer sticks to the skin completely. Failure to replace the gel pad may lead to skin irritation as a result of heightened current density in particular areas.
The provided text is a 510(k) summary for the Hivox Biotek Inc. Heating TENS (FT-810R) device. It details the device's characteristics, its comparison to predicate devices, and the non-clinical tests performed to demonstrate substantial equivalence. However, it explicitly states that "No clinical test data was used to support the decision of substantial equivalence."
Therefore, I cannot provide information on acceptance criteria based on human performance, nor can I describe a study that proves the device meets such criteria, because no clinical efficacy or human performance studies were conducted or presented for this 510(k) clearance. The clearance is based on demonstrating substantial equivalence to existing legally marketed predicate devices through engineering and safety testing.
The document focuses on non-clinical testing to ensure the device meets predefined acceptance criteria for safety and performance, primarily in comparison to its predicate devices.
Here's an analysis of the provided information, addressing your points where possible, and explicitly stating where information is not available:
1. A table of acceptance criteria and the reported device performance
The document mentions that "All the test results demonstrate the subject device, Heating TENS (FT-810R), meets the requirements of its pre-defined acceptance criteria and intended use, and its substantially equivalent to the predicate device." However, it does not explicitly list the specific quantitative acceptance criteria or the reported performance for each criterion in a consolidated table. Instead, it lists the types of non-clinical tests performed and implies that the device passed them by stating it "meets the requirements."
The "Table 1 – Comparison to Predicate Devices and Reference Device" does show comparisons of various technical specifications (e.g., maximum temperatureetting, output voltage, current, pulse width, frequency, maximum phase charge, maximum current density, maximum power density, etc.). While these are comparative performance metrics, they are not presented as explicit "acceptance criteria" with a target value + achieved value in the way you might see for clinical performance. The acceptance here is that it falls within a similar, safe, and effective range as the predicate devices.
For example, we can infer acceptance based on the comparison table:
| Comparison Item | Implied Acceptance Criterion | Reported Device Performance (FT-810R) |
|---|---|---|
| Functional Equivalence | The device's function and design (electrical stimulation and heat) should be comparable to predicate devices. | Identical to predicate device. |
| Power Source | Must use a similar power source to predicate devices. | 3.7 V Lithium-ion battery (identical to Predicate #2, similar to Predicate #1 "Rechargeable battery"). |
| Maximum Temperature Setting | Must operate at or below predicate device temperature settings for safety (e.g., 43℃). | 43℃ (Identical to predicate device). |
| Safety Standards Compliance | Must comply with relevant electrical safety, EMC, usability, and biocompatibility standards (e.g., ANSI/AAMI ES60601-1, IEC 60601 series, ISO 10993 series). | Compliant with ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ISO 10993-5, ISO 10993-10, 21 CFR 898. |
| Output Waveform | Should be similar to predicate devices (e.g., Biphasic, Symmetrical, Rectangular shape). | Biphasic, Symmetrical, Rectangular (identical to predicate device). |
| Maximum Output Voltage (@ 500 Ω) | Voltage profile should be within a safe and effective range comparable to predicate devices. | 72 Vp-p (@ 500 Ω). (Predicate #1: 100 Vp-p, Predicate #2: 72 Vp-p. "No significant differences would raise concern in safety or effectiveness"). |
| Maximum Output Current (@ 500 Ω) | Current profile should be within a safe and effective range comparable to predicate devices. | 144 mAp-p (@ 500 Ω). (Predicate #1: 200 mAp-p, Predicate #2: 144 mAp-p. "No significant differences would raise concern in safety or effectiveness"). |
| Maximum Phase Charge (@ 500 Ω) | Safety margin relative to predicate devices. | 21.6 µC (@ 500 Ω). ("much lower than Predicate device #1 [45 µC]. The differences would not raise concern in safety or effectiveness from predicate device"). |
| Maximum Averaged Current (@ 500 Ω) | Safety margin relative to predicate devices. | 9.04 mA (@ 500 Ω). ("No significant differences would raise concern in safety or effectiveness"). |
| Maximum Current Density (@ 500 Ω) | Max current density should be below safety limits (e.g., 2mA/cm² per IEC 60601-2-10). | 1.01 mA/cm² (@ 500 Ω). ("lower than 2mA/cm² which meets the requirement of IEC 60601-2-10"). |
| Maximum Power Density (@ 500 Ω) | Max power density should be below safety limits (e.g., 0.25 W/cm²). | 0.055 W/cm² (@ 500 Ω). ("< 0.25W/cm²"). |
| Wireless Communication | If applicable, wireless features should meet relevant standards (e.g., FCC Part 15). | Meets FCC Part 15 (identical to reference device). |
| Shelf Life | Device maintains performance over its defined shelf life. | (Passed ASTM F1980-16, results not detailed). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document does not specify a "sample size" in terms of patient data or clinical images, as no clinical studies were performed. The "test set" here refers to the device units themselves that underwent non-clinical testing. The number of physical units tested is not specified (e.g., "N=3 devices passed electrical safety testing").
- Data Provenance: The data provenance is from non-clinical laboratory testing conducted by the manufacturer (Hivox Biotek Inc.) or their contracted labs, primarily in Taiwan (R.O.C.) as indicated by their address. The studies conducted were non-clinical performance and safety tests, not retrospective or prospective patient data studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as there was no test set involving human data or expert review for establishing "ground truth" (e.g., diagnostic labels, disease presence/absence). The ground truth for the non-clinical tests would be the established engineering and safety standards (e.g., IEC 60601 series, ISO 10993 series).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable as no human expert review or adjudication of data (e.g., medical images) was involved in this 510(k) submission.
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
- No MRMC comparative effectiveness study was done. The device cleared is a hardware-based TENS/EMS device with heating function, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable as the device is not an algorithm for diagnosis or interpretation. Its performance is evaluated based on its physical, electrical, and thermal outputs meeting specified safety and performance requirements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical tests was adherence to recognized consensus standards and/or guidance documents (e.g., ASTM F1980-16 for shelf life, ISO 10993 for biocompatibility, IEC 62304 for software validation, ANSI/AAMI ES60601-1 and related IEC 60601 series for electrical safety and EMC). These standards define the acceptable limits and performance characteristics for such medical devices.
8. The sample size for the training set
- This is not applicable as the device is not an AI/Machine Learning algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established
- This is not applicable as there was no training set for an AI/ML algorithm.
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