(444 days)
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
Perfect EMS is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Perfect EMS is intended for over-the-counter use.
The device is battery powered, two channels home use neuromuscular stimulation. The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients' intact skin by the end user. Electrical stimulation is delivered via self-adhesive electrodes to nerves and muscles.
The level of electrical stimulation is easily controlled by the end user using manual, pushbutton controls.
The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has six preset treatment programs and four manually adjustable programmes are available.
Accessories: 2 x 1.25m PVC Lead Wires (L-CPT) 50x50mm hydrogel electrode pads (E-CM5050)
Optional accessories: 50x100mm Large hydrogel electrode pads Pack of 4 (E-CM50100)
The provided text describes a 510(k) submission for the Perfect EMS device, asserting its substantial equivalence to a predicate device (HIVOX OTC Electrical Stimulator Model: EM49-2, K190347). The document focuses on demonstrating that the Perfect EMS meets safety and performance criteria by comparing it to the predicate and through compliance with recognized standards.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Perfect EMS device are implicitly defined by its substantial equivalence to the predicate device, EM49-2 (K190347), and adherence to a battery of safety and performance standards. The table above the horizontal line below summarizes the performance attributes of the Perfect EMS (Subject Device) and the predicate device, along with the comparison stating "Substantially equivalent" or "Identical."
| Attribute | Acceptance Criteria (Implicitly from Predicate/Standards) | Reported Device Performance (Perfect EMS) | Comparison Conclusion |
|---|---|---|---|
| Product Code | NUH, NGX | NUH, NGX | Identical; Substantially equivalent |
| Regulation No. | 21 CFR 882.5890; 21 CFR 890.5850 | 21 CFR 882.5890; 21 CFR 890.5850 | Identical; Substantially equivalent |
| Indications for Use | Same as predicate (TENS: temporary pain relief for sore/aching muscles; EMS: stimulate healthy muscles for improved performance) | Same as predicate | Same indications for use; Substantially equivalent |
| Prescriptive or OTC | OTC | OTC | Identical; Substantially equivalent |
| Number of output modes | Within acceptable range compared to predicate (predicate had 70 modes) | 10 | Substantially equivalent |
| Number of output channels | 2 | 2 | Substantially equivalent |
| Timer (minutes) Range | Adjustable, comparable to predicate (predicate 5-100 mins) | Default 20 mins, Adjustable to 10, 20, 30, 45, 60, 90 minutes | Both are adjustable; Substantially Equivalent |
| Regulated Current or Regulated Voltage? | None | None | Substantially Equivalent. |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Identical control method |
| Automatic No-Load Trip? | Yes | Yes | Identical |
| Automatic Overload Trip? | Yes | Yes | Identical |
| Automatic Shut Off? | Yes | Yes | Identical |
| User Override Control? | Yes | Yes | Substantially Equivalent. |
| Indicator Display: On/Off status | Yes | Yes | Identical |
| Indicator Display: Low battery | Yes | Yes | Identical |
| Indicator Display: Voltage/Current level | Yes | Yes | Identical |
| Indicator Display: Time to cut-off | Yes | Yes | Identical |
| Frequency (Hz) | Within acceptable range compared to predicate (predicate 1-150Hz) | 1-120Hz | Substantially equivalent |
| Pulse Width (µs) | Within acceptable range compared to predicate (predicate 50-450µs) | 50-350µs | Substantially equivalent |
| Waveform | Bi-phasic | Bi-phasic | Identical |
| Shape | Rectangular | Rectangular | Identical |
| Maximum Output Voltage (V) | 50V@ 500Ω | 50V@ 500Ω | Substantially equivalent |
| Maximum Output Current (mA) | 100mA@ 500Ω | 100mA@ 500Ω | Substantially equivalent |
| Maximum Phase Charge (µC) | Within acceptable range compared to predicate (predicate 37.6µC@ 500Ω) | 20.5µC@ 500Ω | Substantially equivalent |
| Maximum Current Density, (mA/cm²) | Safe levels, compared to predicate (predicate 0.07426mA/cm²@ 500Ω) | 0.01013mA/cm²@ 500Ω (Area=25cm²) | Substantially equivalent |
| Maximum Power Density, (W/cm²) | Safe levels, less than 0.25 W/cm² (predicate 0.0066W/cm²@ 500Ω) | 0.00053W/cm²@ 500Ω (Area=25cm²) | Substantially equivalent |
| Power Source | Internal power supply (predicate used AAA batteries) | 2 Alkaline AA 1.5V Batteries | Both are internal power supply source: Substantially equivalent |
| Weight | Comparable to predicate (predicate 83g) | 75 g without batteries | Substantially Equivalent. |
| Dimensions (mm) [W x H x D] | Comparable to predicate (predicate 132 x 63 x 29.5 mm) | 120 x 60 x 31mm | Substantially Equivalent. |
| Housing Materials and Construction | Safe and effective (predicate ABS plastics) | Silicone, ABS plastics | Substantially Equivalent. |
| Electrode lead wires and patient cable | Yes (PVC) | Yes (PVC and nylon yarn) | Substantially equivalent |
| Compliance with Voluntary Standards | Yes | Yes (See section 1.3/VII for specific standards) | Substantially equivalent |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data or patient outcomes. The performance evaluation is based on engineering and safety testing against recognized standards. Therefore, information regarding sample size and data provenance for a test set in the traditional sense (e.g., patient data) is not applicable here. The provenance for the device is the manufacturing facility in China (EasyMed Instruments Co Ltd).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The evaluation framework is based on compliance with established engineering and safety standards, and a comparison to a predicate device. There is no mention of human expert-established "ground truth" for the performance tests conducted on the device's technical specifications.
4. Adjudication method for the test set
This information is not applicable. As there is no clinical "test set" requiring human interpretation or decision-making, an adjudication method for such a set is not relevant.
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
An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic or decision-making systems. The Perfect EMS is an electrical stimulator for pain relief and muscle performance, not an AI diagnostic tool. Therefore, an MRMC comparative effectiveness study is not applicable and was not reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Perfect EMS is a physical medical device, not a software algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable. Performance was assessed by measuring the device's electrical output and adherence to safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the pre-defined acceptance criteria set by recognized safety and performance standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, IEC 62304, ISO 10993-1) and the technical specifications of the legally marketed predicate device (EM49-2 K190347). The device's performance was measured against these established quantitative parameters and qualitative design characteristics.
8. The sample size for the training set
This information is not applicable. The Perfect EMS is a hardware device; it does not explicitly mention any machine learning or AI components that would require a "training set" for an algorithm.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8. There is no mention of a training set or AI algorithm in this context.
§ 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).