(79 days)
These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
EMS, Electrical Muscle Stimulator, which improves, tones, firms & strengthens muscle and relaxes stiff muscle through the skin. It is recognized as a clinically proven, effective, non-medication method of training muscle from certain causes. It manages muscle strengthen, toning and firming. It is also free from side effects when used properly, and can also be used as a simple means of self-training.
HIVOX Spopad EMS SP series, SP-911 and SP-921 are the proposed devices for the 510(k) submission. These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in therapy or for the treatment of any medical conditions or diseases.
SP-911 and SP-921 are 1-channel battery-operated-user-friendly muscle stimulation system specifically designed to exercise the muscles. Each device comprises namely an electronic stimulator module which generates the required stimulation signals. SP-911 comprises 2 electrodes, which connects the signals from the stimulator to the skin. SP-921 comprises 4 electrodes, which connect the signals from the stimulator to the skin. Power is supplied from one battery, CR2032, located in a compartment protected by a removable battery cover. The user cannot access the wiring or connectors.
The provided text is a 510(k) Summary for the HIVOX Spopad EMS SP-911 and SP-921. It details the safety and performance testing conducted to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study for a new, complex algorithm or AI.
The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." (Section 5.9). This means there was no clinical study conducted where the device's performance was measured against established acceptance criteria using human data, adjudicated ground truth, or expert readers.
Instead, the submission relies on non-clinical testing to demonstrate performance and safety, specifically for a "Powered Muscle Stimulator." The acceptance criteria referenced are for electrical and physical performance characteristics of the device itself, rather than diagnostic accuracy or clinical effectiveness in the context of AI.
Therefore, many of the requested details regarding sample size, data provenance, expert qualifications, ground truth, MRMC studies, or standalone algorithm performance are not applicable to this type of device clearance and the information provided.
I can, however, extract the acceptance criteria for the non-clinical tests that were performed, as implied by the statement "All the test result demonstrate HIVOX Spopad EMS SP-911 and SP-921 meet the requirement of its pre-defined acceptance criteria and intended use". The document also implicitly defines acceptance criteria by noting when differences do not adversely impact safety and effectiveness, and by comparing the subject device's performance against the predicate and relevant standards.
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a clean "acceptance criteria" table with "reported performance" directly. Instead, it compares the subject device's performance characteristics to those of its predicate device, and implicitly (though not explicitly numerically) against relevant international standards. The determination of "Identical" implies meeting the same performance characteristics as the cleared predicate, which serves as the de facto acceptance benchmark for substantial equivalence in many parameters. For parameters that are "Different but does not adversely impact safety and effectiveness," the standard or a justified value serves as the acceptance criteria.
| Feature / Acceptance Criteria (Implied) | Subject Device Performance (SP-911 / SP-921) | Predicate Device Performance (SP-910 / SP-920) | Substantial Equivalence Determination / Justification of Acceptance |
|---|---|---|---|
| General | |||
| Intended Use | Identical to Predicate | Indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. | Identical. |
| Technology/Principle of Operation | Electrical Muscle Stimulation | Electrical Muscle Stimulation | Identical. |
| Compliance with Voluntary Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10 | Identical (SP-911/921 also comply with IEC 60601-1-11, which extends compliance). |
| Compliance with 21 CFR 898 | Yes | Yes | Identical. |
| Housing material and construction | Silicone | Silicone | Identical. |
| Electrical / Output Characteristics | |||
| Output waveform | Symmetrical biphasic | Symmetrical biphasic | Identical. |
| Shape | Rectangular | Rectangular | Identical. |
| Duration of primary (depolarizing) phase | 0 | 0 | Identical. |
| Pulse duration (μs) | 400 | 400 | Identical. |
| Max Output Voltage (V, ±10%) at 500 Ω | SP-911: 52 / SP-921: 58.4 | SP-910: 52 / SP-920: 58.4 | Identical. |
| Max Output Voltage (V, ±10%) at 2k Ω | SP-911: 102 / SP-921: 106 | SP-910: 102 / SP-920: 106 | Identical. |
| Max Output Voltage (V, ±10%) at 10k Ω | SP-911: 150 / SP-921: 154 | SP-910: 150 / SP-920: 154 | Identical. |
| Max Output Current (mA, ±10%) at 500 Ω | SP-911: 104 / SP-921: 117 | SP-910: 104 / SP-920: 117 | Identical. |
| Max Output Current (mA, ±10%) at 2k Ω | SP-911: 51 / SP-921: 53 | SP-910: 51 / SP-920: 53 | Identical. |
| Max Output Current (mA, ±10%) at 10k Ω | SP-911: 15 / SP-921: 15.4 | SP-910: 15 / SP-920: 15.4 | Identical. |
| Frequency (Hz) | SP-911: 3/4/5 / SP-921: 2/4/25 | SP-910: 3/4/5 / SP-920: 2/4/25 | Identical. |
| Net charge per pulse at 500 Ω (μC) | SP-911: 0.416 / SP-921: 0.468 | SP-910: 0.416 / SP-920: 0.468 | Identical. |
| Maximum charge at 500 Ω (μC) | SP-911: 41.6 / SP-921: 46.8 | SP-910: 41.6 / SP-920: 46.8 | Identical. |
| Maximum current density at 500 Ω (mA/cm²) | SP-911: 1.672 / SP-921: 1.057 | SP-910: 1.187 / SP-920: 1.057 | SP-911: Different (higher) but does not adversely impact safety and effectiveness. Justified against 0.25 W/cm² acceptance criterion for power density. SP-921: Identical. |
| Maximum average power density at 500 Ω (W/cm²) | SP-911: 0.0869 / SP-921: 0.0617 | SP-910: 0.0617 / SP-920: 0.0617 | SP-911: Different (higher) but does not adversely impact safety and effectiveness. Still below the acceptance criterion of 0.25 W/cm² from the Class II Special Control Guidance Document. SP-921: Identical. |
| Safety Features | |||
| Shelf-Life testing | Met requirements | N/A (implied by predicate clearance) | Met pre-defined acceptance criteria. |
| Performance verification | Met requirements | N/A (implied by predicate clearance) | Met pre-defined acceptance criteria. |
| Usability validation | Met requirements | N/A (implied by predicate clearance) | Met pre-defined acceptance criteria. |
| Method of Line Current Isolation | Battery supply | Battery supply | Identical. |
| Patient Leakage Current Normal Condition (μΑ) | 2.0 | 2.0 | Identical. |
| Patient Leakage Current Single Fault Condition (μΑ) | 2.1 | 2.1 | Identical. |
| Method of channel isolation | Single channel | Single channel | Identical. |
| Average DC current through electrodes when device is on but no pulses are being applied (μΑ) | 0 | 0 | Identical. |
| Number of output modes | 1 | 1 | Identical. |
| Regulated current or regulated voltage? | Voltage | Voltage | Identical. |
| Software / Firmware / Microprocessor control? | Yes | Yes | Identical. |
| Automatic overload trip? | No | No | Identical. |
| Automatic no-load trip? | No | No | Identical. |
| Automatic shut-off? | Yes | Yes | Identical. |
| User overrides control? | Yes | Yes | Identical. |
| Indicator display – On / Off Status | No | No | Identical. |
| Indicator display – Low battery? | No | No | Identical. |
| Indicator display – Voltage / Current level | No | No | Identical. |
| Timer range (minutes) | 20 | 20 | Identical. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The testing was non-clinical (shelf-life, performance verification, usability validation) and involves device samples, not patient data or clinical subjects. The document does not specify the number of devices tested for these non-clinical assessments.
- Data Provenance: The testing was conducted by HIVOX Biotek Inc., based in New Taipei City, Taiwan, R.O.C. (as per "Submitter Address" in Section 5.3). The data is from the manufacturer's internal testing as part of their 510(k) submission. It is not retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As this was a non-clinical submission, there was no "ground truth" derived from expert consensus on medical images or clinical outcomes. The "ground truth" for the device's electrical and physical parameters would be defined by engineering specifications and international standards, measured using appropriate test equipment and procedures.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for the reasons stated above.
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 powered muscle stimulator, not an AI-enabled diagnostic or assistive tool. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" implicitly refers to engineering specifications, regulatory requirements (e.g., 21 CFR 898), and international standards (e.g., IEC 60601 series). Performance verification would involve measuring parameters against these defined acceptable ranges. Usability validation typically involves testing by representative users against predefined usability criteria.
8. The sample size for the training set:
- Not applicable. This device does not involve machine learning or AI that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable for the reasons stated above.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).