(136 days)
The device is indicated for aesthetic use, including facial and neck stimulation or body skin stimulation.
The subject device, the MyoLight Microcurrent Handpieces are intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the device. There are two MyoLight Microcurrent Handpieces that connect to the main unit. The small handpiece (diameter: 3.9 cm, Length: 14 cm) is generally used on the face and the large handpiece (diameter: 6.2 cm, Length: 15 cm) is generally used on the body. The handpieces are different in dimensions but not function. The handpieces contain the electrodes that deliver microcurrent for aesthetic use. The subject device is intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the handpieces. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about therapy type, remaining therapy time and main therapy parameters on the screen.
The provided context does not offer information about the acceptance criteria or a study proving that the device meets specific acceptance criteria in the typical format of a clinical or performance study with metrics like sensitivity, specificity, or AUC.
The document is a 510(k) summary for a medical device (MyoLight Microcurrent Handpiece) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed performance study with acceptance criteria.
However, based on the non-clinical testing section, we can infer some "acceptance criteria" through compliance with recognized standards.
Here's the breakdown of the information that can be extracted, and where the requested information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating compliance with recognized standards and similarity to predicate devices. The "reported device performance" is essentially the device's conformance to these standards and its specifications aligning with the predicate devices.
| Acceptance Criterion (Inferred from Standards & Equivalence) | Reported Device Performance (MyoLight Microcurrent Handpiece) |
|---|---|
| Electrical Safety and Essential Performance (IEC 60601-1:2005/A1:2012) | Compliant with IEC 60601-1 leakage current requirements and isolation requirements. |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2:2014/EN 60601-1-2:2015) | Compliant with IEC 60601-1-2 (implied by listing the standard as tested). |
| Particular Requirements for Nerve and Muscle Stimulators (IEC 60601-2-10 Edition 2.1 2016-04) | Compliant with IEC 60601-2-10 (implied by listing the standard as tested). |
| Biocompatibility (ISO 10993 and FDA Guidance) | Biocompatibility tests performed (exact results not detailed, but implied to be acceptable). |
| Software Validation & Verification | Software V&V tests performed (exact results not detailed, but implied to be acceptable). |
| Bench Testing for Performance | Bench testing performed to verify performance (exact details not provided, but used to support substantial equivalence). |
| Specifications within Acceptable Range of Predicate Devices (e.g., Max output voltage, current, power density, net charge, phase charge, pulse duration, frequency) | Max output voltage (30V @ 500 Ω, 33V @ 1,000 Ω, 35V @ 10,000 Ω), Max output current (60 mA @ 500 Ω, 33 mA @ 1000 Ω, 3.5 mA @ 10,000 Ω), Max current density (82 µA/mm² @ 500 Ω), Max average power density (0.012W/cm² @ 500 Ω), Net Charge (0 µC), Max phase charge (23 µC), Duration of primary (128, 256, 384 µs), Pulse Duration (128, 256, 384 µs), Frequency (1 ~ 63 Hz). These are compared to predicate devices and deemed "substantially equivalent." |
| Safety - Automatic Shut Off | YES |
| Safety - Patient Contact Material | Stainless Steel 304, PMMA (biocompatibility validated). |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical test set in terms of patient samples. The testing described is non-clinical (bench testing, software V&V, and compliance with electrical safety and EMC standards). Therefore, there is no information on sample size or data provenance in the context of a clinical test set.
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 using expert-established ground truth is described.
4. Adjudication method for the test set
Not applicable, as no clinical test set with adjudication is described.
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. The device is a microcurrent handpiece, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as the device is not an algorithm for diagnostic or prognostic purposes. It is a physical device delivering electrical stimulation, with software controls for operation.
7. The type of ground truth used
For non-clinical testing:
- Electrical Safety, EMC, and Nerve/Muscle Stimulator Standards: Compliance is based on objective measurements against defined limits in the respective IEC standards.
- Biocompatibility: Likely based on laboratory assays and tests according to ISO 10993 standards.
- Software Validation & Verification: Based on predefined software requirements specification and test protocols.
- Bench Testing: Based on objective measurements of physical and electrical parameters against design specifications.
8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device. The "training set" concept doesn't apply.
9. How the ground truth for the training set was established
Not applicable.
§ 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).