FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Microcurrent device (Model: HBR2-1) is a hand-held, non-sterile, reusable device designed to achieve the cosmetic effect. The device consist of main unit and wireless charging station with undetachable USB cable. The device is supplied by internal rechargeable lithium battery. It can be recharged by external charger through the charging station. The device design with Micro current output stimulation function. The MCU-controlled microcurrent circuit generates a low-frequency microcurrent which will applied in the facial skin to do facial stimulation. In the microcurrent stimulation mode, there is ten levels of output intensity which would be adjusted by the button in the device. The device is only intended for home use.

AI/ML Overview

Here's an analysis of the provided FDA 510(k) summary regarding the acceptance criteria and study proving device performance:

This document is a 510(k) summary for a Microcurrent device (Model: HBR2-1), seeking clearance for "microcurrent electrical to stimulate facial tissues for aesthetic purposes."

It's important to note that this document addresses substantial equivalence to predicate devices, not a direct clinical efficacy study establishing independent acceptance criteria for the device's aesthetic claims. The FDA clears devices based on demonstrating they are as safe and effective as legally marketed predicate devices, not necessarily on proving new efficacy.

Based on the provided text, a conventional clinical study with predefined acceptance criteria for device performance (e.g., specific metrics for aesthetic improvement) and a direct comparison to a control group or a human-in-the-loop scenario was not conducted or reported in this 510(k) summary. Instead, the clearance relies on demonstrating compliance with safety standards and technical equivalence to existing cleared devices.

Therefore, many of the requested categories for a typical clinical study will be marked as "Not Applicable" or "Not Provided" as they are not part of this type of submission.

Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (as per 510(k))	Reported Device Performance (as per 510(k))
1. Safety Standards Compliance	Compliance with relevant medical electrical safety, EMC, and biocompatibility standards.	- IEC 60601-1: 2012: Complies

IEC 60601-1-2: 2014: Complies
IEC 60601-1-11: 2015: Complies
IEC 60601-2-10: 2016: Complies
ISO 10993-5: 2009: Complies
ISO 10993-10: 2010: Complies
Electrical Safety: Comply with IEC 60601-1 and IEC 60601-2-10; IEC60601-2-57 IEC60601-1-11
EMC: Comply with IEC 60601-1-2
Biocompatibility: All user-contacting materials comply with ISO10993-5 and ISO10993-10. |
| 2. Usability | The lay user can self-select as appropriate, apply treatment safely and correctly, and understand labeling/manual. | Usability testing was conducted and demonstrated these requirements were met. |
| 3. Software | Software verification and validation conducted as per FDA guidance for "moderate" level of concern. | Software V&V testing was conducted, and documentation was provided. The software was determined to be of "moderate" level of concern. |
| 4. Substantial Equivalence to Predicate Devices | Demonstrate that technological characteristics, features, specifications, materials, mode of operation, and intended use are substantially equivalent and do not raise new safety or effectiveness issues. | - Intended Use/Indications for Use: The subject device's indication ("stimulate facial tissues for aesthetic purposes") aligns with the predicates.
Electrical Parameters: While not identical, the output voltage, current, frequency, and pulse width are within ranges considered comparable or acceptable within the context of microcurrent stimulation devices and do not raise new safety/effectiveness concerns. For instance, the subject device's max current density (0.0325 mA/cm² @500Ω) is lower than both predicates (1.591mA/cm2@500Ω for K173093 and 0.044/0.42 mA/cm²@500Ω for K162106), which is generally favorable for safety.
Other Characteristics: Similarities in channels, stimulated muscles (face), auto features (overload, no-load, shut-off), user control, and material (ABS) are noted, establishing equivalence.
Differences Addressed: Key differences (e.g., prescription status of one predicate, output intensity levels) are accounted for, with the usability study addressing the OTC status. |

Breakdown of Specific Study Information:

1. A table of acceptance criteria and the reported device performance: See table above.
2. Sample size used for the test set and the data provenance:
- Clinical Testing/Effectiveness: Not explicitly done or reported for proving efficacy of the aesthetic claim. The "test set" for safety and usability would be the subjects in those respective studies. The document does not specify sample sizes for these.
- Data Provenance: Not specified, but generally, for such an FDA submission, the data is generated by or for the manufacturer. No country of origin is specified for any users or test subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For demonstrating substantial equivalence and safety: The "ground truth" is established by compliance with recognized engineering and biocompatibility standards (e.g., IEC, ISO). The experts involved would be testing engineers, biocompatibility specialists, and regulatory experts within the manufacturing and consulting companies, whose specific numbers and qualifications are not detailed here. No clinical experts (e.g., dermatologists assessing aesthetic outcomes) are mentioned as establishing ground truth for efficacy, as no explicit efficacy study defined with clinical endpoints was performed for this 510(k).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned for clinical outcome adjudication, as no clinical efficacy study focusing on aesthetic outcomes was submitted. Adjudication in the context of standard testing (e.g., electrical safety) refers to whether the device passes or fails the specified test, which is a direct measurement against a standard, not a subjective interpretation.
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 microcurrent stimulator for aesthetic purposes, not an AI-assisted diagnostic tool involving human readers or interpretation of cases. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm. The device operates standalone as a microcurrent stimulator without continuous human intervention during its operation, but its use is entirely human-initiated and directed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For safety and essential performance: Compliance with international safety standards (e.g., IEC 60601 series, ISO 10993 series) serves as the "ground truth." This involves direct measurement by testing laboratories.
- For usability: "Ground truth" is established by demonstrating that lay users can understand and safely operate the device based on the instructions for use.
- For substantial equivalence: The "ground truth" is established by comparing the technical specifications and intended use to those of legally marketed predicate devices, and confirming that any differences do not raise new safety or effectiveness concerns. No clinical outcomes data (e.g., quantifiable aesthetic improvement) from a dedicated study of the subject device defines the ground truth for efficacy.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI-based device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set is relevant to this device's clearance.

Summary

Regulation Number and Section

§ 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).