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510(k) Data Aggregation
(160 days)
Ageless Wonder Facial Toning Device is intended for facial stimulation and is indicated for overthe-counter cosmetic use. The anatomical site for application of the Ageless Wonder Facial Toning Device is the face.
The Ageless Wonder Facial Toning Device is a battery-powered portable EMS device. It applied specially designed bi-polar low voltage micro-current impulses on the face.
Not for use on injured or otherwise impaired skin or muscles, or use in any therapy or for the treatment, diagnosis, prevention or cure of any medical conditions or diseases. The device must only be used for the purpose stated - namely for the stimulation of facial muscles as indicated in the instruction manual for personal beauty purposes. All other uses shall be deemed improper
The provided text describes the 510(k) summary for the "Ageless Wonder Facial Toning Device" (K120511), which is a "Transcutaneous Electrical Nerve Stimulator" for facial stimulation for cosmetic use.
However, the document does not contain acceptance criteria or details of a study that proves the device meets specific performance criteria through clinical data or algorithm-specific metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (NuFace Facial Toning Device, K072260) based on design principles, intended use, functions, materials, and compliance with general safety and electrical standards.
Here's an analysis based on the provided text, highlighting what is present and what is absent regarding your request:
Acceptance Criteria and Reported Device Performance
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state specific acceptance criteria related to clinical performance (e.g., a certain percentage improvement in facial toning or specific electrical output levels for effectiveness). Instead, the "acceptance criteria" are implied by compliance with recognized standards and substantial equivalence to the predicate device.
| Acceptance Criteria (Implied by Standards & Equivalence) | Reported Device Performance (from "Comparison to Predicate Device" table) |
|---|---|
| Compliance with IEC 60601-1 (General Safety) | Complied (Verdict: SE - Substantially Equivalent) |
| Compliance with IEC 60601-1-2 (EMC) | Complied (Verdict: Note 1 - Does not affect safety/effectiveness) |
| Compliance with IEC 60601-2-10 (Nerve & Muscle Stimulators) | Complied |
| Compliance with ISO 10993-1, -5, -10 (Biocompatibility) | Complied (Accessories evaluated, Verdict: SE) |
| Intended Use: Facial stimulation for over-the-counter cosmetic use | Ageless Wonder Facial Toning Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use. (Verdict: SE) |
| Patient Protection (Type BF) | Type BF (Verdict: SE) |
| Protection against Electric Shock (Internally powered) | Internally powered equipment (Verdict: SE) |
| Battery life (similar to predicate) | Approximately 2-3 hours (Verdict: SE) |
| Channel (Single) | Single Channel (Verdict: SE) |
| Current (similar safety profile to predicate) | From 0 to 43.2 uA (Verdict: Note 1 - Does not affect safety/effectiveness despite difference with predicate's 0-400 uA) |
| Pulse Width Range (similar safety profile to predicate) | 150 us (Verdict: Note 1 - Does not affect safety/effectiveness despite difference with predicate's 112 ms) |
| Display (functions as required) | LCD (Verdict: Note 2 - Complies with IEC 60601-1, displays required info) |
| Dimensions/Weight (safe and functional) | 98.5mm x 53mm x 27.5mm; 90g (Verdict: Note 3 - Complies with IEC 60601-1) |
| Operating & Storage Conditions (defined and safe) | Temperature: 10-55°C (storage), 5-40°C (working); Humidity: <=95% RH (storage), <=80% RH (working); Atmospheric Pressure: 500-1060 hPa (storage), -70-106 kPa (working) (Verdict: Note 3 - Complies with IEC 60601-1) |
| Recommendation Accessory (FDA cleared/listed) | 1.5V AAA x 2 batteries; 0.3mm cable; 0.5mm conductive sponge (Verdict: Note 4 - All FDA Listing or cleared devices) |
Notes on the table:
- "SE" (Substantially Equivalent) indicates the subject device is comparable to the predicate device in that aspect.
- "Note 1", "Note 2", "Note 3", "Note 4" refer to the explanations provided in Sections 6.3 and 6.4 of the original document, primarily stating that differences do not affect safety or effectiveness, often due to continued compliance with IEC 60601-1.
Study Details
The provided document does not describe a clinical study or a study specifically designed to assess the performance of the device against specific acceptance criteria for effectiveness. The submission relies on demonstrating substantial equivalence to a legally marketed predicate device through engineering comparisons and compliance with relevant safety and electrical standards.
Therefore, the following points cannot be answered from the provided text:
2. Sample size used for the test set and the data provenance: Not applicable, as no performance test set or clinical study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 not an AI-assisted diagnostic tool but a direct stimulation device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
In summary: The 510(k) submission for the Ageless Wonder Facial Toning Device primarily establishes substantial equivalence to a predicate device (NuFace Facial Toning Device, K072260) by demonstrating similar intended use, design principles, materials, and compliance with recognized electrical and safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993 series). It does not present data from a clinical performance study with specific acceptance criteria, test set sizes, expert ground truth, or MRMC studies, as these types of studies are often not required for devices seeking 510(k) clearance based on substantial equivalence to a predicate, especially for devices like "facial toning devices" with cosmetic indications. The "acceptance criteria" are met by demonstrating that the device's characteristics are safe and effective enough to be considered substantially equivalent to a device already on the market.
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