(96 days)
The FINALLY FREE Ultra tweezer-type epilator is indicated for the removal of unwanted body and facial hair. Like the predicated in the is specifically dosigned for use h is specifically designed for use by consumers.
Finally Free Ultra is a tweezer-type epilator for the removal of unwanted body and facial hair. It is designed for consumer home use. The device removes hair by the application of radio frequency energy to the hair shaft, which in turn conducts it to the hair root. There the energy causes the root to separate from follicle, thereby causing the hair to fall out. Further damage to the surrounding tissue stunts hair growth. This patented process is called NU-Trolysis. Finally Free Ultra is substantially equivalent to Forever Free, another consumer-use tweezer-type epilator manufactured by Burke/Neutech (K952117). Both are plastic encased units which plug into a standard 110V wall socket and which convert the AC current into radio frequency energy by means of a crystal oscillating component and both amplifying and filtering circuitry. The energy is delivered by a line cord attached to a hand-held wand with a tweezer which grasps the individual hair.
Here's an analysis of the provided text regarding the "FINALLY FREE ULTRA" epilator, focusing on acceptance criteria and study details.
1. Table of Acceptance Criteria and Reported Device Performance
The document provided does not specify explicit "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy, as would be typical for diagnostic or AI-driven devices. Instead, the "acceptance" in this context is based on demonstrating substantial equivalence to a predicate device for regulatory clearance.
The core performance comparison is regarding the energy outputs of the device compared to its predicate:
| Characteristic | Acceptance Criteria (Predicate: FOREVER FREE) | Reported Device Performance (FINALLY FREE ULTRA) |
|---|---|---|
| Frequency (MHz) | 27.064 - 27.112 | 27.100 - 27.322 |
| Voltage (p-p) | 30.1 - 31.2 | 39.2 - 59.4 |
Note on "Acceptance Criteria": For this type of device and regulatory submission (510(k)), "acceptance criteria" for performance are not typically quantitative thresholds like those used for AI. Instead, the criteria are centered around demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance data presented (frequency and voltage ranges) are used to support the claim of substantial equivalence, implying that these ranges are within what is deemed acceptable for similar devices. The wider range for "Finally Free Ultra" in both frequency and voltage suggests it either operates across a broader spectrum or potentially with higher power, but the document implies this is still considered "substantially equivalent."
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions that the energy outputs for "FINALLY FREE ULTRA" were measured using "6 Units" and for "FOREVER FREE" using "2 Units." This small sample size of devices (not patients or data points) was used for the direct electrical performance comparison.
- Data Provenance: Not explicitly stated as retrospective or prospective data from a human study. This is an engineering/device performance measurement, likely performed in a lab setting by the manufacturer (Burke/Neutech). The country of origin of this data is not specified beyond being generated by the applicant.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The "ground truth" for the electrical performance metrics (frequency and voltage) is the direct measurement of outputs from the devices themselves using instrumentation. There are no human experts involved in establishing this type of ground truth.
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, this is an objective electrical measurement, not a subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is an epilator, not an AI or diagnostic device that would typically involve human readers interpreting cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this question is not applicable to the device described. This device is a physical epilator, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the "performance data" (frequency and voltage) is direct instrumental measurement of the device's electrical output. For the broader claim of "substantial equivalence" regarding hair removal, the implied "ground truth" would be the established safety and effectiveness of the predicate device, "Forever Free," for its intended use.
8. The Sample Size for the Training Set
Not applicable. This is a physical device submission demonstrating substantial equivalence, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an algorithm.
§ 878.5360 Tweezer-type epilator.
(a)
Identification. The tweezer-type epilator is an electrical device intended to remove hair. The energy provided at the tip of the tweezer used to remove hair may be radio frequency, galvanic (direct current), or a combination of radio frequency and galvanic energy.(b)
Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.