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For the removal of hair

The device works by emitting from the tweezer tips radio frequency energy that is transmitted down an individual hair grasped by the tweezers to the root and papilla of the hair. The tweezers may also be used to slide the hair out after treatment. The radio frequency energy destroys the papilla, with the result that the hair does not grow back. More than one treatment may be necessary.

The provided 510(k) summary for the Sonique™ Hair Remover does not contain the detailed information requested regarding acceptance criteria and a specific study proving the device meets those criteria.

Instead, the summary relies on a Substantial Equivalence claim to an existing predicate device, the IGIÁ Hair Removal System. The core of the submission is that the Sonique™ Hair Remover is "substantially equivalent" to an already marketed device, meaning it has the same intended use and similar technological characteristics, and any differences do as not raise different questions of safety and effectiveness.

Here's a breakdown of what can be extracted from the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not specify quantitative acceptance criteria for efficacy (e.g., percentage of hair reduction over a certain period, permanence of hair removal) or safety (e.g., acceptable rates of skin irritation, burns). The "performance" is primarily described in terms of its mechanism and its similarity to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified.
• Data Provenance: Not specified, as no specific clinical study data is presented for this device. The submission relies on the established safety and efficacy of the predicate device type.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. There is no described test set or ground truth establishment process for this device for efficacy or safety. The FDA's review for substantial equivalence makes a determination based on comparison to an existing, legally marketed device and existing literature (the Federal Register notice).

4. Adjudication Method for the Test Set

• Not applicable. No test set or human adjudication described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC study was not done. This device is a hair removal tool and not an imaging or diagnostic AI-assisted device where such a study would be relevant.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical hair removal device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the Sonique™ Hair Remover's clearance relies on the established regulatory precedent and published literature for tweezer-type epilators, specifically the finding of the FDA in the referenced Federal Register notice (62 Fed. Reg. 31771-775) which discusses the safety and efficacy of this device type generally, and the demonstrated safety and efficacy of its predicate device (IGIÁ Hair Removal System). There is no specific, independent "ground truth" established for this device in this submission beyond its technical specifications being comparable to the predicate.

8. The Sample Size for the Training Set

• Not applicable. This device does not use a "training set" in the artificial intelligence or machine learning sense.

9. How the Ground Truth for the Training Set was Established

• Not applicable.

Summary of the "Study" Proving Acceptance:

The "study" proving the device meets the (implied) acceptance criteria is the demonstration of substantial equivalence to a predicate device, the IGIÁ Hair Removal System.

• The 510(k) submission argues that the Sonique™ Hair Remover shares the same intended use (hair removal) and technological characteristics (emitting a 27 MHz radio frequency signal via tweezers to destroy hair papillae) as the IGIÁ system.
• The key technical differences (battery vs. household power, 6V vs. 9V) are presented as not raising new questions of safety or effectiveness.
• The FDA's previous findings on the safety and efficacy of this class of devices, as published in the Federal Register, serve as the foundational justification for the device's acceptable performance and safety.

In essence, the device is cleared because it is functionally and technically similar enough to a device already deemed safe and effective by the FDA, rather than through independent prospective clinical trials for this specific product.

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For the removal of hair

The device works by emitting from the tweezer tips radio frequency energy that is transmitted down an individual hair grasped by the tweezers to the root and papilla of the hair. The tweezers may also be used to slide the hair out after treatment. The radio frequency energy destroys the papilla, with the result that the hair does not grow back. More than one treatment may be necessary.

Information regarding device acceptance criteria and studies are not available in the provided text. The document is a 510(k) summary and FDA clearance letter for the Feminique™ Sonic Hair Remover. It establishes substantial equivalence to a predicate device (IGIÁ Hair Removal System) based on similar technology (radio frequency energy for hair removal) and output (radio frequency signal characteristics). However, it does not include details on specific performance acceptance criteria or a study demonstrating the device meets such criteria.

The 510(k) summary mentions that "The safety and efficacy of tweezer-type epilators are discussed in the attached Federal Register notice published by the Food and Drug Administration (FDA) on June 11, 1997, 62 Fed. Reg. 31771-775." This suggests that the general safety and efficacy of this type of device have been established by the FDA, and the Feminique™ device is considered safe and effective because it is substantially equivalent to a device already deemed so. However, the specific study details for the Feminique™ device itself are not provided in the given text.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, expert qualifications, or study methodologies based on the provided document.

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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:

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.

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