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IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

IPL Hair Removal Device (Model: KCA511, KCA516,KCA522), is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.

The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts irreplaceable treatment window and the spot size is 3.3cm² that is suitable for multiple hair removal areas. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

IPL Hair Removal Device, model: KCA511, KCA516 and KCA522 have the same indication for use, performance, structure design and operation, the only deference is their appearance size and weight.

IPL Hair Removal is used for removing excess facial hair and body hair and can also reduce hair regrowth. The products can be used on body parts such as underarm, bikini line, arms, facial hair below the chin line, back and legs.

It is designed so that the flash window requires full contact with the skin to work (flash),it will no works as long as the flash window does not contact the skin.

This FDA 510(k) clearance letter and summary is for an IPL Hair Removal Device. It details the device's characteristics and its comparison to predicate devices to establish substantial equivalence. However, it does not contain the specific acceptance criteria or the study details proving the device meets those criteria, especially not in the format requested for AI/ML performance evaluations.

The document focuses on:

• Regulatory Classification: Class II, OHT product code, 21 CFR 878.4810 (Laser surgical instrument for use in general and plastic surgery and in dermatology).
• Intended Use: Removal of unwanted hair and permanent reduction in hair regrowth (measured at 6, 9, and 12 months post-treatment).
• Technological Comparison: Comparing the subject device (IPL Hair Removal Device, KCA511/KCA516/KCA522) to a predicate device (K240282) and a reference device (K230122) in terms of intended use, design, specifications, and performance.
• Performance Data: This section only covers non-clinical testing for:
  • Biocompatibility: Tests conducted according to ISO 10993 series (cytotoxicity, irritation, skin sensitization).
  • Electrical Safety and EMC: Compliance with various IEC 60601 standards.
  • Eye Safety: Compliance with IEC 62471.
  • Software Verification and Validation: Stating that software requirements were met and hazards mitigated.

Therefore, I cannot provide the requested information because it is not present in the provided text. The document does not describe:

1. A table of acceptance criteria and reported device performance (in the context of AI/ML evaluation).
2. Sample size, data provenance, number of experts, qualifications, or adjudication methods for a test set. This type of information is typically associated with clinical studies or performance evaluations where a "ground truth" is established, which is entirely absent here.
3. Whether a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or the effect size of human readers with/without AI assistance. This is relevant for AI-assisted diagnostic or decision-making devices, not a direct energy hair removal device.
4. Whether a standalone (algorithm only) performance was done. Again, pertaining to AI/ML devices.
5. The type of ground truth used (expert consensus, pathology, outcomes data, etc.). This is not applicable given the type of device and the information provided.
6. The sample size for the training set or how its ground truth was established. This refers to AI/ML model development, which is not described.

In summary, the provided FDA 510(k) clearance letter and summary pertains to a physical IPL hair removal device, not a software or AI/ML-driven diagnostic or decision-support system. As such, the requested details regarding acceptance criteria, study methodologies, and ground truth establishment, which are typical for AI/ML performance evaluation, are not present in this document.

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Hair Growth Device is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

The product is composed of main unit, USB cable, and silicone pad. The main unit consists of laser diodes that are spread throughout the helmet. Low-energy laser therapy (LLLT) is a safe and effective treatment for androgenic alopecia (AGA). The Hair Growth Device employs intelligent LLLT technology, utilizing a 650 nm, 5-milliwatt low-energy laser that penetrates the scalp surface to a depth of 3-5 mm, reaching the hair follicles. Hair Growth Device is a small over-the-counter, portable, noninvasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in Males and Females. The product uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. Hair Growth Device consists of main unit, USB cable and silicone strap and no communication function. The device will then turn on and you'll hear an audible beep.

This FDA 510(k) clearance letter is for a medical device (Hair Growth Device) rather than a software algorithm used for interpretation/diagnosis. As such, the information typically requested for AI-powered diagnostic devices (e.g., test set sample size, expert qualifications, adjudication methods, MRMC studies, ground truth types for training/test sets, etc.) is not applicable or present in this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications and non-clinical testing. It explicitly states, "No clinical test data was used to support the decision of substantial equivalence."

Therefore, I cannot provide the requested information about acceptance criteria for an AI algorithm's performance or details about a study proving such performance, as this document does not pertain to such a device or study.

However, I can extract the general acceptance criteria and the type of study performed to prove substantial equivalence based on the provided text, recognizing these are not related to AI performance.

Based on the provided FDA 510(k) clearance letter for the Hair Growth Device:

1. Table of Acceptance Criteria and Reported Device Performance:

• Product service life
• Software validation
• Biocompatibility evaluation
• Electromagnetic compatibility and electrical safety
• Safety of laser products
• Performance test |

Regarding the study that proves the device meets the acceptance criteria (note: this is a substantial equivalence study, not an AI performance study):

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set or patient data was used. The study primarily relies on comparison to predicate devices and non-clinical engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth was used for this substantial equivalence determination.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication was used.

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-powered diagnostic tool, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm. The device operates independently (Over-The-Counter).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI context. For substantial equivalence, the "ground truth" is established by compliance with recognized standards (e.g., IEC, ISO) and comparison to legally marketed predicate devices that have established safety and effectiveness.

8. The sample size for the training set: Not applicable. This is not an AI algorithm, so there is no training set in the machine learning sense.

9. How the ground truth for the training set was established: Not applicable. No AI training set.

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KFB290, KFB291:
Red light: Treatment of full-face wrinkles.
Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
Red+Infrared Light: Treatment of full-face wrinkles.
Amber light: Treatment of full-face wrinkles.
Blue light: Treatment of mild to moderate inflammatory acne.
Mixed light(Red+Blue +Infrared): Treatment of mild to moderate inflammatory acne.

KFB265, KFB293:
Red+Infrared Light: Treatment of wrinkles.
Blue light: Treatment of mild to moderate inflammatory acne.
Amber light: Treatment of wrinkles.

KFB290, KFB291:
LED Light Therapy Device(Models: KFB290, KFB291) is a home use wearable LED phototherapy device which can help reduce wrinkles and acne and provide topical heating. LED Light Therapy Device is consisting of main unit(mask), controller, Silicone eye protector, USB charging cable and straps. The LED Light Therapy Device have 4 kinds of light, which include Red light (wavelength 635nm ± 5mm), Blue light (wavelength 465 ± 5nm), Infrared light (wavelength 850mm ± 5mm), Amber light (wavelength 605 ± 5nm).

KFB 265, KFB 293:
LED Light Therapy Device(Models: KFB 265, KFB 293) is a home use wearable LED phototherapy device which can help reduce wrinkles and acne and provide topical heating. LED Light Therapy Device is consisting of main unit(mask), controller, USB charging cable and adapter. There are several kinds of light having medical effects: Red + Infrared (wavelength 637nm (±5nm), Blue light (wavelength 465nm), Amber light (wavelength 605±5nm).

This section provides information about the acceptance criteria and the study that proves the device meets those criteria for the LED Light Therapy Device (Models: KFB290, KFB291, KFB265, KFB293).

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document details non-clinical performance data (biocompatibility, electrical safety, eye safety, and software verification/validation) and structural equivalence to predicate devices, rather than specific quantitative acceptance criteria for therapeutic efficacy tied to a clinical study. The device is cleared based on demonstrating substantial equivalence to predicate devices, implying that its performance is comparable and acceptable for the stated indications.

The acceptance criteria here are implicitly met by demonstrating compliance with recognized standards and similarity to legally marketed devices.

• IEC 60601-1:2005+A1:2012+A2:2020 (General requirements for basic safety and essential performance)
• IEC 60601-1-2:2014+A1:2020 (Electromagnetic disturbances)
• IEC 60601-1-11:2015+A1:2020 (Home healthcare environment)
• IEC 60601-2-83:2019+A1:2022 (Home light therapy equipment)
• IEC 60601-2-57:2011 (Non-laser light source equipment for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use)
• IEC 62133-2:2017 (Secondary cells and batteries safety) |
  | Eye Safety | Compliance with IEC 62471:2006 (Photobiological safety of lamps and lamp systems). |
  | Software Verification and Validation | Consistent with a moderate level of concern. System validation testing demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. |
  | Technological Characteristics and Intended Use | Demonstrated to have the same intended use and similar technological characteristics, features, specifications, and materials as legally marketed predicate devices (K223544, K230351, K162489, K221151). Minor differences do not raise safety or efficacy issues. |

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

The provided document describes non-clinical performance data and a comparison to predicate devices, not clinical studies with human test sets. Therefore, details regarding sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable in this context. The evaluation relies on standardized testing (e.g., ISO, IEC) and technical comparisons.

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

This information is not applicable as the submission focuses on non-clinical performance and substantial equivalence based on technical comparisons and compliance with recognized standards, rather than a clinical study requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3.

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:

An MRMC comparative effectiveness study was not conducted or described in the provided document. The device is an LED Light Therapy Device, not an AI-assisted diagnostic or interpretable imaging device for human readers.

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

A "standalone" performance evaluation in the context of an algorithm or AI was not performed or described. This device is a direct-use LED therapy device.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is based on:

• Compliance with recognized international standards: (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical and medical device safety, IEC 62471 for photobiological safety).
• Substantial equivalence to legally marketed predicate devices: The predicate devices themselves have established a safety and effectiveness profile for the indications.

There is no mention of expert consensus, pathology, or outcomes data from a clinical trial for establishing ground truth regarding therapeutic efficacy for this submission.

8. The Sample Size for the Training Set:

This information is not applicable as the submission is for a phototherapy device, not an AI/machine learning algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reasons as point 8.

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IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Not Found

The provided FDA document is a 510(k) clearance letter for an IPL Hair Removal Device. It indicates that the device is substantially equivalent to legally marketed predicate devices.

This document DOES NOT contain information about acceptance criteria or a study proving the device meets specific performance criteria as typically found in an AI/ML medical device submission.

510(k) clearances for devices like this IPL hair removal device primarily focus on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics as a legally marketed device, or has different technological characteristics and the information submitted demonstrates that the device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. This often involves performance testing to ensure safety and effectiveness are comparable, but not necessarily adherence to predefined, numerical acceptance criteria for AI/ML performance metrics like sensitivity, specificity, or AUC.

Therefore, I cannot extract the requested information relating to AI/ML device performance from the provided text for the following reasons:

• The device is an IPL Hair Removal Device, not an AI/ML-driven diagnostic or treatment device. The 510(k) addresses an Intensed Pulsed Light device, which is a physical apparatus, not a software algorithm.
• The document is a clearance letter, not a detailed study report or clinical trial summary. Clinical trial data or detailed performance studies (especially relating to AI algorithms) are typically far more extensive than what is summarized in the 510(k) clearance letter itself. Such detailed information would generally be found in the full 510(k) submission, which is not provided here.
• There is no mention of an AI algorithm, machine learning, or software-based analysis of medical images/data. The "Indications for Use" describe mechanical hair removal and reduction, not diagnostic tasks that would typically employ AI.

If you have a document pertaining to an AI/ML medical device, please provide that, and I would be happy to analyze it for the requested information.

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