Search Results

The IPL Hair Removal Device is an over-the-counter device indicated for the removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.

The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

The IPL Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user.

The device provides hair reduction using Intense Pulsed Light technology(suitable for model T21A, T21B and T22A, T22B). The device provides hair reduction using Intense Pulsed Light technology and cooling technology (suitable for model T14B, T16B, T19B, T15B, T17C, T18B, T21C, T21D, T25B, T25C).

The Intense Pulsed Light technology 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. The device contains a Quartz glass Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the skin of the treatment area, the device will not emit light pulses; If the device is properly and fully applied to the skin of the treatment area, the device can emit light pulses in as quickly as 0.5 seconds. In automatic mode, it supports continuous flashing and automatic light emission.

In auto-recognition skin color mode, the skin tone sensor can detect and identify the color of skin, and determine the required intensity based on the recognized skin color. Make sure the skin tone sensor is in full contact with the skin. If a valid skin color is detected, the corresponding energy level is displayed. If it is not in full contact with the skin, the energy level is 0 and no light pulses are emitted.

The cooling technology based on the temperature difference electrical phenomenon through the semiconductor cooling chip inside the IPL main device and uses the principle of the Peltier effect to achieve the purpose of cooling function. The cooling panel is located around the light-emitting window (suitable for model T14B, T16B, T19B) and does not affect the irradiated area (spot size) of the light outlet; The cooling panel is constructed with sapphire, (suitable for model T15B, T17C, T18B, T21C, T21D, T25B, T25CB) and does not affect the irradiated area (spot size) of the light outlet.

The device is available in two designs: straight-panel and gun-shaped, both featuring a compact and lightweight form factor. Moreover, The enterprise has reserved an ample quantity of lamp heads to ensure maintenance accessibility and end-user convenience.

The provided FDA 510(k) clearance letter and summary contain information about the IPL Hair Removal Device. However, they do not include any specific details about acceptance criteria or a clinical study proving the device meets those criteria for hair reduction efficacy and safety on human subjects.

The document primarily focuses on technical comparisons to predicate devices and adherence to various electrical, photobiological, and biocompatibility safety standards. It mentions "Performance data supports that the device is safe and as effective as the predicate device for its intended use" (Page 7), but it does not describe what this performance data entails in terms of clinical efficacy trials.

Therefore, I cannot provide a detailed response to your request for acceptance criteria and a study that proves the device meets them, as the necessary information is not present in the provided text.

Specifically, the following information is missing from the provided document:

1. A table of acceptance criteria and the reported device performance for clinical efficacy: The document states the device is indicated for "permanent reduction in hair regrowth," but no quantitative acceptance criteria (e.g., "X% hair reduction in Y% of subjects") or corresponding performance results from a clinical study are provided.
2. Sample size used for the test set and data provenance: No clinical study data involving human subjects is described, so sample size and data provenance are not available.
3. Number of experts used to establish the ground truth and qualifications: This would be relevant for clinical efficacy studies (e.g., expert assessment of hair counts or density). Such information is not present.
4. Adjudication method for the test set: Not applicable as no clinical efficacy study details are provided.
5. MRMC comparative effectiveness study: Not mentioned, as no clinical efficacy study is described.
6. Standalone (algorithm only) performance: Not applicable for a hair removal device, as its performance is inherently human-applied.
7. Type of ground truth used: For hair removal, ground truth would typically be objective measurements of hair count/density or expert photographic assessment. No such details are given.
8. Sample size for the training set: Not applicable, as this device is not an AI/ML algorithm that requires a "training set" in the context of clinical efficacy demonstration.
9. How the ground truth for the training set was established: Not applicable.

The "Performance Data" section (Page 16) only lists compliance with:

• Biocompatibility Testing: ISO 10993 standards for cytotoxicity, irritation, and skin sensitization.
• Electrical Safety and EMC Safety: IEC 60601 series standards.
• Eye Safety: IEC 62471 standard.
• Software Verification and Validation: Stating "all software requirement specifications are met and all software hazards have been mitigated."

These are all technical and safety performance data points, not clinical efficacy data to support the "permanent reduction in hair regrowth" claim. The FDA clearance is based on substantial equivalence, implying that the device's technical specifications and safety profile are similar enough to previously cleared devices, which would have had their own supporting clinical data. However, the details of this device's specific clinical performance data are not included in this summary.

Ask a specific question about this device

IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.

The IPL Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. There are HCT-1208/HCT-1208B/HCT-1208L 3 models in this application. Their work principle, intended use, structure, appearance，size，and operation are the same, with differences being product function are slight differences, but these parameters are within the predicate device and do not affect or change the intended use of the device.

This document is an FDA 510(k) clearance letter for an IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L). The request asks to describe the acceptance criteria and the study that proves the device meets those criteria, specifically concerning performance beyond basic safety and electrical testing.

However, the provided 510(k) clearance letter and summary primarily focus on establishing substantial equivalence to predicate devices through comparisons of technical specifications and robust safety testing (biocompatibility, electrical safety, eye safety, and software verification).

There is no detailed information provided in this document regarding a clinical performance study (e.g., patient trials, or studies that measure the actual effectiveness of hair removal) beyond the statement that "Performance data supports that the device is safe and as effective as the predicate device for its intended use." The "Performance Data" section specifically lists only safety and software V&V, not clinical efficacy.

Therefore, I cannot fully complete all sections of your request as the provided text does not contain the specific clinical performance study details you are asking for. The clearance is based on the device being "substantially equivalent" to predicate devices that are already cleared for the specified indications for use, and a demonstration that the new device meets relevant safety standards and its software functions as intended.

Here's what can be extracted and inferred based on the provided document:

Acceptance Criteria and Device Performance (Based on Provided Document)

While the document doesn't detail specific clinical efficacy acceptance criteria for the hair removal function, it does outline acceptance criteria for safety and technical performance, which are crucial for FDA clearance. The "study" proving these are met refers to the various engineering and safety tests performed.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Clinical Performance Test Set: Not applicable / Not specified in this document for a clinical efficacy study. The document focuses on bench testing and safety compliance.
• Safety Testing (Biocompatibility, Electrical, Eye): The "sample size" for these tests would typically refer to the number of devices or material samples tested. This information is not detailed in the provided 510(k) summary (e.g., how many units underwent electrical safety testing).
• Data Provenance: Implied to be from the manufacturer's own testing conducted in China (where the manufacturer is located). The nature of these tests (e.g., bench testing) makes the "retrospective or prospective" classification less applicable than for clinical data.

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

• Not applicable for this type of submission. This 510(k) relies on standardized engineering and safety tests, and establishing "ground truth" for these types of tests is typically based on adherence to the specified international standards (e.g., IEC, ISO) and laboratory procedures, rather than expert consensus on observational data.

4. Adjudication Method for the Test Set

• Not applicable for this type of submission. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where expert readers or evaluators independently assess data (e.g., medical images). The tests described here are compliance tests against predefined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is a specific type of clinical study used primarily for medical imaging devices to evaluate human reader performance with and without an AI algorithm. This document describes a physical hair removal device, not an imaging device, and does not mention any clinical comparative effectiveness study, especially not one involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable for this type of device. This device is a direct-use consumer product. While it has "Software Verification and Validation," this refers to the embedded software controlling the device's functions (e.g., light emission, skin sensor), not a standalone diagnostic algorithm whose performance would be measured independently.

7. The Type of Ground Truth Used

• For safety and electrical performance: Ground truth is established by the requirements and methodologies outlined in the referenced international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety). The device's performance is measured against the specifications and limits defined by these standards.
• For substantial equivalence: The ground truth is the performance and safety data of the legally marketed predicate devices, against which the subject device is compared. The argument is that the subject device's technical characteristics and tested safety performance are "substantially equivalent" to these predicates.

8. The Sample Size for the Training Set

• Not applicable. This document describes the clearance of a physical medical device, not a machine learning or AI model that requires a "training set" of data. The software verification mentioned refers to traditional software testing methodologies.

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

• Not applicable. (See point 8).

Ask a specific question about this device

Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the 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.

Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL) with safety and efficacy. It is designed with a lamp that can emit continuously double or triple pulses per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain and nearly heatless.
The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window 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 ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable and safer experience.

The provided FDA 510(k) clearance letter and summary for the "Ice Cooling IPL Hair Removal Device" describe a medical device submission and its review. However, it does not contain the specific information required to describe acceptance criteria and associated study results for an AI/ML-based medical device.

The document primarily focuses on:

• Regulatory classification and product codes: Identifying the device as Class II, Product Code OHT, under 21 CFR 878.4810.
• Intended use: Hair removal and permanent reduction in hair regrowth.
• Comparison to predicate devices: Demonstrating substantial equivalence in terms of intended use, design, specifications, and performance (e.g., wavelength range, energy density, spot size).
• Performance data (Non-Clinical): Referring to biocompatibility testing, electrical safety (EMC), light safety, software verification and validation (not AI-specific performance), and usability testing, all against established industry standards (IEC, ISO).

Crucially, there is no mention of:

• AI/ML components: The device is described as an Intense Pulsed Light (IPL) device, and its operation does not inherently involve AI/ML. "Software Verification and Validation" is a standard requirement for electronic medical devices and does not imply AI.
• Clinical study data for performance metrics: The performance data section refers only to non-clinical tests (biocompatibility, electrical safety, light safety, software V&V, usability). It does not provide details on clinical efficacy (hair reduction) studies with specific performance metrics, sample sizes, or ground truth establishment relevant to the device's hair removal claim. The "permanent reduction in hair regrowth" indication implies clinical testing, but the details are not present in this summary.
• Expert consensus, MRMC studies, or specific AI performance metrics like sensitivity, specificity, AUC: These are typical elements of a study proving an AI device meets acceptance criteria.

Therefore, it is not possible to fill in the requested table and answer the questions based solely on the provided text, as the device described is not an AI/ML medical device, and the document focuses on non-clinical substantial equivalence rather than detailed clinical performance of the hair removal efficacy.

Hypothetical Example (if this were an AI/ML device and the text provided the necessary details):

If, for instance, the device had an AI component to detect skin type or predict hair regrowth, and the document detailed a study on this AI component, the information could be extracted like this (this is purely illustrative and not based on the provided text):

Hypothetical Acceptance Criteria and Study for an AI-Powered Hair Removal Device

Let's imagine this device also had an AI feature, for example, an integrated AI system that analyzes skin pigmentation to recommend optimal IPL settings to minimize adverse events and maximize efficacy.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• AI Skin Type Classification Test Set: 1500 images/cases (1000 for training, 500 for validation/testing).
• Adverse Event/Efficacy Test Set (Clinical Trial): 300 participants.
• Data Provenance:
  • Skin images for AI classification: Retrospective dataset collected from dermatology clinics in North America (USA, Canada) and Europe (UK, Germany).
  • Clinical trial for adverse events/efficacy: Prospective, multi-center, randomized controlled trial conducted in the USA (5 sites) and China (3 sites).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Skin Type Ground Truth: 3 board-certified dermatologists, each with a minimum of 10 years of experience in aesthetic dermatology and laser/IPL treatments. All were trained to consistently apply Fitzpatrick Skin Type scale.
• Adverse Event/Efficacy Ground Truth: Clinical investigators (dermatologists) at each trial site, with at least 5 years of experience in IPL/laser treatments, reviewed and graded adverse events and hair reduction independently at follow-up visits.

4. Adjudication method for the test set

• Skin Type Ground Truth: For the AI classification test set, initial skin type labels were provided by one expert. For any ambiguous cases (e.g., initial disagrement or boundary cases), a 3-expert consensus (2+1 majority rule) was used. If a consensus was not reached (e.g., 1-1-1 split), the case was excluded from the ground truth set.
• Adverse Event/Efficacy Ground Truth: For clinical trial outcome adjudication, two independent, unblinded dermatologists graded outcomes (hair reduction percentage, adverse events) at each follow-up visit. In case of discrepancy, a third blinded dermatologist acted as an adjudicator to reach a consensus.

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

• Yes, an MRMC study was performed to assess the impact of AI-recommended settings vs. manual-expert settings on clinical outcomes.
• Study Design: 10 IPL therapists/dermatologists (readers) were recruited. They each reviewed 50 simulated patient profiles (cases) and recommended IPL settings.
  • Group A (without AI): Readers used standard clinical guidelines and their experience.
  • Group B (with AI assistance): Readers were provided with the AI system's recommended settings and could choose to accept, modify, or reject them.
• Effect Size: The AI-assisted group (Group B) demonstrated a statistically significant improvement in the rate of optimal setting selection (leading to good outcomes without adverse events) by 15% (Cohen's d = 0.65) compared to the unassisted group (Group A). Specifically, the rate of selecting optimal, safe, and effective settings increased from 70% (unassisted) to 85% (AI-assisted).

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

• Yes, a standalone performance evaluation of the AI skin type classification module was conducted prior to its integration into the device and the MRMC study. This included the accuracy, sensitivity, and specificity metrics mentioned in section 1.

7. The type of ground truth used

• Expert Consensus: For skin type classification (AI module training and testing).
• Clinical Outcomes Data: For validating the safety and efficacy of AI-recommended settings (adverse event rates, hair reduction percentage from prospective clinical trial data).

8. The sample size for the training set

• AI Skin Type Classification: 15,000 unique skin images with associated Fitzpatrick Skin Type labels.

9. How the ground truth for the training set was established

• The ground truth for the training set was established by three experienced board-certified dermatologists, similar to the test set experts. Each image was independently reviewed and labeled by all three. If discrepancies occurred, a consensus process involving discussion and re-evaluation was used to arrive at a final label. This iterative process ensured high-quality, reliable ground truth data for training the AI model.

Ask a specific question about this device

Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the 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.

Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It is designed with dual lamps that work together and can emit mutipulses per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain.

The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window 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 ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

Ice Cooling IPL Hair Removal Device includes the following models: UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK. Their intended use, performance and operation are basically identical. The model differences are enclosure color, a detachable accessory cover and skin recognition(only for UI20S series with an accessory cover and with skin recognition). (UI20 series：UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK; UI20S series：UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK).

The provided text does NOT describe a study that proves the device meets specific acceptance criteria related to its performance in hair removal (e.g., efficacy percentages, safety profiles, or long-term hair reduction outcomes). This 510(k) clearance letter primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, safety, and electrical/software compliance, rather than detailed clinical performance studies with specific patient outcomes.

The "Summary of performance testing" section specifically lists tests related to:

• Biocompatibility: Ensuring materials are safe for human contact.
• Electrical Safety and EMC: Compliance with standards for electrical operation and electromagnetic compatibility.
• Eye Safety: Compliance with photobiological safety standards.
• Software Verification and Validation: Ensuring software functions correctly and mitigates risks.
• Usability: Evaluation of user interface and safety from a human factors perspective.

These are all crucial for demonstrating the safety and basic functionality of the device, and that it is as safe and effective as previously cleared devices. However, they do not include the type of clinical trial data (e.g., hair regrowth measurements at 6, 9, 12 months) that would typically involve acceptance criteria for efficacy in hair reduction for a new device claiming permanent hair reduction.

Therefore, I cannot extract a table of acceptance criteria and reported device performance from this document for the stated indications, nor details about sample sizes, ground truth establishment, or expert involvement for performance efficacy studies. The document implicitly relies on the predicate devices having established this efficacy.

If this were a submission for a novel device, or if the manufacturer needed to prove clinical efficacy independently, this section would contain a detailed description of a clinical study, including:

• Acceptance Criteria for Efficacy: e.g., "At least X% reduction in hair count at 6 months post-treatment in Y% of subjects."
• Safety Criteria: e.g., "Incidence of adverse events (e.g., burns, hyper/hypopigmentation) not exceeding Z%."
• Study Design: Sample size, retrospective/prospective, blinding.
• Outcome Measures: How hair reduction was measured (e.g., photodocumentation, hair counts).
• Ground Truth: How hair counts were objectively determined.
• Statistical Analysis: How the data proved the criteria were met.

Conclusion:

Based only on the provided FDA 510(k) clearance letter, I cannot fulfill most of the requested points regarding acceptance criteria and performance studies because the document focuses on demonstrating substantial equivalence based on technological and safety standards, not on presenting new clinical efficacy data for hair removal. The implicit "proof" of efficacy lies in the substantial equivalence to predicate devices that have already established their efficacy for the stated indications.

The document states:
"Performance data supports that the device is safe and as effective as the predicate devices for its intended use." This is a claim of equivalence, not a direct presentation of primary efficacy data for this specific device.

Therefore, the requested table and specific details regarding MRMC studies, standalone performance, ground truth derivation for efficacy, and training/test set sample sizes for hair removal efficacy are not present in this 510(k) summary. The "performance data" referred to in the document pertains to the safety and engineering characteristics listed in the "Summary of performance testing" section.

Ask a specific question about this device

IPL Hair Removal Device is indicated for the 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, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed twenty-three models with the same IPL technology for hair removal, which is model BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL20, BHRL-21, BHRL-22. The device 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.

The IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.6±0.25cm² (Model BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-07, BHRL-08, BHRL09, BHRL-10) and 2.7±0.25cm² (Model BHRL-05, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-06, BHRL-06B, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22) that is suitable for multiple hair removal areas, such as large areas (e.g. face, arms, legs) and small areas (e.g. armpits, bikini line).

The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the cooling function (except model: BHRL-06B), which can be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.

The provided FDA 510(k) Clearance Letter concerns an IPL Hair Removal Device. It is clear from the document that this device is a physical product (Intense Pulsed Light device) designed for hair removal, not an AI/software-based medical device that would involve a test set for ground truth establishment, expert readers, or MRMC studies.

Therefore, the request to describe acceptance criteria and a study proving the device meets those criteria, focusing on aspects like AI performance, sample size for test sets (in the context of AI models), number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for training/test sets, is not applicable to this device clearance.

The performance data provided in the 510(k) summary for this IPL Hair Removal Device focuses on:

• Biocompatibility Evaluation: Ensuring the materials are safe for body contact.
• Electrical Safety and EMC: Compliance with international safety and electromagnetic compatibility standards (IEC 60601 series).
• Eye Safety: Compliance with photobiological safety standards (IEC 62471).
• Software Verification and Validation: This refers to the embedded software controlling the device's hardware functions, not an AI algorithm performing diagnostic or therapeutic analysis based on data inputs. The documentation level of concern is "basic."
• Usability: Evaluation according to FDA guidance for human factors.

These are standard testing requirements for physical medical devices and do not involve the types of studies or acceptance criteria that would be relevant for an AI-powered diagnostic or therapeutic algorithm.

Therefore, I cannot populate the table or answer the specific questions related to AI device performance evaluation based on the provided document. The document describes a traditional hardware-based medical device clearance.

Ask a specific question about this device

Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the 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.

Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It is designed with a lamp that can emit single pulse, double pulse or triple pulse per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window 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 ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

This FDA 510(k) clearance letter pertains to an Ice Cooling IPL Hair Removal Device, not an AI/algorithm-based diagnostic device. Therefore, the information typically requested in your prompt regarding acceptance criteria and studies proving the device meets those criteria (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this type of medical device clearance.

The 510(k) summary for this IPL device focuses on demonstrating substantial equivalence to predicate devices through:

• Identical Intended Use: Hair removal and permanent reduction in hair regrowth.
• Similar Technological Characteristics: Comparison of physical dimensions, power supply, light source, energy medium, wavelength range, energy density, output energy, spot size, pulse duration, pulsing control, delivery device, output intensity levels, and software/firmware. Minor differences are addressed by showing they do not raise new safety or efficacy concerns.
• Performance Data (Non-Clinical Testing):
  • Biocompatibility Testing: Ensuring materials in contact with the body are safe (per ISO 10993 series).
  • Electrical Safety and EMC (Electromagnetic Compatibility): Compliance with relevant IEC 60601 standards to ensure electrical safety and proper operation in the presence of electromagnetic disturbances.
  • Light Safety: Compliance with IEC 62471 for photobiological safety.
  • Software Verification and Validation: Ensuring software functions correctly and mitigates hazards, consistent with a "Basic Documentation Level."
  • Usability: Evaluation and validation per IEC 60601-1-6 and FDA guidance on Human Factors and Usability Engineering.

To directly answer your prompt, but acknowledging its non-applicability to this specific device:

1. A table of acceptance criteria and the reported device performance:

   Acceptance Criteria (General for IPL Device)	Reported Device Performance (Summary of Non-Clinical Testing)
   Biocompatibility (Safety of body-contacting parts)	Passed ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation), ISO 10993-5 (in vitro cytotoxicity).
   Electrical Safety (Prevention of electric shock, fire, etc.)	Passed IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home healthcare), IEC 60601-2-57 (non-laser therapeutic equipment), IEC 60601-2-83 (home light therapy equipment).
   Electromagnetic Compatibility (EMC)	Passed IEC 60601-1-2 (EMC requirements and tests).
   Light Safety (Patient eye/skin safety from light emission)	Passed IEC 62471 (photobiological safety of lamps and lamp systems).
   Software Functionality and Safety	Software documentation consistent with "Basic Documentation Level" submitted. System testing demonstrated all software requirements met and hazards mitigated to acceptable levels.
   Usability (Safe and effective use by intended user)	Evaluated and validated according to IEC 60601-1-6 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices."
   Performance within specified output parameters (Energy density, wavelength, etc.)	Output specifications (e.g., energy density 1.8-6.67 J/cm², wavelength 550-1200nm) are provided and considered substantially equivalent to predicates, with minor differences justified as not raising safety/efficacy issues. Temperature Test Report and Usability evaluation conducted to verify safe multi-pulse use.

2. Sample sizes used for the test set and the data provenance: Not applicable to this type of device and submission. The "test set" here refers to specific non-clinical engineering tests (e.g., electrical safety, biocompatibility) where sample sizes are determined by standard testing protocols for equipment, not by a patient/image dataset. The data provenance is primarily from the manufacturer's internal testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an IPL device is established through engineering specifications and physical measurements, and by adherence to recognized consensus standards for safety and performance, not by expert interpretation of clinical data in the context of diagnostic AI.

4. Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 apply to clinical data interpretation, typically in diagnostic studies.

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 is an IPL device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no AI algorithm being evaluated for standalone performance in this submission.

7. The type of ground truth used: For this device, "ground truth" refers to:

   • Physical Measurements/Engineering Specifications: Ensuring the device operates within its stated parameters (e.g., energy output, wavelength).
   • Compliance with Recognized Consensus Standards: Adherence to standards like IEC 60601 series, IEC 62471, and ISO 10993 series, which define safety and performance requirements.
   • Usability Testing Outcomes: Observing real users to ensure the device can be used safely and effectively.

8. The sample size for the training set: Not applicable. There is no "training set" in the context of an IPL device clearance, as it's not an AI/machine learning model.

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

Ask a specific question about this device

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.

Ask a specific question about this device

Ask a specific question about this device

Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the 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.

Ice Cooling IPL Hair Removal Device is an oversonal device for har reduction by using Intense Pulsed Light (PL). It is designed with a lamp that can emit continuously double of this surface and does not involve any cuting or pulling, reducing har growth with nearly painless pain. The device is only powered by the external pover adapter activation is by finger switch. This product adopts spphire treatment window that is suitable for multiple hair removal areas. It contains a skin contact, if the device is not in full contact with the skin, the device canot emit the treatment light pulses. Besides, the device tunction that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

The provided text is a 510(k) summary for the Ice Cooling IPL Hair Removal Device. It details the device's characteristics, comparison to predicate devices, and performance data submitted to support substantial equivalence.

However, the document does not contain the specific information requested regarding an AI/algorithm-based device, namely:

• Acceptance criteria table and reported device performance for an AI/algorithm. The document focuses on performance data for a non-AI medical device (biocompatibility, electrical safety, light safety, software verification, usability).
• Sample size and data provenance for a test set.
• Number of experts and qualifications for ground truth establishment.
• Adjudication method for the test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
• Stand-alone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/algorithm.
• Sample size for the training set.
• How ground truth for the training set was established.

The device in question, an "Ice Cooling IPL Hair Removal Device," is regulated as a "Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology" (21 CFR 878.4810). While it mentions "Software Verification and Validation" and "Software documentation consistent with Basic Documentation Level," this typically refers to embedded software for device control and safety features, not a diagnostic or prognostic AI algorithm that processes image data to provide clinical insights, which would require the kind of performance study details requested in your prompt.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe a study involving an AI model for which such specific performance metrics and ground truth establishment details would be relevant.

Ask a specific question about this device

IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.

IPL Hair Removal Device is an over-the-counter, home use, light based device for unwanted hair reduction by using Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any cutting or pulling, removing hair growth with minimal pain. The device includes 12 models, they are M8011, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023. Those models with model name of "M80XX" are equipped with cooling function for a better hair remove experience, while those of "M70XX" have no cooling function. The device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission, and it contains a skin sensor to detect appropriate skin contact, if the light outlet is not in full contact with the skin, the device cannot emit light pulses.

This FDA 510(k) clearance letter pertains to an IPL Hair Removal Device. The document provided does not detail specific acceptance criteria for a clinical study proving device performance, nor does it describe such a study. Instead, it focuses on non-clinical testing for safety and electrical performance, and a comparison to predicate devices for substantial equivalence.

Therefore, many of the requested sections about clinical study details cannot be answered from the provided text.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria and reported device performance directly related to hair removal efficacy. The "Performance data" mentioned within the "Comparison of Technological Characteristics With the Predicate Device" section refers to safety and electrical performance to support substantial equivalence, not clinical efficacy.

2. Sample size used for the test set and the data provenance

Not applicable. No clinical testing (test set) is described. The non-clinical testing (biocompatibility, electrical safety, etc.) would typically use material samples or test units, not human subjects or "data provenance" in the sense of clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical testing requiring expert ground truth is described.

4. Adjudication method for the test set

Not applicable. No clinical testing with adjudication is described.

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 an IPL hair removal device, not an AI-assisted diagnostic tool.

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

Not applicable. This device is not an algorithm; it's a physical device for hair removal.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" would be established by validated test methodologies and standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety).

8. The sample size for the training set

Not applicable. No training set is mentioned as there is no AI/machine learning component described for this device.

9. How the ground truth for the training set was established

Not applicable. No training set is mentioned.

Summary of what can be extracted from the document regarding "acceptance criteria" and "study":

The document focuses on establishing substantial equivalence to predicate devices, primarily through non-clinical testing and comparison of technological characteristics, rather than demonstrating efficacy through a dedicated clinical study with specific performance acceptance criteria.

Non-Clinical Testing:

The following non-clinical standards were followed, and presumably, adherence to these standards constitutes the "acceptance criteria" for these specific aspects of the device:

• Biocompatibility:

  • ISO 10993-5: 2009 (Tests for in vitro cytotoxicity)
  • ISO 10993-10: 2021 (Tests for skin sensitization)
  • ISO 10993-23: 2021 (Tests for irritation)
  • Acceptance Criteria (implicit): The device materials must demonstrate non-cytotoxicity, non-sensitization, and non-irritation as per the requirements of these ISO standards.
  • Reported Performance: The document states that differences in materials of patient contact components (compared to the predicate) were "solved by biocompatibility tests," implying the device successfully passed these tests.

• Electrical Safety and Performance:

  • IEC 60601-1:2020 (General requirements for basic safety and essential performance)
  • IEC 60601-1-2:2020 (Electromagnetic compatibility)
  • IEC 60601-1-11:2020 (Home healthcare environment requirements)
  • IEC 60601-2-83: 2022 (Home light therapy equipment particular requirements)
  • IEC 62471: 2006 (Photobiological safety of lamps and lamp systems)
  • IEC 60601-1-6: 2020 (Usability)
  • Acceptance Criteria (implicit): The device must comply with all relevant clauses and performance limits specified in these IEC standards for electrical safety, electromagnetic compatibility, home use, specific light therapy equipment risks, photobiological safety, and usability.
  • Reported Performance: The document provides "performance data were provided in support of the substantial equivalence determination" by listing these standards, indicating successful adherence.

Regarding Clinical Testing:

The document explicitly states: "Clinical Testing: Not applicable." This means no clinical study was conducted, or deemed necessary by the FDA, to demonstrate the device's efficacy for hair removal as part of this 510(k) submission process. Its efficacy is likely presumed based on the established science of IPL technology and the substantial equivalence to already cleared predicate devices for the same intended use.

Ask a specific question about this device