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

IPL Home Use Hair Removal Device is an over-the-counter, home-use, light based device for unwanted hair removal 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 21 models (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S), and the model name with an "S" indicates that the model has a 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 the device 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 the treatment light pulses.

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IPL Home Use 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 Home Use Hair Removal Device 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.

IPL Home Use Hair Removal Device includes five models, JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032. The five models adopt identical intended use, similar performance, operation and structure, with main differences in appearance, dimensions and weight, and light output parameters. Models JD-TM016, JD-TM023 are single pulse devices while models JD-TM027, JD-TM028 and JD-TM032 are double pulses devices. The device is only powered by the external power adapter. This device adopts sapphire flash outlet that is suitable for multiple hair removal areas.

The device is fitted with a skin sensor to detect appropriate skin contact, if the flash outlet of the device is not in full contact with the skin, the device cannot emit light pulses, and the IPL emission activation is by manual finger switch or auto light emission. The device has a cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

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

IPL Hair Removal Device includes two models, IPL-001 and IPL-002. The two models adopt identical intended use, similar performance, operation and structure, with main differences in appearance, dimensions and weight, and light output parameters.

The device is only powered by the external power adapter. This device adopts light exit window (the IPL-002 adopts sapphire light exit window) that is suitable for multiple hair removal areas. The device is fitted with a skin sensor to detect appropriate skin contact, if the light exit window of the device is not in full contact with the skin, the device cannot emit light pulses, and the IPL emission activation is by manual finger switch or auto light emission. Model IPL-002 has a cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

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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 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.

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IPL Hair Removal Device is an over-the counter device intended for removal of unwanted body hair. The device is used for adults with Fitzpatrick skin types I-IV.

IPL Hair Removal Device is a small over-the-counter device for the permanent reduction of hair growth based on 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 IPL Hair Removal Device includes main unit, an adaptor and goggles. The device is only powered by the external power adapter and its IPL emission activation is by a finger switch or auto light emission. If the light outlet of the device is not fully contact with the skin, the device cannot emit the treatment light pulses. The device includes MLY-M011,MLY-M012,MLY-M013,MLY-M015,MLY-T001,MLY-T002 six models. There is difference in product appearance, cooling function, physical product dimension, indicator display and spot size, but their intended use, performance,output energy, structure design and operation are basically identical. MLY-M011 has no cooling function,while other models(MLY-M012,MLY-M013,MLY-M015,MLY-T001,MLY-T002) have cooling function.

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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.

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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).

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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.

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The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.

Intense Pulsed Light (IPL) System, models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF, are a small over-the-counter device for the permanent reduction of hair growth based on 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 power adapter and its IPL emission activation is by a switch or auto light emission.

Intense Pulsed Light (IPL) System, all models, contains a Xenon arc flashlamp, and a touch chip to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses.

Intense Pulsed Light (IPL) System, models: T002AQ, T002AD, T002AF, contains a Xenon arc flashlamp, a touch chip to detect appropriate skin contact, and a skin color sensor to detect the skin color. In "Skin Color Recognition mode", the device's skin sensor automatically detects skin tone for your protection. If your skin tone is not in tone table suitable for treatment, the device must not be used. You need to identify your skin tone before treatment according to skin tone table, and confirm whether the product is applicable to you after the skin color sensor detects a skin tone.

Based on the cooling technology, Intense Pulsed Light (IPL) System, models: T033KQ, T033KD, T033KF, T055KQ, T055KD, T055KH, T050KQ, T050KD, T050KF, has cooling care functions. When the cooling care mode is enabled, it can reduce the excessive heat generated on the skin by the photon irradiation and do cooling compresses during hair removal.

Based on the dual pulse technology, Intense Pulsed Light (IPL) System, models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T050KQ, T050KD, T050KF, has single pulse and dual pulse functions.

The Intense Pulsed Light (IPL) System includes main unit, an adaptor and goggles.

This FDA 510(k) clearance letter and summary describe an Intense Pulsed Light (IPL) System for hair removal. However, it does not contain the detailed acceptance criteria or the specific study outcomes that prove the device meets these criteria in the context of an Artificial Intelligence (AI) enabled device. The provided document primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technical specifications and non-clinical performance data (biocompatibility, electrical safety, eye safety, and general software V&V).

The request specifically asks about acceptance criteria and study data for an AI-enabled device. This document describes a traditional medical device (IPL) and lists "Software Verification and Validation" as a performance data point, but this typically refers to the functional soundness of the device's embedded software, not necessarily an AI algorithm. There is no mention of deep learning, machine learning, or algorithms that would perform diagnostic or treatment-related AI-driven functions.

Therefore, I cannot extract the requested information regarding AI acceptance criteria, specific study performance metrics for an AI component, sample sizes for AI test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, because this information is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance (Non-AI Focused)

Since the document doesn't detail AI-specific acceptance criteria or performance metrics, the "acceptance criteria" can be broadly inferred from the tests performed to demonstrate substantial equivalence to the predicate device. The "reported device performance" is the successful completion of these tests.

Missing Information Regarding AI-Enabled Device Performance

The following information cannot be provided as it is not present in the provided FDA 510(k) clearance letter and summary for an AI-enabled device. This document describes a standard IPL device.

1. Sample sizes used for the test set and the data provenance: Not applicable/Not provided for an AI test set. The document refers to non-clinical tests (biocompatibility, electrical safety, etc.), which don't involve test sets of patient data in the context of AI.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth establishment with experts is a key component of AI algorithm validation, which is not described here.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
4. 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/Not provided. The device is not described as providing AI assistance to human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided.
7. The sample size for the training set: Not applicable/Not provided. Training sets are relevant for AI algorithms.
8. How the ground truth for the training set was established: Not applicable/Not provided.

Conclusion: The provided FDA 510(k) document is for a non-AI medical device (Intense Pulsed Light System). While it includes software verification and validation, this refers to the functional and safety aspects of embedded device software, not a sophisticated AI algorithm for interpretation or assistance that would require the detailed clinical validation metrics requested in the prompt.

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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.

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