Search Results

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.

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 (PL). It is designed with clual lamps that work together and can emit single, continuously double or triple pulses per shot. It works below the sky cutting or pulling, reducing hair growth with nearly pain. It has three modes: Fast Mode, Normal Mode and High Mode. The device is only powered by the external pover adapter and its by finger switch. This product adopts sapplive treatment window that is suitable for multiple hair removal areas. It has 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 plas the ice cooling finction that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

The provided text describes the regulatory filing for the "Ice Cooling IPL Hair Removal Device" and includes a comparison to predicate devices, but it does not contain information about a specific study proving the device meets acceptance criteria in the manner requested (e.g., clinical trial with performance metrics like sensitivity, specificity, accuracy, or effectiveness of AI assistance to human readers).

The document details:

• Indications for Use: Removal of unwanted hair and permanent reduction in hair regrowth (defined as reduction at 6, 9, and 12 months post-treatment regime).
• Comparison to Predicate Devices: A table comparing characteristics like regulation number, product code, light source, wavelength range, energy density, and pulse duration.
• Performance Data (Summary of performance testing): This section outlines bench testing and compliance with various international standards related to biocompatibility, electrical safety and EMC, light safety, software verification/validation, and usability. It does not include clinical efficacy data or performance metrics directly addressing the "permanent reduction in hair regrowth" claim.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance related to a clinical outcome.
2. Sample size for a clinical test set or its provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for a clinical test set.
5. MRMC study effect size.
6. Standalone performance.
7. Type of ground truth used for clinical effectiveness.
8. Sample size for a clinical training set.
9. How ground truth for a clinical training set was established.

The performance data summarized focuses on safety, electrical compliance, usability, and software testing, rather than a clinical study evaluating the device's hair removal efficacy against specific performance targets. The "conclusion" states the device "is as safe, as effective, and performs as well as the legally marketed predicate device," which is a statement of substantial equivalence based on the engineering and safety tests, and similarity to predicate devices, not on a new clinical effectiveness study presented in this summary.

Ask a specific question about this device

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

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 15 models with the same IPL technology for hair removal, which is model LS-T121/12/A/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12 T130/130A/130B, LS-T133/135/136/137, LS-T134/138/139/140. 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.

IPL Hair Removal Device is a Pulsed Light system which emits intense pulsed light (IPL) at a wavelength ranging from 510-1200m and 600-1200mm. The device works on the principles of selective photothermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.

The provided text is a 510(k) Summary for an IPL Hair Removal Device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical performance against acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them, particularly for clinical outcomes like hair removal efficacy, is not present. The document primarily details non-clinical testing for safety and electrical characteristics.

Here's a breakdown of the information that is available, and what is not:

1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria for clinical performance (e.g., specific hair reduction percentages) and then report performance against those criteria. Instead, it demonstrates compliance with recognized standards for safety and electrical aspects.

However, based on the comparative elements section (pages 7-9), we can infer the acceptance criteria for substantial equivalence are aligned with the predicate device's technical specifications and intended use. The performance data provided is primarily for non-clinical testing, as detailed below:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided for any clinical performance or efficacy studies. The document only mentions non-clinical (laboratory) testing for biocompatibility, electrical safety, eye safety, and software, which do not typically involve patient "test sets" in the same way clinical studies do.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as there is no mention of a human-centric "test set" for clinical efficacy or ground truth establishment. The testing described is non-clinical.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.

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
This device is an IPL hair removal device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device does not involve an algorithm with "standalone" performance in the context of diagnostic or assistive AI. It is a physical medical device. The "Software Verification and Validation" section confirms the software meets its requirements, which is a form of standalone testing for the software component, but not in the sense of an independent diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests conducted (biocompatibility, electrical safety, eye safety, software), the "ground truth" is defined by the standards themselves. For example, a successful biocompatibility test result (e.g., no cytotoxicity) is the "ground truth" that the device is biocompatible according to the standard. There is no mention of clinical outcomes data for demonstrating hair removal efficacy in this summary.

8. The sample size for the training set
This information is not provided as the document does not describe any machine learning or AI training, nor any clinical trials with a patient training set.

9. How the ground truth for the training set was established
This information is not provided as no training set or machine learning components are described in the summary.

Ask a specific question about this device

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

The IPL Home Use Hair Removal Device is the professional IPL in five levels and offers a beauty experience in comfort of your own home as well as has been designed with unique features for simple, relaxed and effective hair removal.

IPL Home Use Hair Removal Device includes D-1199, D-T099, D-T018, D-T003B, D-T003W, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, 1196B, D-1196C, D-1196C, D-1196C1, D-T099K, D-T012, D-T012W sixteen models. All have adopted basically identical structure design, consisting of IPL host and power adapter two parts, which the host is mainly composed of lamp cartridge, display screen, power and/or level button, skin sensor, fan, flash button and DC socket. D-T099K, D-T099KM, D-1196B, D-1196W do not contain the lee-Cooling function. D-1199, D-T018, D-T019, D-T003B, D-T003W, D-T019Y, D-T019Y, D-1196C, D-1196C1 have Ice-Cooling function and only perform the hair removal and cold compress function simultaneously. D-T012W have lce-Cooling function and it is able to perform the hair removal and cold compress function simultaneously or separately.

This is an FDA 510(k) summary for an IPL Home Use Hair Removal Device. The document establishes substantial equivalence to a predicate device, which is the primary mechanism for FDA clearance of Class II devices like this.

Based on the provided text, a formal study proving the device meets specific acceptance criteria for a new AI/algorithm-driven medical device, as typically described in an acceptance criteria table, was not conducted or reported in this 510(k) summary.

This 510(k) focuses on demonstrating that the IPL Home Use Hair Removal Device is substantially equivalent to legally marketed predicate devices, not on proving new clinical performance through a comparative effectiveness study involving AI or human readers. The "Performance Data" section primarily addresses safety (biocompatibility, electrical safety, EMC, eye safety, software V&V) rather than clinical efficacy through human subject testing.

Therefore, many of the specific details requested in the prompt, such as "effect size of how much human readers improve with AI vs without AI assistance" or "sample size for the training set" related to an AI/algorithm, are not applicable to the information provided in this 510(k) summary.

Here's an analysis based on the information available:

Acceptance Criteria and Device Performance (Not Applicable in the context of AI/Algorithm Performance)

Since this is an IPL hair removal device and not an AI/algorithm-driven diagnostic or assistive device in the typical sense for which such a table would be generated, there are no specific AI model performance acceptance criteria or reported metrics like sensitivity, specificity, or AUC. The "acceptance criteria" here are implicitly meeting the safety and performance standards demonstrated by the predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Study Details (As applicable from the 510(k) Summary):

1. Sample sizes used for the test set and the data provenance:

   • Test Set: No specific "test set" in the context of an algorithmic performance study for an AI device. The testing outlined (biocompatibility, electrical safety, etc.) is laboratory-based and engineering verification/validation, not a clinical trial with a "test set" of patient data for an algorithm. Clinical performance is demonstrated by the substantial equivalence to the predicate device, which implicitly means its performance for hair removal is considered equivalent without a new clinical study.
   • Data Provenance: Not specified for any performance testing, but the company is Shenzhen Beauty Every Moment intelligent electric Co., Ltd. (China). This suggests testing was likely conducted in China or by labs utilized by the manufacturer. The document doesn't mention retrospective or prospective human data collection for efficacy.

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

   • Not applicable. There is no mention of an expert-adjudicated ground truth for an AI algorithm in this 510(k) summary.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. No such clinical "test set" or adjudication method for an algorithm is described.

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:

   • No. An MRMC comparative effectiveness study was not conducted or reported here. This is an IPL hair removal device, not an AI-assisted diagnostic tool.

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

   • Not applicable. This device is not an AI algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable for an AI algorithm. For the function of the device itself, the "ground truth" for "hair removal" would typically be visual assessment of hair reduction, but no such clinical study specific to this submission is detailed. The performance relies on substantial equivalence to the predicate.

7. The sample size for the training set:

   • Not applicable. There is no AI algorithm being trained mentioned in this submission.

8. How the ground truth for the training set was established:

   • Not applicable. There is no AI algorithm being trained mentioned in this submission.

In summary: This 510(k) clearance document for an IPL Home Use Hair Removal Device relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. This means that its safety and performance (including efficacy for hair removal) are considered equivalent based on engineering design, specifications, and device characteristic comparisons, supplemented by standard safety testing (biocompatibility, electrical safety, eye safety, software V&V). It does not involve the type of clinical performance study required for novel AI/algorithm-driven diagnostic or therapeutic devices that directly assist or interpret medical data for human users or make decisions.

Ask a specific question about this device

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

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 three models with the same IPL technology for hair removal, which is model LS-T107 and LS-T108. 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 3.2cm2 of LS-T106 and LS-T108, 3.7cm2 of LS-T107 that is suitable for multiple hair removal areas, such as face, lips, underarms, bikini lines, arms, legs, etc.

The device contains a skin sensor to detect appropriate skin contact, if the light exti 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, which will be activated throughout the whole har removal process to cool down the treatment area' s temperature and provide the user with a better using experience.

The provided text is a 510(k) Premarket Notification summary for an IPL Hair Removal Device. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data from non-clinical testing. It does not present any clinical study data or acceptance criteria related to device efficacy for hair removal based on human trials.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to a clinical outcome (e.g., hair reduction percentage).
• Sample size and data provenance for a test set for clinical performance.
• Number of experts and their qualifications for establishing clinical ground truth.
• Adjudication method for a clinical test set.
• MRMC comparative effectiveness study results.
• Algorithm-only (standalone) performance.
• Type of ground truth used for clinical efficacy.
• Sample size and ground truth establishment for a training set.

The document primarily covers non-clinical performance data, which includes:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical):

The acceptance criteria for this device are implied by its conformance to various international standards for safety and biocompatibility, as well as the demonstration of similar technological characteristics to predicate devices. The "reported device performance" is framed as successfully meeting these standards and being comparable to the predicate.

Regarding your specific questions related to clinical efficacy studies (which are NOT in this document):

• 2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data for efficacy is provided.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth for efficacy is provided.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set or adjudication process is mentioned.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This document does not describe such a study.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm-only device, but a physical hair removal device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there's no clinical efficacy study reported. For the non-clinical tests, the "ground truth" is defined by the specific requirements and passing criteria of the referenced international standards.
• 8. The sample size for the training set: Not applicable. This document does not describe an AI/ML device that requires a training set of patient data.
• 9. How the ground truth for the training set was established: Not applicable.

In summary: The provided FDA 510(k) summary for the IPL Hair Removal Device focuses on demonstrating substantial equivalence through non-clinical performance data (biocompatibility, electrical safety, eye safety, software validation) and comparison of technological characteristics with legally marketed predicate devices. It does not include any data or studies related to its clinical efficacy in hair removal (e.g., percentage of hair reduction) on human subjects. For medical devices like this, approval based on substantial equivalence often relies on demonstrating that the new device has similar technology and performance/safety characteristics to products already on the market, rather than requiring new clinical efficacy trials if the intended use and technological principles are well-established.

Ask a specific question about this device