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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.

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The Ice Cooling IPL Home Use Hair Removal Device is an over-the-counter device indicated for the removal of unwanted hair such as but not limited to small 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 Ice Cooling IPL Home Use 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 and it has the cooling function that effectively cools the skin.

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. The device contains a 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. Besides, the device has the cooling function that will be activated throughout the whole hair removal process or when the user want to activated to provide users with a more comfortable experience.

The provided document is a 510(k) summary for an Ice Cooling IPL Home Use Hair Removal Device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific performance acceptance criteria through clinical trials.

Therefore, it is not possible to fully answer all aspects of your request based on the provided text alone, as it lacks a standalone clinical study section with detailed acceptance criteria, sample sizes, expert involvement, and ground truth establishment for performance.

However, I can extract information related to the device's alignment with safety and performance standards which serve as a form of acceptance criteria in the context of a 510(k) submission.

Here's the information that can be gleaned from the document:

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

The document lists several international and FDA-recognized standards that the device conforms to. While these are not "performance" metrics in terms of hair reduction efficacy, they represent acceptance criteria for safety, electrical compatibility, usability, and photobiological safety.

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 in the document. The submission focuses on non-clinical engineering and biocompatibility testing against standards, and comparison to predicate devices, rather than a clinical performance study with a specific test set of human subjects.

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 applicable and therefore not provided, as the document does not describe a clinical study with a ground truth established by experts.

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

This information is not applicable and therefore not provided, as the document does not describe a clinical study with a test set requiring adjudication.

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 information is not applicable and therefore not provided. This device is an IPL hair removal device, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.

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

This information is not applicable and therefore not provided. The device is a hardware product for hair removal, not an algorithm.

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

For the non-clinical tests (electrical safety, photobiological safety, biocompatibility, software V&V), the "ground truth" or reference is adherence to the specified international and FDA-recognized standards. For the claimed "permanent reduction in hair regrowth," the document states it is "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." However, explicit outcomes data from a clinical trial to prove this ground truth for the subject device is not presented in this summary, rather the substantial equivalence to predicate devices that have this indication is leveraged.

8. The sample size for the training set

This information is not applicable and therefore not provided. There is no mention of machine learning or AI models with training sets for this device.

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

This information is not applicable and therefore not provided, as there is no training set for a machine learning model.

Ask a specific question about this device

IPL Home Use 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 Home Use Hair Removal Device (Model:515) is an over-the-counter, home-use and single-person-use device for hair reduction by using Intense Pulsed Light (IPL)to emit a specific wavelength of the light ranging from 550-1200m and delivers to the skin. The device is designed to help break the cycle of hair re-growth. Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair shaft. The absorbed light energy (below the surface of the surface of the skin), which disables the har follicle preventing further growth, so as to achieve effective hair removal.

This document is a 510(k) Premarket Notification summary for an IPL Home Use Hair Removal Device. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria for a new clinical claim.

Therefore, the provided text does not contain the information requested to describe acceptance criteria and a study proving the device meets those criteria, specifically for an AI/ML device. The document states:

• "The clinical test is not applicable, there's no clinical data."
• The non-clinical testing focuses on compliance with electrical safety, EMC, photobiological safety, and biocompatibility standards, and software verification and validation, not on demonstrating the hair removal efficacy against quantitative acceptance criteria.

The prompt assumes the document describes an AI/ML device and its performance study, which is not the case here. This is a traditional medical device (IPL hair removal) 510(k) submission, where substantial equivalence is primarily established through technological comparison and compliance with relevant safety standards.

Therefore, I cannot populate the table or answer the specific questions about sample size, expert ground truth, MRMC studies, or training data, as this information is not present in the provided text.

Ask a specific question about this device

IPL Home Use Hair Removal Device is indicated for the removal of unwanted harr. 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 (Models:JD-TM003, JD-TM003, JD-TM012, JD-TM016, JD-TM022),is an over-the-counter, home-use and single-person-use 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 flash window and is suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). 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.

The subject device includes five models. The three models of JD-TM002,JD-TM003,JD-TM012 are white , JD-TM016 has two colors of white and purple while three colors of rose gold, green and champagne for JD-TM022. Except JD-TM022, the other four models have cooling function to relieve pain of burning sensation during operation. Except JD-TM002, you can use auxiliary head to limit the spot area and get better effect with the other four models. The auxiliary head is suitable for small parts such as underarms and lips.

IPL Home Use Hair Removal Device, models: JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 have the same indication for use, performance, structure design and operation. The main difference mainly contains product appearance, size, weight, energy density , number of levels and auxiliary head. The little difference won't affect the safety and effectiveness of the device.

The provided text from the FDA 510(k) summary (K231717) is for an "IPL Home Use Hair Removal Device." This device is not an AI/ML-driven diagnostic or treatment system but rather a physical device that uses intense pulsed light for hair removal.

Therefore, the requested information regarding acceptance criteria and study details for an AI/ML-based device (including expert consensus, sample sizes for training/test sets, ground truth establishment, MRMC studies, etc.) is not applicable to this specific submission.

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

• Indications for Use Comparison: The new device has the same intended use as the predicate devices.
• Technological Characteristics Comparison: Similarities and minor differences in design, materials, and specifications are discussed, with justification that these differences do not raise new safety or effectiveness concerns.
• Performance Data (Non-Clinical):
  • Biocompatibility Testing: Confirmed compliance with ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and skin sensitization).
  • Electrical Safety and EMC: Compliance with relevant IEC and ANSI standards (IEC 60601-1-2, ANSI AAMI ES60601-1, IEC 60601-1-11, IEC 60601-2-57).
  • Eye Safety: Compliance with IEC 62471.
  • Software Verification and Validation: Software documentation consistent with a moderate level of concern, demonstrating that requirements are met and hazards mitigated.
  • Usability: Evaluated and verified according to FDA guidance.

There is no mention of an algorithm that involves machine learning, image analysis, or any form of AI that would require a study setup involving ground truth from experts, MRMC studies, or discussions of sensitivity/specificity beyond basic device performance. The device's "performance" in this context refers to its physical output (e.g., energy density, pulse duration) and safety features, not its diagnostic or predictive accuracy.

Ask a specific question about this device

Hand-held IPL 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.

The IPL Home Use 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 Home Use Hair Removal Device is composed of a hand-held applicator and an external power supply. The spot size (treatment area) in the IPL Home Use Hair Removal Device is 3cm². The device contains a lamp, a skin proximity sensor. If the IPL Home Use Hair Removal Device is not properly applied (in full contact with the skin), the device will not trigger a pulse.

The IPL Home Use Hair Removal Device includes FZ-608, FZ-608G, FZ-100, and FZ-200 four models. Their intended use, performance, structure design and operation are basically identical, with the differences mainly contains product appearance, energy output range and its equipped power supply model. The model difference is embodied in: #1) energy output level of model FZ-608 and FZ-608G has 9 levels, corresponding to an output range of 4.16J10J; model FZ-100 has 9 levels, corresponding to an output range of 5.7J16.26J, and model FZ-200 has 6 levels, corresponding to an output range of 4.6J~13,5J; #2) the main unit FZ-608 and FZ-608G can be supplied by the power adaptor (model: SHCSP2402000FUS), and the main unit FZ-100 and FZ-200 can only be supplied by the power adaptor (model: SHCY-SP2401500EUS), the adapters have been approved in accordance with IEC 62368-1 and tested with equipment, considering as a part of this ME equipment.

The provided document is a 510(k) summary for an IPL Home Use Hair Removal Device (K230739). It outlines the device's substantial equivalence to predicate devices, focusing on safety and efficacy for over-the-counter (OTC) use.

However, the document does not contain information related to an AI/algorithm-driven device or a study involving ground truth, expert consensus, MRMC studies, or training/test sets for AI models. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the regulatory requirements for a medical device's safety and effectiveness for its intended use, not an AI algorithm's performance against specific metrics established by expert review.

The performance testing mentioned is for the physical device itself (electrical safety, EMC, biocompatibility, and usability/self-selection for OTC use), not for an AI's diagnostic or analytical capabilities.

Therefore, I cannot populate the requested table and answer the specific questions about AI acceptance criteria, ground truth, expert adjudication, or MRMC studies for this device based on the provided text.

The relevant "study" mentioned in the document is a usability study for OTC use, not an AI performance study.

Here's a breakdown of what is available in the document regarding the device's acceptance and testing:

Device Acceptance Criteria and Performance (Based on Usability Study for OTC Use)

The document states that a usability study was conducted to demonstrate that the device is safe and effective for over-the-counter (OTC) use by lay users. The "acceptance criteria" here are implied regulatory requirements for OTC medical devices, specifically regarding user comprehension and safe application.

Detailed Information Not Applicable to an AI Study:

Since this is a physical medical device (IPL hair removal) and not an AI/algorithm, the following points outlined in your request are not addressed or are not relevant in the provided text:

2. Sample size for the test set and data provenance:
   • Test set sample size: 24 subjects (for the usability/OTC study).
   • Data provenance: Not explicitly stated, but likely prospective given it's a usability study involving direct interaction with subjects. Country of origin not specified, but the applicant company is Shenzhen, China.
3. Number of experts and qualifications for ground truth: Not applicable. Ground truth for an IPL device's usability doesn't involve expert medical image review.
4. Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in expert review settings (e.g., radiology). For a usability study, the "adjudication" would be whether users successfully completed tasks or understood information.
5. MRMC comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device.
6. Standalone (algorithm only) performance: Not applicable. There is no AI algorithm.
7. Type of ground truth used: For the usability study, the "ground truth" would be the successful demonstration of user comprehension and safe device operation, assessed by usability researchers, not medical experts interpreting data like pathology or outcomes.
8. Sample size for the training set: Not applicable. There is no AI model to train.
9. How ground truth for the training set was established: Not applicable.

In summary, the provided document details the regulatory clearance of a physical medical device. While it includes "performance testing," this refers to electrical safety, biocompatibility, and OTC usability, not the performance of an AI algorithm against clinical ground truth.

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IPL home use hair removal device is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The IPL home use hair removal device is also intended for permanent reduction in unwanted hair. Permanent hair reduction is 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 regimen.

The device is used for adults with Fitzpatrick skin types I - IV.

The Hand-held IPL device are pulsed light hair removal device. Light-based hair removal is based on the theory of selective photosynthesis in which optical energy is used to disable hair growth. The Hand-held IPL device devices are composed of a hand held applicator and an external power supply. The spot size (treatment area) in the Hand-held IPL device devices is 3 cm², The device contains a lamp, a skin proximity sensor. If the Hand-held IPL device is not properly applied (in full contact with the skin) , the Hand-held IPL device will not trigger a pulse.

The main unit FZ-608 and FZ-608G can only be supplied by the power adaptor (model: SHCSP2402000FUS), The main unit FZ-100 and FZ-200 can only be supplied by the power adaptor (model: SHCY-SP2401500EUS), the adapters have been approved in accordance with IEC 62368-1 and tested with equipment, considering as a part of this ME equipment.

FZ-608 and FZ-608G are identical except for model No. and enclosure colour.

The patient is an intended operator.

The provided document is a 510(k) Premarket Notification for a Hand-held IPL device (IPL Home Use Hair Removal Device). This document is primarily concerned with demonstrating substantial equivalence to predicate devices, not with establishing acceptance criteria for a new and novel device, nor does it detail a study proving the device meets specific acceptance criteria related to efficacy beyond showing similarity to already cleared devices.

Therefore, the information required to answer your prompt thoroughly, particularly regarding a multi-reader multi-case (MRMC) comparative effectiveness study, human expert involvement in ground truth, sample sizes for training/test sets for a novel AI algorithm, and quantitative metrics of device performance against specific acceptance criteria, is not present in this type of regulatory submission.

The document discusses performance data in a general sense, focusing on:

• Biocompatibility testing: Cytotoxicity, Sensitization, Irritation. These are related to safety of materials in contact with the skin.
• Electrical safety and electromagnetic compatibility (EMC) testing: Compliance with standards like AAMI/ANSI ES60601-1, IEC 60601-2-83, and IEC 60601-1-2. These relate to electrical safety and electromagnetic interference.
• Software Verification and Validation Testing: Standard V&V for software, with a "Moderate" level of concern.
• Bench Testing: Verification of parameters like wavelength, pulse duration, output energy, and maximum fluence against design specifications and comparison to predicate devices. This is to show the device operates as intended and is similar to predicates.

The "Performance Data" section (Section 7) describes general testing conducted to support substantial equivalence, but it does not provide the kind of detailed study data (like sensitivity, specificity, or improvement over human readers) that would be expected for an AI/ML-based medical device. The "Indications for Use" section focuses on permanent hair reduction, defined by hair regrowth measurements at 6, 9, and 12 months, but the document does not present clinical study results to demonstrate this. Instead, it relies on the predicate devices having similar indications and technology.

Based on the provided document, here's what can be inferred or explicitly stated, with limitations:

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

The document does not provide a table of acceptance criteria for clinical performance (e.g., specific hair reduction percentages) and reported device performance against those criteria. The "acceptance criteria" discussed are largely compliance with electrical safety, EMC, and biocompatibility standards, and demonstrating similar technical parameters to predicate devices.

The closest to "acceptance criteria" are the parameters verified by bench testing and their similarity to predicate devices. However, these are not clinical performance metrics.

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

The document does not describe a clinical "test set" in the context of an AI/ML device or a performance study with human participants. The testing mentioned (biocompatibility, electrical safety, bench testing) does not involve human sample sizes for a clinical performance evaluation of hair reduction efficacy. Data provenance is not applicable here as it's not a data-driven AI/ML model for diagnosis/prognosis.

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

Not applicable. There's no mention of experts establishing ground truth for a test set, as this is not a diagnostic/AI device.

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

Not applicable. There's no mention of a test set requiring adjudication.

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 Intense Pulsed Light (IPL) device for hair removal, not an AI-assisted diagnostic or image interpretation tool. Therefore, an MRMC study is not relevant to this submission.

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

Not applicable. This is not an algorithm-only device.

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

The document does not detail the establishment of "ground truth" for clinical efficacy of hair removal. For the device's stated purpose, "Permanent hair reduction is 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 regimen." However, the 510(k) submission relies on substantial equivalence to predicate devices for this claim, rather than presenting a de novo clinical study with measured outcomes. The "ground truth" for the technical parameters is primarily the design specifications and measurements from the predicate devices.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable. This device does not involve a "training set" or "ground truth" for machine learning.

In summary: This 510(k) submission for a Hand-held IPL device focuses on demonstrating substantial equivalence to already cleared predicate devices through technical comparisons, safety testing (biocompatibility, electrical safety, EMC), and software validation. It does not contain the detailed clinical performance study data that would be required for a novel AI/ML device, nor does it define or report against explicit clinical acceptance criteria using specific patient sample sizes or expert ground truth methods. The "performance data" refers to technical and safety compliance, not clinical efficacy metrics from a human study.

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 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. 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 is by finger switch. The device contains a Xenon lamp and a skin sensor 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 be triggered a pulse emitting.

The IPL Home Use Hair Removal Device includes D-1198, D-1186, D-1189, D-1197 five models. Their intended use, performance, structure design and operation are basically identical, with the differences mainly contains PCB layout, product appearance and internal construction, but these differences do not affect or change the intended use of the device.

This document is a 510(k) Pre-market Notification for an IPL Home Use Hair Removal Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and specific performance metrics for the subject device's clinical effectiveness.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for proving clinical effectiveness cannot be fully provided from the given text. This document primarily addresses safety and technical aspects through comparisons and compliance with standards.

Here's a breakdown of what can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: No specific numerical acceptance criteria for clinical effectiveness (e.g., percentage hair reduction, safety endpoints with thresholds) are explicitly stated for the subject device in this document. The document refers to "similar safety and effectiveness profile" and "performance data supports that the device is safe and as effective."
• Reported Device Performance:
  • Clinical Effectiveness: The document states the device "works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain." However, no quantitative data on hair reduction percentage, pain scores, or other effectiveness metrics are provided for the subject device. The safety is "similar to the predicate device."
  • Technical Performance (derived from comparison table in Section VI):
    • Wavelength range: 550-1100nm
    • Energy medium: Xenon Arc Flashlamp
    • Energy density: 2.0-4.3 J/cm²
    • Spot size: D-1198: 2.7cm², D-1185: 2.7cm², D-1186: 3.0cm², D-1189: 3.0cm², D-1197: 3.4cm²
    • Pulse duration: 5-12ms
    • Pulsing control: Finger switch
    • Delivery device: Direct illumination to tissue
  • Safety Performance (as per Section VII - Performance Data):
    • Biocompatibility: Materials are identical to the predicate device (K211185), thus deemed safe.
    • Electrical Safety & Eye Safety: Passed IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57, and IEC 62471 standards.
    • Software Verification and Validation: Passed, meeting all software requirement specifications and mitigating hazards to acceptable risk levels.

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

• Not provided. This document does not describe a clinical test set with specific sample sizes for evaluating hair reduction or other clinical efficacy outcomes. The safety and effectiveness claims are based on comparison to a predicate device and compliance with technical standards.

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

• Not applicable/Not provided. Since no specific clinical test set for efficacy is described, there is no mention of experts establishing ground truth for such a set.

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

• Not applicable/Not provided. No clinical test set involving human judgment and 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-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant to this submission.

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

• Not applicable in the context of clinical efficacy. While the device itself operates standalone for hair removal, the performance data presented primarily pertains to safety (electrical, eye, biocompatibility) and technical specifications, not a clinical "algorithm only" performance for diagnosis/treatment in the typical sense of AI devices.

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

• Not provided for clinical efficacy. For safety, the "ground truth" is established by compliance with international standards (IEC standards) and prior FDA clearance of similar materials (for biocompatibility).

8. The sample size for the training set:

• Not applicable/Not provided. There is no mention of a "training set" in the context of an IPL hair removal device's clinical efficacy or safety. The device does contain software, and "Software Verification and Validation" was performed, but details about a "training set" for software development are not included.

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

• Not applicable/Not provided. As with point 8, no training set for clinical efficacy is mentioned.

Summary of what is present:

This 510(k) submission primarily relies on demonstrating substantial equivalence to an existing legally marketed predicate device (Bosidin IPL Home Use Hair Removal Device/D-1171, K211185). The key arguments for equivalence are:

• Identical Indications for Use: "removal of unwanted body and/or facial hair." (Section V, VI)
• Similar Mode of Action and Operational Characteristics: Uses Intense Pulsed Light (IPL) technology. (Section VI)
• Comparable Technical Specifications: Wavelength range, energy medium, energy density, spot size, pulse duration, pulsing control, delivery method are similar or within acceptable ranges. (Section VI table)
• Safety Compliance: The device components are biocompatible (identical to predicate materials), and it has passed multiple electrical and eye safety standards (IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57, IEC 62471). Software has also undergone verification and validation. (Section VII)

The document concludes that "the IPL Home Use Hair Removal Device was found to have a safety and effectiveness profile that is similar to the predicate device" and is "substantially equivalent." This type of submission usually implies that extensive new clinical efficacy trials for the subject device were not deemed necessary by the FDA because of the strong similarity to an already cleared device.

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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 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. 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 is by finger switch. The device contains a Xenon lamp and a skin sensor 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 be triggered a pulse emitting.

The IPL Home Use Hair Removal Device includes D-1150, D-1171, D-1153, D-1155, D-1156, D-1126, D-1178, D-1187 eight models. Their intended use, performance, structure design and operation are basically identical, with the differences contains product appearance, display contents and the number of button, lamp cartridge's quantity and appearance; in additional, due to the size of the treatment window in different lamp cartridge, the treatment area (spot size) and output density is a little different; but these differences do not affect or change the intended use of the device.

This document is a 510(k) Summary for an IPL Home Use Hair Removal Device. It describes the device, compares it to predicate devices, and outlines the performance data submitted to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided document:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a specific clinical outcome (e.g., a certain percentage of hair reduction). Instead, it relies on demonstrating substantial equivalence to predicate devices through various performance tests related to safety and general functionality.

However, we can infer the "acceptance criteria" for the tests performed as passing the relevant safety standards.

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

The document does not specify a sample size for a clinical test set for hair removal efficacy. The performance data presented focuses on non-clinical testing (biocompatibility, electrical safety, eye safety, software verification).

• Sample Size for Non-Clinical Tests: Not explicitly stated (e.g., number of units tested for electrical safety).
• Data Provenance: The document is a 510(k) submission, typically containing test reports from the manufacturer. The location of the manufacturer is Shenzhen, Guangdong, China. The document does not indicate whether the data is retrospective or prospective for any clinical studies, as no clinical studies with human subjects are detailed.

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

This information is not applicable or provided in the document as it focuses on non-clinical engineering and safety aspects, not a clinical study requiring expert assessment of outcomes like hair reduction or disease diagnosis. There is no mention of ground truth establishment by experts for the performance data presented.

4. Adjudication method for the test set

This information is not applicable or provided as there is no human-centric clinical test set requiring adjudication.

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 information is not applicable. The device is an IPL hair removal device for direct consumer use, not an AI-assisted diagnostic imaging tool that would involve human readers (e.g., radiologists). There is no mention of an MRMC study or AI assistance for human readers.

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

This information is not applicable. The device is a physical IPL hair removal device, not an algorithm. Its operation involves a user directly applying it.

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

For the non-clinical performance data (biocompatibility, electrical safety, eye safety, software V&V), the "ground truth" is defined by established international and national standards (e.g., ISO 10993, IEC 60601, IEC 62471). The device is tested against these predefined safety and performance criteria.

8. The sample size for the training set

This information is not applicable. As a physical IPL device without an AI component that learns from data, there is no "training set" in the context of machine learning.

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

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

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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 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. 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 is by finger switch. The device contains a Xenon lamp and a skin sensor 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 be triggered a pulse emitting.

The IPL Home Use Hair Removal Device includes D-1129, D-1130, D-1119, D-1119, D-1103, D-1176, D-1151, D-T1002 eight models. Their intended use, performance, structure design and operation are basically identical, with the differences contains product appearance, display contents, lamp cartridge's quantity and appearance as well as the placement location of lamp tube; in additional, due to the size of the treatment window in different lamp cartridge, the treatment area (spot size) and output density is a little different; but these differences do not affect or change the intended use of the device.

The provided document describes an FDA 510(k) summary for an IPL Home Use Hair Removal Device. However, it does not contain information about a study proving the device meets specific acceptance criteria related to efficacy (hair removal performance) using human subjects or an AI component.

Instead, the performance data discussed focuses on the following:

• Biocompatibility Testing: Ensuring the materials in contact with the body are safe.
• Electrical Safety and Eye Safety: Adherence to electrical safety standards and photobiological safety standards.
• Software Verification and Validation: For the device's moderate level of concern software.

The document states: "Based on the above performance as documented in this application, the subject device IPL Home Use Hair Removal Device was found to have a safety and effectiveness profile that is similar to the predicate device." This "effectiveness profile" is likely inferred from the similarity in technological characteristics (like wavelength range, energy density, spot size, pulse duration) to the predicate device, which presumably demonstrated effectiveness in its clearance.

Therefore, I cannot provide the requested table and study details as the document does not present a standalone clinical study with acceptance criteria for hair removal efficacy or an AI component that meets those criteria. The provided information is limited to safety and technical similarity to a predicate device.

If the request was based on a misunderstanding of what information is present in the document, and it's seeking a general outline of what such a response would look like for a hypothetical device with AI and clinical performance data, please let me know.

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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 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. 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 is by finger switch. The device contains a Xenon lamp and a skin sensor 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. The device is for single-person use only.

The IPL Home Use Hair Removal Device includes D-1103, D-1119, D-1129 and D-1130 five models. Their intended use, performance, structure design and operation are basically identical, with the differences contains product appearance, LCD display contents, hair removal lamp cartridge's quantity and appearance, as well as lamp tube's placement location; in addition, due to the size of the treatment window in different lamp cartridge, the treatment area (spot size) is different; but these differences do not affect or change the intended use of the device.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the IPL Home Use Hair Removal Device:

Important Note: The provided FDA 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing de novo acceptance criteria and proving them through a clinical study for a novel device. Therefore, much of the requested information (like specific performance metrics for the device's efficacy in hair removal, sample sizes for test/training sets for an AI, and expert ground truthing) is not present in this document. The "performance data" section primarily addresses safety and general performance aspects relative to standards, not direct efficacy claims against predefined criteria.

Description of Acceptance Criteria and Supporting Study

The provided document describes the IPL Home Use Hair Removal Device and its submission for 510(k) clearance by the FDA. The primary objective of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety or effectiveness.

In this context, specific quantitative "acceptance criteria" for hair removal efficacy are not explicitly defined and measured as the primary outcome for this submission. Instead, the "acceptance criteria" are broad: to establish that the device is as safe and effective as the predicate devices, meeting relevant safety standards and showing similar operational characteristics.

The "study" that proves the device meets these (implicit) acceptance criteria is the collection of performance data, biocompatibility testing, electrical safety, eye safety, and software verification and validation activities performed on the device.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document doesn't present explicit quantitative acceptance criteria for hair removal efficacy that the device must meet, nor does it provide specific numerical efficacy performance results in the given tables. Instead, it demonstrates compliance with safety standards and similarity to predicate devices.

• Passed ISO 10993-5 (In Vitro Cytotoxicity).
• Passed ISO 10993-10 (Irritation and Skin Sensitization). |
  | Electrical Safety: Compliance with relevant electrical safety standards. | - Passed IEC 60601-1-2 (EMC).
• Passed IEC 60601-1 (Basic safety & essential performance).
• Passed IEC 60601-1-11 (Home healthcare use).
• Passed IEC 60601-2-57 (Non-laser source equipment for therapeutic/cosmetic use). |
  | Eye Safety: Compliance with standards for photobiological safety. | - Passed IEC 62471 (Photobiological safety of lamps and lamp systems). |
  | Software Functionality: Software operates as intended and hazards are mitigated. | - Software documentation consistent with a moderate level of concern.
• System validation testing demonstrated all software requirement specifications are met and hazards mitigated. |
  | Functional Equivalence: Same intended use & similar operational characteristics as predicates. | - Same intended use (removal of unwanted body/facial hair).
• Similar mode of action (IPL technology).
• Similar operational characteristics (e.g., energy medium, pulsing control, delivery device).
• Differences in wavelength, energy density, spot size, and pulse duration are considered minor and not affecting safety or efficacy in achieving substantial equivalence. |

2. Sample Size for the Test Set and Data Provenance

This information is not provided in the document. The term "test set" in the context of device performance usually refers to clinical data for efficacy, which is absent as a specific clinical trial outcome here. The performance data presented are primarily safety and engineering tests, not clinical efficacy trials with patient sample sizes.

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

This information is not applicable/provided. The submission is not based on an AI algorithm where ground truth would be established by experts. The "ground truth" for the safety tests is derived from adhering to international standards and passing defined metrics within those standards.

4. Adjudication Method for the Test Set

This information is not applicable/provided. There is no "test set" in the sense of clinical data requiring expert adjudication for this 510(k) summary.

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

This information is not applicable/provided. This is not an AI device or an imaging device where an MRMC study would typically be conducted to compare human reader performance with and without AI assistance.

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

This information is not applicable/provided. This is a physical IPL hair removal device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the safety and general performance data is adherence to recognized international standards (e.g., ISO 10993, IEC 60601 series, IEC 62471). For substantial equivalence, the "ground truth" is also the characteristics and performance of the legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not applicable/provided. This is not an AI/machine learning device that requires a training set.

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

This information is not applicable/provided. As above, no training set for an AI algorithm is involved.

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