Search Results

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

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

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

The document primarily focuses on:

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

Crucially, there is no mention of:

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

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

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

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

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

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

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

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

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

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

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

4. Adjudication method for the test set

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

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

7. The type of ground truth used

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

8. The sample size for the training set

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

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

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

Ask a specific question about this device

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

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

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

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

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

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

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

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

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

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

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

Conclusion:

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

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

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

Ask a specific question about this device

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

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

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

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

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

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

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

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

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

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is an IPL device, not an AI-assisted diagnostic tool.

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

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

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

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

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

Ask a specific question about this device

Jmoon Conductive Gel is intended to be used with microcurrent devices to improve skin conductivity.

The Jmoon Conductive Gel is a clear, viscous and chloride-free formulation. The gel is to be applied to the area under an electrode to reduce the impedance of the contact interface between the electrode surface and the skin.

The provided FDA 510(k) clearance letter and summary for the Jmoon Conductive Gel do not contain any information regarding clinical studies with human participants or the use of AI/algorithms. The document primarily focuses on the device's substantial equivalence to a predicate device based on its physical, chemical, and biological characteristics, as well as biocompatibility and shelf-life testing.

Therefore, many of the requested categories cannot be populated from the provided text.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

Study Details Based on Provided Information:

1. Sample size used for the test set and the data provenance: Not applicable. The studies mentioned (biocompatibility, shelf-life, performance testing) refer to laboratory-based evaluations of the gel's properties, not clinical studies with a test set of human subjects or images.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This information is relevant for studies involving human interpretation or clinical outcomes, which are not present in this document.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human interpretation requiring adjudication was involved.
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. The device is a conductive gel, not an AI-based diagnostic or assistive tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device would be established through laboratory standards and validated test methods for chemical, physical, and biological properties, as well as regulatory standards for biocompatibility (e.g., ISO 10993 series).
7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
8. How the ground truth for the training set was established: Not applicable. No training set was used.

Ask a specific question about this device

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

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

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

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

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

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

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

Ask a specific question about this device

JMOON NouvelleSkin facial toning device is intended for facial stimulation and indicated for overthe-counter cosmetic use.
JMOON NouvelleSkin facial toning device is an over-the-counter device that emits energy in the red and near-infrared spectrum, designed for the treatment of facial wrinkles.

Jmoon NouvelleSkin Facial Toning device is an at-home handled device that provides an advanced, easy-to-use and efficient solution for better facial wellness. This device includes microcurrent, red and infra-red light LED, which allow you to customize your treatments according to your face skin. The device provides indicator lights and beeps feedback to guide the user during the treatment cycle.
The microcurrent therapy will deliver 3 different low-level electrical microcurrent impulses on face within a few minutes to complete facial stimulation. The red light and infra-red therapy is a treatment that uses red light to reportedly improve your skin's appearance, like reducing wrinkles.

The provided text describes a 510(k) premarket notification for the JMOON NouvelleSkin Facial Toning Device. The submission aims to demonstrate substantial equivalence to predicate devices, rather than proving performance against specific acceptance criteria through a clinical study with real-world data and expert adjudication. Therefore, much of the requested information (like sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, and ground truth for training set) is not applicable or not present in the provided document.

However, the document does contain "acceptance criteria" in the form of conformance to various safety and performance standards for non-clinical testing.

Here's the breakdown of the information based on the provided text:

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

The acceptance criteria for this device are its conformance to recognized safety and performance standards. The reported performance is that the device "Conforms" to these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence."
The testing performed was non-clinical (lab bench testing). Therefore, there is no "sample size for the test set" in the context of human subjects or clinical data, nor is there data provenance in terms of country of origin or retrospective/prospective studies.

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)

Not applicable. As no clinical test data was used, no experts were needed to establish ground truth for a test set based on human subjects. The acceptance criteria were based on adherence to international technical standards, which are established by expert consensus in regulatory and technical bodies.

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

Not applicable. No clinical test set with human subject data requiring adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. No MRMC study was conducted, as the device is not an AI-assisted diagnostic or interpretive tool, and no clinical studies were performed.

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

This concept is not directly applicable to this device, which is a physical facial toning device. However, the non-clinical testing evaluates the device's standalone physical, electrical, and biocompatibility performance against specified standards. The results indicate that the device "Conforms" to these standards in a standalone capacity.

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

The "ground truth" for the non-clinical testing is compliance with the specified international standards (e.g., IEC 60601-1, ISO 10993 series). These standards represent an expert consensus on safety and performance requirements for medical devices.

8. The sample size for the training set

Not applicable. The device is not based on a machine learning algorithm; therefore, there is no "training set" in the conventional sense of AI/ML development.

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

Not applicable. There is no training set for this device.

Ask a specific question about this device

Ulike Reglow Light Therapy Device is an over the counter device that is intended for use in the treatment of full face wrinkles and treatment of mild to moderate inflammatory acne.

Ulike Reglow Light Therapy Device adopts light emitting diodes (LED) in the 630mm ± 10nm,830nm ± 10nm,590mm±10nm and 465nm±10nm spectrum to irradiate on the face to realize its therapeutic effect. The Ulike Reglow Light Therapy Device adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller is connected to the main unit to control the device, such as turn on/off the device, switch mode. Power adapter is provided to charge the battery contained in the controller. To use the device, user should place the mask over the face and use the controller to operate. To prevent irradiation of LED lights to eyes during the treatment, Ulike Reglow Light Therapy Device has incorporated protective eye-shield which blocks light energy from LEDs.

The provided text describes the regulatory clearance for the "Ulike Reglow Light Therapy Device (UM10)" based on its substantial equivalence to predicate devices. It does not present any clinical study data or acceptance criteria related to the device's performance for its intended therapeutic effects (wrinkle reduction and acne treatment).

Instead, the document focuses on non-clinical performance data for safety and electrical characteristics required for FDA clearance. Therefore, I cannot generate the requested table or answer several of your questions (1, 5, 6, 7, 8, 9) because the information is not present in the provided text.

The text does mention the following:

• Acceptance Criteria for Non-Clinical Tests: The acceptance criteria for the non-clinical tests (biocompatibility, electrical safety, light safety, software, usability) are that the device "passed" the respective standards (e.g., ISO 10993, IEC 60601 series, IEC 62471). Specific numerical performance metrics for these tests are not provided.
• Study Proving Device Meets Acceptance Criteria: The study proving the device meets the acceptance criteria is the performance of the listed non-clinical tests.

Here's what can be extracted from the document regarding the non-clinical tests:

1. Table of Acceptance Criteria and Reported Device Performance (for Non-Clinical Tests)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable. The document discusses non-clinical tests (electrical safety, biocompatibility, etc.) performed on the device itself, not on a human test set. There is no mention of a clinical test set.
• Data Provenance: Not applicable for clinical data. The tests are general product safety and performance tests against international standards.

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)

• Not applicable. There is no mention of an expert panel or ground truth establishment for a clinical test set as no clinical study data is presented.

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

• Not applicable. There is no clinical test set mentioned.

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

• No, this document does not describe an MRMC study. The device is a light therapy device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is not an algorithm-based device that would require standalone performance evaluation in the context of diagnostic AI.

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

• Not applicable. There is no clinical study data for therapeutic efficacy presented in this document. The ground truth for the non-clinical tests is compliance with published international industry standards.

8. The sample size for the training set

• Not applicable. This document is for a medical device (light therapy) which implies physical product testing, not a machine learning model that would require a training set.

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

• Not applicable. (See #8)

Ask a specific question about this device

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

Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). 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 has skin-safe detection. 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.

The provided text is an FDA 510(k) clearance letter for an "Ice Cooling IPL Hair Removal Device." It describes the device, its intended use, and a comparison with predicate devices to establish substantial equivalence. However, this document does not contain, nor is it expected to contain, the detailed acceptance criteria and study results typically found in a clinical study report for device performance, especially for AI/ML-driven devices involving expert interpretation or comparative effectiveness studies.

The document focuses on:

• Substantial Equivalence: Demonstrating the new device is as safe and effective as legally marketed predicate devices.
• Performance Data (Non-Clinical): Summarizing tests for biocompatibility, electrical safety and EMC, eye safety, software verification and validation, and usability. These are largely engineering and safety tests rather than evaluations of device clinical effectiveness (e.g., hair removal efficacy).

Therefore, I cannot fulfill your request for acceptance criteria and study details related to "device performance" in the context of an AI/ML device (e.g., human reader improvement with AI assistance, standalone algorithm performance, ground truth establishment by experts, MRMC studies) because this information is not present in the provided FDA clearance letter.

The device described is an IPL (Intense Pulsed Light) hair removal device, which is a physical device that emits light to reduce hair growth. It does have software/firmware control, but it's not presented as an AI/ML-driven diagnostic or imaging interpretation device that would involve the kind of "acceptance criteria" you've outlined (e.g., related to sensitivity, specificity, or expert consensus on interpretations). The "performance data" here relates to the safety and fundamental operation of the physical device as required for a 510(k) submission.

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

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 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. This product emits light pulses and is designed to be suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device 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 device includes a cooling function to cool the skin during the hair removal process to provide users with a more comfortable experience.

The provided text is a 510(k) summary for the Shenzhen Ulike Smart Electronics Co., Ltd. Ice Cooling IPL Hair Removal Device. It describes the device, its intended use, and its comparison to predicate devices, along with performance testing. However, it does not contain the specific details about clinical study results, acceptance criteria, or the methodology that would be required to answer all the questions in the prompt.

Here's an analysis based on the available information:

Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria for performance metrics related to hair removal (e.g., specific percentages of hair reduction deemed acceptable). It only mentions 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" as part of the Indications for Use.

The document does not report specific quantitative performance data for the hair reduction effectiveness of the device. Instead, it refers to "Performance data supports that the device is safe and as effective as the predicate devices for its intended use" as a general statement for substantial equivalence.

Therefore, for the specific request of a table of acceptance criteria and reported device performance related to the primary indication of hair removal, the necessary information is not present in the provided text.

The document does list standards and tests for safety and general performance, which implies that the device met the requirements of these standards. For example:

Missing Information:

The following information is not available in the provided text:

2. Sample size used for the test set and the data provenance: There is no mention of a clinical test set or the number of participants.
3. Number of experts used to establish the ground truth for the test set and qualifications: This information would be relevant for clinical studies, which are not detailed here.
4. Adjudication method for the test set: Not applicable as no clinical test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: This type of study is not mentioned. The device is a "home-use" device, so human-in-the-loop performance is not evaluated in the context of an MRMC study with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: While the device functions autonomously for hair removal, the performance described is purely device-centric rather than an "algorithm only" evaluation in the context of diagnostic AI.
7. The type of ground truth used: As no clinical study results are detailed, no specific ground truth for hair removal efficacy is provided or referenced.
8. The sample size for the training set: Not applicable as this document does not describe the development or evaluation of an AI/ML training set.
9. How the ground truth for the training set was established: Not applicable.

Summary based on available info:

The document primarily focuses on establishing "substantial equivalence" to predicate devices through technical comparisons and compliance with relevant safety and performance standards (biocompatibility, electrical safety, light safety, software, usability). It asserts that performance data supports the device's safety and effectiveness, but it does not present the detailed clinical study design, results, or specific acceptance criteria for hair removal efficacy that would directly answer your questions about acceptance criteria and how a study proves it. For a medical device of this type, a clinical study would typically be conducted, and those results would contain the information you are requesting. This 510(k) summary only notes that such data was "provided in support of the substantial equivalence determination" but does not elaborate on the specific findings or methodology of that data.

Ask a specific question about this device