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Jmoon FlexGlow Light Therapy Device is an over the counter device that is intended:

• the Red light and Infrared light is indicated for use in the treatment of full face wrinkles,
• the Blue light and Red light indicated for the treatment of mild to moderate inflammatory acne.

Jmoon FlexGlow Light Therapy Device is an exclusive mirrored tabletop device that contains 464 LEDs. It utilizes LED(light-emitting diode) technology to emit energy in the blue, red and near-infrared spectra for the aim to improve the skin appearance, helping to reduce wrinkles, like fine lines and crow's feet, and treat mild to moderate inflammatory acne. The specific wavelengths of light can act on different skin layers to produce different photobiological effects. The device is to be used at 1 cm distance.The flexible and foldable device unit is designed to be placed on a table for easy exposure to the face and body to ensure consistent light treatment. There are three modes: Acne defense Mode(M01), Anti-wrinkle recovery Mode(M02) and Dual care Mode(M03).

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

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

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

The document primarily focuses on:

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

Crucially, there is no mention of:

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

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

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

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

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

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

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

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

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

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

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

4. Adjudication method for the test set

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

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

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

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

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

7. The type of ground truth used

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

8. The sample size for the training set

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

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

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

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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.

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

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

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

Not Found

The provided text is a 510(k) premarket notification letter from the FDA for an "Ice Cooling IPL Hair Removal Device." This document serves as an approval letter, stating that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text DOES NOT contain the specific information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.

This type of FDA letter typically refers to information already submitted by the manufacturer in their 510(k) application. To answer your questions, one would need to review the actual 510(k) submission, which is not included in the provided text.

Therefore, I cannot fulfill your request with the given input. The document confirms market clearance but does not detail the technical studies and data that led to that clearance.

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

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Ice Cooling IPL Hair Removal Device). It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The letter primarily focuses on:

• Confirming the device's substantial equivalence to predicate devices.
• Outlining regulatory requirements and general controls that apply to the device.
• Providing contact information for regulatory inquiries.
• Stating the intended use (Indications for Use).

Therefore, I cannot extract the requested information from this document.

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

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for an IPL Hair Removal Device. It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls and other regulations.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study as the necessary information is not present in the given text.

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

Not Found

The provided document is a 510(k) clearance letter from the FDA for an IPL Hair Removal Device. It confirms substantial equivalence to a predicate device and provides general regulatory information. However, it does not contain the detailed acceptance criteria or the study data that proves the device meets those criteria.

Specifically, the document does not include any of the following information:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone (algorithm only) performance study details.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on regulatory approval, substantial equivalence, and general controls provisions, rather than the specific technical performance studies of the device.

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

IPL Hair Removal Device (Models: U04 MK, U104 BN, U104 CB, U104 GY, U104 LG, U104 DG, UI04 PL, U104 PN, UI04 SD, UI04 SG, UI04 MG)

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for an IPL Hair Removal Device. It details the regulatory clearance for the device and its indications for use.

The document does not contain any information regarding acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or specific details about ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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

IPL Hair Removal Device (Model: UI04 SD, UI04 DG), is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.

The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts irreplaceable treatment window and the spot size is 3.3cm² that is suitable for multiple hair removal areas. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

IPL Hair Removal Device, model: UI04 SD, UI04 DG have the same indication for use, performance, structure design and operation, the only deference is their enclosure color (UI04 SD is Star White and UI04 DG is Dark Green).

This document is a 510(k) summary for an IPL Hair Removal Device (models UI04 SD, UI04 DG). It outlines the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence.

Based on the provided text, the device in question is an IPL Hair Removal Device. The 510(k) submission primarily focuses on non-clinical performance data to support substantial equivalence, rather than a clinical study involving human readers or AI-assisted diagnostic performance. Therefore, many of the requested elements related to MRMC studies, ground truth establishment for AI, and expert adjudication are not applicable to this type of device and submission.

Here's an analysis of the acceptance criteria and performance as described in the document, focusing on the information that is present:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device's 510(k) clearance are primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices through non-clinical performance testing related to safety and fundamental functionality. The document doesn't present specific quantitative performance metrics like sensitivity, specificity, or AUC, as would be typical for AI/diagnostic devices. Instead, the "performance" is demonstrated by meeting various safety and usability standards and having comparable technical characteristics to cleared predicates.

Study That Proves the Device Meets Acceptance Criteria:

The "study" in this context is a series of non-clinical tests and a detailed comparison to predicate devices, rather than a clinical trial or an AI performance study as might be expected for diagnostic algorithms.

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

   • Test Set (for non-clinical validation): The document does not specify "sample sizes" in the way one would for patient data (e.g., number of patients or images). Instead, testing was performed on physical units of the device and its components to verify their compliance with various electrical, safety, biocompatibility, and usability standards. The number of devices or components tested is not specified but is assumed to be sufficient for standard regulatory compliance testing.
   • Data Provenance: The testing appears to be conducted by the manufacturer or third-party labs on the device itself. The document implicitly suggests this is prospective testing done specifically for this submission. The country of origin of the data is not explicitly stated beyond the manufacturer being in Shenzhen, China.

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

   • Not Applicable. This submission is for an IPL hair removal device, not an AI diagnostic device requiring expert interpretation of medical images or patient outcomes for ground truth. Ground truth in this context means compliance with engineering and safety standards, verified by testing according to those standards.

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

   • Not Applicable. As there are no human readers interpreting data, an adjudication method is irrelevant. Test results against established standards (e.g., pass/fail for electrical safety tests) serve as the "ground truth."

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 study was not conducted as this is not an AI-assisted diagnostic device.

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

   • No. This is not a standalone AI algorithm. The software mentioned is for controlling the device's functions, not for diagnostic or analytical purposes.

6. The type of ground truth used:

   • For Biocompatibility: Positive/negative controls in in vitro cytotoxicity and skin sensitization tests, and adherence to ISO standards.
   • For Electrical Safety/EMC/Eye Safety: Pass/fail criteria defined by the respective international standards (e.g., IEC 60601 series, IEC 62471).
   • For Software V&V: Fulfillment of software requirement specifications and mitigation of identified software hazards.
   • For Usability: Compliance with usability standards and FDA guidance on human factors, likely demonstrated through risk analysis and verification activities.
   • For Functional Equivalence: Comparison of technical specifications (wavelength, energy density, etc.) against those of legally marketed predicate devices.

7. The sample size for the training set:

   • Not Applicable. This device does not use an AI model trained on a data set in the typical sense (e.g., medical images for diagnosis). The term "training set" doesn't apply to the non-clinical performance and safety testing described.

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

   • Not Applicable. See point 7.

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