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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, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed eight models with the same IPL technology for hair removal, which is model DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.

The device is only powered by the external power adapter and its IPL emission activation is by finger switch.

The IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.0± 0.25cm2 (Model BDE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-V, DE03B-V, DE03B-G) that is suitable for multiple hair removal areas, such as large areas (e.g. arms, legs) and small areas (e.g. bikini line).

The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the cooling function, which can be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.

The provided text is a 510(k) summary for an IPL Hair Removal Device. It focuses on demonstrating substantial equivalence to predicate devices, but it does not contain information regarding detailed acceptance criteria for hair removal efficacy/safety or the study that proves the device meets such criteria.

The document primarily covers non-clinical performance data related to:

1. Biocompatibility Evaluation: Conducted according to ISO 10993-1.
2. Electrical Safety and EMC: Tested against IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, and IEC 60601-2-83.
3. Eye Safety: Tested according to IEC 62471.
4. Software Verification and Validation: Documentation consistent with moderate level of concern, demonstrating meeting specifications and mitigating hazards.
5. Usability: Evaluated according to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices."

The document states that the "IPL Hair Removal Device is 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." However, it does not provide any performance data from a clinical study to demonstrate this claim. It explicitly states that "Performance data supports that the device is safe and as effective as the predicate device and reference device for its intended use" but immediately follows this by only listing non-clinical testing.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving those criteria are met, as that specific type of data is not present in the provided text.

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The Medical Electronic Thermometer (FC0). FC02) is intended to measure the human body temperature under the arm. The devices are reusable for clinical or home use for people of all ages.

The Medical Electronic Thermometer (FC01, FC02) is a hand-held device which can measure human body temperature at the site of the armpit. The devices are reusable for clinical or home use for people of all ages. The results can be displayed on the LCD. The FC01 and FC02 have only one operating mode which is direct mode. The Medical Electronic Thermometer measures human body temperature by placing the probe tip under the armpit with a measuring time of about 300 seconds. The Medical Electronic Thermometer consists of a temperature sensor (NTC), low power integrated circuit (IC), buzzer, and battery. The resistance of sensor changes with temperature and the integrated circuit (IC) converts the resistance to frequency and calculates the temperature according to the relation of resistance and frequency. The calculated temperature is displayed on the LCD.

The provided text is a 510(k) summary for a medical electronic thermometer. It details the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence. However, it does not contain information about a study proving the device meets specific acceptance criteria for AI/ML performance, nor does it mention any AI or machine learning components within the device itself.

The document discusses the device's accuracy and performance in relation to established standards for clinical thermometers, which are relevant to device performance but not to the acceptance criteria of an AI/ML model.

Therefore, I cannot fulfill the request to provide acceptance criteria and a study proving an AI/ML device meets those criteria based on the provided text. The text describes a standard medical electronic thermometer and its regulatory clearance process, not an AI-powered device.

To answer your request, if this were an AI/ML medical device, the information you're asking for would typically be found in detailed clinical validation studies, often submitted as part of a 510(k) or PMA submission for AI-driven technologies.

Based only on the provided text, here’s what I can extract regarding device performance, acknowledging that it's for a traditional thermometer, not an AI/ML device:

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

The document refers to adherence to international standards for thermometer performance. The acceptance criteria for the thermometer's performance are defined by these standards, specifically ISO 80601-2-56 and ASTM E1112-00(2018).

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 does not specify sample sizes for performance testing. It states that "Performance data were provided in support of the substantial equivalence determination" and lists the standards adhered to. For a traditional thermometer, performance testing generally involves laboratory bench testing rather than large-scale clinical trials with "test sets" in the way an AI/ML model would use them. No information on data provenance (country, retrospective/prospective) is provided, as this is not detailed for a standard thermometer's testing.

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. This device is a standard medical electronic thermometer, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. Its performance is validated against physical reference standards and established protocols for temperature measurement.

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

Not applicable. See point 3.

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 a standard medical electronic thermometer and does not involve AI assistance for human readers/clinicians, nor does it process medical images.

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

Not applicable. The device itself is standalone in its function as a thermometer, but there is no "algorithm" in the sense of an AI/ML model being assessed for standalone performance. Its performance is evaluated against physical measurement standards.

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

The ground truth for thermometer performance is based on traceable temperature standards and established metrology principles, as outlined in the referenced ISO and ASTM standards. It's not based on expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set

Not applicable. This device does not use a training set as it is not an AI/ML model.

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

Not applicable. See point 8.

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The Intense pulsed light device is an over-the-counter device, intended for removal of unwanted body and/or facial hair.

The Intense pulsed light device is a personal, light-based, hair reduction device. The device provides hair reduction using IPL technology. Of which, the Device includes DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G twelve models. All have adopted the same structure design, consisting of Intense pulsed light device main body and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is powered from power adapter via an external power. The difference of all models is mainly product size, appearance, sapphire, skin color recognition function and enclosure color, DE01A series means without sapphire and skin color recognition function. DE01B series means with sapphire, but without skin color recognition function. DE01C series means with sapphire and skin color recognition function. DE02A series means without sapphire and skin color recognition function. DE02B series means with sapphire, but without skin color recognition function. DE02C series means with sapphire and skin color recognition function. Letter -B the enclosure color is blue, letter -G is green, which do not affect the intended use.

The provided text is a 510(k) summary for an Intense Pulsed Light (IPL) device intended for over-the-counter hair removal. It details the device's characteristics, comparison with predicate devices, and performance data submitted to support substantial equivalence.

However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of advanced AI/ML performance metrics (e.g., accuracy, sensitivity, specificity). The performance data shared are related to:

1. Biocompatibility Testing: Ensuring the device materials are safe for human contact.
2. Electrical Safety and EMC: Verifying the device meets electrical safety and electromagnetic compatibility standards.
3. Eye Safety: Confirming the device is safe for eye exposure.
4. Software Verification and Validation: Demonstrating that software meets requirements and mitigates hazards.
5. Usability: Evaluating and verifying the product's usability.

These are standard regulatory requirements for medical devices, particularly for consumer-grade devices like the IPL hair removal system. They are not AI/ML performance metrics.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to AI/ML, nor details about a study proving this in the context of an AI-driven device, because the provided text is for a physical IPL device and does not mention any AI/ML components or associated performance studies. The request's questions (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are specific to the evaluation of AI/ML algorithms in medical imaging or diagnostics, which is not the subject of this 510(k) submission.

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