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The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.

Intense Pulsed Light (IPL) System, models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF, are a small over-the-counter device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the power adapter and its IPL emission activation is by a switch or auto light emission.

Intense Pulsed Light (IPL) System, all models, contains a Xenon arc flashlamp, and a touch chip to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses.

Intense Pulsed Light (IPL) System, models: T002AQ, T002AD, T002AF, contains a Xenon arc flashlamp, a touch chip to detect appropriate skin contact, and a skin color sensor to detect the skin color. In "Skin Color Recognition mode", the device's skin sensor automatically detects skin tone for your protection. If your skin tone is not in tone table suitable for treatment, the device must not be used. You need to identify your skin tone before treatment according to skin tone table, and confirm whether the product is applicable to you after the skin color sensor detects a skin tone.

Based on the cooling technology, Intense Pulsed Light (IPL) System, models: T033KQ, T033KD, T033KF, T055KQ, T055KD, T055KH, T050KQ, T050KD, T050KF, has cooling care functions. When the cooling care mode is enabled, it can reduce the excessive heat generated on the skin by the photon irradiation and do cooling compresses during hair removal.

Based on the dual pulse technology, Intense Pulsed Light (IPL) System, models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T050KQ, T050KD, T050KF, has single pulse and dual pulse functions.

The Intense Pulsed Light (IPL) System includes main unit, an adaptor and goggles.

This FDA 510(k) clearance letter and summary describe an Intense Pulsed Light (IPL) System for hair removal. However, it does not contain the detailed acceptance criteria or the specific study outcomes that prove the device meets these criteria in the context of an Artificial Intelligence (AI) enabled device. The provided document primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technical specifications and non-clinical performance data (biocompatibility, electrical safety, eye safety, and general software V&V).

The request specifically asks about acceptance criteria and study data for an AI-enabled device. This document describes a traditional medical device (IPL) and lists "Software Verification and Validation" as a performance data point, but this typically refers to the functional soundness of the device's embedded software, not necessarily an AI algorithm. There is no mention of deep learning, machine learning, or algorithms that would perform diagnostic or treatment-related AI-driven functions.

Therefore, I cannot extract the requested information regarding AI acceptance criteria, specific study performance metrics for an AI component, sample sizes for AI test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, because this information is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance (Non-AI Focused)

Since the document doesn't detail AI-specific acceptance criteria or performance metrics, the "acceptance criteria" can be broadly inferred from the tests performed to demonstrate substantial equivalence to the predicate device. The "reported device performance" is the successful completion of these tests.

Missing Information Regarding AI-Enabled Device Performance

The following information cannot be provided as it is not present in the provided FDA 510(k) clearance letter and summary for an AI-enabled device. This document describes a standard IPL device.

1. Sample sizes used for the test set and the data provenance: Not applicable/Not provided for an AI test set. The document refers to non-clinical tests (biocompatibility, electrical safety, etc.), which don't involve test sets of patient data in the context of AI.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth establishment with experts is a key component of AI algorithm validation, which is not described here.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable/Not provided. The device is not described as providing AI assistance to human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided.
7. The sample size for the training set: Not applicable/Not provided. Training sets are relevant for AI algorithms.
8. How the ground truth for the training set was established: Not applicable/Not provided.

Conclusion: The provided FDA 510(k) document is for a non-AI medical device (Intense Pulsed Light System). While it includes software verification and validation, this refers to the functional and safety aspects of embedded device software, not a sophisticated AI algorithm for interpretation or assistance that would require the detailed clinical validation metrics requested in the prompt.

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The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.

Intense Pulsed Light (IPL) System, models: T023K, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T011C, T016K, are a small over-the-counter device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission.

Intense Pulsed Light (IPL) System, models: T023K, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001N, Contains a Xenon arc flashlamp, a touch chip to detect appropriate skin contact, and a skin color sensor to detect the skin color. In "Skin Color Recognition mode", the device's skin sensor automatically detects skin tone for your protection. If your skin tone is not in tone table for treatment, the device must not be used. You need to identify your skin tone before treatment according to skin tone table, and confirm whether the product is applicable to you after the skin color sensor detects a skin tone.

Intense Pulsed Light (IPL) System, models: T011C and T016K, contains a Xenon arc flashlamp, and a touch chip to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses.

Based on the cooling technology, Intense Pulsed Light (IPL) System, models: T023A, T023B, T023D, T023E, T021K, T021A, T011C, T016K, has cooling care functions. When the cooling care mode is enabled, it can reduce the excessive heat generated on the skin by the photon irradiation and do cooling compresses during hair removal.

The Intense Pulsed Light (IPL) System includes main unit, an adaptor and goggles.

The provided text is a 510(k) summary for an Intense Pulsed Light (IPL) System. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical study acceptance criteria and results for the new device's performance.

Therefore, the document explicitly states: "There was no clinical testing performed."

As such, the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria (including sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information) is not available in the provided text.

The document primarily discusses non-clinical tests performed to ensure safety and effectiveness by complying with recognized consensus standards (e.g., electrical safety, EMC, biocompatibility, software verification). The "Discussion of Non-Clinical Tests Performed for Safety and effectiveness" section lists these standards but does not provide specific performance metrics or acceptance criteria related to a clinical outcome of hair removal effectiveness for the subject device.

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The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.

Intense Pulsed Light (IPL) System is a small over-the-counter device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The Intense Pulsed Light (IPL) System includes main unit, an adaptor and goggles. The device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission. Based on the ice-cool technology, the hair removal device with ice-cold compress functions.

I apologize, but the provided text does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of typical AI algorithm performance evaluation.

The document discusses the substantial equivalence of an "Intense Pulsed Light (IPL) System" (models T013C, T015C, T015K) to a predicate device (model T012C) for the purpose of removing unwanted body hair.

Here's a breakdown of why it doesn't fit the request for AI algorithm performance:

• Device Type: This is a physical medical device (an IPL system), not an AI algorithm.
• "Acceptance Criteria" in this context: The "acceptance criteria" here refer to meeting regulatory standards for medical device safety and effectiveness to demonstrate substantial equivalence to a predicate device, rather than performance metrics for an AI algorithm (e.g., sensitivity, specificity, AUC).
• "Study that proves the device meets the acceptance criteria": The document refers to non-clinical testing (electrical safety, EMC, photobiological safety, biocompatibility, software life cycle processes) to demonstrate substantial equivalence and mitigate risks associated with minor design changes. There is explicitly no clinical testing performed (as stated in Section 8).

Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types, as these are related to AI algorithm validation, which is not what this document describes.

The document focuses on non-clinical testing and regulatory compliance for a hardware device.

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The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.

Intense Pulsed Light (IPL) System, model: T012C

I am sorry, but based on the provided FDA 510(k) clearance letters (K212881) for the "Intense Pulsed Light (IPL) System," there is no information available regarding the acceptance criteria, the study that proves the device meets those criteria, or any details about a clinical study.

The documents provided are administrative notifications from the FDA concerning the substantial equivalence determination for an IPL device. They primarily cover:

• Administrative Correction: A notice updating contact information.
• Substantial Equivalence Determination: A letter stating that the device is substantially equivalent to legally marketed predicate devices.
• Regulatory Information: Details about regulations, product codes, a reminder about compliance with general controls, and information on post-market reporting.
• Indications for Use: Stating the device is an over-the-counter device intended for the removal of unwanted body hair.

None of these documents contain the kind of detailed clinical study information (acceptance criteria, performance data, sample sizes, expert qualifications, ground truth establishment, MRMC studies, etc.) that you are asking for.

To get the information you are requesting, you would typically need to refer to the device's 510(k) summary or the full 510(k) submission, neither of which is provided in the input text. FDA 510(k) summaries, when available, often contain a brief overview of the performance data submitted for clearance, if performance data was required and submitted. However, for a Class II device like this IPL system, clearance is often based on demonstrating substantial equivalence to a predicate device, which may or may not require new clinical performance data if the technological characteristics and intended use are sufficiently similar to the predicate.

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The Intense Pulsed Light (IPL) Systems (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic and cosmetic applications in permanent hair reduction, treatment of pigmented lesions, moderate inflammatory acne vulgaris, ephelides (freckles), and vascular lesions.

The Intense Pulsed Light (IPL) Systems are intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 430nm-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin. IPL Systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores.

The provided text describes a 510(k) submission for the Intense Pulsed Light (IPL) Systems (K122995), which seeks to demonstrate substantial equivalence to a predicate device (IPULSELIGHT IPL SYSTEM, K093627). However, it does not contain information about a clinical study demonstrating the device's performance against specific acceptance criteria.

The document focuses on non-clinical bench tests to verify that the proposed device met design specifications and standard compliance, and a detailed comparison with the predicate device to establish substantial equivalence.

Therefore, many of the requested sections regarding acceptance criteria, study details, human reader performance, and ground truth establishment cannot be fulfilled from the provided text.

Here's a breakdown of what can be extracted and what is missing:

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

Based on the provided text, there are no specific performance acceptance criteria reported for clinical efficacy. The "acceptance criteria" discussed are primarily related to safety and technical specifications, which are implicitly met by complying with the listed standards and demonstrating similarity to the predicate device.

Safety and Technical Performance Criteria (Inferred from compliance and comparison):

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

Not applicable/Not provided. The document states "Bench tests were conducted to verify that the proposed device met all design specifications," and these appear to be primarily engineering and safety compliance tests, not clinical performance studies involving a "test set" of patients or data in the typical sense of AI/diagnostic device evaluation. No information on data provenance or study type (retrospective/prospective) is available.

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/Not provided. No clinical ground truth establishment is mentioned, as there is no clinical performance study described.

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

Not applicable/Not provided. This is relevant for studies involving human assessment of data, which is not described here.

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. A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an IPL system for various cosmetic and therapeutic applications, not an AI-assisted diagnostic or interpretation tool. The submission is for a medical device that directly performs a treatment.

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

Not applicable. The device is a physical IPL system, not an algorithm, and its performance is inherently human-in-the-loop (operated by a practitioner).

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

Not applicable/Not provided. For a treatment device, "ground truth" would typically refer to clinical outcomes measured against a recognized standard of care or objective physiological changes. No such clinical performance data or ground truth validation is detailed in this 510(k) summary, as the submission relies on substantial equivalence to the predicate device and compliance with safety standards rather than a de novo clinical efficacy study.

8. The sample size for the training set

Not applicable/Not provided. As there is no AI algorithm being developed or evaluated, there is no "training set" in this context.

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

Not applicable/Not provided. See point 8.

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