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LED Light Therapy Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne.

The LED Light Therapy Mask adopts light emitting diodes (LED) in the red (620mm±10mm), blue (460±10nm) and infrared (850nm=10nm) spectrum to irradiate on the face to realize its therapeutic effect. The LED Light Therapy Mask adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller (Only for SKB-2318L,SKB-2318PRO, IN-FM002,SKB-2418) is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, LED Light Therapy Mask has incorporated protective eye-shield which blocks light energy from LEDs.

The provided document describes the substantial equivalence of the "LED Light Therapy Mask" to predicate devices, referencing several non-clinical tests. However, it does not contain information about acceptance criteria or a "study that proves the device meets the acceptance criteria" in the context of clinical performance data, particularly for the treatment of wrinkles and mild to moderate acne.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
• 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)
• Adjudication method (e.g., 2+1, 3+1, none) for the test set
• 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
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on non-clinical aspects related to safety and general functionality, such as electrical safety, EMC, eye safety, and biocompatibility, to demonstrate substantial equivalence to previously cleared devices. It states: "Performance data supports that the device is safe predicate device and reference devices for its intended use," but does not detail what "performance data" was used to support efficacy claims for wrinkles and acne treatment.

The only "non-clinical studies and tests performed" explicitly mentioned are:

1. Electrical Safety and EMC (Standards: ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 62133-2)
2. Eye Safety (Standard: IEC 62471 Photobiological safety of lamps and lamp systems)
3. Biocompatibility Testing (Standards: ISO 10993-5, ISO 10993-10, ISO 10993-23)
4. Software verification and validation test (According to FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices")

These tests are primarily for device safety and regulatory compliance, not for assessing the clinical efficacy of the LED Light Therapy Mask's stated indications for use (treatment of wrinkles and mild to moderate acne). For a device making therapeutic claims, clinical performance data would typically be required to demonstrate effectiveness. Based on the provided text, this information is not available.

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IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.

The subject device IPL Cooling Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. Also, the subject device is equipped with cooling function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use.

The provided text is a 510(k) Pre-market Notification for an IPL Cooling Hair Removal Device. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, it does not contain the specific information required to complete the table and answer all the questions about acceptance criteria and the study proving the device meets those criteria.

The document primarily focuses on:

• Device Description: What the device is and how it works (IPL technology for hair reduction).
• Comparison to Predicate Device: Technological characteristics like wavelength range, energy density, spot size, pulse duration, and indications for use.
• Performance Data: This section outlines types of testing performed (Biocompatibility Safety, Electrical Safety and EMC Safety, Eye Safety, Software Verification and Validation) and states that the tests passed.

Missing Information:

The document explicitly states that "Performance data supports that the device is safe and as effective as the predicate device for its intended use." However, it does not provide quantitative acceptance criteria or the specific numerical results of those tests (reported device performance) for comparison. It only lists the types of tests performed and the standards they adhered to.

Specifically, the document does not contain any information regarding clinical performance studies, human reader studies, or the establishment of ground truth for such studies. The performance data provided are related to electrical safety, biocompatibility, eye safety, and software validation, which are typically assessed against published standards rather than through clinical effectiveness studies with explicit acceptance criteria for diagnostic or treatment accuracy.

Therefore, I cannot fully complete the table or answer questions 2-9 based on the provided text.

Here's how I can address what is available and highlight the missing parts:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes engineering and biocompatibility tests, not clinical studies with patient test sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as no clinical effectiveness study with human assessment of ground truth is detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as no clinical effectiveness study requiring expert adjudication is detailed.

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

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. This is not an AI algorithm, but a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the safety and performance tests mentioned (biocompatibility, electrical safety, eye safety, software), the "ground truth" is defined by the technical standards (e.g., ISO, IEC). For clinical effectiveness (hair removal), no specific ground truth methodology is described for the subject device, although it is asserted to be "as effective as" the predicate.

8. The sample size for the training set
This information is not provided as it's not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established
This information is not provided as it's not an AI/machine learning device requiring a training set.

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IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.

The subject device IPL Cooling Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. Also, the subject device is equipped with cooling function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use.

The provided document is a 510(k) summary for an IPL Cooling Hair Removal Device, which does not typically include information on clinical studies with acceptance criteria as would be found for a diagnostic device. The device is for cosmetic hair removal and its substantial equivalence is based on engineering performance tests and comparison to a predicate device, rather than a clinical effectiveness study with human subjects in the same way an AI-driven diagnostic device might be evaluated.

Therefore, many of the requested categories for a clinical effectiveness study are not applicable or not provided in this document. The device is regulated as a Class II laser surgical instrument for use in general and plastic surgery and in dermatology, but it is indicated for over-the-counter use for unwanted body hair removal.

Here's a breakdown of the information that is available or applicable based on the provided text, and what is not applicable or not provided:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, acceptance criteria are generally based on meeting specified engineering and safety standards, and demonstrating substantial equivalence to a predicate device.

The study that proves the device meets the acceptance criteria is a set of safety and performance tests conducted in accordance with recognized international standards, along with a comparison of technological characteristics to a legally marketed predicate device (K221001).

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

• Not Applicable/Not Provided. The document describes engineering and safety testing, not a clinical trial with a "test set" of patient data. The tests are performed on the device itself or on components (e.g., biocompatibility on materials).

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

• Not Applicable/Not Provided. This is not a diagnostic device requiring expert consensus for ground truth on medical images or diagnoses. Compliance with standards is typically assessed by testing laboratories and regulatory bodies.

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

• Not Applicable/Not Provided. Adjudication methods are relevant for clinical trials or diagnostic accuracy studies, not for device safety and performance testing against engineering standards.

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/Not Provided. This device is an IPL hair removal device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant.

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

• Not Applicable/Not Provided. This is not an algorithmic device in the context of an AI-driven medical device. Its "software" (for moderate level of concern) would be for device control and safety features, not for standalone diagnostic or analytical performance.

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

• The "ground truth" for this device's acceptance is based on compliance with established international safety and performance standards (e.g., ISO for biocompatibility, IEC for electrical and eye safety), and demonstrating substantial equivalence in technological characteristics and intended use to a legally marketed predicate device. For hair removal effectiveness, the substantial equivalence to an already cleared device implies assumed effectiveness, but no specific effectiveness study data is detailed in this summary.

8. The sample size for the training set

• Not Applicable/Not Provided. This is not an AI/machine learning device that would have a "training set."

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

• Not Applicable/Not Provided. As there is no training set mentioned, this question is not applicable.

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The Galvanic Spa (Model: SKB-1405) is intended for facial stimulation and is indicated for over-the-counter cosmetic use. The anatomical site for application of the Galvanic Spa is the face.

Galvanic Spa, Model: SKB-1405 is a non-invasive facial toning device intended for facial stimulation. It produces micro-current discharged through the dual probes that are designed for optimal contact with faces of all shapes and sizes.Micro-current is an aesthetic modality providing electric current in millionths of an ampere and has the ability to increase facial contour and firm the skin and muscles by supplying 0-390 μΑ.

Galvanic Spa, Model: SKB-1405 is not for use on injured or otherwise impaired skin or muscles, and in any therapy for the treatment, or prevention of any disease. This device is not for use near any devices with Electromagnetic Interference (EMI). This device must only be used for the purpose stated - namely for the stimulation of facial muscles as indicated in the instruction manual for personal beauty purposes. All other uses shall be deemed improper.

The provided text is a 510(k) summary for the "Galvanic Spa, Model: SKB-1405" device. It focuses on demonstrating substantial equivalence to a predicate device, not on proving that the device meets specific acceptance criteria through a clinical study or performance study with a test set, ground truth, or expert readers in the context of AI/machine learning.

Therefore, most of the information requested in your prompt (acceptance criteria, details of a study using a test set, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, training set information) is not present in this type of regulatory submission for this particular device.

This document primarily addresses:

• Device Description and Intended Use: The Galvanic Spa is a non-invasive facial toning device intended for facial stimulation for over-the-counter cosmetic use.
• Comparison to a Predicate Device: The core of the submission is to show substantial equivalence to the NūFACE® Plus device (K103472).
• Bench Testing and Compliance with Standards: The document mentions various bench tests conducted to ensure safety and performance, such as electrical safety tests (IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility tests (IEC 60601-1-2), software verification and validation, and waveform tests.
• Biocompatibility Testing: Details are provided for cytotoxicity, skin sensitization, and skin irritation tests for patient-contacting materials (electrodes made of stainless steel).

The prompt's questions are designed for a situation where a new AI/ML-driven medical device is being evaluated for its diagnostic or prognostic performance against a ground truth, often involving human readers. This document describes a physical electrical stimulation device that does not perform such functions, and as such, the type of "study" described in the prompt is not applicable here.

Here's a breakdown of why the requested information is largely absent or not applicable:

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

   • Acceptance Criteria (as would be understood for an AI/ML device): Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" for this device are demonstrated by compliance with general safety standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2), biocompatibility standards (ISO 10993-5, ISO 10993-10), and substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety.
   • Reported Device Performance: The performance is reported in terms of physical characteristics (e.g., maximum output current, voltage, pulse duration, frequency), and compliance with the aforementioned safety and biocompatibility standards. There are no performance metrics related to diagnostic accuracy or AI/ML output.

2. Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of AI/ML evaluation. The safety and performance are evaluated through bench testing (measuring electrical characteristics, checking biocompatibility, etc.) and comparison to a known safe and effective predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established by experts in the sense of image interpretation or clinical diagnosis for this device type.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. This is not an AI-assisted diagnostic device requiring human reader comparison studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrical stimulator, not an algorithm. Its "standalone" performance is its electrical output and safety, which is evaluated through bench testing.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device is compliance with engineering specifications, safety standards, and observed physical/electrical properties of the device, attested through various lab tests.

8. The sample size for the training set: Not applicable. This device does not use machine learning, so there is no training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device (Transcutaneous Electrical Nerve Stimulator for Pain Relief, specifically for cosmetic facial stimulation) seeking 510(k) clearance by demonstrating substantial equivalence. It is not an AI/ML device, and therefore the framework of questions you've posed is not suitable for describing its "acceptance criteria" and "study" in the way you intend for AI/ML products.

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