Search Results

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

The Red Light is intended to treat full face wrinkles.
The Blue Light is intended to treat mild to moderate inflammatory acne.
The Yellow Light is intended to treat wrinkles.

The GLAM LED light therapy mask is a home use wearable light emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full face wrinkles and mild to moderate acne of the face. The outer shell of the mask is manufactured from Polyethylene terephthalate (PET). The inner shell is a clear Polycarbonate (PC). The Light emitting diodes are mounted behind the clear Polycarbonate. The LEDs generate the light. The ear hooks are made of Acrylonitrile butadiene styrene (ABS) and the silicone goggle protect the eyes from LED lights. Unfold the ear hooks and place the mask on your face, the mask will automatically activate the light therapy mode. The LEDs produce blue, red and yellow light in the visible spectrum (Blue:415nm +/- 10nm, Yellow: 590nm +/-10nm, Red: 625nm +/-10nm.). The device works by emitting the specified wavelengths to treat full face of wrinkles or to treat mild to moderate inflammatory acne. Press the touch switch on the right ear hook twice to select the light therapy mode you want to use. Each mode operates in a 15-minute cycle. After 15 minutes, the device automatically deactivates the light mode and enters the standby mode.

This FDA 510(k) clearance letter for the GLAM LED Facial Mask (TB-2386F) does not include any information regarding clinical testing, acceptance criteria for device performance related to efficacy (e.g., wrinkle reduction or acne treatment), or studies comparing the device's performance against such criteria.

The letter focuses on the substantial equivalence based on:

• Technological Comparison: Comparing light wavelengths, power density, and treatment time to predicates.
• Safety Standards Compliance: Verification through non-clinical tests (electrical safety, EMC, biocompatibility, photobiological safety, software verification).

Therefore, I cannot provide details on the specific acceptance criteria for efficacy or a study proving the device meets those criteria from the provided document. The 510(k) summary explicitly states: "No animal or clinical study is included in this submission."

However, if we were to hypothesize what acceptance criteria and a study might look like for a device with these indications, and then illustrate what would be missing from this document:

Hypothetical Acceptance Criteria and Performance Study (Not Found in Provided Document):

Since the provided document explicitly states no clinical study was included, the following tables and sections represent what would typically be expected for a device claiming therapeutic efficacy, but none of this information is present in the provided 510(k) clearance letter.

Hypothetical Acceptance Criteria and Reported Device Performance (If Clinical Data Existed)

Ask a specific question about this device

Monoject Syringes with Luer tip are intended for single use by health care professionals for general purpose fluid aspiration and and/or injection.

Not Found

The provided FDA 510(k) clearance letter pertains to Monoject™ Syringes, which are physical medical devices (piston syringes) and not an AI/ML software device. Therefore, the concepts of acceptance criteria for algorithm performance, study methodology for AI models, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to this document.

The letter indicates that the device has received substantial equivalence to legally marketed predicate devices, meaning it meets the safety and effectiveness requirements for its intended use, which is general purpose fluid aspiration and/or injection by healthcare professionals.

To answer your request, if this were an AI/ML device, the information would typically be found in the 510(k) submission summary or a separate clinical study report, neither of which is present in the provided FDA clearance letter. The letter itself is a notice of clearance, not a detailed technical report of the studies performed.

Therefore, I cannot extract the requested information from the provided document as it does not contain details about an AI/ML study or its performance criteria.

Ask a specific question about this device

The LED Light Therapy Mask (Model: FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.

FCM902, FCM905, FCM906, FCM908:
a.Red light: Treatment of full-face wrinkles.
b.Blue+Infrared light: Treatment of mild to moderate inflammatory acne.
c.Yellow+Infrared light: Treatment of full-face wrinkles.

11-001-RBMASK:
a.Red+Infrared light: Treatment of full-face wrinkles.
b.Blue light: Treatment of mild to moderate inflammatory acne.

FCM910:
a.Red+Infrared light: Treatment of full-face wrinkles.
b.Blue light: Treatment of mild to moderate inflammatory acne.
c.Yellow+Infrared light: Treatment of full-face wrinkles.

The LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) adopts light emitting diodes (LED) in the red (630nm ±5nm) , infrared (880nm±5nm) and blue (415±5nm) spectrum to irradiate on the face to realize its therapeutic effect.

For FCM902, FCM905, FCM906, FCM908 and FCM910, it also contain yellow (590±5nm) spectrum and green (520±5nm) spectrum.

The LED Light Therapy Mask 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 (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.

a. Red light: Treatment of full-face wrinkles.
b. Blue+Infrared light: Treatment of mild to moderate inflammatory acne.
c. Yellow+Infrared light: Treatment of full-face wrinkles.
d. Green Light: light in wavelength 520nm(±5nm). Green light makes users feel like they are outside in a green world, which may make users relax, which has no medical therapeutic effect.
e. Red+Infrared light: Treatment of full-face wrinkles.
f. Blue light: Treatment of mild to moderate inflammatory acne.

The provided FDA 510(k) Clearance Letter concerns an LED Light Therapy Mask for treating wrinkles and mild to moderate inflammatory acne. However, this document is a clearance letter and a 510(k) summary, not a clinical study report. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing.

Therefore, the document does NOT contain the details required to answer many of the specific questions about acceptance criteria and the study that proves the device meets those criteria, particularly those related to clinical performance, human reader studies, or expert ground truth.

The information provided is mostly about device specifications, comparison to predicates, and compliance with non-clinical safety standards (electrical safety, biocompatibility, photobiological safety). It states that "Non-clinical testings have been conducted to verify that the LED Light Therapy Mask meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device."

Based on the provided text, I can only address what is explicitly mentioned or can be reasonably inferred. Most of the questions below would require a separate clinical study report, which is not part of this 510(k) summary.

Acceptance Criteria and Device Performance (Based only on the provided 510(k) Summary):

The acceptance criteria for this device, as inferred from the 510(k) summary, are primarily centered around Substantial Equivalence (SE) to legally marketed predicate devices for the specified indications for use, and compliance with relevant safety and performance standards for an OTC device. The "performance" reported is largely in terms of meeting these technical and safety standards, rather than clinical efficacy metrics from a new human study.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the study that proves the device meets the acceptance criteria:

Based solely on the provided 510(k) summary, the "study" proving the device meets acceptance criteria appears to be a non-clinical testing program focused on product safety and performance standards for substantial equivalence. There is no mention of a human clinical study, an AI component requiring a test set for diagnostic accuracy, or experts establishing ground truth in a clinical context within this document.

Therefore, I cannot provide answers for many of the following questions as the requested information is not present in the provided text.

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

• Not applicable / Not provided. The document describes non-clinical testing of the device itself (electrical, photobiological, biocompatibility, software V&V), not a clinical test set from patients.

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

• Not applicable / Not provided. There is no mention of a test set requiring expert-established ground truth for performance evaluation in this 510(k) summary. This typically applies to AI/CADe devices or clinical efficacy studies, neither of which are detailed here.

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

• Not applicable / Not provided. Since no clinical test set or expert ground truth process is described, an adjudication method is irrelevant.

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, not done / Not applicable. This device is an LED light therapy mask, not an AI-assisted diagnostic tool. An MRMC study is completely irrelevant to this type of device and its 510(k) clearance.

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

• Not applicable. There is no "algorithm only" performance study as this is a physical light therapy device, not a diagnostic algorithm.

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

• Not applicable / Not provided for clinical efficacy. For the non-clinical tests, the "ground truth" would be the specified parameters and limits of the IEC/ISO standards (e.g., maximum allowable leakage current, certified photobiological safety levels, biocompatibility thresholds). There is no mention of a clinical ground truth (e.g., for wrinkle reduction or acne treatment) from a study in this document.

8. The sample size for the training set:

• Not applicable / Not provided. This device is cleared based on substantial equivalence and compliance with non-clinical performance standards. It implies a known or existing mechanism of action (light therapy) rather than a newly developed AI algorithm that requires a training set of data.

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

• Not applicable / Not provided. As no training set for an algorithm is mentioned, the method for establishing its ground truth is also not applicable.

Ask a specific question about this device

TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

EMS: The device is designed to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. The device is designed to temporarily increase local blood circulation in healthy leg muscles.

Not Found

The provided FDA 510(k) Clearance Letter for Shenzhen Yicai Health Technology Co. Ltd's Transcutaneous Electrical Nerve Stimulator (TENS) does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, particularly for an AI/ML medical device.

This document is a standard clearance letter for a physical medical device (TENS/EMS) and focuses on regulatory aspects like:

• Substantial equivalence to predicate devices.
• General controls (registration, listing, GMP, labeling, misbranding).
• Quality System (QS) regulation.
• Unique Device Identification (UDI) requirements.
• Indications for Use.

It does not detail performance studies conducted to establish effectiveness or safety beyond establishing substantial equivalence to a predicate. Specifically, it lacks any mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or effect sizes for human readers.
• Standalone algorithm performance.
• Type of ground truth used.
• Training set sample size or ground truth establishment for training.

Therefore,Based on the provided FDA 510(k) clearance letter, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the manner requested. The letter is for a physical medical device (Transcutaneous Electrical Nerve Stimulator) and outlines its regulatory clearance, not the details of a performance study, especially not one applicable to an AI/ML device as your detailed questions suggest.

The document does not contain any information related to:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This is a clearance letter for a device whose mechanism of action is electrical stimulation, not an AI/ML algorithm. The information you are seeking would typically be found in the 510(k) summary or the full submission, which are not included in this clearance letter.

Ask a specific question about this device