Search Results

The LUSTRE 3XPRESS Light Beauty Therapy patches (Model: PR6001, PR5001) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.

The LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001 and PR5001 is an over-the-counter light emitting diode (LED) device that emits energy to treat mild to moderate acne. The device uses two types of LEDs: 415 nm and 630nm.

The LUSTRE 3XPRESS Light Beauty Therapy patches components include the device containing two Light Beauty Therapy Patches, an USB Cable with an integrated controller, 120 Mini Dots, a Goggles, a Travel pouch and a User Manual. Among them, mini dots are used for fixed device, goggles are used to protect eyes, and travel pouch are used to store device.

There is a total of 24 LEDs for each model to provide a power intensity of about 30 mw/cm².

The user pastes the device on the treatment area, and the device will shut down automatically after a 3minute after finishing treatment.

The two models are only different in shape. PR6001 is triangular and PR5001 is crescent.

The provided text is a 510(k) Summary for the LUSTRE 3XPRESS Light Beauty Therapy patches. It describes the device, its intended use, and a comparison to a predicate device, as well as non-clinical testing performed.

However, the document states that "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

Therefore, I cannot provide information regarding acceptance criteria and the study that proves the device meets them in a clinical context because no clinical study was conducted or presented in this document. The device's approval is based on substantial equivalence to a predicate device and non-clinical performance testing against recognized standards.

Here's a breakdown of what can be extracted or inferred based on the provided text, while explicitly stating what is missing due to the lack of clinical studies:

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

• Clinical Acceptance Criteria and Performance: Not applicable, as no clinical study was performed.
• Non-Clinical Test Standards and Compliance (Acceptance Criteria & Performance):

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, as no clinical test set was used. The non-clinical tests relate to device hardware and software compliance, not patient data.

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, as no clinical test set with a ground truth established by experts was used.

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

• Not applicable, as no clinical test set was used.

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, as no clinical comparative effectiveness study, MRMC study, or AI component involving human readers was mentioned. This device is a light therapy patch, not an AI diagnostic tool.

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

• Not applicable, as this is a physical light therapy device, not an algorithm, and no standalone performance study in a clinical context was conducted.

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

• Not applicable, as no clinical ground truth was established for a clinical study. The "ground truth" for the non-clinical tests is their adherence to the specified technical standards and safety requirements.

8. The sample size for the training set

• Not applicable, as it's a physical light therapy device, not a machine learning algorithm requiring a training set.

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

• Not applicable, as there is no training set for this device.

Ask a specific question about this device

The Infrared Heat (Model: E0221) is intended to emit energy in the red and infrared spectrum for use in the treatment of full face wrinkles.

The Infrared Heat, model: E0221, is an over-the-counter light emitting diode (LED) device that emits 630nm and 830nm light to treat wrinkles. The device uses three types of LEDs and has two modes to reach those two functions. The user can control the treatment time or automatically shut it off within a set time. The Infrared Heat components include the main unit device (a pad), an adjustable strap, a USB charging cord, goggles and a user manual. The user wears the device in the area which needs to treat, and the device will shut down automatically a 10-minute after finishing treatment.

The provided documentation does not describe a study that involves a test set, expert readers, or ground truth establishment in the context of an AI/ML device. The device in question, "Infrared Heat (Model: E0221)," is an LED device intended for the treatment of full face wrinkles. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to previously marketed predicate devices.

The document explicitly states: "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

Therefore, the information requested in the prompt (regarding acceptance criteria, test set, expert readers, ground truth, MRMC studies, standalone performance, training set details) is not applicable to the provided document. The evaluation of this device relies on non-clinical tests and comparison to predicate devices, rather than a clinical study involving human judgment of AI outputs.

The non-clinical tests performed relate to electrical safety, electromagnetic compatibility, photobiological safety, battery safety, biocompatibility, and software/usability testing, all in conformance with specific international standards (e.g., IEC, ISO). The comparison to predicate devices focuses on design principles, intended use, functions, materials, and compliance with standards.

Ask a specific question about this device

The O-Rejuvalight Pro Facewear (Model: P19-0023) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.

The Q-Rejuvalight Pro Facewear is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles and mild to moderate inflammatory acne. The device uses four types of LEDs for Wrinkles: 605nm, 660nm, and 880nm and two types of LEDs for Acne: 415nm and 630nm. Each mode takes 3 minutes (±3s) for a course of treatment, and the mask will automatically turn off at the end of time.

The Q-Rejuvalight Pro Facewear components include the main device, head strap, eye rest, Latch, User Manual, Storage bag and USB power cord.

The Q-Rejuvalight Pro Facewear is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components.

The submitted document is a 510(k) summary for the Q-Rejuvalight Pro Facewear. This document primarily focuses on demonstrating substantial equivalence to predicate devices based on technical specifications and conformity to recognized safety and performance standards. It does not contain information about clinical studies with acceptance criteria, reported device performance metrics in relation to those criteria, or details regarding ground truth establishment, sample sizes for test and training sets, expert adjudication, or MRMC studies for this specific device.

The "Test Summary" section lists various safety and performance standards to which the device was evaluated, indicating compliance with these standards for electrical safety, EMC, photobiological safety, and biocompatibility. However, it does not provide acceptance criteria or specific performance results for clinical efficacy of wrinkle reduction or acne treatment.

Therefore, many of the requested details cannot be extracted from this document, as they are not present in a typical 510(k) summary for this type of device. The information provided below is limited to what can be inferred or directly stated from the document regarding technical specifications and safety testing, not clinical effectiveness studies.

Here's the breakdown of what can and cannot be answered from the provided text:

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

The document does not explicitly state acceptance criteria related to efficacy for wrinkle reduction or acne treatment, nor does it provide reported device performance data against such criteria in a clinical context. The "Test Summary" table lists standards for safety and performance (e.g., electrical safety, EMC, photobiological safety, biocompatibility) that the device complies with, but these are not the clinical acceptance criteria you're asking for.

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

Not provided. The document focuses on bench testing and comparison to predicate devices, not clinical trials with 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)

Not applicable, as no clinical test set with expert-established ground truth is described.

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, 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 light-emitting therapeutic device, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a standalone therapeutic device.

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

Not applicable. The ground truth for this medical device clearance is compliance with safety and performance standards and substantial equivalence to legally marketed predicate devices, not clinical efficacy data based on ground truth outcomes for individual patients.

8. The sample size for the training set

Not applicable, as no AI/machine learning training set is mentioned or relevant to this type of device submission.

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

Not applicable.

Summary based on the provided document:

The Q-Rejuvalight Pro Facewear device has demonstrated compliance with various recognized safety and performance standards through lab bench testing. The 510(k) submission establishes substantial equivalence to predicate devices based on similar intended use, technology (LED-based light therapy), wavelengths, power density (where comparable), treatment time, and environment of use.

The document highlights the following technical characteristics and safety assessments for the Q-Rejuvalight Pro Facewear:

• Intended Use: Treatment of wrinkles and mild to moderate inflammatory acne (OTC device).
• Wavelengths: 605nm, 630nm, 660nm, 880nm (for wrinkles/combination) and 415nm (for acne/combination).
• Power Density:
  • Single wavelength: 605nm: 15±5mW/cm², 630nm: 20±5mW/cm², 660nm: 25±5mW/cm², 880nm: 10±5mW/cm², 415nm: 25±5mW/cm²
  • Total: 70mW/cm² (wrinkle), 45mW/cm² (acne)
• Treatment Time: 3 minutes per treatment.
• Safety and Performance Standards Compliance (via lab bench testing):
  • ANSI AAMI ES60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance)
  • IEC 60601-1-11 (Requirements for medical electrical equipment in the home healthcare environment)
  • IEC 60601-1-2 (Electromagnetic disturbances - Requirements and tests)
  • IEC 60601-2-57 (Particular requirements for non-laser light source equipment for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use)
  • IEC 62133-2 (Secondary cells and batteries - Safety requirements for lithium systems)
  • IEC 62471 (Photobiological safety of lamps and lamp systems)
• Biocompatibility Standards Compliance:
  • ISO 10993-5 (Tests for in vitro cytotoxicity)
  • ISO 10993-10 (Tests for irritation and skin sensitization)
  • ISO 10993-23 (Tests for irritation)

The "Remark" sections (Note 1, 2, 3, 4) in the comparison table explain minor differences between the subject device and predicate devices in terms of power supply, power density details, safety/EMC standards listed, and LED distribution, concluding that these differences "will not raise any safety or effectiveness issues." This implies that the 'acceptance criteria' are met by demonstrating that any differences from the predicate are not significant enough to raise new questions of safety or effectiveness, as demonstrated by compliance with relevant consensus standards.

Ask a specific question about this device

The Aduro Comb (Model: SZ-22A) is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

The Aduro Comb is (Model: SZ-22A) a comb-shaped device that emits led light with the intention to promote hair growth. The device provides distributed led to the scalp at 650nm (±10nm) while the comb teeth simultaneously part the user's hair to ensure the user's scalp. The device is designed as a handheld product, and it consists of the main unit, the charging dock and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 10-minute treatment is completed.

The Aduro Comb (Model: SZ-22A) is indicated to treat Androgenetic Alopecia and promote hair growth. The following information outlines its acceptance criteria and the studies performed.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states, "Clinical testing was not needed for this 510(k)." Therefore, there was no clinical test set in the traditional sense, and thus no sample size or data provenance from a clinical study for the device's efficacy. The performance evaluation relied solely on non-clinical testing and comparison to a predicate device.

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

Not applicable, as no clinical test set was used to assess the device's efficacy or establish ground truth from experts. The evaluation focused on non-clinical safety and performance.

4. Adjudication method for the test set

Not applicable, as no clinical test set was used.

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 an infrared lamp for hair growth, not an AI-assisted diagnostic or imaging device that would typically involve human readers.

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

Not applicable. This device is a physical infrared light therapy device, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" was compliance with established international and national standards for electrical safety, photobiological safety, battery safety, and biocompatibility.

8. The sample size for the training set

Not applicable, as this device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable, as there was no training set.

Ask a specific question about this device

The CurrentBody Skin™ Led Hair Regrowth (MZ-07) is indicated to treat Androgenetic Alopecia and to Promote Hair Growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and Promote Hair Growth in females who have Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

The CurrentBody Skin™ Led Hair Regrowth, model: MZ-07 is an over-the-counter light-emitting diode (LED) device designed to promote hair growth in women and men by exposing the entire scalp to the photostimulation of visible red light-emitting diodes at 660nm. The CurrentBody Skin™ Led Hair Regrowth includes a hair-growing cap, a device base and a USB power cord. The user turns on the device and then wears the device on his/her head, and the device will turn off automatically after a 10-minute treatment default.

The provided text does not describe a study that proves the device meets specific acceptance criteria related to its clinical efficacy (i.e., hair regrowth performance) with quantitative metrics for artificial intelligence (AI) performance. Instead, it refers to a 510(k) premarket notification for a medical device (CurrentBody Skin™ Led Hair Regrowth) which is largely relying on substantial equivalence to a predicate device (Revian Red).

The "acceptance criteria" and "device performance" mentioned in the document primarily relate to non-clinical performance testing (e.g., electrical safety, electromagnetic compatibility, biocompatibility, software validation), rather than clinical outcomes or AI performance. The document explicitly states: "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

Therefore, I cannot directly fulfill all aspects of your request as it pertains to a study proving the device meets AI performance acceptance criteria or clinical efficacy data with AI assistance. However, I can provide the information available in the text regarding the non-clinical acceptance criteria and testing.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Notes on Clinical Efficacy / AI Performance:

• This document is a 510(k) summary, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new major clinical trials for efficacy.
• The device (CurrentBody Skin™ Led Hair Regrowth) is a light-emitting diode (LED) device, not an AI software. The request itself is framed around AI performance, but the document describes a hardware device.

2. Sample Size Used for the Test Set and Data Provenance

• Non-Clinical Testing: For most tests (General safety, EMC, Home healthcare, Particular requirements for light source equipment, Photobiological safety), the "Device Description/Sample Size" is stated as "The test sample is the final, finished product." This generally implies a very small sample size, often one or a few units, for regulatory compliance testing.
• Biocompatibility: The document states "All patient contacting materials are complied with ISO 10993-5, ISO 10993-10," citing prior clearance (K221444) for identical materials used in another device. This means the actual biocompatibility testing was likely performed for the predicate or a previously cleared device.
• Data Provenance: Not specified beyond standard lab bench testing for regulatory compliance. It's not clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Not applicable. This is a hardware device undergoing non-clinical safety and performance testing for regulatory submission (510(k)). There is no "ground truth" derived from expert consensus for clinical outcomes or AI performance, as no clinical efficacy study or AI component is described as being part of the evaluation for this submission.

4. Adjudication Method for the Test Set

• Not applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is typically performed for imaging diagnostic AI devices to compare human reader performance with and without AI assistance. This document describes a therapeutic LED device, not a diagnostic AI. The document explicitly states: "Clinical testing was not needed for this 510(k)."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. The device is a physical LED hair regrowth cap, not an algorithm.

7. The Type of Ground Truth Used

• Not applicable for clinical efficacy or AI performance. For the non-clinical tests, the "ground truth" is defined by the requirements and performance limits specified in the referenced international standards (e.g., IEC 60601 series, IEC 62471, ISO 10993 series).

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. See point 8.

In summary, the provided document focuses on the regulatory clearance process for a physical medical device (LED hair regrowth cap) based on substantial equivalence and compliance with non-clinical safety and performance standards. It does not contain information about studies involving AI, human reader performance, or detailed clinical efficacy trials with quantifiable acceptance criteria for hair regrowth.

Ask a specific question about this device

The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.

LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of acne and wrinkles. The device has anti-wrinkle mode and anti-acne, the former is to emit red light (630nm) and infrared light (830nm) to treat wrinkles, the latter is to emit red light (630nm) and blue light (415nm) to treat mild to moderate acne. There is only one button on the outside of the mask, which have the functions of controlling startup, shutdown, and switching modes. The treatment lasts for 10 minutes by default, and after the treatment, the device will automatically shut down if it is not operated within five minutes. The product contents include an LED mask, Adjustable Velcro Straps, Removable Eye Protection, USB-C cable, cloth bag and user manual, the function of the Removable Eye Protection is to protect the eyes from the harm of led light.

The provided text is a 510(k) Summary for the LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001). It outlines the device's characteristics and compares it to a predicate device (Shani Darden LED light therapy mask, K214103) to establish substantial equivalence.

Based on the provided document, here's an analysis regarding acceptance criteria and study information:

Key Takeaway from the Document:

The submission explicitly states: "No clinical study is included in this submission." This means that no clinical performance data for the device's effectiveness in treating acne or wrinkles has been provided or evaluated as part of this 510(k) clearance process. Substantial equivalence for this device is primarily based on its technical specifications, intended use, and comparison to a predicate device, along with non-clinical (electrical safety, EMC, biocompatibility) testing.

Therefore, the following points address what can be extracted from the document and what cannot.

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

Since no clinical study was performed for this 510(k) submission, there are no "acceptance criteria" for clinical performance data or "reported device performance" in terms of efficacy on patients. The acceptance criteria here would primarily relate to the non-clinical tests demonstrating safety and technical equivalence to the predicate device.

Since the submission states "No clinical study is included in this submission," the following points cannot be answered from the provided text:

2. Sample sized used for the test set and the data provenance: Not applicable, no clinical test set for performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, no clinical test set.
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 light therapy mask, not an AI diagnostic/imaging device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no clinical study was conducted using patients for efficacy. Ground truth for the safety aspects would be the testing protocols of the listed electrical and biocompatibility standards.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The LED Lip Perfector (Model: ZC-05) is an Over-the-Counter (OTC) device intended to treat fines and wrinkles and increase in circulation within the perioral region.

The LED Lip Perfector (Model: ZC-05) is an over-the-counter light-emitting diode (LED) device that emits energy for dermatology to treat fine lines and increase circulation within the perioral region. The device contains four types of LEDs: 605nm, 630nm, and 850nm The LED Lip Perfector components include the main device, charging base, power cord, alternative mouthpiece, user manual, and storage bag. There is only one button on the top edge of the main unit. Short press the power button to turn on the device, and long press the power button to turn off the device. This device only has one treatment mode. The LED Lip Perfector is applied to the skin to ensure consistent light administration during each treatment. The device is sold Over the Counter (OTC).

The provided text is a 510(k) summary for the LED Lip Perfector (Model: ZC-05). It focuses on demonstrating substantial equivalence to a predicate device through comparison of features and adherence to recognized standards. It does not contain information about acceptance criteria or a study proving device performance in the context of clinical effectiveness or statistical superiority/non-inferiority.

Specifically, the document states: "The LED Lip Perfector (Model: ZC-05) has been evaluated the safety and performance by lab bench testing as following:" and then lists a series of recognized standards (e.g., IEC 60601-1, ISO 10993) related to electrical safety, electromagnetic compatibility, usability, and biocompatibility.

The conclusion is based on comparing the subject device to the predicate device in terms of design, intended use, indications for use, functions, materials, and applicable standards, as well as adherence to these safety and performance standards. It explicitly states: "The subject device is as safe, as effective, and performs as well as the legally marketed predicated devices K172662." This implies that by meeting the same safety and performance benchmarks as the predicate, and having similar characteristics and indications for use, it is considered "effective" in the regulatory sense for substantial equivalence, rather than through a dedicated clinical performance study with specific acceptance criteria.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance or details about a study proving the device meets effectiveness criteria, as this information is not present in the provided text. The document is primarily a regulatory submission demonstrating substantial equivalence through technical and safety standards, not a clinical performance study report.

Ask a specific question about this device

For MK-78, MK-04,
The LED Light Therapy Mask (Models: MK-78, MK-04) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.

For MK66-H, EL00003
The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the treatment of full-face wrinkles.

The LED Light Therapy Mask is a home 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, or mild to moderate acne vulgaris of the face.
The system consists of a flexible silicone mask that contains LEDs and a controller. The mask is worn on the face and is held in place by adjustable Velcro straps. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surfaces are constructed of silicone.
The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The LED Light Therapy Mask cannot be operated while charging.
The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.
Models MK-78, and MK-04 produce red and near infra-red (NIR) light in the visible spectrum (Red: 630+/-5nm, NIR: 830nm) in intended to improve the appearance of wrinkles. The controller switches the LEDs ON/OFF and controls power to the mask. For MK-04, the cable for connecting with the controller is nondetachable, but the cable is detachable for MK-78. Model MK-04 contains many rose quartz crystals in inner surface for decoration purpose, the crystals do not contact with skin and there is no therapeutic effect.
Model MK66-H and EL00003 produce blue, red, and near infra-red (NIR) light in the visible spectrum (Blue: 415nm, Red: 630+/- 5nm, NIR: 830nm). The device works by emitting the specified wavelengths into the skin in order to improve the appearance of wrinkles or to target bacteria that can cause acne vulgaris. The controller switches the LEDs ON/OFF, controls power to the mask, and switches treatment modes. The cable for connecting with the controller is detachable. Both MK66-H and EL00003 have two pieces of removable eye protection which are for protect eyes from the light.

The provided document describes the safety and performance testing of an LED Light Therapy Mask (Models: MK-78, MK-04, MK66-H, EL00003) to support its 510(k) submission for market clearance. The device is intended for the treatment of full-face wrinkles and mild to moderate acne vulgaris of the face.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document indicates that for the performance testing, the "test sample is the final, finished product." This suggests that presumably one or a few units of the final device were used for each non-clinical performance test. No specific sample size (N) for a test set of data or data provenance (e.g., country of origin, retrospective/prospective) is provided, as these were non-clinical bench tests (e.g., electrical safety, photobiological safety), not studies on patient data.

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

Not applicable. The tests were non-clinical bench tests according to international standards (e.g., IEC, ISO). No human experts were required to establish ground truth as these tests evaluate device specifications and compliance rather than clinical outcomes or interpretations of medical images.

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

Not applicable. As described above, no human adjudication was involved in these non-clinical performance tests.

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 an LED light therapy mask, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant.

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

Not applicable. This device does not involve an algorithm with standalone performance for diagnosis or interpretation. The device itself is the "standalone" treatment method.

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

For the non-clinical performance tests, the "ground truth" was compliance with established international standards (e.g., IEC, ISO) for electrical safety, electromagnetic compatibility, photobiological safety, and biocompatibility. For usability and software, compliance with relevant guidelines was the ground truth. There was no clinical ground truth (e.g., pathology, outcomes data) used in these tests since clinical trials were not performed.

8. The sample size for the training set

Not applicable. This device does not appear to utilize machine learning or AI models that would require a "training set" of data in the conventional sense for a software algorithm. The "training" here refers to the device's design and manufacturing processes adhering to established engineering and safety standards.

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

Not applicable, as there is no mention of a training set for machine learning or AI. The "ground truth" for the device's design and manufacturing is established through adherence to recognized international standards and verification/validation processes for hardware and software components.

Ask a specific question about this device

The LED Eye Perfector (Model: EY-36A, EY-36B) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region.

The LED Eye Perfector, model: EY-36A and EY-36B is an over-the-counter light-emitting diode (LED) device that emits energy for dermatology to treat wrinkles within the periorbital region. The device uses four types of LEDs, and for model EY-36A: 605 nm, 633 nm, 660nm, 830 nm, for EY-36B: 605 nm, 625 nm, 660nm, and 880 nm. The treatment time can be controlled by the user, or automatically shut off within a set time. The LED Eye Perfector components contain the main unit device, charging base, USB charging cord, velcro straps and goggles. There is a total of 40 LEDs to provide a power intensity of about 65 mW/cm². The user wears the device on their eye area for the treatment, and the device will shut down automatically after a 3-minute after finishing treatment. There are no differences between the two models other than the output wavelength.

The provided 510(k) summary for the LED Eye Perfector device (K221444) does not contain information about studies measuring the device's performance against clinical acceptance criteria. The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications and adherence to safety standards, rather than proving direct clinical efficacy or performance against specific metrics like sensitivity or specificity.

The "Test Summary" section (page 7) lists various safety and performance standards (e.g., electrical safety, electromagnetic compatibility, biocompatibility) to which the device was evaluated. These are engineering and safety tests, not clinical performance studies for efficacy in treating wrinkles.

Therefore, I cannot fulfill the request to describe acceptance criteria and study results related to clinical performance because the provided document does not include such information.

To elaborate on the specific points requested:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on compliance with general safety and electrical standards, not on clinical performance metrics like "wrinkle reduction percentage" or "satisfaction rates."
2. Sample sizes used for the test set and the data provenance: Not applicable for clinical performance. The "test set" in this document refers to the device itself undergoing engineering and safety evaluations, not a patient cohort.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical efficacy is not discussed.
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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an LED-based treatment, not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a therapeutic device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical efficacy. The "ground truth" implicitly used for the safety and engineering tests is compliance with the specified international standards.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a Class II medical device based on engineering and safety standards, and comparison to legally marketed predicate devices. It does not include data from clinical performance studies against specific acceptance criteria for wrinkle reduction.

Ask a specific question about this device

The LED Light Therapy Mask (Model:MK66R-B) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.

The LED LIGHT THERAPY MASK is a home 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. The system consists of a flexible silicone mask that contains LEDs and a controller. The mask is worn on the face and is held in place by velcro straps. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface. Both surfaces are constructed of sillcone. The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The LED LIGHT THERAPY MASK cannot be operated while charging. The controller switches the LEDs ON/OFF and controls power to the mask. The device does not have an adapter, please use adapters of the following specifications: input: 100-240Va.c., 50Hz/60Hz, output: DC 5V, 2A. The device produces red and near infra-red (NIR) light in the visible spectrum (Red: 630+/-5nm, NIR: 830nm) in intended to improve the appearance of wrinkles. The controller switches the LEDs ON/OFF and controls power to the mask. And the cable for connecting with the controller is non-detachable.

This document describes the premarket notification (510(k)) for the LED Light Therapy Mask (Model: MK66R-B) for treating full-face wrinkles. The notification asserts its substantial equivalence to the predicate device, FaceLITE (K191629).

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria & Reported Device Performance

The acceptance criteria are primarily based on compliance with various international standards for medical electrical equipment and photobiological safety. The device performance is consistently reported as "Pass" for all tests.

2. Sample Size Used for the Test Set and Data Provenance

The "Test Summary" section refers to "The test sample is the final, finished product of representative model: MK66R-B" for all listed non-clinical performance tests. This indicates that one production-representative unit of the device was used for each of the non-clinical tests (electrical safety, EMC, photobiological safety, usability, and shelf-life).

• Data Provenance: The tests are described as "lab bench testing," and the context is a 510(k) submission, meaning these are internal validation tests conducted by or for the manufacturer (Shenzhen Kaiyan Medical Equipment Co., Ltd) to demonstrate compliance with standards. The geographic origin of the testing lab is not explicitly stated, but the manufacturer is based in China. These are retrospective tests conducted on the device model.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable (N/A) as the study described is a non-clinical performance and safety evaluation, not a clinical study involving human patients or expert interpretation of diagnostic data. The "ground truth" here is defined by compliance with established international safety and performance standards.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for the same reasons as in point 3. The "adjudication" is essentially whether the device successfully met the objective criteria of the specified test standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or reported. The document explicitly states: "Clinical testing was not needed for this 510(k)." Therefore, no effect size of human readers improving with or without AI assistance is provided.

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

No, a standalone algorithm-only performance study was not done. This device is a hardware LED light therapy mask, not an AI/software algorithm intended for standalone diagnostic or therapeutic decisions.

7. The Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" is defined by compliance with recognized international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 62471, IEC 62366-1) and internal product specifications (e.g., Power Density: 27-33 mW/cm2 for the Shelf Life Test).

8. The Sample Size for the Training Set

This information is not applicable (N/A). This device is a light therapy mask, not a machine learning or AI-powered system that requires a "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable (N/A) for the same reason as in point 8.

Ask a specific question about this device