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The Skin Care Beauty Mask (Model: MJ-06) emits energy in the red and blue region of the spectrum, specifically indicated to treat full face wrinkles and/or mild to moderate acne.

The Skin Care Beauty Mask (Model: MJ-06) is a facemask-shaped device, which makes use of specific light spectral characteristics and directly applies light onto the face skin surface. The Skin Care Beauty Mask can emit two different kinds of wavelengths. The blue light (465nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. Red light (640nm) is intended to improve the appearance of wrinkles. There are 150 LED lights with a center wavelength of 465nm and 150 LED lights with a center wavelength of 640nm, and the energy provided by each mode is 30mw/cm2 . The user wears the mask on their face for the treatment, and the device will shut down automatically after finishing a 5-minute treatment or 10-minute treatment selected.

The provided text is a 510(k) Summary for the Skin Care Beauty Mask (Model: MJ-06), which is a premarket notification to the FDA for demonstrating substantial equivalence to a legally marketed predicate device. This document focuses on demonstrating that the new device is as safe and effective as existing products, rather than proving a novel clinical benefit through extensive clinical studies with acceptance criteria and statistical analysis.

Therefore, the requested information regarding detailed acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes for test and training sets, expert qualifications, and ground truth establishment, is largely not present within this type of regulatory submission.

The "Test Summary" section primarily refers to bench testing against recognized safety and performance standards, not clinical trials to measure effectiveness against specific numerical acceptance criteria for clinical outcomes. The FDA clearance is based on substantial equivalence to a predicate device (K202390), indicating that its technological characteristics and intended use are similar enough not to raise new questions of safety or effectiveness.

Here's a breakdown of what can be extracted and what is missing, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the typical sense of clinical performance acceptance criteria. The "acceptance criteria" here are compliance with recognized electrical safety, EMC, and biocompatibility standards, and demonstrating substantial equivalence to a predicate device in terms of design, function, and intended use. The table below reflects the comparison to the predicate device and the standards met.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not mentioned. The document primarily refers to "lab bench testing" (Section 6) against recognized standards and a comparison to a predicate device. There is no indication of a clinical "test set" with human subjects specifically for evaluating the effectiveness of the MJ-06 model in a clinical trial setting to establish new performance claims.
• Data Provenance: The document does not specify country of origin for any clinical data because detailed clinical performance data in a trial setting is not provided. It mentions the manufacturer as Shenzhen Kaiyan Medical Co Ltd, China, and a distributor in Denver, CO, USA. The "Test Summary" only lists engineering and biocompatibility standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This information would be relevant for clinical studies where expert consensus or diagnostic interpretation is needed to establish ground truth for a test set. This document relies on compliance with engineering standards and comparison to a previously cleared device.

4. Adjudication Method for the Test Set

• Not applicable. As no clinical test set requiring expert adjudication is described, this information is not present.

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

• No. An MRMC study is a type of clinical study assessing diagnostic performance, usually comparing human readers with and without AI assistance. This document is a 510(k) submission for a physical light therapy device, not a diagnostic AI algorithm, and does not mention any such study.

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

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

7. The Type of Ground Truth Used

• For the technical and biocompatibility testing, the "ground truth" is compliance with the specified international standards (e.g., IEC 60601 series for electrical safety, ISO 10993 series for biocompatibility).
• For the overarching claim of effectiveness, the "ground truth" is established by the predicate device's prior clearance by the FDA for similar indications. The current device demonstrates substantial equivalence to this predicate.

8. The Sample Size for the Training Set

• Not applicable. This information is relevant for AI/machine learning models. The device is a hardware light therapy system.

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

• Not applicable.

In summary: The provided 510(k) summary is a regulatory document focused on demonstrating equivalency to a predicate device and adherence to safety standards. It does not contain the detailed clinical study data typically associated with a novel device proving its effectiveness against specific clinical acceptance criteria. The FDA's clearance (K220168) is based on the argument that the device is "substantially equivalent" to an already approved device (K202390) and meets relevant safety standards, meaning it does not raise new questions of safety or effectiveness.

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The Oren LED Perioral Light Therapy System (Model: OR-01) is an Over-the-Counter (OTC) device intended for the treatment fine lines and wrinkles, and increase in circulation within the perioral region.

The Oren LED Perioral Light Therapy System (Model: OR-01) is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for treatment fine lines and wrinkles, and increase in circulation within the perioral region. The device contains four types of LEDs: 605nm amber, 630m red, 660nm red, and 880nm infrared.

The Oren LED Perioral Light Therapy System components include the main device, Charging base, power cord, adapter. There are two buttons on the top edge of the main unit, Power button and Shutdown button. This device Only has one treatment modes.

The Oren LED Perioral Light Therapy System is applied directly to the skin to ensure consistent administration of light during each treatment. The device is sold as Over the Counter (OTC).

The provided text describes a 510(k) premarket notification for the Oren LED Perioral Light Therapy System (Model: OR-01). This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy or performance against specific acceptance criteria for a new clinical claim. Therefore, the document does not describe a study that proves the device meets specific acceptance criteria related to clinical performance (e.g., reduction in fine lines and wrinkles).

Instead, the document focuses on demonstrating that the new device is as safe and effective as a previously cleared predicate device (reVive Perioral LED Light Therapy System, K172662) by comparing various design, performance, and safety parameters. The "acceptance criteria" in this context refer to demonstrating equivalence to the predicate and compliance with relevant safety and performance standards.

Here's an analysis based on the provided text, addressing your points where possible, and noting where the information is absent due to the nature of a 510(k) submission for substantial equivalence:

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

The "acceptance criteria" for a 510(k) in this context are primarily the demonstration of substantial equivalence to the predicate device and compliance with recognized safety and performance standards. The table provided is a comparison between the subject device and the predicate device, showing their similarities and differences.

Here's a re-imagined table focusing on the comparison elements as "criteria" for substantial equivalence and the reported performance of the subject device (Oren LED Perioral Light Therapy System) against these. The "Verdict" column essentially represents whether the criterion for equivalence was met.

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

The document does not describe a clinical study with a "test set" for efficacy in reducing fine lines and wrinkles. The "tests" mentioned (Section 8, "Test Summary") are laboratory bench testing to confirm compliance with electrical safety, EMC, usability, battery safety, and biocompatibility standards. These are not clinical studies. Therefore, there's no sample size or data provenance in the context of clinical performance.

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 noted above, there was no clinical "test set" for efficacy that would require expert ground truth establishment. The review is based on technical specifications and compliance with standards.

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 system, not an AI-assisted diagnostic or interpretation tool for human readers. No MRMC study was done.

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

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

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

For the 510(k) submission, the "ground truth" for the device's safety and performance is established by compliance with recognized standards (e.g., ANSI AAMI ES60601-1 for basic safety, IEC 60601-1-2 for EMC, ISO 10993 for biocompatibility) and demonstrating substantial equivalence to a predicate device that has previously been determined safe and effective for the indicated use. No clinical outcomes data for the subject device's efficacy are presented.

8. The sample size for the training set

Not applicable. This is a medical device for therapy, not an AI/machine learning model that requires a training set.

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

Not applicable. No training set for an AI model.

In summary:

This document is a 510(k) notification for a Class II medical device (Oren LED Perioral Light Therapy System). The core purpose of a 510(k) is to demonstrate substantial equivalence to a predicate device already legally marketed. It does this by comparing the new device's intended use, technological characteristics, and performance (primarily safety and technical compliance) to the predicate.

The "study" described is a series of laboratory bench tests to ensure the device meets safety (electrical, EMC, battery), usability, and biocompatibility standards. It does not present a clinical study demonstrating the device's efficacy in treating fine lines and wrinkles, nor does it establish specific clinical acceptance criteria for such efficacy. The assumption is that because it is substantially equivalent to a cleared predicate device with the same intended use and energy parameters, it will achieve similar clinical outcomes.

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The DemarkQ is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.

The DemarkQ, Model: DemarkQ WOW(PB-B), DemarkQ POP(SJ-72) are over-the counter light emitting diode (LED) panel device, that emits energy for use in dermatology for the treatment of mild to moderate inflammatory acne. The devices use two types of LEDs: 630nm red and 415nm blue. The device operated only by one key, both wavelengths will be emitted at the same time when it be turned on. The treatment time is controlled by the user. There are no user settings or adjustments required.

The device's components include the main device which containing the LED treatment module, USB power cord and goggles.

The provided document is a 510(k) summary for the DemarkQ WOW and DemarkQ POP devices, which are LED-based light therapy devices for the treatment of mild to moderate inflammatory acne.

Based on the content, here's an analysis of the acceptance criteria and the "study" that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., efficacy rates, reduction in lesion counts) for the device itself in treating acne. Instead, it focuses on demonstrating Substantial Equivalence (SE) to predicate devices based on technological characteristics and adherence to safety and performance standards.

The "acceptance criteria" can be inferred from the comparison to predicate devices and the listed standards. The implicit acceptance criteria are that the device should:

• Have the same intended use and indications for use as predicate devices.
• Have similar technological characteristics (e.g., wavelengths, type of light source, power supply within safe limits).
• Comply with recognized medical device safety, EMC, usability, and biocompatibility standards.

Inferred Acceptance Criteria and Reported Device Performance (Summary derived from the comparison table):

The "study" that proves the device meets the acceptance criteria is primarily a demonstration of Substantial Equivalence (SE) to legally marketed predicate devices through a comparison of technological characteristics and adherence to recognized consensus standards. The document explicitly states: "The DemarkQ, Model: DemarkQ WOW(PB-B), DemarkQ POP(SJ-72) have been evaluated the safety and performance by lab bench testing as following:" followed by a list of international standards.

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

The document describes laboratory bench testing and comparison to predicates, not a clinical study on human subjects for efficacy. Therefore, there is no "test set" in the sense of a patient cohort or retrospective dataset for assessing clinical performance. The testing involved samples of the device itself to verify compliance with various safety and performance standards (e.g., electrical safety, EMC, biocompatibility).

• Country of Origin of the data: Based on the submitter's address (Shenzhen, Guangdong, China), the lab bench testing was likely performed in China or by labs accredited to conduct these tests for the Chinese manufacturer.
• Retrospective or Prospective: Not applicable as it's not a clinical study.

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

This is not applicable. Ground truth, in the context of clinical efficacy, would involve expert assessment of acne lesions or outcomes. Since this 510(k) submission doesn't include a de novo clinical efficacy study, it does not refer to experts establishing ground truth for efficacy. The "experts" involved would be the engineers and testing personnel who evaluated the device against the referenced standards, and possibly the regulatory specialists who prepared the submission, but their qualifications are not detailed here.

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

Not applicable. There is no clinical test set requiring adjudication of findings (e.g., disease presence/absence, lesion counts).

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 device for acne treatment, not an AI-powered diagnostic or assistive tool for human readers/clinicians, and thus an MRMC study is not relevant or mentioned.

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

Not applicable. Pertains to AI/software performance studies, which is not relevant for this hardware light therapy device.

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

The "ground truth" in this context is the compliance with recognized international consensus standards (e.g., IEC, ISO). The device's characteristics (e.g., wavelength, irradiance) were measured against specified parameters outlined in these standards and the comparison to predicate devices, rather than clinical outcomes or expert consensus on clinical images/pathology.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not a machine learning or AI-based device requiring training.

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

Not applicable. As above, no training set for an AI/ML model.

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The Aduro light therapy Handheld (Model:HD-03A,HD-25A,HD-07A),the red light is intended for the treatment of periorbital wrinkles, and the blue light is intended for the mild to moderate inflammatory acne.

Aduro light therapy Handheld (Model: HD-03A, HD-25A, HD-07A)

The provided document is a 510(k) clearance letter from the FDA for a light therapy device. It primarily focuses on regulatory approval and indications for use.

Therefore, the document does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or their data provenance.
• Information on the number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Results or even mention of a multi-reader, multi-case (MRMC) comparative effectiveness study.
• Results or mention of a standalone algorithm performance study.
• The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• The sample size for the training set.
• How the ground truth for the training set was established.

This type of information would typically be found in the 510(k) submission itself or a summary thereof, which is a much more comprehensive technical document than the clearance letter. The clearance letter only states that the FDA reviewed the submission and found the device substantially equivalent based on the provided information.

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For MK-660, MK-66USBO, MK-020:

The Aduro Light Beauty Mask (Model: MK-660, MK-66USBO, MK-020) emits energy in the red and blue region of the spectrum, specifically indicated to treat full face wrinkles and/or mild to moderate acne.

For MK-66USBA, MK-02A:

The Aduro Light Beauty Mask (Model: MK-66USBA, MK-02A) is intended to emit light in the blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face.

For MK-66USBB, MK-02B:

The Aduro Light Beauty Mask (Model: MK-66USBB, MK-02B) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.

For MK-660, MK-66USBO, MK-02O:

The Aduro Light Beauty Mask (Model: MK-660, MK-66USBO, MK-020) is a facemask-shaped device, which makes use of specific light spectral characteristics and directly applies light onto the face skin surface. The Aduro Light Beauty Mask can emit light with two different center wavelengths. The blue light (465nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. Red light (640nm) is intended to improve the appearance of wrinkles. There are a total of 66 LEDs to provide power intensity of about 30mw/cm2.

The user wears the mask on their face for the treatment, and the device will shut down automatically after finishing a 10-minute treatment.

For MK-66USBA, MK-02A:

The Aduro Light Beauty Mask (Model: MK-62A) is a facemask-shaped device, which makes use of specific light spectral characteristics and directly applies specified light onto the face. The Aduro Light Beauty Mask can emit the blue light (465nm) which is intended to help reducing the appearance of mild to moderate inflammatory acne. There are a total of 66 LEDs to provide power intensity of about 30mw/cm².

The user wears the mask on their face for the treatment, and the device will shut down automatically after finishing a 10-minute treatment.

For MK-66USBB, MK-02B:

The Aduro Light Beauty Mask (MK-66USBB, MK-02B) is a facemask-shaped device, which makes use of specific light spectral characteristics and directly applies specified light onto the face. The Aduro Light Beauty Mask can emit the red light (640nm) which is intended to improve the appearance of wrinkles. There are a total 66 LEDs to provide power intensity of about 30mw/cm². The user wears the mask on their face for the treatment, and the device will shut down automatically after finishing a 10-minute treatment.

The provided text describes a 510(k) summary for the Aduro Light Beauty Mask, which aims to demonstrate substantial equivalence to previously cleared predicate devices. This type of submission relies on comparisons to existing devices rather than new clinical effectiveness studies for the product itself. Therefore, the data provided is primarily about comparative equivalence for safety and basic performance metrics, rather than a full-fledged clinical study proving specific acceptance criteria for AI algorithm performance or human-in-the-loop improvements.

Based on the document, here's a breakdown of the requested information, with an emphasis on what is available and what is not in this type of regulatory submission:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria are implicitly defined by the characteristics of the predicate devices. The "reported device performance" is the comparison showing that the subject device's specifications are within an acceptable range or are substantially equivalent to the predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "The treatment time of the subject device is different than the predicate devices. However, it is considered to be within an acceptable range and does not raise concerns regarding safety and effectiveness, and new clinical studies were not considered to be necessary for the subject device." This indicates that while not identical, the differing treatment time was deemed acceptably similar.

Regarding the study proving the device meets acceptance criteria (Note: This is NOT an AI/algorithm study as per the typical questions, but rather a regulatory premarket submission for an LED light therapy device):

This document is a 510(k) Summary, which is designed to demonstrate substantial equivalence to a previously cleared device, rather than proving de novo effectiveness through a full clinical trial with "acceptance criteria" in the sense of an algorithm's performance metrics (e.g., sensitivity, specificity). The "study" mentioned here refers to the non-clinical testing and comparison to predicates.

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

• Sample Size: Not applicable in the context of human clinical trial test sets. The "test set" here refers to the physical device undergoing non-clinical bench testing to ensure it meets safety and performance standards (e.g., wavelength accuracy, power output, electrical safety, biocompatibility). The document does not specify the number of devices tested.
• Data Provenance: The document explicitly mentions "Non-clinical Testing" being performed. It does not provide details on the country of origin for this testing or whether it was retrospective or prospective, but these would typically be lab-based, prospective tests on manufactured units.

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

• This concept is not applicable to this type of device submission. Ground truth, in the context of AI, usually refers to expert-labeled data (e.g., radiologists labeling medical images). For an LED light therapy device, "ground truth" relates to measurable physical parameters and safety standards, verified by engineering and quality control processes.

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

• Not applicable. Adjudication methods like 2+1 (two experts agree, third resolves discrepancy) are used for establishing ground truth in clinical data for diagnostic or AI-assisted devices. This document describes the substantial equivalence of a light therapy device based on physical characteristics and safety 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:

• No, an MRMC comparative effectiveness study was explicitly NOT done. This type of study demonstrates the clinical utility of a device, often for diagnostic tools or AI. The document states in the "Note" section (Page 13): "new clinical studies were not considered to be necessary for the subject device." This strongly indicates that the approval was based on demonstrating equivalence to predicates through technical and safety data, not new clinical effectiveness data. Therefore, there is no effect size related to human readers or AI assistance.

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

• Not applicable. This device is a physical light therapy mask, not an AI algorithm. There is no standalone algorithm performance to evaluate.

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

• The "ground truth" here is based on established engineering and safety standards and specifications (e.g., specified wavelengths, power densities, electrical safety standards like IEC 60601 series, and biocompatibility standards like ISO 10993 series). Device performance is measured against these technical specifications, not against clinical outcomes or expert consensus on clinical findings in patient data.

8. The sample size for the training set:

• Not applicable. This is not an AI algorithm requiring a training set.

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

• Not applicable. As this is not an AI algorithm, there is no training set or ground truth establishment method for it.

In summary: The provided document is a 510(k) summary for a physical medical device (LED light therapy mask), not an AI-powered diagnostic or therapeutic algorithm. Therefore, many of the questions related to AI algorithm acceptance criteria, test sets, ground truth establishment, and multi-reader studies are not applicable to this submission. The "study" proving acceptance criteria is the collection of non-clinical bench testing data and a comprehensive comparison of the device's technical specifications and safety profile to those of legally marketed predicate devices, demonstrating "substantial equivalence."

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