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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.

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The FEATHER 01 02 03 04 (Model: 01) is an Over the-Counter (OTC) device intended for the use in treating wrinkles on the face.

FEATHER 01 02 03 04 (Models: 01) is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles. The device works by simultaneously emitting 630nm±10nm, 660nm±10nm, 850nm±10nm wavelengths for the treatment of wrinkles. There is only one power/control key on the device, press and hold it for 1.5s to turn on or off the device. Short press the button to adjust the intensity, the white indicator light means the device is running, the flash quickly indicator light means the device is low on power, the slow flashes indicator light means the device is charging.

Based on the provided FDA 510(k) clearance letter for the FEATHER 01 02 03 04 (Model:01) device, here's a breakdown of the acceptance criteria and the study that proves the device meets them.

It's important to note that the provided document is a 510(k) summary, which generally focuses on substantial equivalence to predicate devices rather than detailed clinical trial results for effectiveness when non-clinical tests are deemed sufficient. For this specific device, the submission explicitly 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, the "study that proves the device meets the acceptance criteria" refers to the non-clinical testing, not a clinical trial demonstrating efficacy.

Acceptance Criteria and Reported Device Performance

Since no clinical efficacy study was conducted for this 510(k) submission, the "acceptance criteria" primarily relate to safety and performance characteristics that demonstrate substantial equivalence to predicate devices. The performance is assessed through non-clinical testing against recognized standards.

Table of Acceptance Criteria and Reported Device Performance

Study Details (Non-Clinical Performance Testing)

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not specified in terms of number of devices tested. For non-clinical performance and safety testing against standards (e.g., IEC 60601 series), usually a sample of devices is tested to demonstrate consistent performance and compliance. The document does not provide specific numbers of units tested.
   • Data Provenance: The testing appears to be conducted by the manufacturer or a third-party testing facility, as indicated by compliance reports against international standards (IEC).
   • Retrospective or Prospective: This type of non-clinical testing is inherently prospective, as it involves newly manufactured devices undergoing specific tests to demonstrate compliance.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • Not applicable in the typical sense for this submission. Ground truth for non-clinical performance testing is established by compliance with objective, measurable engineering and safety standards (e.g., electrical parameters, light output, battery performance). These are verified by accredited testing labs or qualified in-house engineers, not typically "experts" in the clinical interpretation sense.

3. Adjudication Method for the Test Set:

   • Not applicable. Results are based on objective measurements against predefined thresholds specified in the engineering and safety standards. There's no subjective interpretation requiring adjudication.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. 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, no MRMC study, AI assistance, or human reader improvement data is presented.

5. Standalone (Algorithm Only) Performance:

   • This is not an AI/algorithm-driven diagnostic or treatment device in the context of typical standalone performance studies. It is a light-emitting medical device. The "software" mentioned is for device operation (e.g., power control, intensity adjustment), and its validation ensures the proper functioning of the device, not an algorithm's performance in interpreting data or making clinical decisions.

6. Type of Ground Truth Used:

   • For safety and performance testing, the "ground truth" is defined by the requirements of the international consensus standards (e.g., IEC 60601-1, IEC 62471, IEC 62133-2) and the specifications of the predicate devices. The device is deemed "effective" (in the context of a 510(k) for this type of device) if it meets these safety and performance benchmarks and is substantially equivalent to legally marketed devices for its intended use. There is no pathology or outcomes data presented from a clinical study.

7. Sample Size for the Training Set:

   • Not applicable. This is not a machine learning or AI device that requires a "training set" of data for algorithm development. The testing described is for hardware and embedded software compliance.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set for an AI/ML algorithm.

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TRUDERMAL Pro (Model: ZLD-390) is an over-the-counter(OTC) device that delivering targeted phototherapy using three wavelengths(blue:415nm, red:630nm, Infrared(IR):850nm):

Red light: Reduces full-face wrinkles.
Blue light: Treats mild to moderate inflammatory acne.
IR light: Provides topical heating for the purpose of elevating tissue temperature, temporarily relieving minor muscle and joint pain, arthritis and muscle spasms; relieving stiffness; promoting relaxation of muscle tissues and temporarily increasing local blood circulation.

Mixed lights:
Red+IR light: Reduces full-face wrinkles.
Blue+Red light:Treats mild to moderate inflammatory acne.

The TRUDERMAL Pro is an over-the-counter LED light therapy medical device. The device emits specific wavelengths of low level, narrow band light for the treatment of certain dermatological and musculoskeletal indications. The wavelengths used in the TRUDERMAL Pro system are Blue 415nm, Red 630nm and Near Infrared 850nm.

The device consists of a TRUDERMAL Pro (with LED flexible silicone panel, Controller and AC/DC adapter), power cable, and 2 base seats, a pair of eye protectors. The TRUDERMAL Pro enables treatment of the face and the body via a LED flexible silicone panel.The system is operated by a controller and treatments can be performed by selecting different wavelengths. The light is generated by Light Emitting Diodes(LED's) that are contained within the LED flexible silicone panel. The LED panel can be placed into the Base, holding in the appropriate position to administer a facial treatment. For use on the body,the LED panel is removed from the Base unit and placed over the appropriate body part.

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.

I apologize, but I cannot fulfill your request to create a table of acceptance criteria and reported device performance, nor can I describe a study that proves the device meets specific acceptance criteria based solely on the provided FDA 510(k) Clearance Letter for TRUDERMAL Pro (ZLD-390).

Here's why:

• No Performance Data or Acceptance Criteria in the Document: The provided 510(k) clearance letter and its associated summary (510(k) Summary) do not contain any information about specific performance acceptance criteria or the results of clinical performance studies that demonstrate the device meets such criteria.
  • The document 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." This explicitly indicates that no clinical performance data (which would typically include performance against acceptance criteria) was provided or evaluated for this 510(k) submission.
  • The non-clinical tests mentioned (electrical safety, EMC, biocompatibility, software V&V) are regulatory compliance tests, not performance studies assessing the therapeutic efficacy against specific clinical endpoints or acceptance criteria.

Therefore, I cannot extract or infer the following information from the provided text:

1. Table of acceptance criteria and reported device performance: This data is not present. The document explicitly states clinical testing was not needed.
2. Sample size used for the test set and data provenance: Since no clinical performance study was conducted or reported, there is no test set, sample size, or data provenance information.
3. Number of experts used to establish ground truth & qualifications: Not applicable, as no clinical performance study data relying on expert ground truth is provided.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study: Not conducted or reported. The device is a phototherapy device, not an AI-powered diagnostic tool, so an MRMC study is generally not relevant.
6. Standalone (algorithm only) performance study: Not applicable. This is a physical phototherapy device, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable, as this is a phototherapy device, not an AI model that would have a "training set" in the traditional sense.
9. How ground truth for the training set was established: Not applicable.

What the document does provide regarding "performance" is:

• Comparison to Predicate Devices: The submission argues for substantial equivalence by comparing the TRUDERMAL Pro's technical characteristics (wavelengths, irradiance, treatment time) to legally marketed predicate devices. The claim is that "The subject device's wavelengths, treatment time, irradiance and radiation dose are similar and close to those of the predicate devices," and this, combined with non-clinical tests, "supports that the subject device is safe and as effective as the predicate devices for its intended use."
• Non-Clinical Test Summary: This section lists the electrical safety, electromagnetic compatibility, biocompatibility, and software verification/validation tests performed, demonstrating compliance with relevant industry standards (IEC, ISO). These tests ensure the device is safe and functions as designed electrically and mechanically, but they do not prove clinical efficacy against specific performance metrics related to wrinkle reduction, acne treatment, or pain relief.

In summary, the provided FDA document is a clearance letter and 510(k) summary that emphasizes substantial equivalence to existing predicate devices based on design, intended use, and non-clinical safety testing, rather than presenting a performance study with defined acceptance criteria and clinical results.

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M01, M02, M06, M07, M08:

• Red light: Treatment of full-face wrinkles.
• Red+Infrared Light: Treatment of full-face wrinkles.
• Amber light: Treatment of full-face wrinkles.
• Blue light: Treatment of mild to moderate inflammatory acne.

M09:

• Red+Infrared Light: Treatment of full-face wrinkles.
• Amber light: Treatment of full-face wrinkles.
• Mixed light: Treatment of mild to moderate inflammatory acne.

LED Light Therapy Mask is a home use wearable LED phototherapy device which can help reduce facial wrinkles and mild to moderate inflammatory acne. LED Light Therapy Mask is consisting of main unit (mask), controller, Type-C charging cable and so on. There are 4 kinds of light, including Red light (wavelength 630nm), Blue light (wavelength 415nm), Amber light (wavelength 605nm), Infrared light (wavelength 850nm).

The M01, M02, M06, M07, M08 output 4 kinds of treatment modes: red+infrared, red, amber, blue. The M09 outputs 3 kinds of treatment modes: red+infrared, amber, blue+red+infrared.

This FDA 510(k) clearance letter does not describe a study that proves the device meets acceptance criteria. Rather, it indicates clearance due to substantial equivalence to predicate devices based on non-clinical testing.

Here's a breakdown of why the requested information cannot be provided from the given document:

• No Clinical Study Details: The document explicitly states "Non-Clinical and/or Clinical Tests Summary & Conclusions (21 CFR 807.92(b))" and then lists only non-clinical tests (ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83, IEC 62471). There is no mention of any clinical study, patient data, ground truth establishment, or expert reviews.

Therefore, for your subsequent requests regarding acceptance criteria and a study that proves the device meets them, the following answers are based on the absence of such information in the provided document:

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

• Acceptance Criteria: Not explicitly stated in the document. The clearance is based on substantial equivalence to predicate devices, implying performance comparable to those devices rather than specific quantitative acceptance criteria for clinical efficacy.
• Reported Device Performance: Not reported in clinical terms. The document only references non-clinical testing for safety and electrical 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 study test set is described. The non-clinical tests would have involved specific samples (e.g., device units, materials for biocompatibility) but these are not "test sets" in the context of clinical performance evaluation.

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 study with a test set requiring ground truth establishment is described.

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

• Not applicable as no clinical study with a test set requiring adjudication is described.

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 MRMC comparative effectiveness study was done, nor is there any mention of AI in this device. This is an LED light therapy mask, 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 an LED light therapy mask, not an algorithm or AI device.

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

• Not applicable as no clinical study requiring ground truth is described.

8. The sample size for the training set

• Not applicable as this is an LED light therapy mask; there is no mention of machine learning or an algorithm requiring a training set.

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

• Not applicable as this is an LED light therapy mask; there is no mention of machine learning or an algorithm requiring a training set with established ground truth.

Summary of what is contained in the document regarding "proof" of meeting criteria:

The FDA clearance for the LED Light Therapy Mask (K251667) is based on substantial equivalence to legally marketed predicate devices, not on a new clinical study demonstrating specific efficacy or performance criteria. The "proof" provided in the 510(k) summary focuses on non-clinical testing and technological comparisons:

• Non-Clinical Testing:

  • Biological evaluation (ISO 10993-1:2018)
  • Electrical safety (IEC 60601-1:2020)
  • Electromagnetic compatibility (IEC 60601-1-2:2020)
  • Home healthcare environment requirements (IEC 60601-1-11:2020)
  • Specific requirements for home light therapy equipment (IEC 60601-2-83:2022)
  • Photobiological safety (IEC 62471:2006)

• Technological Comparison (Substantial Equivalence): The device's indications for use, power supply (lithium batteries tested per IEC 62133-2), LED wavelengths (red: 630nm, amber: 605nm, blue: 415nm, infrared: 850nm), irradiance levels, and safety features (Type BF applied part) were found to be similar or within the acceptable range of the predicate and reference devices.

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The KALA Therapy Wand (Model: KALA-03) is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne.

The KALA Therapy Wand (Model: KALA-03) is indicated for over-the-counter aesthetic use. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne. The device is vibrating in red light model. The device is powered by a Lithium-Ion rechargeable battery, and it has a charging cable, USB charging stand, protective goggles, storage case and instruction manual.

The wand can be rotated 135 degrees in either direction.

There are two switches of the device: one function is red light to wrinkle removal and vibration for relax, the other function is blue light to treat mild to inflammatory acne.

The device will automatically shut down after 12 minutes of operation. The recommended treatment time is 3 minutes per area. After every three minutes of treatment, the device will vibrate to indicate the time. If you need to continue treatment, simply turn on the device again.

The provided FDA 510(k) clearance letter and summary for the KALA Therapy Wand (Model: KALA-03) indicate that no clinical performance study was conducted to prove the device meets acceptance criteria. The summary explicitly states:

"7.2 Summary of Clinical Performance: 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 following information cannot be extracted from the provided document as it pertains to clinical performance which was not performed or deemed necessary for this 510(k) clearance.

1. A table of acceptance criteria and the reported device performance (for clinical performance)
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
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 is typically for AI/imaging devices, not a light therapy wand)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done (Not applicable for this device type)
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

However, based on the non-clinical tests performed, we can infer the acceptance criteria for those tests and their reported performance:

Non-Clinical Acceptance Criteria and Reported Device Performance

Additional Information Not Applicable/Provided:

• Sample size used for the test set and the data provenance: Not applicable as no clinical study was performed. For non-clinical tests, these metrics are not typically reported in this format.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study was performed.
• Adjudication method: Not applicable as no clinical study was performed.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is typically for AI/imaging devices.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is typically for AI/software devices.
• The type of ground truth used: Not applicable as no clinical study was performed.
• The sample size for the training set: Not applicable as no clinical study was performed.
• How the ground truth for the training set was established: Not applicable as no clinical study was performed.

In summary, the KALA Therapy Wand (Model: KALA-03) received 510(k) clearance based on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and compliance with relevant safety and performance standards, without the need for a separate clinical effectiveness study.

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The CurrentBody Skin™ LED Light Therapy Mask Series 2 (Model: MK-90H) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.

The CurrentBody Skin™ LED Light Therapy Mask Series 2 (Model: MK-90H) is a home use wearable LED phototherapy device whose purpose is to produce an even, cool, narrow band of light for aesthetic indication for treating facial wrinkles. It emits light energy in the red and near infrared (NIR) region of the light spectrum.

The device consists of a flexible silicone mask that contains light emitting diodes (LEDs) and a controller, multi-straps, a USB-C charging cord, a pair of eye inserts and a storage bag. The LEDs generate the light. The mask is worn on the face and is held in place by the adjustable strap. The controller contains a rechargeable Lithium ion polymer battery and controls power to the mask. The controller has only one key to switch the LEDs ON/OFF and it will automatically shut down after a 10-minute treatment is completed.

The provided FDA 510(k) clearance letter for the CurrentBody Skin™ LED Light Therapy Mask Series 2 (K250966) does not contain the detailed study information typically associated with acceptance criteria and clinical performance for an AI/ML device in the context of diagnostic performance (e.g., detecting a disease).

This device is an LED light therapy mask intended for treatment of full-face wrinkles, falling under the regulation 21 CFR 878.4810 (Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology). The primary focus of the regulatory review for such a device is safety and effectiveness based on its physical properties and intended use for cosmetic purposes, rather than diagnostic accuracy or AI-driven image analysis.

Therefore, many of the requested elements are not applicable to the information provided in this document. The document explicitly states:

• "Clinical testing is not needed for this 510(k)."
• "The non-clinical performance testing described above is sufficient to demonstrate that the device can be used safely and effectively."

This indicates that the device's clearance was based on demonstrating substantial equivalence to a predicate device through non-clinical tests (electrical safety, EMC, photobiological safety, battery safety, biocompatibility, and software verification/validation) and not on clinical performance metrics like sensitivity, specificity, or reader studies for diagnostic accuracy.

Addressing the Request Based on the Provided Document:

Given the nature of the device and the clearance documentation, I will answer the applicable points and explain why others are not present.

Acceptance Criteria and Device Performance for CurrentBody Skin™ LED Light Therapy Mask Series 2 (K250966)

The CurrentBody Skin™ LED Light Therapy Mask Series 2 is an LED phototherapy device for the treatment of full-face wrinkles. The acceptance criteria and performance evaluation for this device, as detailed in the 510(k) summary, are primarily focused on safety, electrical performance, material compatibility, and functional equivalence to a predicate device, rather than diagnostic performance metrics (e.g., accuracy in identifying wrinkles).

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for this device is primarily based on compliance with specific international safety and performance standards, and demonstrating substantial equivalence to a predicate device for its intended use. "Device performance" is therefore reported in terms of compliance with these standards and matching key operational parameters with the predicate.

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

Not applicable for performance evaluation in the context of typical AI/ML diagnostic devices. The clearance is based on non-clinical engineering and safety testing, component material equivalence, and functional equivalence to a predicate device. There is no "test set" of patient data or images in the conventional sense for evaluating diagnostic accuracy or clinical outcomes directly in this 510(k) submission.

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

Not applicable. No ground truth established by experts for a test set of clinical data, as no clinical performance study was conducted or required for this 510(k). Approval is based on safety, hardware specifications, and substantial equivalence.

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

Not applicable. No clinical test set requiring adjudication 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 is not a diagnostic AI device. No MRMC study was conducted or is relevant for this product's intended use (treatment of wrinkles).

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

Not applicable. This device is a hardware LED light therapy mask. While it has software for control (e.g., timer), it is not a standalone diagnostic algorithm.

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

The "ground truth" for this device's clearance is not related to clinical data or diagnostic accuracy. Instead, the "truth" is established by:

• Compliance with recognized international standards for electrical safety, electromagnetic compatibility, photobiological safety, battery safety, and biocompatibility.
• Demonstration of substantial equivalence (same intended use, similar technological characteristics, and no new questions of safety or effectiveness) to a legally marketed predicate device (K221946).

For the purpose of treatment effectiveness validation in general, the underlying scientific basis for LED light therapy's effect on wrinkles (which is outside the scope of this specific 510k submission's clearance process details) would typically stem from clinical trials and dermatological research. However, this 510(k) relies on the predicate's established performance without new clinical studies.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set of data for learning or inference.

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

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

In summary, the provided 510(k) clearance letter details an approval based on substantial equivalence and compliance with safety and performance standards for a hardware medical device, not on the clinical performance or diagnostic accuracy of an AI/ML driven system. Therefore, many of the requested details regarding AI/ML study methodologies are not present in this document.

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• Red light: Treatment of full-face wrinkles.
• Blue light: Treatment of mild to moderate inflammatory acne.
• Red+Blue light: Treatment of mild to moderate inflammatory acne.

The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.

The LED LIGHT MASK adopts light emitting diodes (LED) in the red (635nm ± 5nm) + blue (425 ± 5nm) and red-blue (635nm + 425nm ± 5nm) spectrum to irradiate on the face to realize its therapeutic effect (i.e. treatment of wrinkles and mild to moderate acne. The LED LIGHT MASK adopts the form of a mask that contains 64 LEDs on the inner surface of the main unit. A wired controller is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). The subject device operates in three treatment modes. One mode emits red light, one mode emits blue light, and the third mode emits red-blue light (i.e. mixed light). 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, the user must wear the product before turning it on, then the built-in eye mask of the face mask can block the radiation of LED light to the eyes during each treatment.

The provided FDA 510(k) clearance letter for the LED Light Mask (A093) does not contain any information about acceptance criteria or specific study results proving the device meets these criteria in a performance study with human subjects, AI, or expert adjudication.

The document focuses on:

• Substantial Equivalence: It asserts that the device is substantially equivalent to a predicate device (LED Light Therapy Mask, Model(s): RB-008G/RB-008GB/RB-008J/RB-008JB, K243423).
• Non-Clinical Performance Testing: It lists various safety and performance standards (Biocompatibility, Electrical Safety, Software Verification and Validation) that the device complies with.
• Claim of No Clinical Testing Needed: Section 11.0 explicitly states, "Clinical testing is not needed for this device." This means there was no de novo clinical trial or performance study conducted to establish clinical efficacy for wrinkles or acne beyond demonstrating functional safety and equivalence to a previously cleared device.

Therefore, I cannot fulfill your request for information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

These elements are typically part of a clinical performance study (often required for devices claiming new indications or significant technological differences), which the manufacturer declared was "not needed" and was therefore not submitted or reviewed by the FDA for this particular 510(k) clearance. The clearance is based on similarity to a predicate device and compliance with relevant safety and performance standards.

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The LED Facial Mask is an over-the-counter (OTC) device intended for the following uses:

For Red Mode(s): The device emits energy in the red spectrum and is intended for the treatment of full-face wrinkles.

For Red + NIR Mode: The device emits energy in the red and infrared spectrum and is intended for the treatment of full-face wrinkles.

For Blue Mode: The device emits light in the blue region of the spectrum and is specifically indicated for the treatment of mild to moderate acne on the face.

For NIR Mode: The device is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

The LED Facial Mask is a device used for treatment of full-face wrinkles, mild to moderate acne on the face, and providing topical heating. LEDs housed inside the device emit light onto the face. These LEDs generate blue, red, and infrared wavelengths.

This product is composed of the main device, controller, fastening straps, storage bag, blindfold, and charging cable.

This FDA 510(k) clearance letter pertains to an LED Facial Mask, which is categorized as a Class II medical device. The information provided outlines the manufacturing, intended use, and comparison to predicate devices, but it does not contain the specific performance data one would expect for a study proving the device meets acceptance criteria.

The document primarily focuses on demonstrating substantial equivalence to already cleared predicate devices based on technological characteristics and intended use. The "Performance Data" section lists various recognized consensus standards to which the device was tested (e.g., electrical safety, electromagnetic compatibility, usability, biological evaluation), rather than clinical study results establishing efficacy.

Therefore, I cannot create the detailed table of acceptance criteria and reported device performance, nor can I answer questions about sample size, ground truth establishment, expert adjudication, or MRMC studies, as this information is not present in the provided FDA clearance letter.

It explicitly states: "Clinical/animal testing was not performed for the proposed device as part of the submission." This confirms the absence of efficacy studies that would typically define acceptance criteria for performance outcomes.

The acceptance criteria for this device, as implied by the FDA 510(k) process for a Class II device, are largely related to safety, performance against engineering standards, and substantial equivalence to legally marketed predicate devices. The clearance is based on the premise that if the new device is sufficiently similar to existing cleared devices in terms of its technology and intended use, and meets relevant safety standards, it does not require new clinical efficacy data.

Here's a breakdown of what can be inferred from the document regarding acceptance criteria and the "study" (non-clinical testing) that proves the device meets them:

Inferred Acceptance Criteria and Device "Performance" (Non-Clinical)

Since no clinical efficacy studies were performed, the "acceptance criteria" are not related to a specific clinical outcome (e.g., X% reduction in wrinkles, Y% clearance of acne). Instead, they relate to safety, electrical performance, and biocompatibility, as demonstrated through testing against consensus standards.

Study Details (Based on the Provided Document)

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

   • Test Set Sample Size: Not applicable in the context of clinical data for efficacy. The "test set" here refers to the device itself being tested against engineering and safety standards. There is no patient sample size.
   • Data Provenance: The tests conducted are in vitro (bench testing) and in silico (software analysis) or conducted on the physical device itself, not on human subjects. Therefore, there's no country of origin for patient data, nor is it retrospective or prospective clinical data.

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

   • Not applicable. The "ground truth" for the engineering and safety tests is defined by the consensus standards themselves (e.g., a certain voltage tolerance, a specific emission limit). The "experts" would be the engineers and technicians performing the tests and verifying compliance with the standards, not clinical experts establishing ground truth for medical conditions.

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

   • Not applicable. This concept pertains to clinical studies where human interpretation of medical data needs to be harmonized. For engineering tests, results are typically objective measurements against a standard.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This type of study is for AI/CADe devices and involves human readers reviewing cases. This device is an LED facial mask, not an AI diagnostic tool.

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

   • No. This applies to AI/CADe devices.

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

   • The "ground truth" for this clearance is adherence to recognized consensus standards for safety, electrical performance, photobiological safety, and biocompatibility, as well as demonstrated technical similarity and intended use alignment with predicate devices. There is no clinical ground truth (e.g., biopsy results, clinician's diagnosis) involved in this substantial equivalence determination.

7. The sample size for the training set:

   • Not applicable. There is no AI model or "training set" for this device.

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

   • Not applicable.

In summary, the provided FDA 510(k) clearance document for the LED Facial Mask demonstrates that the device was cleared based on its substantial equivalence to existing devices and its adherence to a series of non-clinical safety and performance standards. No clinical efficacy studies were conducted or required for this particular clearance, as explicitly stated in the document.

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