Search Results

The KALA Red Light Face Mask (Model: KALA-01) is an over-the-counter device that is intended to emit energy in the red and near-infrared spectrum and is intended for the use in the treatment of full-face wrinkles.

The KALA Red Light Face Mask (Model: KALA-01) is an over-the-counter device that is intended to emit energy in the blue region of the light spectrum and is intended for the use in the treatment of mild to moderate acne vulgaris of the face.

KALA Red Light Face Mask is a home wearable light-emitting diode phototherapy device with three proven wavelengths of light 630nm Red light, 830nm Near infrared red light and 465nm blue light, all of these lights are known to treat wrinkles and mild to moderate acne vulgaris of the face. Among them, the device emits energy in red and near-infrared spectrum to treat full-face wrinkles, emits energy in the blue region of the light spectrum to treat 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 Head Straps. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface. Both surfaces are constructed of silicone.

The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and be connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The KALA Red Light Face Mask cannot be operated while charging. The controller switches the LEDs ON/OFF and controls power to the mask. Switch the controller ON and allow the mask to run for Red + NIR or Blue modes and 10- or 20-minutes treatment time program. The cable for connecting with the controller is detachable.

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.

The provided FDA 510(k) clearance letter and summary for the KALA Red Light Face Mask (KALA-01) primarily focus on non-clinical performance testing and substantial equivalence to predicate devices, rather than a detailed study demonstrating the device meets clinical acceptance 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 indicates that the regulatory clearance was based on demonstrating the device's technical performance, safety, and similarity to already approved devices, rather than a clinical trial with specific acceptance criteria related to efficacy (e.g., wrinkle reduction or acne treatment efficacy percentages).

Therefore, the following information will be based on the provided non-clinical performance testing and will highlight the absence of clinical study data as explicitly stated in the document.

Acceptance Criteria and Device Performance (Non-Clinical)

Since no clinical study focusing on efficacy endpoints (like wrinkle reduction percentage or acne lesion count reduction) was presented as part of the 510(k) summary, the acceptance criteria and performance reported here are for the non-clinical performance tests conducted to ensure the device's safety and fundamental operational characteristics.

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

Study Details (Based on Non-Clinical Testing)

As explicitly stated in the 510(k) summary, no clinical testing was performed or required for this clearance. The "study" here refers to the collection of non-clinical tests performed to demonstrate safety and technical performance.

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

• Sample Size: The document does not specify a "sample size" in the context of a patient cohort. For the non-clinical tests, it would typically refer to a statistically relevant number of devices or components tested. This information is not provided in detail, but it's understood that typical engineering and safety tests involve a representative sample of manufactured units or materials.
• Data Provenance: The tests were conducted in a lab setting, likely by the manufacturer or accredited testing facilities. The country of origin for the data (tests) is not explicitly stated beyond the manufacturer being in Shenzhen, China. The nature of these tests is prospective in the sense that they are planned tests on the device or its components to demonstrate compliance with standards.

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

• This concept is not applicable to the non-clinical performance and safety tests described. These tests involve objective measurements against established engineering and safety standards (e.g., electrical safety, optical power, material biocompatibility). "Ground truth" in this context is the standard itself (e.g., IEC 60601-1 requirements).
• For biocompatibility, the equivalence relies on the materials being identical to those of a previously cleared device (K202390), implicitly accepting that the ground truth for those materials' biocompatibility was established in the prior clearance.

4. Adjudication Method for the Test Set:

• None in the sense of clinical adjudication by multiple human experts. The compliance for non-clinical tests is determined by adherence to predefined, objective criteria outlined in the relevant international standards (e.g., IEC, ISO). Test reports are typically reviewed by regulatory bodies like the FDA.

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

• No. An MRMC study is relevant for evaluating the performance of diagnostic devices or AI systems where human readers interpret medical images or data. This device is a therapeutic light-emitting mask, and no such study was conducted or presented for its 510(k) clearance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

• Not applicable. This device does not involve a diagnostic algorithm or AI for interpretation that would necessitate a "standalone" or "human-in-the-loop" performance evaluation. Its performance is based on its physical emission characteristics and safety features.

7. The Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" is defined by international safety and performance standards (e.g., IEC 60601 series, IEC 62471, ISO 10993 series) and the specified technical requirements for the device (e.g., power density, leakage current limits).
• For biocompatibility, the ground truth is established by the prior clearance (K202390), based on the assumption that the identical materials have already demonstrated acceptable biocompatibility.

8. The Sample Size for the Training Set:

• Not applicable. The provided documentation does not describe any training set, as it does not involve machine learning or AI models that require specific training data.

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 HIGHERDOSE Red And Infrared Light Mask (Model: MK66-L) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.

The HigherDose Red and Infrared Light Mask is a home wearable light-emitting diode phototherapy device with two proven wavelengths of light 630nm and 830nm(near infrared light ) for treatment of fullface wrinkles,

The face mask combine Red (630nm)and near infrared light (830nm).Harnessed at the perfect measurement to rejuvenate the skin, these two wavelengths work below the skin's surface to stimulate the natural rejuvenation process ,creating a complexion that is visibly growing and noticeably healthier looking.

The mask is worn on the face and is held in place by head 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 HIGHERDOSE Red And Infrared Light 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.

The provided document is a 510(k) premarket notification for a medical device (HIGHERDOSE Red and Infrared Light Mask). It primarily focuses on demonstrating substantial equivalence to already marketed predicate devices, rather than presenting a detailed clinical study for novel performance claims.

Therefore, the information required to fully answer your request regarding acceptance criteria and performance studies for an AI/software-based device, particularly those concerning human-in-the-loop performance, expert ground truth, and training data provenance, is not present in this document.

However, I can extract the information provided about the non-clinical performance testing of this light therapy mask, which is a hardware device with some embedded software for control (e.g., timer).

Here's a breakdown of what can be inferred and what is explicitly stated:

Device: HIGHERDOSE Red and Infrared Light Mask (MK66-L)

Indications for Use: The HIGHERDOSE Red And Infrared Light Mask (Model: MK66-L) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.

Non-Clinical Performance Testing (Hardware and Embedded Software)

The document lists several non-clinical performance tests conducted, relevant to the safety and fundamental operation of the device, rather than its clinical efficacy in treating wrinkles which is established by substantial equivalence to predicates.

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

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

• Sample Size: "The test sample is the final, finished product." For each test, it implies at least one production unit was tested. The specific number of units is not stated, but typically for these types of tests, a small representative sample or even a single unit is sufficient to demonstrate compliance with standards.
• Data Provenance: Not specified, but generally, these tests are conducted by accredited labs. The manufacturer is based in Shenzhen, Guangdong, China. These are typically lab bench tests, not involving human subjects or real-world data collection in the sense of a clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not applicable and not provided. These are engineering/safety/performance tests against established international standards, not diagnostic device studies requiring medical expert ground truth.

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

• Not applicable. These are objective engineering tests with pass/fail criteria based on 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 MRMC or comparative effectiveness study was conducted or reported. This device is a direct-to-consumer light therapy mask, not an AI-assisted diagnostic tool.

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

• Not applicable in the context of an AI algorithm. The device has embedded software for basic control (like a timer), and "Software verification and validation testing" was conducted for this embedded software, considered a "moderate" level concern. However, this is not a standalone AI algorithm being evaluated for diagnostic or interpretive performance.

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

• For the non-clinical tests, the "ground truth" is adherence to the specified international safety and performance standards (e.g., IEC 60601-1, IEC 62471), determined through objective measurements and validated test methodologies.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a "training set." The embedded software is deterministic and not trained on data.

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

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

Summary regarding AI/Software-based device criteria:

The provided document is not for a device that fits the typical "AI/software-based device" criteria you've outlined (e.g., requiring MRMC studies, expert ground truth for image interpretation, or large training datasets). This 510(k) is for a hardware device (a light therapy mask) with embedded software for basic functionality (like a timer). The review focuses on demonstrating safety, fundamental performance, and substantial equivalence to existing predicate devices based on non-clinical engineering and safety standards. No clinical efficacy study data is presented, as it was deemed "not needed for this 510(k)" due to the substantial equivalence pathway.

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 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