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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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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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• 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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The CurrentBody Skin Dual Light Hair Growth Helmet is indicated to promote hair growth in males with who have Norwood-Hamilton classifications of IIa-V or females with who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.

The CurrentBody Skin Dual Light Hair Growth Helmet (model:MZ-07A) is an over-the-counter device designed to promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V patterns of hair loss and to promote hair growth in females who have Ludwig-Savin Classifications of I-II; both with Fitzpatrick Skin Types I-IV.

The device consists of 100 laser diodes with wavelength at 655±5nm, and 200 red light diodes with wavelength at 660±5nm.

The CurrentBody Skin Dual Light Hair Growth Helmet includes a hair-growing cap, a device base and a USB power cord. There are LEDs and lasers diodes inside the cap to emit visible red light, the device base acts as a support when the device is not used. There is a power button on cap to turn on/off the device, a digital display to show the remaining treatment time, an power indicator to show charging status and a USB port for charging.

The treatment parameter is pre-set by manufacturer, the device will auto off after treatment.

The provided FDA 510(k) clearance letter and summary for the CurrentBody Skin Dual Light Hair Growth Helmet (K251017) indicate that clinical performance testing was explicitly stated as "not needed" for this 510(k) submission. Therefore, the document does not contain information regarding acceptance criteria or a study that proves the device meets those criteria based on clinical performance data.

The submission relies on non-clinical performance testing to demonstrate substantial equivalence and safety/effectiveness. This non-clinical testing focuses on electrical safety, EMC, photobiological safety, battery safety, biocompatibility, and software validation.

Here's a breakdown of why the requested information about acceptance criteria and a clinical study proving performance cannot be extracted from this document, along with information that is available:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)

Since no clinical performance study was provided, there are no specific performance acceptance criteria for hair growth or efficacy reported in the document. The acceptance criteria for this submission are related to meeting established safety and performance standards through non-clinical testing.

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

Regarding a Clinical Study (Not Applicable for this Submission)

As stated in Section 7.2 of the 510(k) Summary:
"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, which would typically be included for a clinical study proving efficacy/performance, is not available in this document:

1. Sample sizes used for the test set and the data provenance: Not applicable.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method for the test set: Not applicable.
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: Not applicable (This is generally for diagnostic AI devices, not a therapeutic device like this).
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: Not applicable.
7. The sample size for the training set: Not applicable (referring to clinical training data for performance, not engineering/software validation training).
8. How the ground truth for the training set was established: Not applicable.

Summary of Device Performance Claim Basis for Hair Growth:

The claim about promoting hair growth is based on:

• Substantial Equivalence: The primary strategy for clearance is demonstrating that the CurrentBody Skin Dual Light Hair Growth Helmet is substantially equivalent to legally marketed predicate devices (K231153: Neuhat Hair Growth System; K240456: Bosley Booster Laser Caps). The predicate devices were previously cleared for the same indication (promote hair growth in specific Norwood-Hamilton and Ludwig-Savin classifications with Fitzpatrick Skin Phototypes I-IV).
• Similarity in Design and Parameters: The submission highlights similarities in the intended use, indications for use, type of light (low-level laser and LED), wavelength (very close to predicates), number of diodes, energy per laser diode, and treatment time/irradiance (very close to predicates). The argument is that these similarities mean the subject device will have a similar therapeutic effect to the already-cleared predicate devices.
• Non-Clinical Data: As detailed in the table above, the non-clinical testing ensures the device meets safety standards (electrical, EMC, photobiological, battery, biocompatibility, software) which indirectly supports its safe use for its intended purpose without raising new questions of safety or effectiveness compared to the predicates.

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The Red Light Hair Growth Cap is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I-IV.

The Red Light Hair Growth Cap is an over the counter (OTC) home-use, non-invasive device indicated to treat androgenetic alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I-IV.

The Red Light Hair Growth Cap is a portable, therapeutic device whose purpose is to provide even, cool, narrow-band wavelengths of polychromatic light (660nm red light) produced by LEDs to treat androgenetic alopecia and promote hair grown.

The device comprises of a wearable soft textile cap, a controller, an AC adaptor and a USB cable. The device can be powered by the AC adaptor which connected to the mains directly, also it can be powered by a power bank. The device is operated by the controller. There are 2 buttons on controller, ON/Off button is used to turn on/off the device, time button is used for setting treatment time from 10 to 30 minutes, each press in 5-minute increments./decrements. The device will shut off automatically after reach treatment time.

The provided FDA 510(k) clearance letter and summary for the "Red Light Hair Growth Cap" do not contain the detailed clinical study information typically associated with acceptance criteria, reported device performance for clinical endpoints, sample sizes for test/training sets, expert qualifications, or adjudication methods for AI/software devices. This is because the device, an "Infrared Lamp" (a physical medical device), was cleared based on its substantial equivalence to predicate devices and extensive non-clinical (electrical safety, EMC, software verification/validation) testing, rather than a clinical effectiveness study.

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

Therefore, I cannot directly extract the requested information (points 1-9) in the manner typically expected for an AI/software medical device that undergoes rigorous clinical validation with specific performance metrics against a ground truth.

However, I can describe the acceptance criteria and study type that proves the device meets those criteria based on the provided document:

Acceptance Criteria and Study for the Red Light Hair Growth Cap

The Red Light Hair Growth Cap (LP-RJVGRW-BLK) received FDA 510(k) clearance based on its substantial equivalence to legally marketed predicate devices, combined with comprehensive non-clinical performance testing. The core "acceptance criteria" for this specific submission were centered around safety and effectiveness being comparable to existing devices and meeting established electrical and software safety standards.

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

Since this was a 510(k) based on substantial equivalence and non-clinical testing, the "acceptance criteria" are primarily related to safety standards and comparison to predicate device characteristics. There are no specific clinical performance metrics for "hair growth" reported in this document.

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

• Test Set (Clinical): Not applicable. Clinical testing was explicitly stated as "not needed" for this 510(k). The evaluation relied on non-clinical engineering and software testing.
• Data Provenance: The document does not specify country of origin for any safety testing data, only that the sponsor is Shenzhen Idea Light Limited, China. The testing itself is non-clinical (lab-based engineering/software V&V).

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. There was no clinical "test set" requiring expert ground truth establishment for clinical endpoints.

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

• Not applicable. There was no clinical "test set" requiring adjudication.

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 not an AI/software diagnostic tool; it is a therapeutic device that does not involve human readers interpreting output or AI assistance.

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

• Not applicable. This is a physical therapeutic device, not an algorithm.

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

• For the non-clinical testing, the "ground truth" refers to the established requirements and specifications of the referenced IEC standards (e.g., IEC 60601-1 for electrical safety) and FDA software guidance. Compliance with these standards served as the "ground truth" for safety and performance.
• For substantial equivalence for indications for use, the "ground truth" was the cleared indications for use of the predicate devices.

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set" in the context of data-driven algorithm development.

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

• Not applicable, as there is no training set.

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The Medical Diode Laser Systems, include model: VELASⅡ-30A, GBOX-15AB, GBOX-20B, CHEESEⅡ-10B are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.

The Medical Diode Laser Systems, model: VELASⅡ-30B is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.

The Medical Diode Laser Systems, model: VELASⅡ-30B is also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

The "Medical Diode Laser Systems", include model: VELASⅡ-30B, VELASⅡ-30A, GBOX-15AB, GBOX-20B, CHEESEⅡ-10B which consist of three main components: Main device; Foot switch; Accessories.

Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source.

The diode laser for this unit is GaAlAs diode bar, and the wavelength is 810nm and/or 980nm+/-10nm (pilot beam: 650nm+/-10nm). It features impact structure, high efficiency and long lifetime. Generally, the beam shall be emitted as the big beam divergence of the laser from the diode. With the unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber.

MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system. It supplies power for MCU, diode laser module by DC-DC conversion module and temp system by temp-control circuit. MCU controls the drive current of diode laser module by adjusting the DC-DC module and current-control circuit. The MCU has three external input sources: footswitch, remote interlock connector and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system.

The provided FDA 510(k) clearance letter for the Gigaalaser Medical Diode Laser Systems does not contain a study that proves the device meets specific acceptance criteria related to its clinical efficacy. Instead, it demonstrates substantial equivalence to legally marketed predicate devices based on technological characteristics and safety standards.

The document focuses on non-clinical performance data (electrical safety, EMC, software V&V, mechanical/acoustic, animal, and clinical studies are noted as "not applicable" for this submission type) to argue that the proposed device is as safe and effective as its predicates.

Therefore, I cannot directly provide a table of acceptance criteria and reported device performance in the context of a clinical efficacy study, as such a study is explicitly stated as "not applicable" in this 510(k) submission. Similarly, details about sample size, expert ground truth, adjudication methods, MRMC studies, or standalone performance are not present because clinical efficacy testing was not required for this type of submission.

However, I can interpret the acceptance criteria in the context of a 510(k) submission as the requirements for demonstrating substantial equivalence to predicates, particularly regarding safety and technological characteristics. The "performance" reported is the demonstration that these criteria are met through compliance with recognized standards.

Here's an interpretation based on the provided document:

Overview of "Acceptance Criteria" for Substantial Equivalence and Device Performance (as demonstrated in the 510(k))

Within the context of a 510(k) submission, "acceptance criteria" are primarily established through demonstrating compliance with recognized performance standards and substantial equivalence to legally marketed predicate devices. The "study" proving this involves a comprehensive technical comparison and non-clinical testing.

The document explicitly states that clinical studies are "not applicable" for this 510(k) submission, meaning the acceptance criteria are focused on non-clinical performance and technological equivalence rather than empirical clinical efficacy data from a human trial.

1. Table of "Acceptance Criteria" (Substantial Equivalence) and "Reported Device Performance" (Demonstrated Compliance)

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

This document does not describe a "test set" in the context of clinical data for efficacy. The "testing" referred to is primarily bench testing and compliance validation with international safety and performance standards. Therefore, concepts like sample size for a patient test set and data provenance (country of origin, retrospective/prospective) are not applicable as no clinical study for efficacy was performed or presented.

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

Not applicable. As no clinical efficacy test set was used, there was no need for experts to establish ground truth on patient outcomes/diagnoses. The "ground truth" for the substantial equivalence argument relies on comparison to the published specifications and regulatory clearances of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

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

No. The document explicitly states "Clinical Studies: It is not applicable." Therefore, no MRMC study for human reader improvement with AI assistance was conducted or reported.

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

No. This device is a laser system hardware, not an AI algorithm. Its performance is inherent to its physical output characteristics, not an algorithm's classification or detection performance.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is primarily:

• Predicate Device Specifications: The established technical parameters and indications for use of the legally marketed predicate devices (K142078, K150138, K121363, K230047).
• Industry Standards: The requirements laid out in the cited IEC and other international standards for medical electrical equipment and laser safety.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device, not a machine learning model that requires a training set of data.

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

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

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Hair Growth Device is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

The product is composed of main unit, USB cable, and silicone pad. The main unit consists of laser diodes that are spread throughout the helmet. Low-energy laser therapy (LLLT) is a safe and effective treatment for androgenic alopecia (AGA). The Hair Growth Device employs intelligent LLLT technology, utilizing a 650 nm, 5-milliwatt low-energy laser that penetrates the scalp surface to a depth of 3-5 mm, reaching the hair follicles. Hair Growth Device is a small over-the-counter, portable, noninvasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in Males and Females. The product uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. Hair Growth Device consists of main unit, USB cable and silicone strap and no communication function. The device will then turn on and you'll hear an audible beep.

This FDA 510(k) clearance letter is for a medical device (Hair Growth Device) rather than a software algorithm used for interpretation/diagnosis. As such, the information typically requested for AI-powered diagnostic devices (e.g., test set sample size, expert qualifications, adjudication methods, MRMC studies, ground truth types for training/test sets, etc.) is not applicable or present in this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications and non-clinical testing. It explicitly states, "No clinical test data was used to support the decision of substantial equivalence."

Therefore, I cannot provide the requested information about acceptance criteria for an AI algorithm's performance or details about a study proving such performance, as this document does not pertain to such a device or study.

However, I can extract the general acceptance criteria and the type of study performed to prove substantial equivalence based on the provided text, recognizing these are not related to AI performance.

Based on the provided FDA 510(k) clearance letter for the Hair Growth Device:

1. Table of Acceptance Criteria and Reported Device Performance:

• Product service life
• Software validation
• Biocompatibility evaluation
• Electromagnetic compatibility and electrical safety
• Safety of laser products
• Performance test |

Regarding the study that proves the device meets the acceptance criteria (note: this is a substantial equivalence study, not an AI performance study):

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set or patient data was used. The study primarily relies on comparison to predicate devices and non-clinical engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth was used for this substantial equivalence determination.

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 device is not an AI-powered diagnostic tool, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm. The device operates independently (Over-The-Counter).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI context. For substantial equivalence, the "ground truth" is established by compliance with recognized standards (e.g., IEC, ISO) and comparison to legally marketed predicate devices that have established safety and effectiveness.

8. The sample size for the training set: Not applicable. This is not an AI algorithm, so there is no training set in the machine learning sense.

9. How the ground truth for the training set was established: Not applicable. No AI training set.

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Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.

Air Compression Leg Massager is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading of tissue with the hards by use of inflatable presure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.

Air Compression Leg Massager supplied clean and non-sterile, utilizes the pneumatically controlled by an electronically controlled air pump unit. A pump, battery and control components are protectively housed in a plastic case of Controller.

Function buttons and light emitting diode (LED) indicators on the user interface. There is a charging port at the bottom of Controller for connecting the alternating current (AC) adapter plug.

Each leg wap has an air hose for connection to Controller, and both encase a 2-chamber air bladder inside. It can be wrapped and massaged separately by the two chambers. The soft medical fabric of wraps provides patient comfort and biocompatibility compliance.

Air Compression Leg Massager is also capable of providing the warming and vibration, these are included for an improved user experience.

The provided text does not contain detailed information about acceptance criteria for device performance or a study that specifically proves the device meets those criteria. The document is a 510(k) summary for an Air Compression Leg Massager, primarily focusing on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and results for the subject device.

The "Performance Data" section (VIII) lists several non-clinical tests performed to support the substantial equivalence determination, but these are primarily related to safety, electromagnetic compatibility, battery safety, and software validation, not the direct clinical performance of improving circulation or relieving aches and pains.

Therefore, many of the requested details cannot be extracted from this document. However, I can summarize what is present:

What is present in the document:

• Non-clinical tests performed: Biocompatibility, Electrical Safety and EMC, Battery Safety, and Software Verification and Validation.
• Result of these tests: They "passed" or "demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels."
• Overall Conclusion: The device is considered "as safe, as effective, and performs as well as the primary predicate device and secondary predicate device" based on this analysis and non-clinical tests.

What is NOT present in the document (and thus cannot be filled in):

• A table of acceptance criteria and reported device performance for clinical effectiveness (e.g., specific metrics for pain relief or circulation increase).
• Sample size used for a performance test set.
• Data provenance (e.g., country of origin, retrospective/prospective) for a performance test set.
• Number of experts used or their qualifications for establishing ground truth (as no clinical performance study is detailed).
• Adjudication method for a test set.
• Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
• Information on a standalone (algorithm only) performance study.
• The type of ground truth used for clinical performance.
• The sample size for the training set (as it's a physical device, not an AI/ML algorithm that requires a training set in the described sense).
• How the ground truth for the training set was established.

Based on the available information, here's a summary of the compliance for the listed non-clinical tests:

Study that proves the device meets the acceptance criteria:

The document states that the substantial equivalence determination is supported by these non-clinical performance data. It does not describe a clinical study measuring the device's efficacy in achieving "temporary relief of minor muscle aches and pains" or "temporary increase in circulation," as the FDA often relies on technological similarity to a predicate device for this type of claim, assuming the predicate's effectiveness. The listed tests are primarily aimed at ensuring the device's safety and fundamental operational integrity as an inflatable tube massager.

Therefore, for the clinical performance claims (pain relief, circulation increase), the "study" is implicitly the demonstration of substantial equivalence to already cleared predicate devices that have established these claims, rather than a de novo clinical trial with specific clinical acceptance criteria for the subject device.

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M1 is used to reduce the circumference of the hips, waist and is indicated for use as a noninvasive dermatological.

M2 is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full-face wrinkles.

M3 is intended to emit energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis, pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.

The EnergyLounger, Model: TY-01 a device designed similar to a recliner, with 1260 LED lights, a switch for power on/off, and it can automatically stop treatment after 20 minutes use for M1/M2 and after 30 minutes use for M3, 2 buttons for mode selection, and an AC power supply for power supply.

The LED in the EnergyLounger, Model: TY-01 is a 1W imitation current light. It's a 4-in-1 LED, including 630nm, 630nm, 850nm and 940nm.The EnergyLounger, Model: TY-01 includes a detailed Instruction Manual, operators need to read the instructions carefully before use.

This device uses three types of LEDs and has three working modes, which can be selected by the user by pressing a button.

The device consists of an Energy Lounger, power cable, Product protect cover, Reflector, Goggles and User Manual.

I'm sorry, but this document does not contain the detailed information necessary to entirely fulfill your request. The provided text is a 510(k) premarket notification letter and a 510(k) summary for a medical device called "EnergyLounger (TY-01)".

While it discusses the device's indications for use, its comparison to predicate devices, and non-clinical tests performed (electrical safety, EMC, biocompatibility, usability validation), it 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."

This means there was no clinical study, human reader study, or establishment of ground truth regarding clinical outcomes (e.g., reduction of hip/waist circumference, treatment of wrinkles, pain relief) performed for this submission. Therefore, I cannot provide information on:

• A table of acceptance criteria and reported device performance related to clinical effectiveness. The acceptance criteria mentioned are for non-clinical aspects like electrical safety and biocompatibility.
• Sample size used for the test set (clinical).
• Number of experts used to establish ground truth for the test set.
• Adjudication method for the test set.
• MRMC comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used (clinical outcomes/pathology).
• Sample size for the training set (clinical data).
• How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical safety/performance standards, rather than direct clinical efficacy trials.

However, I can extract information about the non-clinical acceptance criteria and tests:

1. A table of acceptance criteria and the reported device performance (Non-Clinical):

Regarding the other points, as stated above, the document explicitly indicates that no clinical testing was performed or needed for this 510(k). Therefore, questions related to clinical test sets, ground truth establishment for clinical outcomes, or human reader studies cannot be answered from this document.

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