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

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

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

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

Key Takeaway from the Document:

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

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

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

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

• Wavelengths: Red (630±5nm), Blue (415±5nm), NIR (830±5nm)
• Intensity (e.g., Blue, Red, NIR mW/cm²)
• Total Intensity (e.g., Blue/Red, Red/NIR mW/cm²)
• Dose (J/cm²)
• Treatment time (10 minutes)
• Treatment protocol (Acne: 4x weekly, 6 weeks; Wrinkles: 5x weekly, 6 weeks)
• Software Control (timer for treatment duration)
• Intended Location of Use (Face)
• Energy Type (LEDs) | Substantial Equivalence Demonstrated to Predicate Device (K214103)
• Design Principle, Intended Use, Indications for Use, Functions, Material, and Applicable Standards: "The subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards."
• Wavelengths: Matches predicate (Red: 630±5nm, Blue: 415±5nm, NIF: 830±5nm vs. Predicate Red: 630nm±10nm, Blue: 415nm±10nm, NIF: 830nm±10nm).
• Intensity: Blue: 26 mw/cm² (Predicate: 28 mw/cm²); Red: 16 mw/cm² (Predicate: 16 mw/cm²); Red (for wrinkles): 18 mw/cm² (Predicate: 18 mw/cm²); NIR: 12 mw/cm² (Predicate: 11 mw/cm²).
• Total Intensity: Blue/Red: 42 mw/cm² (Predicate: 44 mw/cm²); Red/NIR: 30 mw/cm² (Predicate: 29 mw/cm²).
• Dose: Blue: 15.6J/cm² (Predicate: 16.8J/cm²); Red: 9.6J/cm² (Predicate: 9.6J/cm²); Red (for wrinkles): 10.8J/cm² (Predicate: 11J/cm²); NIR: 7.2J/cm² (Predicate: 7J/cm²).
• Treatment Time: Same (10 minutes).
• Treatment Protocol: Same (Acne: 4x weekly, 6 weeks; Wrinkles: 5x weekly, 6 weeks).
• Software Control: Same (device uses a timer and software to control treatment duration).
• Intended Location of Use: Same (Face).
• Energy Type: Same (Light emitting diodes).
• Minor Differences Justification: Despite slight differences in intensity and dose, "the treatment parameters of the subject device are very close to the predicate device and both of them meet the requirements of the IEC 60601-2-57. So, the minor difference... will not raise any safety or effectiveness issues." |
  | Electrical Safety Standards Compliance:
• ANSI AAMI ES60601-1
• IEC 60601-1-11
• IEC 60601-1-2
• IEC 60601-2-57
• IEC 62133-2
• IEC 62471 | Compliance Demonstrated: "LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) has been evaluated the safety and performance by lab bench testing as following: [Lists all standards]... and the test results are compliance with safety standards' requirements." |
  | Biocompatibility Standards Compliance:
• ISO 10993-5 (Cytotoxicity)
• ISO 10993-10 (Sensitization)
• ISO 10993-23 (Irritation) | Compliance Demonstrated: "The component materials for Adjustable Velcro Straps, Removable Eye Protection, shell (Inner surface), and shell (Outer surface) of the subject device are identical to the corresponding component materials of the K2217752. So, the subject device can comply with the biocompatibility requirements..." |

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

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

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