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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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