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The Anti-Wrinkle Light, model: AAL, is a handheld device intended for use in the treatment of periorbital wrinkles.
The Anti-Wrinkle Light is a hand held device intended to emit energy in the visible and IR regions of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

The Anti-Wrinkle Light, Model AAL is a hand-held device consisting of low intensity light emitting diodes (LED's) that emit Low and Sub- IR light for direct exposure to the skin. The device components include an LED array of 605nm, 630nm, 660nm, and 855nm wavelengths, a (non-flammable plastic) hand piece housing a printed circuit board upon which the LED's are mounted, single non-timer on/off switch with 5-ohm resistor, receiver jack in the hand piece accommodating a removable power cord and a separate AC to DC ( 9-volt ) power supply. Treatment time is recommended to be 3 minutes and is controlled by the user.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Anti-Wrinkle Light, Model AAL:

It's important to note that the provided 510(k) summary (K092800) for the Anti-Wrinkle Light, Model AAL, is extremely limited in the detail it provides about the clinical study conducted. Many of the requested details are not present in the document.

Acceptance Criteria and Reported Device Performance

The document states, "After an analysis of the safety, indications and intended uses, performance, features, technological properties and methods of operation, LED Intellectual Properties, LLC believes that no significant differences exist between the predicate devices listed in Section 3, above. A clinical study has been submitted."

This implies that the acceptance criterion was likely demonstrating substantial equivalence to predicate devices, particularly in performance for the reduction of periorbital wrinkles and rhytides. However, the specific quantitative acceptance criteria (e.g., a certain percentage reduction in wrinkles, or a specific score improvement) and the corresponding reported device performance (i.e., the numerical results from the clinical study) are NOT provided in this summary.

Therefore, a table of acceptance criteria and reported device performance cannot be fully constructed from the given information as the specific performance metrics and outcomes are absent. The general "performance" stated is that it is believed to be "no significant differences" from predicates.

Study Details:

Here's what can be extracted and what is missing:

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

   • Acceptance Criteria: Implicitly, substantial equivalence to predicate devices for the reduction of periorbital wrinkles and rhytides. No specific quantitative criteria (e.g., target percentage reduction, statistical significance) are stated.
   • Reported Device Performance: Not provided in the summary. The summary only states that "LED Intellectual Properties, LLC believes that no significant differences exist between the predicate devices," implying successful performance relative to the predicates, but no specific outcome data is presented.

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

   • Sample Size: Not specified. The document only mentions "Individual subjects participating in the clinical study."
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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 provided in the document.

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

   • This information is not provided in the document.

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

   • This is not applicable as the device is a therapeutic light device, not an AI diagnostic/interpretive tool that assists human readers.

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

   • This is not applicable as the device is a therapeutic light device, not an AI algorithm. Its performance is measured directly on the patient's skin condition.

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

   • The "ground truth" for a device intended for wrinkle reduction would typically involve clinical assessment of wrinkle severity before and after treatment, possibly using standardized grading scales (e.g., Fitzpatrick Wrinkle Scale, photonumeric scales) or objective measurements (e.g., 3D imaging). However, the specific method used is not detailed in this summary. It would fall under "outcomes data" or expert assessment of outcomes.

8. The sample size for the training set:

   • This device is not an AI/machine learning algorithm that requires a "training set" in the conventional sense. It's a light therapy device. The clinical study mentioned would be considered the validation or performance study, typically for demonstrating safety and effectiveness on an independent cohort.

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

   • Not applicable for a therapeutic light device.

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