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The Cold Sore Device is indicated for shortening the time to healing of herpes simplex labialis lesions on or around the lips with time to healing defined as the time to patient described re-epithelialization.

The Cold Sore Device is a solid state opto-electronic device that emits a controlled quantity of 1072mm +/-12nm peak wavelength near infrared light for a period of approximately 3 minutes. The maximum peak light intensity across the treatment surface is 20mW/cm². The light output and duration are monitored by a microprocessor. The tip of the device that contacts the patient is made out of Acrylonitrile Butadiene Styrene (ABS) + PC. Treatment with the device is commenced at the first symptoms of a cold sore 3 times a day with 4 hours in between each treatment for 2 consecutive days. The treatment area is approximately 3 cm². There are 2 light emitting diodes (LEDs) in the treatment area. The light within the device is activated by opening the cover of the device and automatically shut down after the preprogrammed treatment time (3 minutes). The device is designed for external, limited duration skin contact in an environment free from fluids and is provided non-sterile. The LEDs do not come in direct contact with the patient based upon the design of the device. The device is for OTC use and single patient use as described in the patient and box labeling.

The provided text is a 510(k) summary for the Cold Sore Device (Model: QPZ-01). It outlines the device's characteristics, its comparison to a predicate device, and the testing conducted to support its substantial equivalence. However, the document explicitly states that "no clinical test on our device" was performed. This means the information requested about acceptance criteria and studies proving the device meets those criteria through clinical trials (e.g., sample size for test set/training set, expert involvement, adjudication, MRMC studies, standalone performance, ground truth establishment) cannot be extracted from this document because such studies were not conducted for this submission.

The FDA cleared this device based on its substantial equivalence to a predicate device (ViruLite Cold Sore Machine) and extensive non-clinical testing, including electrical safety, electromagnetic compatibility, photobiological safety, usability, and biocompatibility.

Here's a breakdown of what can be extracted and what cannot:

What can be extracted/inferred:

• Acceptance Criteria (Implied): The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device and compliance with relevant safety and performance standards. The key performance measure for the intended use is "shortening the time to healing of herpes simplex labialis lesions on or around the lips with time to healing defined as the time to patient described re-epithelialization." The submission argues that since the new device has the same wavelength, energy density, and treatment schedule as the predicate, it is expected to achieve similar efficacy.
• Device Performance (Reported): The device is reported to emit a controlled quantity of 1072nm +/-12nm peak wavelength near infrared light with a maximum peak light intensity of 20mW/cm² for approximately 3 minutes.
• Sample size used for the test set and the data provenance: No clinical test set was used to evaluate efficacy directly. Usability testing was conducted with 45 initial subjects (3 withdrew for not being suitable), and then 42 subjects participated in a usability study and label comprehension. The provenance of this usability data is not specified beyond "simulated user's home environment".
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for efficacy data, as no clinical study was performed. For usability, "researchers" made judgments, but their qualifications are not specified beyond their role in the study.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for efficacy data. For usability, "investigator will record the operation of the subject" and "investigators will record and analyze responses," implying a direct observation/analysis by the researchers. No formal adjudication process with multiple independent reviewers is described.
• 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 study was done, as this is not an AI-assisted diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical light therapy device, not an algorithm.
• The type of ground truth used: Not applicable for efficacy data. For usability, the ground truth was the ability of subjects to correctly self-select, perform device operations, and comprehend labeling based on researcher observation/evaluation.
• The sample size for the training set: Not applicable, as no algorithm/AI training was performed.
• How the ground truth for the training set was established: Not applicable, as no algorithm/AI training was performed.

Summary Table of Applicable Information (based on the provided document):

In conclusion: The device was cleared based on its substantial equivalence to a legally marketed predicate device, along with extensive non-clinical and usability testing, as explicitly stated in the "Discussion of Clinical Tests Performed" section: "So there is no clinical test on our device." This type of submission relies on proving the new device is as safe and effective as a previously cleared device, rather than conducting new clinical trials to establish de novo efficacy.

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