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The PlasmaLuxLS is a medical light source, which is intended for use for the treatment of moderate acne vulgaris with blue light.
The PlasmaLuxLS is a medical laser device, which is intended for the treatment of moderate inflammatory acne vulgaris.

The PlasmaLuxLS is a compact light source that delivers a uniform distribution of light, with spectral output at peak wavelengths of 417 nm (Blue Light) a It is intended for use by or under the direction of a physician for the treatment of moderate acne vulgaris with blue light. The desired dose is selected using the operator interface located on the front panel of the device. The PlasmaLux LS device delivers local area phototherapy, whereby lamps deliver the specified dose of Blue Light.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

This 510(k) summary does not contain any information about acceptance criteria or specific studies to prove device performance.

The document explicitly states under the "Performance Data" section: "No Data Provided."

Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices. This means the manufacturer is asserting that their device is as safe and effective as existing, approved devices because it has a similar design, operates on the same principles, and is intended for the same use.

Therefore, since no performance data was provided, it's impossible to fill out a table of acceptance criteria or describe a study proving the device meets them.

However, I can extract the other requested information based on the premise that a study would exist, though none is present in this 510(k) summary.

Summary of Acceptance Criteria and Device Performance (Not Applicable - No Data Provided)

Since no performance data was provided, the following sections will indicate "Not Applicable" or "No information provided" as the relevant details are missing from the given document.

Detailed Information about the Study (Not Applicable - No Study Data Provided)

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

   • Sample Size (Test Set): No information provided.
   • Data Provenance: No information provided.

2. 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):

   • No information provided.

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

   • No information provided.

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 information provided. (The device is a light therapy device, not an AI-assisted diagnostic tool, so an MRMC study in this context is unlikely).

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

   • No information provided. (The device is a light therapy device, not an algorithm, so this concept does not apply).

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

   • No information provided.

7. The sample size for the training set:

   • No information provided.

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

   • No information provided.

Reasoning for "No Data Provided"

The Daavlin Distributing Company's 510(k) submission for the PlasmaLuxLS relies on demonstrating substantial equivalence to predicate devices rather than providing new performance data from clinical studies for this specific device. They state:

• "The PlasmaLuxLS is constructed in the same design configuration as the predicate devices, utilizing similar energy types and materials of identical composition."
• "The light emitted by the PlasmaLux is of identical spectrum and power as that of the predicate devices."
• "The PlasmaLux can be used with exactly the same treatment regimes as the predicate devices."

This approach is common for devices that are very similar to already approved ones, where the FDA determines that new clinical performance data is not necessary to establish safety and effectiveness. The "Performance Data: No Data Provided" explicitly indicates that the manufacturer did not submit specific studies for this device.

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