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The LH-75 Phototherapy System is intended for use, by or under the direction of a physician, in UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma.

The LH-75 Phototherapy System is intended for use on all skin types (I -VI).

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The provided 510(k) summary for the LH-75 Phototherapy System does not contain information about specific acceptance criteria or a study designed to prove the device meets such criteria.

The 510(k) process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring formal clinical trials with pre-defined acceptance criteria and reported performance metrics in the same way a PMA (Premarket Approval) would.

Therefore, many of the requested details about acceptance criteria, study sample sizes, expert involvement, and ground truth establishment are not typically found in a 510(k) submission for a device like this.

However, based on the information provided, here's what can be extracted and what cannot:

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

• Not provided. The document describes the device and its intended use, but does not list specific performance metrics with acceptance criteria and corresponding reported performance from a study. 510(k)s for this type of device often rely on electrical safety, EMC, and photometric output testing to demonstrate substantial equivalence, rather than clinical performance metrics with defined acceptance criteria.

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

• Not provided. No clinical performance study is described that would have a test set.

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)

• Not applicable/Not provided. Since no clinical performance study with a test set is described, there's no mention of experts or ground truth establishment for such a set.

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

• Not applicable/Not provided. No clinical performance study with a test set is described.

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/Not provided. This device is a phototherapy system, not an AI-assisted diagnostic device. Therefore, an MRMC study is not relevant.

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

• Not applicable/Not provided. This is a hardware device for phototherapy, not a standalone algorithm.

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

• Not applicable/Not provided. No clinical performance study requiring ground truth is described in the 510(k) summary. The "ground truth" for a phototherapy device would generally relate to its ability to emit specific UV dosages and wavelengths, and its safety, rather than diagnostic accuracy.

8. The sample size for the training set

• Not applicable/Not provided. This device is a physical phototherapy system, not a machine learning model that requires a training set.

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

• Not applicable/Not provided. As above, no training set is relevant for this type of device.

Summary based on the 510(k) Document:

The 510(k) summary for the LH-75 Phototherapy System focuses on demonstrating substantial equivalence to predicate devices (TheraLight, Inc. UV1 20-2 UVA / UVB Phototherapy System, Lerner Medical Devices, Inc. LH-75T Phototherapy System, Daavlin Distributing Co. 3 Series Phototherapy Cabinet, Daavlin Distributing Co. Flex Controlled Phototherapy Equipment).

The "study" implied by a 510(k) is the comparison to predicate devices, focusing on technological characteristics, indications for use, and safety/performance data (often non-clinical, such as electrical safety, EMC, and photometric output testing) to show that the new device is as safe and effective as the predicate. The document does not detail specific acceptance criteria or results from a dedicated clinical performance study with human subjects, as would be expected for a PMA or for certain novel devices requiring such evidence.

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