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The PanaLight-BLU™ Illuminator, Model 4175 is intended to provide phototherapeutic light to the body. The PanaLight-BLU™ is generally indicated to treat dermatological indications. The PanaLight-BLU™ is specifically indicated to treat moderate inflammatory acne vulgaris.

The PanaLight-BLU™ is a compact light source that delivers a uniform distribution of narrowband blue light to the body with a spectral output at a peak wavelength of 417 +/- 5 nm. The principal parts of the system include the light unit head and floor stand with timer.

The provided text is a 510(k) Summary of Safety and Effectiveness for the DUSA PanaLight-BLU™ Illuminator, Model 4175. It explicitly states that no performance data is required for this Class II device, nor has it been requested by the Food and Drug Administration (Office of Device Evaluation).

Therefore, the study does not include acceptance criteria, specific device performance metrics, or details typically found in studies designed to prove a device meets performance criteria. The basis for clearance is substantial equivalence to predicate devices.

Given this information, a table of acceptance criteria and device performance, and details about a study proving these criteria, cannot be extracted from the provided document.

However, I can address the other points based on the document's content:

1. A table of acceptance criteria and the reported device performance:
Not applicable. The document states: "No performance data is required for this Class II device nor has it been requested by the Food and Drug Administration (Office of Device Evaluation)."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No performance study, test set, or data provenance is mentioned as no performance data was required.

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. No ground truth establishment for a test set is discussed as no performance study was required.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method for a test set is discussed as no performance study was required.

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. The device is a blue light illuminator for phototherapy, not an AI-assisted diagnostic tool involving human readers. No MRMC study was conducted or referenced.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical light source, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No performance study requiring ground truth was conducted for this device's 510(k) clearance.

8. The sample size for the training set:
Not applicable. The device is a physical light source, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:
Not applicable. As above, no training set or ground truth for it is relevant to this device's 510(k) submission.

Summary based on the provided document:

The DUSA PanaLight-BLU™ Illuminator, Model 4175, received 510(k) clearance based on substantial equivalence to predicate devices (BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170, and ClearLight™ Phototherapy Device, Model CL-420), rather than on specific performance data from a clinical study. The submission explicitly states that "No performance data is required for this Class II device nor has it been requested by the Food and Drug Administration (Office of Device Evaluation)." The rationale is that the PanaLight-BLU™ has the same spectral output, mode of operation, treatment area, general operating principles, and same intended use and indications for use as the predicate devices, leading to the conclusion that no significant differences exist and therefore it raises no new questions of safety or efficacy.

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The BLU-U® Blue Light Photodynamic Therapy Illuminator Model 4170 is intended to provide phototherapeutic light to the body. The BLU-U® is generally indicated to treat dermatological indications. The BLU-U® is specifically indicated to treat moderate inflammatory acne vulgaris.

The BLU-U® 4170 is a compact light source that delivers a uniform distribution of blue light to the body with a spectral output at a peak wavelength of 417 nm and a Full Width at Half Maximum (FWHM) of 30 nm (407 - 437 nm). The principal parts of the system include the light unit and floor stand with timer.

The provided text is a 510(k) summary for the BLU-U® Blue Light Photodynamic Therapy Illuminator Model 4170. It explicitly states that no performance data was required by the FDA for this Class II device, and therefore, no specific acceptance criteria or studies demonstrating device performance against such criteria were submitted.

The basis for clearance was substantial equivalence to a predicate device (ClearLight™ Phototherapy Device, Model CL-420), meaning the FDA determined the new device is as safe and effective as a legally marketed device without needing new clinical studies.

Therefore, the requested information regarding acceptance criteria and studies demonstrating performance against those criteria cannot be extracted from this document, as it was not part of the submission.

Here is a summary of why the requested information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document states, "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)."
2. Sample size used for the test set and the data provenance: Not applicable. No test set was used for performance evaluation as no performance data was required.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth was used.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring ground truth adjudication was used.
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. This device is a light therapy device, not an AI-assisted diagnostic tool involving human readers. No such study was conducted or required.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a light therapy device, not an algorithm.
7. The type of ground truth used: Not applicable. No performance data requiring ground truth was generated.
8. The sample size for the training set: Not applicable. This device is a light therapy device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established: Not applicable. No training set was used.

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