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The 3 Series PC & SP, full body phototherapy device, is a medical ultraviolet cabinet, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (1 - VI).

The 3 Series PC & SP phototherapy cabinet is a microprocessor controlled full body fluorescent ultraviolet light source, with spectral output at peak wavelengths of 311 nm (Narrow Band UVB) and 350 nm (UVA). It is intended for use by or under the direction of a physician, for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). The desired dose is selected using the operator interface located on the front panel of the device. The 3 Series delivers full body phototherapy, whereby fluorescent tubes, which surround the patient, deliver the specified dose of UVA and/or UVB light.

This is a medical device application for a phototherapy cabinet. The provided text describes the device, its intended use, and a comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a diagnostic AI device would.

The key points from the document regarding performance are:

• Performance Data: "The Daavlin 3 Series PC & SP full body phototherapy cabinet performance data is the same as or very similar to that of the claimed predicate device. The ultraviolet light tubes and cabinet construction used in the production of the predicate device and the 3 Series PC & SP device are the same."
• Predicate Device Comparison: The device "is constructed in the same design configuration as the predicate device, utilizing identical energy sources (UV lamps) and materials of identical composition. The 3 Series varies from the predicate device, in that the control system hardware and software of the 3 Series has been updated to utilize current technology."

This submission relies on substantial equivalence to a predicate device (Daavlin Distributing Company Spectra 300 Series Ultraviolet Phototherapy Cabinet, K828654) and states that the performance data is "the same as or very similar." This approach implies that the predicate device's performance already met acceptance criteria, and since the new device is fundamentally the same in its core UV light delivery, it is assumed to meet those same unstated criteria.

Therefore, many of the requested details about acceptance criteria and a specific study proving the device meets them (especially in the context of AI or diagnostic performance) are not available in the provided text.

Here is an attempt to address your request based on the available information, noting where information is not present:

Acceptance Criteria and Device Performance

Study Details

1. Sample sized used for the test set and the data provenance: Not applicable. This submission relies on substantial equivalence to a predicate device, rather than a de novo clinical or performance study with a test set of data. The performance data is asserted to be "the same as or very similar" to the predicate.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There was no specific "test set" or ground truth established in the context of diagnostic performance or AI validation.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication was described.
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: Not applicable. This is a phototherapy cabinet, not an AI-powered diagnostic device, and no MRMC study was performed or referenced.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device does not involve an algorithm with standalone performance in the diagnostic sense.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device revolves around its physical light output and controls, presumed to be consistent with the predicate device.
7. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of Device Rationale:

The Daavlin 3 Series PC & SP Phototherapy Cabinet obtained 510(k) clearance by demonstrating substantial equivalence to a predicate device (Daavlin Distributing Company Spectra 300 Series Ultraviolet Phototherapy Cabinet, K828654). The core technology (UV lamps and cabinet construction) and spectral output are stated to be "identical" or "the same as or very similar" to the predicate. The primary difference is an update to the control system hardware and software to utilize current technology. The intended use, general and specific indications for use, spectral output, mode of operation, labeling, treatment area, and general operating principles are stated to be the same or similar. Therefore, the performance data and "acceptance criteria" are implicitly met by virtue of this substantial equivalence to a previously cleared device. There was no new study involving acceptance criteria and performance data in the typical sense of a diagnostic or AI device.

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