(14 days)
The DT Controlled Phototherapy Equipment devices are indicated for use to treat diagnosed skin disorders such as, but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.
The DT Controller is a modernization of the DermaPal Controller (510(k) K073587). Like its predicate, the DT Controller is designed to turn a phototherapy device on and off based on time. It is designed to be installed in a wider family of devices. It uses the same 4 button UI with a larger backlit screen for better readability and is based on a more commercially available PIC16 processor. A modification to the way a prescription is entered was done to harmonize the process across different devices.
This is a 510(k) premarket notification for a phototherapy device, not an AI/ML device, therefore, many of the typical acceptance criteria and study attributes for AI/ML performance evaluation are not applicable. The device is a "DT Controlled Phototherapy Equipment" which is a modernization of a previous controller for phototherapy devices. The change is primarily to the controller unit's hardware and software (UI, processor, prescription entry method).
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in the typical sense of AI/ML performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance is based on the device performing as expected for a phototherapy controller and maintaining substantial equivalence to its predicates.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Functional equivalence to predicate device (Dermapal Controller - K073587). | "Functional testing in the form of Black Box testing was completed on the DT controller and the functions appear to be working per the specifications." |
| Electrical safety and EMC compliance. | Conformance to IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC) standards. (Indicated by device testing, though specific results are not detailed in the summary). |
| Software validation. | Software validation activities were performed. (Details not in summary, but indicated as required for this type of device). |
| Usability of User Interface (UI). | "uses the same 4 button UI with a larger backlit screen for better readability" and "A modification to the way a prescription is entered was done to harmonize the process across different devices." (Implied improvement and functional review). |
| Radiation output equivalence (as a component of the overall phototherapy system). | "The ultraviolet lamps and cabinet construction used in the production of the predicate device and the DT controlled phototherapy equipment are the same." (Ensures the core therapeutic elements remain consistent). |
2. Sample size used for the test set and the data provenance
Not applicable for this type of device. The "test set" here refers to the functional testing of the controller, not a data set of patient cases or images. The testing would involve a rigorous set of test cases designed to exercise all functionalities of the controller. The document indicates "Functional testing in the form of Black Box testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of device. "Ground truth" for this device relates to whether the controller correctly performs its functions (e.g., sets time, turns on/off, displays correctly). This is typically verified by engineers and quality assurance personnel against design specifications, not clinical experts establishing medical ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device. Functional verification and validation do not typically involve adjudication methods like those used for clinical image interpretation. Performance is assessed against predefined specifications.
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 phototherapy unit controller and does not involve AI or human "readers" interpreting medical data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. Its performance is evaluated as a standalone electronic device controller.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is its conformance to engineering specifications and regulatory standards (e.g., electrical safety, EMC, software validation). Functional tests ensure the device operates as designed and intended.
8. The sample size for the training set
Not applicable. This is not an AI/ML device and does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable.
§ 878.4630 Ultraviolet lamp for dermatologic disorders.
(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.