(42 days)
The LH-75T 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-75T Phototherapy System is intended for use on all skin types (I -VI).
The LH-75T Phototherapy System is an ultraviolet Light Source and energy delivery system. The System emits UV-B (290-320 mm) light for use in phototherapy and allows delivery of controlled doses!
The LH-75T consists of a Console that contains the electronics and a Handpiece that contains the lamp and the ballast. The console and handpiece are connected with an electrical cable. A Spot Treatment Attachment (LP-3) jand a Fiber-optic Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Attachment (LB-10) are connected to the handpiece for selective treatment of skin lesions without exposure of adjacent, healthy tissues. The desired dose is selected using controls on the panel of the console and activated with either a switch on the panel or foot-switch. The system is powered by a common household AC outlet. Protective eyewear is supplied with the system.
The LH-75T Phototherapy System is an ultraviolet light source and energy delivery system designed for UVB phototherapy. The study supporting its substantial equivalence focuses on its spectral output and technological specifications compared to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Spectral Output: The device must emit UV-B light within the spectral band of 290 - 320 nm. | The LH-75T Phototherapy System "is between 290 and 320 nm." |
| Technological Specifications: The device's technological specifications should be similar to those of legally commercialized predicate devices. | "Other performance data included in the application show that the technological specifications are similar to those of the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly mention a "test set" in the context of a clinical study with real patient data. The performance evaluation seems to be based on engineering and technical data comparing the device to predicate devices rather than a human-centric outcome study. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a clinical test set is not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
As there is no mention of a clinical test set requiring expert ground truth establishment, this information is not provided.
4. Adjudication Method for the Test Set:
Given the nature of the evaluation (spectral output and technological specifications), an adjudication method for a clinical test set is not applicable and therefore not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not conducted or reported in this 510(k) summary, as the performance data focuses on technical characteristics and not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The LH-75T Phototherapy System is a hardware device for light therapy, not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.
7. Type of Ground Truth Used:
The ground truth for the device's performance is based on engineering measurements and technical specifications (e.g., spectral analysis to confirm UV-B output, comparison of hardware configurations with predicate devices). It is not based on expert consensus, pathology, or outcomes data in a clinical trial setting.
8. Sample Size for the Training Set:
Since this is a hardware device and not an AI algorithm, the concept of a "training set" in the context of machine learning is not applicable.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for an AI algorithm, this information is 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.