(32 days)
The Flex controlled phototherapy equipment is a medical ultraviolet device, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (1 - VI).
The Flex controlled phototherapy equipment is a microprocessor controlled fluorescent uitraviolet light source, with spectral output at peak wavelengths of 311 nm (Narrow Band UVB), 305 m (Broad 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 Flex controlled devices deliver full body phototherapy, whereby fluorescent tubes deliver the specified dose of UVA and/or UVB light.
Unfortunately, I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text. Here's why:
The provided text is a 510(k) summary for a medical device called "Flex Controlled Phototherapy Equipment." This document primarily focuses on establishing substantial equivalence to a predicate device, not on proving that the device meets specific acceptance criteria through a performance study.
Here's a breakdown of what's missing and why I can't extract the requested information:
- Acceptance Criteria and Reported Device Performance (Table): The document does not define specific acceptance criteria (e.g., accuracy thresholds, failure rates, etc.) nor does it present detailed performance data of the "Flex controlled phototherapy equipment." It states its performance "is the same as or very similar to that of the claimed predicate device." This is a claim of equivalence, not a direct measurement against defined criteria for the new device.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set Size, Training Set Ground Truth: All these points relate to a detailed performance study with a test set, expert evaluation, and ground truth establishment. The 510(k) summary explicitly states: "The Flex controlled phototherapy equipment 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 Flex controlled phototherapy equipment are the same." This indicates a reliance on the predicate device's established performance rather than a new, independent performance study for the specific device being submitted. The only "performance data" mentioned is the shared components and similar operational principles.
In essence, the document you provided is a regulatory filing for substantial equivalence, which is a different type of submission than a detailed clinical or technical performance study. To answer your questions, I would need a different type of document, such as a full clinical study report, a technical validation report, or a comprehensive premarket approval (PMA) application that typically includes such performance data.
§ 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.