(20 days)
All Models in this submission are phototherapy products designed for individuals who require specific Ultraviolet radiation therapy for the treatment of psoriasis.
A family of 4 Home UV Phototherapy Sources consisting of the 672 BD Jordan Light©, and the three versions of the S2000 Series, ie., the S-2400, the S-2600, and the S-2800.
The provided text is a 510(k) summary for a medical device (Home UV Phototherapy Sources) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study outlining acceptance criteria and device performance in the context of an AI/algorithm-driven medical device.
Therefore, many of the requested categories for AI/algorithm performance are not applicable to this document. The document describes the device's characteristics and compares them to predicate devices to establish safety and effectiveness for their intended use.
Here's an attempt to answer the questions based on the available information, noting where the information is absent or not relevant given the nature of the submission:
1. A table of acceptance criteria and the reported device performance
This document does not present acceptance criteria and reported device performance in the manner typically seen for an AI/algorithm-driven device. Instead, it asserts substantial equivalence based on similar technical characteristics and intended use compared to predicate devices. The "performance" described is in terms of design features and regulatory compliance rather than metrics like sensitivity, specificity, or accuracy.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as described in the 510(k) Summary) |
|---|---|
| Intended Use: Treatment of psoriasis. | Same area of intended treatment (single shaped panels or connected panels for half-body exposure). |
| Ultraviolet Bulbs: Use of specified UV fluorescent tubes from accredited manufacturers. | Uses same specialty fluorescent tubes (FS-72 SL-UVB, FS-72-HO-UVB, FS-72-TL-01/100W/TL-01, F-72-HO-UVA) from accredited manufacturers (Voltarc, Light Sources, Philips Lighting). |
| Electrical Rating: Similar power requirements to predicate units. | AC power requirements (voltage and current) similar to predicate units. All electrical components (except digital timer) commercially available and UL listed. |
| Digital Timer: Accurate and compatible with predicate device timers. | Digital timer has an exposure time range from 1 second to 9 minutes 59 seconds, accurate to +/- 1 second, technically compatible with predicate timers, and UL Listed. |
| Manuals: Effective in guiding physicians and patients. | Physician's Technical Manual provides pertinent technical data. Patient treatment manuals (Wide Band and Narrow Band UVB) guide setup and treatment, considered "at least as effective" as predicate device manuals. |
| Safety Features: Prevention of unauthorized usage, tube protection, UV goggles, alerting/shutdown mechanisms. | Keyswitch for unauthorized usage prevention, wireguards to protect tubes, FDA compliant UV goggles supplied. Digital Timer emits audible "beeps" at 30-second intervals and includes a supplemental circuit to shut down at 10 minutes. |
| Regulatory Compliance: Designed and manufactured according to FDA GMP. | Designed and manufactured according to FDA Good Manufacturing Practices. |
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. This is a 510(k) submission for conventional phototherapy devices, not an AI/algorithm-driven device that would involve test sets or data provenance in this context. The demonstration of substantial equivalence relies on comparing technical specifications and intended use to existing devices, not on performance data from a specific patient cohort or test set.
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. This type of information is pertinent to studies involving expert review for AI/algorithm performance, which is not described in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or expert adjudication related to algorithm performance is mentioned or relevant to this type of device submission.
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 phototherapy source, not an AI-assisted diagnostic or therapeutic tool. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" in the context of an AI/algorithm's performance on a dataset is not relevant to this submission. The "truth" for this device lies in its physical specifications, safety features, and functional equivalence to legally marketed predicate devices for treating dermatologic conditions like psoriasis.
8. The sample size for the training set
Not applicable. There is no AI/algorithm for which a training set would be required for this device.
9. How the ground truth for the training set was established
Not applicable. As there is no AI/algorithm, there is no training set or ground truth in that context.
§ 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.