Search Results

Intended to provide light to the body. Generally indicated to dermatology use for the treatment of benign superficial and pigmented lesions in patients with Fitzpatrick Skin Types II and III excluding vascular lesions such as hemangiomas, telangiectasia, and benign pigmented lesions such as solar lentigo, age spots, or freckles.

The Rogers Sciences Inc.'s Lumina 24 is a light-emitting diode therapy system used to treat superficial and pigmented skin lesions. It consists of a battery-powered light source (Illuminator), optical fibers, and an optical pad (Light Patch). The Light Patch and its adhesive are made from hypoallergenic materials designed to be safe for Fitzpatrick Skin Types II and III. The Lumina 24 system applies Red Light (RL) therapy directly to the treatment area of the skin. To begin treatment, the patient applies the Light Patch to the treatment area and turns on the Illuminator. Light travels from the Illuminator through the optical connector to the Light Patch and to the skin. The Illuminator turns off automatically after 1 hour but treatment may be stopped at any time by turning it off manually. Because Lumina 24 is portable and batterypowered, treatment can take place while the patient is doing other activities.

Here's an analysis of the provided document to extract the acceptance criteria and study details:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Lumina 24 device appear to be primarily based on demonstrating substantial equivalence to the predicate device (EVIS MD Platinum Red Light Therapy) in terms of clinical effectiveness and safety. The key metric for clinical effectiveness is the "percent clearance of lesions" evaluated by a panel of experts. The safety criteria include the absence of adverse events and maintenance of device specifications (uniformity and repeatability) after use.

The study aimed to demonstrate that the Lumina 24 system is "substantially equivalent in clearance of lesions related to photo aging" and that there is "no statistically significant difference between the two devices" (Lumina 24 and EVIS MD Platinum).

• Q1 (76-100%): 1 patient
• Q2 (51-75%): 0 patients
• Q3 (26-50%): 6 patients
• Q4 (0-25%): 10 patients |
  | Safety | |
  | Absence of adverse events (Secondary Endpoint) | Reported Performance: "No Adverse Events were reported by any subjects during their treatments with either the Lumina24 or EVIS MD Platinum system devices." (Evis AE = 0, Lumina24 = 0). |
  | Subject satisfaction with skin appearance (Secondary Endpoint) | Reported Performance: "The week to week response variation per subject was not significant for both the Lumina24 and EVIS MD Platinum systems. The variation in satisfaction across all subjects for all weeks was not significant. The variation in satisfaction between devices for all weeks and all subjects was not significant."
  Mean VAS (10 pt Scale) for Lumina 24 (Weekly Avg): 4.8946
  Mean VAS (10 pt Scale) for EVIS (Weekly Avg): 5.0911 |
  | Device uniformity (irradiance at each measurement point within +/-20% of the mean irradiance value) (Secondary Endpoint) | Reported Performance: For Lumina 24 Light Patches, the uniformity on a given LP and across all LPs given to subjects was less than 10% before and after the study. The uniformity between the devices (referring to Lumina 24 units) before and after the study for each subject was less than +/-20%.
  All subjects' Lumina 24 systems "held up to the specifications of uniformity." |
  | Device repeatability (irradiance at each measurement point within +/-20% of the median over 3 distinct measurements) (Secondary Endpoint) | Reported Performance: For Lumina 24 devices, "The repeatability of these devices shows that there was less than a 3% difference in light output before and after the study for each subject."
  All subjects' Lumina 24 systems "held up to the specifications of... repeatability." |

Here's the breakdown of the study details:

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): 17 subjects completed the study.
• Data Provenance: The study was a "prospective, randomized, controlled, masked study." The location or country of origin of the data is not explicitly stated in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: A panel of four (4) independent dermatology providers.
• Qualifications of Experts: They are described as "independent dermatology providers" and members of a "qualified review panel." Further specific qualifications (e.g., years of experience, board certification) are not provided.

4. Adjudication method for the test set

• The panel of four independent dermatology providers "reviewed the 1 month visit photos of the treated sites from all enrolled subjects and evaluated the number of lesions for a given anatomical site before (pre) or after (post) treatment."
• They were "blinded as to treatment used and whether the site was pre or post-intervention."
• The document implies a consensus-based adjudication, or at least a collective evaluation leading to the "percent clearance" calculation, but does not explicitly state a specific adjudication rule like 2+1 or 3+1. It seems their collective evaluation contributed to the overall percentage clearance calculation for each subject's treated area.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was NOT done in the context of human readers improving with or without AI assistance.
• This study was a comparative effectiveness study between two medical devices (Lumina 24 and EVIS MD Platinum), both of which are light-emitting diode therapy systems. There is no mention of AI or artificial intelligence facilitating human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. This study is comparing two medical devices, not an AI algorithm. There is no AI algorithm being evaluated for standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for lesion clearance was established based on expert visual assessment of high-resolution digital images. The "percent clearance of lesions" was calculated from the exact number of lesions counted by the panel of four independent dermatology providers (expert consensus).

8. The sample size for the training set

• Not applicable. This study is not evaluating an AI model that requires a training set. It is a clinical study comparing two physical medical devices.

9. How the ground truth for the training set was established

• Not applicable. As this is not an AI model evaluation, there is no training set and therefore no ground truth establishment for a training set.

Ask a specific question about this device