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510(k) Data Aggregation
(87 days)
UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma
The XTRAC XL2 Excimer Laser System Model AL8000 is a complete self-contained compact UVB laser light source, which utilizes a XeCl gas mixture to generate an operator selected dose and target-specific ultraviolet light at monochromatic operater services ann. The laser system consists of a touch-screen display, an advanced fiberoptic cable attached to a handpiece, and a foot-switch to initiate exposure. The laser is enclosed in a protective interlocked housing. The unit is designed to operate on standard AC power available from wall outlets and can accommodate US, European and other nominal supply voltages and operating frequencies.
The provided 510(k) summary for the PhotoMedex XTRAC XL2 Excimer Laser System, Model AL8000, does not contain the type of acceptance criteria and study information typically associated with AI/ML device evaluations. This document is for an excimer laser system for dermatological conditions and its clearance is based on substantial equivalence to previously cleared predicate devices, rather than new clinical performance data demonstrating device performance against specific acceptance criteria.
Therefore, many of the requested sections below cannot be filled from the provided text, as the document focuses on regulatory clearance for a hardware device, not an AI/ML algorithm.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:
Acceptance Criteria and Device Performance Study (XTRAC XL2 Excimer Laser System)
This 510(k) submission for the XTRAC XL2 Excimer Laser System, Model AL8000, evaluates its substantial equivalence to previously cleared excimer laser systems for dermatological phototherapy. The submission does not present new clinical data against specific performance acceptance criteria for the device itself, but rather relies on the established safety and effectiveness of its predicates.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document is for a medical device (laser system), not an AI/ML diagnostic or prognostic tool. Therefore, standard AI/ML performance metrics (sensitivity, specificity, AUC, etc.) and associated acceptance criteria are not applicable or mentioned. The "acceptance criteria" here relate to meeting safety standards and demonstrating equivalence to predicate devices, which is largely qualitative in the provided summary.
| Acceptance Criterion (Implicit from 510(k) process) | Reported Device Performance (based on substantial equivalence) |
|---|---|
| Safety and Effectiveness Equivalence: No new issues of safety or efficiency compared to predicates. | The device performs in an identical manner as the identified predicates, and differences (size, weight, ergonomics, enhanced operating parameters, maintenance improvements) do not affect safety or intended use. |
| Intended Use Equivalence: Identical intended use. | Intended use (targeted UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma) is identical to predicate devices. |
| **Technological Characteristics Equivalence (or | |
| differences do not raise new questions of safety/effectiveness):** Monochromatic (308nm) UVB light generation and therapeutic mechanism. | The device is a "complete self-contained compact UVB laser light source, which utilizes a XeCl gas mixture to generate an operator selected dose and target-specific ultraviolet light at monochromatic wavelength (308nm)." This mechanism is identical to the predicates. |
| Compliance with Standards: Meets relevant electrical safety, performance, and risk management standards. | Complies with current applicable international EN 60601 series of standards, 21 CFR Part 1040.10 & 1040.11 Performance Standards for Light-Emitting Products, UL 2601-1/UL60601-1, and EN ISO 1497 (risk management). |
2. Sample size used for the test set and the data provenance
No new clinical test set data was used or presented for this 510(k) submission, as the clearance is based on substantial equivalence. The document explicitly states: "PhotoMedex believes duplicative clinical data is not required as a condition of granting market clearance for the XTRAC XL2 Excimer Laser System Model AL8000."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new clinical test set was used.
4. Adjudication method for the test set
Not applicable. No new clinical test set was used.
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 an excimer laser system, not an AI/ML diagnostic tool, and no MRMC study was conducted or presented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an excimer laser system, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no new clinical data was collected or analyzed for ground truth in this submission. The "ground truth" for the device's efficacy is based on the previously cleared predicate devices and the established understanding of UVB phototherapy for the indicated conditions.
8. The sample size for the training set
Not applicable. This document is for a hardware device clearance via substantial equivalence, not an AI/ML training set.
9. How the ground truth for the training set was established
Not applicable. This document is for a hardware device clearance via substantial equivalence, not an AI/ML training set.
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