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510(k) Data Aggregation
(186 days)
PHAROS EXCIMER LASER SYSTEM, MODEL EX-308
The PHAROS Excimer Laser will be indicated for use for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma.
RA Medical Systems, Inc.'s PHAROS Excimer Laser is a medical laser that is a self-contained UV laser light source that emits a wavelength of 308 nm. The PHAROS Excimer Laser utilizes a XeCl gas mixture to generate an operator-selected dose and targetspecific UV light. The laser dose is activated by a footswitch with the therapeutic radiation emitting from a handheld device. The laser operation is key controlled and is contained within an interlocked housing.
This looks like a 510(k) premarket notification for a medical device. Based on the provided text, here's a breakdown of the requested information. It's important to note that this submission emphasizes substantial equivalence to predicate devices rather than a standalone clinical study with new acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices, which implies that the new device (PHAROS EX-308 Excimer Laser) performs at least as well as and is as safe and effective as the existing devices for the stated indications. There are no specific quantitative performance metrics or acceptance criteria stated for the PHAROS EX-308 itself in this document, as the comparison is made against already cleared devices.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate Devices) | Reported Device Performance (PHAROS EX-308) |
|---|---|
| Same intended use as predicate devices (treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma) | Has the same intended uses as the cited predicate devices. |
| Similar or identical technology/design as predicate devices (e.g., self-contained UV laser, 308 nm wavelength, XeCl gas mixture) | Utilizes XeCl gas mixture to generate an operator-selected dose and target-specific UV light. Emits a wavelength of 308 nm. Uses similar or identical technology as the predicate devices. |
| Clinically performs equivalently to predicate devices for the specified indications | "Will clinically perform equivalent to the predicate devices." |
| Conforms to relevant applicable standards (Product Performance Testing) | "Conforms to the relevant applicable standard." |
| Does not introduce any new indications for use or raise new concerns regarding safety and effectiveness | Does not introduce any new indications for use. "Should not raise any concerns regarding the safety and effectiveness of the laser." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a separate "test set" or a new clinical study with a specific sample size for the PHAROS EX-308 to prove its effectiveness. The submission relies on the established safety and effectiveness of its predicate devices. Therefore, there is no new data provenance (e.g., country of origin, retrospective/prospective) explicitly mentioned for a test set for this specific device. The "clinical performance testing" section explicitly states: "the indications requested have been previously cleared in predicate devices."
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Since no new clinical study data with human assessment as "ground truth" was conducted specifically for the PHAROS EX-308, information regarding experts for ground truth establishment is not provided. The "ground truth" for its effectiveness is implicitly derived from the prior clearances of the predicate devices based on their historical clinical trials (which are not detailed here).
4. Adjudication Method for the Test Set
Not applicable. As no new clinical study requiring ground truth establishment was conducted for the PHAROS EX-308, there is no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission relies on substantial equivalence to existing predicate devices rather than a new comparative effectiveness study showing improvement with AI assistance (which is not relevant for this type of laser device).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "Product Performance Testing" and "Clinical Performance Testing" sections confirm that testing was done on the PHAROS EX-308 laser itself to show it conforms to standards and performs equivalently to predicate devices. This can be seen as testing the "algorithm only" (the laser's physical and technical performance) in its standalone capacity, without necessarily a human-in-the-loop performance evaluation in a new clinical trial context.
7. The Type of Ground Truth Used
The "ground truth" used is essentially the prior clearances and established safety and effectiveness of the legally marketed predicate devices. The PHAROS EX-308 is deemed substantially equivalent because it shares the same intended use and similar technology, implying it will achieve similar clinical outcomes (safety and effectiveness) as those devices, for which the "ground truth" was established in their original clearance processes (likely through clinical trials and expert consensus at the time).
8. The Sample Size for the Training Set
Not applicable. This device is a laser system, not an AI/machine learning algorithm that requires a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an AI/ML algorithm involved in this device.
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