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510(k) Data Aggregation
(150 days)
ACCULASE, INC.
UVB Phototherapy for Psoriasis
The Excimer Laser Phototherapy System, AL7000 is a complete self-contained compact laser light source, which utilizes a XeCl gas mixture to generate ultraviolet light at wavelength of 308 nm wavelength. The laser system consists of a keypad and display, a fiberoptic delivery system, a footswitch, and a handpiece. The laser is enclosed in a protective interlocked housing.
The provided text describes the AccuLase, Inc. Excimer Laser Phototherapy System, AL7000, and its 510(k) submission. However, it does not provide detailed information about specific acceptance criteria or a study that explicitly proves the device meets those criteria with quantitative values.
Instead, it focuses on demonstrating substantial equivalence to predicate devices. Here's a breakdown based on the information available and what is not present:
Missing Information:
- Specific quantitative acceptance criteria (e.g., "Psoriasis Area and Severity Index (PASI) score reduction of X% in Y% of patients").
- Reported device performance against such criteria with numerical results.
- Detailed methodology of any clinical study, including sample sizes, ground truth establishment for the test set, expert qualifications, adjudication methods, or specific study designs (MRMC, standalone).
Based on the provided text, here's what can be extracted and what remains unknown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied by the text) | Reported Device Performance |
|---|---|
| Safety: Device is safe for use in UVB phototherapy for psoriasis. | "A dose response study using a 308 nm excimer laser showed the safety... of the excimer laser for the treatment of Psoriasis." (No specific metrics or thresholds reported) |
| Effectiveness: Device is effective for UVB phototherapy for psoriasis. | "A dose response study using a 308 nm excimer laser showed the... effectiveness of the excimer laser for the treatment of Psoriasis." (No specific metrics or thresholds reported) |
| Technological Equivalence: Produces ultraviolet light at 308 nm wavelength, similar operating principles to predicate excimer lasers. | "The Excimer Laser Phototherapy System is substantially equivalent to the technological characteristics of the predicate excimer laser device. Both devices share the same operating principles and produce an identical wavelength." (Stated as a qualitative finding of equivalence, not a direct performance measure) |
| Conformance to Standards: Conforms to relevant International EN 60601 / IEC 601 series and applicable laser standards. | "Testing conducted on the Excimer Laser Phototherapy System, AL7000 includes conformance to all relevant International EN 60601 / IEC 601 series of standards and applicable laser standards." (Stated as a qualitative fact, no specific test results provided) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified. The text mentions "A dose response study" but does not provide details on the number of subjects or cases included.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the text. The study mentioned is a "dose response study," which typically involves clinical observation and measurement by medical professionals rather than a consensus of experts adjudicating an output.
4. Adjudication method for the test set
- This information is not provided as the nature of the study (dose response) doesn't typically involve adjudication of diagnostic outputs in the way an AI algorithm assessment would.
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. This was not an MRMC comparative effectiveness study involving AI. The device is a laser phototherapy system, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a medical device (laser system) for treatment, not an algorithm.
7. The type of ground truth used
- For the "dose response study," the ground truth would implicitly be clinical outcomes/patient response to treatment, likely assessed by clinicians (e.g., improvement in psoriasis severity, reduction in lesion size/number). The text doesn't explicitly state "pathology" but clinical assessment of psoriasis would be the primary basis.
8. The sample size for the training set
- This information is not applicable as the device is not an AI/machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
- This information is not applicable as the device is not an AI/machine learning algorithm.
Summary of what is present:
The 510(k) submission for the AccuLase AL7000 relies on demonstrating substantial equivalence to predicate devices: existing UV lamps for intended use and another excimer laser for technological characteristics. It mentions a "dose response study" that "showed the safety and effectiveness" for psoriasis treatment, but provides no quantitative details on this study, its design, sample size, or specific outcomes. Technical testing for conformance to safety standards (EN 60601 / IEC 601) was also performed. The document primarily focuses on regulatory compliance and equivalence rather than detailed clinical performance metrics typical of, for example, a diagnostic AI device requiring extensive ground truth validation.
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