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The intended use is targeted UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and non-autoimmune based leukoderma of affected skin.

The XTRAC Excimer Laser System is a complete self-contained compact UV laser light source, which utilizes a XeCl gas mixture to generate an operator selected doseand target-specific ultraviolet light at wavelength of 308 nm. The laser system consists of a keypad and display, a fiberoptic delivery system, a handpiece and a footswitch. The laser is enclosed in a protective interlocked housing.

The provided 510(k) summary for the PhotoMedex XTRAC Excimer Laser System, model AL7000, discusses its substantial equivalence to predicate devices and supports an additional indication for leukoderma treatment. However, it does not explicitly state quantitative acceptance criteria for device performance beyond general "successful repigmentation" or "50% to 75% improvement or greater."

Here's an analysis based on the provided text, addressing your specific points to the best extent possible given the information:

Acceptance Criteria and Device Performance

Note: The document does not provide specific numerical targets or thresholds for success beyond "50% to 75% improvement or greater," which is a relatively broad qualitative statement.

Study Details

1. Sample sized used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated. The summary refers to "subjects" but does not provide a number.
   • Data Provenance: The study referenced is "Friedman, Paul MD, Geronemous, Roy MD, Use of the 308-nm Excimer Laser for Postresurfacing Leukoderma, ARCH DERMATOL, vol. 137, June 2001, 824-825." This is a published clinical study, implying prospective data collection relevant to the study's design. The country of origin is not specified but given the publication title and authors, it is likely from the United States.

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

   • Not explicitly stated. The study authors are dermatologists (Paul Friedman, MD, and Roy Geronemous, MD), and it can be inferred that they, as clinical experts, would have assessed the treatment outcomes. However, the number of experts specifically involved in "ground truth" establishment for the entire test set (e.g., blinded evaluators) is not detailed.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not explicitly stated. Given it's a clinical study, assessment would have been done by the treating physicians, but specific adjudication methods for determining "50% to 75% improvement" are not mentioned.

4. 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 study is a clinical trial evaluating the effectiveness of a laser device for a dermatological condition. It is not an MRMC study and does not involve AI or human readers for diagnostic interpretation.

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

   • No. This is a medical device (laser system) for direct treatment of patients, not an algorithm. Its performance is assessed in a clinical setting with human operators and direct patient outcomes.

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

   • Clinical outcomes data, specifically "successful repigmentation" and "50% to 75% improvement or greater" in treating leukoderma, as assessed by clinical experts (the study authors).

7. The sample size for the training set:

   • There is no "training set" in the context of this device. This is a physical medical device, not a machine learning algorithm that requires a separate training data set. The clinical study described served as validation for the device's efficacy for the new indication.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of medical device.

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