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UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma

The XTRAC Ultra Excimer Laser System, Model AL10000 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 of 308 nm. 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.

This document describes the PhotoMedex XTRAC Ultra2 Excimer Laser System, Model AL10000. However, the provided text does not contain information about acceptance criteria or a study proving the device meets them in the way a typical diagnostic or AI device submission would.

Instead, this is a 510(k) premarket notification for a medical device that appears to be seeking substantial equivalence to previously cleared predicate devices. This means the manufacturer is asserting their new device is as safe and effective as existing legally marketed devices, rather than conducting new clinical trials to demonstrate efficacy from scratch.

Here's an analysis based on the provided text, highlighting what is and is not present:

Acceptance Criteria and Study for PhotoMedex XTRAC Ultra2 Excimer Laser System, Model AL10000

The provided 510(k) summary for the PhotoMedex XTRAC Ultra2 Excimer Laser System, Model AL10000, does not detail explicit acceptance criteria for clinical performance or a rigorous clinical study designed to prove the device meets such criteria. Instead, the submission relies heavily on substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: In a substantial equivalence submission for a laser device, the "acceptance criteria" revolve around demonstrating that the new device's technological characteristics (e.g., wavelength, energy output, repetition rate, safety features) are either identical to or do not raise new safety or efficacy concerns compared to the predicates. The clinical performance itself is accepted based on the established performance of the predicate devices.

2. Sample Size for Test Set and Data Provenance

• Sample Size (Test Set): Not applicable. No new clinical "test set" was used for performance evaluation in the context of this 510(k) submission.
• Data Provenance: Not applicable. The submission refers to previously cleared indications and performance of predicate devices, rather than new data generated for this specific model's effectiveness.

3. Number of Experts and Their Qualifications (for Ground Truth)

• Not applicable. No new ground truth establishment by experts for a test set is described in this submission. The efficacy of UVB phototherapy for the stated conditions is presumably well-established from the predicate devices' clearances.

4. Adjudication Method (for Test Set)

• Not applicable. No new clinical test set or adjudication process is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This device is a laser system for dermatological treatment, not a diagnostic imaging or AI-assisted interpretation device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

6. Standalone Performance Study (Algorithm Only)

• Not applicable. This device is a physical laser system, not an algorithm.

7. Type of Ground Truth Used

• Implicit Ground Truth: The ground truth for the efficacy of targeted UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma is implicitly derived from the clinical evidence and regulatory clearances of the predicate devices. The submission argues that since the new device operates similarly and introduces no new safety/efficacy issues, the prior established "ground truth" (i.e., that these treatments are effective for these conditions) applies.

8. Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set.

9. How Ground Truth for the Training Set Was Established

• Not applicable.

Summary of Approach:

The PhotoMedex XTRAC Ultra2 Excimer Laser System, Model AL10000, gained market clearance through the 510(k) substantial equivalence pathway. The core argument is stated in Section 6 and 7:

• Identical Intended Use: The intended use (targeted UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma) is identical to previously cleared predicate devices (K992914, K003705, K011382, K020847, K031451, K041943).
• Similar Technology: The difference is "limited to a moderate increase in the maximum laser repetition rate."
• No New Safety/Efficacy Issues: The manufacturer believes this increase "will not affect the device's safety or intended use as compared to the identified predicates."
• No Duplicative Clinical Data Required: Because the device "does not introduce any new indications for use, and will perform in an identical manner as the identified predicates," PhotoMedex states that "duplicative clinical data is not required."

Instead of clinical performance testing, the submission highlights Product Performance Testing (Section 8), which includes:

• Conformance to IEC 60601 standards.
• Conformance to 21 CFR Part 1040.10 & 1040.11 (Performance Standards for Light-Emitting Products).
• Certification to UL 60601-1 Medical Electrical Equipment classification standard.
• Risk management utilizing ISO 14971.

These product performance tests ensure the device meets safety and operational standards but do not constitute clinical efficacy trials as would be expected for a novel diagnostic or therapeutic approach.

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UVB phototherapy for skin conditions which include psoriasis, vitiligo, atopic dermatitis, and leukoderma.

The VTRAC Excimer Lamp System is a self-contained non-invasive (non-ablating) system that emits targeted (ultra-narrow) ultraviolet wavelength that is included in the UV-B region of the electromagnetic spectrum centered at 308 mm, which is effective for the treatment of skin conditions that respond favorably to and available UV-B phototherapy. UV-B is emitted from a XeCl excimer lamp inside a handpiece used to apply targeted UVB energy to only areas that require treatment, thus allowing non-involved areas (healthy) of the skin to be spared from exposure.

The provided text describes a 510(k) summary for the VTRAC Excimer Lamp System. Unfortunately, the document does not contain a detailed study proving the device meets specific acceptance criteria in the format requested.

The document primarily focuses on establishing "substantial equivalence" to predicate devices, rather than presenting a novel study with specific performance metrics against acceptance criteria. It mentions that the device is "designed, tested and are to be manufactured in accordance with both mandatory and voluntary standards" (e.g., 21 CFR PART 820, EN60601-1, etc.) to ensure safety and effectiveness. However, it does not provide the results of such testing or a direct comparison to acceptance criteria.

Therefore, I cannot provide the detailed table and information as requested because the source document does not contain this specific type of clinical or performance study data.

Here's what I can extract based on the provided text, acknowledging the limitations:

Acceptance Criteria and Device Performance (Based on "Substantial Equivalence" Argument):

Missing Information (Not available in the provided text):

1. Sample size used for the test set and the data provenance: Not applicable as a specific test set for performance against acceptance criteria in a study is not described. The "published clinical data" mentioned is not detailed or provided.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method: Not applicable.
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: Not applicable. This device is an excimer lamp system for phototherapy, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
6. The type of ground truth used: Not applicable for a performance study. Clinical outcomes and expert assessment would typically be the ground truth for treatment efficacy had a study been detailed.
7. The sample size for the training set: Not applicable as this is not a machine learning or AI device.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) premarket notification for a medical device (an excimer lamp system). It focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting a detailed clinical study with specific performance acceptance criteria and results from a test set. The "acceptance criteria" are implied by the safety and effectiveness of the predicate devices and compliance with general standards.

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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.

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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UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma

The XTRAC XL Plus Excimer Laser Phototherapy Svstem is a complete self-contained compact UV laser light source, which utilizes a XeCl gas mixture to generate dose-selected and 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 foot-switch. The laser is enclosed in a protective interlocked housing.

This document is a 510(k) premarket notification for a device modification, not a submission for a new device requiring extensive clinical trials to establish efficacy against acceptance criteria. Therefore, the provided text does not contain information typically found in studies designed to prove a device meets specific performance acceptance criteria for a novel device.

The submission focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and conformance to established standards, rather than clinical performance metrics.

Here's a breakdown of the requested information based on the provided text, highlighting what is not applicable or not found in this specific type of 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable/Not Found: This submission is a modification to an already cleared device. Performance testing referenced is related to safety, electrical, and laser standards (EN 60601, 21 CFR 1040.10 & 1040.11, UL 2601) for the modified hardware, and not clinical efficacy testing with a "test set" of patient data. Therefore, there's no mention of a clinical test set, data provenance, or sample size for such a set.

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

• Not Applicable/Not Found: As there is no clinical test set for efficacy described, there's no mention of experts or their qualifications for establishing ground truth. The "ground truth" for this modification centers on regulatory compliance and substantial equivalence to an existing device.

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

• Not Applicable/Not Found: No clinical test set means no adjudication method described.

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/Not Found: This device is a laser phototherapy system and does not involve AI or human "readers" in the diagnostic sense. Therefore, an MRMC study is irrelevant to this submission.

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

• Not Applicable/Not Found: This is a hardware device (excimer laser system) for phototherapy, not an algorithm or AI system.

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

• For demonstrating substantial equivalence: The "ground truth" is that the predicate device (XTRAC Excimer Laser System, model AL7000) is already cleared and shown to be safe and effective for its intended use. The modified device's "ground truth" for clearance is its adherence to relevant safety and performance standards and its technological similarity to the predicate.
• For efficacy: The document refers to "Current published data supports 308 nm UVB to be effective of providing efficacy to the currently approved indications for use." This implies the "ground truth" for the treatment itself comes from existing medical literature and prior clearances of similar devices, rather than new primary data generated for this specific 510(k).

8. The sample size for the training set

• Not Applicable/Not Found: This 510(k) is for a hardware device modification, not a machine learning or AI algorithm. There is no concept of a "training set" in the context of this submission.

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

• Not Applicable/Not Found: As there is no training set, this question is not applicable.

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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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