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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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The BClear™, Targeted PhotoClearing™ System, is a medical ultraviolet lamp and delivery device intended for the treatment of leukoderma. The BClear, Targeted PhotoClearing System, is also indicated for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. The BClear, Targeted PhotoClearing System, is intended for use on all skin types (I - VI).

The BClear, Targeted PhotoClearing System, is an ultraviolet light source and energy delivery system that provides targeted energy to the treatment site while avoiding unnecessary exposure to non-affected tissue. The light source is contained within a protective console. The complete system also includes a handpiece connected to the console via an umbilical. Timing and dosing parameters and an interface to other system features are controlled from a display panel on the console. The delivery system allows UV-B light to pass through the handpiece to selectively treat skin and nail lesions without exposure to the healthy skin.

The provided document is a 510(k) summary for the BClear, Targeted PhotoClearing System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study data against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and performance study details is explicitly not applicable or not provided in this specific document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable. The document explicitly states: "Performance Data: None. The technological specifications of the BClear, Targeted PhotoClearing System, are the same or very similar to those of the claimed predicate devices. The BClear, Targeted PhotoClearing System, has the same indications for use for which the claimed predicates have been cleared. Therefore, performance data is not required."
• Data Provenance: Not applicable, as no new performance data was generated for this 510(k) submission. The decision is based on substantial equivalence to previously cleared predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable, as no new performance study with a test set was conducted.

4. Adjudication Method for the Test Set

• Not applicable, as no new performance study with a test set was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. The document explicitly states "Performance Data: None."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

• No. This device is a physical medical ultraviolet lamp and delivery system, not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant. The substantial equivalence argument is based on the device's physical and functional similarity to predicate devices.

7. The Type of Ground Truth Used

• Not applicable, as no new performance study was conducted. The "ground truth" for the device's safety and effectiveness relies on the prior clearance and established use of the predicate devices for their indicated conditions. The document mentions "Currently published clinical data supports UVB treatment of hypopigmented or depigmented skin (leukoderma)," which indirectly points to existing clinical evidence for the treatment modality, but not for this specific device's new performance evaluation.

8. The Sample Size for the Training Set

• Not applicable, as this device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

• Not applicable, as this device is not an AI/ML algorithm that requires a training set.

Summary of the Study Proving Acceptance Criteria:

The "study" in this case is not a clinical trial or performance study of the BClear device itself. Instead, the document describes a substantial equivalence claim based on a comparison to legally marketed predicate devices:

• Predicate Devices: Lumenis Inc., BClear, Targeted PhotoClearing System (K011197, K020591); PhotoMedex, XTRACTM Excimer Laser Phototherapy System, AL7000 (K011382, K992914, K003705).
• Argument: The applicant argues that the BClear, Targeted PhotoClearing System, is substantially equivalent because:
  • Its technological specifications are the same or very similar to those of the claimed predicate devices. (This implies that the underlying technology for delivering UV-B light to treat dermatological conditions is consistent with established and cleared devices).
  • It has the same indications for use as the cleared predicate devices (treatment of leukoderma, psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis, for all skin types I-VI).
• Basis for No Performance Data: Because of this perceived substantial equivalence in both technology and indications for use, the submission explicitly states that "performance data is not required." The assumption is that since the device is essentially the same as (or very similar to) a device already on the market and cleared for the same purposes, its performance will be comparable.

Therefore, the "study" proving the device meets acceptance criteria is fundamentally a comparative analysis of device characteristics and intended use against already cleared predicate devices, rather than a de novo performance evaluation.

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The SurgiLight, Inc. EX-308 Excimer laser, handpieces and laser related accessories is indicated for use for the treatment of psoriasis and for the treatment of vitiligo.

The SurgiLight EX-308 Excimer Laser is a medical device that is capable of emitting a treatment laser beam at a wavelength of 308nm under the quidance of a visible aiming beam. This laser may be used in a pulsed mode at various repetition rates.

This 510(k) submission (K020973) for the SurgiLight, Inc. EX-308 Excimer Laser does not contain the type of detailed information typically found in studies for AI/ML-driven devices. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through a comparison of technological characteristics and intended use, rather than presenting a performance study against specific acceptance criteria.

Therefore, many of the requested fields cannot be filled based on the provided text, as this device is a laser for medical treatment, not a diagnostic or AI-powered device that relies on performance metrics like sensitivity, specificity, or reader studies.

Here's a breakdown based on the provided text, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This submission doesn't define acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that would be relevant to an AI/ML device study. The "performance" described is about the laser's physical characteristics and its ability to emit light at a specific wavelength, which are compared to a predicate device for substantial equivalence.

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

Not applicable. No test set or data provenance related to a performance study for an AI/ML device is mentioned. This submission is for a physical medical device (excimer laser).

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

Not applicable. No ground truth establishment for a test set is discussed, as this is not an AI/ML performance study.

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

Not applicable. No adjudication method for a test set is mentioned.

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 is not a diagnostic AI/ML device, and no MRMC study is mentioned.

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

Not applicable. This is not an AI/ML algorithm.

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

Not applicable. Ground truth for an AI/ML performance study is not discussed.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not an AI/ML device.

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

Not applicable. No training set ground truth establishment is discussed.

Summary of Device and Approval from the Provided Text:

The SurgiLight, Inc. EX-308 Excimer Laser is a medical device designed to emit a treatment laser beam at a wavelength of 308nm for the treatment of psoriasis and vitiligo.

The 510(k) submission (K020973) sought to establish substantial equivalence to existing predicate devices (e.g., PhotoMedix K003705). The core argument for approval was that:

• The candidate and predicate laser devices are of similar technology.
• They have the same intended use (treatment of psoriasis and vitiligo).
• Based on an analysis of overall performance characteristics (implicitly, the physical characteristics and laser output, not clinical outcome studies in this document), no significant differences exist.

The FDA's approval letter confirms the determination of substantial equivalence, allowing the device to be marketed. The submission did not seek new indications for use; it relied on the existing clearances for the predicate devices.

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