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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 BClear™, Targeted PhotoClearing System, is a medical ultraviolet lamp and delivery device that is intended 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 exposure to nonaffected 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 510(k) summary for the BClear™ Targeted PhotoClearing System does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices. This means the manufacturer is asserting that their new device is as safe and effective as existing devices already cleared by the FDA, based on similar intended use and technological specifications.

Therefore, many of the requested details, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth methodologies, are not applicable in this specific 510(k) submission.

Here's a breakdown of what can be extracted from the provided text based on your prompt:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. No new performance study evaluating the device against a test set was conducted or reported in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new performance study requiring expert ground truth for a test set was conducted.

4. Adjudication method for the test set: Not applicable.

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 a UV phototherapy system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a phototherapy system, not an algorithm.

7. The type of ground truth used: Not applicable.

8. The sample size for the training set: Not applicable. No new development of an algorithm or model requiring a training set is described.

9. How the ground truth for the training set was established: Not applicable.

Explanation from the document:

The key section regarding performance data states:

"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, [new] performance data is not required."

And in the Conclusion:

"Based on the foregoing, the BClear, Targeted PhotoClearing System, is substantially equivalent to the legally marketed, claimed predicate devices for the purposes of this 510(k) submission."

This indicates that the FDA clearance for this device was based on demonstrating its similarity to devices already on the market, rather than submitting new clinical performance data with specific acceptance criteria.

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