FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Pulsaderm Acne Device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face.

Device Description

The Pulsaderm Acne Device is a device that uses Blue and Red Light Emitting (LED) Diodes to provide LED Light therapy to the skin. A combination of red light and blue light is emitted for the treatment of mild to moderate acne.

AI/ML Overview

The Pulsaderm Acne Device is compared against predicate devices to demonstrate substantial equivalence, rather than establishing specific acceptance criteria for performance metrics like accuracy, sensitivity, or specificity commonly seen in diagnostic devices. The acceptance criteria and supporting studies focus on safety, proper use by lay users, and observable clinical benefits relevant to its intended use for mild to moderate acne.

Here's an analysis based on the provided document:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Safety	Compliance with electrical safety standards IEC 60601-1, IEC 60601-1-2, and photobiological safety standard IEC 62471. Biocompatibility according to ISO 10993.	The Pulsaderm Acne Device "has been tested and found in conformance with test standards: IEC 60601-1, IEC 60601-1-2, and IEC 62471. Biocompatibility testing to ISO 10993." The device was "designed and developed under a quality management system conforming to ISO 14971," indicating a structured approach to risk management.
Proper Use by Lay Users	Lay users should be able to properly self-select for the device using box labeling and correctly use the device by following instructions in the user manual without assistance.	"100% of lay users were able to properly self-select themselves using the box labeling and 98% of lay users were able to properly use the device by reading instructions in the user manual without any assistance." Conclusion: an "average lay user can read and comprehend correctly the user manual and package labeling."
Clinical Effectiveness	The device should be able to significantly decrease the size and redness of facial acne lesions. This translates to a statistically significant reduction in lesion size and redness compared to baseline, specifically after 24 hours (for redness), 48 hours (for combined lesions), and one week (for lesion size, redness, and combined lesions).	"The Pulsaderm acne device significantly decreased lesion size and redness when compared to baseline. Treated lesions significantly decreased in size after one week. Patients saw a significant reduction in redness after 24 hours, 48 hours and one week. Subjects had significant reduction in combined lesions (redness and size) after 48 hours and one week." The data described indicates that the device met these clinical effectiveness criteria by demonstrating statistically significant improvements in the measured parameters over the specified timeframes. While raw data or specific statistical values (e.g., p-values, effect sizes) are not provided in this summary, the qualitative statements affirm that the device met these endpoints.
Substantial Equivalence	The device should have the same intended use, be as safe and effective, and employ similar technological characteristics (energy type, wavelength, etc.) as legally marketed predicate devices, with any differences not affecting safety or efficacy. The comparison table directly addresses this by showing similarities in intended use, energy type, OTC status, and similar wavelengths/dose rates/treatment schedules.	The document extensively argues for substantial equivalence by comparing the Pulsaderm Acne Device to three predicate devices (Tanda Mini Skincare System K124042, illuMask Acne Light Therapy Mask K123999, Omnilux Clear-U K081307). It states, "Pulsaderm Acne Device has the same intended use as the predicate devices... is as safe and (commensurate to number of diodes) effective as K124042... uses a combination of red and blue light as K123999 and K081307... has same treatment schedule as K124042." The comparison table supports that, despite some differences in dose rate and treatment schedule details, the overall technological characteristics are very similar. The conclusion is that "no significant differences exist between this device and the predicates."

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

Lay-user study (for proper usage): The document does not explicitly state the sample size for the lay-user study. It mentions the study was conducted to "determine if lay users could read the product labeling and then self-assess if the Pulsaderm acne device would be beneficial for them to use."
Clinical Study (for effectiveness): 26 male and female subjects
Data Provenance: Both studies were conducted with "Institutional Review Board (IRB) approval and oversight." This indicates a prospective study design. The country of origin of the data is not specified, but the submission is to the U.S. FDA, suggesting the studies were likely conducted in the U.S. or to international standards acceptable to the FDA.

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

Lay-user study: No experts were explicitly mentioned for establishing ground truth regarding proper usage. The "ground truth" here was the observed ability of lay users to follow instructions and self-select.
Clinical Study: An "expert clinical grading of facial lesion redness" was performed.
- Number of experts: Not specified.
- Qualifications of experts: Only "expert clinical grading" is mentioned. Specific qualifications (e.g., dermatologist, years of experience) are not provided in this summary.

4. Adjudication Method for the Test Set

Lay-user study: Not applicable. The assessment was based on direct observation of user behavior and self-assessment of selection criteria.
Clinical Study: Not explicitly stated. For "expert clinical grading," a single expert could have performed the grading, or multiple experts might have been involved without a specified adjudication method like 2+1 or 3+1. However, the summary does not provide these details.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a light therapy device, not an AI-powered diagnostic or assistive tool, so such a study would not be relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

This question is not applicable as the Pulsaderm Acne Device is a physical light therapy device, not an algorithm or software. Its performance is inherent in its physical emission of light, with the subject ("human-in-the-loop") being the direct recipient of treatment.

7. Type of Ground Truth Used

Lay-user study: The ground truth for proper use was established by observing user behavior against defined instructions and their self-assessment based on provided labeling.
Clinical Study:
- Lesion size: Measured by an "electronic caliper," which can be considered an objective measurement providing clinical ground truth.
- Redness: Established by "expert clinical grading," indicating expert consensus/assessment.
- Combined lesions: A combination of objective measurements and expert assessment.
- Consumer perception questionnaires: Used to gather subjective patient feedback, which is also a form of data collection in clinical assessment but distinct from objective or expert-derived ground truth.

8. Sample Size for the Training Set

Not applicable. The Pulsaderm Acne Device is a hardware medical device and does not involve AI or machine learning algorithms that require a "training set" in the computational sense. The studies described are performance validation studies for the device itself.

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

Not applicable for the reasons stated in point 8.

Summary

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.