(245 days)
The illuMask Acne Light Therapy Mask 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.
The IlluMask Acne Light Therapy device uses known LED light therapy technology for the treatment of mild to moderate acne. A combination of red light (630mm) and blue light (445nm) is emitted. Users place the lightweight mask over the face press the On button on the controller button to start treatment. The device will automatically turn off after each treatment, and there is a total of 30 treatments.
Here's a breakdown of the acceptance criteria and the study that demonstrates the illuMask Acne Light Therapy Mask meets these criteria, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list "acceptance criteria" as a separate table. However, it presents the "Treatment Period Results" as evidence of the device's efficacy, which effectively serve as the performance benchmarks the device achieved.
| Performance Metric (Implicit Acceptance Criteria) | Reported Device Performance (Treatment Period Results) |
|---|---|
| Decrease in inflammatory acne lesions | 82.8% decrease |
| Decrease in non-inflammatory acne lesions | 71.2% decrease |
| Improvement in acne severity (FDA Global Acne Severity Scale) | 50% improvement (median movement of 2 points) |
| Reduction in total acne lesions (independent doctor evaluation, Week 4) | 36% reduction |
| Reduction in total acne lesions (independent doctor evaluation, Week 8) | 65.8% reduction |
| Patient compliance, satisfaction, and questionnaire grading | Highly favorable |
| Serious adverse events | None reported |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Clinical Study: 30 patients were initially enrolled for both the Washout and Treatment Periods. 27 of 30 subjects completed each period.
- Usability Study: 35 participants.
- Self-Selection Study: 47 randomly selected participants.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It describes it as an "IRB (Institutional Review Board) approved 12-week clinical study," suggesting a formal clinical investigation. The Self-Selection Study was conducted "in a typical retail / shopping mall environment," implying a US-based setting given the context of FDA submission. The Usability Study was conducted by an "independent testing group." The studies appear to be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Clinical Study:
- Principal Investigator: Conducted in-person clinical grading for acne counts and FDA Global Acne Severity Scale, and recorded adverse events. Qualifications are not explicitly detailed but implied to be a medical professional ("physician investigator").
- Independent Doctors: Two independent doctors conducted physician grading on the clinical photographs. Their specific qualifications (e.g., "dermatologist with 10 years of experience") are not provided, but they are described as "independent doctors."
4. Adjudication Method for the Test Set
- For the clinical photographs, "an average of the two independent doctor evaluations" was used to report the reduction in total acne lesions. This suggests a form of averaging or consensus between two independent readers. The phrase "adjudication" is not explicitly used, but the averaging of independent readings serves a similar purpose.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The provided summary does not describe a formal Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The study described is a clinical trial evaluating the device's efficacy in treating acne, not comparing diagnostic accuracy or efficiency with AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The illuMask is a light therapy device, not an AI algorithm. Therefore, the concept of a "standalone algorithm" performance study is not applicable to this device. The clinical study assessed the device's direct therapeutic effect on patients.
7. The Type of Ground Truth Used
- Clinical Study Ground Truth: The ground truth for the clinical study was established through a combination of:
- Expert Clinical Assessment: In-person grading by the principal investigator using metrics like the FDA Global Acne Severity Scale and lesion counts.
- Expert Consensus on Photography: Two independent doctors evaluating standardized clinical photography in a blinded and randomized manner.
- Patient Self-Evaluation: Subjective assessments by patients on 14 attributes.
- Outcomes Data: Reduction in lesion counts and improvement in acne severity over time.
8. The Sample Size for the Training Set
The illuMask is a light therapy device, not a machine learning model. Therefore, there is no training set in the context of AI or algorithm development. The "training" in this context refers to the development and refinement of the physical device and its instructions, which was informed by the Usability and Self-Selection studies but not in the sense of an algorithm training set.
9. How the Ground Truth for the Training Set Was Established
As stated above, this device does not involve a machine learning algorithm, and thus, no ground truth for a training set was established. The Usability and Self-Selection Studies helped refine the device's instructions and packaging to ensure ease of use and understanding by the target audience, which could be considered an iterative design and development process rather than algorithmic training.
{0}------------------------------------------------
510(k) Summary for illuMask Acne Light Therapy Mask
1. Submission Correspondent
Emergo Group 611 West 5th Street, Third Floor Austin, TX 78701 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Robert Seiple, RAC. Sr. Consultant QA/RA
2. Date Prepared
12 December 2012
AUG 2 8 2013
Revised 27 August 2013
3. General Information
Trade/Proprietary Name: illuMask Acne Light Therapy Mask Common/Usual Name: Acne Light Therapy System Classification Name: Over-the-counter powered light based laser for acne' Classification Regulation: 21CFR 878.4810 Classification Panel: General and Plastic Surgery Product Code: OLP Device Class: II
4. Predicate Device
Omnilux Clear-U Acne Treatment System. Manufactured by PhotoTherapeutics, Ltd. Montgomeryville, PA 18936. K081307.
5. Device Description
The IlluMask Acne Light Therapy device uses known LED light therapy technology for the treatment of mild to moderate acne. A combination of red light (630mm) and blue light (445nm) is emitted.
Users place the lightweight mask over the face press the On button on the controller button to start treatment. The device will automatically turn off after each treatment, and there is a total of 30 treatments.
1 NOTE: OLP is the best description and closest match to this device uses LED light sources; there is no coherent (laser) light involved.
{1}------------------------------------------------
6. Intended Use
The illuMask Acne Light Therapy Mask 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.
7. Technological Characteristics and Substantial Equivalence
The following table compares the PhotoTherapeutics Omnilux Clear-U device (K081307) to the illuMask device with respect to intended use, technological characteristics, principles of operation and performance data.
| Trade Name | IlluMask Acne Light Therapy | Predicate Device -PhotoTherapeutics Ltd., OmniluxClear-U (K081307) |
|---|---|---|
| 510(k)Number | To be assigned | K081307 |
| Product Code | OLP | OLP |
| Indicationsfor Use | IlluMask Acne Light Therapy Maskis intended to emit energy in the redand blue region of the spectrum,specifically indicated to treat mildto moderate acne on the face. | The Omnilux Clear-U is intended toemit energy in the red and blueregion of the spectrum, specificallyindicated to treat mild to moderateacne on the face. |
| Over-the-Counter Use | Yes | Yes |
| Energy Type(Technology) | LEDs (Light emitting diodes) | LEDs (Light emitting diodes) |
| Wavelength(nm) | Blue light: 445nm | Blue light: 415nm |
| Red light: 630nm | Red light: 633nm |
Device Comparison Table
{2}------------------------------------------------
| Dose(J/cm^2) | ||
|---|---|---|
| Blue Light: 10.44 J/cm^2Red Light: 17.91 J/cm^2 | Blue Light: 10.46 J/cm^2Red Light: 21.31 J/cm^2 | |
| IEC 60601Compliant | Yes | Yes |
8. Non-Clinical Testing
This device is in conformity with IEC 60601-1 310 Edition electrical safety testing, IEC 60601-1-2 EMC testing and IEC 62471 photobiological safety testing.
Additionally, Usability and Self-Section Studies were conducted and demonstrated that the intended users of the device could successfully follow the instructions and use the device as intended.
The May 2013 Usability Study was conducted to provide a basis for the Company to gather data from the lay-person relative to level of understanding of what the device is, what the device does and how it works. This Study addressed the level of understanding of the layperson from three aspects:
-
- The Outer packing and box label
-
- The Instructions for Use (Manual included inside the packaging)
-
- The Use of the device by laypersons
The study was conducted by an independent testing group and enrolled a total of 35 participants, male and female, from 12 - 33 years of age. Each of the participants were provided the opportunity of reviewing the illuMask product and written information about the device followed by their actual using the device. The participants were asked to complete questionnaires regarding the labeling and use of the device and were observed/evaluated by monitors to assess their understanding of the device.
The Usability Study results demonstrate that the illuMask is easy to use by the layperson. The overall success rate for the participants in all areas of using the device was greater than 85.7%. The labeling accompanying the illuMask is easy to understand and was comprehended by the majority of the participants. The overall success rate for the participants in all areas of labeling was greater than 87.2%.
{3}------------------------------------------------
KI23999
The July 2013 Self Selection Study was conducted to evaluate the lay person's understanding of minor revisions to the external packaging i.e., clarification of mild, moderate and severe acne by the addition of graphics and the addition of Warnings / Precautions on the external labelling, etc. The participant demographics included a cross section of individuals representative of the US population which the illuMask is designed for. The study was conducted in a typical retail / shopping mall environment and included 47 randomly selected male and female shoppers ranging in age from 12 to 37 years.
The results of the study showed that 100% of participants found that the package labeling provided sufficient information for them to determine if the product was for them based on the presence, absence or severity of acne and that the information provided sufficient information for them to assess the warnings and risks of using the product.
9. Clinical Summary
An IRB (Institutional Review Board) approved 12-week clinical study was conducted with the illuMask Acne Light Therapy Mask to assess the safety and efficacy of the device in normal therapeutic use for the treatment of mild to moderate acne vulgaris. Note that the device was determined to be a non-significant risk (NSR) device by the governing, independent IRB based on guidance written by the FDA, titled "Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors Significant Risk and Nonsignificant Risk Medical Device Studies."
Inclusion criteria for the study stated that subjects be aged 14-40 and have 10 or more acne lesions with mild to moderate acne. There were no exclusion criteria for skin types as classified in the Fitzpatrick Classification Scale were included in the study.
A Treatment Period of 30 patients was studied and compared to a Washout Period of 30 patients. The same set of patients were followed for total of 12 weeks with the first 4 weeks being the Washout Period and the last 8 weeks being the Treatment Period. During the Washout Period, patients were given a basic facial cleanser to use in the morning and evening. None of these patients were exposed to any forms of treatment during the Washout Period: the illuMask device was not used. In the Treatment Period, subjects were only allowed to use the illuMask device and a basic facial cleaner in the morning and evening.
The principal investigator and patients recorded clinical outcomes using various matrices, including the FDA Global Acne Severity Scale, lesion counts, patient self-evaluations, standardized clinical photography, and documentation of adverse events over Baseline, Week 4, and Week 8 assessment periods. Additionally, two independent doctors conducted physician grading on the clinical photographs, which were evaluated in a blinded and randomized manner, over Baseline, Week 4, and Week 8 assessment periods.
{4}------------------------------------------------
Washout Period Results:
- . In the Washout Period, 27 of the 30 subjects completed the study. The three subjects who did not complete the study were due to lack of patient follow-through for reasons outside the study; no subjects were dropped because of adverse reactions or dislike of the product.
- . The Washout Period showed a 3.13% increase in total acne lesion count from the beginning to the end of the 4-week period. This difference was minor and not clinically significant. Thus, the Washout Period showed no difference in total lesion count.
Treatment Period Results:
- In the Treatment Period, 27 of the 30 subjects completed the study. The three subjects . who did not complete the study were due to lack of patient follow-through for reasons outside the study; no subjects were dropped because of adverse reactions or dislike of the product.
- . At the end of the 8 week Treatment Period, patients showed a 82.8% decrease in the number of inflammatory acne lesions, 71.2% decrease in the number of noninflammatory acne lesions, and a 50% improvement in acne severity in accordance with the FDA Global Acne Severity Scale, which corresponds to a median movement of 2 points. This clinical grading, including the acne counts, was conducted in person by the principal investigator.
- . Patient self-assessment for 14 attributes, including Appearance of pimples, Number of pimples, Appearance of redness associated with pimples and Size of pimples all showed continued improvement throughout the 8 week Treatment Period.
- . Additionally, an average of the two independent doctor evaluations of the clinical photographs showed at week 4, subjects showed a reduction of total acne lesions by 36%; and at week 8, a reduction by 65.8%.
In summary, patients experienced much greater decreases in total lesion counts in the Treatment Period than in the Washout Period at both Weeks 4 and 8. For the Treatment Period, improvements were noted across all clinical endpoints. Patient compliance, satisfaction and questionnaire acne grading were all highly favorable. There were no serious adverse events reported by the patients and the physician investigator.
10. Conclusion
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the
{5}------------------------------------------------
predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
We have shown in this 510(k) submission that the Company has found no significant differences between the illuMask device and the predicate device, and that the illuMask device raises no new issues of safety and effectiveness. The illuMask Acne Light Therapy Mask, as designed and manufactured, has been found to be substantially equivalent to the referenced predicate device.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and monochromatic.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Humpshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
August 28, 2013
La Lumiere, LLC % Emergo Global Consulting, LLC Robert Seiple, RAC 611 West 57" Street Austin, Texas 78701
Rc: K123999
Trade/Device Name; illuMask Acne Light Therapy Mask Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: OLP Dated: July 26, 2013 Received: July 29, 2013
Dear Mr. Seiple:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA`s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
{7}------------------------------------------------
Page 2 - Robert Seiple, RAC
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7 ! 00 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
FOR
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{8}------------------------------------------------
Indications for Use Form
510(k) Number (if known): K123999 Device Name: illuMask Acne Light Therapy Mask Indications for Use:
The illuMask Acne Light Therapy Mask 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Neil R Ogden. 2013.08.28 16:27:24 -04'00' (Division Sign-Ott) for MXM Division of Surgical Devices 510(k) Number K123999
§ 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.